ST HELENS & KNOWSLEY HOSPITALS NHS TRUST Policy v4 final.doc  · Web viewThe prescribing process....

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DOCUMENT NUMBER Version 4 (Final) APPROVING COMMITTEE Clinical Effectiveness Council DATE APPROVED July 2015 DATE IMPLEMENTED July 2015 NEXT REVIEW DATE June 2018 ACCOUNTABLE DIRECTOR Medical Director POLICY AUTHOR Head of Pharmacy TARGET AUDENCE All staff who have involvement with handling or use of medicines KEY WORDS Access the Medicines Resources Intranet site for information, policies, procedures & guidance on medicines including prescribing, the Formulary, administration, controlled drugs, storage, adverse drug reactions Click Here Important Notes: This Policy is designed for optimal use as an electronic document. It contains bookmarks and hyperlinks which will not function if the Policy is printed. Page 1 of 132 Medicines Policy (June 2015) Current version is held on the Policy section of the Intranet MEDICINES POLICY Document Summary Define the key aspects of safe & effective use of medicines including prescribing, supply and administration Define the Trust-approved practices relating to the safe & secure handling of medicines

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DOCUMENT NUMBER Version 4 (Final)

APPROVING COMMITTEE Clinical Effectiveness Council

DATE APPROVED July 2015

DATE IMPLEMENTED July 2015

NEXT REVIEW DATE June 2018

ACCOUNTABLE DIRECTOR Medical Director

POLICY AUTHOR Head of Pharmacy

TARGET AUDENCE All staff who have involvement with handling or use of medicines

KEY WORDS

Access the Medicines Resources Intranet site for information, policies, procedures & guidance on medicines including prescribing, the Formulary, administration, controlled drugs, storage, adverse drug reactions Click Here

Important Notes:

This Policy is designed for optimal use as an electronic document. It contains bookmarks and hyperlinks which will not function if the Policy is printed.

The Intranet version of this document is the only version that is maintained.

Any printed copies should therefore be viewed as “uncontrolled” and, as such, may not necessarily contain the latest updates and amendment

Page 1 of 93 Medicines Policy (June 2015)Current version is held on the Policy section of the Intranet

MEDICINES POLICYDocument Summary

Define the key aspects of safe & effective use of medicines including prescribing, supply and administration

Define the Trust-approved practices relating to the safe & secure handling of medicines

Minimise and control the risks to patients, the staff and the organisation associated with medicines

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CONTENTS

This Policy is designed to be used in electronic rather than print format

To aid the location of commonly asked questions, specific policy subsections have been bookmarked and listed in the contents section.

If the topic you are looking for is not listed in the contents tables: either go to the most relevant topic heading you and read the section Simultaneously press the ‘Ctrl’ and ‘F’ keys on your keyboard to display a FIND

dialogue box. Enter the term you are interested in and click NEXT. This will highlight each reference to the search term throughout the document

Ask a pharmacist or call Pharmacy Medicines Information on ext 1565

Item No. Subject (click hyperlinks to go directly to the section or contents sub-table)

Page No.

1 Scope 62 Introduction 63 Statement of intent 74 Definitions 75 Duties, accountabilities and responsibilities 76 Medicines Optimisation Strategy 97 Committees – Area Prescribing Committee, Drug & Therapeutics

Group, Medicines Safety Group9

8 Electronic prescribing & medicines administration system (ePMA) 99 Information sources on medicines (including patient information) 1110 Prescribing

(click to go to contents sub table)12

11 NICE technology appraisals and clinical guidelines 2812 Medicines Formulary 2813 Individual funding requests 2914 Antimicrobials 3015 Outpatient antimicrobial therapy (OPAT) 3016 Unlicensed medicines 3117 Clinical trial medicines 3218 Non-medical prescribing 3319 Transcribing 3720 Patient group directions (PGDs) 3821 Drug history taking and medicines reconciliation on admission 3922 Accuracy checking of prescriptions 4423 Procurement, Supply and Dispensing

(click to go to contents sub table)46

24 Homecare delivery of medicines 5625 Patients own drugs (PODs) 5826 Storage of Medicines 5927 Administration of Medicines

(click to go to contents sub table)60

28 Miscellaneous 65 Drug Incidents 62 Drug Defect Reporting Procedure 65

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Adverse Drug Reaction Reporting 65 Suspected Theft or Fraudulent Procurement of Medicines 66 Liquid nitrogen 67 Disposal of unneeded and expired medicines and waste 67 Leeches and maggots 68 Medical gases 68 Medicines-related policies, procedures and guidelines 68

29 Implementation of the Medicines Policy 6930 Training 6931 Monitoring compliance 7032 Counter Fraud Statement also LSMS 7133 References and bibliography 7134 Policy history 7235 Equality Analysis 7436 Appendicies 76

Appendix 1 Self Medication Policy 77

Contents sub-tables

10 Prescribing of Medicines 12Drug history taking and medicines reconciliation 39General principles of prescribing 12

Medicines optimisation & understanding patient experience 12Patient details & addressographs 13Age & Weight 13Names of medicines 13Doses & units 13Routes 14Frequency 14Abbreviations 14Blister packs 15

Inpatient prescribing 17Signatures & prescriber identity 17Multiple kardexes per patient 18Allergies, sensitivities & warning information 18When required (prn) prescribing 18Administration times 18Discontinuations 19Alterations 19Rewriting kardexes 19

Verbal prescriptions in emergencies 19

Discharge prescribing (TTOs) 21Outpatient prescribing 24FP10(HP) prescriptions 25Controlled Drugs (CDs) 26Cytotoxic chemotherapy & cytotoxics used for non-cancer indications 26Prescribing by staff for themselves, their families, those with 27

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whom they have close relationships, signed ordersPurchasing medicines for professional use 27Private prescriptions 27Non-medical Prescribing 33Transcribing of prescriptions by 5 th year medical students, pharmacy and other staff

37

Patient Group Directions (PGDs) 38Use of unlicensed medicines and use of medicinesfor unlicensed indications

32

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23 Procurement and Supply of Medicines 46Purchasing 46Procurement contracts 46Quality of purchased medicines 47Quality of unlicensed medicines 47Free samples of medicines 47Supply of controlled drugs (CDs) 47Supply of cytotoxic chemotherapy 47Supply of medicines for inpatients 48

Non-stock medication 49 Dispensing for discharge 49 Ward/Dept medicines stocks 49 Medicines optimisation & patient experience 50 Returning medicines 50

Dispensing discharge prescriptions (TTOs) 50Delivery of drugs, receipt of deliveries and collection from Pharmacy

52

Dispensing outpatients prescriptions 52Containers 53Emergency cardiac arrest boxes 54

Medicines required urgently and in emergencies 54

Over the counter medicines 55Aseptic Dispensing Unit 55Blister packs 15

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27 Administration of Medicines 60General principles of administration of prescribed medicines 60Medicines optimisation and patient experience 60

Non written prescriptions 60

Emergency situations 60

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Verbal prescriptions By telephone 61 Patient Group Directions (PGDs) 61 Homely remedies 61

Use of patients own medicines 61Self-administration of medicines 62

Supervised self administration 62 Security of self-administered medicines 62 Rescue medicines 62 Symptom relief medicines (low risk) 62 Independent self-administration 62 Non-approved self-administration 62

Covert administration of medicines 63Administration of cytotoxic chemotherapy 63Supply of discharge prescription medicines (TTOs) to patients on wards

64

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1. SCOPE

Aims of the policy

The aims of the Medicines Policy are to:

Define the Trust-approved practices relating to the safe and secure handling of medicines for all staff involved in the handling and use of medicines.

Minimise and control the risks to patients, the staff and the organisation associated with medicines

Provide a auditable standards for medicines optimisation

Policy description

This Policy provides information and guidance to staff involved with prescribing, supplying and administering medicines.

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2. INTRODUCTION

All Trusts are required to have a Medicines Policy to ensure the safe and secure handling of medicines.

The Policy should be read by all individuals who are involved with medicines within the Trust. The scope of the Policy is very broad, including most aspects of medicines handling eg. prescribing, ordering, supply, transport, storage, administration. The Policy may be used during the induction of new staff and also as a general reference source. It should be used in conjunction with other relevant Trust policies, procedures and guidance eg. Medicines Formulary, Emergency Prescribing Guide, Noddy’s Guide (Paediatrics), Antibiotics Policy, ‘Clinical policies, procedures, protocols and guidance’.

Access to the Medicines Policy and other key references, procedures and guidelines relating to medicines within the Trust is recommended via the Medicines Resources Intranet site. This is accessible from the Home page of the Trust intranet by clicking the STHK MEDS logo.

click to access the Medicines Resources Intranet Site

Key documents underpinning this Policy include legal and professional references: The Medicines Act 1968 and subsequent amendments The Misuse of Drugs Act 1971 and subsequent amendments The Safe and Secure Handling of Medicines – A Team Approach (RPSGB 2005) Good practice in prescribing medicines – guidance for doctors (GMC 2013) Standards for Medicines Management (NMC 2010) Medicines, ethics and practice – a guide for pharmacists (RPSGB 2014) British National Formulary (RPSGB & BMA Sept 2014) BNF for Children 2014-15 (RPSGB, BMA, RCPCH)Page 6 of 93 Medicines Policy (June 2015)

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The Best Medicine: The Management of Medicines in Acute and Specialist Trusts (HCC 2007)

NICE National Guideline – Medicines Optimisation (NICE March 2015)

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3. STATEMENT OF INTENT

The safe, secure and cost-effective management of medicines within the Trust in accordance with legal, professional, regulatory and advisory standards. Relevant processes are defined and guidance is provided for key topics including: Prescribing Checking the accuracy of prescriptions Supply of medicines Administration of medicines Patient self-administration Storage and security of medicines Adverse drug reactions Disposal of unneeded medicines Monitoring compliance with the above

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4. DEFINITIONS

Abbreviations are clarified within the body of the document. The following are commonly used terms:

Drugs - Prescribed medicinesKardex - Inpatient prescription chartNMP – Non-medical prescriberPODs - Patients’ own drugsPrescribing - To authorise, by means of a prescription, the supply or administration of a medicine to a named patient. Registered Practitioner - When used alone, refers to registered nurses, midwives and operating department practitioners

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5. DUTIES, ACCOUNTABILITIES AND RESPONSIBILITIES

Chief ExecutiveThe Chief Executive has overall responsibility for the strategic and operational management of the Trust including and ensuring that the Trust complies with all legal, statutory and good practice requirements

Medical DirectorThe Medical Director is accountable to the Trust Board for providing assurance of compliance with this Policy in all parts of the Trust and ensuring that the Policy is reviewed and updated by the specified review dates.

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Head of PharmacyThe Head of Pharmacy has delegated responsibility for reviewing and revising this Policy. He/she has responsibility for ensuring operational implementation and associated monitoring of compliance with the Policy.

Chairperson of the Drugs and Therapeutics Group (DTG)The DTC is the approving committee for the Medicines Policy. The Chairperson must complete and sign the checklist for the review and approval of policy documents when the committee agrees. The chairperson must ensure the minutes accurately reflect discussion and approval of the Policy.

Chairperson of the Medicines Safety Group (MSG)The MSG functions in parallel to the DTG and promotes the reduction of risk associated with medicines, including storage, security and drug administration. The Chairperson and supporting staff will ensure effective working in partnership with the DTG.

Director Nursing, Midwifery and GovernanceResponsibility to ensure that nursing and midwifery staff are aware of and comply with the relevant sections of the Medicines Policy.

Divisional and Clinical DirectorsResponsibility to ensure medical staff that they line manage comply with the Medicines Policy within their directorates.

Directors, Assistant Directors of Operations, Directorate Managers, Department HeadsResponsibility for ensuring staff they line manage comply with the Medicines Policy

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6. MEDICINES OPTIMISATION STRATEGY

The Trust’s Medicines Optimisation Strategy 2014-18 provides medicines-specific aims and objectives which support the Trust’s aims & objectives, the Trust Clinical & Quality Strategy, the Nursing & Midwifery Strategy and other requirements eg. NICE, CQC, NHSLA, TDA etc.

This Strategy can be accessed on the Medicines Resources Intranet site via this link

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7. COMMITTEES – DRUG & THERAPEUTICS GROUP AND MEDICINES SAFETY GROUP

Within the Trust there are two multidisciplinary, specialist groups with responsibility for medicines:

Drug & Therapeutics Group (DTG, formerly called Drug & Therapeutics Committee DTC) Medicines Safety Group (MSG)

The roles of the DTG include management of the Joint Medicines Formulary, consultation/review/approval of Pan-Mersey APC recommendations, antibiotics, medicines-related guidelines & policies, PGDs, drugs expenditure. The DTG reports to the Clinical Effectiveness Council.

The roles of the MSG include review of medicines incidents, drug safety & security, medicines administration, controlled drugs, medicines safety initiatives. The MSG reports to the Patient Safety Council.

Both Groups may be contacted via the Head of Pharmacy.

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8. ELECTRONIC PRESCRIBING & MEDICINES ADMINISTRATION SYSTEM (ePMA)

The Trust will commence implementation of the JAC ePMA, electronic prescribing and medicines administration system during 2015. This will be rolled out across the Trust in an incremental manner and is intended to eventually manage the majority of medicines prescribing and administration within the Trust. The implementation of the system is being managed by the multidisciplinary, clinically-led ePMA Project Board. The Chair of the Project Board is a member of consultant medical staff nominated by the Medical Director.

Instruction provided in the Medicines Policy regarding prescription documents, handwriting, abbreviations, signatures etc will not apply within the ePMA environment. However, the principles of prescribing, supply and administration of medicines described in this Policy will remain relevant and applicable even though the appearance of the prescriptions will change.

All medicines-related policies, procedures, guidelines etc with content regarding current paper-based prescription documentation will be reviewed and updated in due course. In the interim, prior to update, clinical staff are authorised to apply the requirements of legacy Page 9 of 93 Medicines Policy (June 2015)

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policies to the equivalent actions within the ePMA environment eg. record administration of a drug in the electronic record rather than the old, card inpatient kardex.

During roll-out and development of the system capability, certain prescribing and administration functions may not be possible within the ePMA environment eg. oxygen, and complex intravenous infusions. In such cases, the medicine must still be prescribed on ePMA but in the dose instructions it will specify that the details for dose administration are as prescribed on a specialist card prescription sheet.

As with other clinical record and clinical informatics systems, adherence to Trust Information Governance requirements including security, confidentiality and accuracy is mandatory for all staff using the ePMA system.

Management of the ePMA system will be conducted by authorised staff from Health Informatics and Pharmacy.

Existing Trust working groups with an interest in medicines will review and approve changes to the ePMA system relating to the clinical use of drugs. This will include the Drug & Therapeutics Group and the Medicines Safety Group.

There will be a systematic approach to developing decision support within ePMA, reducing risks by applying lessons learned from incidents and feedback.

A balance will be maintained between interaction with system users through pop-up messages, mandatory fields and usability.

Wherever suitable, the most common doses, routes and frequencies will be pre-filled for drugs within the ePMA database.

Tall man lettering and the National dm+d drugs dictionary will be used wherever possible when setting up drug files.

The ePMA software and supporting hardware is designed to support prescribing & drug administration within the clinical environment. Medicines administration to inpatients on wards will be recorded on ePMA using computers on medicines trollies in a similar manner to the historical use of inpatient kardexes.

A medicine may only be recorded as administered on ePMA after it has been administered to a patient, NOT before.

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9. INFORMATION SOURCES ON MEDICINES (including patient information)

Good quality, up to date information is essential for the safe and cost-effective use of medicines. Increasingly, major reference sources are being published electronically and the circulation of paper, hard-copy editions is being reduced. It is essential that out-of-date information is not used for the care of patients. The web versions of major reference sources are updated continuously whereas print copies may only be updated less often. As a result, it is becoming preferable to use the web reference sources.

Within the Trust, the Medicines Resources intranet site has been created to provide easy access to key information about medicines. The site includes readily accessible links to the web versions of key reference sources on medicines such as the BNF, BNF-C, Electronic Medicines Compendium and Medusa. The intranet site also includes extensive links to policies, procedures, guidelines, local & national guidance, the Pan Mersey Formulary, professional standards, patient information etc.

Click this link to access the Medicines Resources intranet site

Increasingly, key reference sources are available as apps for smartphones and tablets. These can be highly useful. Caution is advised to users of apps to ensure that they are high quality and up to date. The following apps are recommended:

BNF British National FormularyBNF-C BNF for ChildreneMC Electronic medicines compendium – contains manufacturers’ summaries

of product characteristics for most UK-licensed medicines. Also contains patient information leaflets and other information such as videos on use of devices eg. inhalers

Mersey Micro St Helens & Knowsley Teaching Hospital’s award winning, MHRA CE-approved app for our Trust antibiotics guidelines

Within the new electronic prescribing system (ePMA) decision support information is provided by First Data Bank (FDB). FDB is an international leader in medicines information and their electronic databases are extensively used with many electronic clinical systems both in primary and secondary care.

Other sources of information include advice from peers, senior clinical staff, ward pharmacy staff, on-call pharmacists

Pharmacy provides a Medicines Information helpline within the Trust. This is available on ext 1565 or 0151 430 1565 (direct line)

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10.PRESCRIBING OF MEDICINES

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General principlesInpatient prescribingDischarge prescribingOutpatient prescribing

GENERAL PRINCIPLES OF PRESCRIBING

All medicines intended to be administered to a patient under the care of the Trust must be prescribed by an authorised prescriber on an official Trust prescription document, except in strictly defined circumstances eg. under the terms of a PGD, midwives.

The GMC guidance document – ‘Good practice in prescribing and managing medicines and devices’ underpins prescribing practice and the Trust supports prescribing in accordance with these principles.

Should anyone be found to have prescribed drugs without authority then this may be construed as Fraud and the matter should be referred to the Trust’s Local Counter Fraud Specialist to investigate.

Medicines optimisation – understanding the patient’s experience Up to 50% of patients do not take their medicines as recommended. To ensure the best possible outcome from medicines, there must be an ongoing, open dialogue with the patient and/or their carer(s) about the patient’s choice and experience of using medicines to manage their condition. It must be recognised that a patient’s experience may change over time even if their medicines do not.

