Pharmacist Given 12-Month Conditions for Inadequate Control of Codeine Linctus Sales

The General Pharmaceutical Council (GPhC) Fitness to Practise Committee investigated a pharmacist after concerns were raised about the sale of large quantities of codeine linctus without proper safeguards.

Between July 2017 and September 2020, the pharmacist:

1. Failed to put adequate controls in place to prevent the misuse of codeine linctus.
2. Supplied large volumes of the medication to two customers (Persons A and B) despite recognising the potential for addiction.
3. Did not maintain proper records, monitor sales, or refuse supply when misuse was suspected.
4. Allowed customers to regularly purchase up to two 200ml bottles at a time, in some cases every three days.
5. Did not implement any system to track repeat customers or offer alternative treatments.

The GPhC’s investigation was triggered in 2020 following an inspection of the pharmacy, during which it was found that excessive amounts of codeine linctus had been ordered and sold.

Findings:

The Fitness to Practise Committee found that the pharmacist’s conduct amounted to serious professional misconduct, considering:

1. Failure to Manage the Risks Associated with Pharmacy-Only Medicines:
   • The pharmacist did not put in place any system to track or restrict excessive purchases of codeine linctus.
   • No records were kept of who was purchasing the medication or how often.
   • The committee noted:“The pharmacist failed to take even basic steps to safeguard customers from the risks of dependency and misuse.”
2. Supplying Codeine Linctus Despite Clear Evidence of Misuse and Addiction:
   • The pharmacist continued to supply large quantities of codeine linctus to two specific customers over a prolonged period.
   • He admitted he suspected they were addicted but continued selling to them.
   • The committee ruled:“Pharmacists have a duty to ensure that medicines are supplied safely. The registrant’s failure to refuse supply, despite knowing the risks, represents a serious lapse in judgment.”
3. Lack of Professional Judgment and Leadership:
   • As the owner and Responsible Pharmacist, the registrant was responsible for implementing safeguards to prevent misuse.
   • The pharmacy was flagged for ordering large volumes of codeine linctus, yet no action was taken to limit sales or review practices.
4. Failure to Engage with the GPhC Hearing Process:
   • The pharmacist chose not to attend the hearing, submitting only a brief written response admitting to selling codeine linctus to an inspector.
   • The committee considered his lack of engagement as further evidence of limited insight into the seriousness of his misconduct.

GPhC Determination on Impairment:

The GPhC ruled that the pharmacist’s fitness to practise was impaired, citing:

• Failure to uphold professional standards for safe medicine supply.
• Potential risk to patients due to lack of proper safeguards.
• Significant impact on public confidence in pharmacy.

The committee stated:

“The registrant’s misconduct spanned several years and involved the supply of a potentially addictive medicine without proper safeguards. This failure compromises public confidence in the pharmacy profession.”

However, the committee acknowledged that:

• There was no evidence of financial motivation behind the pharmacist’s actions.
• He had complied with previous GPhC-imposed conditions on his pharmacy.
• He had no previous disciplinary history.

Given these factors, the committee found that:

“While the pharmacist has shown some cooperation, his lack of engagement with this hearing and failure to demonstrate insight into the risks associated with his conduct warrant regulatory action.”

Sanction:

The committee imposed conditions on the pharmacist’s practice for 12 months, considering:

• Aggravating Factors:
  • Failure to implement basic safeguards over an extended period.
  • Continued supply of codeine linctus despite knowing the risks of addiction.
  • Lack of engagement with the GPhC hearing process.
• Mitigating Factors:
  • The pharmacist had followed previous regulatory conditions on his pharmacy.
  • There was no evidence of harm to specific patients as a direct result of his actions.
  • He had an otherwise unblemished career.

The committee ruled that:

“Conditions are necessary to ensure the pharmacist takes appropriate steps to improve his practice and safeguard patients from medication misuse.”

A review hearing will take place before the conditions expire to assess whether further action is necessary.

Key Learning Points for Pharmacy Professionals:

This case highlights critical lessons regarding the responsible sale of pharmacy-only medicines, professional judgment, and regulatory compliance.

1. Pharmacists Must Implement Safeguards for High-Risk Medications:
   • Codeine linctus is known to have potential for misuse, and pharmacists must ensure sales are appropriately controlled.
   • Failure to track and manage sales can lead to regulatory action.
2. Selling Pharmacy-Only Medicines Must Be Based on Clinical Justification:
   • Selling excessive quantities of a medication to the same customers over time raises concerns about misuse.
   • Pharmacists must refuse supply if misuse or dependency is suspected.
3. Regulatory Compliance Is Essential for Maintaining Public Trust:
   • Failing to follow good pharmacy practice damages confidence in the profession.
   • GPhC inspections are taken seriously, and non-compliance can result in conditions, suspension, or removal from the register.
4. Engagement with Regulatory Proceedings Is Critical:
   • The pharmacist’s decision not to attend his hearing and provide only a short response was noted negatively by the committee.
   • Demonstrating insight and taking accountability for past mistakes can impact regulatory outcomes.

Conclusion:

This case serves as a strong reminder that pharmacists must take their responsibilities seriously when supplying pharmacy-only medicines.

While the pharmacist avoided suspension, his 12-month conditions highlight the need for stricter controls, professional accountability, and ensuring medicines are supplied safely.

Pharmacists must ensure they are always acting in the best interests of patient safety and maintaining public confidence in the profession.