Schedule 8 medicines, in particular opioids, are often involved in notifications to PDL.
An Australian Institute of Health and Welfare report on opioid harm in Australia, published in 2018, highlighted that three people die every day from drug-induced deaths involving opioid use, while nearly 150 hospitalisations and 14 emergency department admissions occur every day involving opioids. Many of these cases involve prescribed opioids rather than illicitly sourced opioids.
The key objective of each state and territory regulator is to ensure public safety. Subsequently, complaints and investigations regarding S8 medications are taken very seriously by regulators.
To avoid S8 incidents, PDL recommends the following:
1. Conduct a risk assessment before dispensing
An individual risk assessment of all medications should be performed prior to supply. Pharmacists are expected to make the final decision to supply based on their own clinical judgement. This was discussed in the previous PDL Practice Alert ‘RTPM and your responsibilities‘.
2. Follow the legislation
S8 incidents reported to PDL often involve simple breaches of the legislation. Pharmacists are reminded of their responsibilities to ensure the safe storage and management of S8 medicines and should consider the following:
- S8s must be kept in a locked safe, unless under the direct supervision of the pharmacist. The key or access code must be controlled by the pharmacist at all times. Leaving S8 medicines out of the safe for convenience (e.g., opioid replacement therapy) increases the risk of loss or theft.
- Conduct stock checks per any state or territory legislation as a minimum and preferably more frequently than mandated.
- Enter all S8 transactions in the register as per the regulations, ideally at the time of supply or receipt, as this allows for immediate identification of any discrepancy.
- Report all S8 discrepancies to state or territory health departments.
- Report all theft and forgeries to police and state or territory health departments.
- Enter returned or expired medicines into the register for destruction when they are received or identified, not on the day of destruction, and keep them clearly separated from other medicines in the safe. Consider keeping them in a box or bag clearly marked for destruction, to ensure they are not used in error. The drugs for destruction should be audited in the same manner as all other S8 medicines.
- Be aware of state-specific legislation e.g., prescribing of psychostimulants and self-prescribing.
3. Be alert for forgeries
PDL continues to see notifications involving forged prescriptions. Pharmacists need to be vigilant when checking the validity of S8 prescriptions. AJP Daily have recently reported on common features of forged prescriptions in the article ‘Pharmacists on alert over forged S8 scripts‘.
PDL tips to prevent dispensing from a forged script:
- Verify the script with the prescriber if you are not familiar with the patient and/or prescriber. (Check the prescriber contact details using an independent resource e.g., Google, White Pages or Ahpra register regarding the location of the prescriber. Consider Does the address exist? Does the practice have a website? Is this phone number real? Forgeries often include fake contact details, and you may not be speaking with the actual prescriber.)
- Check the Real Time Prescription Monitoring (RTPM) system to confirm the prescriber has recorded the prescription. This is not 100% reliable as handwritten prescriptions will not display as being prescribed.
- Stay up to date with published lists of lost, stolen or forged prescriptions if available from your local health department e.g., NSW Health – Lost, stolen or forged prescriptions. Check not only the prescriber’s name on these lists but the addresses and phone numbers as well.
- If a prescription is seemingly valid but the prescriber is not available, consider providing a small verification supply if permitted by your state legislation.
- Report all forgeries to your State Health Department and police.
4. Good governance
Often incidents and regulatory notifications could have been prevented by better procedures and protocols. Proprietors must ensure they have adequate oversight of S8 transactions.
- Develop and implement a protocol for storing cancelled S8 duplicates. Duplicates and documentation should be stored in compliance with local legislation and readily accessible in the event they are requested by regulators.
- Consider having a second pharmacist check S8 prescriptions when multiple pharmacists are on duty.
- Regularly audit S8 transactions for compliance with legislation and prevention of diversion. Consider random audits on S8 invoices from wholesalers to ensure stock is accounted for, received and recorded. PDL has received a small number of reports of S8 diversion that may have been detected through random audits.
- Use RTPM systems where available, even in those jurisdictions where they are not yet mandatory.
- Identify high risk patients and document all communication with the patient and prescriber.
- Regularly review current opioid therapeutic guidelines.
5. Register for the Take Home Naloxone Program
The Take Home Naloxone Pilot Program has been expanded across Australia and is available in all states and territories from 1st July 2022. Registered pharmacies can supply free naloxone to any person at risk of experiencing or witnessing an opioid overdose or adverse event. The pharmacy will be reimbursed by the PPA if it is registered for this program.
PDL supports the free supply of naloxone through this program as the previously mentioned report highlights it’s not only illicit drug users who can experience an opioid overdose.
To register for the National Take Home Naloxone Program, go to the Pharmacy Programs Administrator website.
For immediate advice and incident support, call PDL on 1300 854 838 to speak with one of our Professional Officers. We are here to support our pharmacist members 24/7, Australia-wide.