The prescribing process

i. Decision is made to prescribe a medicine for the treatment of a patient by an authorised prescriber

ii. Only official Trust prescription documentation can be used (paper or electronic)iii. If completing the prescription in handwriting, use indelible black ink and write clearlyiv. Include the patient’s name, address, hospital or NHS number on the prescription (or

use and addressograph label). Include other details such as date of birth and weight when required

v. Specify the location/cost centre from which the patient is being treated eg. ward number, clinic speciality

vi. Specify the name of the consultant responsible for the patient’s carevii. Specify the drug name, dose, route and frequency for each medicine prescribed.

Include duration and other details as relevant.viii. The prescriber must sign, print their name & contact details and date the prescription

(or authorise electronically for e-prescriptions)

Definition of prescribing - to authorise, by means of a prescription, the supply or administration of a medicine to a named patient. Page 12 of 93 Medicines Policy (June 2015)

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Official Trust Prescription Documents – these include inpatient prescription kardexes/charts, outpatient prescriptions, discharge prescriptions (TTOs), anaesthetics record sheets, ICU & HDU Drug Prescription Chart. The Trust Drug and Therapeutics Group must be consulted about proposed changes to prescription documents. A selection of the most commonly used Trust prescription types may be viewed via this link.

The clarity of a prescribing instruction is the legal and professional responsibility of the prescriber. The prescription must be legible and it must not be open to variability in interpretation. The Trust considers that failure to prescribe clearly is a matter of professional misconduct.

Patient details & addressographs. Addressograph labels must be placed on all prescription sheets. These give full identification details for patients and also a bar code. These details should only be handwritten in exceptional circumstances when addressographs are not available. If the details are handwritten, the patient’s name must be written in full.

Patient’s age and weight. These details are necessary on prescriptions for children and also for many adults.

Consultant and cost centre details. Details of the consultant, ward/clinic/dept must be written on all prescriptions.

Name of the medicine must be written clearly in indelible ink using approved names when possible. Proprietary names (ie. brand names) must not routinely be used. Exceptions include multi-ingredient preparations with no approved names or products whose proprietary names define a specific formulation (eg. slow–release theophylline and morphine preparations). Patients with sensitivities to particular excipients may benefit from proprietary names being specified.

Doses and units . The dose must be prescribed using S.I. units using weights whenever possible.

Decimal points should be avoided, for example 500mg should be prescribed instead of 0.5g. If a decimal point is unavoidable eg. for digoxin doses, great care must be taken by both the prescriber and the nurse administering the drug. The terms microgram and nanogram must not be abbreviated but must be written in full and used for quantities less than one milligram. Only approved abbreviations are acceptable.

When the dose of a drug is expressed in units eg. insulin and heparin, the term ‘units’ must be written in full and not abbreviated.

The dose required should not be expressed in terms of the number of tablets/capsules/spoonfuls. For example “Atenolol 2 tablets” is unclear as there are 3 strengths of tablets. It should be written as “Atenolol 100mg tablets”

Drugs which are to be administered via the intravenous route should state the doses and the diluent to be used including the amount. Details of the duration of administration should also be specified. eg. clarithromycin 500mg diluted in 250ml of 0.9% sodium chloride and infused over 1 hour. The Electronic Medicines Compendium or the Medusa database provides this information.

It is not practical to prescribe some medicines by specific weight or volume eg. creams, eye drops. In such cases the prescriber should be as specific as possible about the dose eg. instil 2 drops, apply sparingly to the hands.

Routes of administration Page 13 of 93 Medicines Policy (June 2015)

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Routes must be clearly indicated to avoid misinterpretation of the intentions of the prescriber. Only the approved abbreviations are acceptable.

Frequency of administration Frequency must be clearly indicated to ensure that doses are administered at the correct times. Only approved abbreviations for frequency may be used

Abbreviations

Drug names – Do not use abbreviations for drug names as this increases the risk of error. eg. ISMN, KCl, NaCl. The only exception is the use of GTN as an abbreviation for glyceryl trinitrate.

Dose abbreviations. The following abbreviations are acceptable

QUANTITY APPROVEDABBREVIATION

milligram mggram g

kilogram kglitre L

millilitre mlmillimole mmol

Route abbreviations. The following abbreviations are acceptable

ROUTE APPROVED ABBREVIATION

Intramuscular IMInhalation INH

Intravenous IVNasogastric NGNebulised NEB

Percutaneous Endoscopic Gastrostomy

PEG

Oral PORectal PR

Subcutaneous SCSublingual SL

Topical TOPVaginal PV

ALL OTHER ROUTES MUST BE WRITTEN IN FULL

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Frequency abbreviations and other instructions. The following abbreviations are considered acceptable when writing discharge or outpatient prescriptions

Abbreviation Meaning of Abbreviation

ac Before foodbd Twice dailye/c Enteric coatedhs At bedtime

mane In the morningnocte At night

od Dailyom In the morningon At nightprn When requiredPc After foodqds Four times dailyq8h Every 8 hoursqqh Every four hourssos When necessary

STAT One-off dosetds Three times a daytid Three times a day

Child resistant containers (CRCs) eg. clic-lock caps are used routinely on discharge and out patient prescriptions. If CRCs would be difficult for the patient to open, then plain tops will be provided if the prescriber writes NO CRC on the prescription. If this is not specified by the prescriber, but clinical staff (eg. nurse, pharmacist) judge that CRCs are inappropriate, the prescription should be endorsed and signed to indicate that CRCs are not required.

Documentation in medical records. Details of new medicines, discontinued medicines and changes to existing treatments should be documented in the patient’s medical records. It is good clinical practice to document the rationale eg. indication for treatment, discontinued due to side effects etc. The intended plan of treatment should be indicated eg. duration, review, monitoring etc.

Blister packs . If compliance is thought to be a problem the Pharmacy will, if appropriate, provide blister packs.

The Pan Mersey Local Professional Network for Pharmacy has issued a guidance document to support appropriate use of blister packs. This emphasises the importance of a holistic approach to patient management when blister packs are being considered including handover and continuation of use in primary care. There are many blister pack systems available and unless a community pharmacy provider continues care using the same devices issued in hospital, this could lead to unintended patient confusion. This is impractical and in many cases it may be better to arrange for the patient’s GP to arrange a prescription for blister packs from the patient’s regular community pharmacy than to make the supply from hospital. Click here to access the Pan Mersey Pharmacy LPN guidance document on blister packs.

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The doctor should clearly annotate the prescription ‘BLISTER PACKS’. Not all drugs are suitable for blister packing (speak to your ward pharmacy staff or Pharmacy Medicines Information for advice).

For outpatients or patients being discharged, consideration must be given to the continuation of the blister packing in primary care.

Because of the time taken to prepare dispense a prescription into blister packs, 24 hours notice is required except in exceptional circumstances. The blister packing service is not available at weekends.

The likelihood of children coming into contact with the medicines contained in a blister pack should be considered and advice given.

Medicines Formulary. Prescribers must prescribe in adherence with the Trust’s Medicines Formulary. Click this link to go to the Policy section on the Formulary

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INPATIENT PRESCRIBING

The general principles for prescribing apply as described earlier in this Policy

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Drug history on admission and medicines reconciliation). Click here to go to the section on medicines reconciliation on admission

Inpatient prescription documents include the inpatient prescription kardex, anticoagulation prescription, anaesthetic chart, intensive care prescription, ChemoCare e-prescriptions, JAC ePMA prescriptions.

The function of the inpatient prescription kardex (and other inpatient prescription charts) is: To provide a permanent record of the patient's medication To indicate the patient’s medicine sensitivities/allergies To facilitate the supply of the correct medicines from Pharmacy To direct the administration of medicines to the patient To record the administration of medicines

A new inpatient prescription kardex (chart) must be written for each new admission of an individual patient. It is not necessary to rewrite prescriptions for patients who have been on short term leave from the ward eg. cytotoxic chemotherapy patients on weekend leave.

Patient details. The patient’s name (written in full), hospital number, date of birth, ward and the name of the consultant must be entered on the front of each medicine kardex. An addressograph label is recommended.

Weight should be accurately recorded in kilograms (kg) on the inpatient medicines kardex and clinical record. For paediatric patients and those on drugs with weight dependant doses, the weight must be entered. Signatures & prescriber identity . All prescriptions must be signed (with name & contact details printed in the section on the front of the kardex) by one of the following: A registered medical or dental practitioner Provisionally registered medical or dental practitioners carrying out prescribing activities

relating to their duties as foundation stage trainees A non-medical prescriber authorised to prescribe within the Trust

Click here to view a memo giving illustrated instruction on signatures and prescriber identity

Medical students employed as “locums” in the absence of FY1 foundation stage doctors ARE NOT allowed to sign prescriptions.

Should anyone be found to have prescribed drugs without authority then this may be construed as Fraud and the matter should be referred to the Trust’s Local Counter Fraud Specialist to investigate. Page 17 of 93 Medicines Policy (June 2015)

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Multiple kardexes . When a patient requires more than one kardex, the number of kardexes should be clearly stated on each kardex .

Allergies, sensitivities, intolerances and other important warning information Details of any allergies must be recorded in the designated section on the front of the

medicines kardex. If the patient has no known allergies then this must be indicated using the approved abbreviation NKDA (no known drug allergies). This must also be entered on subsequent prescription sheets. The absence of allergy documentation leads to delays in the administration of medicines as clinical staff need confirm if it is safe to administer them.

Other factors relevant to the safe prescribing and administration of medicines such as intolerances, insensitivities, renal or liver impairment, pregnancy, special diet or disability eg. blindness should also be indicated on the kardex.

If inappropriate or impractical to enter such details on the kardex, a note on the kardex to direct other health professionals to details in the medical notes should be provided.

Date. The date upon which treatment is to commence must be written for each drug newly prescribed. When a kardex is rewritten, the date that the drug was initially started should be entered in the date section (not the date that the kardex was rewritten).

Validity. The prescription will be considered valid until cancelled by the prescriber, the administration section is full or the patient has been discharged.

Duration. All prescriptions for antibiotics must have a review date or course duration specified. Course duration for other relevant drugs should be also specified eg. ‘for 5 days’, ‘for 9 months’. This may be reinforced by crossing off the days on which treatment should not be given in the administration section of the kardex. This Policy requirement is audited for antibiotics and other drugs specified in CQUIN requirements and the Pan Mersey APC Formulary recommendations eg. atorvastatin, clopidogrel, PPIs.

All current medicines need to be written on the prescription sheet, including details of oxygen therapy, irrigations, parenteral nutrition and dressings supplied by Pharmacy, iv line flushes all of which are prescription only medicines. Dieticians may add dietary supplements to the prescription sheets. Cross-reference must be made on the prescription chart to other drugs prescribed on separate charts eg. anticoagulants, cytotoxics and dialysis fluids

When required (PRN) medicines . For prn medicines which can be administered by multiple routes depending upon patient needs, it may be clearer to prescribe the drug once on the kardex but to indicate the prescribed routes eg. O/IV. This is only appropriate when the doses by each route are the same eg. metoclopramide. If the doses by each route are different eg. prochlorperazine, each route required must be prescribed individually.

Guidance on the frequency of administration of prn medicines must be indicated and a maximum dose in 24 hours specified if applicable eg. “metoclopramide 10mg PRN” is not adequate. It should be “metoclopramide 10mg every 6 – 8 hours PRN, MAX 30mg in 24hours.”

Times of administration . For ‘regular medicines’ the prescribing times should be in accordance with regular medication rounds wherever possible. Care should be taken to space the doses evenly especially in the case of vancomycin and enoxaparin and modified release opioid preparations. Consideration should also be given to the time of administration and the timing of samples for therapeutic drug monitoring eg. warfarin,

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digoxin.

Discontinuing medicines The date of discontinuation must be entered into the “finishing date” box The entry must be initialled by the prescriber discontinuing the medicine A diagonal line should be drawn through the prescription so that its cancellation is

obvious, but the prescription should not be obliterated Incorrect entries must be scored through and the word ‘cancel’ written against them by

the prescriber and signed Medicines prescribed on separate charts eg. warfarin must be discontinued on both

documents Click here to view an illustrated guide to discontinuing medicines

Altering prescriptions If a prescription for a medicine requires alteration (eg. changed dose, frequency or

route) it should be discontinued as detailed above and rewritten. This is essential to maintain an accurate record of changes to a patient’s treatment and

also to prevent fraud.

Re-writing of Prescriptions CAUTION – the transcribing of information from one prescription sheet to another

is the most common cause of prescribing errors. Prescription sheets must be re-written when they become untidy especially after several

medications have been stopped and/or changed. When re-writing prescriptions, the prescriber must ensure that the dates entered relates

to the date when the therapy commenced and not the date of re-writing. It should be indicated on the prescription that the treatment has been reviewed. The date of re-writing should be recorded on the top right hand corner of the front of the prescription sheet.

Verbal prescriptions in emergencies and prescribing by telephoneIn the interest of patient safety, prescriptions must not be given or accepted over the telephone, except in an emergency (see section on non-written prescriptions). Telephone orders will NOT be accepted by Pharmacy.

Process for ensuring the accuracy of all prescription chartsClick this link to go to the section on accuracy checking of prescriptions

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DISCHARGE PRESCRIBING (TTOs)

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The general principles for prescribing apply to discharge prescriptions written on the ICE electronic discharge system (and also the hard-copy TTO form for areas authorised to use this). When JAC ePMA electronic prescribing is rolled out, TTOs will be written using ePMA.

The function of the discharge (TTO) prescription is primarily: To facilitate the supply of the correct medicines from Pharmacy To provide a record of medicines supplied on discharge for the medical notes To provide a list of current medicines treatment to the GP for the purpose of handover of

care and continuation of treatment Essential information should be communicated on the discharge prescription to facilitate

safe transfer of care. This is particularly important for medicines where this information is required to ensure that future doses are safe, such as dose, weight, renal function, indication and duration of treatment eg. prescriptions for enoxaparin, reducing courses of steroids, warfarin, antibiotics, clopidogrel, proton-pump inhibitors, ticagrelor

TTO documents. All discharge prescriptions must be written on a Trust-approved discharge prescription form. Whenever possible this will be through the ICE electronic discharge system. The only exception at the time of writing this Policy is for Obstetrics who write discharge communications using the Medway system.

TTO authorisation & signatures. TTO prescriptions may only be electronically submitted (or signed & dated) by one of the following: A registered medical or dental practitioner Provisionally registered medical or dental practitioners carrying out prescribing activities

relating to their duties as house officers (FY1) Non-medical prescriber authorised to prescribe within the Trust

Medical Students. Medical students employed as “locums” in the absence of FY1 foundation stage doctors ARE NOT allowed to sign or authorise prescriptions

Date and time of discharge. The date and time of discharge should be specified on the TTO. This is done automatically on ICE.

Multiple TTO sheets for individual patients. If more than one TTO sheet is required for a patient eg. when on many medicines, the number of sheets should be indicated clearly on each sheet eg. 1 of 2, 2 of 2 or on the appropriate section of the TTO.

Additional TTOs. If an additional TTO is submitted after the original TTO has been authorised and dispensed, it is essential that the TTO is clearly endorsed ‘additional TTO’ to advise pharmacy and nursing staff to ensure that all medicines are supplied when the patient is discharged. If a controlled drug (CD) prescription on ICE, the CD must be prescribed in full on ICE and also prescribed on a green CD TTO prescription. With ICE, the ‘see CD prescription’ option in the Pharmacy Notes box should be selected.

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All medicines should be prescribed. The prescriber should prescribe every medication that the patient is taking and not just those that need to be dispensed for discharge. Where supplies are not required this should be indicated if known. Exception to this recommendation is acceptable when a patient has been admitted for a very short stay eg. over-night, GPAU, Acute Medical Unit. In such cases the TTO should document that there have been no changes to the medicines on admission. If there are changes follow the instructions in the next section below.

Changes to medicines during an admission. Details of any changed or discontinued medicines should be provided on the discharge summary form if possible (this will be prompted on the new electronic discharge system). The prescriber should be clear whether a medicine is being stopped or withheld. If withheld, when it is to be restarted? Include any instructions necessary (such as blood tests) for restarting the medicine eg. in patients with Acute Kidney Injury

Advanced planning for TTO prescribing is essential to avoid discharge delays The multi-disciplinary team has a key role to play in discharge planning. Doctors are responsible for ensuring that TTO prescriptions are written giving Pharmacy

sufficient time to dispense and return them to the ward without delaying discharge. This is particularly important for complex prescription requirements eg. blister packs.

Prescriptions received in Pharmacy after 3.30pm may not be received back on wards until after 6pm, leading to delayed discharge and inconvenience.

Process for accuracy checking of TTO prescriptions. Please refer to section 2.1 for general requirements for accuracy checking. TTO prescriptions should be checked against inpatient kardexes by a pharmacist for any

transcribing errors before dispensing On wards where there is a regular ward pharmacist and/or pharmacy technician service

the TTO prescription should be retained on the ward until the ward pharmacist can check it for correctness against the kardex. This avoids the need for the kardex to leave the ward. Many wards have access to pharmacists and pharmacy technicians via a designated bleep which can be used to inform them that a newly written TTO is ready for checking.

If TTOs are written after a scheduled pharmacist/technician visit or there is no scheduled visit, the ward is required to send their TTOs to Pharmacy along with the corresponding medicines kardexes. TTOs cannot be dispensed unless they are checked against the kardex for correctness. Upon receipt in Pharmacy, a pharmacist will check the TTO against the kardex and arrange for the kardex to be returned to the ward as soon as possible via the Pharmacy porters.

Out of hours TTOs. Good planning can minimise the need for TTO dispensing during evenings and weekends. This also ensures that the TTOs are thoroughly reviewed for safety, quality and whether supplies need to be dispensed. Targeted TTO dispensing service for urgent patients is available on weekend afternoons. This is co-ordinated by the site manager/bed manager. Check with the ward, operational services or Pharmacy for current Pharmacy service availability for TTO dispensing outside of normal hours.

A number of wards have the facility to use pre-labelled medicines to support out of hours discharges. These include the Acute Medical Unit, Surgical Admissions Unit, Paediatrics, Maternity Unit. Guidance is in place in these areas to support the safe use of this facility. In an emergency, the on-call pharmacist can provide advice.

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Discharge prescription supply quantities Patients will receive a minimum of 14 days supply of regular medicines on discharge

(more will be given to cover public/bank holidays). For very short admissions eg. an overnight admission, if the patient has more than 7

days of their own regular drugs a further supply of these from Pharmacy will not usually be made. However, in most cases Pharmacy will supply medicines in manufacturers’ original packs which usually contain 28 days’ supply of medicines.

