The term legislation is used to describe laws and statutory guidance on the legal rules that affect people in society.
Legislation has been developed to keep people safe in the use and administration of medicines.
We found 14 relevant pieces of legislation – that’s a lot!
Don’t worry, you don’t need to know all the details but you need to know what legislation exists and why. These are the main points.
Health and Safety at Work Act 1974
Sets out how employers and employees must work in a safe way, giving every person legal duties and responsibilities.
This is very general to Health and Safety so other more specific regulations have been put in place about medication.
Medicines Act 1968
Defines the legal status of pharmaceutical products. It regulates the manufacture, supply, sale and import of medicines and medicinal products.
Misuse of Drugs Act 1971
Controls the use of potentially dangerous or highly addictive drugs; defined as ‘controlled drugs’. It states how they should be stored, recorded and administered. Controlled drugs are divided into classes A, B and C and specified penalties are given for illegal possession or supply.
Misuse of Drugs Act (Safe Custody) 1973
Specifies how controlled drugs need to be stored.
Misuse of Drugs Regulations 2001
Controlled drugs are divided into 5 schedules depending on their medicinal benefit/potential for harm.
The legislation specifies who can produce, possess and supply these drugs and how they should be stored administered and destroyed.
Health and Social Care Act 2008 (Regulated Activities)
This states that the registered person must protect individuals against the risks associated with the unsafe use and management of medicines. It covers making appropriate arrangements for obtaining, recording, handling, using, safe keeping, dispensing, safe administration and disposal of medicines used.
Compliance with the regulations is monitored by the Care Quality Commission.
The Health Act 2006
Strengthens the monitoring arrangements for controlled drugs following the Shipman enquiry.
Healthcare organisations need to appoint an accountable officer to oversee management of controlled drugs.
The Mental Capacity Act 2005
Considers mental capacity in the best interest of the individual.
A lack of capacity must be clearly demonstrated and assessed and if an individual lacks capacity then staff must act in the person’s ‘best interest’.
Controlled Drugs (Supervision of Management & Use) Regulations 2013
Outlines the responsibility of an Accountable Officer for supervision of management and use of controlled drugs.
The Care Standards Act 2000
Established national minimum standards applicable to the care sector to be monitored by the Care Quality Commission.
The Care Act 2014
Promotes well-being to ensure individuals gain the right care and support. It promotes person centred approaches and safeguarding. It puts the focus on prevention and ensuring things don’t get worse for an individual; providing information to ensure people can make informed decisions.
Regulations and compliance are monitored by the Care Quality Commission – this includes administration of medication.
Data Protection Act 2018
Ensuring personal data held by organisations is kept confidential, not kept longer than necessary and is accurate. This includes data about an individual’s medication.
The Act gives individuals the right to see the data and information held about them.
Supported by the General Data Protection Regulations or GDPR.
Control of Substances Hazardous to Health Regulations (COSHH) 2002
This is designed to protect people from hazardous substances that may cause harm. It is important that any medications are not left out for individuals or for staff to mistakenly drink or misuse.
Personal Protective Equipment must be provided to staff when working with hazardous substances.
Organisations with responsibilities for medicine use are:
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