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Pharmaceutical Society NI
Pharmaceutical Society Northern Ireland
Pharmaceutical Society Northern Ireland
Pharmaceutical Society Northern Ireland
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Pharmaceutical Society Northern Ireland

Learnings from Fitness to Practise Cases

Learnings from fitness to practise cases

 

Introduction

The Pharmaceutical Society of Northern Ireland is the regulator for pharmacists and pharmacies in Northern Ireland. One statutory function is to investigate and process fitness to practise issues regarding registrants. The processes are led through the offices of the Registrar.

Complaints and concerns are raised from a wide variety of sources. If these issues meet our threshold criteria, they are referred to the appropriate fitness to practise panel i.e. Scrutiny Committee or sometimes directly to the Statutory Committee. We wish to share learning points from recent fitness to practise cases to highlight prevalent and recurring issues in order to improve practise among registrants.

The Statutory Committee inquired into the adulteration of NHS prescription forms by a registered pharmacist. Prescription forms were redacted and altered to represent medications not prescribed by the originating GP. The amended forms were faxed by the pharmacist to a UK manufacturer to verify a need for the medicines which were ordered by the pharmacy. The medications were supplied by the manufacturer in good faith in order to meet the immediate needs of patients. The pharmacist however further distributed the medications through wholesale licensed supply solely for commercial gain.

The outcome of the inquiry was that the pharmacist was found to be impaired and suspended for a period of three months from the register.

　Learning points

  1. A pharmacist has no authority to amend the integrity of a prescription for any purpose or use for anything other than to supply to the patient for whom it had been written.
  2.  The MHRA have produced guidance on the separation of wholesaling and retailing from premises that have dual functions. Procurement of medicines stocks through the retail supply chain should be to meet immediate patient need and not for further re-distribution.
  3. Wholesaling should be conducted within the licence obtained from the MHRA and should also be focused on patient need. If a wholesaler chose to trade medicines for export that were in short supply in the UK and as a consequence the needs of patients in the UK are not met, the holder of a wholesale dealer licence maybe in breach of the Regulations, and could face regulatory action, and/or criminal prosecution.
  4. The holder of a wholesale dealer licence may only legally obtain medicinal products from licensed manufacturers or licensed wholesale dealers in the UK or other EEA Member States. A licence holder obtaining products from outside of the regulated supply chain, including obtaining stock from a pharmacy would be in breach of their licence and could face regulatory action, and/or criminal prosecution.

The Statutory Committee inquired into the supply of medication to a patient, authorised on an NHS prescription. The medications prescribed were for an infant and required the products to be dispensed extemporaneously to accommodate the required dosages for the patient.

The pharmacist made errors in calculations and the two medications were prepared incorrectly at higher dosages than those prescribed.　 When dispensed to the patient’s carer, the dosages were queried by the carer due to significant dose changes. The pharmacist conducted a check of the calculations previously made and verified the integrity of the dispensed product, to the patient’s carer. The carer pursued further checks with secondary care providers and established the error that was made. None of the erroneous medications were administered to the infant; in this case the matter was classified as a near miss.

The outcome of the inquiry was that the pharmacist was given advice by the Committee on observing SOPs with regard to future practice..

　Learning points

  1. A pharmacist has a duty of care to clinically and accurately check all medicines dispensed.
  2. Where medications are compounded with respect to body weights of an infant due diligence is needed in the;
    • Assessment of the prescription;
    • Calculations undertaken;
    • Appropriateness of the medication with respect to the prescription;
    • Dosages dispensed to the patient especially when he/she is an infant.
  3. Pharmacy procedures must ensure adequate quality and safety in the compounding and supply of medicines.
  4. Records of all extemporaneous preparations should be made and retained for an appropriate time period to allow further audit and manage risk.
  5. When a patient or carer queries a prescription supply, due diligence must be observed in any reassessment of the supply function.
  6. Paediatric medications can have the potential to have greater harm for the patient when doses are incorrect.
  7. Adhere to robust protocols and maintain clear records in order to significantly reduce risk and assure quality.

The Statutory Committee inquired into the supply of medication to 42 patients by a pharmacist by way of monitored dosage systems. The prescription only medications supplied were not all in accordance with legislation in that medicines were supplied using historical pharmacy patient histories. On occasion the medications supplied were either different to the strength or product authorised on the prescriptions.　 There were also instances of medications supplied in the absence of authorising prescriptions. No harm was suffered by patients. The pharmacist was prosecuted and convicted of a number of breaches of the Medicines Act 1968.

The outcome of the inquiry was that the pharmacist was found to be impaired and remained registered but subject to conditions. The pharmacist was directed to produce a personal development plan and to undertake a period of 12 months supervised practise.