When suitable, Pharmacy may supply inpatients with original packs of non-stock medicines, devices, topical medicines, calender packs etc fully labelled with instructions for use. This is termed dispensing for discharge (or one-stop dispensing OSD). These medicines can then stored in the locked cabinet by each patient’s bed.

Dispensing for discharge is used in conjunction with utilisation of patients own drugs (PODs) if these are available and suitable for use.

When the decision to discharge the patient is made most, if not all, of their medicines will be ready dispensed on the ward in a form suitable for patients to take home.

With good organisation and planning, this minimises the delays inherent in dispensing all of the TTO medicines on the day of discharge.

Only 7 days will be supplied on discharge for monitored dosing systems such as blister packs.

A minimum of 14 days’ supply (when appropriate) will be supplied (except for very short admissions as explained above) or for blister packs.

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OUTPATIENT PRESCRIBING

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The general principles for prescribing apply apply for outpatient prescriptions. When JAC electronic prescribing (ePMA) is rolled out, outpatient prescribing will always be via e-prescribing where possible.

The outpatient prescription enables the legal supply of medicines from the hospital Pharmacy only. They cannot be dispensed by community pharmacists in primary care on the NHS.

Is there a need to prescribe? Prescribers are asked to consider if it is always necessary to prescribe for individual outpatients. They should not prescribe to replenish GP-prescribed medicines which the patient is running short of. If a treatment is not urgent and is for a non-specialist drug, consideration should be given to writing to the patient’s GP requesting that they initiate the recommended treatment. This has the advantage of reducing waiting times in the outpatients pharmacy and also reducing confusion for patients (as community pharmacist dispensed medicines may differ considerably in appearance from brands used in hospital). Recommended treatments must still comply with the Formulary.

Outpatient prescription documents & prescription pad security. All prescriptions must be on the Trust-approved outpatient prescription sheets or where appropriate the green FP10 (HP) prescriptions. Both types of prescription are controlled stationary and may only be ordered from Pharmacy by authorised staff. Collection of supplies of pads must be signed for. Stocks of prescription pads within clinical areas must be stored securely. In-use pads must be managed securely and always locked away when not in use.

Prescribers authorised to sign outpatient prescriptions. Only the following staff can sign outpatient prescriptions: Registered medical or dental practitioner A non-medical prescriber authorised to prescribe within the Trust

Pre-registration FY1 foundation stage doctors and medical students employed as “locums” in the absence of FY1s ARE NOT allowed to sign outpatient prescriptions

Quantities of supply. 28 days supply will be dispensed unless circumstances dictate that a different supply is necessary. This includes: Antibiotics - 7 days unless otherwise specified Short term analgesics - original packs A&E prescriptions - 7 days unless otherwise specified Hospital only medicines – these cannot be prescribed by General Practitioners Clinical Trial medicines Pulsed/cyclical treatment Antidepressants prescribed by consultant psychiatrists to ensure continuity of treatment Reducing/ increasing doses of drugs e.g. steroids Drugs for tuberculosis treatment Haematology treatment Drugs with shared care agreements (e.g. donepezil, riluzole)

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Drugs to ensure continuous supply over public/bank holiday Anticoagulants

Process for ensuring the accuracy of outpatient prescriptionsPlease refer here for details regarding accuracy checking

FP10(HP) prescriptions

a) A restricted number of clinics/prescribers are provided with FP10 (HP) prescription pads. These are normally for use ‘out of hours’ or for outreach clinics to allow patients to obtain medicines from community pharmacists, where it would be of great inconvenience to the patient insist on supply from the hospital pharmacy.

b) FP10 (HP) prescription forms are only to be used for registered out-patients to take to outside pharmacies. Green FP10(HP) must not be used to order food or toilet articles and other prescriptions which are not drugs or appliances other than those specified in the drug tariff

c) Pre-registration FY1 House Officers ARE NOT allowed to sign FP10 (HP) prescriptions

d) FP10 (HP) must not be used to prescribe for in-patients, private patients, by hospital staff for themselves or their families/colleagues unless specific approval has been given by the Head of Pharmacy usually in combination with service managers and a Trust Executive.

e) FP10 (HP) must not be used for prescribing outside of the Formulary guidance.f) Medicines prescribed on FP10(HP) often cost the Trust far more than when

dispensed by the Trust Pharmacy Dept.g) Poorly written or incomplete FP10(HP) prescriptions can cause great difficulty and

inconvenience for patients and community pharmacists. h) Data relating to medicines prescribed using these forms are collated by the

Prescription Pricing Bureau in electronic format, including prescriber details and the drugs prescribed. This information is audited regularly.

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PRESCRIBING CONTROLLED DRUGS

Click here to access the Trust Policy for the Management of Controlled Drugs. ( Prescribing is covered in Chapter 5, pages 9-12 ).

Methadone must NOT be prescribed for discharge where an addict has a registered pick-up point. If it is not possible to make arrangements the minimum possible quantity should be provided and an absolute maximum of 2 days prescribed for addicts.

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PRESCRIBING CYTOTOXIC CHEMOTHERAPY (INCLUDING METHOTREXATE FOR NON-CANCER INDICATIONS)

Unless you are trained, authorised and registered within the Trust to prescribe intrathecal chemotherapy, you MUST NOT prescribe or administer these treatments.

Separate polices are available for vinca alkaloids, oral anti-cancer medicines and intrathecal chemotherapy. Click here to go to the Medicines Resources Intranet site to access these

The Trust follows Merseyside and Cheshire Cancer Network policies, guidelines and protocols for chemotherapy prescribing in cancer. Detailed information is available of the MCCN website.

Cancer chemotherapy within the Trust will be prescribed using the ChemoCare electronic prescribing systems wherever possible. The strategy is for all chemotherapy prescribing to be via ChemoCare when all of the necessary protocols are uploaded.

Particular care is needed when a patient is treated with potent cytotoxic chemotherapeutic agents.

Records of the prescribing and administration of chemotherapy should be organised and clear so that the overall plan of treatment given is intended and clear.

Regimes must be prescribed on the basis of a protocol whenever possible. The first course must be prescribed by a Consultant, Senior Registrar, Staff Grade or Associate Specialist with appropriate training and experience

Methotrexate. Methotrexate is commonly prescribed for non-cancer indications. These indications will usually be restricted to rheumatoid arthritis and psoriasis for which they are usually initiated by specialists. Patients may admitted to hospital for other conditions whilst on methotrexate. Prescribers should note that methotrexate is prescribed as a WEEKLY dose on a specified day per week. Methotrexate must NEVER be prescribed daily for non-cancer indications. To avoid misinterpretation and accidental daily administration prescribers must specify the day of administration and cross off the days in the administration section of the kardex when patients are not to receive methotrexate. Methotrexate must not be prescribed in any circumstance with the dose, frequency or route specified ‘as directed’. Specific procedures are in place for managing oral methotrexate. These can be obtained from Pharmacy Medicines

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Information or via this link on the intranet. Pharmacy will only supply 2.5mg strength tablets of methotrexate when tablets are prescribed in line with Pan Mersey locality policy.

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PRESCRIBING BY STAFF FOR THEMSELVES, THEIR FAMILIES, CLOSE COLLEAGUES, ORDERS FOR PERSONAL SUPPLIES AND DUTIES OUTSIDE OF THE TRUST

Medical staff and non-medical prescribers must not prescribe for themselves, their families or anybody with whom they have a close personal relationship in line with the current GMC guidelines http://www.gmc-uk.org/guidance/ethical_guidance/14318.asp. Advice must be sought from the Head of Pharmacy or Medical Director BEFORE prescribing in these scenarios if an exception is believed appropriate. Concerns regarding attempts to inappropriately prescribe will be passed to the Medical Director. Such instances may also result referral to the Local Counter Fraud Specialist (LCFS) for investigation.

In emergencies, medical staff should attend existing facilities in outpatients, the Accident & Emergency Department or Occupational Health, where a senior doctor will prescribe as necessary. The current prescription charge will be payable.

FP10 (HP) prescription forms must never be used by medical staff to prescribe for themselves or their families. This may be classed as Fraud and such matters should be referred to the Trust Local Counter Fraud Specialist to investigate.

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PURCHASE OF MEDICINES FOR PROFESSIONAL USE

Due to changes in the interpretion of European law, the MHRA has advised during 2014 that only MHRA-licensed medicines wholesalers may supply stock of medicines to other organisations or individuals.

Therefore Pharmacy can no longer make sales via signed orders to consultant medical staff for use within their private practice

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PRIVATE PRESCRIPTIONS

Private prescriptions will not be dispensed by Pharmacy unless by specific arrangement with the Head of Pharmacy or Deputy. The only appropriate circumstances foreseen at the time of writing this Policy would be to support Trust-run private clinics or other clinical activity. Pharmacy will not dispense private prescriptions for patients, the public or members of staff and their families unless in the course of official Trust activity.

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11.NICE TECHNOLOGY APPRAISALS AND CLINICAL GUIDELINES

The National Institute of Clinical Effectiveness (NICE) has published many technology appraisals (TAs) and clinical guidelines (CGs) relating directly to medicines or including medicines as elements of treatment within them.

There is a National requirement for NICE TAs for medicines to be implemented within 3 months of publication. This also requires update of the Trust’s Medicines Formulary and publication within the 3 month time period.

The Trust’s Drug & Therapeutics Group works closely with the Pan-Mersey Area Prescribing Committee to ensure that the Joint Medicines Formulary is updated within 3 months. The policy and procedures for the Area Prescribing Committee provide details of the approach and processes involved to achieve this.

All Trust prescribing must be consistent with relevant NICE requirements (and timescales) unless there are specific reasons why this is not appropriate. For individual patients this may include situations where NICE-recommended treatments are contra-indicated.

The management of NICE implementation within the Trust is covered within the Trust Policy for Implementation of NICE Guidelines. Click here to access this Policy.

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12.MEDICINES FORMULARY

Prescribers should only initiate prescriptions for medicines which have been approved by the Trust Drug and Therapeutics Group (DTG) for use within the Trust. Medicines have been selected for inclusion in the Medicines Formulary taking consideration of cost-effectiveness, safety and relevant guidelines (eg. NICE Technology Appraisals).

The approved drugs are listed in the Pan Mersey Area Prescribing Committee Joint Medicines Formulary (click here to access the Formulary)

Click the icon to access the Formulary

The Formulary cannot accommodate every possible prescribing scenario and individual patient need. Therefore exceptions can be made when individual patient circumstances justify eg. allergy, side effects, failure to respond to formulary-listed drugs.

It is acceptable for prescribers to continue prescriptions for non-Formulary drugs which have been initiated by another prescriber (eg. a GP, tertiary care consultant) for individual patients whose condition does not justify changing their prescription. This is commonly the case for elective patients admitted for surgical procedures.

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If a patient is admitted already on a non-formulary drug we will normally continue their treatment using their own supply of this drug. If further supplies are required, the minimum to provide for this patient’s needs will be ordered by Pharmacy.

Prescribers who wish to request that a new drug be added to the Formulary, or for other amendments to be made should correspond with the DTG via the Head of Pharmacy or the Chairman of the DTG. The Trust’s DTG collaborates with other Trusts and CCGs within the Pan Mersey locality. The process for changes to the Formulary requires approval by the Pan Mersey Area Prescribing Committee.

High cost non-Formulary drugs required for isolated treatment of an individual patient will be subject to an individual patient commissioning process (often referred to as individual funding requests or IFRs).

Audit systems are in place both within the hospital and in primary care to monitor Formulary compliance. This includes the recommendation of non-Formulary drugs by referral to GPs by letter. Compliance by Trust prescribers with the local Formulary is included as a performance measure within the Trust’s Quality Contract with local commissioners.

Click this link to go to the Pan Mersey Area Prescribing Committee website

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13. INDIVIDUAL FUNDING REQUESTS (IFR)

Application for funding of exceptional cases should be made via an IFR. Such applications must comply with both of the following requirements: The patient is significantly different to the general population of patients with the

condition in question the patient is likely to gain significantly more benefit from intervention than might

normally be expected for patients with that condition. IFR applications must be approved by the Chair of the Drug and Therapeutics Group or Head of Pharmacy before submission, completed forms should be sent to [email protected].

The full requirements and application form may be found on the Pan Mersey Area Prescribing Committee website http://www.panmerseyapc.nhs.uk/index.html .

If you require further information / assistance please contact Mike Welsby on ext 1565 or [email protected].

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14.ANTIMICROBIALS

The use of antimicrobials, including antibiotics, antifungals and antivirals is detailed within the Trust Antibiotic Policy and supporting Antibiotic Guidelines

Click this link or the logo below to go to the Antibiotic Policy

Smartphone and tablet access to the Trust’s Antibiotic Policy and Guidelines is available through the Mersey Micro app.

Click the link to find out more

The Trust supports the UK Antibiotic Guardian initiative.

This link takes you to Trust guidance about what you can do to be an antibiotic guardian.

15.OUTPATIENT ANTIMICROBIAL THERAPY (OPAT)

This is a scheme to enable patients to receive intravenous antimircobial treatment in the home setting when appropriate. This is particularly suitable for extended courses of intravenous antibiotics when it is not possible to substitute with an oral equivalent. This reduces the need for clinically stable patients to have prolonged inpatient stays simply to enable intravenous antibiotic therapy. Clinical responsibility and supplies of antibiotics remain the responsibility of the Trust even though the patients are managed at home and may have been technically discharged from the Trust’s Admissions/Discharges & Transfers (ADT) System. Detailed guidance about the OPAT scheme is provided in the Trust’s Antibiotic Policy via this link.

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16.UNLICENSED MEDICINES

There are two main categories:1. Drugs which have no MHRA product licence in the UK. This includes drugs licensed in

other countries, drugs manufactured by a specials manufacturer, individually-prepared medicines made by a pharmacy

2. Off-label use of licensed drugs – ie. prescribed for an indication not listed in the licensed indications which are detailed in the drug’s summary of product characteristics.

Considerations when prescribing unlicensed medicines for the Trust’s patients: Medicines should be prescribed within their licensed indications whenever possible. Off-

label use is only appropriate when there is no suitable product which is licensed and available for the required indication. Sometimes national and expert guidance recommends the use of medicines for off-label indications. Examples include amitriptyline in neuropathic pain and many drugs used in paediatrics & palliative care.

Medicines which have a product licence for use in the UK by the MHRA will be prescribed and supplied unless there is adequate justification eg. allergy to excipients, formulation unavailable

Prescribers take on extra responsibilities when prescribing for off-label indications or for unlicensed medicines. There must be adequate clinical justification and medicolegal consequences should be considered.

Pharmacists should make the prescriber aware that a prescribed medicine is unlicensed in the UK.

Patients should agree to treatment with an unlicensed or off-label drug before it is prescribed. The process of informed agreement may be performed in the same way that agreement for treatment with other medicines is gained from patients without requirement for additional specific documentation.

A patient information leaflet explaining unlicensed medicines should be provided to patients. This is available from Pharmacy.

Patient-specific decisions about unlicensed medicines should be documented in the patient’s medical records.

Pharmacy, through the Drug and Therapeutics Group, will regularly review unlicensed drugs usage and to encourage the use of licensed alternatives where possible.

Pharmaceutical Quality Control NW (QCNW) guidance on the supply of unlicensed medicines will be followed within the Trust.

Supplies of unlicensed medicines may be quarantined whilst quality control assessment is conducted if the supplier is not a QCNW-approved supplier. This may lead to delay in supply. Exception to release a quarantined medicine prior to QC test results may only be made in very urgent situations when the clinical need of a patient provides justification. The permission of the consultant, purchasing pharmacist and the patient should be provided.

Detailed advice is available from Pharmacy Medicines Information on ext 1565

Hyperlink to Pharmacy/DTG guidance on unlicensed drugs

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17.MEDICINES AND CLINICAL TRIALS

The use of medicines, including both investigative medicinal products (IMPs) and licensed medicines, within clinical trials is strictly regulated.

All clinical research within the Trust is managed by the Trust’s Research, Development and Innovation (RDI) Department. Research within the Trust is governed by the Trust’s Research, Innovation and Development Group which is chaired by the Medical Director.

Approval and support of the above is mandatory before any research activity is permitted, including those requiring the use of medicines.

The RDI Department SOPs may be accessed via this link.

Close liaison is required between the pharmacy lead for clinical trials, the principal investigator and the RDI department prior to and following commencement of a clinical trial which includes medicines. This is essential to ensure the safe and successful conduct of the study in accordance with Trust policy & procedures, pharmacy SOPs, research network requirements, sponsor requirements (eg. drug company if not the research network) and MHRA Good Clinical Practice (GCP).

All medicines intended for use within a Trust-approved clinical trial must be managed by Pharmacy. Medicines storage requirements will be discussed with and approved by Pharmacy on an individual trial basis.

Supply of medicines for a clinical trial from Pharmacy will only be made if the specifications of the trial protocol are met.

Code breaking may be required to identify a clinical trial product for specific patients in the event of an emergency. The trial protocol must specify the procedure to be followed in such an event and must be followed by pharmacy and other clinical staff.

Adverse events occurring within clinical trials involving medicines will be managed in accordance with MHRA GCP requirements and must be specified within the trial protocol.

All staff involved with prescribing, storage, supply, administration and management of clinical trials involving medicines must have received training in accordance with Trust policy.

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18.NON-MEDICAL PRESCRIBING

Non-medical prescribing is prescribing by specially trained nurses, optometrists, pharmacists, physiotherapists, podiatrists and radiographers, working within their competence as either independent and/or supplementary non-medical prescribers (NMPs).

All NMPs will work within agreed local & national policies and within their scope of professional practice.

All NMPs must prescribe in accordance with Trust Medicines Policy, the Pan-Mersey Formulary and other policies relating to prescribing

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Definitions Independent prescribing

Prescribing by a practitioner (e.g. doctor, dentist, nurse or pharmacist) responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing.

Independent non-medical prescriber (IP) A specially trained nurse or pharmacist who can prescribe any licensed or unlicensed medicine, including schedule 2-5 controlled drugs, within their clinical competence

Supplementary prescriber (SP) A voluntary partnership between a doctor (Designated Medical Practitioner, DMP) and a supplementary prescriber (SP) to prescribe within an agreed patient-specific clinical management plan (CMP) with the patient’s agreement.

