GPhC suspends Responsible Pharmacist for 3 months after CD register failures and unsafe reuse of returned medicines

Date of Decision: August 14, 2025

Registrant's Role: Pharmacist

Allegations:

• Between approximately June 2018 and 18 October 2022, failed to maintain any, or any adequate, controlled drug (CD) register entries for CDs received and/or supplied.
• On or about 18 October 2022, failed to ensure one or more CD registers were kept on the pharmacy premises.
• On or about 18 October 2022, failed to store CDs securely: CDs were found in unlocked tote bags within the dispensary.
• Between 19 April 2022 and 5 August 2022, on one or more occasions placed patient-returned medication back into stock for reuse.
• Between 19 April 2022 and 5 August 2022, on one or more occasions instructed a colleague to use contents of unmarked dosette boxes to prepare new dosette boxes.
• Around 18 May 2023, failed to ensure the multicompartment compliance pack (MDS) service was safe: packs were stored unsealed while awaiting the accuracy check.
• Around 18 May 2023, did not monitor and record temperatures for all medicines fridges, so could not assure appropriate cold-chain storage.
• Around 18 May 2023, did not ensure measuring equipment used in the dispensary was clean and hygienic.

Outcome: 3-month suspension

GPhC Standards Breached:

• Standard 1 – Provide person-centred care.
• Standard 5 – Use professional judgement.
• Standard 8 – Speak up when things go wrong.
• Standard 9 – Demonstrate leadership.

Case Summary

Allegations
This case centres on CD governance and unsafe medicines handling at a community pharmacy where the registrant was the Responsible Pharmacist (RP) and manager. Following an unannounced visit by the Controlled Drugs Liaison Officer on 18 October 2022, CD registers were not on site; they were later retrieved from the registrant’s home. On inspection, CD registers showed no updates since approximately June 2018. Tote boxes containing CDs were stacked in the dispensary, with the CD cabinet full and out-of-date CDs awaiting destruction. Thirty-five CD balance discrepancies were subsequently reported.

In addition, a dispenser (later pharmacy manager) alleged that patient-returned medicines were placed back into stock and that contents of unmarked dosette trays were reused to make new trays during April–August 2022. The registrant denied both allegations. A later inspection in May 2023 found unsealed MDS awaiting accuracy checks, incomplete fridge-temperature monitoring across all fridges, and unclean measuring equipment.

Findings
The registrant admitted particulars 1, 2, 3, 6, 7 and 8. After hearing live evidence, the Committee preferred the witness evidence for particulars 4 and 5, finding them proved on the balance of probabilities. The Committee recognised the registrant’s lack of personal financial motive but noted that, by the registrant’s own account, processes had fallen seriously behind, creating “chaos and confusion” in the dispensary that extended to unsafe reuse of medicines from returns and unlabelled dosette boxes.

The Committee concluded that the registrant breached legal requirements for CDs: Regulation 20 of the Misuse of Drugs Regulations 2001 (timely CD register entries kept at the relevant premises) and Regulation 3 of the Misuse of Drugs (Safe Custody) Regulations 1973 (secure storage of CDs in a locked safe/cabinet/room). It also found breaches of the GPhC Standards for Pharmacy Professionals: Standard 1 (person-centred care) given the patient-safety risks of reusing unverified returns or unlabelled dosette contents; Standard 5 (professional judgement) due to sustained failures in record-keeping and storage; Standard 8 (speak up) because the registrant did not escalate early and initially misled the CD inspector about registers; and Standard 9 (leadership), given the registrant’s direction to a staff member to reuse dosette contents and the overall governance failures whilst RP.

The Committee considered particulars 6–8 (unsealed MDS awaiting checking; incomplete fridge records; unclean equipment) breaches of standards but, taken alone, not sufficiently serious to amount to misconduct; the sustained CD governance failures and unsafe reuse (particulars 1–5) crossed the misconduct threshold.

