Following a patient’s death, PDL has issued a reminder to pharmacists to exercise their own judgement about whether it’s safe to dispense a prescribed medicine

An inquest into the death of 77-year-old Melbourne man Ian John Gilbert found that his death due to methotrexate toxicity was “needless and entirely preventable”.

He had complained of a flare-up of psoriasis, and visited a GP who prescribed the chemotherapy drug – sometimes used to treat severe recalcitrant psoriasis via a single weekly dose – at a daily dose.

When the patient’s daughters took the script to their usual pharmacy, the pharmacist on duty immediately recognised that the prescribed daily dose appeared to be incorrect, and got in touch with the GP to advise that the drug was normally taken once weekly.

She informed the GP that the dose prescribed was “potentially lethal,” but the GP confirmed the dose, telling the pharmacist that he had checked the product information in MIMS.

“After some hesitation, the pharmacist dispensed the methotrexate at a daily dose, as prescribed,” writes PDL.

“The patient took the methotrexate for several days, which ultimately led to his decline.

“Two weeks later after his systems began to fail, he died.”

The cause of death was given as “Complications of methotrexate toxicity in a man with chronic renal impairment, chronic obstructive pulmonary disease, cardiomegaly and ischaemic heart disease”.

Since the inquest, the TGA has released a medicines safety alert reminding pharmacists about the importance of reiterating the once-weekly dosing regimen.

“The unfortunate events that transpired in this case emphasises that pharmacists need to exercise independent judgement when dispensing medication,” PDL has advised.

“Pharmacists are independent health care professionals. They perform a vital role in preventing inappropriately prescribed medication from reaching patients.”

PDL cites the Pharmacy Board’s Guidelines for Dispensing of Medicines (September 2015), which state that:

“In dispensing a prescription, a pharmacist has to exercise an independent judgement to ensure the medicine is safe and appropriate for the patient… At all times the dispensing of a prescription or any other action taken by the pharmacist, must be consistent with the safety of the patient.”

The Coroner found that the Board’s Guidelines make it clear that the ultimate decision of whether to supply a prescribed medication rests with the pharmacist.

“The facts of this case compels an adverse finding against both the GP and the pharmacist… the patient died because a dangerous drug was inappropriately prescribed and then dispensed,” the Coroner said.

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

The Coroner made a number of recommendations regarding ways to prevent inappropriate dispensing:

  • “Doctors and pharmacists should trust and respect each other, whilst retaining their independence. In dismissing her concerns, it appears that the GP did not afford the pharmacist the respect she deserved. In dispensing methotrexate despite her concerns, it appears that the pharmacist afforded the doctor too much respect, or at least lost sight of her role as an independent safeguard against inappropriate prescribing.
  • “Similarly, whilst pharmacists should respect the doctor-patient relationship, they should not underestimate their own importance in the delivery of healthcare. Regard for the doctor–patient relationship should not prevail against their own duty to prevent medication misadventure.
  • “More assistance could be provided to community pharmacists to enable them to discharge their obligations in difficult situations such as when dealing with a difference of opinion that arose in this case.
  • “Further education and amending of the Pharmacy Board of Australia’s ‘Guidelines for Dispensing of Medicines’ to provide illustrations and advice are obvious possibilities in providing pharmacists with guidance when faced with such issues.”

PDL has now made some recommendations of its own.

“It is a well-established principle that the role of the pharmacist is to be a check and balance for any prescription written by a qualified practitioner,” says PDL.

“It is the pharmacist’s duty to raise a concern if he or she believes there is a problem with a prescribed item.

“The medicine should not be dispensed until the pharmacist believes it is safe to do so. If a discussion with the prescriber fails to resolve the situation, the prescription could be annotated with a brief reason for declination and the consumer directed back to the prescriber.

“A pharmacist has every right to refuse to dispense what is considered an unsafe prescription provided it is done in an appropriate manner with due care being given not to undermine the prescriber or question their competence.

“Pharmacists should always remember that it will be their initials on a dispensed prescription if a problem occurs.”

It advises pharmacists that there are steps pharmacists can take if faced with a conflict between the prescriber and the risk of harm:

  • Delay supply until further information can be gathered.
  • Seek advice from sources such as drug information centres.
  • Contact other practitioners including specialists that the patient may have seen previously for the condition.
  • Consider whether it is vital that the medicine be supplied immediately, based on the indication and the severity of the condition.

Pharmacists can also document all actions and reasoning associated with actions, and provide patients with a clear understanding of their concerns, reinforced by documents such as CMIs and/or extracts from references if needed, to justify their actions.

PDL also outlines a number of scenarios in which methotrexate has been implicated, including one in which the drug was dispensed correctly but a wrong label was attached to the bottle.

At the same time in this case, another medicine was dispensed, and the two labels transposed.

This resulted in “the methotrexate being labelled with directions that stated the dose was one tablet daily. This daily dosing led to the patient being hospitalised in a critical condition,” says PDL.

Another source of methotrexate misadventure involves the supply of injections.

“The injectable form is available in many strengths including 10mg/0.2ml and 50mg/2ml,” says PDL.

“In a recently reported incident, the 50mg/2ml was incorrectly supplied instead of the 10mg/0.2ml and the full amount was injected resulting in a fivefold overdose. Fortunately, the patient was not adversely affected on this occasion.”

PDL also warns that it has had a number of incidents reported to it where methotrexate was packed daily in a DAA instead of once a week – an error which can be difficult to spot as folic acid tablets are a similar shape and colouring.

PDL “strongly suggests” that methotrexate should be packed in a separate DAA to ensure that it is clearly identified by those who pack DAAs.

The TGA has recently worked with the sponsor of Methoblastin (methotrexate) to update the carton and container label artwork to include a new warning – ‘Caution: Usual dose is once weekly. Check dose and frequency with your doctor or pharmacist.

For pharmacists and other health professionals that are treating patients with methotrexate tablets, the TGA recommends reiterating the once-weekly dosing regimen and specifying which day of the week the dose is to be taken.

“You are also encouraged to educate those patients about the signs and symptoms of toxicity and advise them of the circumstances in which they should seek medical advice,” says the TGA.

“Good dispensing practices can also help to avoid dosing errors, including:

  • Labelling the medicine container and not just the external packaging; and
  • Ensuring that the label specifies the number of tablets to be taken and the specific day of the week they should be taken.”