Medicines Optimisation: A CQC Compliance Guide for GP Practices

Medicines optimisation is a central part of patient safety in primary care and the focus of much guidance for providers; it is a heavily inspected quality statement of the CQC’s ‘safe’ key question: 

“We make sure that medicines and treatments are safe and meet people’s needs, capacities and preferences by enabling them to be involved in planning, including when changes happen.”

The CQC expects providers to ensure that medicines are appropriately prescribed, supplied and administered in accordance with relevant legislation and professional guidance. It also expects accurate medicines information, safe management of controlled drugs and appropriate arrangements to support patients in understanding and managing their treatment:

• Patients feel safe and understand how to manage risks associated with their care.
• Patients know whom to contact if their health deteriorates or they have concerns.
• Patients understand and participate in decisions when medicines or treatments change.
• Patients receive considerate support from appropriately competent staff.

How can GP practices maintain compliance with Medicines Optimisation?

1. Maintain a comprehensive prescribing and repeat prescribing policy

Every practice should have a clear prescribing policy covering the full prescription process, from receiving requests through to authorisation, monitoring and review. It should address:

• Repeat prescription requests, turnaround times and clinical reauthorisation.
• Medicines that are not routinely suitable for repeat prescribing.
• High-risk medicines and patients requiring additional safeguards.
• Requests for medicines before the usual renewal date.
• Patients who repeatedly fail to attend monitoring or reviews.
• Recording medicines prescribed by hospitals, private providers or obtained over the counter.
• Antimicrobial stewardship and medication overuse.

2. Ensure medication reviews are clinically meaningful

Medication reviews are a key part of medicines optimisation, particularly for patients living with multiple conditions, frailty or polypharmacy.

It is important to distinguish between a repeat medication check, which reauthorises ongoing prescriptions, and a structured medication review, which examines medicines more comprehensively.

A meaningful medication review should consider:

• Whether each medicine remains clinically appropriate.
• Effectiveness, adverse effects and potential interactions.
• Patient adherence, preferences and concerns.
• Allergies, as-required medicines and ongoing monitoring.
• Opportunities to simplify treatment or deprescribe.
• Changes to prescribing instructions or treatment duration.

3. Establish reliable high-risk medicines monitoring

Medicines such as DMARDs, lithium, warfarin, DOACs and amiodarone require appropriate monitoring because of their potential risks.

Practices should have documented protocols identifying:

• Which patients require monitoring.
• What tests or clinical assessments are needed.
• How frequently monitoring should take place.
• Who is responsible for arranging and reviewing results.
• How missed appointments are followed up.
• What action is required when results are abnormal or monitoring is overdue.

Ardens CQC searches can help identify patients requiring attention, but the CQC is clear that these should supplement rather than replace the practice’s own monitoring and recall arrangements.

4. Strengthen medicines reconciliation and continuity of care

Hospital admissions, discharge and transfers between care settings can introduce medication discrepancies. Practices should have a documented process for reconciling medicines following discharge and for reviewing changes made by other providers particularly since NICE recommends undertaking medicines reconciliation as soon as practically possible, within one week of receiving discharge information and before issuing a new prescription or supply.

5. Maintain appropriate Patient Group Directions and Patient Specific Directions

Many GP practices supply or administer medicines through Patient Group Directions (PGDs) or Patient Specific Directions (PSDs), particularly in vaccination and treatment clinics. These arrangements must be appropriate, current and legally valid.

For PGDs, practices should check that:

• Current approved versions are in use.
• Eligible registered healthcare professionals have been appropriately authorised.
• Practitioner and authorising manager signatures and dates are correctly completed.
• Relevant training and competence assessments remain current.

Healthcare assistants, nursing associates and physician associates cannot operate under PGDs.

PSDs provide a separate route for named-patient treatment following an individual assessment by a prescriber. Appropriately trained and competent staff may administer medicines under a valid PSD within their role.

6. Ensure non-medical prescribers are supported and competent

Clinical pharmacists, nurses, paramedics and other appropriately qualified professionals may undertake prescribing responsibilities in general practice, particularly under ARRS roles. The practice must ensure that non-medical prescribers work within their professional competence and have appropriate governance arrangements which should include verification of professional registration and prescribing qualifications, appropriate indemnity, access to clinical supervision and clarity over prescribing responsibilities.