Designated Medical Practitioner (DMP) A doctor who agrees to supervise NMPs throughout their period of training and practice.

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Scope Prescribers who qualified prior to joining the Trust must apply, in the same way as a

new prescriber, to prescribe in their new role. NMPs who change their role within the Trust must have their competencies ratified by

their designated medical officer/ mentor and apply in the same way as a new prescriber, to prescribe in their new role.

The policy does not include Registered Nurses, Midwives or Pharmacists employed through the staff bank or locum agencies.

The policy does not include qualified non-medical prescribers employed by the Trust where the Trust does not support their role as a prescriber.

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Responsibilities

Non-Medical Prescribing Lead (Deputy Director of Nursing & Midwifery)On behalf of the Trust the appropriate prescribing lead will:a. Formulate the non-medical prescribing policy.b. Determine the applicant has appropriate qualification and experience to undertake the

course. c. Determine that there is a clinical need within the applicant’s role to justify prescribing.Page 33 of 93 Medicines Policy (June 2015)

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d. Recommend the non-medical prescriber to the Trust Board for written authorisation to practice

e. Maintain a register of the individuals’ copy of the NMC / GPhC statement of entry into the professional register and forward a copy to the individual’s line manager for inclusion into the personal file.

f. Cascade relevant information to NMPs.g. Provide a regulatory/ advisory role to the NMPs.

PharmacyThe Clinical Pharmacy Services Manager on behalf of the Head of Pharmacy is responsible for:

Advising the Trust on aspects of legislation relating to Non Medical Prescribing. Maintaining up to date registers, including signatures, of:

o active non-medical prescribers. o non-medical prescribers prescribing controlled drugs

The pharmacist clinically verifying the prescription is responsible for ensuring the prescriber is authorised by the Trust to prescribe.

Trust Designated Medical Practitioner (DMP) Is a registered medical practitioner who;

Has at least three years recent clinical experience in the relevant field of practice. Is a consultant, registrar or speciality doctor within the Trust Has experience in teaching training or supervising practice Has support of the Trust in acting as the DMP Is familiar with the NMP programme and the need for the trainee to achieve the

learning outcomes. Has agreed to be the DMP for a named NMP trainee Is responsible for facilitating 90 hours/ 12 days clinical practice supervision, to

support and develop the NMP trainee’s competencies in prescribing.

Line ManagerThe line manager is responsible for

Supporting the application procedure: When signing the application of a candidate for NMP training, the line manager is confirming that the applicant is capable of carrying out non-medical prescribing within the role, including ability to assess and diagnose the patient’s condition.

Ensuring that the employees job description / Knowledge and Skills Framework (KSF) includes a clear statement that prescribing is part of that employee’s role.

Monitoring prescribing by the non-medical prescriber Supporting professional development for NMP and ensuring that the NMP has met

with at least the minimum annual mandatory Trust CPD requirements to allow the NMP to continue prescribing.

Ensuring the NMP prescribes within their designated role.

The Non Medical PrescriberIt is the responsibility of the non-medical prescriber to: - Practice within the legal framework and codes of professional practice and conduct as

determined by their regulatory bodies Maintain standards of proficiency regarding prescribing practice. Provide annual self-declaration to the NMP lead to confirm continuing practice having

undertaken appropriate measures to maintain competency.

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Where relevant, provide annual self-declaration to the NMP lead to confirm intention to prescribe controlled drugs having undertaken appropriate measures to maintain competency.

Attend minimum of one mandatory CPD session per year and undertake other appropriate CPD to maintain competency in own area of prescribing.

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Authorisation for NMPs to practice within the Trust All independent and supplementary prescribers must have undergone the appropriate

training and have written evidence of qualification. All independent and supplementary prescribers must have received their prescribing

qualification registered with their professional body (NMC or GPhC) and have a unique prescribing registration number.

All supplementary and/or independent prescribers must have written authorisation from the Trust to practice as a supplementary and/or independent prescriber.

Copies of the individual authorisation will be kept by:o The individualo The appropriate prescribing lead (i.e. for nursing, pharmacy or midwifery)o The Pharmacy departmento The line manager

Each independent or supplementary NMP will provide specimen signatures and their unique registration number to be kept in a register in the pharmacy department to allow the necessary prescription checks to be made.

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Steps to be followed upon completion of training It is the individual NMP’s responsibility to forward 2 copies of the NMC/ GPhC statement

of entry in the professional register, verifying annotation onto the register to the Trust leads. One copy will be placed into the practitioner’s personal file and one copy will be retained by the Trust leads.

Before commencing prescribing duties the nurse will have a meeting with the relevant Trust lead in order to clarify details and receive supporting procedures including the written authorisation to practice.

The Trust leads will contact the relevant line manager to ensure prescribing responsibilities are added to the non-medical prescriber’s job description.

The non-medical prescriber may prescribe only after the qualification has been recorded on the professional register and steps have been completed.

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Independent Non-Medical Prescribing A Nurse Independent Prescriber (NIP) must be a 1st level registered nurse, Registered

Midwife or Registered Specialist Community Public Health Nurse whose name in each case is held on the Nursing and Midwifery Council professional register, with an annotation signifying that the nurse has successfully completed and approved programme of preparation and training for nurse independent prescribing.

A Pharmacist Independent Prescriber (PIP) must be a registered pharmacist, whose name is held on the membership register of the GPhC, with an annotation signifying that the pharmacist has successfully completed an education and training programme accredited by the GPhC and is qualified as an independent prescriber.

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Nurse and Pharmacist independent prescribers can prescribe any licensed medicine for any medical condition within their competence. This includes Controlled Drugs in schedule 2-5 of the Misuse of Drugs Act 1971, with the exception of cocaine, diamorphine and dipipanone for the treatment of addiction.

Nurse and Pharmacist prescribers can prescribe medicines for uses outside their licensed indications for patients on the same basis as doctors provided they are competent and take full responsibility for doing so.

Nurse and Pharmacist prescribers can prescribe medicines for uses outside their licensed indications / UK marketing authorisation (so called “off-licence or off-label”) provided they are competent and take full clinical and professional responsibility for their prescribing and should only prescribe ‘off-label’ where it is considered best practice to do so.

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19.TRANSCRIBING OF PRESCRIPTIONS BY 5TH YEAR MEDICAL STUDENTS, PHARMACY and OTHER STAFF

The Trust’s Clinical Education Team manage a scheme to enable 5th year medical students to transcribe prescriptions under close supervision. Any prescription written by a student must be stamped to clearly indicate that it was written by a student. The supervising foundation stage doctor or senior doctor must check and authorise/sign the prescription and undertake full clinical responsibility. Under no circumstances may a student write up a controlled drug.

Registered pharmacy staff, when given permission to do so, may complete the list of current medicines on the ICE TTO. This task involved transcribing the current list of medicines from the inpatient kardex(es) into ICE. However, these staff must must NOT submit or authorise TTO. They can only input and save. Authorisation may only be conducted by a foundation stage doctor or registered doctor who will take full clinical responsibility.

Other staff may include registered nurses and midwives eg. nurse specialists who will pre-write prescriptions which will then be checked and authorised/signed by a registered doctor or foundation stage doctor.

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20.PATIENT GROUP DIRECTIONS (PGDs)

A Patient Group Direction is a written instruction for the supply and administration of medicines without a prescription to groups of patients who may not be individually identified before treatment

Certain healthcare professionals within the Trust are authorised to supply and administer medication under a PGD. All such directions must be developed in accordance with the Trust Policy on the Development of Patient Group Directions and be approved by the Trusts Drug and Therapeutics Group

The person named in each direction is not authorised to delegate to a second person the administration or supply of the drug specified. Therefore all such drugs must be administered or supplied directly to the patient by the practitioner named in the direction

Click here to go to the Trust Policy for Patient Group Directions (PGDs)

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21.DRUG HISTORY TAKING AND MEDICINES RECONCILIATION

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ROLES

The admitting doctorAs part of their admission history in the patient’s medical notes, should compile a drug history/list of medicines the patient has been taking prior to admission. This should include: Name of medicine Dose Route Frequency Allergies (and other important warnings)If this information is not available or is unclear, this should be documented in the admission history.

PharmacistAs soon as possible after admission (ideally within 24 hours) a pharmacist should undertake a medicines reconciliation to ensure the medicines prescribed on admission correspond to those the patient was taking before admission; taking into account any appropriate changes made to the patient’s prescription eg. dosage change or drug omission due to adverse event.

Pharmacy Technicians/Pre-Registration PharmacistTo assist the pharmacist in drug history taking and medicines reconciliation as follows Compile the list of medications the patient was taking before admission as detailed

below under drug history taking. This should include over the counter medicines as well as those medicines that have been recently changed or stopped

Document the list of medicines on the specific medication history form

Nursing & Midwifery StaffNursing & midwifery staff should ensure where possible that patient’s own medicines arekept with the patient on admission to facilitate the reconciliation process

DRUG HISTORY TAKINGThis may also be carried out by the admitting doctor/NMP, by pharmacy staff or by nurses working in pre-admission clinics. Amongst Pharmacy staff, this task can be performed by a pharmacy technician, a preregistration pharmacy graduate or a pharmacist.

Collecting InformationGP referral letters, hospital medical records, the patient, carer, nursing homes, community pharmacists and GP surgeries can all provide information on individual drug histories. However, each of these sources has its limitations.

Patient/CarerThe patient/carers who have knowledge about the patient’s medication are the bestsource to obtain information from, as they can provide accurate and up-to-date drughistories. Alternative sources of information (listed below) may need to be used inPage 39 of 93 Medicines Policy (June 2015)

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patients with communication difficulties or if the patient/carer is unclear about themedicines they usually take at home.

The patient should be consulted initially regarding their medication: Confirm the patient’s name & date of birth Confirm allergy status Has the patient any medication with them (see Patients Own Drugs PODs below) Has the patient a list of their medication (it is important to check the date of issue

on each prescribed medicine on the script, as discontinued drugs tend not to be cancelled from the script until the patient has a medication review)

Ask if the patient takes or uses any other medication e.g. inhalers, eye drops, creams etc

Ask if the patient takes any Herbal or OTC products Ask if there have been any recent changes to the patient’s medication e.g. any

medication recently discontinued Confirm the patient takes the medication as directed (Alternative formats available on request, e.g. translation services, sign language

services).

Patient Own Drugs (PODs): If the patient has brought their own medications in to hospital, these must be checked using the POD algorithm for suitability of re-use. Check if the PODs are labelled with the current doses and if the patient is still taking them.

Relatives/Carers may also be used as a source to confirm a patient’s current medication details (although consideration must be taken to assure patient confidentiality). Relatives/Carers should be encouraged to bring in patient’s own medication Relatives/Carers should be encouraged to bring in the patient’s repeat prescription requests

General Practitioner (GP) Referral LetterPatients who are referred by their GP may bring a referral letter with them, whichdetails their current medication and drug allergies. Unfortunately, such letters are oftenfar from complete. A number of studies have shown omitted drug details and incorrectinformation on such letters – see below in SCR information.

Summary Care Record (SCR)Most patients of St Helens and Knowsley localities have consented to their GPs sharing electronic summary health record information onto the NHS Summary Care Record. Information on current and previously prescribed medicines is available on SCR. Access to SCR is via Smartcard for specifically approved staff. Permission from patients must be sought before accessing a patient’s summary care record. This must be recorded when accessing the system. In emergencies when gaining permission is not possible (eg. if patient is unconscious and a carer/relation is not available), access may be obtained but recorded as emergency access.

It is essential to remember the GP records may not list all medicines which a patient is currently taking. Specialist medicines such as ‘memory drug’ for Alzheimers disease, antipsychotic drugs, biologics, clinical trial drugs, ongoing cancer chemotherapy etc may not be recorded. Over the counter (OTC) medicines and herbal/homeopathic medicines will not be listed.

Users of SCR are advised to check the last supply date on SCR as this will give indication of how up to date the record is.Page 40 of 93 Medicines Policy (June 2015)

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Contacting the GP SurgeryThis can be a good source to acquire information, particularly for patients who are not listed on SCR. There are a number of issues to take into consideration to ensure you are receiving ‘up-to-date’ and accurate information (also see text above in SCR) Has the patient been in hospital or attended a clinic recently where a hospital clinician

may have made changes to their drug therapy, which the GP has not yet been notified of?

The patient may have had a recent consultation with the GP, who may have given verbal instructions on medication changes, which are often only recorded in the paper notes with no alterations made to the computer records until sometime later

Where the medication history is incomplete, the GP Surgery must be contacted and afaxed copy of the recent medication history requested.The GP surgery details must be obtained from the patient notesThe GP receptionist must be contacted via telephone and informed of the following:

a) Name of pharmacist/technicianb) Hospital and wardc) Name, date of birth & address of patientd) Request via fax an up-to–date list of patient’s current medication list including

acute medication & allergy status.e) Ask for the GP surgery fax number & notify that this request will be faxed on a

“Request for Medication Details” form (see Pharmacy SOP)f) Clinical details regarding the patient must not be discussed.

Once the fax has been obtained the patient’s name & date of birth must be highlighted (underlined/circled) on all pages to avoid incorrect medications being prescribed to the wrong patient

The date of administration must also be highlighted to ensure it is the most up to date record

The hard copy and the fax request slip should be placed in the patient’s notes for reference

Nursing HomeNursing homes are a very reliable source and can inform you exactly what the patienthas been taking, as they tend to administer all medicines to their residents. The majority of nursing homes will send a computerised medication administration record (MAR) into hospital with the patient.It is also useful to check if a supply of medicines will be required by the nursing home on discharge.When contacting the nursing home follow the steps as for GPs above: Once the fax has been obtained the patient’s name & date of birth must be highlighted

(underlined/circled) on all pages to avoid incorrect medications being prescribed to the wrong patient

The date of administration must also be highlighted to ensure it is the most up to date record

The hard copy and the fax request slip should be placed in the patient’s notes for reference

Community PharmacistThis is another source from which to acquire information from, relating to drughistories, as many community pharmacies maintain computerised patient medicationrecords. However, it is essential to understand that patients may not use the samepharmacy all the time.Page 41 of 93 Medicines Policy (June 2015)

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The community pharmacist can help in confirming if the patient requires a complianceaid and which device they normally use

Hospital RecordsThe Electronic Document Management System (EDMS) provides quick access to scanned medical records and correspondence from previous admissions or appointments in the Trust.

A recent TTO form may be useful to obtain up-to-date information if the patient has had a recent episode in hospital.

The patient’s medical records are a good source to obtain information if the patient has had a recent episode in hospital or attended a clinic. If the clinician in the hospital has made changes to the medication regime, this should be documented in the medical notes (a copy of the letter to the GP following discharge will also be in the notes and should provide information on changes to therapy).It is essential to remember that when obtaining information from medical records or the Pharmacy JAC system that you are assuming that an accurate drug history was taken on the last admission (if regular medication were omitted non-intentionally on the last admission there would therefore be no record in the notes or JAC system)

Other useful sourcesDrugs teams eg Addaction, Lighthouse Project for methadone dose confirmation

MEDICINES RECONCILIATION

Once all the relevant drug history information has been obtained: Compare the confirmed medication history with the medication prescribed on the

patient’s prescription kardex. √ Place a tick in the pharmacy section of the drug chart beside the medications the

patient was taking on admission Ensure any discrepancies are rectified. Technicians should make their ward pharmacist

aware of any discrepancies. The pharmacist will ensure these are rectified with medical/nursing staff.

Remember certain alterations to a patient’s medication may well be intentional eg.reduced doses in renal impairment.

Communicating Information: Alterations to a patient’s medication must be annotated by the ward pharmacist in the

pharmacy section of the inpatient prescription kardex eg. dose increased on admission or dose reduced due to poor renal function etc.

Stopped/Withheld medications and the reasons why should be annotated by the ward pharmacist on the patient’s kardex (in the space available at the top of page 2 of the inpatient prescription kardex).

Newly started medications and the reasons why should be annotated by the ward pharmacist in the pharmacy section of the kardex e.g. digoxin – AF

Documentation of medicines reconciliationOnce an accurate medication history has been confirmed this must be transcribed intothe patient’s medical notes. The entry must be signed, dated and timed and all sourcesPage 42 of 93 Medicines Policy (June 2015)

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used to confirm the drug history stated.The appropriate section of the kardex must also be completed to confirm an accuratemedication history has been taken.

Pharmacy Technicians must have completed the Pharmacy Drug History Training Module in order to transcribe directly in to the patient’s medical notes. Technicians who have not completed this module should communicate the drug history to the ward pharmacist who in turn must enter this in to the notes. The Medication History Form may be used by untrained technicians.

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22.ACCURACY CHECKING OF PRESCRIPTIONS

a) Supplies of medicines for individual patients from Pharmacy may only take place after a pharmacist has checked the prescription. This is termed a clinical check (or alternatively a professional check). The clinical check can take place in any appropriate location. This will usually be on a ward or within Pharmacy.

b) Guidance on the professional checking process is provided to pharmacists within the Pharmacy SOPs.

c) A pharmacist has authority to make amendments to prescriptions in accordance with guidance detailed in Pharmacy SOPs.

d) A pharmacist has authority to refuse or to withhold supply of medicines if the prescription is considered unsafe. In such circumstances the pharmacist will take action to ensure the prescription is made safe, taking account of the patient’s condition and priority of treatment. Usually such action will involve liaison with the prescriber to confirm their intentions or any amendments required. If the prescriber is not available and correction is urgent, the pharmacist will seek the assistance of another prescriber.

e) If a prescriber does not agree to a pharmacist’s advice but the pharmacist still believes the prescription to be unsafe, they must consult a more senior doctor. Support from a senior pharmacist may also be sought.

f) Each pharmacist performing a clinical check on a prescription will sign or initial the prescription for non-stock inpatient, discharge, day-case and outpatient prescriptions in accordance with Pharmacy SOPs.

g) A signed clinical check for a medicine gives authorisation for technical staff in Pharmacy to dispense the medicine in accordance with the details on the prescription or requisition.

h) The clinical check of requisitions for named inpatients and for discharge prescriptions requires the pharmacist to check for transcription errors against the inpatient medicines kardex. Authorisation of supplies for such patients without seeing the inpatient kardex should only be in exceptional circumstances. If a supply is authorised without the kardex, measures should be taken to satisfy the pharmacist that it is safe and in the best interests of the patient to do so. This is a matter of professional judgement.

i) Pharmacists will be scheduled to visit wards in the hospital to review inpatient prescriptions within a near-patient environment.

j) Where possible wards are visited by a pharmacist each day (Monday to Friday) and every patient will be reviewed during their admission.

k) On Saturday mornings all wards are visited by pharmacy staff to review new prescriptions with them aim of preventing need to sending kardexes to pharmacy and to organise any stocks required.

l) Medical wards receive clinical pharmacy visits on Saturdays and Sundays in order to review new patients and to support discharges

m) When resources do not permit daily visits and reviews of every patient, the Head of Pharmacy has authority to prioritise service delivery. Critical Care, SCBU, Haematology, Paediatrics, AMU and SAU are given highest priority. A lower level of ward pharmacist visit may be provided to other wards. If no service can be provided to a ward this must be authorised by the Head of Pharmacy (or deputy). These occurrences will be reported on Datix and presented at the Clinical Performance Council as part of the prescribing accuracy update reports.

n) Pharmacists will seek to review new patients and reconcile drug histories as soon as possible after admission. Pharmacy technicians with extended skills may assist in obtaining and confirming drug histories.

