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Chapter Twenty
Complementary/alternative medicine
G. Brian L ockwood
20
STUDY POINTS
*
Types of complementary medicines and
complementary therapies
*
Extent and reasons for use of complementary/
alternative medicine (CAM)
*
Regulation of CAM practitioners and
complementary medicines
*
The interrelationship between pharmacy and CAM
Introduction
Complementary/alternative medicine (CAM), originally referred to as ‘fringe’, ‘holistic’ or ‘natural’
medicine, was known as ‘alternative’ medicine in
the 1970s and 1980s. Today it is increasingly called
‘integrated’ or ‘integrative’ medicine. Generally, it is
referred to as complementary/alternative medicine,
although the terms complementary medicine, alternative medicine and complementary therapies are
used interchangeably.Zollman & Vickers’ (1999) definition of CAM, which has been adopted by the
Cochrane Collaboration (see Ch. 17), is given in
Box 20.1.
Historically, CAM was the main form of medicine
available to the world’s populations, including those
of Europe and the UK. In many parts of the world it
still is today. What we now know as conventional or
pharmaceutical medicine did not exist, hence the
modern usage of the term. With the advent and expansion of discovery and production of mainly synthetic medicines by pharmaceutical companies, usage
of mainly plant-based traditional medicines declined.
These medicines are what we now refer to as CAM.
In essence, CAM is an umbrella term for a collection of different approaches to diagnosis and treatment. Over 50 diverse complementary therapies
have been listed, some involving use of medicinal
substances, while others use a range of therapeutic
techniques. These range from homoeopathy (which
involves the use of infinitely dilute preparations) to
herbal medicine (the use of chemically rich plant
material), and from acupuncture (the insertion of
needles into specific points on the body) to therapeutic touch and spiritual healing (including ‘distant’
healing, which does not require the laying on of
hands). Among the many forms of complementary
therapies available, some use a variety of techniques
but no medicinal products, some use only medicinal
products, and there are also those which involve both
medicines and techniques.
Some of the most well known complementary
therapies, including those using medicinal products,
are described in Box 20.2.
Several complementary therapies, such as herbalism, homoeopathy, aromatherapy and others, involve
the administration of remedies, often in recognizable
pharmaceutical formulations, e.g. herbal medicines,
homoeopathic remedies and essential oils. These are
collectively referred to as complementary (or ‘alternative’) medicines. As well as being used by some
CAM practitioners in their practice, these types of
products are widely available for purchase for selftreatment from pharmacies, health food stores, supermarkets, by mail order, via the Internet and from
other outlets. Many of these are administered or
recommended after consultation with therapists with
varying range of abilities and qualifications, or simply
bought by patients believing that they will be
SECTION THREE Pharmacy prescribing and selection of medicines
Box 20.1
Definition of complementary and alternative
medicine (Zollman & Vickers 1999)
‘Complementary and alternative medicine (CAM) is a
broad domain of healing resources that
encompasses all health systems, modalities and
practices and their accompanying theories and
beliefs, other than those intrinsic to the politically
dominant health system of a particular society or
culture in a given historical period. CAM includes all
such practices and ideas self-defined by their users
as preventing or treating illness or promoting health
and well-being. Boundaries within CAM and between
the CAM domain and that of the dominant system are
not always sharp or fixed.’
beneficial. In the UK, patients, the public, the media
and many other groups consider the use of herbal
medicines (whether prescribed by a herbalist or purchased over the counter) to be part of CAM. However, there is a view that herbal medicinal products with
documented pharmacological activity and clinical efficacy lie alongside conventional medicines. Indeed,
some herbal medicines, such as senna preparations,
are conventional medicines.
This chapter discusses CAM, mainly from a UK
perspective. In particular, the extent of use and regulatory aspects of CAM are considered, as well as issues
of importance to pharmacy and pharmacists. There is
a particular emphasis on complementary medicines,
as these are widely available in pharmacies, and especially on ‘European’ herbal medicines, as these are
Box 20.2
Descriptions of complementary therapies common in the UK
Complementary medicines can be conveniently divided into three categories: those using only medicinal
substances, those using a therapy without medicinal substances, and those using both.
A. Therapies using medicinal substances
Aromatherapy
The therapeutic use of aromatic substances, largely essential oils which typically contain numerous chemical
constituents and are extracted from plants.
Aromatherapists believe that essential oils can be used not only for the prevention and treatment of disease, but
also for their effects on mood, emotion and well-being. Aromatherapy is claimed to be a holistic therapy in that
practitioners will select an essential oil or combination of essential oils to suit each client’s symptoms, personality
and emotional state. The most common method used for application of essential oils is massage using a carrier oil;
other methods include the addition of essential oils to baths and footbaths, inhalations, compresses and use in
aromatherapy equipment, e.g. burners and vaporizers.
