When prescribing, doctors usually only consider the ‘active’ component of any drug’s formulation ignoring the majority of the agents which make up the bulk of the tablet or capsule, collectively known as excipients. Many urological drugs contain the excipient gelatin which is, universally, of animal origin; this may conflict with the dietetic ideals of patients. A questionnaire-based study, undertaken between January and June 2010 in a mixed ethnicity inner-city population presenting with urological symptoms, asked which patients preferred not to ingest animal-based products, who would ask about the content of their prescribed treatment and who would refuse to take that medication if alternatives were available. Ultimately, the authors sought to find out how many patients had been inadvertently prescribed gelatin-containing oral medications and to suggest ways in which prescriptions might be more congruous with an individual patient’s dietetic wishes. This study demonstrated that 43.2% of the study population would prefer not to take animal product-containing medication even if no alternative were available. 51% of men with lower urinary tract symptoms were also found to have inadvertently been prescribed gelatin-containing products against their preferred dietary restriction. Education of healthcare professionals about excipients and getting them to ask about a patient’s dietetic preferences may help avoid inadvertent prescription of the excipient gelatin in oral medications. Substitution of gelatin with vegetable-based alternatives and clearer labelling on drug packaging are alternative strategies to help minimise the risks of inadvertently contravening a patient’s dietetic beliefs when prescribing oral medication.

Discussion

Our current study shows that, in our inner-city catchment area, 40% of patients would prefer to take oral medication which contains no animal products; this is considerably in excess of the 20% of our population which might practice dietetic restriction on a religious basis. Patients practicing dietetic restriction do not ask what the formulation contains before commencing drug treatment, which puts them at risk of transgressing their belief. This may simply be due to ignorance about what an oral medication contains, not reading, or being able to read, the patient information leaflet which contains a list of excipients, or belief that the doctor or pharmacist involved in the prescription would tell them if the medication contained ingredients that might contravene their beliefs. We already know that doctors are fairly ignorant about the issue of excipients in medication,4 while data from 2008–20097 shows that pharmacists are dispensing only 50% of the generic oral medications prescribed. This indicates that pharmacists are tailoring prescriptions for an individual patient’s needs, and this could, possibly, include reasons of dietetic preference. Those patients preferring to avoid the ingestion of animal products do, however, appear willing to take gelatin-containing medication if no effective alternative oral drug was available, as is permitted by dietarily restrictive religions.8

This observational study may include bias as a consequence of questionnaire design and the limited use of interpreters to enable the most appropriate response from the multi-cultural population studied. Equally, the dietetic preferences of our ambient population may not be totally referable to other communities, and this means our conclusions may need to be used with caution when considering the applicability of these data.

This study does, however, highlight the importance of asking about cultural and lifestyle factors in the prescription and dispensing of oral medications when more than 50% of men with lower urinary tract symptoms were already receiving medications which transgressed their dietetic preference. This is, almost certainly, a much bigger issue for the 860 million non-urological preparations, prescribed in the UK each year, whose excipient content is not easily identified.2 These data highlight the necessity to prescribe, and dispense, with diligence across the totality of the pharmacopea9 as is recommended for best practice.10

Although this study shows there is significant potential for transgressing an individual’s dietetic preferences, many excipients, such as gelatin, have non-animal-based alternatives. Agar Agar (E406) and Carrageenan (E407) are derived from various seaweed species and are used as gelling agents, in the food industry, and in some oral medications already.11 Universal incorporation in oral medications would negate the potential for dietetic transgression.

It is tempting to suggest that several things might decrease inadvertent prescription of animal-product-containing medications. These could be educating healthcare professionals about the issue of dietetic preference, making it easier to identify a medication’s constituents or by altering the manufacturing process so that only non-animal excipients are used in drug formulation.

In particular, we would recommend that every doctor needs to be aware that it is not just the active drug being dispensed but a whole group of other agents which may have relevance to an individual patient’s compliance with treatment when oral treatments are prescribed. We would also suggest that it should be easier to find out what the composition of a drug’s formulation is; hierarchical constituent listing, as used on food packaging,12 is one option, although labelling to denote products of vegetarian composition might be easier. Adoption of the Vegetarian Society’s ‘Seedling’ symbol,13 a voluntarily applied symbol used on accredited merchandise,14 might be an easily identified logo to denote a medication containing no animal ingredients.

In conclusion, we feel that our service evaluation has identified a number of issues for further research and which, clearly, have ethical implications for doctors across the totality of drug prescribing. Systems to help patients, doctors and pharmacists identify those oral medications containing animal-based products require evolution. This would facilitate choice for patients about the oral medication they take, whatever their dietetic beliefs, and would conform to best practice in medical care.

Source: BMJ.

Increased risk of inflammatory bowel disease in women with endometriosis: a nationwide Danish cohort study

Abstract

Background An association between endometriosis and certain autoimmune diseases has been suggested. However, the impact of endometriosis on risk of inflammatory bowel disease (IBD) remains unknown.

Objective To assess the risk of Crohn’s disease (CD) and ulcerative colitis (UC) in an unselected nationwide Danish cohort of women with endometriosis.

Design By use of national registers, 37 661 women hospitalised with endometriosis during 1977–2007 were identified. The relative risk of developing IBD after an endometriosis diagnosis was calculated as observed versus expected numbers and presented as standardised incidence ratios (SIRs) with 95% CIs.

Results Women with endometriosis had a increased risk of IBD overall (SIR=1.5; 95% CI 1.4 to 1.7) and of UC (SIR=1.5; 95% CI 1.3 to 1.7) and CD (SIR=1.6; 95% CI 1.3 to 2.0) separately, even 20 years after a diagnosis of endometriosis (UC: SIR=1.5; 95% CI 1.1 to 2.1; CD: SIR=1.8; 95% CI 1.1 to 3.2). Restricting analyses to women with surgically verified endometriosis suggested even stronger associations (UC: SIR=1.8; 95% CI 1.4 to 2.3; CD: SIR=1.7; 95% CI 1.2 to 2.5).

Conclusion The risk of IBD in women with endometriosis was increased even in the long term, hence suggesting a genuine association between the diseases, which may either reflect common immunological features or an impact of endometriosis treatment with oral contraceptives on risk of IBD.

Source: BMJ.