Dietary restrictions – Ingredients and excipients in Hormone Replacement Therapy (HRT) products

Abstract

Up to 20% of the UK population may have dietary restrictions due to ethical, lifestyle or religious views. It is important for clinicians to be aware of the constituents of what is prescribed, so that the patient can make an informed choice about their medication. This will improve both compliance and the therapeutic relationship. This article looks at the constituents of common HRT preparations currently available in the United Kingdom.

Keywords

HRT menopause

Introduction

Increasingly, there is a move to providing patient-centred care and shared decision making, so it is wise to ask sensitively whether any patient has any dietary restrictions or allergies before prescribing. Many patients with concerns about these issues will ask, but equally as many may not know they need to.

Different populations prefer to avoid certain animal-derived ingredients. Patients have a right to know what is contained within their medicines if this would contravene their beliefs, in order that they can make an informed decision about whether to take the product recommended by their doctor.

This paper has been prepared to advise clinicians working in this field, so that they can provide the necessary information to their patients. Patients are more likely to adhere to prescribed medicines if they have been actively involved in prescribing decisions, and if their views and preferences have been recognised and taken into account.²

It is also important to be aware of common allergens that may be present in pharmaceutical products that are commonly prescribed.

All medicines licensed in the United Kingdom are tested on animals as a regulatory requirement of the Medicines and Healthcare products Regulatory Authority (MHRA).

Information

The largest population groups of the different forms of ethical food choices and religious requirements are as below. This list is not exhaustive.

Ethical food preferences – Vegan

There are 1.5 million Vegans in the United Kingdom, which is 3% adult population. This number is rising rapidly. People following veganism have increased by 40% in 2020. (Feb 2021).⁴

The Vegan Society acknowledge that it is not always possible to make a choice that avoids the use of animals, and sometimes there may not be an alternative to taking a prescribed medication containing animal-derived ingredients. They do not recommend that people avoid taking medicines prescribed by their doctor but encourage discussion about possible alternatives to medicines containing animal-derived ingredients with healthcare professionals.² (Figure 1).

Figure 1.

Definition of veganism.³

Vegetarian

Six percent adults (3.1 million) are vegetarian in the United Kingdom (Feb 2021). Vegetarians do not eat meat fish or birds. Most do not consume gelatine. A further 2.5 million (5%) do not eat meat or birds, only fish.³ Vegetarians and pescatarians vary in whether they will use/consume the other animal products that vegans avoid.

Religious dietary guidelines and restrictions

A number of religions have dietary guidelines which might be observed more or less closely. Different denominations and different families within the same religion may have differences in food guidelines.

Bhuddist – Bhuddists follow Ahisma, which means “Do no harm” and so many follow a lacto-vegetarian diet (with dairy but no eggs.)

Jain – Jains also follow Ahisma and will be either lacto-vegetarian or vegan, avoiding, for example, sometimes milk and sometimes root vegetables.

Seventh day Adventists are lacto-ovo-vegetarian and avoid alcohol.

Rastafarian – Rastafarians do not eat meat and some seafood.

Hindu – In Hinduism, the cow is considered sacred. Beef cannot be consumed and a lacto-vegetarian diet is followed (dairy but not eggs).

Muslim – Pork and pig derivatives plus alcohol are banned under the Islamic or Halal rules.

Jewish – Pork and shellfish are not allowed to be consumed under the Jewish Kosher rules.

Both Jewish and Muslim leaders have said that their people should be allowed to take/use products of animal origin if this is for medical purposes and certainly when there is no suitable alternative or in a life-saving situation.²

Non- Christian religions encompass around 5% of the UK population (Figure 2).There are therefore up to 21% of the population that may have dietary restrictions. If a fifth of the population are potentially affected, I would argue that this becomes a routine question clinicians should be asking.

Figure 2.

Estimated % UK population with dietary restrictions 2022.¹

Manufacture of medicines

The active ingredient is often a relatively small proportion of the content of the product. Excipients make up the additional non-active material in a product. Some excipients are part of the process of manufacture of the product and others may be used to regulate the bioavailability of the active ingredient. They also act as antioxidants, emulsifying agents, aerosol propellants and colours.² Animal-derived ingredients may be included as excipients (Figure 3).

Figure 3.

Common animal-derived excipients found in medicines [3].⁵

The Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs) for licensed medicines, (https://www.medicines.org.uk/emc), include a list of excipients and are easily checked on line. However, it is not always possible to tell whether ingredients are derived from animals.

Pharmaceutical companies cannot always identify the specific sources of ingredients as their sources and suppliers can change. They may also change the formulation of their active ingredients or excipients. Generic forms of the same drug may have different excipients.

The information in this article can only therefore be said to be accurate at the time of publication to the best of the knowledge of the BMS MAC.

In the preparation of this article, the manufacturers have been consulted about the formulation of their product where there has been any doubt from the SPC (Figures 4–6). If there remains doubt, the product is listed in Figure 7.

Figure 4.

HRT products that contain no animal-derived ingredients – suitable for all.

Figure 5.

HRT Products that contain derivatives of milk.

Figure 6.

HRT products that contain derivatives of Animals.

Figure 7.

HRT products that contain derivatives that are of unclear origin.

Conclusions

It is really useful to have as much information as possible when counselling patients about any new treatment or medicine, to enable the discussion to be relevant to the patient’s individual concerns. The clinician needs to understand the patient and the patient to feel included in choices and decision making for the optimal therapeutic relationship to be established and the best treatment to be chosen, for that patient at that time to achieve compliance and the best therapeutic result.

Footnotes

Acknowledgements

Support from PRH editors.

Declaration of conflicting interests

The author(s) declared the following potential conflicts of interest with repect to the research, authorship, and/or publication of this article: Conflicting interests Personal interest in this issue as vegetarian since 1987, Previous funding for research from Servier 2001, Previous funding for travel from Galen and Ferring 2001–4, Previous funding from Shionogi, Besins, 2020-21.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Annie Hawkins

References

World population review 2022.com/country-rankings.

Implications of religious and cultural beliefs on selection of medicines. Drug Ther Bull 2016;54(4):45–48.

The Vegan Society . Accessed online via, https://www.vegansociety.com/.

UK diet trends 2021 | Finder UK www.finder.com/uk/uk-diet-trends.

Strickland

. Dietary restrictions: implications on medication choice. Br J Gen Pract 2014; 64: e670–e671. DOI: 10.3399/bjgp14X681865.