Unauthorised generic substitutions, changes warning


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Some pharmacists feel that they can make generic substitutions or changes to instructions where this is unauthorised, thinking these actions have no consequence – but that’s not the case

In a warning to members, Pharmaceutical Defence Limited has reminded the profession that the organisation has assisted “numerous” pharmacists in the past who have been reprimanded for taking this kind of action.

It cites case studies in which a substitution may have resulted in hospitalisation.

“Complaints to pharmacy regulators usually happen in one of two ways: consumers who specifically direct that no substitution take place will often file a complaint if a pharmacy generically substitutes without their permission,” PDL warns.

“Alternatively, a prescriber who ‘ticks the box’ may report a pharmacist for unauthorised substitution if they become aware that this has occurred.

“Consumers who have their directions on no substitution ignored will often choose to change pharmacies which is an economic hit to the business.”

PDL points out that that there are often good reasons why brands should not be substituted.

These factors may include the risk of elderly patients, or those with poor health literacy, swapping away from a familiar brand, with the potential for confusion and medical misadventure.

And placing a sign in the pharmacy stating that the store’s policy is to use generics is not good enough, PDL says: it’s not a licence to substitute.

“The consumer must verbally agree that generic substitution is acceptable to them,” PDL says.

“Generic substitution also relates to brand substitution where items are not ‘flagged’ on the Pharmaceutical Benefits list.

“Some drugs including warfarin should never have their brands interchanged for clinical reasons of differing bioavailability. Another class of drugs which should have brand consistency are the anti-epileptics.”

PDL offers an example where a pharmacist swapped a script for Coumadin 1mg to Marevan 1mg.

“The pharmacist was subsequently contacted by a hospital pharmacist asserting that the brand change may have altered the patient’s INR resulting in hemorrhage,” it notes.

“Although the assertion was not proven, the risk of swapping brands is real.”

In another “ill-considered” case, a change in warfarin brands led to an investigation by AHPRA.

“A patient who was managed on the Coumadin brand of warfarin was notified to take warfarin 3mg as a result of a change in INR,” PDL notes.

“A pharmacist dispensed Marevan 3mg stating that Coumadin did not come in a 3mg tablet. Again, a patient was hospitalised with problems relating to the INR.”

PDL also cautions that it is not acceptable to change instructions issued by a prescriber without seeking permission, including a scenario to demonstrate this problem.

“Amoxil 500mg x 20 at a dose of 1 tds is ordered.

“Amoxil 500mg is unobtainable so a pharmacist decides to provide Amoxil 250mg and 40 capsules with instructions of 2 tds. without consulting the prescriber.

“The overall results are identical but this change should not take place without seeking permission from the prescriber.”

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