EveryDayMeds (9012878) - Improvement action plan

When supplying higher-risk medicines the pharmacy does not routinely use two-way communication with patients to make sure that it has the information it requires to support prescribing decisions. And it doesn’t always obtain independent evidence of any health conditions the person says they have in their questionnaire. It uses real time photographs of people to make a visual assessment of weight. But these photos do not provide robust ways of assessing a person’s weight, height or body mass index. So the pharmacy does not accurately verify the information people provide before it makes supplies.

The pharmacy has revised its Action Plan, which previously relied on prescriber judgement alone, to set out the structured safeguard framework required by GPhC guidance 4.2 i and j. Weight-management medicines and black-triangle medicines (▼) are both named examples in that guidance, and the service’s GLP-1 medicines fall into both categories. The service is expressly not a questionnaire-only model: the structured online consultation is only the starting point and is supported by the safeguards below before any supply. Prescriber standards (4.2 i): all prescribing is undertaken by pharmacist independent prescribers, who as registered professionals are expected to work in line with the GPhC ‘In practice: Guidance for Pharmacist Prescribers’, the RPS Competency Framework for all Prescribers, and — where they widen or change their scope of practice — the RPS guidance on expanding scope of prescribing practice. Within the SOP, prescriber responsibilities, oversight and new-prescriber probation are governed at §5.3 and §8.2, and the Clinical Lead provides clinical oversight and acts as the senior point of escalation for prescribers and clinical checkers. Safeguards before supply (4.2 j): ● Independent identity and body verification — Yoti digital identity verification plus a live-captured full-body video and a live-captured weight-scale video, both recorded in real time within the consultation using the website’s Live Video Camera (pre-recorded uploads are not accepted, as a safeguard against reused, edited or third-party recordings). The full-body video shows the patient head to toe with the face clearly visible for body-habitus assessment against the declared height, weight and BMI; the weight-scale video is one continuous recording showing the patient stepping onto the scale, the stable final reading and the unit of measurement. Detailed accept/reject standards and prescriber actions are set out at §6.3.2, and the objective checklist the prescriber must apply and document is at §6.3.1. Fresh verification videos are required at months 4, 7 and 10 and every three months thereafter, or sooner where clinical judgement requires it (§6.3–§6.3.2). ● Independent verification of declared information — SCR review is mandatory at first supply wherever access is available, and before any transfer or step-up order; where the SCR is unavailable or insufficient, independent supporting evidence must be obtained for any clinically material factor. Prescribers must not proceed on a documented rationale alone where independent verification of a material factor is achievable but has not been obtained (§6.4, §6.5). ● Two-stage independent clinical review — every order undergoes prescriber review (§7) and then a separate pharmacist clinical check by a different pharmacist (§8) before supply. ● Two-way counselling communication — following approval the prescriber initiates and maintains two-way communication with the patient via RxPortal secure messaging, and patients may respond with further questions (§7.7). ● Ongoing monitoring — inter-order weight-change monitoring, with tailored review where there is significant weight gain or loss, a treatment gap or a medicine switch (§9.5). ● Side-effect and safety pathways — a structured side-effect severity pathway with red-flag escalation, and black-triangle (▼) adverse-reaction reporting to the MHRA via the Yellow Card scheme (§9.6). ● GP notification — the patient’s GP is notified via Docman, supporting continuity and shared oversight (§11). ● Formulary scope — the live formulary consists solely of GLP-1 weight-management medicines (Wegovy and Mounjaro); the service does not prescribe antimicrobials, medicines liable to misuse (opioids, sedatives, gabapentinoids, stimulants), medicines for other long-term conditions requiring ongoing monitoring, or any pregnancy-prevention-programme medicines.

Prescribers do not regularly record consultation notes when prescribing and do not consistently demonstrate how they make their decision to prescribe or not. And prescriber records do not contain the level of detail that includes information such as advice given, ongoing monitoring or consideration for any follow-up required. This makes it harder for the pharmacy to demonstrate continuity of care and show the supplies it makes are appropriate.

The pharmacy reviewed and strengthened its consultation documentation and prescribing governance within the updated SOP, and made prescribers aware of the inspection findings relating to consultation detail, prescribing rationale and documentation standards. The updated SOP now includes: ● A mandatory clinical documentation standard (§7.6) that maps each GPhC record-keeping expectation to how it is met in this service and makes documentation mandatory rather than discretionary. ● A requirement for a free-text clinical note wherever clinical judgement is exercised — for example borderline BMI, a reviewed flag, a treatment gap, a dose change, or proceeding without an SCR. ● A mandatory critical note for every rejection, dose change, borderline or flagged decision, deviation from SOP/SPC, decision to proceed without supporting evidence, or lifting of an account restriction, stating the reason for the decision. Critical notes are downgraded (with date, reason and name) rather than deleted (§7.6). ● A documentation gate at clinical checking (§8.1) requiring the checker to confirm the note meets the standard before release; inadequate documentation is returned for completion before supply. ● Retrospective sampling of documentation quality in the biweekly random prescription audit (§14.2). The pharmacy is also exploring further prescriber education with Novo Nordisk and Eli Lilly.

The pharmacy sets out clear processes for the regular auditing of its pharmacist independent prescriber’s (PIP) prescribing. But the pharmacy has not completed any audits. So, the pharmacy cannot ensure that its prescribing decisions meet the prescribing safeguards it has in its policies. Or ensure it continues to make appropriate supplies.

The pharmacy has implemented the formal audit programme now defined within the updated SOP and has commenced audit activity. The programme is deliberately proportionate for a small remote prescribing team while satisfying GPhC clinical governance expectations: ● Random prescription check — five completed cases reviewed biweekly by the Responsible Pharmacist or Clinical Lead, covering identity/BMI verification, eligibility, contraindications, dose selection, documentation, counselling and GP notification (§14.2, Audit 1). ● Rejection audit — rejected orders reviewed weekly to confirm decisions were clinically appropriate and correctly documented (§14.2, Audit 2). ● Side-effect and escalation review — side-effect queries, dose-escalation decisions, holds and escalations reviewed weekly, including MHRA Yellow Card checks (§14.2, Audit 3). ● Every audited case is assigned a RAG rating; Red-rated findings are escalated to the Clinical Lead the same day, and outcomes are recorded in the Weekly Audit Log. ● A monthly governance review (§14.3) examines audit trends, tracks open actions against a named owner and target date, and feeds learning back into the SOP, training and workflow. All records are retained and available for GPhC inspection.