Introduction

In all settings where drugs are stored and administered for the benefits of clients there are laws governing the settings and all third parties.

The Misuse of Drugs Act (1971)

Prohibits the possession, supply and manufacture of medicinal and other products except where such possession, supply and manufacture has been made legal by the Misuse of Drugs Regulation 2003.

Ø  Covers the Classification of Drug by Class

Ø  Class denotes their hazardous potential as regards addiction

Class A

•     Heroin, Methadone, Remifentanil, Dihydroetorphine, Opium, Cocaine, Crack LSD, Cannabis Oil, Ecstasy, Processed Magic Mushrooms

•     Any Class B drug that is injected

Class B

•     Amphetamines (Speed)

•     Barbiturates

•     Codeine

•     DF118s

Class C

•     Mild Amphetamines (e.g. Slimming tablets)

•     Cannabis

•     Tranquillisers (Temazepam, Valium
Zolpidem) (see next slide)

•     Certain Anabolic
Steroids

•     GHB - Gammahydroxy- butyrate

Special Notes

Tranquillisers: Temazepam, Valium and Zolpidem, etc

Ø  It is not illegal to use them but it is illegal to give/sell them for non-medical use (in this case, they are considered Class C drugs)

Ø  It is illegal to sell/supply (without a licence) any prescribed drug for non-medical use

The Misuse of Drugs Regulations 2003

This Regulation classifies Controlled drugs into five schedules according to the different levels of control given to them

The class of drug does not necessarily indicate which schedule it should be in

Schedule 1

•     Halluninogenic Drugs (LSD & Cannabis)

•     A license is required to hold these drugs and a pharmacist cannot hold them except where exemption has been granted

Schedule 2

•     Opiates (Diamorphine, Morphine, Remifentanil, Dihydroetorphine and Methadone)

•     Cocaine and Pethidine

•     Major Stimulants (Amphetamines)

Ø  Can only be dispensed by a pharmacist on production of a handwritten authorised prescription

Ø  Only a qualified medical person can administer these drugs

Ø  Storage comes under strict Controlled Drug requirements

Ø  Records should be maintained in a Controlled Drug Register

Schedule 3

•     Barbiturates (Temazepam, Phenobarbitone)

Ø  Can only be dispensed by a pharmacist on production of an authorised prescription

Ø  Can be administered by an unqualified person but only under supervision and with training in the administration of medicines

Schedule 4

•     Steroids

•     Benzodiazepines: (except Flunitrazepam and Temazepam)

Ø  Can only be dispensed by a pharmacist on production of an authorised prescription

Ø  Can be administered by an unqualified person only under supervision and with training

Schedule 5

•     This schedule contains both non-prescription and prescription only drugs

•     If any preparation contains a certain controlled drug (e.g. Codeine or Morphine) they would come under prescribed drugs or available only at pharmacies

•     They can be administered by an unqualified person, but preferably with training in the administration of drugs

The Misuse of Drugs Regulations 2001

This regulation controls the safe storage and administration of drugs

Dispensing and Stocking of Medicines:

•     Nursing Homes:  A Home Office Licence is required to maintain stocks of Schedule 2 and 3 Controlled Drugs

•     The pharmacist must ensure the home has this licence before making any supply of these drugs

•     Residential Homes: All controlled drugs held by a residential home must be client specific and can only be supplied by a pharmacist on an authorised prescription

•     A residential home cannot hold stocks of Schedule 2 or 3 Controlled Drugs

•     All medications within a home must be recorded, stored, handled and disposed of in compliance with the requirements of the recognised professional bodies and the local Health Authority

The Care Standards Act 2000

Under this Act, various bodies were set up to cover England, Scotland and Wales, each accountable to its own Minister for Health

The National Care Standards Commission, set up in 2000, was replaced in April 2004 by two new inspectorates:

Commission for Social Care Inspection (CSCI)

•     The CSCI combines the work previously undertaken by the Social Services Inspectorate, the SSI/Audit Commission joint review team and the social care functions of the National Care Standards Commission

Commission for Healthcare Audit and Inspection (CHAI)

•     The CHAI now includes all the current and proposed work of the Commission for Health Improvement (CHI) and the Mental Health Act Commission (MHAC), the national NHS value for money work of the Audit Commission and the independent healthcare work of the National Care Standards Commission

