Reprimand after lethal script


A pharmacist has been reprimanded after she dispensed a lethal dose of methotrexate, despite her concerns, to a man who then died

The Victorian Civil and Administrative Tribunal has heard that on 29 January 2015, Ian Gilbert, a 77-year-old man, visited a GP and was prescribed methotrexate to treat a psoriasis flareup.

While a specialist had prescribed the drug for Mr Gilbert in the past, this GP had not prescribed it before, and had to look up the appropriate dosage for psoriasis in MIMS.

However, when he did so, he did not read that part of the entry which state that methotrexate needed to be prescribed by a specialist.

He also did not perform or order any blood tests before prescribing the medicine, or inform Mr Gilbert about potential side-effects.

The next day, Mr Gilbert’s daughters went to the suburban pharmacy owned solely by the pharmacist, and presented the script. It was then made up by a dispensing technician.

When the technician gave it to the pharmacist to authorise, she immediately became concerned.

The script said, “METHOTREXATE TABLETS 2.5mg (METHOBLASTIN) Qty 30. Take TWO tablets daily,” —a dose of 5mg per day, for five days, with five repeats, the Tribunal heard.

The pharmacist told Mr Gilbert’s daughters that methotrexate was normally taken once a week rather than daily, and asked them to wait while she telephoned the prescribing doctor.

On the phone, she informed the doctor that the drug should be taken weekly.

“She told him she was extremely concerned about the dose prescribed, describing the daily dose as possibly lethal,” the Tribunal noted.

But the doctor confirmed the dosage as prescribed, telling the pharmacist he had “checked it in MIMS”. He said that the medicine was to be taken for only five days, and that the patient was scheduled for a review appointment with him a few days later.

The Tribunal heard that during this conversation, the pharmacist was “quietly spoken and polite,” while the doctor was “firm, confident and resolute”.

After the phone conversation, the pharmacist remained worried about the dosage, and considered altering the instructions to the patient.

She told Mr Gilbert’s daughters about her concerns, and stressed the importance of attending the follow-up appointment.

However, she then dispensed the methotrexate in accordance with the script, giving Mr Gilbert’s daughters the CMI to go with the medicine.

She then completed a clinical intervention form, noting that, “dr ordered methotrexate 2.5mg bd instead of weekly’; and ticking boxes that recommended dose decrease, dose frequency/schedule change and “refer to prescriber”. She also noted that the doctor had confirmed the 5mg daily, but for only five days, and the upcoming review.

Over the next few days, Mr Gilbert became unwell.

He was hospitalised, and died on 13 February 2015.

An inquest was then held, at which Coroner Rosemary Carlin ruled that Mr Gilbert’s death was “needless and entirely preventable,” attributing it to “complications of methotrexate toxicity in a man with chronic renal impairment, chronic obstructive pulmonary disease, cardiomegaly and ischaemic heart disease”.

At the 2021 hearing, the Tribunal heard several remarks made by the Coroner, including that she had sympathy for the pharmacist, who “clearly felt conflicted”.

“However, in reality her choice was clear,” Coroner Carlin said. “Since [the pharmacist] was not satisfied that the prescribed dose of methotrexate was safe, she should not have dispensed it.”

She said that given a refusal to dispense would not have carried a risk to Mr Gilbert’s health, the right decision “should have been even more obvious”.

She made a number of recommendations, noting that the GP had apparently not afforded the pharmacist “the respect she deserves,” when he dismissed the pharmacist’s concerns.

She also noted that in dispensing as prescribed, the pharmacist had afforded the doctor too much respect… “or at least lost sight of her role as an independent safeguard against inappropriate prescribing”.

“Whilst, I am satisfied that the fundamental obligation of pharmacists not to dispense medicine unless they are satisfied it is safe and appropriate to do so…

“In my view the single most effective measure would be a professional advice service. Such a service could, for example, be staffed by senior pharmacists who volunteer to receive calls on a rotational basis

“Importantly, advice from such a service would reassure and embolden community pharmacists in situations of conflict.

