Retail pharmacy inspection: expired stock, broken cold chain and a request to backdate the narcotic register

Three statutes are engaged here, and separating them is the whole point of the question:

• Drugs Act 2035 and the rules made under it govern the premises licence, product registration, storage and the sale of prescription-only medicines. Jurisdiction: the Department of Drug Administration.
• Narcotic Drugs (Control) Act 2033 and its rules govern controlled preparations and register-keeping. Jurisdiction: DDA, with police involvement for offences.
• Pharmacy Council Act 2055 governs registration and professional discipline of the individual pharmacist. Jurisdiction: the Pharmacy Council.

Applying this:

1. Expired amoxicillin-clavulanate on sale: an offence under the Drugs Act. The licensee is legally answerable for the premises and the stock; the pharmacist-in-charge is professionally answerable because control of the drug store is a pharmacist function. Both are exposed, but the licensing consequence falls on the proprietor.
2. Insulin at 13 °C: a departure from the storage conditions attached to registration and from good storage practice. It is not automatically a reason to destroy stock: quarantine it, obtain the manufacturer's permitted excursion data, and document the decision.
3. Prescription-only medicines and tramadol sold by an unregistered assistant: sale without a valid prescription, and arguably practice as a pharmacist by an unregistered person. The proprietor is liable for the employment; the pharmacist carries professional liability if he knows of it and does not object in writing.
4. Codeine syrup with no register entries: controlled-drug record-keeping. Before concluding, verify from the registration certificate and schedule whether this strength is a preparation requiring register entry - do not assume either way. If it is scheduled, unrecorded dispensing is a serious offence.

No. He must not sign.

Reasoning, in order of weight:

• The register is a contemporaneous legal record. An entry asserts that a named pharmacist dispensed a specified quantity to a specified person on a specified date. Backdating and signing creates a false record; under the narcotic drugs law that is falsification of a controlled-drug record, and it converts a record-keeping failure into a deliberate offence.
• He would be signing for acts he did not perform. His signature is a personal attestation of knowledge he does not have. None of the 60 dispensings were his, and he cannot truthfully certify them.
• It destroys his own defence. At present he can show that the dispensing happened in his absence, under an arrangement he did not control. A signed false register removes that distinction and makes him the author of the discrepancy.
• Professional duty under the NPC framework requires honesty in dealings with the regulator; assisting a licensee to mislead an inspector is misconduct independent of the narcotic law.

What to do instead: state plainly, in front of the officer, that the entries were not made and that he did not dispense those items; put the same in writing in a signed statement and in the register's remarks column; hand over the dispensing slips and stock records that do exist; notify the proprietor in writing that he has done so; and record the sequence of events (request made, request refused). If pressure continues, report it to the Pharmacy Council. He should also refuse to be the named pharmacist-in-charge of premises he cannot supervise - a pharmacist who is a name on a certificate for eight unsupervised hours is professionally exposed for everything that happens in them.

Stops today (within the pharmacist's own control):

1. Sale or supply of any prescription-only medicine by unregistered staff - physically move those products to a locked cabinet and instruct staff in writing.
2. Sale of the expired amoxicillin-clavulanate - pull it, quarantine it in a labelled 'do not dispense' bin, and record quantities.
3. Dispensing of the codeine preparation until its schedule is confirmed from the registration certificate.
4. Use of the refrigerator for insulin until temperature is verified with a second thermometer and a data logger; quarantine the affected vials pending the manufacturer's excursion advice.
5. Signing anything he cannot personally verify, including the register.

Requires an application, notification or authority:

• Variation/notification to DDA of the pharmacist-in-charge and of the actual opening hours; if a registered pharmacist cannot be present for all opening hours, the hours must be reduced - that is a licensing decision, not a staffing preference.
• Written report to DDA of the expired stock, the cold-chain excursion and the unrecorded controlled-drug dispensings, with the quantities and batch numbers, and a destruction plan for the expired stock witnessed and documented.
• Verification that every product on the shelf has a valid DDA registration number, and removal of any that do not.

System fixes: twice-daily temperature logs with min-max reset; a dated quarantine bin; a register completed at the moment of dispensing; written standard operating procedures for prescription screening and for staff authority limits; staff training records; and a copy of all correspondence kept on file for the next inspection. He should also confirm his own NPC registration is current.