Requirements and Recommendations (Including Acceptable and Unacceptable Practices)

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This document has been prepared by Drugs and Poisons Regulation (DPR) to address a troubling incidence of pharmacists failing to comply with regulatory requirements relating to the storage and recording of Schedule 8 poisons. In some cases, the non-compliance was associated with or contributed to the extent of misappropriation of Schedule 8 poisons for misuse or diversion. For full details of legislative requirements, reference should be made to the Drugs Poisons and Controlled Substances Act 1981 and Regulations 2006 (at www.legislation.vic.gov.au). Documents dealing with other key legislative requirements and issues may be found on the DPR website (at www.health.vic.gov.au/dpcs/reqhealth).

Drug registers for Schedule 8 poisons

Requirements and recommendations (including acceptable and unacceptable practices)

Bound books with consecutively numbered pages are the basic acceptable option. Loose-leaf pages do not satisfy regulation 41(5) because records of transaction in Schedule 8 poisons must be in a form that cannot be altered, obliterated, deleted or removed without detection.

Manual registers should be clearly labelled, indexed and marked with clear references to previous/next pages - to prevent multiple pages being used concurrently for the same drug.

Electronic drug registers

Electronic registers may be used, provided the records comply with the regulations, including the requirement that the records cannot be altered, obliterated, deleted or removed without detection.

Pharmacists using electronic registers are strongly advised to employ passwords that are unique and not readily determined by others. In one case of systematic misappropriation, a pharmacist was able to create false records using the identification of other pharmacists, because all pharmacists were using their initials as passwords.

Records of transaction and the remaining balance to be made contemporaneously

It is not acceptable to wait for days, weeks or months until it is more convenient to record transactions because regulation 41(1) requires the records to show the true and accurate balance of each Schedule 8 poison remaining after each transaction.

When Schedule 8 poisons are supplied and the prescriber is to forward the prescription subsequently, the pharmacist must record the transaction in the register when supply occurs and must not delay recording until the prescription is received.

When only a portion of a prescribed quantity is supplied, the supplied portion is the quantity that must be recorded, with the supply of the remaining quantity to be recorded at the corresponding time.

The remaining balance must be accurately recorded

The accuracy of a recorded balance should be regularly confirmed as true and accurate in the drug register. Some pharmacists do this by consistently ticking (or highlighting) a recorded balance or making separate line entries to indicate that the recorded balance has not been merely calculated.

Repeated recording of a ‘negative balance’ is unacceptable because it cannot be true and accurate. It would only be sensible for a calculated balance to be negative if the record of supply is made at or about the time that the stock to be supplied was received from a supplier.

Discrepancies in Schedule 8 poisons

Pharmacists must investigate discrepancies without delay (regulation 43). It is not acceptable to ‘correct’ the balance without resolving the discrepancy or without clearly recording how the discrepancy was resolved.

Discrepancies that cannot be resolved must be reported to DPR; emailed to .

Responsibilities of individual pharmacists

The regulations require each pharmacist to record the true and accurate balance after each transaction. Any pharmacist who records an incorrect balance has contravened the regulations, regardless of whether the incorrect balance was due to calculations involving previous recording errors by other pharmacists.

Whilst non-compliance or errors by other pharmacists can be a major factor in creating, perpetuating and compounding discrepancies, individual pharmacists must take action when they identify discrepancies between recorded and actual balances when dispensing Schedule 8 poisons. They are advised to:

• Record the true and accurate balance in the register.
• Identify the discrepancy prominently in the register.
• Investigate and make a meaningful attempt to resolve the discrepancy.
• If unable to resolve the discrepancy, report the matter to the proprietor or pharmacist-in-charge.
• If unable to resolve the discrepancy, ensure that the department is notified in accordance with regulation 43.
• To demonstrate compliance with regulation 43, it is recommended that all relevant actions are documented, possibly in the drug register.

Storage of Schedule 8 poisons

Pharmacists must store all Schedule 8 poisons in a steel drug cabinet or safe (regulation 35). Larger or additional cabinets or safes must be obtained if existing facilities are insufficient to retain all Schedule 8 poisons.