“The concern that a pharmacist’s refusal to dispense may simply create a problem for another pharmacist, should also be addressed in the amended Guidelines.”

 

Navigating the relationship

Following the release of the Coroner’s report, there was significant discussion within the pharmacy sector about the extent to which pharmacists could feel disempowered when questioning scripts.

Mark Naunton, Associate Professor and Head of Pharmacy at the University of Canberra, wrote in the Journal of Pharmacy Practice and Research that “In this case, the pharmacist was clearly knowledgeable and identified an error; perhaps if the GP had been more receptive and the pharmacist more assertive, then the outcome may have been different”.

“Perhaps we need to reconsider pharmacists’ competence to practice and consider more overtly their competence to practice persuasively?”

Pharmacist Jeff Lerner wrote a column for the AJP in which he suggested that the case “indicates a real need for universities to provide assertiveness training during the pharmacy course. It might have helped to avoid the tragic outcome of this case.”

Following an AJP poll in which 63% of readers said that they had had concerns about a script, contacted the prescriber and refused to dispense the medication – and 24% said that they had had concerns about a script but felt pressured and dispensed it anyway – PDL also offered some advice.

“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,” it said.

The TGA then released a medicines safety alert reminding pharmacists about the importance of reiterating the once-weekly dosing regimen.

Packaging for Methoblastin was updated to include a new warning, and the CMI updated to more prominently warn of the risk of accidental dosing errors.

At the 2021 hearing, the Board submitted that it was reasonable to expect that the pharmacist, who had 35 years’ experience in the profession, should be able to navigate the relationship between herself and a prescribing doctor – and of the option of not dispensing medicines when she believed the risk of harm was too great.

Despite the GP’s assertions on the phone, the pharmacist should not have dispensed the methotrexate, it said.

The Board’s expert, Kelli Lincoln, said that, “We [pharmacists] are trained in communication and how to build relationships with other health professionals. It is part of our job as pharmacists to work regularly with other health professionals and interact in a professional manner, while maintaining our independence.

“It is one of the main reasons that pharmacists exist, to provide that safeguard between prescribers and patients. This responsibility is instilled into us from the moment we begin our pharmacy degree, to ensure that we are capable of performing this role.

“We are taught how to call doctors confidently and assertively and ask for changes in therapy to be made for the good of the patient.

“If we cannot bring about a safe outcome for the patient, then we are taught to refuse to dispense.”

The Tribunal found that the pharmacist’s conduct constituted professional misconduct.

It reprimanded the pharmacist and imposed conditions on her registration.

These included that she successfully complete an approved course on ethics and dispensing; that she undertake five hours’ education with a suitable mentor; and that she provide the Board with a written essay demonstrating that she has reflected on the issues involved and how she has incorporated lessons from the mentoring into her practice.

Methotrexate dosing issues were also highlighted in another recent case, in which a GP was found to have engaged in professional misconduct after he prescribed methotrexate daily instead of weekly, among other errors, on more than one occasion.

In this case, the errors were detected by pharmacists and no adverse outcomes occurred.

Pharmacists can contact the Pharmacists Support Service on 1300 244 910 for peer support related to the demands of being a pharmacist in Australia.

Members can call PDL on 1300 854 838 for support from a Professional Officer.

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16 Comments

  1. glenn
    19/01/2021

    Interesting case. Recently I received a repeat script for Seroquel Repeat form for quick release duplicate for slow release no annidation for change contacted the pharmacy no notes on why the change or if the dr had been contacted. Tried to ring the dr (hospital script) No response tried again a few days later again no response. Issued the patient with some quick release tablets to continue therapy and had to ask them to see another dr for review. Not an ideal situation.

    • Steven Julius
      21/01/2021

      Seroquel slow-release hospital script. Was it for 8 tablets?

