scottish commission forthe regulation of care

Health Guidance for Care Commission staff

Developed by: Alison Rees & David Marshall Pharmacy AdvisersDate: Agreed by QPF, May 2007Review by: May 2009

The use of monitored dosage systems in care homes for adults and 24 hour respite services

Improving care in Scotland

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Introduction and purpose of guidanceChoice is an underlying principle of the National Care Standards and a small percentage of service users choose to manage their medication in care homes. Compliance aids such as medidose or dosette boxes are designed for self-administering service users only and can be of help in this regard (see health guidance note ‘Monitored Dosage Systems and Compliance Aids in Support Services: care at home and day services for adults’).

However, many service users do not choose to manage their own medication, instead relying on the care home to manage most, or all, medication for them.

Many care homes use monitored dosage systems (MDS) as a method for managing the medication for service users. This document tells you about the issues relating to the use of MDS in care homes for adults.

BackgroundThe National Care Standards for care homes for adults state that:

If you have your medication managed for you, you can be confident that the home has comprehensive systems in place for its safe storage and administration. You are confident that staff will monitor your medication. If there are any changes or concerns about the medication, they will seek your permission to get medical advice. If your medicines are being organised for you, you can be sure that the staff are knowledgeable and following up-to-date best-practice guidance. The staff are fully aware of the home’s systems for giving medication. They know how to store and administer your medication safely and in the way that suits you best.

In accordance with the Medicines Act 1968, a care worker may administer medication to a service user as long as they are acting in accordance with the directions of a practitioner/prescriber.

It is safe practice to ensure that care workers only give medicines to service users from a container that the pharmacist or dispensing GP has labelled and dispensed. This container must have the name of the service user on the label and full instructions to the care worker for safe administration of medication, such as any special dosage instructions.

What are MDS?MDS is a medication storage device designed to simplify the administration of solid oral dose medication by a formal carer to a service user. They are filled at the point of dispensing in a pharmacy and are primarily intended for situations where solid oral medication is to be administered to a large number of service users, for example care homes.

There are various types of MDS. Some contain seven days of medication with separate daily time compartments for the medication, for example breakfast, lunch, teatime and bedtime. Examples of this type include the NOMAD, Plus Pak and Venalink 7 Day systems.

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health guidance on monitored dosage systems in care homes for adults and 24 hour respite services

scottish commission for the regulation of care

A NOMAD system

Other systems contain 28 days worth of medication with separate blisters or sheets containing all the medication to be administered at a given time (for example, breakfast), or one type of medication per blister/sheet per given administration time.

Examples of 28 day systems

Issues for considerationAdvantages of MDSMDS have been extensively and successfully marketed as time saving devices that simplify the medicines administration process to large groups of people on complicated medication regimes, freeing up care staff to concentrate on caring.

They are tamper-evident and have facilities for labelling of medicines in compliance with legislation and good practice, such that the carer administering the medication can identify what they are giving and any special dosage instructions, for example ‘before food’. However, it is

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worth noting that this is not always up to date, for example the brand on Fluoxetine used one week by the pharmacist may differ in colour from the brand used the following week and the capsule description on the back of the MDS may not have been changed to accommodate this.

MDS do offer an easy visual check on whether medicines have been given to a service user or not.

Disadvantage of MDSMDS are only suitable for certain solid oral dose medication. Liquid medicines, creams, eye drops, inhalers, wafers, suppositories etc must be supplied in traditional containers. Therefore, any care home that uses MDS will need to operate two different systems of medicines administration: MDS and original manufacturers packs/pharmacy labelled bottles.

There are certain tablets and capsules that should not be placed in a MDS. The Royal Pharmaceutical Society of Great Britain’s (RPSGB) audit for pharmacists recommends the following should not be placed in a MDS:

‘when required’ medication; drugs which may cause hypersensitivity reactions on prolonged contact, for example Chlorpromazine; drugs with a cytotoxic potential, for example Methotrexate; drugs whose dose can vary, for example Warfarin; dispersible medication, for example soluble Aspirin; drugs which are hygroscopic or photosensitive, for example Sodium Valproate, Glyceryl Trinitrate; and drugs requiring special temperature control, for example fridge lines.

The last two on the above list pertain to the stability of medicines in a MDS. A recent article in the Pharmaceutical Journal expanded the debate on this issue. Based on information from drug manufacturers about the possible stability of medicines after they had been removed from their original packaging, the authors graded nearly 400 common drugs on their suitability for such devices. Examples of commonly used medicines with grade 1 (do not place in compartmental aids) included Aspirin, Ranitidine (Zantac), and Sodium Valporate (Epilim). Grade 2 and 3 examples (not recommended for such devices) included Atenolol, Chlordiazepoxide, Thyroxine and Atorvastatin. 320 out of the 392 drugs listed were in codes 1, 2 or 3 (Church and Smith 2006). As definitive safety data regarding stability of drugs in a MDS is largely lacking, however, the ultimate responsibility for placing medicines in such devices lies with the pharmacist.

