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Within the MHRA, she was initially involved in the assessment of new chemical entities and is now mainly involved with abridged applications and has specific responsibility for herbal products. On retirement he became Emeritus Professor of Pharmacognosy. His research included investigations of the chemistry and biological activities of natural products from higher plants with special interests in indole and isoquinoline alkaloids, and plants used in traditional medicines for the treatment of malaria and other protozoal diseases.
Collaboration with the pharmaceutical industry included the application of radioligand—receptor binding assays in the search for natural products with activity in the central nervous system. He has supervised 33 PhD students and 11 postdoctoral researchers, publishing some full research papers, short communications, 42 review articles, and has edited six books on natural products.
Collaborative research was established with scientists in many countries world-wide and in he was appointed Honorary Professor of the Chinese Academy of Medical Sciences at the Institute of Medicinal Plant Research and Development, Beijing, China. For 19 years he was a member of the Natural Products Group of the International Foundation for Science, Sweden, helping to award research grants to individual young scientists in developing countries.
How to Use Herbal Medicines Purpose and Scope Herbal Medicines is intended to serve as a reference work for pharmacists, doctors, nurses and other healthcare professionals, assisting in their provision of advice on the use of herbal medicines to members of the public.
Herbal Medicines is not intended to represent a guide to self-diagnosis and self-treatment with herbal medicines, and should not be used as such. The term 'herbal medicine' or 'herbal medicinal product' or, less frequently, 'herbal remedy' is used to describe a marketed product, whereas 'herbal ingredient' refers to an individual herb that is present in a herbal medicine. Thus, as examples, Valerian Tablets are a herbal product, valerian root is a herbal ingredient, and valtrate is a herbal constituent of valerian.
The main criterion for inclusion of a herbal ingredient in the text is its presence in herbal medicines that are used in the UK, particularly those which are sold through pharmacies. In addition, herbs that have recently been the subject of media or scientific interest have been included. In addition, any known or potential toxicities of herbal ingredients, and how these may influence the suitability for inclusion in herbal medicines or for use with conventional medicines, are also discussed.
Introduction to the Monographs The introductory section to the monographs on the individual herbal ingredients contained in Herbal Medicines discusses the legal aspects of herbal medicines including licensed medicines and non-licensed products in the UK and within the European Union EU.
All medicines are assessed for their quality, safety and efficacy and, in the context of herbal medicines, there are often specific criteria which are not encountered in the assessment of other medicines. As a first line in ensuring the safety and efficacy of herbal medicines there is a series of guidelines for quality assessment and this is briefly discussed.
In terms of safety, it is a popular conception that because herbs are 'natural' then they must also be safe. This is a misconception, and it is emphasised that some herbal ingredients have the capability to cause adverse effects, whilst some are decidedly toxic.
Within the context of the monographs on herbal ingredients, most have documented adverse effects, or the potential to interact with other medication, and few can be recommended for use during pregnancy. Tables in the Introduction and appendices at the end of the monographs summarise the safety aspects of these herbal ingredients and give information on biologically active herbal ingredients and their active principles.
Clinical efficacy has not been established for the majority of the herbal ingredients described in this handbook and, in some instances, there is a lack of documentation for chemical constituents and for pharmacological actions. The Herbal Monographs Some monographs on individual herbal ingredients found in herbal products are included, the title used for the monograph being their preferred common name. A data sheet-type format was chosen for the monographs because it was felt important to arrange the relevant information in a format familiar to pharmacists, doctors, nurses and other healthcare professionals.
Although conventional data sheets are written for products, it was decided to draw up the data sheets for herbal ingredients and not for specific products, although where possible details are provided of the specific products assessed in the studies discussed. The headings used in the herbal monographs are listed below with a brief explanation of the information provided under them. Monograph title Common name for the herbal ingredient; if more than one common name exists, this is the chosen preferred name.
