Pharmacist refusal, despite prescription


Pregnant women with morning sickness report being denied doxylamine and ondansetron by pharmacists, new Australian survey reveals

A recent Australian survey of 249 women found approximately one in four reported being denied a medication by a healthcare professional during pregnancy.

Medications most commonly denied included doxylamine (n = 45) and ondansetron (n = 16) and mainly involved interactions with community pharmacists (n = 44) but also included medical practitioners (n = 19).

Almost half of the women (38%) were pregnant at the time of survey, with nearly 80% having received a formal diagnosis of hyperemesis gravidarum, according to the study published in the Australian and New Zealand Journal of Obstetrics and Gynaecology.

Survey participants recalled accounts of being told the medications were not recommended or safe for pregnant women, or that they were not sick enough to warrant the medication.

“I always dreaded going into the chemist to get doxylamine as I had to plead with 90% of the pharmacists that the obstetrician advised me to take it for hyperemesis gravidarum,” stated a respondent.

Eight women reported pharmacist refusal, despite presenting prescriptions for either doxylamine, ondansetron or prednisolone.

“I would have a script and still be turned away for doxylamine and ondansetron because the chemist didn’t believe it was ok to give a pregnant woman the medication,” said a participant.

Another received the medicine but only after providing supportive evidence in the form of a clinical guideline.

She shared: “Pharmacy stating that medication was unsafe in pregnancy despite having script. Had to show them guidelines before they would dispense medication, and they did so reluctantly.”

Some women also reported resorting to lying about not being pregnant, or sending someone else in on their behalf, to get the medicine from the pharmacist.

“Doxylamine – I always had to lie and say it was for sleep and that I wasn’t pregnant or breastfeeding. Or get my husband to buy it. On the packet it says not safe for pregnancy even if it is category A,” said a respondent.

While up to 90% of women experience symptoms of nausea and/or vomiting during pregnancy, symptoms can range from mild to severe, explained pharmacist researchers Han-Fang Hsiao, Alicia Thomas, and Luke Grzeskowiak from SA Health, and Caitlin Kay-Smith from Hyperemesis Australia.

Hyperemesis gravidarum is considered a severe form and has been reported to affect up to 10% of pregnancies.

The most important thing is for pharmacists to recognise that doxylamine is a safe and effective medication to use for the treatment of nausea and vomiting in pregnancy, co-author A/Prof Grzeskowiak told the AJP.

“Pharmacists should seek to engage in conversation with women to better understand what treatments they have tried (if any) and what symptoms they are experiencing,” said A/Prof Grzeskowiak.

“It is not uncommon for women to try and ‘tough it out’, so pharmacists are in a position to recognise women that could benefit from a referral to a doctor or emergency department should they also be experiencing other associated symptoms such as dehydration or malnutrition.”

He noted that women provided experiences of pharmacists refusing to dispense medications that had been prescribed by a doctor, including ondansetron.

“Reasons for refusal largely focused on altered perceptions of safety and poor recognition of the importance of treating women’s illness,” said A/Prof Grzeskowiak.

“As medicines experts, pharmacists play a really important role in addressing the stigma often surrounding the use of medication in pregnancy and this means being up to date with the latest evidence and providing care that is consistent with best practice recommendations,” he said.

“The provision of misleading information is clearly the most harmful thing that can occur as this could prohibit women from taking medications and therefore unnecessarily prolong their suffering, or add to feeling of anxiety, guilt and shame if they are taking something that they think could be harmful for their baby.”

He added that multiple guidelines are available to assist in making treatment recommendations. The most recent guidelines have been developed by the Society of Obstetric Medicine of Australia and New Zealand and endorsed by numerous professional organisations including The Society of Hospital Pharmacists of Australia (SHPA).

Labelling confusion called out

Meanwhile the ANZJOG study authors, as well as the authors of a recent letter published in the Medical Journal of Australia, have called on the TGA to improve its medicines labelling.

Dr Debra Kennedy, director of the MotherSafe service at the Royal Hospital for Women, and obstetrics and medicines safety pharmacist Ron Batagol recently wrote to the MJA to outline their concerns about the labelling of single-ingredient non-prescription doxylamine products.

“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’,” Dr Kennedy and Mr Batagol pointed out.

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

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 healthcare professionals.”

“In some cases, pharmacists have refused to sell doxylamine to women with nausea and vomiting in pregnancy because of the product information, considering the use of doxylamine … to be off-label and thus not indicated or safe,” they 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,” Mr Batagol added.

Pharmacist readers of the AJP have shared their frustration at the lack of consistency between the product labelling and apparent guidelines.

One commenter recently said: “In defence of pharmacists, we are challenged by manufacturer’s packaging that contradicts clinical evidence. For example, Restavit packing states ‘DO NOT USE IF YOU ARE PREGNANT OR BREAST FEEDING.’ It undermines the consumer’s confidence in their pharmacist’s recommendation.”