Many care services believe that MDS are easier and safer to use where staff are untrained in medicines management issues, as medicines are packed into separate compartments allowing the person to be given the correct medicine, at the correct dose, at the correct time. However, a care worker should never perform medicines administration without appropriate training.Where MDS systems are re-used the devices need to be properly cleaned to remove all traces of the previous supply of tablets and capsules, and any extraneous items.

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When a medicine is repackaged into a MDS it has the shelf-life reduced to eight weeks, so any ‘when required’ medicines dispensed in this way needs to be destroyed after eight weeks, whereas medicines supplied in the manufacturers original packs can be used until the expiry date. This increased wastage of drugs is a cost to the NHS.

The NHS does not fund the supply of MDS. Pharmacists and dispensing GPs cannot be compelled to supply medication in MDS. Many pharmacies supply MDS free of charge, absorbing the costs into the fee they receive for each item dispensed, however a new system for funding community pharmacy services from 2007/08 may impact on the sustainability of this ‘free’ service. Care service providers should consider if their staff would be able to ensure continuity of care if medicines were no longer supplied in MDS. Are their staff trained to administer solid oral dose medication that is supplied in original manufacturers’ packaging or tablet bottles? Repackaging medicines into similar containers called compliance aids (for example dosettes, medidose) with the intention that a different care worker will give it to the service user at a later time is called ‘secondary dispensing’. Care staff should be aware that this is not recommended safe practice (see health guidance note ‘Authorisation to Administer Medicines’).

Health guidanceThe Commission for Social Care Inspection (CSCI) have published ‘The Administration of Medicines in Care Homes’ which states ‘MDS have been promoted as a safe system of medicine administration in care homes. But MDS are merely a convenient form of packaging for a limited group of medicines. Safe practice is not guaranteed by use of any system alone but is promoted by only allowing staff who are trained and competent to give medicines’ (see health guidance note ‘Authorisation to Administer Medicines’).

There is a misunderstanding by some service providers that they have to have their medication supplied in a MDS, and/or that the Care Commission actively recommends the use of MDS. This is not Care Commission policy. It is not appropriate for Care Commission officers to recommend or require the use of MDS or any other medicines administration system. That decision rests with the care service provider. However, Care Commission officers should make sure that whatever system is used is managed correctly.

Despite guidance from the RPSGB mentioned above, experience has shown that medication not designed for a MDS is sometimes still placed in this system, for example ‘when required’, hygroscopic medication. This has potential problems for service users not receiving medication that is fit for purpose. These issues are not inspected as a matter of routine in each care service inspection. However, if Care Commission officers or care providers have any doubt about the appropriateness of medication in an MDS they should contact the care service’s supplying pharmacist for clarification.

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Summary1. Many care homes use monitored dosage systems as a method for managing the medication for service users.2. MDS have been marketed as time saving devices that simplify the medicines administration process.3. Only certain solid oral dose medication can be placed in MDS. Care providers need to ensure staff are trained to administer any type of medication that the service user requires.4. There are certain tablets and capsules that are not recommended for placement in a MDS. If care service providers have any doubt about the suitability of medication for a MDS they should contact the supplying pharmacist for clarification.5. MDS are simply a form of packaging for a limited group of medicines. Safe practice is not guaranteed by use of any system alone.6. The Care Commission do not recommend or require the use of MDS, or indeed any other medicines administration system.

Useful links/further readingThe Use of Monitored Dosage Systems and Compliance Aids in Support Services: Care at Home and Day Services for Adults. www.carecommission.com

National Care Standards www.scotland.gov.uk

Monitored Dosage Systems Audit, Royal Pharmaceutical Society of Great Britain. www.rpsgb.org.uk

How Stable are Medicines Moved from Original Packs into Compliance Aids? Church and Smith, 2006, Pharmaceutical Journal Vol 276, 75-81 www.pharmj.com

Authorisation to Administer Medicines www.carecommission.com

The Administration of Medicines in Care Homes, Commission for Social Care Inspectionwww.csci.org.uk

RPSGB Fitness to Practice and Legal Affairs Directorate: Fact Sheet 9 – Labelling of MDS and Compliance Aids. www.rpsgb.org.uk

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© Scottish Commission for the Regulation of Care 2007Published by: Communications