Flower remedies and essences
Developed in the UK by Dr Edward Bach, who believed that physical disease was the result of being at odds with
one’s spiritual purpose, i.e. negative states of mind induce illness. His approach to health focused only on the
mental state of the patient. He identified 38 negative psychological states of mind (e.g. jealousy, guilt,
hopelessness) and developed a remedy designed to be used for each of these emotional states. The Bach
collection comprises 39 remedies, 37 of which originate from flowers/trees, one from natural spring water, and
‘Rescue Remedy’, a combination of five of the other 38 remedies. Flower remedies are extremely dilute
preparations, but are not homoeopathic remedies.
Many countries have their own collection of flower remedies/essences based on native plants/trees,
e.g. Australian Bush Essences.
Herbalism
Traditional herbalism had a historical basis, partly based on the galenical model of the four ‘ humours’ and the
belief that an excess of any of the humours leads to disease. Today treatment is aimed at ‘restoring balance’ and
‘strengthening bodily systems’. Herbalists aim to treat patients in a holistic way by selecting a herb or combination
of herbs to treat a particular person and his/her unique set of symptoms. One of the principal tenets is that the
whole plant extract, and not an isolated constituent, is responsible for the clinical effect. It is claimed that herbal
constituents, and even combinations of herbs, work synergistically to achieve benefit and reduce the possibility
of adverse effects.
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Complementary/alternative medicine CHAPTER 20
Rational phytotherapy/phytomedicine (science-based herbal medicine) has an entirely different approach to
that of traditional herbalism. It involves the use of specific plant (or plant part) extracts standardized to
specific constituents (where possible) with documented pharmacological activity for the treatment of
specific clinical conditions. In this regard, phytotherapy has a similar approach to that of conventional
medicine.
Herbalism involves preparations made from plants or plant parts. In some instances (e.g. use by herbalists), a
crude drug (e.g. dried leaf) is used. Manufactured products use extracts of plants or plant parts, formulated as, for
example, tablets, capsules, creams and tinctures. They may contain a single or multiple herbal ingredients,
obviously including numerous single chemical entities.
Homoeopathy
The use of highly dilute, succussed substances to stimulate the body’s own healing activity (the ‘vital force’). One
of the key principles is ‘like cures like’ – a substance which in large doses causes a set of symptoms in a healthy
person can be used to treat such symptoms in an ill person, e.g. homoeopathic preparations of coffee (Coffea) are
used to treat insomnia. Treatment is holistic – two patients with the same set of symptoms may be given different
remedies depending on their personal characteristics, physical appearance, mental and emotional state, etc.
Although there are several hypotheses, there is not yet a plausible explanation for the mechanism of action of
homoeopathy. Furthermore, on balance, rigorous clinical trials do not show an effect for homoeopathy over that of
placebo.
Homoeopathy uses highly dilute preparations which may be of plant, animal, mineral, insect, biological, drug/
chemical or other origin. Formulations include tablets, pillules, creams/ointments, liquids and injections.
Nutritional medicines
Nutraceuticals and food supplements are preparations of substances commonly found in the diet, e.g. fish oils, or
occurring naturally in the body, e.g. co-enzyme Q10. In the UK, many herbal products, e.g. garlic tablets, are sold
as dietary/food supplements.
Traditional Chinese medicine (TCM)
An ancient Chinese method of health care which coexists alongside orthodox medicine today. TCM includes a
range of therapies, such as Chinese massage, but is best known for the practices of traditional Chinese
acupuncture (see Acupuncture) and traditional Chinese herbal medicine (CHM). The basic concepts of TCM
(‘yin-yang’ and the ‘five elements’) apply to CHM. The fundamental principle of treatment is to restore ‘balance
and harmony’. Medicinal substances are classified as having particular attributes, e.g. hot, cold, tonifying,
moistening, and it is the consideration and combining of these attributes during therapy that is thought to bring
about balance to patterns of clinical dysfunction. For example, ‘cooling’ herbs would be used to treat a patient
whose pattern of illness is described as ‘hot’. Usually, herbal formulae comprising around 4–12 different medicinal
substances are used to treat specific clinical patterns. Substances used as part of TCM may include animal as well
as herbal material.
B. Therapies not using medicinal substances
Acupuncture
This involves insertion of needles into a specific point or set of points on the body for the treatment of specific
conditions. Various forms exist, such as auriculoacupuncture (needling of specific points on the ear) and
electroacupuncture (electrical stimulation of inserted needles). The two main types practised in the UK are
described below.
*
Medical acupuncture: usually practised by doctors who have trained in acupuncture and who use the therapy
alongside conventional medicine. Insertion of needles is given as far as possible according to the principles
of neurophysiology and anatomy (i.e. directed at stimulating nerve endings).
*
Traditional Chinese acupuncture: part of the broader system of TCM. Uses concepts of ‘yin-yang’ and the ‘five
elements’ to explain the physiological functioning of the human body and the development of medical disorders
in order to guide diagnosis and treatment. Traditional Chinese acupuncturists aim to restore the balance of
energy in the body by ‘unblocking meridians’ (pathways along which life energy is believed to flow) by inserting
needles strategically in specific points along meridians.
