Safer Management and Use of Controlled Drugs

Audrey ThompsonLead Pharmacist, CD Governance

NHS Greater Glasgow & Clyde

Aim: to provide an overview of CD legislation• Objectives: At the end of the session

participants will be able to:– Describe the role of the Accountable

Officer for CDs– Describe the requirements for

destruction of stock and patient returned CDs

– List three of the details required on an instalment prescription for CDs

Why are we here?

• CD governance is important!• Linked to fourth report from

Shipman enquiry.• Shortcomings identified in audit and

management of CDs• Changes to CD legislation started

July 2006.

Why are we really here? • Harold Shipman killed at least 218 patients

– Probably ~ 250• 1976: plead guilty to 3 counts of obtaining

pethidine by deception– Asked for 76 other offences to be

considered– GMC decided on no disciplinary action– Home Office decided to take no action

• 2000: erased from GMC register after being found guilty of murder

How do you judge a GP?• Good “old fashioned” GP, liked by patients,

member of LMC, active in audit, regular attended CE events

• “His patients appear to have regarded him as the best doctor in Hyde ”

• “Shipman did not always comply with the official guidance on prescribing. He was unwilling to prescribe generic drugs and preferred … various new and expensive products… his drugs bill consistently 60% above the average… Shipman would produce scientific papers showing the efficacy of the drugs.”

Death Disguised

“None of your victims realised that yours was not a healing touch. None of them knew that in truth you had brought her death, death which was disguised as the caring attention of a good doctor.” – At sentencing 31st January 2000

How Shipman Accessed CDs

• Shipman did not hold personal stock• Shipman collected controlled drugs for

patients – Gave patients reduced supply?

• In some instances he requested scripts after their death

• He also removed drugs from patients’ homes after their death

Health Act 2006

• Strengthened Governance• Three key elements

– Appointment of Accountable Officers (AOs) for health boards, independent hospitals and hospices

– Duty of co-operation between health bodies and other organisations

– New powers of entry and inspection

Role of the Accountable Officer• Responsible for a range of measures relating to

the monitoring of the safe use and management of controlled drugs within the organisation and taking appropriate action where necessary.

• Required to develop and implement systems for routinely monitoring the management and use of controlled drugs through pro-active analysis and identifying triggers for concern, and taking action.

• Need to ensure that appropriate arrangements are in place for assessing and investigating concerns and that they are alerted to any significant findings.

New Regulations Aim to:

• Support healthcare professionals• Encourage good practice• Identify potential criminality or

areas of poor practice • Not deter use of controlled drugs

when clinically required for patients

Misuse of Drugs Act 1971 controls:

• Possession– Collection

• Supply– Dispensing

• Requisitions• Prescriptions

• Storage• Record keeping• Destruction• Manufacture• Import and

export– Travel abroad

• Prescriptions for CDs must include:– Drug, strength, quantity, form– Dose– Amount of instalment– Intervals to be observed when

supplying by instalment

Instalments for Controlled Drugs

• Cannot presume dose = instalment amount

• Dose and instalment amount must be stated separately

• All directions including instalment intervals must be clear and unambiguous

Instalments for Controlled Drugs

Instalment Scripts: not acceptable• Methadone mixture 1mg/ml• 875ml (eight hundred and

seventy five mls)• Label 125ml daily• Supply daily

Instalment Scripts: acceptable

Dose

Instalment amount

Instalment Scripts: acceptable

Dose

Instalment amount

Instalment Scripts: not acceptable• Methadone mixture 1mg/ml• 875ml (eight hundred and

seventy five mls)• Label 25ml daily• Supply 175ml weekly

Instalment Scripts: acceptable• Methadone mixture 1mg/ml• 875ml (eight hundred and

seventy five mls)• Label 25ml daily• Supply 175ml weekly on Fridays

– Or every 7 days– Or specify dates

Home Office Wording

• Allows variation in the amount of each instalment and the timing of instalments to cover various issues:– Closure– Non-collection on specified day

Home Office wording: supervised• Instalments due on the days when pharmacy is

closed should be dispensed on the day immediately prior to closure.

• Supervised consumption of daily dose on specified days: the remainder of supply to take home.

