Superintendent Pharmacist Issued Warning for Dispensing Generic Medicines against Branded NHS Prescriptions

Date of Decision: August 20, 2025

Registrant's Role: Pharmacist

Allegations:

  • Dispensed generic versions of POMs where branded items were prescribed without a Serious Shortage Protocol (SSP).
  • Dispensed medication of a different strength than prescribed.
  • Labelled medication to reflect what was dispensed rather than what was prescribed.
  • Allegation of dishonesty in relation to the above actions (not proved).

Outcome: Warning

GPhC Standards Breached:

  • Standard 1 – Pharmacy professionals must provide person-centred care
  • Standard 5 – Pharmacy professionals must use their professional judgement
  • Standard 9 – Pharmacy professionals must demonstrate leadership

Case Summary

Allegations

The case centred around the conduct of the registrant, a superintendent and responsible pharmacist at Frodsham Pharmacy, involving a series of medication dispensing practices that occurred over a period from July 2022 to January 2024. The General Pharmaceutical Council (GPhC) raised concerns after the registrant repeatedly dispensed generic medications instead of branded prescription-only medicines (POMs), contrary to the specific items prescribed. This occurred without the support of any Serious Shortage Protocols (SSPs), which are formal authorisations required to substitute medications under certain circumstances.

Additionally, on at least one occasion, the registrant supplied lorazepam tablets of double the prescribed strength (1mg instead of 500mcg), splitting the tablets to reach the intended dosage. Furthermore, the registrant ensured that medication labels reflected the dispensed item rather than the originally prescribed product—raising questions around audit trail integrity and safe administration in the care home settings being serviced.

A particularly concerning outcome of these actions was an incident where a patient suffered an allergic reaction due to receiving a patch with an adhesive that differed from the one prescribed. While this was not linked to deliberate misconduct, it highlighted the potential dangers of unilateral medication substitution without appropriate consultation.

Findings

The Committee found allegations 1, 2, and 3 proved based on the registrant’s own admissions. These included the dispensing of:

  • Branded medications like Bunov, Duotrav, Epilim, and others being substituted with generic alternatives.
  • Lorazepam being dispensed in split tablet form to approximate the correct dose.
  • Medication labels being altered to reflect the generic products provided rather than what was originally prescribed.

While these acts did occur, the panel scrutinised whether the registrant’s actions were dishonest. Allegation 4, which alleged dishonesty, was not proven. The registrant denied seeking to conceal any substitutions and maintained that his actions were motivated by concern for patients amid supply challenges.

In his defence, the registrant cited:

  • Longstanding supply shortages.
  • Inability to obtain branded drugs despite having contracts with nine wholesalers.
  • Lack of practical alternative options, such as obtaining medication from competitor pharmacies.
  • Time constraints and practical limitations in seeking prescriber amendments.

The panel accepted the registrant’s explanation, noting no evidence of intent to deceive. Moreover, care homes were often informed of the substitutions via Medication Administration Records (MARs), and no patients were known to have suffered harm (with the exception of the aforementioned allergic reaction, where fault was acknowledged).

GPhC Determination on Impairment

The panel considered whether the actions constituted misconduct and if they amounted to a current impairment of fitness to practise.

Although both the GPhC and the registrant’s counsel argued that the threshold for professional misconduct was not met, the panel concluded otherwise. It found that allegations 1 and 2 did amount to misconduct. These findings were based on the registrant’s:

  • Knowing breach of the Human Medicines Regulations 2012.
  • Failure to consult prescribers or care homes.
  • Role as Superintendent and RP, from whom higher standards are expected.

The panel did not find misconduct in relation to allegation 3 (labelling), as the changes were made to reduce confusion among care home staff, not to deceive.

However, despite the finding of misconduct, the panel determined that the registrant’s fitness to practise was not currently impaired. The reasoning included:

  • Full admission and acceptance of fault.
  • A robust and sincere reflective statement.
  • Extensive remediation including SOP changes, cessation of blister pack usage, and reduction in care home contracts.
  • Strong workplace supervision reports and professional testimonials.
  • The rare nature of the conduct relative to the overall scale of dispensing.

In particular, the Committee stated:

“The Committee is of the view that the Registrant is to be commended for the assiduous care he has taken to learn from his failings and improve his practice. It is satisfied that the Registrant has remediated his misconduct and that it is highly unlikely that he will repeat it in future.”

Sanction

Although no finding of impairment was made, the panel issued a formal warning. This was deemed necessary to:

  • Publicly affirm that the registrant’s past conduct fell below expected standards.
  • Uphold public confidence and reinforce professional norms.

The warning, recorded on the register for 12 months, addressed breaches of:

  • Standard 1 – Person-centred care: especially the risk of unintended consequences when dispensing unapproved alternatives.
  • Standard 5 – Professional judgment: substitution without lawful authority or guidance breaches both regulatory and clinical expectations.
  • Standard 9 – Leadership: as Superintendent, the registrant had an amplified duty to role-model safe and compliant practice.

Key Learning Points for Pharmacy Professionals

This case offers multiple vital insights for pharmacy professionals:

  1. Medication Substitution Must Be Lawful and Justified: Dispensing a generic in place of a prescribed branded medicine is not permitted without an active Serious Shortage Protocol or express prescriber authorisation. Convenience or patient need, while important, cannot override legal obligations.
  2. Label Accuracy and Transparency Are Critical: Altering labels to match what is dispensed, even if well-intentioned, can undermine audit trails and clinical safety. Any deviation from prescriptions should be clearly justified and properly documented.
  3. Responsibility Increases with Seniority: Holding the role of Superintendent or Responsible Pharmacist entails elevated responsibility to maintain standards and lead by example—especially when making operational decisions affecting vulnerable populations like care home residents.
  4. Mitigation Doesn’t Eliminate Accountability: Even in the absence of malicious intent or patient harm, breaches of regulatory expectations can still warrant warnings or sanctions.
  5. Reflective Practice and Remediation Matter: The registrant’s proactive learning, procedural reforms, and collaborative engagement with the GPhC demonstrated effective remediation. This ultimately spared a more serious sanction and underscores the value of early, honest reflection in response to regulatory scrutiny.
  6. Clinical Implications of Substitution: Specific medications involved—such as lorazepam, Sinemet, and Bunov—carry varying bioequivalence and excipient profiles. Pharmacists must consider allergy risks, therapeutic ranges, and patient-specific factors before substituting products.

This case reinforces that professional integrity, regulatory compliance, and clear communication with prescribers and care providers are fundamental pillars of pharmacy practice.

Original Case Document

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