On Doxylamine


monochrome of pregnant belly

Following a recent AJP article about pharmacists denying doxylamine for morning sickness, Ron Batagol responds

Earlier this week, the AJP reported on a letter written by 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 to the Medical Journal of Australia, outlining concerns about contradictory information about the medicine.

The pair wrote that while doxylamine is a Category A medicine, it is frequently denied to women wanting to manage nausea and vomiting in pregnancy, due to the content of the product information.

Following discussion in the comments section, AJP prints Ron Batagol’s response in full below:

Thanks for the interest in this issue and the many comments posted.

I think there are three main points that need clarification:

1: With regard to  the status of off-label prescribing, I refer to an NPS Medicine Wise Editorial from 2013 (view the Editorial here), which stated:

“Off-label” prescribing occurs when a drug is prescribed for an indication, a route of administration, or a patient group that is not included in the approved product information document for that drug.

Also, importantly it states: “Prescribing off label is unavoidable and very common, especially if your practice includes children, pregnant women or palliative care. Off-label prescribing means that the Therapeutic Goods Administration (TGA) has not approved the indication, route of administration or patient group.

“IT DOES NOT MEAN THAT TGA HAS REJECTED THE INDICATION. COMMONLY THE TGA HAS NOT BEEN ASKED TO EVALUATE THE INDICATION.” (Capitals mine, for emphasis.)

The product information will not include advice about unapproved indications and the drug companies are unable to promote these indications.

This Editorial  also states: “It is important to know when you are prescribing off label and it is good that your patients know and understand why.

“Having evidence or information from the Australian Medicines Handbook, Therapeutic Guidelines or NPS MedicineWise that supports your prescribing decision is very desirable.”

Thus, In this context, we not only have those sources, but also this indication for Doxylamine is listed in local and overseas clinical guidelines, including the RACGP Guidelines for nausea and vomiting in pregnancy, and guidelines from the Society of Obstetric Medicine of Australia and New Zealand.

2: On the issue of whether or not Doxylamine products can be SOLD ON REQUEST for an “off-label” purpose, in this case, use in pregnancy, it is also important to note that The National Poisons Standard, under Schedule 2, does include therapeutic indications for some, BUT NOT ALL, of the medications listed in this schedule.

For instance, DIMENHYDRINATE is listed  as “in primary packs of 10 doses or less for the prevention or treatment of motion sickness”.

In the case of Doxylamine, however, Schedule 2 simply states: “DOXYLAMINE when combined with one or more other therapeutically active substances in oral preparations when:

  1. at least one of the other therapeutically active substances is a sympathomimetic decongestant; OR (my capital letters)
  2. in a day-night pack containing doxylamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper.

3: Finally, and most importantly, it is a contradiction in terms for PIs and CMIs to list Doxylamine, firstly, 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 should also say that, in the past, when I have written to TGA on conflicting information in CMIs or PIs, they have contacted the manufacturer, and the issue has been promptly rectified.

To date, this has not occurred in this case.

Read the original AJP discussion here.

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