• If an instalment prescription covers more than one day and is not collected on the specified day, the total amount prescribed less the amount prescribed for the day(s) missed may be supplied.

Home Office wording: unsupervised• Instalments due on the days when pharmacy is

closed should be dispensed on the day immediately prior to closure.

• Instalment prescriptions covering more than one day should be collected on the specified day, if this collection is missed the remainder of the instalments (i.e., the instalment less the amount prescribed for the day(s) missed may be supplied.

Frequently Asked Questions

Controlled Drugs

1. How long are CD scripts valid for?• Both private and NHS

prescriptions for schedule 2, 3 and 4 controlled drugs are valid for 28 days from the date signed by the prescriber or from a start date specified by the prescriber.

What quantity of CD may be prescribed on a script?

• Other than in exceptional circumstances, prescribers are strongly advised to restrict prescribing of schedule 2, 3 and 4 controlled drugs to amounts sufficient to meet their patient’s clinical need up to a maximum of 30-day supply. – Where a prescriber considers it clinically appropriate

to supply more than a 30-day quantity and this does not pose an unacceptable risk to patient safety the patient’s notes should be annotated to that effect.

– Prescribers who prescribe more than a 30-day supply should be prepared to justify their decision.

Can CD instalment scripts be for longer than 28 days?• Yes.

– NB Owings are different. – The 28-day validity period will apply as for

other prescriptions for controlled drugs. The 28-day period starts on the date of signing by the prescriber or on a start date specified by the prescriber.

– The first instalment must be dispensed within the 28-day limit, with the remainder dispensed in accordance with the instructions on the form.

– Patients are not required to sign for each instalment.

Can owings for CDs be issued after 28 days from start date of script?• No.

– NB Instalments are different.– Patients should be made aware that

the balance will need to be collected before the 28 day period has elapsed.

How should CDs be obtained on a private basis?• To prescribe schedule 2 and 3 CDs,

prescribers must use the standard PPCD form which can be obtained after making an application to the Health Board. – To requisition stocks of schedule 2 and

3 CDs should use CDRF pads. – Pharmacies should use CDRF forms for

branch transfers.

Do patients need to provide identification to collect CD scripts?

• People collecting schedule 2 controlled drugs should be asked to sign the back of the prescription form (NHS or private) and to provide evidence of identity. – In all cases, if the person collecting the drug declines

to sign the form the dispenser has the discretion to supply the drug.

– The dispenser will not be required to seek evidence of identity if it is felt that this request would compromise patient confidentiality.

– If the person collecting the drug is already known to the dispenser evidence of identity need not be requested.

Do healthcare professionals need to provide identification to collect CD scripts?• If the person is a healthcare professional

acting in his professional capacity on behalf of the patient, the pharmacist must obtain the person’s name and address and must ask for proof of identity unless the health professional is known to them. – The dispenser has the discretion to

supply the drug where evidence of identity is not presented.

Can pharmacists dispense CD scripts where the quantity is not in words and figures?• Pharmacists can amend a CD prescription where there

are minor typographical errors, spelling mistakes or where the total quantity or the number of dosage units is specified in either words or figures but not both. – Pharmacists must exercise all due diligence and be

satisfied on reasonable grounds that the prescription is genuine and that they are supplying in accordance with the instructions of the prescriber.

– The pharmacist will need to amend the prescription in ink or otherwise indelibly and mark the prescription so that the amendment is attributable to them.

Can doctors prescribe CDs for themselves or family members?

• The different regulatory bodies have similar restrictions. The GMC advises that doctors should not prescribe CDs for themselves or someone close to them unless – there is no other person with the legal right to prescribe

available to assess the patient’s clinical condition – and to delay prescribing would put the patient’s life or

health at risk, or cause the patient unacceptable pain. – The treatment should be immediately necessary to:

• Save life• Avoid significant deterioration in the patient’s

health, • Alleviate otherwise uncontrollable pain.

Can GPs destroy their own out of date CD stock if witnessed by a nurse?

• No.– All out of date stock must be destroyed in

the presence of someone authorised as a witness by the relevant Accountable Officer.

– In most Health Board areas stock destruction in GP practices is undertaken by one of the Controlled Drug Team or other authorised member of pharmacy staff.

