It was during a recent conversation with a scientist involved in the production of heparin that I learnt, quite by accident, that it is derived from porcine intestinal mucosa. I have since scoured the British National Formulary (Royal Pharmaceutical Society of Great Britain, 2011) and several product information leaflets, but have been unable to find any mention of this, although this fact is confirmed by other literature (Parfitt, 1999; Kumar and Clark, 2002; Koytchev, 2011).
This led me to think about the range of medicines derived from animal products, and prompted me to question the ethics of administering them to women from various religious and cultural groups, or for women who are vegetarian. Many other drugs that I subsequently looked at clearly state that they contain gelatin – antibiotics in capsule form being a notable example. In the case of many other products including heparin, this is less obvious.
The use of low molecular weight heparin would appear to be quite widespread in midwifery, both in pregnancy and especially post-caesarean section, for women at intermediate or high risk of venous thromboembolism, as recommended by current guidelines (RCOG, 2009; NICE, 2010; Drife, 2011). Community midwives are therefore likely to attend women who have been shown in hospital prior to discharge how to self-administer this medication postnatally. Compliance is not usually a problem, but I have been asked on occasion by women to administer heparin while visiting them, and this then brings the ethical question into sharp focus.
It is my understanding that practising Muslims are prohibited from eating anything made with pork products, and may also wish to avoid such substances in medication (Schott and Henley, 1996). In a study exploring religious and cultural attitudes towards medicines containing ingredients derived from animals, Muslim respondents expressed concern over both porcine and bovine derivatives, and a desire to avoid other animal substances that had not been prepared according to Islamic law (Mattick, 2003).
Similarly, Jewish women, who may not eat pork or anything derived from it, would prefer to avoid products from any animal that has not been slaughtered according to Jewish law. Products of bovine origin would appear to present a potentially difficult issue for Hindu women, who regard the cow as a sacred animal (Schott and Henley, 1996). Furthermore, Hindus, many of whom are vegetarian, may object to the use of any animal derivatives (Mattick, 2003).
While considered to be generally less strict with regard to dietary restrictions (Schott and Henley, 1996), the literature suggests that Sikhs would also wish to avoid bovine derivatives (Mattick, 2003). There are, of course, instances where medication is prescribed for use in a life-saving situation and, in certain circumstances, such as an emergency scenario, or in the absence of a suitable alternative, some patients may accept such products (Schott and Henley, 1996). These products may, for example, include plasma expanders containing gelatin.
Low molecular weight heparin is the thromboprophylactic drug of choice for various reasons, when compared with warfarin (Royal Pharmaceutical Society of Great Britain, 2011) or other alternatives (RCOG, 2009). Warfarin is not derived from animal products. Its administration does, however, require monitoring of the woman’s baseline prothrombin time, and subsequent frequent monitoring of her international normalised ratio. It takes 48-72 hours for the anticoagulant effect of warfarin to develop fully, and drug interactions are reported with not only many drugs routinely prescribed in the postpartum period (Baxter, 2006), but also with several food groups (Royal Pharmaceutical Society of Great Britain, 2011). Furthermore, it carries a risk of haemorrhage, which renders it unsuitable for use until five to seven days postpartum. To date, other alternatives have been considered, but are not adequately researched or not licensed for use in the UK or in this situation (RCOG, 2009).
The issue remains, however, that women are discharged from hospital with a supply of heparin syringes and a product leaflet that does not inform them of the product’s origins. I recently enquired about the reason for this omission from a manufacturer and have been informed that this information is not required by the regulatory agency, as the source of the active ingredient is not considered ‘medically relevant’ (Koytchev, 2011). A personal email from the Medicines and Healthcare Products Regulatory Agency confirms that the ‘origin of an active ingredient would not be required in the leaflet unless it affects the safety or efficacy of a medicine within a particular patient group’ (Medicines and Healthcare Products Regulatory Agency, 2011).
Many of the health professionals to whom I have spoken are unaware of the drug’s origin. This would seem to be a common finding (Enoch et al, 2005). It would be reasonable to assume, therefore, that this information is not passed on to women, with whom the final decision rests. However, in not conveying this information to women, it has been stated that we have not obtained consent, and that this omission then constitutes a breach of the Human Rights Act, if we suspect that this information is important to them with regard to their beliefs and culture (Enoch et al, 2005). Although we, as midwives, may not have prescribed the medication, it is clear that we share the responsibility of ensuring its ‘suitability of use’ (Nursing and Midwifery Council, 2008). Further study of the literature (Jones and Jenkins, 2004; Dimond, 2006) leads me to conclude that, as I now have this knowledge, it is incumbent upon me to pass it on. Nevertheless, I acknowledge that the amount of information we give to women is likely to remain a very complex issue.
We, as midwives, spend a great deal of time explaining to families the rationale for the administration of various drugs used in midwifery, and carefully documenting women’s wishes with regard to, for example, the administration of blood and blood products. Bearing in mind the lack of clear, accessible information as to the constituents of drugs such as heparin, my concern is whether maternity units and individual practitioners routinely consider the views of these women when prescribing or administering medication containing animal derivatives.
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