To CMI or not to CMI


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A reader has commented on a recent PDL column on the importance of using CMI when dispensing a drug to a patient for the first time.

Majella Hill, a counsellor at MotherSafe, The Royal Hospital for Women, Sydney, says: 

“I refer to John Guy’s article regarding the importance of using the CMI in protecting the pharmacist when counselling  patients on the first time use of a drug. 

It is unfortunate that he has used this example by way of highlighting his point as in fact the information in the CMI regarding paternal exposures of griseofulvin has no evidence at all for the claim and by using the information the pharmacist has actually given wrong information.

Were one also to look at the AMH entry for griseofulvin one would see the following: “Men. May affect sperm; manufacturer advises men not to father a child during, and for 6 months after, treatment despite no reports of adverse effects on the fetus.’

Interestingly the AMH advice goes on to state that women should use additional contraception whilst taking and for one month after stopping. Given that the half-life of griseofulvin is 9-24 hours, it is difficult to correlate the manufacturer’s advice for  men to wait 6 months with the potential mother only having to wait one month before attempting to conceive, purely on a logic alone basis.

Whilst it is well-recognised that certain paternal exposures eg  radiotherapy, and some antineoplastic agents such as alkylating agents and antimetabolites, can cause germ cell loss and either temporary or permanent infertility, there is no human evidence that any paternal exposure causes a birth defect or any adverse outcome on a pregnancy  (1,2)

On a broader issue, the fact of the matter is that the advice provided from manufacturers  and therefore, the CMI, with respect to pregnancy and breastfeeding is consistently wrong and does not reflect evidence-based advice. Manufacturer’s advice invariably relies on the animal studies done prior to the drug’s release on the market and is rarely ever changed from that point onwards.

We at MotherSafe,  a counselling service for exposures in pregnancy and breastfeeding, based at the Royal Hospital for Women in Randwick, regularly have to correct  the advice given to women by health care professionals, including pharmacists, which has been based on the manufacturers advice and the CMI. 

Our advice is based on evidence from human studies which take into account  such things as the stage of the pregnancy, the route of administration, the risk of treating the patient  versus non- treating  the condition.  With respect to breastfeeding, considerations include, age and health of the infant, the relative infant dose, the extent of protein binding, the molecular weight,  the oral absorption and half life. (3)

Pharmacists, therefore need to be aware of this deficiency before counselling in this very specialised and sensitive  area and seek evidenced  based information rather than  using the CMI. 

Indeed they should go further and  advise their patient that the CMI does not reflect current evidence based medicine  with respect to the pregnancy and breastfeeding  so that patients are not unnecessarily alarmed when they go home and read  the CMI. 

Without this, there is a risk that a pregnant woman may consider terminating an otherwise wanted pregnancy at worst or stop taking a vital medication thus jeopardising the pregnancy or their ability to actively look after their newborn babe”.

Responding to Majella’s comments, PDL chairman Dean Schulze said: “Pharmacists are advised to use the CMI when counselling to help protect the consumer.

Majella Hill’s point on other potential side-effects is a good example of why counselling, by the appropriate professional heath care practitioner, and CMIs go hand-in-hand to help the patient. By applying an effective counselling process a pharmacist will often discover additional information that can be used in concert with the CMI to provide more specific and helpful health information.

The issues raised in this particular example also reinforce the importance and value of health professionals working together.

PDL believes open discussion on the issue is beneficial and thanks Majella Hill for her response to the article by John Guy”.

References

  • 1/ Mother to baby factsheet by the Organisation of teratology specialiststs  August 2014 Paternal Exposures and Pregnancy

  • 2/ Mothersafe factsheet Paternal Exposures March 2016

  • 3/ The MotherSafe experience: demystifying perceptions regardingtreating pregnant or breastfeeding mothers.  Majella Hill  Journal of Pharmacy Practice and Research (2015) 45, 72–75

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2 Comments

  1. Ron Batagol
    28/06/2016

    As an obstetric medicines information advisor, consultant and author for 40 years,
    I wholeheartedly agree with the comments of Majella Hill of Mothersafe.
    Two key points in the article are:

    .1.”There is no human evidence that any paternal exposure causes a birth
    defect or any adverse outcome on a pregnancy”‘, and very importantly:

    2. On a broader issue, the fact of the matter is that the advice provided from
    manufacturers and therefore, the CMI, with respect to pregnancy and breastfeeding is consistently
    wrong and does not reflect evidence-based advice. Manufacturer’s advice invariably relies on the animal studies done prior to the drug’s release on the market and is rarely ever changed from that point onwards.

    In fact, I have written to TGA on many occasions and had information that did
    not reflect the consensus of expert opinion, changed in PIs and CMIs. both in
    obstetric and related areas, and in some other areas of therapeutics.
    Some examples of these:

    (a) In 2004,I had TGA negotiate with the manufacturer to change the obsolete
    “14 days before effective contraception”-warning on a brand of
    progestogen-only pills.to the correct 48 hours.

    (b) Also in 2004, I had TGA negotiate with the manufacturer to add the important
    counselling measure on a brand added to a brand of Cyclophosphamide tablets of
    drinking plenty of fluids to avoid haemorrhagic cystitis, and

    (c) I had TGA negotiate with the manufacturer to remove the discredited warning
    on a brand of Chloramphenicol eye drops and ointment that that it “may
    pose a risk of “grey baby syndrome:” when used in in infants.

    (d) I also had TGA negotiate with the manufacturer to change the listed
    pregnancy category on oral corticosteroids from the incorrect C, to the correct
    A Category ( important for women who are asthmatic and may periodically require
    corticosteroids).

    These are just four examples of PIs and CMIs that needed to be changed to reflect contemporary counselling advice.

    So, fellow pharmacists please don’t rely on general information guides, from which
    CMIs are derived when seeking information on the safety of medicines and
    pregnancy! And for the most part, you can rely on the A.M.H for counselling information.

    Ron Batagol,

    Pharmacist
    and Obstetric Drug Information Consultant.

    • Peter Crothers
      28/06/2016

      So why then don’t we have consumer medicines information (nb: no caps) based on evidence????? Apologies to all those who – like me – were having this argument 25 years ago, The answer, by the way, is that the Consumers Health Forum jumped into bed with the the (forerunner to) Medicines Australia and f***ed-over the pharmacists. Wonder who had consumers’ best-interests at heart that day??

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