Summary and Pharmaceutical Comment This section is designed to give the reader an overall summary of the monograph contents, indicating the extent of phytochemical, pharmacological and clinical data available for the herbal ingredient, whether or not proposed herbal uses are justified, concerns over safety and, based on this information, whether or not the herbal ingredient is considered suitable for use as a herbal medicine Species Family Preferred botanical name with authority, together with the plant family.
Synonym s Other common or botanical names. Part s Used Plant part s traditionally used in herbal medicine. Pharmacopoeial and Other Monographs Key pharmacopoeial monographs and texts on herbal medicines. UK Legal Category Legal category of the herb with respect to licensed products. Constituents Main documented chemical constituents grouped into categories such as alkaloids type specified , flavonoids, iridoid glycosides, saponins, tannins, triterpenes, volatile oil and other constituents for miscellaneous and minor chemical components.
This information supplements the textual information on constituents. Quality of plant material and commercial products This section has been included for several herbal ingredients commonly encountered in commercial products.
It describes studies examining the variation in phytochemical content of crude plant material and marketed products and other aspects relating to product quality, such as differences between actual and labelled content of commercial products.
Food Use Provides an indication as to whether the herbal ingredient is used in foods. The Council of Europe COE category, which reflects the opinion of the COE on the suitability of the herbal ingredient for use as a food flavouring, is quoted where applicable. Herbal Use States the reputed actions and uses of the herbal ingredients, based on information from several sources.
In some instances, current investigations of particular interest are included. Photographs Provided for most of the monographs for the crude drug substance and the plant from which it originates. As we do not provide botanical, macroscopical or microscopical descriptions, these photographs are for illustrative purposes only and are not intended to be used for identification purposes.
Where possible, dosages typically used in clinical trials are included. Pharmacological Actions Describes any documented pharmacological actions for the herbal ingredient. This is further divided into a section on In vitro and animal studies and a Clinical studies section, which describes studies involving humans.
Side-effects, Toxicity Details documented side-effects to the herbal ingredient and toxicological studies. If side-effects or toxicity are generally associated with any of the constituents in the herbal ingredient, or with its plant family, then these are mentioned here. See also Table 1 and Table 2 in the Introduction. Contra-indications, Warnings Describes potential contra-indications and potential side-effects, and individuals who may be more susceptible to a particular side-effect.
This section should be used in conjunction with Appendices 1—3. Comments on Pregnancy and lactation are included; a summary is provided in Table 3 of the Introduction. Preparations Describes product information from over 35 countries. Arranged in two sections, the first section lists by country the proprietary names product names of preparations containing the single herbal ingredient described in the monograph. The second section lists by country products that contain multiple ingredients including the herbal ingredient described in the monograph.
Specific suppliers of preparations are shown in Appendix 4 along with the supplier contact information in Appendix 5. References References are included at the end of the text on each monograph. There is considerable literature on herbal plants and general references have been selected for use with the handbook.
For some well-known herbal ingredients only general references are cited. The majority of the monographs also contain specific references which are cited at the end of each monograph.
Introduction A general disillusionment with conventional medicines, coupled with the desire for a 'natural' lifestyle has resulted in an increasing utilisation of complementary and alternative medicine CAM across the developed world. The use of herbal medicine increased particularly in the s and then again in the s. The report concluded that the continuing demand for CAM will affect delivery of healthcare for the foreseeable future.
Estimates of expenditure on herbal medicines vary, but data generally show that the global market for herbal products has grown rapidly in the past decade. Against this background of increasing usage of herbal medicines by the public, a number of major public health issues have raised concerns about these products and have highlighted the need for healthcare professionals to have up-to-date scientific information on the quality, safety and efficacy of these products.
The substitution of toxic Aristolochia species in traditional Chinese medicines TCM has resulted in cases of serious renal toxicity and renal cancer in Europe, China and America.
Studies in the UK, Australia and the US show that pharmacists are frequently involved in the supply of herbal medicines. The need to be reliably informed of the quality, safety and efficacy of herbal medicines has been highlighted.
