Support use of medication in social care settings
Handout 2: Key legislation and guidance
Learning outcome 1 Assessment criteria 1.1, 1.2, 1.3
It is important to know which pieces of legislation have a direct impact on your practice in whatever health or social care setting you work. Policies and procedures are guidelines provided by your organisation which you must follow to ensure you are working within the law.
It helps to understand why policies and procedures are in place and how they link to specific legislation which affects your practice.
Which legislation is relevant to this unit?
The Medicines Act 1968 was the first comprehensive legislation on medicines in the United Kingdom. A combination of this law and the various regulations applying to medicines produced since then provides the legal framework for the manufacture, licensing, prescribing, supply and administration of medicines.
Misuse of Drugs Act 1971
The Misuse of Drugs Act (MDA) 1971 and associated regulations provide the statutory framework for the control and regulation of Controlled Drugs (CDs). CDs may be used in health and care for the relief of chronic pain or in end of life care. The aim of this legislation is to prevent the misuse of CDs.
Misuse of Drugs Regulations 2001, 2007 (MDR) and Misuse of Drugs Regulations Northern Ireland (NI) 2002
The purpose of these regulations is to safeguard the use of CDs in healthcare. They are classified in five schedules according to the different levels of control required. Schedule 1 CDs are subject to the highest level of control, and Schedule 5 CDs to a much lower level of control. These controls are regularly revised and staff need to be aware of the most current regulations.
The Misuse of Drugs and Misuse of Drugs (Safe Custody) 1973 and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007. Controlled drugs must always be stored in a cabinet that complies with these regulations. Since January 2008, all care homes, including those registered only for personal care, are required to store controlled drugs securely.
Health Act 2000
Following the Shipman Inquiry, procedures for handling controlled drugs have been tightened up. New methods have been introduced to monitor and inspect the secure handling of controlled drugs in care homes. The Care Quality Commission (CQC) is obliged to share information with other regulators including the police to check the use of controlled drugs in care homes. It allows a power of entry and inspection for the police and other nominated people to enter premises to inspect stocks and records of Controlled Drugs.
The Care Standards Act 2000
Standard 9 of the National Minimum Standards for Older People and Standard 20 for Younger Adults relates to medication. It identifies the guidelines to be followed, and these should be clearly set out in policies and procedures covering the storage, recording, handling, administering and disposing of medicines.
These guidelines include:
· individuals should be encouraged to take responsibility for their own medication following a comprehensive risk assessment
· medicines for individuals receiving nursing care must be administered by a medical practitioner or a registered nurse
· all medicines should be administered by designated, appropriately trained staff
· controlled drugs should be administered and witnessed by two members of staff, both suitably trained
· staff should monitor all individuals who are taking medication and inform the prescribing officer if concerned about changes in their condition which are suspected to be due to medication
· in the event of a death all medicines must be retained for seven days in case of a coroner’s inquest.
Domiciliary Care Agencies Regulations 2002
Regulation 14 requires all domiciliary agencies to:
· assess the amount of assistance each individual needs to take prescribed medication
· provide written procedures for administration of medicine
· make arrangements for safe practice in individuals’ homes when dealing with medicines
· provide care workers with appropriate training
· draw up a written plan to meet the needs of each individual to be reviewed regularly or as needs change.
Standard 10 of the National Minimum Standards for Domiciliary Care Agencies states that medication procedures should protect individuals and support them to either maintain responsibility for their own medication or to receive the necessary support in their home if they are unable to do this.
Control of Substances Hazardous to Health 2002 (COSHH) deals with chemical hazards at work and the provision of training, the carrying out of risk assessments to prevent and control exposure to hazardous substances. Some medications are hazardous so there must be a designated ‘responsible person’ who will assess the hazard and risk of medicines stored on the premises. This senior practitioner is responsible for ensuring that the systems for safe and secure storage are followed to ensure that the quality of medication and its security are maintained.
Hazardous Waste Regulations outline the process required to dispose of a range of medication and give guidance for different Care settings. Many medicines are potentially dangerous if disposed of incorrectly or may fall into the wrong hands.
A residential home which is registered as nursing or has dual registration will have to make arrangements with a licensed waste company to dispose of unwanted medication.
The Controlled Waste Regulations 1992 determines that waste is classified as ‘industrial’ unless the premises are domestic. Clinical waste from a nursing home is classed as industrial.
Medication is classed as ‘special waste’ and is covered under the Special Waste Regulations1996. Care homes must complete the correct documentation relating to medication that has been disposed of. This forms part of the organisation’s audit trail. All unused medicines, except for providers registered for nursing care, should be returned to the pharmacy for safe disposal.
The Handling of Medicines in Social Care
This document produced in 2007 by the Royal Pharmaceutical Society, provides guidance on the handling of medicines which applies to all care settings. It is a comprehensive document which includes information about the safe storage, administration, recording and disposal of various medicines and applies to different types of settings.
The Duthie Report 1988 was a multi-disciplinary review of medicine management which developed Guidelines for the safe and secure handling of medicines. This was updated in March 2005 with the publication of a new guidance document The Safe and Secure Handling of Medicines; a Team Approach. It provides guidance for different clinical areas.