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Regulatory Issues

Safe Management of Medicines
A Guide for Managers of Old People's Homes and Residential Care Facilities

September 1997

Introduction
Message
Part 1
    Ordering and Receiving Medicines
    Custody and Storage of Medicines
    Administration of Medicines
        Administration Procedure
        Where Residents are Responsible for their own Medication
    Administration of Household Remedies (Standing Orders)
    Protocols for Administering Household Remedies
    Non-prescribed Remedies
Part 2
    The Supplying Pharmacy
    Supply of all Pharmaceutical Requirements
    Provision of Comprehensive Pharmaceutical Care^TM
    Provision of Staff Training
Part 3
    Written Protocol for the Safe Management of Medicines in Old People's Homes and Residential Care Facilities

 

Introduction

These guidelines outline the most suitable procedures for ensuring the safety and efficacy of medicines used in residential care facilities. They describe minimum standards for storage and use of medicines for all residential care facility managers to achieve.

The guidelines have been written in consultation with the Ministry’s Licensing and Therapeutics Sections. While there may be several ways to achieve or even surpass the standard set out in the document, their universal adoption will maximise the benefits which residents can gain from medicines.

Message

Every manager of a residential care facility must take all reasonable steps to ensure that at all times the storage, administration and disposal of medicines are strictly controlled and that safety, efficacy and accuracy are maintained with respect to "the right dose being administered to the right person in the right form at the right time"; as prescribed by the medical practitioner.

PART 1

Ordering and Receiving Medicines
Custody and Storage of Medicines
Administration of Medicines
Administration Procedure
Where Residents are Responsible for their own Medication
Administration of Household Remedies (Standing Orders)
Protocols for Administering Household Remedies
Non-prescribed Remedies

Ordering and Receiving Medicines

1. Medicines must be authorised in writing on the Resident Medication Profile and signed by the resident’s medical practitioner.
   In an emergency the doctor can give telephone instructions. Enter these on the Resident Medication Profile and get them signed by the doctor as soon as possible on the next visit.
   A senior staff member must note, date and sign immediately all telephone changes in therapy.
2. Check all medicines arriving at the facility against the Resident Medication Profile as they are unpacked. Place all checked medicine in the security of the medicine room or cupboard.
   Read labels carefully and note any specific storage requirements, interactions or dose instructions on the Resident Medication Profile and action them. Failure to do so may reduce the effectiveness of the medicine. If you do not understand any medical instructions contact the supplying pharmacy or the prescribing doctor for help. Check the Resident Medication Profile and return any discontinued medicines to the pharmacy.
3. The prescribing doctor should review each resident’s medications at least every three months.

Custody and Storage of Medicines

1. Store medicines in a locked room or locked cupboard which is free from heat, moisture and light.
2. Store all medicines in the original dispensed packs. Keep all foil or blister unit dose packs unopened in the original dispensed pack until the dose is given.
3. Store all residents’ medications in an orderly fashion. Keep medicines in their original dispensed containers until immediately prior to administration. Do not remove labels from medicine containers.
4. Some medicines require refrigeration. If a separate fridge is unavailable, keep the medicines in an airtight container in the fridge in a separate area from food to avoid contamination. Use a maximum/minimum thermometer to make daily checks on storage temperature. Keep a weekly record of temperatures.
5. Keep all Controlled Drugs in a locked safe or locked cupboard accessible only to senior staff. Record administration in a Controlled Drug Register to keep a running balance of stock. Nominated staff members must sign all entries in the register.
6. Keys to the medicines and Controlled Drugs rooms or cupboards are to be held by one senior staff member responsible for drug administration on each duty. Access to these areas should be restricted to staff authorised to handle medicines. Display a list of these persons.
7. Nominated senior staff or the supply pharmacist should check all medicines for expiry dates and deterioration each month. Rotate stock so that oldest stock is used first. Keep expired and discontinued medicines separate and in a secure area for return to the pharmacy for disposal.
8. To reduce the risk of error, keep the medicine room or cupboard clean and tidy at all times. Clean up any spillage immediately to prevent contamination and deterioration of the medicines.