National Minimum Standards

The standards relating to the handling of medication within a care home promote the safety and well-being of the client and a framework of safe practice for the care worker, irrespective of whether the care worker is a registered nurse

•     The registered person ensures that there is a policy which all staff adhere to regarding medicines - responsible also for the policy on clients taking responsibility for their own medication (within a risk management framework)

•     Records must be kept of all medicines received, administered and leaving the home or disposed of

•     A record should be maintained of current medication for each client (including those self-administering)

•     Medicines in the custody of the home are handled according to the requirements of the Medicines Act 1968, guidelines from the Royal Pharmaceutical Society, the requirements of the Misuse of Drugs Act 1971

•     All nursing staff are to work to the UKCC Standards for administration of medicines

•     Controlled drugs administered by staff should be stored in a metal cupboard (complying with the Misuse of Drugs (Safe Custody) Regulations 1973)

•     Only a medical practitioner or registered nurse can administer medicines, including
Controlled Drugs, for clients receiving nursing care

•     In residential care homes, all medicines, including Controlled Drugs,  (except those self-administered) must be administered by designated and appropriately trained staff

•     A different designated, appropriately trained member of staff must witness the administration of Controlled Drugs

National Minimum Standards

The training for care staff must be accredited and must include:

•     Basic knowledge of how medicines are used and how to recognise and deal with problems in use

•     The principles behind all aspects of the home's policy on medicine handling and records

Receipt, administration and disposal of Controlled Drugs must be recorded in a Controlled Drugs register

The Registered Manager should seek information and advice from a pharmacist regarding medicines' policies within the home and medicines dispensed for individuals in the home

Staff should monitor the condition of the client on medication and contact the GP if they are concerned about any change in condition that may be a result of medication

If a client dies, medicines must be retained for a period of seven days, in case there is a coroner's inquest

The Control of Substances Hazardous to Health Regulations (1994)

Medicines can be dangerous to health if misused, handled or stored incorrectly

Medicines are dangerous if not administered in the appropriate manner

Failure to comply with this regulation can result in prosecution

Requires employers to:

•     Inform, instruct and train employees regarding substances, the risks involved in their incorrect storage and management

•     Assess the risk to health of anyone likely to be exposed to risk from a hazardous substance

•     Introduce appropriate precautions to prevent or reduce identified risks

•     Employees must have sufficient information and training on precautions needed and emergency procedures

The Data Protection Act 1968

Any setting wanting to hold clients’ records on its computer should consult with the Data Protection Agency

EEC Directives

EEC Directives now govern any amendments to UK Acts and Regulations

EC legislation takes precedence over the Medicines Act

The UK Medicines Act 1968 is continually being amended and new regulations brought in to conform to any EC legislation

Medicines and Healthcare Products Regulatory Agency (April 2003) (MHRA)

Responsible for protecting public health by ensuring the safety, quality and efficiency of medicines available in the UK

In April 2003, it merged with the Medical Devices Agency responsible for the safety of medical devices, to form the MHR

•     Monitors existing medicines and devices and regulates all medicinal products for human use (whether new or existing) in accordance with EC directives

•     Responds to and monitors reports regarding allergic reactions and side effects from existing medicines

Adverse effects from drugs are reported through the yellow card scheme

•     GPs, pharmacists and nurses can submit yellow card reports

•     Care home staff should liaise with prescribers about the submission of a report, as appropriate

Royal Pharmaceutical Society of Great Britain (RPSGBB) Guidelines

The standard of record keeping should ensure that records are properly completed, legible and current, providing a complete audit trail of medication

All records must be referred back to the original prescription and not to previously held records

Nursing and Midwifery Council (NMC) - Guidelines

•     In principle guidelines relate to registered nurses and midwives (they are also applicable to any healthcare personnel involved in the administration of medicines)

•     Guidelines can be accessed and printed from the website of the NMC: www.nmc-uk.org

Policies & Procedures

Medicine rounds should be at specific times to maintain continuity in record keeping and to ensure security

•     Exceptions  - client specific according to the requirements of the medicine (e.g. before meals) and whether there is a specific dosage regime

•     All adverse reactions/side effects must be reported immediately and recorded on the client's MAR

At all times, the client’s privacy and dignity must be maintained