Off-label scripts under the spotlight


medicines meds shortages prescription rx

Pharmacists should be notified when and why a drug is being prescribed off-label says MP who has called for an inquiry into the practice

A federal MP, whose daughter suffered severe health issues after being prescribed an off-label medication, has called for an independent inquiry into Australia’s pharmacovigilance regime.

Among his suggestions is a requirement for pharmacists need to be informed when and why a drug is being prescribed off-label.

Julian Hill, MP for the Victorian seat of Bruce, spoke at length on the health problems experienced by his daughter after she was prescribed the “old and dangerous drug Diane-35” for use as a contraceptive pill to regulate irregular periods.

Mr Hill said the drug, banned in Europe for a time was prescribed “off list” and led to his “healthy 20-year old daughter” almost dying and needing two year of treatment. She now has irreversible damage to multiple veins and post-thrombotic syndrome, he said. 

He says Australia’s pharmacovigilance system has fallen behind world-leading standards, and an investigation is required. 

“I’ve come to realise… that the problem is wider than just Diane-35. Australia’s whole
pharmacovigilance regime—a fancy word for drug safety—needs strengthening. So I call tonight for an independent inquiry to officially review Australia’s pharmacovigilance system, as we have now fallen behind many other countries in too many areas,” he said in Parliament this week (19 February).

“More can and must be done to improve drug safety and to minimise harm to Australian patients”.

Among his suggestions are for pharmacists to play a greater role in vigilance of off-label prescribing, and for regulators to have the ability to impose restrictions, where appropriate.

A “key focus… should be to examine the introduction of a mandatory requirement for
prescribers to notify pharmacists on prescriptions when a drug is off-label and what ailment or illness it is being prescribed for,” Mr Hill said.

“Australian pharmacists are not generally involved in overseeing or second-guessing prescriptions. Nevertheless, pharmacists usually check patient understanding of prescription drugs and dosages prior to dispensing them.

With off-label prescriptions, this final check cannot be as effective in Australia, as pharmacists are unlikely to know why a drug is being prescribed or to have sufficient pharmacological information about a drug’s risk profile if it’s used off-label”.

“In other countries, such as the US, some European countries, Thailand and the Philippines, there is this extra check, and pharmacists are notified when a drug is prescribed off-label so that better conversation can occur at the counter at that last check”.

He said that, as the last professional link in the prescription chain, pharmacists could “provide a critical extra check in improving patient awareness of and education about those risks so patients don’t just take off-label drugs unwittingly and so they can encourage patients to return to them or to their doctor if they’re experiencing any adverse drug effect or side effect”.

He also said the inquiry should examine the introduction of a mandatory requirement that doctors advise patients that they are being prescribed an off-label drug with a potentially higher
or different risk profile and that they seek their consent prior to issuing the prescription, “unless this is practically impossible”.

“Some jurisdictions also give drug safety regulators an explicit power to step in and impose special conditions or restrictions in relation to off-label prescribing,” he said.

“I wish this would happen in Australia in relation to Diane-35 to stop it being handed out by lazy doctors as a first-line contraceptive”.

Click here to read more on the story of Mr Hill’s daughter’s health problems, which he says is linked to use of Diane-35 

 

Previous World news wrapup: 21 February 2019
Next DDS on top

NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.

5 Comments

  1. Ron Batagol
    21/02/2019

    It’s a real dilemma!
    As a general comment, without going into the specifics of this situation, from an overall pharmacy practice perspective, currently, outside of institutional practice, there is no direct mechanism for the pharmacist to be certain of the diagnosis for which the medication is being used. Nevertheless, we know that within most pharmacy practice environments, medications are often used, for well- justified evidence-based purposes, to treat conditions beyond the list of TGA- approved conditions.
    We are all familiar with the current “indirect approach”, that frequently occurs, between the pharmacist and the prescriber regarding the justification for prescribing “off-label”.

    These discussions often occur after a pharmacist, acting with due diligence, queries the patient as to the diagnosis for which the medication is being prescribed, to enable the pharmacist contact the prescriber, in order to be satisfied as to the dosage and any related safety issues prior to dispensing the medication.

    Clearly, for pharmacists to fulfil their requisite patient care and professional responsibilities in the 21st. century, we need to move towards an agreed position between the medical and pharmacy professional groups and legislators, that the therapeutic indication for use of a medication is listed on the prescription.

    Sadly, however, given the current state of professional political turf-wars, and, rightly or wrongly, the often perceived privacy considerations for including a diagnosis on all prescriptions, one has to say- good luck in achieving that any time soon!!

  2. Ron Batagol
    21/02/2019

    It’s a real dilemma!
    As a general comment, without going into the specifics of this situation, from an overall pharmacy practice perspective, currently, outside of institutional practice, there is no direct mechanism for the pharmacist to be certain of the diagnosis for which the medication is being used. Nevertheless, we know that within most pharmacy practice environments, medications are often used, for well- justified evidence-based purposes, to treat conditions beyond the list of TGA- approved conditions.
    We are all familiar with the current “indirect approach”, that frequently occurs, between the pharmacist and the prescriber regarding the justification for prescribing “off-label”.

    These discussions often occur after a pharmacist, acting with due diligence, queries the patient as to the diagnosis for which the medication is being prescribed, to enable the pharmacist contact the prescriber, in order to be satisfied as to the dosage and any related safety issues prior to dispensing the medication.

    Clearly, for pharmacists to fulfil their requisite patient care and professional responsibilities in the 21st. century, we need to move towards an agreed position between the medical and pharmacy professional groups and legislators, that the therapeutic indication for use of a medication is listed on the prescription.

    Sadly, however, given the current state of professional political turf-wars, and, rightly or wrongly, the often perceived privacy considerations for including a diagnosis on all prescriptions, one has to say- good luck in achieving that any time soon!!

  3. Jarrod McMaugh
    21/02/2019

    This quote is interesting:

    “Australian pharmacists are not generally involved in overseeing or second-guessing prescriptions. Nevertheless, pharmacists usually check patient understanding of prescription drugs and dosages prior to dispensing them.

    This is the entire reason pharmacists exist. We aren’t just a second step between prescribing and a person accessing a medicine – the entire reason dispensing is separated from prescribing for potent substances is so that the pharmacist can assess the appropriateness of a medicine or the person in front of them, which REQUIRES an understanding of the prescriber’s intent.

    The proposal to include indication on all prescriptions (or via an electronic health record that is readily accessible) should be strongly supported.

    Here is another interesting quote:
    He also said the inquiry should examine the introduction of a mandatory requirement that doctors advise patients that they are being prescribed an off-label drug with a potentially higher
    or different risk profile and that they seek their consent prior to issuing the prescription, “unless this is practically impossible”.

    My understanding is that this is already a requirement… at least from a medicolegal view (that is, insurers take a dim view of off-label use without consent)

    • Ron Batagol
      21/02/2019

      BUT, wouldn’t you want to know something the about underlying conditions, which may be of significant importance in your counselling. eg.an atypical antipsychotic given to a patient who is at risk for type 2 diabetes? And, yes, medico-legally, as Jarrod has noted, patients should give consent prior to a prescription being presented for an off-label indication.

  4. Peter Bayly
    21/02/2019

    Prescriptions should ALWAYS include the indication (but not the diagnosis). So if an antidepressant is used for nerve pain we don’t start discussing depression. Our Italian patients used to return their packs showing “per dormire” on hypnotics and “per cholesterola” on statins so I adopted it as policy with never a complaint from a prescriber and lots of thanks from the patient. And establishing the indication opened up counselling opportunities.

Leave a reply