Administration of Medicines

Under no circumstances give a medicine to anyone except the person it was prescribed for.

Check prepared daily doses against the Resident Medication Profile and enter them on the Medication Administration Record for signing off as the dose is administered.

Use the original dispensed container or unit dose pack to administer medicines.

If this is not possible, management must arrange a suitable alternative system which ensures that the right dose is administered to the right person at the right time. Take all reasonable steps to ensure strict control of storage and administration of medicines - even during the Medication Round.

Administration Procedure

1. Check the name of the resident against the name on the medicine container.
2. Check the instructions.
3. Administer the medicines directly from the container to the resident.
4. Make sure the resident has fluids to take with the medicine, or that special instructions for administration are complied with.
5. Ensure that oral medicines are swallowed. Medicine must not be left for the resident to take later.
6. Record on the Medication Administration Record sheet that the medicine has been administered and taken, by signing in the space provided. The sheet should also allow the recording of withheld doses, refused doses or extra doses given in the event of wastage.
7. Controlled Drug administration must be recorded on the Medication Administration Record and Controlled Drugs Register, and signed for.
8. Record and report to management at the earliest opportunity if medicine is not taken for any reason.
9. If the wrong medicine is given, report this immediately to the senior staff member on duty, who will inform the doctor. Complete an incident report.

Where Residents are Responsible for their Own Medication

1. Store the medicines, including Controlled Drugs, in the resident’s room in a locked cupboard or drawer that is accessible to the resident and staff.
2. Medicines should be checked every week. Appropriate senior staff and the doctor must assess a resident’s ability to take their own medicine at least every three months.

Administration of Household Remedies (Standing Orders)

Keep remedies for the relief of minor ailments in a separate area of the medicine cupboard.

Household remedies are for conditions such as occasional headache, constipation and cough. Their use must be authorised by the resident’s doctor and entered on the Resident Medication Profile with details of dosage. Record the administration on the Medication Administration Record.

It is important to remember that minor ailments may be symptoms of other more serious diseases. They may also be adverse reactions to medicines already prescribed.

A non-prescribed medicine may cause a reaction to other prescribed medicines. Always check with the supplying pharmacy for any adverse reactions before administering a household remedy.

Protocols for Administering Household Remedies

If the prescribing doctor agrees to a list of household remedies for occasional use, then clearly record their protocol and strictly adhere to them. Include a definite period of time for their use and an expiry date when they should be reviewed by the doctor.

If a household remedy is prescribed for an individual, then it may only be administered to that person. Some household remedies are for the use of all residents and are purchased by the management.

Non-prescribed Remedies

Where a resident is self-administering vitamins and other non-prescribed items, record them on the Resident Medication Profile and bring it to the attention of the doctor. Notify the supplying pharmacy so they can check for any possible reaction with the prescribed medicine.

PART 2

The Supplying Pharmacy
Supply of All Pharmaceutical Requirements
Provision of Comprehensive Pharmaceutical Care™
Provision of Staff Training

The Supplying Pharmacy

Your supplying pharmacy should be willing to undertake the following:

• Prompt, accurate supply of all pharmaceutical requirements at agreed times.
• Provision of pharmaceutical advice and information.
• Training of staff where appropriate.

Supply of All Pharmaceutical Requirements

Aim

To provide a system for efficient and effective supply of pharmaceuticals which meets the requirements prescribed or recommended for a resident

The supplying pharmacy and the facility should together write a protocol or contract to cover the following points.

