Unauthorised generic substitutions, changes warning

pharmacist phone query script refuse supply

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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  1. Matt Low

    Interested to hear PDL’s & peoples opinion on the last example if the prescriber is uncontactable resulting in the patient taking a turn for the worse overnight resulting in sepsis & a hospital admission?

    • Jarrod McMaugh

      You provide an emergency supply of the strength that is available, then consult with the prescriber when they are available

      more importantly, if someone develops sepsis overnight, it’s not because they missed 2 or 3 doses of amoxicillin…. they should have been hospitalised if they were that close to a serious outcome

      • Matt Low

        the Strength prescribed is not available so your not authorized to change it at all, as I read it.

        • Tamer Ahmed

          Thats an excellent point and its a very real scenario.I work at the hospital which has a limited imprest so by all means if a patient is out of their favourite brand we have no solution as we dont deal with brands.If AHPRA really reprimnds pharmacists for dispensig 2 capsules of Amoxil 500 rather than 1000 mg then we have been demoted to techs.One of the most unreasonable things I have ever heard

          • Ephraim Ekweanua

            Not sure what we call ourselves professionals for. I wonder if some of us realise how ridiculous making some of these phone calls sound to prescribers. There is no 500mg amoxil and you give patient 2X250mg capsules instead; can someone tell me what difference if any therapeutically should the patient be happy to swallow two capsules at a time. Just last week a colleague was telling me of how a Doctor friend of his working in the hospital was asking ‘ why does Pharmacists drop all these messages on his pager line, that he come out from ward rounds and always have lots of such messages to listen to. He obviously couldn’t figure out the issue with such changes. Granted no one should toil with drugs of low therapeutic index or certain disease conditions stabilised with specific brands, but for Amoxil???

        • Jarrod McMaugh

          You have the capacity to do an emergency supply for a therapeutic equivalent, but you so not have the capacity to do a complete change for the entire course to a therapeutic equivalent without authority to the prescriber.

          So while you can’t provide 40 x 250mg capsules, you CAN provide 6 x 250mg to get them through three doses and call the doctor in the morning

          • Matt Low

            It’s the weekend practice is closed. Send them to another dr?

    • Big Pharma

      You don’t think a pharmacist should phone the GP to ask whether it is ok to supply 500mg paracetamol tablets when a Rx comes in for 1g QID? When a prednisolone Rx is written for 30mg mane 5/7….You mean to say you don’t phone the GP immediately to let them know that’ll need a supply of 25mg and 5mg tablets?

      These examples are no different. This is the sad state of the profession as it stands.

  2. Paul Sapardanis

    I would have joined the thread earlier but I have spent all my morning contacting doctors re out of stocks. Sorry where are we?

  3. Red Pill

    We have a Dr in the area that ticks Brand Substitution not permitted as default for all patients. Majority of patients are Concession card holder and can’t afford the Brand price premiums. We call her at least 5 times a day to inform her and she changes her mind over the phone. But she continues to tick the box next time the patient sees her for a prescription. It’s become kind of ridiculous.
    Can someone advise how we can overcome this issue? Should we just ignore her ticks from now on??

    • Jarrod McMaugh

      “Should we just ignore….”

      That is the complete opposite of what the PDL message says

  4. Big Pharma

    That amoxycillin example is bizarre. It really is time that pharmacy as a profession stands up and stops being a doormat. The profession needs to stop being spoonfed to the nth degree. There’s always talk of pharmacist role expansion……..Good luck when you’re not even given the authority to perform simple multiplication.

    What is even more concerning is that this has obviously been an official complaint that has been reported. PDL is just making people aware of the scenarios that come across their desk. This is indeed the letter of the law and the law needs to be addressed with extreme urgency! Rules like this fracture relationships between pharmacists and GPs and it is the patient who suffers at the end of the day as the GP will start refusing to take phone calls if most discussions are deemed not urgent or relevant.

    No wonder pharmacy has such high AHPRA fees compared to any other healthcare professionals if this is what they spend time and money investigating.

  5. Craig Fell

    As a dinosaur of pharmacy I have to say that the warnings from PDL are only a reminder of the rules that have been in place forever. When Generics were first available on the market the golden rule was to “ask if the patient preferred a generic ” otherwise no substitution occurred and if the drug was not flagged there could be no substitution….in fact claims were rejected by PBS ( Maxolon/Pramin for example). However changing the strength/form and directions ( for any reason ) without consultation leaves you open to “prescribing” which at this point we are unable to do, even for Amoxil!!!

    • Big Pharma

      No brand substitution is ticked to mark the intention of the prescriber. It indeed shouldn’t be changed without consulting with the doctor. I’ve seen plenty of patient admissions due to therapy duplication as a result of generic substitution. I do believe a reason for ticking this box should however be stipulated such as poor cognition…..as I’ve also seen the not for substitution box ticked because the GP had shares in the company. Not substituting warfarin brands is a no-brainer (pharmacy school day 2).

      The amoxycillin example is totally different in my opinion….same dose, same form. The prescriber’s intensions are clear. If amoxycillin 500mg was indeed out of stock surely the pharmacist (being the medication expert) should have enough professional clout to make this amendment. Law needs to indeed change. This type of substitution is done in every hospital in the country, on a daily basis, as imprest stock often has the lowest strength available. It is no wonder pharmacy entrance scores are at all time lows and viva examinations now impossible to fail.

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