This handbook brings together in one text a series of monographs on herbs commonly present in herbal medicinal products sold through pharmacies in the UK. Three appendices are also presented, grouping together herbs with specific actions, and highlighting potential interactions with conventional medicines. As a preface to the monographs, an overview of UK and European legislation concerning herbal products is provided, together with issues pertaining to their quality, safety and efficacy.
In addition to retail purchase, herbs can be obtained by picking the wild plant or from a herbal practitioner. This handbook does not discuss the self-collection of plant material for use as a herbal remedy or the prescribing of herbal medicines by herbal practitioners. The use of herbal medicines in an evidence- or science-based approach for the treatment and prevention of disease is known as rational phytotherapy. This approach to the use of herbal medicines contrasts with traditional medical herbalism which uses herbal medicines in a holistic manner and mainly on the basis of their empirical and traditional uses.
For example, traditional herbalism is also described as 'phytotherapy' and refers to preparations of plant material as 'herbal medicines'. Today, a continuum between these approaches exists and many herbalists also use scientific evidence to support their traditional use of herbal medicines.
Plants have been used medicinally for thousands of years by cultures all over the world. Herbal medicine has a long history and tradition in Europe. Herbal medicines and homeopathic remedies are often mistaken by the layperson to be similar. However, homeopathy is based on the principle of 'like should be treated by like', and involves the administration of minute doses of remedies that, in larger doses, produce symptoms in a healthy person mimicking those expressed by people who are ill.
Many, but not all, homeopathic remedies originate from plants.
By contrast, herbal medicine phytotherapy involves the use of dried plant material or extracts of plant parts in therapeutic doses to treat the symptoms exhibited. In this latter respect, it is similar to conventional medicine. Regulatory Controls on Herbal Medicines Herbal medicinal products in Europe Herbal products are available in all Member States of the European Union EU , although the relative size of their markets varies between countries.
Since the late s, the regulation of herbal products has been a major issue within the EU because of the differences between Member States in the way herbal products are classified and the difficulties this might present in the completion of the single market for pharmaceuticals. The situation is further complicated in that some Member States, including the UK see Current regulatory position of herbal products in the UK , have national provisions which permit certain herbal medicinal products to be exempt from the licensing provisions under specific conditions.
In general, in all Member States, herbal products are classified as medicinal products if they claim therapeutic or prophylactic indications. The new systems for marketing authorisations involve three procedures: centralised, decentralised mutual recognition and national. Since then, simultaneous national applications have been possible, but the mutual recognition system automatically becomes involved once an authorisation has been granted in the first Member State.
The original intention was to retain existing national procedures for medicinal products requesting authorisation in a single Member State only. However, the European Commission agreed that national procedures could continue for bibliographic applications, including those for herbal products until the harmonisation issues could be resolved.
A major study undertaken by the AESGP Association of the European Self-medication Industry in at the request of the European Commission confirmed the different approaches taken by Member States in the regulation of herbal medicinal products. For example, ginkgo Ginkgo biloba is available as a prescription-only medicine in some EU countries, but as a food supplement in others. Similarly, St John's wort Hypericum perforatum is accepted as a treatment for depression in some Member States, but not in others.
The AESGP study revealed that, in general, herbal medicinal products were either fully licensed with efficacy proven by clinical trials or by bibliography in accordance with Article Furthermore, the study found major discrepancies between Member States in the classification of individual herbal preparations and products into one of these categories, as well as in the requirements for obtaining a marketing authorisation product licence.
The report highlighted the need for clarification Introduction of the regulatory framework and harmonisation of the regulatory requirements to ensure that herbal medicinal products could have access to the single market for pharmaceuticals.
An important initiative in the harmonisation process has been the formation of the European Scientific Cooperative on Phytotherapy ESCOP , an organisation representing national associations for phytotherapy.
ESCOP was founded in by six EU national scientific associations with the objective of establishing a scientific umbrella organisation to provide harmonised criteria for the assessment of herbal medicinal products, to support scientific research and contribute to the acceptance of phytotherapy in Europe.
