Why therapeutic need matters

stop sign

PDL has issued a reminder of pharmacists’ obligations when supplying pseudoephedrine, citing recent cases where disciplinary action was taken

In one case the pharmacist understood his obligations, but was found not to have adequately assessed therapeutic need.

Scott Ames, principal of Meridian Lawyers, with assistance from colleague and solicitor Sheridan Kersey, outlined these obligations in PDL’s latest newsletter, and highlight the fact that pseudoephedrine is targeted for non-therapeutic purposes including the manufacture of illicit drugs.

Mr Ames writes that Meridian has recent helped pharmacists who have had notifications referred to AHPRA over the issue.

“In those cases, a public health unit audit of the pharmacy found that the sales of PSE products were abnormally high for a community pharmacy environment,” he says.

“As a result, the practice of each pharmacist that worked in the pharmacy was scrutinised, and this ultimately resulted in disciplinary action against them.

“This should serve as a timely reminder of pharmacists’ obligations when a patient requests medications that contain PSE.”

Mr Ames points out that before supplying an S3 pseudoephedrine product, pharmacists must be satisfied that it is required due to genuine therapeutic need.

If they do not know the purchaser, they must sight an acceptable form of identification.

“Therapeutic need is to be established by careful questioning.”

In all jurisdictions apart from Victoria, pharmacists must also record the date, brand name and quantity of the pseudoephedrine product, the purchaser’s name and address and details of the identification they have sighted.

“In most jurisdictions, the failure to make an appropriate record may be considered an offence punishable by payment of a monetary penalty,” Mr Ames advises.

“Where available, pharmacists should review Project STOP for prior sales of PSE to the purchaser and also enter the above details into the database.

“Project STOP may assist the pharmacist to make a more informed decision on the appropriateness of the proposed sale by helping them to avoid value judgements based on superficial qualities like physical appearance and answers to questions.

“Because Project STOP records PSE sales in real time, it will alert the pharmacist to prior sales during a threshold period.”

Mr Ames cites one of the recent cases where the pharmacist actually demonstrated an in-depth understanding of these requirements, saying they consistently complied with the legislative requirements whenever they sold pseudoephedrine.

Unfortunately for the pharmacist, the Pharmacy Board was still not satisfied that the pharmacist had adequately assessed therapeutic need, “because if there had been, certain instances of supply should not have occurred”.

“The pharmacist was ultimately cautioned for his failure to make an appropriate record of sale and also had conditions imposed on their registration requiring the completion of education on the safe and appropriate sale of PSE (at their own cost).”

Further decision have occurred in instances when there was inadequate or no assessment of therapeutic need by pharmacists.

In some of these instances, the amount requested was high, well in excess of any indication.

Pharmacists can be reprimanded, fined and/or in extreme cases, their registration suspended or cancelled, Mr Ames cautions.

“In addition, in some jurisdictions, pharmacists can be ordered to pay the legal costs of the statutory authority that referred them to the Tribunal,” he observes.

“Such orders can, in some instances, amount of tens of thousands of dollars.”

PDL encourages members to call it on 1300 854 838 if this topic raises any concerns; it offers 24/7 access to Professional Officers for advice and incident support.

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