By Eberhardie, Christine
Summary
Over-the-counter food supplements and herbal medicines are a growth industry in the UK and are now regulated under European Union (EU) directives 2002/46/EC, 2004/24/EC and 2004/27/EC (European Parliament and Council of the European Union 2002, 2004a, 2004b). In practice, the use of food supplements and herbal medicines should be considered in association with the individual’s diet, medical history and prescribed treatments, especially drug therapy, since interactions with drugs can be dangerous and even fatal in some cases. As members of the interprofessional team, nurses can play a key role in identifying problems through careful assessment and prevention by health education.
Keywords
Alternative therapies; European Union; Law; Nutrition and diet
These keywords are based on the subject headings from the British Nursing Index. This article has been subject to double-blind review. For related articles and author guidelines visit our online archive at www.nursing-standard.co.uk and search using the keywords.
THERE ARE a variety of definitions for food supplements and herbal medicines in the international literature (World Health Organization (WHO) 2000). Food supplements are sometimes also referred to as dietary supplements (US Food and Drug Administration 1994, Office of Dietary Supplements 2004). Until 2002 the term ‘food supplement’ had no clear definition in the European Union (EU) and the industry was poorly regulated. There was confusion in this growth industry which, in the UK alone, was valued at 335 million in 2000 (Mintel 2001). Extravagant claims were made for the healing properties of a variety of vitamins and minerals and regulation came under the Trades Description Act 1968, the Food Safety Act 1990 and the Food Labelling Regulations (amended) Act 1996. Food supplements and herbal medicines were therefore not subject to the same stringent regulations as prescribed medicines.
There was considerable concern in medical and scientific nutritional circles worldwide about insufficient rigour in establishing the safe dosage of food supplements and herbal medicines, safe manufacture and side effects and interactions with pharmaceutical medicines (Barnes 2003, Ferner and Beard 2005). At the same time, the differences in availability of these products throughout the EU were leading to confusion for the consumer and inequality in the market. It was decided that EU directives controlling the market would result in safer food supplements and herbal medicines throughout the EU (European Commission 2001, Medicines Control Agency (MCA) 2002).
The Food Supplements directive (2002/46/EC) came into force on August 1 2005 and the acts implementing the Traditional and Herbal Medicines directives (2004/24/EC and 2004/27/EC) will come into force on October 30 2005 (European Parliament and Council of the EU 2002,2004a, 2004b). Along with the EU Clinical Trials directive (2001/20/EC) (European Parliament and Council of the EU 2001), they will affect nurses who are carrying out research into herbal medicines and food supplements, and those who practise relevant complementary therapies such as optimum nutrition therapy or herbal medicine.
In EU directive 2004/24/EC there was also recognition that many modern pharmaceutical drugs had been developed originally from plant sources and that some have a well-established safety record as well as proven efficacy. To ensure that a traditional herbal medicine product is recorded on the approved list the applicant has to give written evidence of its ‘medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the European Union’ (EU Directive 2004/24/EC Article 16c/1c) (European Parliament and Council of the EU 2004a).
To the lay person the situation remains confused at present and it is in this context that patients are at risk. Is it better to take a supplement? Are supplements safe? If not, what are the risks?
Box 1 outlines some of the reasons that patients may take food supplements and herbal medicines.
Food supplements directive
The EU directive for the regulation of food supplements is 2002/ 46/EC. It defines food supplements as ‘foodstuffs the purpose of which is to supplement the normal diet and which are concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and other similar forms of liquids and powders designed to be taken in measured small unit quantities’ (EU Directive 2002/46/EC Article 2).
In accordance with the directive, the four countries of the UK have drawn up national regulations based on the EU directives. They are similar and the English regulations, for example, are the Food Supplements (England) Regulations 2003 (The Stationery Office 2003).
The directive came into force on August 1 2005. In the past three years the food supplements industry has had the opportunity to adopt the required changes and submit safety dossiers to the European Food Safety Authority (EFSA) for supplements which they consider are safe to produce and sell but which are not on the ‘positive list’ – the list of approved food supplements and their active ingredients. The directive prohibits the sale of all vitamins and minerals not on the positive list and ensures that supplements are sold to the consumer in a prepackaged form with appropriate labelling. The Food Standards Agency Expert Group on Vitamins and Minerals (EVM) (2003) has produced a comprehensive survey of the safe upper limits of vitamins and minerals, which will inform national upper limits of vitamins and minerals in the future. Some examples of the information currently available are shown in Table 1.
However, there is still further work to be done on drug-nutrient and nutrient-nutrient interactions with daily users of supplements who have a high vitamin and mineral content in their diet.
Herbal Medicines directive
Herbal medicines are now subject to EU directives on traditional herbal medicinal products (2004/24/EC) and medicinal products for human use (2004/27/EC) and many will be unavailable for purchase after October 30 2005, for example, 1,000mg and above doses of vitamins such as vitamin C, and minerals such as boron, tin, nickel, silicon and cobalt. A medicinal product is defined in the directive as: ‘a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis’ (2004/2 7/EC Article 1).
Chemical and microbiological contamination during the production of herbal medicines on a large scale have been major issues (EFSA Scientific Committee 2004). Some Chinese herbal medicines have been mixed with synthetic chemicals including heavy metals (Ernst 2002, EFSA Scientific Committee 2004).
