Superintendent Pharmacist Suspended for Nine Months After Failing to Safeguard Patients in Online Pharmacy

Date of Decision: April 6, 2023

Registrant's Role: Pharmacist

Allegations:

• As the Superintendent Pharmacist (SI) at SQ Invest Ltd, which operated an online pharmacy, the registrant:
• Failed to implement proper identity verification procedures for patients ordering medicines online.
• Allowed patients to select high-risk medicines, strengths, and quantities before consultations.
• Supplied opioids (codeine, dihydrocodeine) and sleeping aids (zopiclone, zimovane) without verifying GP approval.
• Allowed medicines to be supplied solely based on a self-completed online questionnaire.
• Did not conduct audits on prescribing practices or refusals, increasing the risk of inappropriate supplies.
• Used prescribers based in Romania but did not ensure they were following UK guidelines or properly registered.
• Did not have proper indemnity insurance for the prescribing services provided.

Outcome: A nine-month suspension was imposed

GPhC Standards Breached:

• Standard 1 – Provide Safe and Effective Care
• Standard 2 – Work in Partnership with Others
• Standard 5 – Use Professional Judgment
• Standard 8 – Speak Up When Things Go Wrong
• Standard 9 – Demonstrate Leadership

Case Summary

The General Pharmaceutical Council (GPhC) Fitness to Practise Committee investigated a Superintendent Pharmacist (SI) following serious patient safety concerns at an online pharmacy.

Between December 2018 and November 2019, the registrant managed SQ Invest Ltd, an online pharmacy that:

• Supplied high-risk medicines, including opioids (codeine, dihydrocodeine) and sleeping aids (zopiclone, zimovane).
• Operated on a questionnaire-based model, allowing patients to select medicines, strengths, and quantities before a consultation.
• Used non-UK prescribers based in Romania, without ensuring they followed UK prescribing guidelines.
• Dispensed medication even when GP responses were missing or inconclusive.
• Lacked appropriate indemnity insurance for prescribing services.

These systemic failures posed serious risks to patient safety, prompting the GPhC to impose urgent conditions on the pharmacy’s registration in November 2019, preventing it from selling controlled drugs.

Findings:

The Fitness to Practise Committee found that the pharmacist’s actions amounted to serious misconduct, specifically:

1. Lack of Proper Identity Verification and Patient Safeguarding:
   • The pharmacy allowed users to create accounts and order medication without proper ID verification.
   • Some users created multiple accounts to bypass restrictions.
2. Unsafe Prescribing and Dispensing Practices:
   • Patients could select medicines, strengths, and doses before consulting a prescriber.
   • No face-to-face or telephone consultation took place—prescriptions were issued based on online questionnaires alone.
   • Prescriptions were dispensed even if no GP response was received, increasing the risk of misuse and addiction.
3. Failure to Conduct Risk Assessments and Audits:
   • No audits were conducted on prescribing decisions or refusals.
   • No checks were made to prevent excessive orders or overuse of high-risk medicines.
   • There was no tracking of how many patients had received opioids multiple times without GP oversight.
4. Failure to Ensure Prescribers Were Properly Registered and Compliant with UK Guidelines:
   • The pharmacy relied on non-UK prescribers based in Romania.
   • The pharmacist could not provide proof that the prescribers followed UK standards.
   • The pharmacist did not confirm that prescribers were registered with the appropriate regulatory bodies in their home country.
5. Lack of Professional Oversight and Leadership as a Superintendent Pharmacist:
   • The registrant admitted not fully understanding her responsibilities as an SI.
   • She did not ensure that the pharmacy’s online prescribing practices met UK regulatory standards.
   • The business operated on a “commercial transaction” model, rather than prioritizing patient safety.

Given these failings, the committee ruled that her fitness to practise was impaired and that sanctions were necessary to protect the public.

GPhC Determination on Impairment:

The committee ruled that the pharmacist’s actions represented a serious risk to patient safety and public confidence in the profession.

Key considerations included:

• The risk of harm to vulnerable patients receiving addictive medicines without proper checks.
• The failure to follow national prescribing and pharmacy guidelines.
• The registrant’s lack of insight into her role and responsibilities as an SI.

While the pharmacist expressed remorse and had undertaken further training, the committee was not satisfied that she had fully demonstrated insight or remediation.

Sanction:

The committee imposed a nine-month suspension, considering:

• Aggravating Factors:
  • The pharmacy dispensed opioids and high-risk medicines without proper GP oversight.
  • Prescriptions were issued based solely on patient-completed questionnaires.
  • The registrant failed to audit prescribing practices, creating a high-risk environment for patient safety.
• Mitigating Factors:
  • The pharmacist admitted all allegations and cooperated fully with the investigation.
  • She undertook training and professional development after the incident.
  • There was no evidence of direct patient harm, although the risk of harm was significant.

The committee ruled that suspension was necessary to:

• Send a clear message about the importance of patient safety in online pharmacy services.
• Ensure public confidence in the pharmacy profession.
• Give the pharmacist time to further develop insight and demonstrate remediation.

Review Requirements Before Reinstatement:

Before being allowed to return to practice, the pharmacist must provide:

1. Evidence of continued professional development (CPD) during the suspension.
2. A reflective statement showing full understanding of the responsibilities of an SI and how she will prevent similar failings in the future.
3. Further proof of remediation, including testimonials from pharmacy professionals.

Failure to provide sufficient evidence at the review hearing could result in an extension of the suspension or further sanctions.

Key Learning Points for Pharmacy Professionals:

This case highlights critical lessons for pharmacists managing online services:

1. Online Pharmacies Must Prioritize Patient Safety Over Convenience:
   • Self-selection of high-risk medicines before consultations is unsafe and unethical.
   • GP approval and proper identity verification must be mandatory.
2. Superintendent Pharmacists Must Ensure Full Compliance with UK Regulations:
   • Non-UK prescribers must follow UK prescribing guidelines.
   • There must be proper oversight of online prescribing and dispensing practices.
3. Patient Safeguarding is Essential When Supplying Opioids and High-Risk Medicines:
   • Prescribing based only on online questionnaires is inadequate.
   • Regular audits must be conducted to detect and prevent misuse.
4. Regulatory Sanctions Can Have Long-Term Consequences:
   • The pharmacist must now prove full remediation before returning to practice.
   • Failure to demonstrate insight or learning could result in further sanctions.

Original Case Document

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