Lapsed Premises Registration, a Vacant Superintendent Post and Wholesale Dealing From the Back Room
A retail premises in Kisumu is registered as a pharmacy. Its annual retention fee was unpaid and its registration expired on 31 December; today is 27 January. The superintendent pharmacist resigned on 5 January. The owner, a businessman with no health qualifications, has placed an enrolled pharmaceutical technologist 'in charge', and the shop continues to sell prescription-only medicines, including amoxicillin capsules and diazepam tablets. From a store at the back, the owner also supplies several small shops in the county, issuing invoices in the pharmacy's name. A customer complains that insulin bought last week arrived warm and that the receipt shows no batch number. On a routine visit an inspector finds the medicine fridge at 12°C and a temperature log whose entries are in identical handwriting for the past two months. The technologist says she only follows the owner's instructions and asks whether she can keep the shop open until a new pharmacist is found.
1. Identify the breaches and rank them by risk.
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Rank by patient harm first, legality second, records third.
- Cold chain failure (highest patient risk). Insulin stored at 12°C may be degraded; patients who received it are at risk of poor glycaemic control. This is both a quality defect and a patient safety event.
- Prescription-only medicines sold through an unlicensed chain. Supplying POMs to small shops means supply to persons not entitled to hold or dispense them - a direct public safety exposure.
- Practising on a lapsed premises registration. The registration expired on 31 December and the retention fee is unpaid; trading after expiry is unlicensed practice, regardless of intent to renew.
- No superintendent pharmacist. A pharmacy must be under the personal supervision of a registered pharmacist. An enrolled pharmaceutical technologist cannot lawfully occupy that role; she is acting outside her scope.
- Wholesale dealing without a wholesale dealer's licence. Invoices in the pharmacy's name point to unlicensed distribution, which carries separate premises, qualification and record-keeping requirements.
- Records and data integrity. Missing batch numbers on receipts defeat traceability and recall; identical handwriting across two months of temperature logs suggests retrospective fabrication and must be investigated, not simply corrected.
2. What immediate actions do you require, and what do you tell the technologist?
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Actions. Stop the sale and supply of medicines until a registered pharmacist is appointed as superintendent and the premises registration is regularised (outstanding fees plus any penalty). Quarantine all insulin and any other cold-chain stock, do not dispense it, arrange replacement stock, and contact patients who received the affected insulin with advice and a prompt to report problems. Cease the wholesale supply from the back store immediately. Secure invoices, dispensing records and the temperature logs as evidence; do not allow the log to be rewritten. Require an application for change of superintendent, a separate wholesale dealer's licence application if distribution is intended, fridge repair with a calibrated thermometer, an alarm, and contemporaneous temperature records.
To the technologist. Tell her plainly that she cannot act as superintendent, that continuing to do so exposes her to disciplinary proceedings before the Board and possible removal from the register, and that 'following instructions' is not a defence. She should put the owner's instructions in writing, cooperate fully with the inspection, and not obstruct any sealing of premises or seizure of stock. Advise the owner in writing that the inspector may seal the premises and that prosecution is possible.