Disclaimer: This article was published in 2021 and reflects the information available at that time.
Most pharmacists would be aware that the Pharmacy Regulation Authority SA (PRASA) has been undertaking an inspection program of pharmacy premises for the last nine years. In that time, it is true to say that the overall level of performance of pharmacy premises against the nominated requirements has improved considerably. Pharmacists and their staff are to be congratulated on their efforts across that period.
That being said, there remains one area of legislated requirements within pharmacy practices where PRASA has observed a disappointing lack of wider improvement. PRASA records show just over 60% of breaches of nominated standards or requirements occur with regard to the handling, storage and supply of Schedule 8 medicines. Currently, pharmacists working within registered pharmacy premises have significant legislative authority in dealing with Schedule 8 medicines but with that authority comes the burden of responsibility.
PRASA wishes to reinforce the maintenance of professional diligence in dealing with Schedule 8 medicines to ensure public safety and confidence as well as meeting all the professional and legal requirements demanded in operating a pharmacy premises. PRASA provides the following short summary of areas that have commonly seen breaches by pharmacy premises.
1. Schedule 8 medicines must be stored at all times in an approved and locked safe that meets the requirements of the SA Health Code for the storage of Schedule 8 medicines. This, for example, does not include a locked draw or cabinet under the dispensary bench. If a pharmacy premise cannot adequately store its Schedule 8 medicines in its existing safe(s) then there will be a need to purchase further appropriate storage capacity.
2. Schedule 8 medicines activities are to be recorded to show the true and accurate balance of each Schedule 8 medicine remaining after each transaction. Waiting for days, weeks or months until it is more convenient to record transactions offends the current legislation and has been shown to be fraught with legal and professional dangers.
3. When discrepancies arise in the Schedule 8 medicines register then:
- Record the true and accurate balance in the register;
- Prominently identify the discrepancy in the register;
- Attempt to resolve the discrepancy;
- If unable to do so, advise other professional staff working within the pharmacy premises; and
- Record the action(s) taken to resolve or report the discrepancy in the register and notify the Drugs of Dependence Unit at the end of the month of the discrepancy.
4. Drug substitution program services are delivered throughout SA and the legal requirements with regard to the medicines used in this area of practice, such as methadone and buprenorphine, remain exactly the same as that for any Schedule 8 medicine. The storage, recording, reporting and supply obligations to be met by a pharmacist do not change because of the frequency of supply or the volume of medicines involved.
5. When supplying dose administration aid products (for example Webster packs) to patients, Schedule 8 medicines should only be included just prior to collecting or if Schedule 8 medicines are packed in anticipation of collection at some extended point in the future (for example the following day) then the pack needs to be stored in the safe until collected.
This article was released by PRASA.
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