Allcures Pharmacist Warned for Controlled Drug Recording Breaches and Dispensing Error Involving Medikinet and Tranquilyn

Date of Decision: August 7, 2025

Registrant's Role: Pharmacist

Allegations:

• Dispensing a mixture of Medikinet 5mg tablets and Tranquilyn 5mg tablets against a prescription for Medikinet 5mg tablets, without an approved shortage protocol in place.
• Failing to make accurate records in the controlled drug register.
• Retrospectively altering entries in the controlled drug register for Tranquilyn 5mg tablets.

Outcome: Warning published on the register for 12 months.

GPhC Standards Breached:

• Standard 1 – Pharmacy professionals must provide person-centred care.
• Standard 5 – Pharmacy professionals must use their professional judgement.
• Standard 6 – Pharmacy professionals must behave in a professional manner.
• Standard 8 – Pharmacy professionals must speak up when things go wrong.

Case Summary

Allegations
This case concerned a registered pharmacist acting as the Responsible Pharmacist at Allcures Pharmacy in July 2024. The allegation centred on the dispensing of a controlled drug — Medikinet 5mg tablets (methylphenidate hydrochloride) — for a patient. Instead of supplying the full quantity prescribed, the pharmacist dispensed a mixture of Medikinet 5mg and Tranquilyn 5mg (another methylphenidate brand) without any authorised Serious Shortage Protocol (SSP) in place. An SSP is the only lawful mechanism by which a substitution of medication, especially for a controlled drug, can be made without a prescriber’s intervention.

Alongside the dispensing error, the pharmacist was alleged to have failed to maintain accurate entries in the Controlled Drug (CD) register — a legal requirement under the Misuse of Drugs Regulations 2001. The situation was further aggravated by the retrospective alteration of CD register entries relating to Tranquilyn 5mg tablets. Such retrospective amendments are a red flag in the context of CD governance, as they raise concerns about potential concealment of errors or irregularities.

Findings
The General Pharmaceutical Council’s Investigating Committee found that the registrant’s actions constituted breaches of multiple professional standards. Dispensing the mixed medication without a valid SSP risked patient safety and undermined the principle of providing person-centred care (Standard 1). The alteration of the CD register — especially after the fact — called into question the registrant’s honesty and integrity, engaging Standards 5 (professional judgement), 6 (professional behaviour), and 8 (speaking up when things go wrong).

The panel stressed that maintaining an accurate and contemporaneous CD register is not merely an administrative task but a fundamental safeguard for both patient safety and legal compliance. The pharmacist’s failure to do so was viewed as serious, particularly because controlled drugs such as methylphenidate are subject to strict legal controls to prevent misuse and diversion.

GPhC Determination on Impairment
The Committee noted that the registrant’s conduct “calls into question their honesty, integrity and trustworthiness and is likely to undermine confidence in the profession.” This language reflects a finding of impairment in the public interest domain — not necessarily because the registrant poses a continuing clinical risk, but because their actions could damage public confidence in pharmacy services.

While there was no evidence of deliberate patient harm, the nature of the errors and the retrospective record changes were considered incompatible with the high standards expected of a Responsible Pharmacist. In particular, the Committee considered that failure to escalate the shortage or error to relevant stakeholders — instead making an unauthorised substitution — demonstrated a significant lapse in judgement.

Sanction
The Investigating Committee determined that the proportionate outcome in this case was a formal warning, to remain on the GPhC register for 12 months.

The warning included the statement:

“This case relates to… the safe custody and accurate recording of drugs [which] is essential for safe and effective patient care and that Pharmacy professionals must act with integrity at all times.”

The Committee considered that a warning, rather than referral to a Fitness to Practise Committee hearing, was sufficient because the registrant had shown some insight and the incident appeared to be isolated. Nevertheless, the sanction serves as a clear reminder to the registrant and the wider profession of the seriousness of any breach involving controlled drugs.

Key Learning Points for Pharmacy Professionals

1. Controlled Drug Substitution Without SSP Is Not Permitted
   Even where the substitution is clinically appropriate, dispensing a different brand or formulation of a controlled drug without an authorised Serious Shortage Protocol or prescriber authorisation is a breach of both law and professional standards.
2. CD Registers Must Be Accurate and Contemporaneous
   The CD register is a statutory document. Entries must be made promptly and without retrospective alteration, except in cases where a clear, lawful correction is documented. Any change must maintain the original entry’s visibility and include a clear explanation.
3. Integrity Is Non-Negotiable
   Pharmacy professionals must act with absolute honesty when recording and reporting incidents. Retrospective changes without transparency undermine trust and can escalate a minor dispensing error into a regulatory breach.
4. Speak Up When Things Go Wrong
   If a medicine supply problem or error occurs, it should be escalated immediately. This includes notifying the prescriber, informing the patient appropriately, and making a record in the pharmacy’s incident log.
5. Role of the Responsible Pharmacist
   The RP’s signature on the pharmacy’s daily record is more than a formality — it signals accountability for the safe running of the pharmacy, including lawful handling of controlled drugs.

This case stands as a cautionary example for all pharmacists: controlled drug governance is one of the most scrutinised aspects of pharmacy practice. Even seemingly minor deviations — such as brand substitutions without protocol, or “tidying up” the register after the fact — can lead to formal regulatory action.

Original Case Document

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