Can patient returned CDs be destroyed only in the presence of an authorised witness?• No.

– Ideally, patient returned CDs should be taken to a pharmacy for destruction.

– These products should not be stockpiled but destroyed as soon as practicable to minimise risks of loss, theft or dispensing to patients.

– It is good practice for another member of pharmacy staff to act as a witness.

What standard operating procedures are required for CD use?• Various bodies such as NPC, community multiples, AO

Network Scotland have produced templates for a number of clinical areas. SOPs should cover:– who has access to CDs;– where CDs are stored;– security (storage and transportation of CDs);– disposal and destruction of CDs;– who is to be alerted if complications arise; – record keeping, including:

• maintaining relevant CD registers• maintaining a record of Schedule 2 CDs returned by

patients.

Who performs inspections in relation to CD management?

• Board areas will have different arrangements.

• In many areas, a Controlled Drugs Team perform inspections in GP practices and some other managed service departments. – GPhC undertake inspection of registered

pharmacies.– Hospital pharmacy staff perform checks

in wards and departments.

Should CD registers contain running balances of stock?

• Yes.– This is not currently a legal

requirement. – It is good practice to keep running

balances– This is expected to become a legal

requirement once electronic registers are in common use.

Can CD registers be kept electronically?• Yes.

– However, systems must include safeguards to ensure, among other things:• The author of each entry is identifiable.• Entries cannot be altered at a later date.• A log of all data is kept and can be recalled

for audit.• Access control minimises the risk of

unauthorised access.• Adequate backups are made

You supply the local GP surgery with all stock order medication. Dr Jones comes in with 2 ampoules of diamorphine which have expired and asks you to destroy them. What can you do?

• People who are legally in possession of CDs can lawfully give them back to the person who legally supplied them with the CD.– But…– Waste management regulations do not permit

pharmacies to accept returned medicines from GP practices.

– Only from individuals, households or care services.

– Refer GP to local authorised witness for destruction.

Why can’t CDs that are no longer required be returned to patients when they leave hospital?

• Under the Misuse of Drugs Act, it is an offence to possess or supply CDs unless the person holds an exemption. – Patients are legally allowed to possess CDs

that have been prescribed for them. – When there is no longer a clinical need for

the CD supplying them a drug they no longer need could be considered an illegal supply.

You usually stock Durogesic patches but have recently been supplied with Mezolar. Can you keep the records of the same strengths of different brands together?

• The register should have separate sections for each class of drug, form and strength.– How do you define form?

•Wouldn’t separate different manufacturers of morphine injection

– Separate reservoir type patches from others

What are the security requirements for CDs?

• There are different requirements in different settings, however in general:– A suitable locked receptacle is required. – Keys / codes should be kept securely.– CDs do not need to kept locked when under the

direct supervision of a relevant practitioner.– A full audit trail is required for all movement.– Where possible, two people should be involved

in all transactions involving CDs.

Who should be notified of an incident involving a CD?

• Normal clinical incident reporting procedures should be followed.– The Accountable Officer must be

notified of all incidents or concerns involving CDs.

– There will be different arrangements in each Health Board area.

References• AO Network Scotland

– http://www.knowledge.scot.nhs.uk/accountableofficers.aspx

• Medicines Ethics and Practice– http://www.rpharms.com/law-and-ethics/med

icines-ethics-and-practice-guide.asp• NPC resources (England)

– http://www.npci.org.uk/cd/public/home_page.php

References• HDL (2007) 12: Safer Management of Controlled Drugs:

Guidance on Strengthened Governance Arrangements• CEL 21 (2007): Safer Management of Controlled Drugs• CEL 7 (2008): A Guide to Good Practice in Secondary

Care (Scotland)• CEL 13 (2008) Information Sharing Between NHS

Scotland and the Police • HDL (2006) 27: Private CD Prescriptions and Changes to

NHS Prescriptions• HDL (2007) / CEL 14 (2007) Standing Operating

Procedures• CEL 16 (2007)- Private requisition forms (CDRF)• CEL 25 (2010): Accountable Officer Contact Details• www.sehd.scot.nhs.uk and search for controlled drugs