Another wrote: “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.”

The TGA told AJP it is aware the labelling on doxylamine is creating confusion and concern for pregnant women.

“The labels of some over-the-counter (OTC) medicines are required to contain particular warning or cautionary statements. The required statements are detailed in the Required Advisory Statement for Medicine Labels (RASML),” the TGA said.

“The current RASML requires that the labels of doxylamine-containing medicines indicated for short term use in insomnia include either ‘Not recommended for use by pregnant or breastfeeding women’ or ‘If pregnant or breastfeeding, consult a doctor or pharmacist before use’.

“The TGA is aware that this pregnancy warning statement is inconsistent with the pregnancy classification of doxylamine (Category A in the TGA’s ‘Prescribing medicines in pregnancy database’) and that this creates confusion and concern for pregnant women who are advised to take doxylamine for nausea and vomiting.

“For this reason, the TGA is currently conducting a public consultation seeking comments on the proposal to remove the pregnancy warning from RASML. The consultation commenced on 6 April 2021 and closes on 18 May 2021. Further information about this consultation can be found on the TGA website.”

The PSA declined to comment.

This article was updated at 12.30pm on 17/5/21 to include a comment from the TGA.

Read the full ANZJOG study here

You may be interested in reading:

Confusion sees pharmacists deny first-line treatment

On Doxylamine

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8 Comments

  1. Ron Batagol
    15/05/2021

    The solution to this dilemma is very simple, as noted in the “On Doxylamine” article, as per the above link.
    The fact is that it is obviously a confusing contradiction in terms, for PIs and CMIs to list Doxylamine, firstly, (and quite correctly), as a “Category A in pregnancy” medication, and then to have the contradictory caveat listed, stating that its safety has not been established in pregnancy.

    I also noted that, in the past, when I have written to TGA drawing their attention to conflicting information of this nature in some CMIs or PIs, (indeed on several occasions!), they have contacted the manufacturer, and the issue has been promptly rectified.

    However, to date, this has not occurred in this case, despite repeated correspondence to TGA on this important issue!

    • Genevieve Adamo
      16/05/2021

      The TGA currently has a consultation open for public comment on the labelling of antihistamines to address this exact issue.

      • Ron Batagol
        16/05/2021

        Yes, I’ve made a submission, and was pleased to see the preamble to the public comment document spell out the that “available safety evidence. Doxylamine is frequently recommended by doctors for treatment of nausea and vomiting in pregnancy, consistent with the Therapeutic Guidelines and Australian Medicines Handbook”. So I’m glad that it has (finally!) been taken up by TGA under the RASML labelling provisions. Hopefully, the proposed changes will be soon put into place (but having previously had suggested changes implemented by the TGA RASML process, there is often a long lead time with changes of labelling), So, let’s hope common sense supported by the evidence base, will prevail in the meantime, to reassure consumers and health professionals.

  2. Umer
    15/05/2021

    Gggg

  3. Benjamyn Sung
    15/05/2021

    if all that a pharmacist can do is to read the label on the box (and not referring to other evidence based information such as AMH, eTG or TGA website), then any non-professional people can do the same. It is important that a professional pharmacist needs to be more resourceful, if they claim to be the drug expert…TGA labeling helps, but the pharmacist is ultimately responsible for his knowledge and information delivery

    • James Lawson
      15/05/2021

      The pharmacist is ultimately responsible for his knowledge and information delivery…

      …and the Pharmacy Board of Australia is ultimately responsible for allowing that person to continue practicing as a pharmacist.

      Given that one of the requirements of the Pharmacy Board of Australia is to follow the TGA’s restrictions on supply of medicines, it’s little wonder many pharmacists feel a professional conflict between following ‘accepted safety’ versus ‘legislated safety.’

      In situations where the choice is between supply outside of TGA approval and refusal to supply, medico-legal advice will often err on the side of caution.

  4. John Guy
    15/05/2021

    Whilst having no issue with the content of this article, I do have a problem with the title, Pharmacist Refusal despite a Prescription.
    This implies that a prescription is an absolute order for a pharmacist to supply which of course it is not.
    Also the statement equating 38% being almost half should be amended to ‘just over a third’
    I must have gotten out of the wrong side of the bed this morning hehehe

  5. Beverley Baxter
    16/05/2021

    Professional responsibility entails DO NO HARM – improve outcomes. So this article is WELCOME although in my opinion should include the difficult area of HARM Minimisation ie researching options for requests you are unable to fulfil for any reason- moral, uneasiness included and necessarily includes distribution and collection of injecting equipment, hire of crutches etc, JUST where is the nearest SHARPS distribution/ collection point. or where there is the ability to hire CRUTCHES? It is not acceptable that the QUALITY CARE PROGRAM does not cover this aspect and allows a TICK OFF not utilised in the pharmacy as an acceptable answer

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