NSW regulator raids ORT pharmacies

NEW South Wales Health has recently conducted a blitz against pharmacies which provide opioid-replacement therapy (ORT) services, resulting in members of PDL seeking support in handling regulator inquiries, the indemnity insurance provider has advised in its latest Practice Alert.

Inspections have been, and will continue to be, conducted without notice at any time, with breaches being very quickly reported to the regulator, PDL said.

“Pharmacy inspectors will check the inventory of ORT products, check the prescriptions for ORT clients, observe the dosing of ORT and take photographs of the premises and any other component of ORT dispensing that is deemed necessary,” the alert explained.

Penalties such as restrictions on practice for pharmacy owners and employed pharmacists can be imposed.

“These incidents highlight the importance of adhering to current State-based legislation when dealing with all S8 medications, including ORT products such as methadone syrup, Subutex and Suboxone.”

PDL reports that common discrepancies found included: poor record keeping, Dangerous Drugs (DD) register not available for inspection, or filled out by nonpharmacist staff.

Some inspections have found entries in the DD register crossed out, missing or incomplete, or methadone and biodone recorded on the same page.

There have also been instances of large discrepancies of quantities of opioids used in ORT, all of which should be reported to the Pharmacy Regulation Unit, while storage and security issues around S8 products were also identified.

Performing regular self-audits and training will ensure that, should an inspection occur, the pharmacy can display compliance in the area of ORT, PDL recommended.

Reference documents are available - CLICK HERE or HERE.

PDL members are urged to ensure they have these documents available either in hard copy in the pharmacy or in an electronic form.