Another concern is the extent to which the concentrations of an active ingredient are consistent, in other words, whether each drop or pill contains the same concentration of the active ingredient (MCA 2002). The directive seeks to ‘harmonise’ legislation and regulation throughout the EU.
Both directives have been controversial, especially among those who favour high-dose vitamin therapy. The Alliance for Natural Health (2005) believes that modern farming methods and Western lifestyles have so depleted the soil that we must take supplements to have a healthy body. However, organisations which produce or promote herbal medicines, such as the Herb Society (2005), have acknowledged that EU directive 2004/27/EC provides a legal basis for these substances for the first time and so has prevented herbal medicines being taken off the market. Herbal medicines have been safeguarded in the EU legislation but manufacturers have to be more rigorous with regard to ingredients, packaging, labelling and advertising.
BOX 1
Patients’ reasons for taking food supplements and herbal medicines
The role of the nurse
The public should have clear definitions and factual information on food supplements and herbal medication. The producers of food supplements and traditional herbal medicines should acknowledge the actual and potential dangers of over-promotion of products in isolation from other dietary and therapeutic factors and the effects of misleading advertising. It is here that the nurse can play a key role in the assessment of the patient because legislation alone will not prevent the potential dangers of vitamins, minerals and herbal medicines when taken inappropriately. Danger occurs when there is interaction between any one or more of these substances (Sorensen 2002, De Smet 2004).
TABLE 1
Examples of vitamin and mineral dosages and the effects of deficiency and overdosage
Holistic and detailed assessment of patients can aid the prevention of ill health and promote wellbeing. Assessment should take account of the patient’s daily diet related to lifestyle, age and activity, prescribed and over-the-counter medicines, food supplements and complementa\ry therapy nutrients, botanicals and other products, such as ointments and oils which can be absorbed into the bloodstream.
Some of the concerns that patients may have can be met by ensuring a good, healthy balanced diet and an examination of lifestyle. Nurses can help by giving advice on healthy eating, and non-pharmacological therapies such as relaxation, counselling, massage and exercise, which will not only prevent illness and disability but reduce the risk of depression and poor quality of life. Supplements, medicinal remedies and drugs are not the only option for many patients and other options should be discussed and information provided. Some patients may benefit from being referred to a dietician.
Nurses should inform patients of the potential dangers of self- medication and of mixing different medicinal approaches to address a health problem. There is a need to be cautious about food supplements and herbal medicines without condemning them. Patients should be asked to inform medical staff of any over-the-counter pharmaceutical or herbal medicines and food supplements they are already taking. They should be encouraged to discuss any proposed new remedies or supplements with the GP before taking them.
The risks
Even when supplements or herbal medicines are well manufactured and given at a safe dose, it is important to find out if the patient is taking a prescribed medication to assess the risk of interaction. This is particularly important in multicultural settings and as a result of international travel. In some parts of Europe and the wider world herbal medicines are used more frequently than in the UK.
In a UK study of 2,723 pre-operative patients, anaesthetists Skinner and Rangasami (2002) found that 4.8 percent were taking one or more herbal medicines such as garlic, ginseng, ginkgo biloba, St John’s wort and echinacea. All of these substances can ha ve a peri or post-operative effect. Garlic, ginseng and ginkgo biloba can all increase the risk of bleeding. Some examples of common food supplements and herbal remedies, and their interactions with drugs are outlined in Table 2.
St John’s wort reduces the plasma levels of prescribed drugs such as indinavir, cyclosporin and digoxin. Patients who are HIV- positive should not take St John’s wort but if they have, they should stop and have their HIV viral load checked. St John’s wort also interacts with, among others, warfarin, digoxin, carbamazepine, phenobarbital, phenytoin and oral contraceptives. In all of these cases, St John’s wort reduces the blood levels of the prescribed drug. It should be stopped immediately if the patient is taking oral contraceptives or antidepressive triptans such as sumatriptan or selective serotonin reuptake inhibitors (SSRIs) (Committee on the Safety of Medicines 2000). St John’s wort should not be taken with, or within two weeks of having taken, SSRIs such as citalopram or fluoxetine because it can cause an increase in serotonin. Excess serotonin can cause tremor, altered mental state and other unpleasant side effects (Haller 2004). Taken on its own St John’s wort is a mild antidepressant.
Conclusion
Many food supplements and herbal remedies are taken quite safely by the public even when there is no scientific proof of their efficacy. Herbal remedies and over-the-counter food supplements may not in themselves be dangerous but mixed with other nutrients or medicines they can create metabolic imbalance, toxic effects and/or impairment of treatment efficacy (MCA 2002). More research is needed in the light of the new regulations and nurses should take a lead in the assessment and evaluation of such therapies. To this end, the WHO research guidelines may be helpful (WHO 2000)
TABLE 2
Examples of common food supplements and herbal remedies and drug interactions
Eberhardie C (2005) Food supplements and herbal medicines. Nursing Standard. 20, 3, 52-56. Date of acceptance: August 16 2005.
References
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Author
Christine Eberhardie is senior lecturer in nursing, Faculty of Health and Social Care Sciences, Kingston University and St George’s, University of London, London. Email: [email protected]
Copyright RCN Publishing Company Ltd. Sep 28-Oct 4, 2005
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