A ‘needless and entirely preventable’ death: Coroner

pharmacist phone query script refuse supply

Pharmacists are reminded of their right to refuse supply in the wake of an inquest into a man’s death due to methotrexate toxicity

Earlier this year, media outlets reported on the inquest into the death of 77-year-old Melbourne man Ian John Gilbert, who was prescribed methotrexate in 2015 to treat a flareup of psoriasis on his back and legs.

On Thursday Coroner Rosemary Carlin found that his death due to methotrexate toxicity was “needless and entirely preventable”, reports The Age.

The pharmacist who dispensed the medicine became worried that the dose could be lethal, and telephoned the doctor with “extreme concerns” over the twice daily 2.5mg dose of methotrexate, writes health reporter Aisha Dow.

But when she called the GP who had written the prescription, he insisted the dosage he had given Mr Gilbert was correct, so she dispensed it anyway, the court heard.

According to Fairfax, the dispensing pharmacist was so concerned for Mr Gilbert’s safety she changed the instructions on the medication label, before changing it back.

The coroner questioned why a pharmacist with 35 years’ experience did not refuse to dispense the drug.

Coroner Carlin said it appears the GP did not afford the pharmacist the respect she deserved, and conversely the pharmacist afforded the GP “too much respect, or at least lost sight of her role as an independent safeguard against inappropriate prescribing.”

The coroner found Mr Gilbert should have never been prescribed methotrexate by his GP, and said she was compelled to make an adverse finding against both the GP and pharmacist.

“Mr Gilbert died because a dangerous drug was inappropriately prescribed and then dispensed,” she said.

“The fact the drug was intended to treat a non-life threatening condition makes his death all the more tragic and the decision to prescribe and dispense all the more inexplicable.”

According to the Herald Sun, the coroner said she felt sympathy for the pharmacist in the conflicting situation, but said “a refusal to dispense would have carried absolutely no risk to Mr Gilbert’s health” and the pharmacist “should not have dispensed it”.

Coroner Carlin reportedly made five recommendations covering the drug and its prescription limits, and to explore further support for pharmacists when they feel conflicted or concerned by prescription advice from doctors.

A duty of care

According to an AJP poll of more than 500 respondents (n=507), 63% said they have had concerns about a script in the past, and their response was to contact the prescriber and refuse to dispense the medication.

However about a quarter of respondents (24%) said they have had concerns about a script and contacted the prescriber, “but felt pressured and dispensed anyway”.

Nearly a third (30%) reported that they have had “several” experiences where they had to push back on scripts during their pharmacy career.

And 5% said that at one point they have had concerns about a script, didn’t contact the prescriber and dispensed anyway.

Pharmacy indemnity provider PDL says all pharmacists have a duty of care to ensure that any script they dispense is appropriate and safe.

“If a prescription raises concerns, the prescriber must be contacted and these concerns raised,” says PDL.

“Even after insistence from the prescriber that a script not be altered, a pharmacist has the right to refuse supply after informing the prescriber of their concerns and reasons.

“The role of a pharmacist is not to be a mere rubber stamp for all prescriptions received,” says the organisation.

“When the dispensing of a prescription is denied by a pharmacist, the consumer should be referred back to the prescriber after being tactfully informed there are concerns about the prescription.”

PDL says its pharmacist members are covered for dispensing dangerous drugs under its Professional Liabilities Insurance (PI) cover, provided they follow the relevant protocols for dispensing medications.

In addition, the PDL Guide to Good Dispensing may be downloaded via the member portal.

Alternatively pharmacists can call 1300 854 838 to speak with a professional officer regarding dispensing of dangerous drugs.

Stories from the frontline

Victorian pharmacist and proprietor Jarrod McMaugh says that during his career, he’s refused supply “perhaps 100 times – that’s in about 20 years.”

