Confusion sees pharmacists deny first-line treatment

Experts have called on the TGA to clarify information about doxylamine, saying pharmacists often deny the drug to pregnant women trying to manage morning sickness

Dr Debra Kennedy, director of the MotherSafe service at the Royal Hospital for Women, which provides advice on medicines safety in pregnancy and breastfeeding, and obstetrics and medicines safety pharmacist Ron Batagol have written to the Medical Journal of Australia to outline their concerns about the labelling of doxylamine.

The medicine, in combination with pyridoxine, is a first-line treatment for nausea and vomiting in pregnancy (NVP), and has been listed as a Category A medicine by the TGA: “Drugs which have been taken by a large number of pregnant women… without any proven increase in the frequency of malformations”.

The pair point out in the letter that “many single-ingredient non-prescription doxylamine products continue to carry misleading product and consumer information”.

“While correctly assigning Category A, they then contradictorily include warnings such as ‘do not use during pregnancy’ and/or ‘studies to prove it is safe for the developing baby have not been done’.

“There is no validity or justification to such statements, which are inconsistent with both available data and the Category A status.”

The pair state in the letter that of the 20,000 calls to MotherSafe each year from health workers and women around NSW, many are from women who have been given “conflicting advice about using doxylamine in pregnancy from pharmacists and other health care professionals.”

“In some cases, pharmacists have refused to sell doxylamine to women with NVP because of the product information, considering the use of doxylamine for NVP to be off-label and thus not indicated or safe.”

Dr Kennedy later told AusDoc’s Kemal Atlay that “notoriously risk-averse” pharmacists frequently refuse to supply the medicine to pregnant women.

“We sometimes tell patients to lie to their pharmacist and say their partner needs the medication for sleep.”

Ron Batagol told the AJP that doxylamine in combination with pyridoxine has been used to combat NVP for around 50 years.

“It’s a very old drug,” he said. “I happened to be working with an epidemiologist in 1985, and we published the world’s first meta-analysis of this medicine, because there were concerns about it being teratogenic. We showed it wasn’t teratogenic.

“It’s now been reapproved by the US Food and Drug Administration in 2014; and in Australia it’s been classified by the TGA as Category A, and has been used by large numbers of women without any evidence of abnormalities.”

But the conflicting labelling advice has led pharmacists and other health professionals, including GPs and obstetricians, to say “we’re not sure if it’s safe,” he said.

“But it’s listed by the College of Obstetricians and Gynaecologists as a first-line treatment. It’s well recognised as a first line treatment.”

The two co-authors wrote in the MJA letter that despite contacting the TGA to have the matter clarified for health professionals and patients, they are “yet to see any progress”.

They also note that the issue highlights “Australia’s confusing pregnancy risk classification” and the need for the TGA to use a more consistent, evidence-based labelling and information protocol than the current alphabetical system.

Ron Batagol encouraged pharmacists to become up to date with the categorisation of doxylamine.

“It’s a real issue,” he said, warning that if untreated, morning sickness can be distressing, and make the management of a healthy pregnancy more difficult “because they may not be getting relief, and may be dehydrated”.

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  1. Cabs

    While I agree that this confusion needs to stop, frankly I’m appalled that health professionals would tell consumers to lie to another health professional to get the product they want. This is never ok. We have enough problems with misuse of medicines in this country, without encouraging people to manipulate health professionals to get the outcome they desire. A better approach would be a quick call to the pharmacist and having a discussion, not teaching the consumer how to ‘get around’ them.

    • Nicholas Birnie

      If the positions were reversed and we told our patients to lie to their doctor to get a medication it would likely land us in front of the board/AHPRA

      Why do those doctors get a free pass for incredibly unethical behaviour? (Don’t get me wrong, only referring to that minority who encourage their patients to lie to us, not doctors as a whole)

  2. Denise Hope

    In defense of pharmacists, we are challenged by manufacturer’s packaging that contradicts clinical evidence. For example, Restavit(tm) packing states “DO NOT USE IF YOU ARE PREGNANT OR BREAST FEEDING.” It undermines the consumer’s confidence in their pharmacist’s recommendation.

    • Nicholas Birnie

      I was under the impression dispensing S3 medications for indications other than what it was approved under S3 (i.e. off-label) for was generally not a good idea as should anything go wrong our indemnity insurance may not cover it?

      If it’s on the recommendation of their doctor, I have no problems with it and am happy to dispense it generally (assuming no contraindications etc).
      Ron is really highlighting how detached from the rest of allied health some doctors are….either he expects us to expose ourselves to risk that our insurance doesn’t cover, or doesnt realise indemnity insurance varies considerably between fields in allied health

      Which either way reflects very poorly upon him

      • Jarrod McMaugh

        You indemnity insurer should cover you for off-label use, so long as the clinical logic for the use of the item you recommend is sound.

        if you recommend the use of a product off-label for which there is no evidence or clinical purpose, then you should expect your insurer to have many many questions for you.

    • James Lawson

      The manufacturers are required by the TGA under the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines federal legislation to caution against use in pregnancy. This is per the Guidance on TGO 91 and TGO 92 from the TGA.

      Pharmacists are required to follow the TGA guidelines on the use of medicines in Australia per the Pharmacy Board of Australia Code of Conduct. The TGA says doxylamine is safe in pregnancy. The TGA says do not use doxylamine in pregnancy.

      Catch 22.

  3. Kylie Henricks

    If a consumer is telling you that this medication has been recommended to them by another health professional and you as the pharmacist are seeing contradictory warning labels then the minimum requirement is to actually look it up. Information is easily available in this particular area (and even dr google supports its use). Just reading the label and then denying supply is not meeting any professional expectation and reflects poorly on us all.

  4. James Lawson

    From the current electronic edition of the Australian Pharmaceutical Formulary and Handbook clinical monograph on doxylamine:

    Nausea and vomiting in pregnancy (not an approved indication)

    While both the Australian Medicines Handbook and Therapeutic Guidelines support the use of doxylamine as a first line treatment for nausea in pregnancy, this discrepancy above may bear review by the editors of the APF, given it’s a mandatory reference for community pharmacy practice.

    • Jarrod McMaugh

      The entry in the APF is correct though

      It isn’t an approved indication.

      While the TGA may have say that doxylamine is safe in pregnancy via the ADRAC rating, but none of the products licensed for sale in Australia have this as an approved indication

      This is an important distinction.

      Pharmacists have the capacity to recommend it’s use, but the product itself cannot be marketed for this purpose, and all documentation must include those statements set out by TGA based on approved indication.

      • James Lawson

        This sounds similar to the situation with melatonin.

        The product is safely used overseas without restriction.

        The product has clinical evidence for its effectiveness.

        The TGA has placed restrictions on the sale of the product in Australia.

        Pharmacists cannot supply the product without contradicting the restrictions imposed by the TGA.

        Given that melatonin is soon to become S3 on 1st June 2021, hopefully we’ll see approval for a product to supply the demand for a doxylamine based anti-nauseant approved for use in pregnancy too.

        Until that point, deciding to supply doxylamine for nausea and vomiting in pregnancy fails to follow the Pharmacy Board of Australia’s Code of Conduct for registered pharmacists by ignoring the TGA’s guidelines on the use of the registered medicine.

  5. margaret williams

    If the dr wants to make sure his/her patient gets access to doxylamine maybe he should write a script with a large no of repeats

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