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o) When a pharmacist is not available to check a prescription, greater responsibility is placed upon nurses and midwives administering medicines to ensure it is safe to do so. If there is any doubt, even after checking standard reference sources and with other nurses, the prescriber or Pharmacy should be contacted for advice about the concern.

p) Out of hours supplies of medicines for discharge are available on some wards & clinics. These enable the dispensing of commonly required medicines without the need for a prescription to come to Pharmacy for dispensing. Each ward operating such a facility has an SOP for its use. It is the responsibility of the ward manager to ensure that all staff using the facility can safely follow the SOP. In the absence of a pharmacist, each prescription will require a second check by another registered nurse, midwife, doctor or pharmacist to ensure it is safe to make a supply as prescribed.

q) Similar facilities to the out of hours supplies described above are being made available for use in specific clinical areas during normal hours. The processes and responsibilities are very similar to the out of hours procedures.

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23.PROCUREMENT AND SUPPLY OF MEDICINES

Staff are reminded that medication supplied to each clinical area is for administration the patients under the care of the Trust only. Misappropriation or theft of medicines by staff constitutes gross misconduct and will be managed in accordance with the Trust’s disciplinary procedure. Such instances may be classed as Fraud and matters will be referred to the Trust’s Local Counter Fraud Specialist (LCFS) to investigate. Reporting to the appropriate professional body will be strongly considered. (See section on Suspected Theft or Fraudulent Procurement of Medicines).

Supplies from Pharmacy can only be provided against prescriptions, requisitions and signed orders provided on official Trust stationary or media eg. e-top up, e-prescribing.

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PURCHASING OF MEDICINES

Medicines are unlike any other items of commerce and for this reason the purchase, storage and distribution must be under the control of a pharmacist.

The Trust Standing Financial Instructions (contained in the Corporate Governance Manual) delegates the financial responsibility, within pre-set limits, for tenders and the signing of orders for medicines to the Head of Pharmacy and authorised deputies.

Medical, nursing, technical and other staff are not permitted to undertake contracting or tendering for, or purchasing of medicinal products intended for administration to patients within the Trust.

Medicines procurement contracts MHRA-licensed medicines suppliers will be used NHS Commercial Medicines Unit (CMU) co-ordinated NW regional medicines contracts

will be used whenever possible The Trust will participate in the NW Regional medicines contracts and comply with the

terms and conditions required The Trust will provide medicines purchasing data to the NHS CMU via Pharmex data to

enable drug contract tendering, scoping and contract performance monitoring on the Trust’s behalf.

Where NHS CMU contracts are not available, whenever possible the Trust will procure drugs through a supplier listed on a NW Regional SBS tender framework (or similar). Frameworks are presently available for pharmaceutical wholesalers, homecare delivery and specials (unlicensed medicines) suppliers

Off-contract purchasing of medicines wil only occur when contrated suppliers are unable to supply or when a contracted product is unsuitable for Trust requirements. The Drug & Therapeutics Group will review proposals for planned off-contract purchasing. Planned decisions to purchase off-contract will be communicated with the NHS CMU and the NW technical services pharmacist for procurement.

Trust pharmacy staff will participate in NW pharmaceutical procurement groups and tender adjudication

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Quality of purchased medicines Drug contract tenders, adjudication and post-award monitoring involve significant and

direct input from Quality Control NW, our NHS hospital pharmaceutical quality control service to which the Trust subscribes. Quality requirements and QC analysis are major components in contract specifications.

Concerns regarding quality of medicines can occur and all staff involved in the use of medicines are requested to be vigilant for these. Concerns can include matters such as unclear labelling, cloudy liquids, broken ampoules, insoluble material etc.

If a problem arises as a result of poor quality it must be reported promptly to the Pharmacy so that action can be taken. Action will include reporting to QCNW. A national pharmacy network exists for reporting and disseminating drug defects to ensure patient safety and MHRA awareness.

Quality of unlicensed medicines All unlicensed products purchased for use within the Trust must be checked by the Pharmacy before issue. There may be delay in the availability of medicines whilst quality control analysis is performed, but this ensures that the quality and efficacy of these medicines (for which the Trust must take some liability) is suitable for their intended use. See section on unlicensed medicines

Free samples of medicines for professional use All free samples provided by drug companies for use within the Trust must be authorised by the Drug and Therapeutics Committee and issued through the Pharmacy Department. Any samples supplied directly to clinicians must be provided to pharmacy for assessment before they are made available for patient use.

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SUPPLY OF CONTROLLED DRUGS (CDS)

Please refer to the Trust Policy for the Management of Controlled Drugs and related procedures for further advice.

Refer to Pharmacy departmental SOPs for Pharmacy-specific information about supply of CDsClick to go back to main contents table

SUPPLY OF CYTOTOXIC CHEMOTHERAPY (INCLUDING METHOTREXATE)

Separate polices exists for intrathecal chemotherapy, vinca alkaloids and oral chemotherapy. Click here to locate these policies on the Medicines Resources Intranet Site

a) Unless supplied ready for use, injectable cytotoxic drugs MUST be prepared in Pharmacy or Clatterbridge Centre for Oncology. The only exception is when methotrexate used in tubal pregnancy termination in a specialist obstetrics and gynaecology ward or clinic.

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b) Pharmacy should receive adequate advance warning of intended injectable chemotherapy, even when this is provisional and the final decision to prepare and administer the medicine depends, for example on the patient’s blood count

c) Only specially-trained, designated Pharmacy staff may prepare cytotoxic chemotherapy

d) The required medicines are prepared by the Pharmacy to be ready for use at the time indicated and should be administered as soon as possible after receipt. Some medicines deteriorate rapidly after reconstitution. Contact the Pharmacy Aseptic Dispensing Unit on ext 1514 if further advice is required.

e) Storage conditions must be noted and the cytotoxic drugs must be kept separate from other drugs

f) Methotrexate. Methotrexate is commonly prescribed for Rheumatology and Dermatology patients. As per national and local health economy policy, the only strength of methotrexate tablets which will be supplied will be 2.5mg. The dose of methotrexate for these patients will be once per week. If any other dose frequency is prescribed, a supply will not be made until the correct dose and frequency is verified. Prescriptions with the dose and frequency ‘as directed’ will not be dispensed. Specific procedures and guidance are available for the use of methotrexate in accordance with NPSA recommendations.

g) Non-cancer indications. Cytotoxic chemotherapeutic drugs are being used more commonly for indications outside of cancer/haematology. At the present time cyclophosphamide and rituximab are being used intravenously in rheumatology, methotrexate injections in rheumatology and irrigations of mitomycin in Urology. The same standards of supply and handling are required in these locations as in cancer wards & clinics. Please contact Pharmacy for specialised advice.

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SUPPLY AND DISPENSING OF MEDICINES FOR INPATIENTS

Clinical pharmacists visit designated wards on a scheduled basis. The pharmacists’ duties include checking patients’ ward and discharge prescription documents and arranging supplies of non-stock medicines.

Pharmacists will check patients’ medicines kardexes in accordance with the section on accuracy checking and the relevant Pharmacy SOP. Endorsements include the following:

If the allergy status is not written, take action to ensure it is completed Any special instructions relating to administration Sign their initials in the appropriate box(es) The date the item was checked and the ward where it is to be supplied Write ‘POD’ if the patient’s own medicine is to be used and the quantity if

appropriate For rewritten kardexes, the chart rewritten box should be signed and dated after

checking items against the previous kardex Stock drugs do not require endorsement

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Non-stock medication

Non–stock medication will usually be supplied by the Pharmacy as an original pack of medication labelled with the patient’s name, the approved name of the preparation and administration instructions. Proprietary names will only be used when the proprietary name defines a specific formulation or combination (e.g. slow-release theophylline preparations). Drugs with frequently changing doses and also injections & infusions may be supplied to the ward without the inclusion of instructions for administration on the label. If multiple patients are taking changing doses of the same medicine then supply to the ward as a temporary stock line may be appropriate.

Medicines which have been dispensed in original packs with directions for administration should be stored in the patients’ bedside medicine cabinets. These medicines are suitable for patients’ to take home on discharge provided there is sufficient quantity. If a patient is transferred to another ward it is essential that these medicines are transferred with them.

Patients’ own drugs may be re-used in hospital, but they must first be inspected and re-labelled if necessary, in accordance with the relevant pharmacy SOP. Patients’ own drugs must not be administered until they have been positively identified.

If the clinical pharmacist has already visited the ward earlier in the day and there are no arrangements to return, then the medicine kardex should be sent to the Pharmacy at the earliest opportunity to order the medication. If the patient has more than one kardex then they should ALL be sent to the pharmacy. (Critical Care Unit do not need to send their Kardexes to Pharmacy).

Dispensing for discharge (one-stop dispensing)

This system has the benefit that all regular, non-parenteral medicines are individually dispensed for each patient ready for discharge. Every patient, soon after admission, will be supplied with 28 days of medication fully labelled with instructions for use (except controlled drugs and changeable treatments)

The medication is stored in a locker by each patient’s bed. Pharmacy technicians visit the ward regularly to review each patient’s medicine kardex and order new items if required. Items where the dosage has changed will be relabelled by the Pharmacy if necessary. This system is used in conjunction with the reuse of patients own drugs scheme.

Ward/Department medicine stocks

Many medicines will be held as stock on wards/depts. A copy of the stock list is held on the ward and additional copies will be supplied on request. Ward managers may request changes at any time and need to sign the list each time a new copy is produced.

Pharmacy Technicians and Pharmacy Assistants visit wards and departments regularly to top-up stock medicines.

Some wards are participating in trials with Pharmacy to modify and improve stock medicines supply systems.

In the event of stocks of a medicine running short before the next top-up, one of the ward Pharmacy staff regularly visiting the ward should be informed. If the supply is urgent and required before Pharmacy staff next visit, the ward stock top-up sheet should be filled-in with the required extra medicines and sent to Pharmacy without delay.

In the event of an urgent shortage of stock or any other medicines outside of normal hours, please call the on call pharmacist (via Switchboard) for advice.

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Medicines optimisation – understanding the patient’s experience Up to 50% of patients do not take their medicines as recommended. To ensure the best possible outcome from medicines, there must be an ongoing, open dialogue with the patient and/or their carer(s) about the patient’s choice and experience of using medicines to manage their condition. It must be recognised that a patient’s experience may change over time even if their medicines do not.

Pharmacy staff will support and develop medicines optimisation, helping patients to get the most from their medicines on an individual basis. This support will include promotion and support for medicines optimisation being carried out by all appropriate members of the clinical teams, not just Pharmacy staff.

Returning Medicines to Pharmacy

The SOP for safe storage and security of medicines gives details about returns All stock and individually dispensed medicines which are no longer required should be

placed in a Pharmacy Delivery Bag/Box (or specialist returns bin) and sealed. A goods return form must be completed. The person taking the box from the ward to Pharmacy must sign the form and take this, along with the bag/box and return it to the Pharmacy Department as soon as possible. A copy of the completed form remains on the ward. Pharmacy will sign and retain the form upon receipt of the sealed box/bag.

Medicines which are suitable for re-use are returned to stock by Pharmacy and the ward/dept will be credited. All other medicines will be destroyed.

Anyone unsure of how to dispose of, or to return a particular item should seek advice from Pharmacy before taking action.

Patients own medicines remain the patient’s property. If they are no longer required, they should be securely returned (with the patients permission) to Pharmacy for destruction.

Dispensed for discharge and patients own medicines may be required by Pharmacy when dispensing discharge medicines. The medicines transfer books must be used to provide an audit trail for such returns.

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DISPENSING OF DISCHARGE PRESCRIPTIONS (TTOs)

TTOs should ideally be received in Pharmacy before 3.30pm on weekdays to avoid delays in discharge and inconvenience to patients and their carers.

Patients must always be dispensed supplies of medicines which comply with current legal and good practice requirements.

Patient information leaflets must be provided within all packs of dispensed medicines wherever possible. Additional leaflets and cards will be provided or updated for specific medicines eg. steroids, anticoagulants, mono-amine oxidase inhibitors (MAOIs).

Compliance aids such as spacers for inhalers must be specified upon prescriptions to ensure supply. Pharmacy staff will routinely query obvious needs eg. spacers for inhalers, but this should not solely be relied upon.

5ml spoons will be supplied as standard for administering liquid medicines. Administration instructions will be in multiples of 5ml spoonfuls.

Oral syringes will routinely be supplied for young children and for adults requiring doses which are not multiples of 5ml. A separate oral syringe will be supplied for each prescribed liquid. Each syringe will be marked to indicate the volume of liquid to be

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drawn up. A bung to fix into the neck of each bottle will be supplied along with an instruction leaflet.

Process for Discharge Prescriptions (TTOs)

Doctors are responsible for ensuring that TTO prescriptions are written leaving sufficient time for them to be checked and dispensed without delaying discharge.

Wards should endeavour to retain newly written TTO prescriptions on the ward until the pharmacist or pharmacy technician visits at their agreed time. Those wards provided with a TTO bleep service should bleep the pharmacist/technician when there is a new TTO on the ward ready for checking. The ward pharmacy staff will check the TTO against the inpatient kardex for transcription errors and other problems, allowing the kardex to be retained on the ward.

In the absence of ward pharmacy staff being available, the TTO prescription plus the corresponding inpatient kardex(es) must be sent to Pharmacy giving sufficient time for them to be dispensed and returned to the ward before the patient is discharged, ideally 24 hours. Any medicines which have been individually supplied and labelled for the patient being discharged (and usually stored in their bedside medicines cabinet) must be sent to Pharmacy along with the prescription and the kardex.

The date and if possible, the time of discharge should be written on the TTO prescription (ICE does this automatically).

The prescriber are encouraged to prescribe every medication that the patient is taking and not just those that are required for discharge. Where supplies of medicines are not required this should be indicated. Each patient will normally receive at least 14 days supply from Pharmacy (more may be given over a bank holiday). This should allow sufficient time for the discharge letter to get to the General Practitioner (GP) before replenishment of their supplies is necessary.

In an emergency, out of hours, the on-call Pharmacist should be contacted for advice; pre-packs are available in Accident and Emergency Rooms and on some wards. Pharmacy does NOT routinely dispense TTOs out of hours.

Nurses MUST NEVER ‘dispense’ from general ward stock for patients going home as this is specifically prohibited within the terms of the Medicines Act 1968. The Trust will accept no responsibility should a drug related incident occur in these circumstances. Provision for emergency and out-of-hours supplies of medicines are detailed in section 2.11.

On discharge, nurses may supply/hand over to patients their ‘patients’ own medications’ and medications dispensed ‘ready for discharge’ by Pharmacy eg. original packs, non-formulary drugs, inhalers, topical formulations and other drugs labelled for that patient with instructions for use. These medicines are usually kept in the patient’s bedside medicines locker. The TTO will be endorsed “from ward” or “POD” by Pharmacy for such drugs when they have not been dispensed and supplied in the bag along with other TTO medicines.

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DELIVERY OF DRUGS, RECEIPT OF DELIVERIES & COLLECTION FROM PHARMACY

Click here to go to the SOP for safe storage & security of medicines which gives details about delivery and collection

Liquid nitrogen will only be delivered in well-maintained, dewar flasks, specifically designed for this use.

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DISPENSING OF MEDICINES FOR OUTPATIENT PRESCRIPTIONS

Prescription charges and exemptions. Prescription charges at the national rate will apply to all non-exempt patients.

Information upon pre-payment will be provided to patients where this may help them to reduce the financial burden.

If payment cannot be made, a reduced emergency supply will be made. The patient will be requested to return for the rest of the prescribed quantity along with payment.

Proof of exemption or pre-payment will be required from patients claiming exemption.

Signing backs of prescriptions.The details required on the backs of the prescriptions, including signatures are required from patients, relatives or messengers must be completed.

Patient information leafletsPatient information leaflets should be provided within all packs of dispensed medicines. Additional leaflets and cards will be provided for specific medicines eg. steroids, anticoagulants, MAOIs, lithium.

Compliance aidsCompliance aids such as spacers for inhalers must be specified upon prescriptions to ensure supply. Pharmacy staff will routinely query obvious needs eg. spacers for inhalers, devices for insulin injection etc but this should not solely be relied upon.

Liquid measures and instructions Administration instructions will usually be in multiples of 5ml spoonfuls. 5ml spoons will be supplied as standard for administering liquid medicines. Oral syringes will routinely be supplied for young children and for adults

requiring doses which are not multiples of 5ml. A separate oral syringe will be supplied for each prescribed liquid. Each syringe will be marked to indicate the volume of liquid to be drawn up. A bung to fix into the neck of each bottle will be supplied along with an instruction leaflet.

Duration of supply A maximum of 28 days supply will be dispensed for the majority of outpatient

medicines if a quantity is not specified, unless circumstances dictate that a different supply is necessary.

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If a quantity is not indicated, only seven days supply of antibiotics, short term hypnotics and analgesics will be provided. Single original packs of inhalers, topical preparations and other devices will be dispensed.

No more than 14 days supply will be dispensed to any patient considered to be at risk of suicide.

7 days supply will usually be provided for prescriptions from Accident and Emergency.

