Administering Medication – Laws, Policies and Legislation

People may require both routine and life-saving medication to help them fight infection or disease, overcome illnesses or live with life-long conditions.

It is important that patients receive the correct medicine at the correct dosage as failure to comply with this could result in serious consequences, including death, for the patient.

An estimated 237 million medication errors are made in England every year, with research outlining that ‘definitely avoidable’ errors cost the NHS over £98 million per year and, more importantly, the lives of 1,708 patients. Errors are made at every stage of the process, with more than half being made at the point of administration; error rates are highest in care homes (42%) and approximately 1 in 5 errors are made in hospitals.

These shocking statistics highlight the importance of effective medication management for everyone who works across the health and social care sector, in any capacity, in order to reduce the rate of errors made and save lives. 

Legal framework in the UK

The main piece of legislation that relates to administering medication in the UK is The Human Medicine Regulations 2012 which came into effect on 14th August 2012.

The regulations outline in detail the law relating to medicine, including its:

• Manufacture
• Sale and supply
• Distribution
• Labelling
• Advertising
• Authorisation

Other relevant legislation includes The Misuse of Drugs Act 1971. 

The Medicines and Healthcare products Regulatory Agency (MHRA) is the only governing body that can grant a licence for a medication to be licensed for use. This is subject to strict clinical trials.

Medicine can be described as over the counter, or OTC, (non-prescribed) or prescribed. Prescription medicine can only be authorised by someone who has the legal right to do so. 

Some non-prescription medications can be bought at pharmacies and supermarkets with a pharmacy department and do not require a prescription form from a doctor or a GP to authorise them. These include:

• Some painkillers
• Cough syrups
• Topical creams

Other items such as medicated eye drops or emergency contraception cannot be bought directly from the shelves but can be given under the supervision of a pharmacist. The pharmacist may be required to ask some questions first to assess your suitability for the medication.

Prescription-only medicine must be given by someone who is appropriately certified, such as your GP. Prescription-only medicine includes:

• Strong  opioid painkillers
• Antibiotics
• Anti-psychotic medication
• Medicines considered ‘controlled drugs’

Policies and guidelines

Prescription medicine should only be prescribed by a qualified healthcare professional. 

Depending on your circumstances and the medicine in question, this could be a:

• GP
• Doctor at the hospital
• Nurse
• Dentist
• Pharmacist
• Optometrist
• Physiotherapist
• Radiographer
• Paramedic
• Podiatrist
• Psychiatrist
• Midwife

Not all healthcare professionals will be able to prescribe all medication. In recent years, some developments have occurred that allow some medicine to be given by ‘non-medical prescribers’ such as nurses or pharmacists. This is happening across the NHS to reduce wait times, decrease pressure on doctors and streamline patient services.

To assist with this new way of working, medicines are being coded by colour on a type of traffic light system. 

This means that medicines are labelled as:

GREEN – these are regarded as suitable for primary care prescribing (including non-medical prescribers with correct training and certification).

AMBER – these will usually be prescribed in secondary care or by a specialist. These are suitable for a GP to prescribe as part of ‘shared care’ on an ongoing basis.

RED – these are generally considered suitable only to be prescribed by a specialist or consultant (on both an initial and ongoing basis).

BROWN/GREY – this is medication that is not normally used or only used in exceptional circumstances, if it is deemed helpful.

Some medications are coded as DO NOT PRESCRIBE, or DNP, including drug treatments or medical devices. DNP medication may be problematic, unavailable or unlicensed and should not be prescribed by anyone.

Both prescribed and non-prescribed medicine may need to be administered in a number of settings, including healthcare and non-healthcare settings, such as:

• Doctor’s surgery
• Hospital
• Sexual health clinic
• NHS walk-in centre
• Dentist surgery
• Nursing home
• Care home
• School
• Nursery
• A patient’s home

Wherever a medication is being given it is important that those who are administering it are mindful of being compliant with law and legislation, best practice and the needs and dignity of the patient. 

You must have a policy or standard operating procedure that details how you manage controlled drugs in your organisation. As a minimum, this should cover:

• Ordering medication
• Storing medication
• Administering medication
• Recording how medication is used
• Disposing of medication

Non-medical settings, for example nurseries, childminders or care homes, will draft their own policies regarding over-the-counter medication. This sometimes means that GPs are asked to prescribe non-prescription medication for routine use just to satisfy their policies. This is not a legal requirement.

The Care Quality Commission (CQC) states that access to over-the-counter medication is a matter of equity, and care homes should allow OTC remedies to support patient care, including if it is brought in by a family member, providing all medicine is:

• checked with an appropriate healthcare professional to ensure its suitability;
• is in date; and
• is stored according to the manufacturer’s guidance.

Over-the-counter medication that is administered within any setting is still subject to normal record-keeping practice, including the date, time and dosage of the product.

Medication management systems

Simply put, safe medication management means that the right people know what medication to give to who, as well as when and how much. It also involves the purchasing, storing, disposal and record-keeping of medication. 