      • glenn
        21/01/2021

        no for a full packet given out 7 days supply on stages supply

  2. Tamer Ahmed
    19/01/2021

    I dont think that pharmacy has ever seen such injustice.As if it is not enough that it’s clear that the coroner is biased.He has clearly marginalised GP’s assertion regarding his stubborness to receive advice and tunnel visioned on the pharmacist’s role. The total focus was on the pharmacist to be assertive.So what kind of assertion is expected from us ?.The pharmacist has clearely expressed to the GP that the patient is in mortal danger .What else do you have to do to clarify how serious the situation is ?Should the pharmacist hold the GP on gun point to persuade him that he is serious ?.So the pharmacist is responsible now if the GPs blantly refuses to hear advice ?.How long wecare going to be scapegoated ?

    • Jarrod McMaugh
      19/01/2021

      the answer is pretty clear – don’t fill the script.

      It is really unfortunate for this pharmacist that this case keeps coming up in the media, but it is an instructive lesson… it doesn’t matter how stubborn the doctor is, you don’t dispense it when you believe it is unsafe, and you annotate the prescription to show that you refused to fill it, so that the next pharmacist also knows there is an issue.

      If the doctor is behaving in an unprofessional manner (ie anything other than a difference of opinion, so aggression, belittling, etc) then note all of the details and report them to the medical board.

      • Tamer Ahmed
        19/01/2021

        Your comment is too black and white.And this is definetly not a straightforward case where the pharmacist didn’t try to intervene or wasn’t suspecious.There is no mentioning of the culture , workloads , etc .. of that pharmacy.There is no mention if that specific GP had a history of being difficult to communicate with or not.This is not utopia .Community pharmacy is not practiced in an air conditioned office without distractions where everybody is helpful/understnding and all the information needed is provided to take the best decision possible.I have personally seen pharmacists beeing fired because the owner of the pharmacy was unhappy cause the local GP complained to him that “your pharmacist keeps wasting my time by calling me and telling me how to prescribe and I am going to divert my scripts to another pharmacy”.Patients in community dont arrive to the pharmacy carrying a file which has their progress notes , pathology reports , presenting complaints and history of medical conditions.Any community has pretty much access to no information except what the little patients knows and what the GP decides he wants to share.It is immpossible to do a risk/benefit analysis with the information available in community pharmacy.Community pharmacy is a dangerous place to practice at the moment and it doesnt appear that the employee pharmacist can expect any support/understanding from any party regarding the daily challenges he faces.

        • Patrice Hogan
          19/01/2021

          Thank-you for your thoughtful input and clear examples. P

  3. Jarrod McMaugh
    19/01/2021

    “In my view the single most effective measure would be a professional advice service. Such a service could, for example, be staffed by senior pharmacists who volunteer to receive calls on a rotational basis

    “Importantly, advice from such a service would reassure and embolden community pharmacists in situations of conflict.

    This is such bullshit

    Not that such a service couldn’t be useful, but that it should be staffed by volunteers.

    A service like this might be valuable, but if it were to exist, it should be funded appropriately.

    • Ron Batagol
      19/01/2021

      I agree Jarrod- this is no solution at all- totally impractical and won’t service the day-to-day needs of pharmacists and other health professionals.
      In this context, I note in an editorial in “Australian Prescriber” in December 2019:
      Medicines information: dwindling support in the age of information overload
      • Felicity Prior
      • Aust Prescr 2019;42:178–9
      • 2 December 2019
      • DOI: 10.18773/austprescr.2019.068
      • I refer particularly to the last line, which neatly summarises this dilemma:
      • , “Funding restrictions are affecting access to medicines information services especially for community health professionals who provide the majority of care for Australians. The need for timely, accurate, current, unbiased, clinically relevant, evidence-based therapeutic advice will continue, but who is willing to pay for this?”
      Well, maybe, the need has now been identified by the Coroner, (even if the proposed solution is impractical), the various Pharmacy and other health professional “movers & shakers” can work out a way of persuading the health resource funding gurus to utilise (already existing) medicines information centres, by providing the the required amount of funding needed to deal with this urgently-needed medication safety resources to minimise the risk of such tragedies. occurring in the future Let’s hope so!!!