Longer durations of supply can be made in some situations including: Hospital only medicines - these cannot be prescribed by GPs Clinical trial medicines Pulsed / cyclical treatment Antidepressants prescribed by consultant psychiatrists to ensure

continuity of treatment Reducing doses of drugs e.g. steroids Drugs for tuberculosis treatment Haematology-oncology treatment Donepezil (prescribed by named consultants only) Drugs to ensure continuous supply over public / bank holidays Courses of antibiotics for acute treatment When packs cannot be split Other situations when it is considered appropriate

Owings If Pharmacy does not hold enough stock to make a supply to a patient they will

make arrangements with the patient for notification and collection/delivery when the supply is obtained. If the prescribed medicine is considered urgent, the prescriber may be consulted to discuss alternative treatments, should a delay in treatment be detrimental.

Handover of dispensed medicinesPharmacy staff may require proof of identification and reserve the right to refuse hand-over of dispensed prescriptions unless they are satisfied of the authority of the person collecting. Members of staff collecting prescriptions on patients’ behalf will be asked to sign the pharmacy record book for collection.

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CONTAINERS

Child-resistant containers (CRCs) are used routinely on discharge and out patient items. If a member of the ward staff feels that CRCs would be difficult for the patient to open, plain tops will be fitted provided that the prescriber writes ‘No-CRC’ on the TTO or outpatient prescription

The likelihood of children coming into contact with the medicines should be considered

Liquid nitrogen will only be supplied in suitable, purpose-designed dewar flasks which are in good condition

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EMERGENCY CARDIAC ARREST BOXES

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Opened cardiac arrest boxes must be returned to the store in the Cardio-Respiratory Department as soon as possible and a replacement obtained.

The store is usually checked twice a day by Pharmacy staff to ensure there are sufficient boxes available.

In the event of no boxes being available contact the Pharmacy Department. Out of hours, the On-Call Pharmacist can be contacted via Switchboard.

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MEDICINES REQUIRED URGENTLY AND IN EMERGENCIES

During working hours, Pharmacy should be called. In a true emergency scenario it is imperative that, before relating any details, ward/dept staff ask to speak immediately to a pharmacist in order to prevent delays.

Outside of Pharmacy hours, urgent supplies of medicines may be obtained from the Pharmacy Emergency Supply Room. The Trust Site Managers (Bed Managers) have access to the swipe card/fob and procedures to access this room. Ward staff should call the Site Manager to make arrangements for obtaining stock of medicines from this room. They will need to accompany the site manager to the room with the relevant inpatient kardex. Documentation and signatures are required for any stock removed from the room. Pharmacy staff check the room daily to update records and stocks.

If the medicine is unavailable from the Emergency Supply Room, the doctor or a senior registered practitioner on the ward should contact the on-call pharmacist via Switchboard for advice. The on-call pharmacist has on-line access to hospital stock lists and the Pharmacy computer system and may be able to locate supplies of the medicine elsewhere in the hospital. Alternative treatments may also be discussed. If supplies of a medicine are to be obtained from another ward, the procedure for transfer of medicines must be followed to ensure an audit trail and security is maintained. Pharmacy is open seven days a week so the need for an emergency supply may also be discussed. In the event of the medicine not being available on another ward and confirmation that an urgent supply is necessary, the on-call pharmacist will advise upon the necessary action. This may involve coming in to dispense the medicine from Pharmacy stocks or sourcing the medicine from another hospital or wholesaler.

A list of critical medicines where timeliness of administration is crucial is available. If for any reason a medicine on this list cannot be administered, the doctor responsible for the patient must be informed immediately and the appropriate drug omission code should be used to indicate the reason why. If a patient is likely to suffer a detrimental effect due to non-administration it is the nurse’s responsibility to take timely action, as outlined above and an IR1 should be completed. In some situations eg. acute infection, even the missing of one dose can be serious.

It is the responsibility of the administering nurse/midwife to ensure the drug is obtained as outlined above. The non-administration of a medicine in accordance with a prescription without taking the necessary action to remedy the situation is a matter of professional misconduct or negligence.

Medicines for discharge, outside of normal hours. Several locations within the hospitals have been provided with ‘out of hours’ cupboards. These contain stocks of pre-labelled, ready for discharge, commonly prescribed medicines. They may be used outside of normal Pharmacy hours. Standard operating procedures exist for their use.

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In brief, only registered nursing, midwifery or Pharmacy staff may dispense from these cupboards. Packs may only be removed if there is a valid prescription written by an approved prescriber. The patient’s name and the date of dispensing must be written on each pack supplied. Details of the packs dispensed must be noted upon the prescription. The dispensed prescription must be checked by checked by a second registered nurse/midwife, pharmacist or doctor. At the time of writing, ‘out of hours’ cupboards are available on A&E, Paediatrics, Maternity, Admissions Units.

Please note that the on-call pharmacist will NOT routinely dispense TTOs.

Major incidents/pandemics etc. The most senior pharmacist available will liaise with key Trust staff in accordance with the Major Incident Plans. In order to manage a particular emergency it may be necessary to waive or vary elements of the Medicines Policy. This will only be conducted with the approval and instruction of the pharmacist in charge at the time of the emergency. Approval of other key senior staff eg. Medical Director, Nursing Director may also be required. Variances will be reported to the Trust Major Incident Management Team at an appropriate time. Normal practice will be resumed at the earliest appropriate opportunity.

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OVER THE COUNTER (OTC) MEDICINES

The Drug and Therapeutics Group will approve the list of OTC drugs sold from retail outlets within the Trust eg. WHSmith

In the event of staff or relatives requiring an OTC medicine, they must be obtained from an official outlet and NOT from ward stocks

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ASEPTIC DISPENSING AND MANUFACTURING

Pharmacy provides an aseptic dispensing and manufacturing service for intravenous medicines. All preparation of cytotoxic chemotherapy and TPN within the Trust will be made by the Pharmacy Aseptic Unit. Other intravenous products are prepared within the Unit such as intravenous antibiotics and biologic products such as monoclonal antibodies. The Unit is strictly regulated and is inspected annually by Quality Control North West. The Unit is MHRA-licensed for manufacture of unlicensed special intravenous products and is inspected by the MHRA.

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24.HOMECARE DELIVERY OF MEDICINES

Homecare delivery of medicines involves a third party ‘homecare’ pharmacy dispensing hospital prescriptions and delivering dispensed medicines directly to the patients.

Homecare delivery is particularly suitable for repeat supplies of long-term, high-cost specialist medicines. This removed the need for patients having to come to hospital to collect prescriptions and await them being dispensed by the hospital pharmacy. The ongoing care, monitoring and review of the patients remains the responsibility of the relevant hospital specialist.

The Trust only uses homecare delivery suppliers as follows: Suppliers designated as the sole homecare supplier by the drug manufacturer or Suppliers who are listed in the NW Homecare Delivery Contract Framework

Before use of a particular ‘approved’ supplier for the first time for a specific medicine, Pharmacy and the consultant specialist will confirm that the supplier can meet the Trust’s requirements to ensure safe and timely supply of medicines to our patients. This may require the provision of sharps boxes, collection and safe disposal of sharps. The details of the service which will be provided will be summarised in a Service Level Agreement (SLA) which will be signed by representatives of Pharmacy and the homecare delivery supplier.

Patients will be offered the choice of supply of their medicines by homecare delivery or by the hospital pharmacy. All patients will be provided with an information leaflet explaining homecare delivery, along with explanation of the service before a decision is made. Patients are not obliged to agree to homecare delivery. Patients may opt out of homecare delivery at any time by communicating their wishes to their consultant specialist or pharmacy.

Once a patient has opted to receive homecare delivery of their medicines they will be registered with the relevant homecare delivery supplier. A patient registration form will be completed. One copy will be provided to Pharmacy and one copy will be kept in the patient’s medical records.

The specialist will provide a prescription for the required medicine(s) to Pharmacy. A pharmacist will clinically check the accuracy of the prescription to the same standard as for hospital-dispensed prescriptions. If the prescription is correct and safe to dispense it will then be posted to the homecare delivery supplier.

The homecare delivery company will then contact the patient to confirm arrangements such as contact details, delivery dates, times for delivery etc.

The pharmacy of the homecare delivery supplier will then dispense the medicines to the standards specified in the contract and also the General Pharmaceutical Council and CQC. Delivery of the medicines to the patient will then be arranged and carried out.

Confirmation of delivery and details of each supply made will be provided to the hospital pharmacy. Pharmacy will then check that the details are correct and record the supplies in the Pharmacy JAC system.

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performance will be provided to the supplying company, the lead for the NW homecare contract framework (curently SBS), the NW technical services pharmacist for procurement and the drug manufacturer if appropriate (eg. when the manufacturer specifies a sole homecare supplier).

Homecare delivery will be co-ordinated and managed within Pharmacy by the Pharmacy Procurement Team.

The Trust is committed to developing the management of homecare delivery to implement the recommendations of national guidance on homecare delivery.

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25.PATIENTS OWN DRUGS (PODs)

Patients own drugs may be used for inpatients and on discharge in accordance with the algorithm below. PODs may only be used for the patients named on the labels.

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26.STORAGE OF MEDICINES

The Trust SOP for the Safe Storage & Security of Medicines contains both policy requirements and detailed advice. This SOP replaces the section on medicines storage and security which was in previous editions of the Medicines Policy.

Click this link to access the SOP via Medicines Resources Intranet site

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27.ADMINISTRATION OF MEDICINES

The Medicines Resources Intranet site provides a detailed section on medicines administration. This lists the Trust SOPs for administration of different types of medicines, providing both policy requirements and detailed procedural instructions.

The NMC provides standards for medicines management, including administration of medicines. These are supported by the Trust.

The SOP for ‘General Principles of Medicines Administration’ underpins all of the SOPs.

Please click this link to go the Medicines Resources Intranet site section on Medicines Administration

Action if there is any concern about a prescription before administrationIf there is any doubt about the clarity, accuracy, appropriateness or legality of a prescription, or if the registered practitioner does not understand the prescription, he/she must consult the prescriber and ask for clarification. The prescriber or on-call doctor must re-write the prescription or administer the medicine personally. If the prescriber refuses to re-write the prescription, the registered practitioner must not administer the dose but should contact his or her manager, or a more senior member of medical staff.

Medicines optimisation – understanding the patient’s experienceUp to 50% of patients do not take their medicines as recommended. To ensure the best possible outcome from medicines, there must be an ongoing, open dialogue with the patient and/or their carer(s) about the patient’s choice and experience of using medicines to manage their condition. It must be recognised that a patient’s experience may change over time even if their medicines do not.

Controlled drugs (CDs) – follow this link

Cytotoxic chemotherapy – follow this link

Blood products – are not covered by the Medicines Policy

Epidural & spinal injections & infusions are high risk routes and may only be administered by individuals who have undergone specific training and demonstrated competence.

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NON-WRITTEN PRESCRIPTIONS

No medication should be normally administered to a patient in the absence of a valid written prescription. There are currently some exceptions:

Emergency Situations In situations of extreme urgency a qualified registered practitioner may accept verbal

prescriptions BUT NOT FOR CONTROLLED DRUGS, INSULIN OR IV POTASSIUM.

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The doctor should undertake to sign the entry on the drug prescription sheet within 12 hours.

Signatures still required at the end of the period of duty must be highlighted at shift handover, signatures outstanding after 12 hours must be notified to the Matron

In an emergency situation when drugs are given by the Doctor or by a registered practitioner in the presence of a Doctor without written prescriptions, the registered practitioner preparing the drug must show the labelled container to the doctor before the drug is administered. This will enable them to reaffirm the verbal prescription and avoid the possibility of mistakes being made.

The initials of the person administering the drug and witness must be recorded in the administration section of the prescription also.

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Verbal Prescriptions By Telephone

The following must be adhered to: The prescribing Doctor clearly spells out the name of the drug, the dosage and the

times to be given. This should be repeated back to the Doctor by the registered practitioner.

In the interests of both parties, wherever possible, the Doctor should repeat the message to a second person acting as a witness. It is appreciated however, that this cannot happen when the registered practitioner is alone.

In the event of a Doctor refusing to comply with the above procedure, nurses, midwives and ODP’s are advised to refuse to administer the drug.

The nurse/midwife/ODP will enter the details of the drug on the drug prescription sheet, indicating the time of the telephone call

Patient Group Directions (PGDs)

Click this link to go to the section on PGDs

Homely remedies At the time of writing this Policy a PGD for nurse/midwife administration of homely

remedies without a prescription is under development. Homely remedies include medicines such as paracetamol, senna, lactulose, chlopheniramine.

An authorised Trust prescriber must prescribe all doses of these medicines unless a relevant PGD is applicable.

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USE OF PATIENTS’ OWN DRUGS (PODs)

Patients’ own medications may be used for inpatients only if of suitable quality for use and for the individual named patient only. Whenever possible PODs will be checked by Pharmacy staff for suitability. However, outside of Pharmacy hours, to avoid delaying or missing a dose, nurses may assess PODs and if suitable for use, administer a dose.Click this link to go to the checklist for suitability of PODs for use

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SELF-ADMINISTRATION OF MEDICINES

Supervised self-administration. On all wards & departments, registered practitioners may supervise the self-administration of a medicine by a patient whilst maintaining responsibility for the safe storage and safe administration of the medicine. The registered practitioner is responsible for assessing the patient’s capability for supervised self-administration. The patient’s ability may change over time, therefore reassessment must be undertaken regularly. Knowledge of a patient’s ability to correctly administer medicines without supervision at home is particularly important prior to discharge from hospital. Supervised self-administration is particularly useful prior to discharge and may accompany training on the correct use of medicines. Common examples of medicines which are suitable for supervised self-administration and which may require training include inhalers, creams, eye drops, pre-filled insulin pens.

Security of self-administered medicines. Ward staff must ensure the security of medicines being self-administered by patients. These should normally be stored in the locked bedside medicines lockers or the CD cupboard or fridge if appropriate.

Rescue medicines. Patients may keep rescue medicines such as salbutamol inhalers and GTN sprays at the bedside when appropriate. The ability to competently self-administer these medicines must be confirmed. These patients must be instructed to advise the nursing staff of any use as soon as possible so that the administration can be recorded on the medicines kardex.

Symptom-relief medicines (low risk). Patients may keep low risk medicines for ‘as required’ symptom relief at the bedside if appropriate. Such medicines will include artificial saliva, artificial tears, emollients & moisturisers, throat lozenges (eg. Strepsils). The ability to competently self-administer these medicines must be confirmed. These patients must be instructed to advise the nursing staff of any use so that the administration can be recorded on the medicines kardex.

Independent self-medication. The Trust Policy for Self Administration of Medicines gives detailed guidance on the management of independent self-administration where patients may be given responsibility for the storage and administration of their medicines. This Procedure is not in widespread use and the Deputy Director of Nursing and Midwifery or the Head of Pharmacy should be contacted for further advice by any wards/depts considering full patient self-administration. This Policy is included as Appendix 1 at the end of this Policy.

Non-approved self-administration. The concealed and non-approved administration of medicines to patients by themselves or by relations or visitors is highly dangerous. This includes any medicine which is administered without the knowledge of nursing or clinical staff. Any such incidents must be reported to the ward manager or lead clinician immediately. Details of the medicines administered must be sought and a member of medical staff must be informed. Other action should be determined according to the circumstances and medicines involved. The incident must be documented in the medical notes and reported on Datix.

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COVERT ADMINISTRATION OF MEDICINES

Guidance on Trust policy is available regarding administration of medicines to adult patients who refuse medicines and who are judged to lack the capacity to give consent. Click here to go to the Covert Medicines Guidance.

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ADMINISTRATION OF CYTOTOXIC CHEMOTHERAPY

Vinca alkaloids. Click here to access the policy which includes requirements for administration

Oral anticancer medicines. Click here to access the policy which includes requirements for administration

IntraTHECAL chemotherapy. A separate policy exists for intrathecal chemotherapy

Authorisation to administer cytotoxic chemotherapy. Cancer chemotherapy can only be administered by authorised medical and

nursing staff. Medical staff must be authorised by the supervising consultant who is

experienced in the administration of cytotoxic chemotherapy after receiving specific training.

Registered nurses must have successfully attended a post registration IV study day and have undergone training and assessment in intravenous and/or other routes of cytotoxic drug administration.

The Trust follows Merseyside & Cheshire Cancer Network procedures & guidelines for administration and management of cancer chemotherapy. This information is available via the internet and within folders held on Ward 2a and in the Lilac Centre. This information includes action required for extravasation.

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TAKE HOME MEDICATIONS (TTOS) – SUPPLY TO PATIENTS ON WARDS

Take home medications will normally be explained and handed over to patients on wards by nursing or midwifery staff in accordance with Trust Policy for Discharging Patients.

Nurses must never dispense from ward stocks for patients going home as this is specifically prohibited within the terms of the Medicines Act (1968). Some wards have designated pre-dispensed, ready-labelled medicines suitable for supplying outside of Pharmacy hours in accordance with an SOP for this purpose.

Arranging for Pharmacy to supply TTO medicines Careful discharge planning should ensure sufficient time for for TTOs to be

dispensed and returned to the ward so as not to delay discharge. The take home prescription must be written on ICE discharge and approved by the

prescriber. Whenever possible, the ward staff should liaise closely with their ward pharmacy team to arrange for the TTO prescription to be checked on the ward.

If it is not possible for pharmacy staff to check the TTOs on the ward within a suitable timescale, the TTO must be sent to Pharmacy along with the inpatient prescription kardexes, patients own drugs (PODs) and any individually labelled medicines such as inhalers, creams, eye drops etc.

Receipt of dispensed TTO medicines on wards. All take home medication should be checked against the TTO prescription by a

Registered Nurse/Midwife, upon arrival on the ward from Pharmacy. An entry must be made in the patient’s case sheet stating that the medication is

correct, dated and signed by the checking nurse. All take home medication must then be stored in a locked drug cupboard specifically

identified for this purpose, until the patient is discharged

Upon discharge. All take home medication must be checked by a registered nurse/midwife together

with the patient/relative (where appropriate) just before the patient leaves the ward. An entry must be made in the patient’s case sheet stating that the medication is

correct, dated & signed by the Nurse and the patient/relative Where the patient/relative is unable or refuses to sign the case sheet, the check

must be made by two nurses who must both sign the case sheet. The registered nurse/midwife must always be satisfied of the correct identity of the

patient before handing over medicines. When a patient has already left the ward, a relation or other person may return to the

ward to collect the take-home medicines. Ward staff must be assured of the identity and authority of the person presenting for collection prior to handing medicines over.