　Learning points

  1. A pharmacist has a duty of care to clinically check all prescription medicines dispensed against the authority of the prescriptions.
  2. Patient medication records are an adjunct to clinical care of patients. They do not form any authority to dispense to patients without a prescription.
  3. It is high risk practise to dispense off historical pharmacy records and therefore when dispensing medication a new entry should be created in PMRs using the authorising prescription. Adherence to pharmacy procedures [sops] helps to quality assure the safe and effective supply of medicines.
  4. Reconciliations through the audit of prescription forms and corresponding correlation with pharmacy PMR data will help affirm safe supply of medication.

The Statutory Committee inquired into the supply of medication to several patients using monitored dosage systems. The medications supplied were not all in accordance with statutory legislation, in that medicines were supplied only using pharmacy patient histories. On occasions the medications supplied had been discontinued or substituted by the prescribing physician with new drug therapy. The patient subsequently received both medications.

There were also instances of medications being supplied where there were no authorising prescriptions were issued. No harm was suffered by the affected patients.

The registrant failed to engage with the regulator throughout the investigation. The outcome of the inquiry was that the pharmacist was found to be impaired and was suspended for 12 months to be reviewed at that time.

　Learning points

  1. A pharmacist has a duty of care to clinically check all medicines dispensed.
  2. Patient medication records are an adjunct to clinical care of patients. They do not form any authority to dispense to patients without a prescription.
  3. It is high risk practise to dispense off historical pharmacy records and therefore when dispensing medication a new entry should be created in PMRs using the authorising prescription.
  4. Adherence to pharmacy procedures [sops] helps to assure quality the safe and effective supply of medicines.
  5. Reconciliations through the audit of prescription forms and correlation with pharmacy PMR data will help affirm safe supply of medication.
  6. Registrants are advised to engage with the regulator throughout fitness to practice investigations. A lack of engagement will be taken into consideration by fitness to practise panels when making a decision on impairment.

The Statutory Committee inquired into the records relating to the supply of medications, to a number of patients, from a community pharmacy, relating to medications controlled under the Misuse of Drugs Regulations. Prescriptions were not always dispensed in accordance with the prescriber’s directions. There were instances of medication subject to safe custody and or registers being dispensed in advance of prescriptions without the authority of a prescription. The record keeping in relation to controlled drugs prescriptions and registers was poor.

No harm was suffered by patients. The result of the inquiry was that the pharmacist was found to be impaired and was suspended for six months subject to a further review.

　Learning points

  1. A pharmacist has a duty of care to clinically and legally check the authority for all medicines dispensed.
  2. Adherence to pharmacy procedures [sops] helps to assure quality in the safe and effective supply of medicines.
  3. Medications which are controlled under the Misuse of Drugs Regulations are subject to greater legislative control and pharmacists should ensure that there are enhanced systems managing safety and quality in the processing of prescriptions for controlled drugs and any dispensing of same, to patients.
  4. Medications requiring entries in registers should be treated with extra caution and contemporaneous records should be made. Where prescriptions are endorsed this should again be contemporaneous and reflect the prescribers instructions.

Engagement and Insight

Any registrant, who finds themselves subject to Fitness to Practise proceedings, should engage with the Statutory Committee in as full a manner as possible.  When considering whether a registrant’s fitness to practise is currently impaired, the Statutory Committee will consider a registrant’s insight into the set of circumstances which led to the Fitness to Practise proceedings.  The Statutory Committee will also consider any actions taken to date to address and remediate the causes of the Fitness to Practise issue.  Whilst all cases will be considered on their individual merits, a number of Fitness to Practise issues have the potential to be remediable, for example, robust personal training and reflection have the potential to allow a registrant to learn the lessons of the Fitness to Practise issue, thereby, potentially reducing the risk of the issue being repeated.

If the Statutory Committee finds that a registrant’s fitness to practise is currently impaired, when considering on an appropriate sanction, it will again reflect on the level of engagement from the registrant, any insight shown and any remedial actions taken.  The purpose of a sanction is not punitive, but rather to protect the public, to maintain public confidence in the profession and to maintain proper standards of behaviour.  Disengagement from the Statutory Committee process has the potential of excluding the option of imposing Conditions on a registrant’s practise, as any such conditions have to be workable, enforceable and verifiable.  Being unable to demonstrate to the Statutory Committee how Conditions will work, be enforced and verified is likely to increase the potential of suspension or striking off from the Register.

Case Presentation  

In cases where both an allegation of Misconduct and Conviction are being pursued, the Statutory Committee should be asked to consider the misconduct ground first.  Only when a determination is made on that ground, should the Committee be advised of the conviction ground of the allegation (this includes the presentation of any relevant papers).  The rationale for this approach is that the Statutory Committee’s determination on misconduct might be perceived to be pre-determined if the Statutory Committee has previous knowledge that, arising from the same facts, there has been a conviction.

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