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.