GPhC Determination on Impairment
Applying Rule 5(2) and relevant case law, the Committee assessed both the personal component (current risk) and the public component (wider public interest). On remediation, the registrant had left the original branch in November 2023, was working as a locum RP at another site, and had since maintained CD records and destruction processes promptly. An employer reference reported accurate CD balance spot-checks and timely entries; a later CDLO visit raised no concerns. The registrant provided CPD evidence and a reflective statement acknowledging failures and detailing improvements (e.g., immediate destruction logging for CD returns, improved cleaning controls, sealing MDS on the day of assembly, and structured fridge monitoring for all fridges).

The Committee found the conduct remediable, remedied, and unlikely to be repeated. It therefore concluded that the registrant was not currently impaired on the personal component. However, not making a finding of impairment would, in the Committee’s view, undermine public confidence and standards, given the gravity and duration of the CD governance failures and the unsafe reuse of returned medicines/dosette contents. Accordingly, the Committee found current impairment on public-interest grounds alone.

Sanction
Considering sanctions in ascending order, the Committee rejected “no action” and a “warning” as insufficient to mark the seriousness for the profession and public. Conditions were deemed disproportionate and unnecessary: the registrant had demonstrated remediation, and risks were not ongoing. A short, time-limited suspension was judged necessary to uphold public confidence and standards. The Committee imposed a 3-month suspension with no review, explicitly to mark the seriousness of the misconduct and deter repetition by the profession.

“This will make clear the fundamental responsibility for pharmacists to take seriously their role and privilege as gate-keepers of medicines, including Controlled Drugs.”

The decision records that this appealable outcome would not take effect until 12 September 2025 (or the conclusion of any appeal).

Key Learning Points for Pharmacy Professionals

1. CD registers must be accurate, contemporaneous, and kept at the premises. Regulation 20 requires entries on the day of supply/receipt or the next day; systemic delay over years is indefensible. Keeping registers off-site (e.g., at home) is non-compliant and undermines auditability. Build protected time and dual-checking systems to prevent backlog.
2. Safe custody is non-negotiable. CDs in unlocked totes or overflow locations breach the 1973 Safe Custody Regulations. If the cabinet is full, escalate for additional secure capacity immediately—never park CDs in unsecured containers. Regularly segregate out-of-date/returned CDs for timely destruction records.
3. Never reuse patient-returned medicines. Returns lack assured storage history, batch/expiry verification, and integrity; reintroducing them into stock or mining unlabelled dosette trays creates unacceptable clinical risk (degradation, contamination, wrong drug/strength). This also destroys the audit trail required for safe provision. Train all team members to refuse reuse categorically and to follow SOPs for quarantine and destruction.
4. MDS governance must protect patients between assembly and check. Unsealed compliance packs awaiting accuracy checks invite contamination, mix-ups, and spillage. Seal on the day of assembly or store in a controlled, sealed state pending final check as per SOP. Document assembly/clinical/accuracy checks on the PMR and on the MDS log to preserve accountability.
5. Cold-chain assurance needs complete records for every fridge in use. If your RP log only accommodates one fridge, add a second log or electronic record so all fridges are monitored and documented daily (min/max). Out-of-range excursions should trigger a documented investigation and product-integrity decisions (quarantine, consult manufacturers/MHRA guidance).
6. Hygiene is a clinical safety control, not housekeeping. Measuring cylinders, beakers, and ancillary equipment must be clean, dry, and stored correctly; dirty equipment can cross-contaminate extemporaneous preparations and liquid measures. Build cleaning into the end-of-day checklist with accountability.
7. Speak up early and lead by example. If record-keeping slips, escalate promptly to the superintendent/owner and seek support rather than attempting to “catch up” off-site. As RP, you set the tone; instructing staff to reuse medicines (including from dosettes) models unsafe practice and will be treated as a leadership failure under Standards 8 and 9.
8. Remediation matters—but it does not erase the public interest. The Committee accepted genuine remediation and low risk of recurrence, yet still imposed a suspension to maintain public confidence and standards. Build robust SOPs (CD management, returns, MDS, cold chain, cleanliness), train the team, and audit regularly so you never have to rely on post-event remediation.

Overall, this determination is a clear reminder that CD governance and medicines integrity are foundational. Even amid workload pressures, pharmacists must preserve audit trails, secure storage, and robust MDS/cold-chain processes—every time.

Original Case Document

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