7. Maintain safe medicines administration, storage and emergency drug arrangements

Practices must ensure that medicines administered or held on site are managed safely. This includes vaccinations, injectable medicines, emergency drugs and controlled medicines.

Appropriate systems should cover:

• Staff competence and lawful authorisation for administration.
• Safe medicines storage and restricted access.
• Vaccine cold chain monitoring.
• Regular stock and expiry-date checks.
• Emergency medicines appropriate to the services provided.
• Maintenance and checking of associated clinical equipment.

Weekly emergency medicines checks are recommended and should be recorded and any missing or expired items are promptly addressed. The practice should also document its rationale for the emergency medicines it holds, taking account of its patient population, services and current clinical guidance.

8. Maintain appropriate controlled drug safeguards

Controlled drugs require additional safeguards in relation to prescribing, storage, record-keeping and disposal.

Requirements will vary according to whether a practice prescribes controlled drugs, holds stock or administers them.

Where relevant, practices should maintain standard operating procedures covering ordering, receipt, secure storage, administration, recording, stock reconciliation and disposal.

Staff should understand how to report discrepancies or concerns and how to access the relevant Controlled Drugs Accountable Officer arrangements.

9. Secure blank prescription forms and stationery

The security of blank prescription forms is an important medicines safety and fraud prevention responsibility. Practices should have arrangements for securely receiving, storing, issuing and tracking prescription stationery, including paper held in printers and prescription pads used during home visits.

10. Respond promptly to medicines safety alerts

Practices must have reliable systems for receiving and responding to relevant MHRA safety alerts, drug recalls and national patient safety alerts.

The process should include:

• A named responsible person and appropriate deputy cover.
• Clinical review of relevant alerts.
• Communication to affected staff.
• Patient identification through clinical searches.
• Documented actions and completion dates.
• Follow-up checks where necessary.

11. Identify inappropriate prescribing and medication overuse

Medicines optimisation involves identifying patients who may be receiving unnecessary, unsuitable or potentially harmful treatment.

Relevant clinical searches could be:

• Excessive use of short-acting bronchodilator inhalers.
• Long-term or frequent prescribing of benzodiazepines and Z-drugs.
• Gabapentinoid prescribing requiring review.
• Potentially inappropriate non-steroidal anti-inflammatory drug use.
• Anticoagulation risks or possible omissions.
• Medicines requiring pregnancy-related safety precautions.

Practices should also consider the NHS STOMP and STAMP programmes, which address the inappropriate use of psychotropic medicines in people with learning disabilities and autistic people, including children and young people where relevant.

13. Use prescribing data to identify variation and improvement opportunities

Publicly available prescribing data can help practices understand their prescribing patterns and identify areas requiring further investigation. OpenPrescribing provides measures and comparative data at practice, PCN, ICB and national levels.

Variation does not automatically mean unsafe prescribing; it should prompt further consideration of patient populations, clinical circumstances and applicable guidance.

How can practices demonstrate compliance?

The CQC considers different forms of evidence when assessing medicines optimisation, including people’s experiences, staff feedback, observations, processes and outcomes.

For practice leaders, this means demonstrating not only that systems exist, but that they operate effectively and result in safer care.

A useful self-assessment should therefore consider three questions:

1. Are the right systems in place?

Does the practice have appropriate prescribing policies, monitoring protocols, staff authorisations and escalation arrangements?

2. Are those systems being followed?

Can the practice demonstrate that clinical searches are completed, missed monitoring is followed up, medicines reviews are meaningful and safety alerts result in action?

3. Are the systems effective?

Do audits, incident reviews and prescribing data show that risks are being managed and identified problems are being addressed?

Evidence will typically include clinical records, monitoring reports, documented policies, audit findings, staff training records, incident reviews and action plans.

Conclusion: Medicines optimisation requires ongoing assurance

The CQC’s Medicines Optimisation quality statement is fundamentally about ensuring that treatment is safe, appropriate and responsive to patients’ individual needs. For GP partners and practice managers, compliance depends on the effectiveness of everyday prescribing and medicines management arrangements.

Clear policies, competent staff, reliable monitoring, meaningful medication reviews and safe administration are all important. Equally important is the practice’s ability to recognise weaknesses, respond to incidents and demonstrate continuous improvement.