Safe medicines management is part of the wider requirement to provide safe care and treatment. A practice should understand the risks in its own service and use the findings of audits, incidents, patient feedback and any CQC assessment to decide what needs attention.
What Regulation 12 asks
CQC’s Regulation 12 guidance covers risk assessment and mitigation, staff competence, medicines management and coordination where care is shared or transferred. Compliance involves the care actually delivered as well as evidence of how it is organised.
A medicines concern does not determine a practice’s rating by itself. Read any assessment finding and regulatory action in context, using CQC’s current guidance.
Governance and staffing duties
Medicines concerns may also involve Regulation 17 (good governance), including the systems used to learn from incidents, respond to safety alerts and maintain reliable records. CQC’s non-medical prescribing guidance also links competence and supervision to Regulation 18 (staffing). The regulation relevant to a particular finding depends on the facts; a medicines issue is not automatically confined to Regulation 12.
Monitoring higher-risk medicines
Identify the medicine-specific checks required, review available results and document actions. Missing results, non-attendance, symptoms and abnormal findings need assessment and follow-up according to urgency.
Shared-care arrangements should make the work and escalation routes clear. Where responsibilities are unclear, resolve them promptly with the relevant clinicians; do not assume that the absence of an agreement automatically transfers every duty to one party.
Safety alerts and incidents
Review relevant alerts, identify affected patients or products, document the assessment and take or escalate the required action. A record should show why an alert did or did not require local action.
Incident review should support learning and practical improvement. An alert log helps trace the work, but the log alone does not demonstrate that the clinical response was appropriate.
Prescribing competence and authorisation
Match prescribing work to the professional’s qualification, assessed competence and agreed scope. Maintain appropriate supervision and review of clinical work. Check the applicable authorisation and expiry requirements wherever a patient group direction is used.
Prescription systems and storage
Review the controls relevant to each site and the medicines or prescription stationery it handles. Include secure handling, stock and expiry checks, storage conditions and a response to identified problems. Do not assume one branch or profession is the source of a concern without evidence.
Repeat prescribing and eRD
Repeat authorisation and electronic repeat dispensing need appropriate clinical review, monitoring and arrangements for treatment changes. The duration and suitability of an eRD issue depend on the patient and medicines; it is not a universal twelve-month decision.
Documentation and quality review
Record the clinical assessment, patient discussion where relevant, decisions and outstanding actions. Where a record is incomplete, establish what happened and what care is needed. Do not retrospectively invent a consultation or treat a coding change as a substitute for clinical work.
CQC clinical searches can identify records requiring review. They complement the practice’s own governance; a clear result is not a guarantee of safe care and a flagged result is not automatically a proven breach.
Where managed support fits
Virtual Pharmacist supports agreed medicines work through monitoring, safety alerts, repeat prescription reviews and CQC preparation.
Frequently asked questions
Does missing shared-care documentation automatically make all monitoring the GP’s responsibility?
Do not make that assumption. Clarify the agreed responsibilities promptly with the relevant clinicians and address the patient’s current needs and any risks.
Does a clear search result prove compliance?
No. Searches support review but do not replace clinical judgement, routine monitoring and wider governance.
Can better coding fix unsafe care?
Accurate records matter, but coding alone cannot replace care that has not been delivered. Establish what happened, address clinical needs and correct records transparently.
Who should oversee the work?
Agree clear ownership, cover, escalation and review of outstanding actions. The arrangement should continue to work when individual staff members are absent or change.
The service is delivered remotely under agreed clinical protocols, with documentation and escalation. Scope is defined in writing: DOAC initiation and opioid or gabapentinoid deprescribing are excluded without prior agreement. No clinical pharmacy service can guarantee an inspection outcome. Contact us to discuss the work required.
Primary references
CQC Regulation 12 guidance; CQC guidance on clinical searches; NICE NG5 medicines optimisation.
