Generic substitution and unauthorised changes to prescriptions

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Some pharmacists feel that they can make generic substitutions where it is unauthorised and that they will act without consequence. This is not the case as PDL has assisted numerous pharmacists in the past who have been reprimanded for acting this way.

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. 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.

There are often good reasons why the substitution of brands should not take place. Commonly with elderly patients or those with poor health literacy, swapping away from a familiar brand may lead to confusion and medical misadventure.

The provision of a sign in the pharmacy stating that it is the policy of the pharmacy to use generics is not a license to substitute. The consumer must verbally agree that generic substitution is acceptable to them.

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 that should have brand consistency are the anti-epileptics.

Case studies

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

Another ill-considered change of warfarin brands led to an AHPRA investigation. A patient who was managed on the Coumadin brand of warfarin was notified to take warfarin 3 mg as a result of a change in INR. A pharmacist dispensed Marevan 3 mg stating that Coumadin did not come in a 3mg tablet. Again, a patient was hospitalized with problems relating to the INR.

Changing prescribers’ instructions

Some pharmacists believe it is okay to change instructions issued by a prescriber without seeking permission. The following scenario demonstrates this issue.

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.

Call 1300 854 838 if this topic raises any concerns for you. PDL membership includes 24/7 access to speak with a Professional Officer for immediate advice and incident support, Australia-wide. Please leave a comment or question for our Professional Officers via the blog.