“A lot of the time it has been for opioid replacement therapy initiation doses that are unsafe…. and in those cases it’s usually an issue of starting at a safe dose despite insistence from prescriber to start higher (so not a refusal to supply, but a refusal to supply at the demanded dose).”

“My general advice is to always ask if concerned,” says Mr McMaugh.

“If your concerns aren’t addressed by the prescriber, then advise that you aren’t comfortable with dispensing the medication. Annotate the prescription and return it to the patient.

“A pharmacist should also never dispense a prescription just because ‘someone else will eventually dispense it anyway’ – this is not a good reason to dispense anything.”

Gregory Kossena, managing partner of Priceline Pharmacy Cowes in Victoria, says he has also experienced many scenarios where refusal to dispense a prescription was the appropriate pathway.

“The majority of these end in cancellation of the prescription and it being changed to something more appropriate or the patient being notified to return to the prescriber for further assessment,” says Dr Kossena.

“It really is the job of the pharmacist to use their experience to step into such situations. If a prescription is not in line with recommended or ‘common’ practice, it should be expected that the pharmacist questions it.”

The major problem often seen is reluctance or hesitation of the pharmacist to act based on ‘experience’, due to not wanting to question a ‘senior’ medical practitioner, he says.

“I have seen many examples where a younger pharmacist is spoken down to (often not able to get a word in) by medical practitioners over the phone.

“I have even had a case of a younger female pharmacist employee being ‘intimidated’ by an older male medical practitioner demanding things that most would consider unreasonable, simply because they are the ‘doctor’.

“This is definitely not something new. But it is fair to say that whilst such arrogance exists in the medical field, we are also blessed with many wonderful medical practitioners who are more than open to the advice of the pharmacist, and in fact welcome it as a safety shield for their own practice.”

Failing a safe and acceptable outcome, such as in the example of the methotrexate, Dr Kossena says it is pharmacists’ duty to inform the patient of the safety issue.

“This is vital – they should not leave the pharmacy being unclear as to why we refused to dispense, as it is likely they may go elsewhere and get it dispensed without understanding the reasons.”

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  1. Glen Bayer

    I’d be interested in thoughts on cases where the prescribed dose is described in the PI (from Methoblastin “Divided oral dose schedule: 2.5 mg at 12 hour intervals for three doses or at 8 hour intervals for four doses, each week.”) and the dose is confirmed by the prescriber as being correct, should pharmacists be expected to refuse supply?

    • Jarrod McMaugh

      It’s not about adhering to PI, it’s about using clinical knowledge, then ensuring that the patient is not exposed to dangerous doses as per the application of that knowledge.

      • Glen Bayer

        Thanks Jarrod, but “adhering to a PI” wasn’t the intent of the question, the PI was merely used to highlight the fact that (as was incorrectly assumed by a number of colleagues I talked to about this case) the dose was in fact correct as per the PI, and not simply an error on the prescription. You could substitute PI for any guideline or other published literature.

        • Jarrod McMaugh

          Ahh, so we were both addressing the same point – you were doing so using a rhetorical question to get people to think about what they should be doing.

          I think it’s well worth a discussion about following the PI or even the CMI as a guide to correct dosing – if you look at many CMIs for topical corticosteroids, most of them still say “use sparingly” when we know this isn’t correct.

          Pharmacists have to use their clincal judgement. We have to get away from reliance on PI or CMI (which aren’t capable of providing tailored advice), and we have to get away from accepting a prescriber’s stance as the final say.

          I had lecturers at university who drilled this in to us…. and I know there are lecturers know who are doing the same…. yet we continue to have pharmacists who can’t stand by their own decisions.

  2. (Mary) Kay Dunkley

    The Pharmacists’ Support Service is available to support pharmacists, interns and pharmacy students in situations like this. The service is available every day of the year between 8am and 11pm EST on 1300244910 and is manned by volunteers who are pharmacists or retired pharmacists. While we are not a drug information service we can support a pharmacist in a difficult situation to work through a decision in relation to the best interests of the patient.

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