TTOs with controlled drugs (CDs) Nursing staff must follow the process described in the Trust SOPs for Controlled

Drugs

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28.MISCELLANEOUS

DRUG INCIDENTS

Drug incidents may include prescribing, supply or administration errors, loss or wastage of a drug, or product faults.Drug incidents will be managed in accordance with the Trust Incident Reporting and Management Policy.For drug administration incidents, brief medicines-specific guidance on use of the Trust Incident Reporting & Management Policy is provided in the SOP for Administration of Medicines – General PrinciplesIf a drug incident occurs then the following people must be informed immediately:

The ward/dept manager or nurse in charge of the ward or department The doctor concerned if inappropriate administration of a drug has occurred The matron or site manager, if out of hours A pharmacist, if the incident involves loss of a drug A pharmacist for advice on drug effects and management if administered

An Datix report must be completedIncidents, including those involving drugs will be reviewed at Care Group Governance meetings, Trust Medicines Safety Group and the Patient safety Council on a regular basis.

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DRUG DEFECT REPORTING

All Hospitals are required to comply with strict procedures for the notification of defects found in medicinal products. Anyone becoming aware of a defective medicine should contact a pharmacist without delay (out of hours - contact the on-call pharmacist). This will enable the pharmacist to institute a local recall of that batch and notify the Department of Health so that a warning can be cascaded throughout the NHS.

Alerts giving warnings about the safety of medicines may be received from a number of sources including the MHRA, CSM, NPSA, local alerts. The Pharmacy is a member of a National cascade system which makes provision for in-hours and out-of-hours alerts. Upon receipt of a new alert Pharmacy staff will follow departmental procedure. Briefly, this requires an assessment of the relevance of the alert to the Trust. Cascade of information within the Trust and/or recall of affected products will be conducted as appropriate and within timescales specified within the alerts. If the alert relates to treatment which patients of the Trust have received, the relevant clinical directors and consultants will be notified immediately. Documentation will be completed and retained in the Medicines Information section of Pharmacy.

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ADVERSE DRUG REACTION REPORTING

All staff with involved with medicines (doctors, registered practitioners and pharmacists) are strongly urged to report or to prompt the submission of a report of any suspected adverse drug reaction (ADR). If in doubt, or unsure of procedure, please seek the advice of a ward pharmacist or Pharmacy Medicines Information on ext 1565. The British National Formulary (BNF) provides advice about reporting ADRs.

What to Report

New drugs (marked in the BNF with an inverted black triangle) Report all suspected reactions, however minor, which could be attributed to the drug. The reaction should be reported even if well-recognised or if you are unsure of the

causal relationship

Established drugs Report serious suspected reactions, including fatal, life threatening, disabling or

incapacitating events Report a serious reaction even if it is already well recognised Do not report minor reactions for established drugs Report all reactions, including minor ones, for children aged under 18 years.

How to ReportYellow cards for reporting ADRs to the CSM are available

In the BNF Via the Trust Medicines Resources Intranet site page on Adverse Drug Reactions On the internet at www.yellowcard.gov.uk

When completing the form, please give details, if possible of brand name and batch number. This is particularly important for:

Over the counter drugs Slow or delayed-release formulations Vaccines Biotechnology products eg. Human growth hormone

Where to ReportCompleted hard-copy forms should be sent to the Committee on Safety of Medicines (CSM) via the Pharmacy Medicines Information.

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SUSPECTED THEFT OR FRAUDULENT PROCUREMENT OF MEDICINES

In some circumstances there may not be enough evidence to determine if an incident has occurred or not. An example is if the usage of a drug on a ward increases without obvious explanation relating to clinical activity. Some drugs have been implicated in theft and abuse more than others. In particular staff should be vigilant for unexplained usage of the following:

Codeine Co-codamol Co-dydramol

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Dihydrocodeine All benzodiazepines eg. diazepam, nitrazepam, lorazepam, midazolam Zopiclone, zolpidem and zaleplon Cyclizine Nicotine replacement treatment Weight loss products Impotence treatments Drugs with potential for abuse in sport or bodybuilding

Theft and fraudulent procurement can occur from ward stocks, non-stock medicines and patient’s own medicines.

If theft of fraudulent procurement of medicines is suspected, this must be reported immediately to a matron/Dept Manager, Deputy Director of Nursing, the Head of Pharmacy (or deputy), clinical director. The Trust’s Local Counter Fraud Specialist, NHS Protect Local Security Management Specialist and the Police may be contacted to advise and to investigate.

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LIQUID NITROGEN

Liquid nitrogen is a cryogenic liquid gas which is used in cryotherapy performed within Dermatology clinics. It is stored in specialised storage flasks in purpose-designed stores which have good ventilation. At Whiston Hospital it may only be dispensed by specifically trained pharmacy or portering staff. At St Helens Hospital it may only be dispensed by specifically trained pharmacy, portering or nursing staff. Dispensing of liquid nitrogen will be in accordance with a specific SOP. Flasks containing liquid nitrogen must never be transported in a lift or stored in a confined space due to the risk of asphyxiation.

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DISPOSAL OF UNNEEDED & EXPIRED MEDICINES AND WASTE

Empty medicines boxes should be disposed of in accordance with the Trust’s Waste Management Policy & Guidelines. Folders providing instruction on waste management are available in all clinical areas.

Patient identifiable labels must be removed before disposing of empty medicines containers in the black waste bags. These labels must be disposed of in accordance with procedures for disposing of other patient-identifiable confidential waste.

Part-administered doses of injections of infusions in clinical areas should be disposed of using the appropriate sharps disposal bins. Gel Vac sachets are available to absorb liquid medicines within sharps bins in order to reduce the risk of splashes and render any drug residue unusable.

All packs of medicines which are no longer required, including non-stock medicines, patients’ own drugs, expired medicines must be placed in a Pharmacy Returns bin (Glasdon Bin) if available or otherwise securely stored in the clinical area before returning securely to Pharmacy for processing. Details are provided in the Trust SOP for Safe Storage and Security of Medicines.

Pharmacy does not re-use plastic or glass bottles. Empty glass bottles should be disposed of in the glass bins provided.

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All unusable medicines, including all patients own drugs are processed in accordance with Pharmacy procedures for handling waste.

Leeches and maggots are disposed of as per 5.7. Returns to Pharmacy are detailed in the SOP for Safe Storage and Security of

Medicines

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LEECHES AND MAGGOTS

Biotherapy with leeches and maggots is conducted within the Trust. Therapy must be prescribed as for the generic standards detailed for other drugs. SOPs are available which provide detailed guidance upon their supply, use and disposal. Guidance on their use is available from Pharmacy and clinical staff who are experienced in their use. Maggots and leeches may only be used once in a named patient. After use they are killed in accordance with the relevant SOP. The subsequent waste is disposed of as per the Infection Control Policy guidance for infectious waste. They are double bagged in yellow clinical waste bags. The waste management team are then contacted, who will arrange for collection and destruction by incineration.

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MEDICAL GASES

Medical gases including oxygen, medical air and nitrous oxide are licensed medicines. The storage, transport and maintenance of equipment relating to medical gases is managed on behalf of the Trust by Vinci FM and overseen through the Trust Medical Gases Committee. Testing of the medical gas storage and distribution system (piping) is contracted on the Trust’s behalf to Pharmaceutical Quality Control North West (QCNW). The clinical management of medical gases is managed by the Trust’s Oxygen Steering Group. The clinical use of oxygen and medical air is covered by the Trust SOP for Management of Medical Gases, Oxygen and Medical Air.

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MEDICINES-RELATED POLICIES, PROCEDURES, PROTOCOLS AND GUIDELINES

Medicines-related policies, procedures, protocols and guidelines should be approved by the Trust’s Drug and Therapeutics Group or Medicines Safety Group before implementation. Documents must comply with the standards specified in the relevant Trust policy for document control where appropriate. Before producing such documents, staff are advised to consult a pharmacist who will then provide guidance or will refer on to an appropriate colleague.

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29.PROCESS FOR IMPLEMENTING THE MEDICINES POLICY

The Medicines Policy and subsequent updates will be implemented by the following: Trust Team Brief Global e-mail to all staff following approval of new version Publication on the Trust Intranet including the Medicines Resources Intranet Site Inclusion in Trust induction for all new clinical staff Inclusion in Mandatory Training on Medicines for all clinical staff Inclusion in the foundation stage junior doctors teaching curriculum including an

extended induction session Medicines management link nurses Updates to ward and clinical areas presented by pharmacists on an ongoing basis as

requested or required

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30.EDUCATION AND TRAINING

Training required to fulfil this Policy will be provided in accordance with the Trust’s Induction Mandatory and Risk Management Training Policy – Training Needs Analysis.

The Policy and key messages are included within the Trust Mandatory Training on Medicines Optimisation which is provided to all clinical staff.

The Medicines Policy and key medicines management messages are highlighted to all new Trust clinical staff at Trust induction.

Detailed aspects of prescribing, including the Medicines Policy are included in the foundation stage doctors induction programme and their curriculum for education on prescribing.

Training for nursing staff with specific medicines components includes the Trust’s intravenous administration course and preceptor nurse study days.

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31.MONITORING OF THIS POLICY

Monitoring of compliance with this Policy will be overseen by the Clinical Effectiveness Council

Key Performance Indicators of this PolicyProcess for prescribing and accuracy of prescriptions

Annual review Head of Pharmacy

Mandatory Training Monthly Assistant Director of HR

Medicines-related incidents Quarterly Head of Pharmacy

Aspect of compliance or effectiveness being monitored

Monitoring method

Individual responsible for the monitoring

Frequency of the monitoring activity

Group / committee which will receive the findings/monitoring report

Group / committee / individual responsible for ensuring that the actions are completed

a Process for prescribing medicines

Scheduled pharmacist visits to wards

Pharmacists

Daily or as scheduled

Clinical Effectiveness Council

Medicines Safety Group

b Process for ensuring the accuracy of all prescription charts.

a) Annual standards of prescribing reviewb) Pharmacist intervention monitoring

Pharmacy a) Annualb) Annual

Clinical Effectiveness Council

Medicines Safety Group

c Mandatory training Monitoring of ESR and Trust performance management reports

Assistant Director of HR (Organisational Development)

Monthly HR Council

d Medicines-related incidents

Review of incidents reported on Datix

Principal Pharmacist

Quarterly Patient Safety Council

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32.COUNTER FRAUD STATEMENT

Staff are reminded that to make a fraudulent claim is, potentially, a criminal offence as well as being contrary to Trust policies. Contacting your Local Counter Fraud Specialist (LCFS) with any concerns will not breach the Data Protection Act as section 29 (3) of the Act allows for the release of information for the ‘prevention and detection of crime’. Your Local Counter Fraud Specialist can be contacted on 0161 206 8162. Alternatively, information can be given to the confidential NHS Fraud and Corruption Reporting Line (FCRL) by phoning 0800 0284060. The FCRL is a Freephone number and a simple means of reporting concerns about NHS fraud. It allows NHS staff who are unsure of internal reporting procedures or who wish to speak with complete confidentiality to report their concerns. All calls are dealt with by experienced, trained staff and callers may remain anonymous if they wish. You can also report online at www.reportnhsfraud.nhs.uk.

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33.REFERENCES / BIBLIOGRAPHY

The Medicines Act 1968 and subsequent amendments The Misuse of Drugs Act 1971 and subsequent amendments The Safe and Secure Handling of Medicines – A Team Approach (RPSGB 2005) Good practice in prescribing medicines – guidance for doctors (GMC 2013) Standards of conduct, performance and ethics for nurses and midwives (NMC 2008) Standards for Medicines Management (NMC 2010) Medicines, ethics and practice – a guide for pharmacists (RPSGB 2014) British National Formulary (Sept 2014) BNF for Children 2014-15 The Best Medicine: The Management of Medicines in Acute and Specialist Trusts (HCC

2007) NHSLA Risk Management Standards for NHS Trusts providing Acute, Community or

mental Health & learning Services and Independent Sector Providers of NHS Care CQC Guidance for providers on meeting the regulations (March 2015)

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34.POLICY HISTORY

Date Version Author Designation

Summary of key changes

1.2.08 2 Head of Pharmacy

Update of previous Policy

9.6.11 3 Head of Pharmacy

Complete revision of the Policy to reflect NHSLA, Standard 4, Criterion 5 requirements: The NHSLA Risk Management Standards for NHS Trusts providing Acute, Community or mental Health & learning Services and Independent Sector Providers of NHS Care

Replacement of the term ‘nurse/midwife’ with ‘registered practitioner’ to recognise that ODPs now have legal status in medicines management processes.

Incorporation of stronger counter fraud statements Inclusion of the Policy for Self-medication as an appendix rather than a

stand-alone policy Inclusion of ‘Standards of Prescribing’ assessment tools for prescription

accuracy as appendices

1.3.12 3.01 Head of Pharmacy

Added in requirement to report when no planned ward pharmacist visit can be provided

Updated pharmacist checking and endorsement details to correspond with new kardexes

Removed obsolete references to ‘yellow label’ supplies

25.11.13 3.02 Head of Pharmacy Amend discrepancy between Policy and SOP for intravenous drug

administration – section 4.4.3, page 45

18.3.14 3.03 Head of Pharmacy

Extension of review date recommended by Drug & Therapeutics Committee and approved by Clinical Effectiveness Council

Updates relating to medicines security and administration of medicines to ensure consistency between policy and relevant Trust SOPs

Additional contents section added to aid location of medicines security information

Update relating to GMC guidance on prescribing for persons with whom there is a close personal relationship

Reference to ICE electronic discharge prescriptions

24.10.14 3.04 Head of Pharmacy

Extension to review date recommended by Drug & Therapeutics Group Signposting to the Medicines Resources intranet site added throughout

the Policy Change of name of Drug & Therapeutics Committee to Drug &

Therapeutics Group (DTC to DTG) Reference to Medicines Safety Group (MSG) Reference to electronic prescribing implementation in 2015

17.6.15 4 Head of Pharmacy

Reformatting in line with revised Trust document control policy Hyperlinked contents to aid navigation Use of hyperlinks to web-sites and intranet locations Reduced overlap with other Trust policies & procedures and risk of

non-alignment eg. storage & security, medicines administration Cite Medicines Optimisation Strategy Active references to Medicines Resources Intranet site Enabling statements for ePMA Incorporation of Non-Medical Prescribing Policy Incorporation of Medicines Reconciliation Policy New sections on information sources, NICE, homecare delivery,

antimicrobials, OPAT, patients own drugs, clinical trials Updates to sections on unlicensed medicines, transcribing, self-

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medication, cytotoxics, TTOs References to NHS Protect LSMS in addition to Counterfraud Service

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35.EQUALITY ANALYSIS

Equality Analysis Stage 1 Screening

1 Title of Policy:Organisation-wide Medicines Policy

2 Policy Author(s):Simon Gelder, Head of Pharmacy

3 Lead Executive:Dr Kevin Hardy, Medical Director

4 Policy SponsorDr Kevin Hardy, Medical Director

5 Target Audience All Trust staff involved with the prescribing, supply, administration and handling of medicines

6 Document Purpose: Define the Trust-approved practices relating to the safe and secure handling of medicines for all staff involved in the handling and use of medicines.

Minimise and control the risks to patients, the staff and the organisation associated with medicines

7 Please state how the policy is relevant to the Trusts general equality duties to: eliminate discrimination advance equality of opportunity foster good relations

This is an operational Trust policy which does not have direct relevance to Trust equality duties

8 List key groups involved or to be involved in policy development (e.g. staff side reps, service users, partner agencies) and how these groups will be engaged

This Policy is a revision. Consultation has been held with suitably qualified members of staff including members of the Drug and Therapeutics Committee, Pharmacy, MIAA Local Counter Fraud Specialist.

NB Having read the guidance notes provided when assessing the questions below you must consider; Be very conscious of any indirect or unintentional outcomes of a potentially discriminatory

nature Will the policy create any problems or barriers to any protected group? Will any protected group be excluded because of the policy? Will the policy have a negative impact on community relations? If in any doubt please consult with the Patient and Workforce Equality Lead

9 Does the policy significantly affect one group less or more favorably than another on the basis of: answer ‘Yes/No’ (please add any qualification or explanation to your answer particularly if you answer yes)

Yes/No Comments/ Rationale Race/ethnicity

No Disability (includes Learning Disability,

physical or mental disability and sensory impairment) No

. Gender No

Religion/belief (including non-belief)No

Sexual orientation No

AgeNo

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Gender reassignmentNo

Pregnancy and MaternityNo

Marriage and Civil partnershipNo

Carer statusNo

10 Will the policy affect the Human Rights of any of the above-protected groups?

No

11 If you have identified potential discrimination, are there any exceptions valid, legal and/or justifiable?

N/A

12 If you have identified a negative impact on any of the above-protected groups, can the impact be avoided or reduced by taking different action?

N/A

13How will the effect of the policy be reviewed after implementation?

The Policy will be audited at least annually in line with key performance indicators

If you have entered yes in any of the above boxes you must contact the Patient and Workforce Equality Lead (ext 7609/ [email protected]) to discuss the outcome and ascertain whether a Stage 2 Equality Analysis Assessment must be completed.

Name of manager completing assessment: (must one of the authors) Simon GelderJob Title of Manager completing assessment

Head of PharmacyDate of Completion:

6.5.15

The Trust has a duty as a public body to publish all completed Equality Analysis Screening and Assessments. Please forward a copy of your completed proforma to [email protected]

The Patient and Workforce Equality Lead will conduct an audit on all completed Screening and Assessments every six months.

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36. APPENDICES

Appendices follow on the next pages

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SELF MEDICATION POLICY

INDEX

Section and Contents Page

Introduction 3

Education and training 3

Procedure for self-medication 4

Supply and storage of medication 7

Drug administration errors 8

Discharge procedure 9

Audit and review 9

Appendices

1. Patient consent for self-medication 10

2. Algorithm for the assessment of patients’ ability to self-medicate 11

3. Patient information leaflet 14

4. Medication reminder chart 16

DEFINITION OF TERMS

Self-Medication is the term used to describe the process whereby patients administer their own medication under various levels of supervision by qualified nursing staff.

