3.1. Summarise current legislation and policy that govern the management of medicines

This guide will help you answer 3.1. Summarise current legislation and policy that govern the management of medicines.

The management of medicines in health and social care settings in the UK is guided by legislation, policies, and procedures. These have been designed to ensure that medicines are stored, administered, recorded, and disposed of properly to safeguard individuals who rely on these services. This guides covers the main regulations and policies relevant to medicine management.

The Human Medicines Regulations 2012

The Human Medicines Regulations 2012 is one of the key pieces of legislation governing medicines in the UK. It consolidates and updates previous laws related to the manufacture, import, labelling, licensing, distribution, and sale of medicines.

Medicines are grouped into three categories under this law:

• Prescription-Only Medicines (POMs): These require a prescription written by a qualified health professional.
• Pharmacy Medicines (P): These can only be sold in registered pharmacies, under the supervision of a pharmacist.
• General Sales List (GSL) Medicines: These are available for sale without any restrictions.

The regulations ensure that medicines are safe and effective for public use. They also prevent misuse or unauthorised distribution of controlled substances.

The Misuse of Drugs Act 1971

The Misuse of Drugs Act 1971 is vital for managing controlled drugs. It categorises drugs into three classes (A, B, and C) based on their potential for harm and abuse.

Key responsibilities under this law include:

• Proper storage of controlled drugs in locked cabinets.
• Accurate record-keeping of their usage.
• Preventing unauthorised access.

This law is crucial for safeguarding individuals from drug misuse. It also supports the safe and lawful handling of controlled drugs such as morphine and fentanyl in care settings.

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 outline standards that health and social care providers must meet. Regulation 12 (‘Safe Care and Treatment’) specifically addresses medicine management. It requires care providers to:

• Administer medicines safely.
• Follow prescription instructions accurately.
• Maintain proper storage conditions (e.g., refrigeration when required).
• Maintain clear records of medicine administration.
• Manage medication errors promptly and effectively.

These regulations are enforced by the Care Quality Commission (CQC), which inspects health and social care organisations to ensure compliance.

The Mental Capacity Act 2005

The Mental Capacity Act 2005 is key when administering medicines to those who may lack the ability to make informed decisions.

Important principles of the Act include:

• Presuming a person has capacity unless proven otherwise.
• Supporting individuals to make their own decisions wherever possible.
• Acting in the individual’s best interests when they are unable to decide.

Healthcare workers may need to involve legal representatives or follow specific protocols for administering medicines to individuals who lack capacity.

The Data Protection Act 2018

Managing medicines also involves handling personal information, such as prescriptions and medical histories. The Data Protection Act 2018 states that this information must be:

• Kept secure and confidential.
• Shared only with authorised personnel or organisations.
• Stored for the necessary period as dictated by law or policy.

For example, electronic records on medicine administration should be password-protected and accessible only to relevant staff.

NICE Guidelines

The National Institute for Health and Care Excellence (NICE) issues evidence-based guidance on medicine management. For example:

• NICE Guideline NG67: Covers managing medicines in care homes. It advises on proper administration, record-keeping, and staff training.
• NICE Guideline SC1: Addresses medicines optimisation, helping individuals get the best outcomes from medication.

While NICE guidelines are not laws, they often shape best practices.

Policies and Procedures in Organisations

Each health and social care organisation must implement policies and procedures on the management of medicines. These policies are tailored to meet the requirements of the legislation above while addressing the organisation’s specific needs.

Typical organisational policies include:

• Administration protocols: Ensuring the correct medicine is given to the correct person at the correct time.
• Storage guidelines, such as keeping medicines in locked cabinets.
• Disposal procedures for expired or unused medicines to prevent environmental damage or misuse.
• Reporting systems for errors, adverse reactions, or near-misses.

Organisations regularly review and update these policies to reflect changes in the law or best practices.

Roles and Responsibilities

Safeguarding individuals during medication management requires the involvement of various people:

• Prescribers: Such as GPs, nurse prescribers, or pharmacists. Prescribers must ensure accuracy and clarity in prescriptions.
• Care Workers: Care workers administering medicines need proper training. They must check the prescription, dosage, and individual’s medical history before administering medication.
• Pharmacists: Responsible for ensuring medicines supplied are correctly labelled, safely prepared, and legally dispensed.

Everyone has a duty of care to follow the laws and policies aimed at protecting the individual.

Training and Competence

Policies often require staff to complete formal medicine management training. This ensures they develop the competence to:

• Administer medicines safely.
• Identify side effects or errors.
• Understand legal responsibilities around controlled drugs.

Regular refresher courses help staff stay updated with changes in procedures or legislation.

Errors in Medicine Management

When errors occur, correct policies must be followed. These may include:

• Reporting the error immediately to the supervisor.
• Notifying the individual and their GP or prescriber.
• Addressing the cause of the error (e.g., through retraining or revising processes).

Errors can have serious consequences, such as harm to the individual or legal penalties for the care organisation.

Public Accountability

Finally, medicine management policies promote transparency and accountability in healthcare and social care organisations. By complying with legislation, organisations gain public trust and provide a higher standard of care.

Effective communication between health professionals, care workers, and individuals receiving medication is crucial for safe medicine management.

Final Thoughts

Current legislation and policies governing the management of medicines in the UK aim to protect individuals, ensure safety, and prevent misuse. They require health and social care organisations to maintain high standards of practice and provide clear procedures for staff to follow. These laws and guidelines create a system where medicines are managed effectively to support health and wellbeing.