The supplying pharmacy should:

• agree to a system for the dispensing and delivery of medicine within a timeframe which ensures that the residents’ pharmaceutical needs are mets.
• arrange delivery of medicine to the facility by a pharmacist or nominated employee known to the staff
• provide a pharmacist to visit the facility regularly at a time to be agreed by the staff e.g. weekly
• provide assistance to the facility’s staff member in charge of medicines by checking records against the medicine stocks to ensure the system is running correctly
• dispense prescriptions in quantities of not more than one month’s supply to avoid overstocking and wastage
• supply dispensed medicines with clear labels on each container with full directions for use and cautionary and advisory labels where appropriate. The directions must be in accord with the Resident Medication Profile. The pharmacy must relabel the containers of any changed medicine
• supply medicines in containers suitable for direct administration to the individual resident
• maintain a small stock of "household remedies" in consultation with medical practitioners and staff
• monitor the stock of medicines held in the facility and be responsible for the removal and disposal of expired, discontinued and damaged medicines
• ensure the continuity of supply of medicines to residents who are being transferred or are temporarily absent
• maintain a medication profile for every resident receiving medication from the pharmacy.

Provision of Comprehensive Pharmaceutical Care™

Aim

To provide information on medicines to the staff, resident, and medical practitioner where appropriate, to ensure that the maximum therapeutic benefit is obtained by the patient.

The supplying pharmacist should:

• advise on the storage of medicines to ensure that:
  - the potency of the product is maintained
  - medicines are not muddled
  - external and internal preparations are kept apart
  - adequate security is maintained
• monitor all prescribed medicines and where indicated advise the medical practitioner on dosage, interactions and adverse reactions
• ensure that the relevant and accurate details on medication are maintained
• advise staff on the correct use and administration of medicines
• provide any information sought by staff on the medicines used by the residents
• provide a formal review of Comprehensive Pharmaceutical Care™ on a regular basis

Provision of Staff Training

Aim

To provide in-service education programmes for facility staff in order to promote the safe and effective use of medicines.

A pharmacist from the supplying pharmacy should be available to educate staff on the safe handling, storing, administration and dosage of medicines when requested by the facility.

PART 3

Written Protocol for the Safe Management of Medicines in Old People’s Homes and Residential Care Facilities

A written protocol providing guidelines for the facility is necessary to:

• ensure high standards of care for the residents
• protect residents and staff by ensuring safe methods of medication administration
• enable facility and public accountability
• encourage a standard code of practice for all staff.

The protocol should contain statements on:

• the availability of the protocol document for use by staff, residents, the supplying pharmacy, doctors and relatives of residents of the facility
• custody of all medicines prescribed or a description of the conditions whereby residents may take charge of their own medication
• the procedures for prescribing medicines by medical practitioners, both in the case of a written prescription and an oral instruction
• the system by which the prescriptions/orders are obtained
• the positions of staff and their responsibilities relating to medicines at the facility
• the assurance of safe and proper storage of medicines
• a general description of the records kept of resident medication and administration
• the method of payment of practitioners fees and prescription fees and charges
• the procedure for disposal of medicines
• a statement of confidentiality of residents’ medical records

The protocol should detail specifically who is responsible for:

• taking charge of the key to the medicine room/cupboard
• preparation of medicine rounds
• administration of medicines
• recording details of medicines prescribed for residents
• recording medicine administration
• supplying household remedies to residents
• disposal of medicines

The facility must meet the requirements of the following (where applicable) and any legislation pertinent to the specific type of Residential Care Facility:

Hospitals Regulations 1993
Old People’s Homes Regulations 1987
Misuse of Drugs Act 1975
Misuse of Drugs Regulations 1977
Medicines Act 1981
Medicines Regulations 1984
Standards of Care for Old People’s Homes.

Documentation

These guidelines have been prepared using:

Standards of Care for Old People’s Homes
Old People’s Homes Regulations 1987
Medicines Act 1981
Medicines Regulations 1984
Misuse of Drugs Act 1975
Misuse of Drugs Regulations 1977
Hospitals Regulations 1993

Published with the permission of the Director-General of Health

ISBN 0-478-22851-1