New regulations for traditional herbal medicinal products in the EU From the late s, the need for a new regulatory framework for herbal products has been under discussion supported by the European Parliament and the European Commission.
It was generally accepted that a significant number of herbal medicinal products did not fulfil the requirements for marketing authorizations. In September , the European Pharmaceutical Committee set up a working group of Member States to investigate the possibility of a directive for traditionally used medicines. For unlicensed herbal medicines legally on the market on 30 April , the Directive provides a seven-year transitional period to allow companies time to meet the new requirements.
The new Directive provides a framework for the regulation of traditionally used herbal medicinal products requiring them to meet specific and appropriate standards of safety and quality and for the product to be accompanied by suitable information to ensure its safe use.
Registered products are required to be suitable for self-medication without the need for the intervention of a medical practitioner. Registration applications have to include a bibliographic review of the safety data associated with the use of the herbal product in a particular indication. In addition, this review will need to be accompanied by an expert report on the safety data submitted. The normal quality requirements applicable to licensed medicines will apply, including good manufacturing practice GMP and European Pharmacopoeia standards.
Labelling and package leaflets for registered products will be required to include 5 information and instructions about the safe use of the product and will include a statement to the effect that the product is based on long-standing use. In addition to the herbal ingredients, vitamins and minerals can be added provided that they are ancillary to the herbal active ingredients. Manufacturers will be required to have in place an adequate pharmacovigilance system to maintain records of all suspected adverse drug reactions ADRs occurring world-wide and will have to report all ADRs to the national regulatory licensing authority.
A Community herbal monograph comprises the committee's scientific opinion on a given herbal medicinal product, based on its evaluation of available scientific data well-established use or on the historic use of that product in the European Community traditional use.
For some herbal medicinal products, the Community monograph will cover both well-established use and traditional use.
The Community monographs are intended to assist harmonisation of requirements for 'bibliographic' marketing authorisation applications.
The comments received are subsequently reviewed and the final version of the Community herbal monograph is published. The Community list will contain, for each herbal substance or preparation, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance or preparation used as an ingredient of a traditional medicinal product.
The Community list will provide a harmonised approach at EU level for providing information on substance s or preparation s that constitute traditional herbal medicinal products. The list will cover substances and preparations that have been in medicinal use for a sufficiently long time, and therefore considered not to be harmful under normal conditions of use.
List entries are also released for public consultation on the EMEA website, usually for a period of three months. Applicants for traditional registrations can refer to the list rather than have to provide evidence of traditional use and safety thus further simplifying the registration procedure. A new advisory committee, the Herbal Medicines Advisory Committee HMAC , has been established to advise Health Ministers on issues relating to registration of traditional herbal medicinal products and the safety and quality of unlicensed herbal remedies.
Current regulatory position of herbal products in the UK Herbal products are available in the UK through various retail outlets, such as pharmacies, health-food shops, mail order companies, supermarkets, department stores and, increasingly, via the internet.
Some herbal products consist solely of loose, dried plant material; others are presented as pre-packaged formulated products in a variety of pharmaceutical forms for both internal tablets, capsules, liquids and external use creams, ointments and may contain one or several herbal ingredients which may be dried herbs or their extracts.
The current regulatory position is complicated by the fact that herbal products can fall into one of three categories: licensed herbal products, those 6 Introduction exempt from licensing and those marketed as food supplements. In addition, from November , the registration procedure for traditional herbal medicinal products has introduced a further category, that of 'registered products'.
The majority of herbal products are marketed without medicinal claims either exempt from licensing see Herbal remedies exempt from licensing or as food supplements. Those supplied as food supplements are controlled under food legislation whilst those exempt from licensing are controlled under medicines legislation.
Difficulties in defining the status of products occupying the borderline between medicines and foods have resulted in similar products being marketed in both these categories.
Provided the products were marketed without reference to medicinal claims, the Medicines and Healthcare products Regulatory Agency MHRA; formerly Medicines Control Agency MCA , the government body responsible for regulating medicinal products has, in the past, generally been satisfied that the products were not subject to medicines legislation.
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