Good and consistent administration is key to effective medication management. The roll-out of new technology and software can help organisations to collate and share information about medication. They can also be used to:

• Record what medicine a patient is taking
• Record when medication is administered, at what dose and frequency
• Record and monitor any side effects
• Note changes to medicine or patient health

However, even with the best systems in place, if staff are not adequately trained or the correct protocols are not being enforced, mistakes will be inevitable.

Why is it so important to monitor and control medication?

There are a  number of reasons it is important to monitor and control the administration of medication; patient safety is at the heart of them all. Some of the reasons it is important to be compliant and monitor medications are:

• Medicines can interact with one another and it is important to be mindful of this to ensure patients receive the best care
• Some medicines can cause addiction; it is important to monitor patients who are taking these medicines and take note of these risk factors
• Medication comes with side effects that can range in severity from mild to fatal
• People can be allergic to medicine

In addition to managing medication using software, medicine needs to be physically managed in the correct way. In practice this means:

• Storing medication in original, labelled packaging
• Storing medicine as per instruction (such as in the fridge if required)
• Using appropriate storage units or rooms
• Limiting access to medication to authorised personnel only
• Enforcing compliance with record-keeping such as signing in and signing out sheets and stock control

It is also of high importance to make sure that medication is managed easily and effectively to remove the possibility of levels of important medicine falling to critical levels. Effective medication control can also help to monitor stock levels and identify any supply chain issues early on before they impact on patient care.

Patient rights and informed consent

The concept of informed consent is both a legal and ethical matter.

There are four basic principles of informed consent in the UK. They are:

• Decision capacity
• Documentation of consent
• Disclosure
• Competency

In 2015, a legal case meant that the law around informed consent was changed. Doctors now need to give patients information about any treatment, including side effects, risks and implications, before the patient can make an informed decision about whether to proceed. They are also required to suggest alternatives where applicable.

This puts patients at the centre of their own care and helps them to make more informed and empowered decisions, including around what medication they take.

Documentation and record-keeping

Keeping accurate records can also help with ease of transition when a patient moves from one setting to another, such as from a hospital to a care home or from home into hospital. If accurate and easily sharable documentation about a patient’s health and any medicine they are taking is available this makes the move between settings less stressful and safer for the patient. It also means they will continue to receive the correct care immediately.

Keeping accurate documentation:

• Reduces the chances of errors occurring
• Protects patients and staff
• Improves compliance
• Safeguards patients

The movement of certain controlled drugs (Schedule 2 controlled drugs) has to be recorded in a controlled drug register. This could be a book with bound pages or an electronic register. These items also need to be held in a secure controlled drugs cupboard.

Common Schedule 2 drugs include:

• Morphine
• Methadone
• Diamorphine
• Fentanyl

Schedule 3, 4 and 5 drugs (including codeine and benzodiazepines) do not need to be recorded in the controlled drugs register but do need to be stored securely and in line with policy.

Accurate record-keeping is vital in order to identify any missteps, such as if a controlled drug goes missing or a patient dies under suspicious circumstances. The keeping and sharing of accurate records can help with investigations into incidents and help to maintain accountability and compliance.

It is also highly important that you keep records of patients (or those acting on their behalf) having given informed consent before treatment. This can help protect you from any future action if things go wrong.

Medication errors reporting

Errors in medication administration may occur for a number of reasons including:

• Accidental error
• Intentional malpractice (rare)
• Problems within the supply chain

It is important that medication errors are recorded and reported and that appropriate treatment is given to a patient at all times. 

Transparency is key in correct practice around administering medication, particularly to vulnerable people and it is vital that your organisation is:

• Compliant
• Transparent
• Accountable
• Responsible
• Competent

The risks of poor medication management include:

• Fatalities – the most serious consequence of giving incorrect medication or an incorrect dose is undoubtedly the loss of a patient.
• Illness – poor medication management can lead to patients becoming ill with serious side effects or long-term problems. This affects their quality of life and also has financial implications on the NHS.
• Poor patient experience – making mistakes with patient care leads to a loss of trust and damage to your reputation.
• Impacts on staff – the responsibility for medication errors is usually left with the person who made the error but it may also be indicative of a wider, systemic problem within the organisation. To maintain compliance, reduce errors, and improve staff retention and experience, robust controls should be in place to mitigate errors from occurring.
• Financial impact – this may be from paying out compensation, legal costs, sourcing new staff or treating the long-term effects on the patient who suffered from the medication error.

Impact of legislation on practice

Failure to comply with law and legislation on medication administration could result in legal action which could result in:

• Fines
• Imprisonment
• Being struck off
• Job loss
• Stress and upheaval

If there are discrepancies within controlled drugs in a medical environment, the CQC outlines the following may need to be actioned:

• Contact your local NHS England Controlled Drug Accountable Officer (CDAO)
• Inform your local police CD liaison officer: Your nearest CDLO
• Consider if you need to inform CQC if the incident meets the criteria of a statutory notification

The widespread use of databases and ease of sharing information as well as improvements to shared care and patient-led care has improved communication within the health and social care sectors.  This means that it is becoming easier to track, trace and understand what medication a patient is taking, who prescribed it and any other information needed.

Clear legislation around who can administer medication and how medicines should be controlled leads to a more compliant medical system, with fewer errors and an improved outlook for the safety of patients, but only if this legislation is understood, adhered to and enforced correctly.