Compliance in medicine taking can be defined as the patient taking a dose at exactly the correct time and in exactly the correct way.

Concordance is an agreement between a patient and a healthcare professional that respects the beliefs and wishes of a patient in determining whether, when and how medicines are taken.

Nurse – within this Policy, the term nurse refers to both registered nurses and registered midwives

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Appendix 1

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1. INTRODUCTION

1.1 Scope and Implementation

This Policy is a developmental Policy. It is only for use on wards/departments which have been approved by the Trust to implement this Policy, and also those which plan to gain approval in future. Approval to implement this Policy upon a ward or department must be gained from all of the following: Director of Nursing & Midwifery Clinical Director for the relevant directorate Head of PharmacyWards which are not approved to implement this Policy must continue to follow the standards for administration detailed in the Trust Medicines Policy and the Clinical Policies, Procedures, Protocols & Guidelines. Provision for supervised self-administration of medicines is provided.

1.2 Aims

To implement National policy which supports the wider implementation of patient self-medication. To assess and improve patients understanding of their medication in order to improve

concordance and compliance with their medication regime To enable the Trust to fulfil its requirement to have a robust process for patient self-administration

whilst maintaining the safe and secure handling of medicines

1.3 Objectives

To ensure that patients can take their medication correctly during their hospital stay in preparation for discharge.

To identify those patients who need further assistance with their medication in order to improve their compliance. This could be for example in the form of a compliance aid or in the provision of education and information about their medication.

To allow patients experiencing problems to practice taking their medication under supervision. To return custody and control of medication to the patient, thereby promoting involvement,

improving morale and empowering patients to achieve/maintain a greater degree of independence during their stay.

To allow medication to be taken at more appropriate times rather than fixed to nurse drug rounds e.g. pain relief can be taken when required and medication taken on a full or empty stomach where indicated.

To promote a multi-disciplinary approach to the management of patients’ medication. To implement the professional standards and guidance on patient self-administration detailed in

the NMC document ‘Standards for Medicines Management’ 2007.

2. EDUCATION AND TRAINING

Nursing and medical staff working on a ward participating in self-medication must read this Policy and sign to confirm that they have both read and understood the policy. A copy of the self-medication policy and the list of staff signatures will be kept in a file on each participating ward.

Pharmacists, one stop technicians and all nursing staff involved in self-medication should also attend an in-house training session conducted by the Pharmacy department. Bank staff will not be routinely trained unless they regularly work on a participating ward. They should ask for assistance from staff trained in self-medication when conducting medication rounds.

3. PROCEDURE FOR SELF-MEDICATION

3.1 Consent

All patients who participate in self-administration of medication must give their consent to participate. Patients should be informed that participation is entirely voluntary and if they decide to ‘opt out’ their care will not be affected in any manner.

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After being assessed as competent to self-administer medicines the patient will be asked to sign their consent to inclusion in the scheme. The signed consent must be stored in the medical notes (see Appendix 1).

3.2 Assessment

All patients will be assessed by appropriately trained nursing staff, as to their ability to self-medicate whilst in hospital. The Algorithm (see Appendix 2) will be used for this purpose. This nurse will also be responsible for explaining the self-medication scheme to the patient, providing the patient with an explanatory information leaflet (see Appendix 3) and obtaining their signed consent (see Appendix 1).

If the patient is deemed unfit to self-medicate, formal assessment will be delayed until such time that the patient’s condition improves. This should be documented on the assessment form.

3.2.1 Levels of self-medication

Levels ofself-medication

Description

1 Not self-medicating2 Self-medicating under Nurse supervision3 Self-medicating independently

The registered nurse responsible for the patient will assign the patient to one of three levels of self-medication depending upon their assessment. Patients may then move through the level, up or down, as their condition, confidence and competence allow. If a patient’s ability to self-administer their medication changes, this must be recorded on the results of assessment form (Appendix 2).

Patient safety is of paramount importance and caution should be applied at all times. Where a patient’s competency is unclear, or in situations where a patient is assessed as ‘at risk’ of deliberate or accidental overdose, they will be assessed as level 1 (Note exclusion criteria section 4.6).

Level 1 Not self-medicating The nursing staff will administer the medication from the patient’s medication cabinet

The nurse administering the medication initials the inpatient prescription chart.

Level 2 Self-medicating under nurse supervisionThe nursing staff open the patient’s medication cabinet at the appropriate times. The patient administers the medication with nurse supervision, using the medication reminder chart (Appendix 4) as a prompt.

The nurse will be able to assess the patients understanding of their medication and of the process of medicines administration. Also they will be able to observe the patient’s physical ability to read and understand labelling instructions and their ability to open packaging (Any difficulties should be reported to the ward pharmacist).

The nurse initials the inpatient prescription chart.

NB: The master key should be used to open the cabinet for patients on levels 1 and 2. The individual cabinet key must remain stored in a suitable locked cupboard and not issued to the patient.

Level 3 Self-medicatingAn initial period of supervision at level 2 should occur until the trained nurse is satisfied that the patient is competent.

The patient can then move to level 3. The patient is issued with a key to their individual medication cabinet and the patient administers his or her own medication without direct supervision. The patient will be given a medication information chart to aid them.

The nurse should check the in-patient prescription chart for any changes 4 times a day and cross reference this with the medication information chart and update this where necessary.

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The nurse initials the in-patient prescription chart with the self-medication code daily after confirming self-medication with the patient and also signs their own initials.

Medical staff must inform patients who self-medicate when they make a change to their prescription. They should also inform the nurse looking after the patient who should stop the patient self-medicating until new medication is supplied or existing medication re-labelled. It is the nurse looking after the patient who is responsible for removing discontinued medication from the patient’s medication cabinet. The patient must then be re-educated on the changes by the nursing staff and the medicine information chart updated before self-medication can re-commence.

The pharmacy staff will complete a twice weekly tablet count of the patient’s medication to ensure compliance. The result of which will be documented on the nursing assessment documentation. (See Appendix 2).

3.4 Key responsibilities

Key responsibilitiesNursing staff Understand and implement this Policy

Assess patient suitability to self-medicate Patient support and education Check medication chart for changes and remove discontinued

medication Write and update medication information chart Check administration with patient and initial in-patient prescription

chart Documentation Key and medicines security Report all drug administration errors (see Section 5) Participate in reviews and audits of this Policy

Doctor Inform nursing staff and patients of any changes made to medication and amend the in-patient prescription chart

Review any patient where a drug administration error has occurred

Pharmacist and Pharmacy Technician

Education and training to relevant hospital staff on self-medication policy

Checking all medication is suitable for self-medication. Supplying new and further supplies of medication

Patient education and supply of medicine information if necessary Pharmacist to provide second check on the medication information

chart Review of patients referred by nursing staff who may require

compliance aids Investigating drug administration errors Weekly tablet counts Participate in reviews and audits of this Policy

Patient Safe custody of individual locker key and medication

3.5 Checks and controls

Patients participating in self-medication must be assessed by the nurse each day for their ability to continue, during the daily check the nurse must:

1. Check the in-patient prescription chart for changes and update the medication information chart2. Assess if the patient’s ability to self-medicate at the same level has changed

3. Discuss the drug regime with the patient to confirm their understanding4. Document result of the checks on the assessment form (Appendix 2)

3.6 Exclusion criteria

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In the following circumstances patients should be excluded from unsupervised self-medication (level 3): -

Patients with chronic confusion or dementia Patients with a potential to self-harm Patients with a history of alcohol or drug misuse Patients not expected to be responsible for their own medication after discharge i.e. nursing

home patients If there is any other reasons that the patient is thought to be unsuitable by medical, nursing or

pharmacy staff If any other patients in the bay are likely to cause problems with key/drug custody Patients who are unwell, medically unstable or requiring frequent changes to medication or

dose

NB: Depending on the nursing assessment it may be possible for some patients covered by the above to enter Level 2 supervised self-medication.

3.7 Documentation

It is the responsibility of the nurse in charge of the patient to complete the in-patient medication information chart. This must be checked and countersigned by the ward pharmacist before the patient is entered onto level 2 or 3 of the scheme. It is the joint responsibility of the nurse and the pharmacist to educate the patient. The pharmacist will provide the patient with medication patient information leaflets if required.

If a patient is self medicating this must be documented on the in-patient prescription chart by the nursing staff. This will state the level of self-medication and the date self-medication commenced.

4. SUPPLY AND STORAGE OF MEDICATION

4.1 CabinetsTo participate in the self-medication scheme wards must be equipped with individual lockable medication cabinets located by the patient’s bed. The patient’s medication will be stored in this cabinet. Each cabinet will have an individual key and can also be opened with a master key. A small supply of ward stock will continue to be held on the ward in drug cupboards or trolleys.

All staff must remain vigilant to ensure that medication is locked away and keys are stored out of sight. It is the responsibility of the registered nurse to monitor the safe and secure handling of medicines belonging to patients assessed at level 3 and recommend appropriate remedial action if drug security is ascertained to be at risk.

4.2 KeysMaster keys will be held by the nursing staff on the ward and must be accounted for at the beginning of each shift. One key will also be stored in the Pharmacy Department for use by the pharmacist and pharmacy technician.

The patient will be responsible for the individual cabinet key whilst participating in level 3 of self-medication. It is the responsibility of the nurse discharging the patient to retrieve the key on discharge. Individual cabinet keys, when not in use, must be stored in a suitable locked cupboard and must remain inaccessible to patients.

All efforts should be made to find lost keys. If a master key is lost, all cabinet locks will have to be changed. If an individual cabinet key is lost, then only that lock need be changed.

4.3 Medication supply and changesAll medicines self-administered by patients must be presented and labelled in a form that provides all the information necessary for the patient to self-medicate without risk of error. This is achieved by:-

Re-use of patients own drugs if considered suitable (see below) Individually dispensed items from Pharmacy

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A 28-day supply of medication (except for treatment courses i.e. antibiotics) will be ordered by the pharmacist and pharmacy technician on the ward, which will then be supplied by the Pharmacy department labelled with directions.

Repeat supplies will also be organised by the ward pharmacist or pharmacy technician.

Patient’s own medication or medication transferred with the patient from a different hospital must be checked for suitability for re-use by the pharmacy technician prior to the patient starting on the self-medication scheme. Nursing staff should refer to the guidance on the re-use of patients own drugs (PODS) and transfer of medicines between wards found in the Trust Medicines Policy if outside of Pharmacy hours. If the assessing nurse is satisfied with the medicines suitability, self-medication at level 2 can commence but they should ensure the medication is checked by Pharmacy staff at their next ward visit.

The patient should verbally consent for the re-use or destruction of their own medication and should be given the leaflet ‘Using your own medicines during your hospital stay’ found in the Trust’s Medicines Policy.

Ward stock should be used until a labelled supply for the patient is available, however, ward stock bottles should never be left in the patient’s medication locker and patients must never self-medicate from ward stock bottles.

Controlled drugs, once-only medication and injections/infusions are not covered by the scheme. These should be administered by nursing staff as per normal procedure. (Insulin can however be self-administered by patients where appropriate).

5. DRUG ADMINISTRATION ERRORS

All drug administration errors must be reported promptly in accordance with the Trust Drug Incident Procedure for Nursing Staff. Details of the incident must be reported promptly using an IR1 form. The following people must be informed immediately: The nurse in charge of the ward The consultant responsible for the patient, or the most senior doctor accountable for the patient if

out of hours The ward pharmacist, or if out of hours, the on-call pharmacist for advice on possible adverse

effects and managementThe patient must then be re-assessed for suitability to self-medicate.

6. DISCHARGE PROCEDURE

Medication in the patient’s cabinet must be checked against the discharge prescription by the ward pharmacist or pharmacy technician (after the pharmacist has clinically checked the prescription) before they are issued to the patient. In the absence of a ward pharmacist/technician during working hours the prescriptions (inpatient prescription chart and discharge prescription), and the medication from the individual cabinets must be sent to the Pharmacy Department to be checked. Outside Pharmacy hours when a discharge is required urgently the nursing staff should refer to the procedure in the Trusts Medicines Policy.

The patient will be issued with at least two weeks supply of medication when appropriate.

It is the responsibility of the nursing staff to ensure the medication is explained to the patient prior to discharge.

On discharge, the patient may be issued with a pink medication reminder chart (available from Pharmacy) if required. This may be of use for patients or carers who have difficulty remembering when medication should be taken or what it is prescribed for. It is also useful in situations when mediation changes have occurred during admission to hospital. This will either be completed by the pharmacist or the nursing staff. If completed by nursing staff it must be checked by the pharmacist against the discharge prescription before issued to the patient.

All paperwork associated with the self-medication scheme must be filed in the patient’s medical notes.

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7. Audit and review

Multi-disciplinary audits of the implementation and operation of this Policy will be conducted within the approved wards/departments. The Senior Clinical Pharmacist – Intermediate Care will be responsible for the audit program and the production of reports and recommendations. These will be presented at Clinical Audit and other groups as required eg. Nursing Policy Group. Copies of the reports and recommendations should be provided to the Drug and Therapeutics Committee.

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Self Medication Policy APPENDIX 1

PATIENT CONSENT FOR SELF-MEDICATION

I have read and understood the information leaflet ‘Self-medication’ and had the scheme explained to me by

the nursing staff.

I understand that the medication is for my use only and I am responsible for the key I have been given for the

medication cabinet. I will return this key on my discharge from the ward.

I am aware that a decision may be taken to withdraw me from the scheme if thought necessary by nursing,

medical or pharmacy staff. An explanation for this will be given.

I may withdraw from the scheme at anytime by informing my named nurse.

I have read and understood the above and wish to take part in the self-medication scheme.

Patient Witness

Name: Name:

Signature Signature

Date: Date:

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Self Meds Policy APPENDIX 2ALGORITHM FOR THE ASSESSMENT OF PATIENTS’ ABILITY TO SELF-MEDICATE

INITIAL ASSESSMENT

1. Have you explained the scheme to the patient and supplied the patient information leaflet. Does the patient wish to participate and if so have they signed the consent form?

●Yes ●No Level 1

2. Is the patient confused or unwell?

●No ●Yes Level 1

3. Are there any other patients in the bay likely to cause problems with drug or key custody?

●No ●Yes Level 1Refer to Pharmacist then re-assess

COMPLIANCE

4. Was the patient self-administering prior to admission?

●Yes ●No Level 1

5. Does the patient use a compliance aid (i.e. dosette box, blister pack) to help them with their medication?

●No ●Yes Level 1Refer to Pharmacist then re-assess

6. Can the patient open the medication locker?

●Yes ●No Level 1 or 2Continue to question 7 to assess for level 2

7. Can the patient read the medication label?

●Yes ●No Level 1Refer to Pharmacist then re-assess

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8. Can the patient open the medication container or blister independently?

●Yes ●No Level 1Refer to Pharmacist then re-assess

9. Can the patient dispense and administer the medication independently (i.e. liquids, eye drops, inhalers etc)?

●Yes ●No Level 1Refer to Pharmacist then re-assess

10. Does the patient know when to take their medication?

●Yes ●No Level 1Educate then re-assess

11. Does the patient know why they are taking the medication and any of the possible side effects?

●Yes ●No Level 1Educate then re-assess

Level 2

12. Has the patient completed an initial period of supervision at level 2 to which the assessing nurse is satisfied with the patient’s competence?

●Yes ●No Level 2

Level 3

Document results of assessments

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RESULTS OF NURSING ASSESSMENT OF PATIENTS ABILITY TO SELF-MEDICATE

KEY FOR SELF-MEDICATIONLevel 1 Not self-medicatingLevel 2 Supervised self-medicationLevel 3 Unsupervised self-medication

(Patient must sign consent form)

DATE ASSESSED LEVEL

COMMENTSSignature

For Pharmacy use onlyResults of weekly tablet count for patient on level 3

DATE COMMENTS/ RESULTS OF TABLET COUNTSSignature

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Creation Date – July 2007Review Date October 2013Produced by Intermediate Care Pharmacist

APPENDIX 3

PHARMACY

DEPARTMENT0151 430 1565

WHISTON HOSPITALWarrington Road

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SELFMEDICATION

Patient information leaflet

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Prescot L35 5DR

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What is self-medication? Self-medication is a scheme which

will enable you to take your own medicine whilst in hospital.

The aim of the scheme is to help you to gain a greater understanding of your medicine:-

- why you are on them,- possible adverse effects from

you medication,- how and when to take them.

What happens how?

If you are interested in participating in self-medication the Nursing staff or Pharmacist will explain the scheme in more detail.

PLEASE NOTE IT IS NOT COMPULSORY TO PARTICIPATE

The Nursing staff will complete an assessment with you to determine your ability to self-medicate. This will establish any help you may need, such as large labels or easy to open bottles

.

You will be provided with a medication chart to help you take the correct dose of your medicine at the right time of the day.

Who will supply the medication?

If you have brought in your own medicine from home, these will be used where suitable.

If you have not brought medicine into hospital with you, or if new medicine has been started, these will be provided by the Pharmacy department.

The Pharmacy staff will occasionally check the medicine in your locker and re-order supplies.

Where will I keep my medicine?

Medication will be stored in a locked cabinet by your bed.

Initially the Nursing staff will help you to self-medicate. They will use a master

If you are able to self-medicate without help you will be issued with your own key to the cabinet. It will be your responsibility to keep your medicines in the cabinet

and to keep the key in a safe place. (Please remember to return your Key on discharge).

What happens when I am ready to be discharged from hospital?

The pharmacy staff will use the medicine in the cabinet to dispense your discharge prescription.

You will get at least two weekssupply to take home giving you timeto order a new prescription from your General Practitioner (GP) andPharmacy

REMEMBER THAT MEDICINES CAN BE DANGEROUS IF NOT

USED PROPERLY

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The Nursing Staff or Pharmacist will explain your medicine to you and answer any enquiries you may have.

key to open the cabinet at the times when your medication is due.

DO NOT EXCEED THE STATEDDOSE

Self Medication Policy Appendix 4MEDICATION INFORMATION CHART

NAME AND STRENGTH OF MEDICINE

WHAT IT’S FOR HOW MUCH TO TAKE AND WHENi.e. how many tablets/sachets/spoonfuls/drops

SPECIAL INSTRUCTIONS

BREAKFAST LUNCH EVENING MEAL

BEDTIME

Nurse Signature:

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