Note: If a pharmacy lacks adequate capacity for storage of Schedule 8 poisons, employed pharmacists are advised to inform the proprietor, in writing, and to retain documentary evidence that they have done so.

Keys to drug cabinets must be strictly controlled to prevent unauthorised access and to reduce the likelihood of misappropriation. It is not acceptable to leave the key in the door of the cabinet or to keep it in a ‘hidden’ location that is known to staff other than pharmacists. This practice has contributed to misappropriation at some pharmacies.

Destruction of Schedule 8 poisons

A pharmacist may destroy Schedule 8 poisons with a medical practitioner, veterinary practitioner, dentist, nurse practitioner, nurse or another pharmacist acting as witness (regulation 51). Both participants must sign the register to confirm the destruction.

Where a pharmacist is only initiating the destruction of Schedule 8 poisons that are intended for subsequent high-temperature incineration, the Schedule 8 poisons must be rendered unidentifiable and unrecoverable.

Using a separate register or designated page/s of the drug register to record, “Drugs for Destruction”, is a practice that often proves valuable in accurately accounting for returned or expired drugs.

Pharmacists must record the receipt of identifiable Schedule 8 poisons that are returned to the pharmacy for destruction.

Retaining prescriptions for Schedule 8 poisons

Prescriptions for Schedule 8 poisons must be retained for 3 years and must be produced on demand to an authorised officer of the Department of Health (regulation 33).

• It is recommended that prescriptions are filed in chronological order in a container of a size that keeps them neatly in order. Placing the prescriptions haphazardly into a larger box will make it much more difficult for a pharmacist to locate specific prescriptions when required to do so.
• Some pharmacists prefer to use expanding files or file boxes and to sort prescriptions by drug names. This option may facilitate searches associated with discrepancies or make it easier to locate prescriptions to compare handwriting but, unless filing is carried out in a consistent manner, it may be more difficult to locate specific prescriptions when required to do so.
• Prescriptions should not be placed on a spike as this practice may damage details of a prescription.
• It is recommended that retained prescriptions are neatly bundled and clearly labelled on a regular basis (e.g. monthly or quarterly) and stored securely at the pharmacy; not at another location, which would prevent the prescriptions being produced on demand.
• To enable prescriptions to be located when required, it is recommended that prescriptions associated with pharmacotherapy are stored separately from prescriptions for other Schedule 8 poisons.

Misappropriation of drugs of dependence

In recent years, DPR has investigated pharmacies in relation to misappropriation and/or unlawful diversion of significant quantities of Schedule 8 poisons including cocaine, dexamphetamine, methylphenidate, morphine, methadone, pethidine, oxycodone and alprazolam plus other drugs of dependence, diazepam, anabolic steroids and analgesics containing codeine (e.g. Panadeine Forte®). Offenders have been identified as pharmacists as well as dispensary technicians and other (previously) trusted staff members.

Lack of adequate supervision or inventory control by pharmacists and, where Schedule 8 poisons were involved, non-compliance with regulation 41 (maintaining accurate records) and regulation 43 (investigating discrepancies) were often contributing factors in enabling offenders to operate for many months (or years) without detection.

Offending pharmacists have been found to have tried to conceal their activities by:

• creating false records of prescriptions or of drugs purportedly supplied to other pharmacies
• ordering Schedule 8 poisons but not recording the receipt of the drugs in the drug register
• falsely recording the destruction or spillage of Schedule 8 poisons
• creating forged prescriptions or fraudulent repeat authorisations
• failing to record Schedule 8 poisons that were returned to the pharmacy for destruction.

Misappropriation by other staff has sometimes involved ordering drugs of dependence and removing corresponding invoices; or deleting, amending and manipulating inventory records. Delegation of duties does not relieve pharmacists of their responsibilities to prevent unauthorised access to Schedule 4 and Schedule 8 poisons; pharmacies should have procedures in place to deter misappropriation and to detect it promptly, should it occur.

For further information

Department of Health (DH)

Drugs and Poisons Regulation,

GPO Box 4541

Melbourne 3001

Tel: 1300 364 545

Fax: 1300 360 830

Email:

Web: www.health.vic.gov.au/dpcs

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