      • Tamer Ahmed
        19/01/2021

        Why pay for a service when it’s way easier to scapegoat a pharmacist and replace him/her within a couple of days from a sea of unemployed pharmacists.The strongest factor in any industry is always demand and supply. What would happen if that pharmacist got derigestered , pretty much nothing and the show continues.

    • Paul Sapardanis
      19/01/2021

      Great post. Let us not be upset by the fact that people think a pharmacist will volunteer their time though. This is a culture that we have created so we only have ourselves to blame.

  4. (Mary) Kay Dunkley
    19/01/2021

    This is a very difficult situation to be in and my thoughts are with the pharmacist who was involved. As Jarrod says this case keeps coming up and this must be very hard to deal with. The Pharmacists’ Support Service (PSS) is available to support pharmacists in this type of situation. We do not provide clinical advice but we can support any pharmacist through the decision making process. Our aim is to empower a pharmacist to make a decision in the best interests of a patient. Assertiveness does not come easily to everyone and it can be difficult to think clearly when under pressure. PSS is available every day of the year between 8am and 11pm on 1300244910. We provide a colleague who understands pharmacy who will listen and support you in the decision making process. After an event like this we provide non-judgemental support whatever the situation.

  5. Michael Ortiz
    19/01/2021

    This is an unfortunate situation. It is never easy to confront a GP with an obvious mistake and most Pharmacists have been on the receiving end of a condescending response. I remember one such interaction many years ago, where the GP told me that “he had been doing for 30 years why should he change now!” My response was to decline to dispense and suggest to the patient to get a second opinion.

    The pharmacist seems to have done all the right things other than to decline to dispense. The bottom line is that she has knowingly supplied a medication that was likely to cause harm to the patient

    This case suggests two things:
    1. All prescriptions should now come with the indication for use?
    2. pharmacists should take a few minutes to record the facts before calling a prescriber and this should include a suggestion to address the issue.

    Just wait for all the confusion when prescribing goes generic and the public request and receive brand name products.

  6. Dr Evan Ackermann
    19/01/2021

    The GP should be held accountable for the prescribing error

    The pharmacist should be held accountable for the dispensing error

    It is not about assertiveness, communication, respect or other issues raised here – it’s about professional responsibilities under the relevant acts/laws/regulations. With respect to the pharmacist – a recognizably unsafe script should not have been dispensed.

    With the clearly preventable death of a patient – professional penalties should be applied to both practitioners.

    Whilst there a some examples of incompetence, what I find is that these incidences commonly occur in good people who inadvertently let their professional guard slip. I personally think the conditions on her registration were professionally degrading and will do little to stop this issue from recurring.

    Its time perhaps systematic changes were undertaken (eg “Practice Policy” that methotrexate is clearly prescribed weekly or the prescription will not be dispensed, or warning in dispensing software.) It give the professional support and an “out” with patients.

  7. Patrice Hogan
    19/01/2021

    I have indeed contacted the Queensland Drug Information Centre for support in my own decision making. On this topic I believe it is important to mention five points.
    a) Some pharmacies are open for longer trading hours than support services are staffed.
    b) Drug companies are poorly responsive to enquiries. Phone lines may not be staffed. Return calls to answer messages are not prompt. Further delays are necessary for research.
    c) Some dispensaries do not have up to date texts or clear procedure on how to access suitable online resources. Employers who fail to provide this access, fail to support Pharmacists in professional decision-making.
    d) Pharmacists face extraordinary workload pressures every day, from multiple angles.
    e) Doctors can be abusive. I recently chose NOT to supply based on significant concerns. I clearly educated the elderly Client’s Daughter. For several days I tried to contact the GP. When we spoke, he abused me for jeopardising the health of his Client plus insulting his Secretary (The Client’s other Daughter). Righto….
    * We can talk around in circles about what should or could be appropriate supports/ penalties, however the culture within our workplace can be quite unpleasant. There is not one ‘problem’ here. P

  8. Li Chang Choo
    20/01/2021

    Why the doctor was not charged with same misconduct? The doctor was acting in negligence and incompetent as well.

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