201
SECTION THREE Pharmacy prescribing and selection of medicines
Chiropractic
Chiropractors believe that misaligned or maladjusted vertebrae (‘subluxations’), caused by accidents, strains,
poor posture, innate skeletal distortions, etc. affect the spine and surrounding muscles, nerves and ligaments.
This is believed to result in local or radiating pain, affecting joint movement, and causing swelling or weakening of
muscle groups, thereby contributing to the disease process. There is, as yet, no clear explanation from current
knowledge of spinal mechanics and neurophysiology as to how this might happen.
Chiropractic diagnosis includes physical examination, palpation of the vertebral column, assessment of posture,
etc. and often the use of X-rays to examine bone alignment and to detect conditions such as osteoporosis which
would contraindicate manipulative treatment. The principal technique used in chiropractic is a series of short
sharp thrusts aimed at restoring normal joint motion, correcting subluxations, improving posture and/or removing
painful stimulation to the nerves. Generally, chiropractors manipulate the neck and spine, but may also use
techniques such as massage and even dietary and lifestyle advice as part of a holistic approach. McTimoney
chiropractic uses lighter movements than does standard chiropractic.
Healing
A transmission of ‘therapeutic energy’ between healer and patient, which may or may not be associated with
particular religious beliefs. It can be performed at a distance (‘distant healing’) or by laying on of hands
(‘therapeutic touch’).
Osteopathy
Osteopaths believe that a wide variety of disorders can be traced to disorders of the musculoskeletal system,
particularly the spinal vertebrae, but also to dysfunction in certain muscle groups. Manipulative techniques are
used to correct these joint and tissue disturbances to restore normal bodily function. Osteopaths use a detailed
medical history, physical examination, assessment of posture, observation of patient movement, etc. and,
occasionally, X-rays in diagnosis. Direct techniques (soft tissue and joint movement, and high-velocity thrusts)
and indirect techniques (positioning-type techniques where the joints are moved without force) are used in
treatment. Generally osteopaths use more rhythmical and gentler pressure on the whole body, including the spine,
whereas chiropractors tend to use more sharp, short, thrusting pressure on the spine (see Chiropractic).
Reflexology (also known as reflex therapy)
A form of treatment and diagnosis which involves massage of specific points on the feet (mainly on the soles but
also on the tops and sides – maps of the areas of the feet corresponding to different areas/organs of the body have
been drawn up). It is based on the belief that there are reflexes in the feet for all parts of the body. Reflexologists
claim to be able to identify sites of tenderness and ‘ lumps’ or granules of crystalline material, which, in reflexology,
are taken to represent remote organ disease. Manual stimulation of the reflex points is believed to break down the
deposits so that they can be eliminated, and to increase the flow of ‘healing energy’ through ‘channels’.At
present, these theories are unsubstantiated.
C. Therapies using both medicinal substances and other treatment
Anthroposophical medicine
A philosophical vision of health and disease based on the work of Rudolf Steiner who explored how man’s soul and
spiritual nature relate to the health and function of the body. Steiner viewed each person as having four ‘bodies’ or
‘forces’: physical; etheric; astral; spiritual. Practitioners of anthroposophy aim to understand illness in terms of
how these four elements interact; the aim of treatment is to stimulate the natural healing forces of the body. The
anthroposophic approach is a holistic one; practitioners may use a range of therapies including diet, therapeutic
movement (eurhythmy) and artistic therapies as well as anthroposophic medicines in an integrated therapeutic
programme. The medicines are derived mainly from plant and mineral sources; many are combinations of herbal
ingredients. Particular attention is paid to the source and methods of farming used in growing raw plant materials
for preparing anthroposophic medicines (e.g. organic culture only).
Ayurvedic medicine
The traditional system of medicine of India. Its essence is to achieve and maintain balance between the ‘elements’
and ‘energies’; illness is believed to result from imbalance. Ayurvedic diagnosis is based on physical observation
and questioning. Treatment usually involves Ayurvedic herbal remedies as well as dietary modifications,
meditation, exercise, massage. The medicines are herbal/mineral preparations; heavy metals (e.g. lead, arsenic)
are sometimes used in the manufacturing process.
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Complementary/alternative medicine CHAPTER 20
among the most widely used ‘complementary medicines’ in the UK. Also, from a biomedical perspective,
herbal medicines (rather than for example homoeopathic remedies) are likely to have the greatest potential in terms of both benefits and risks.
Extent of use of CAM
The use of CAM is a popular healthcare approach in
developed countries, and there is evidence that use of
complementary therapies and complementary medicines is increasing. For example, data from nationwide
surveys involving US adults indicated that the use of
CAM was increasing (Eisenberg et al 1998). Use of at
least one of 16 complementary therapies in the previous year had risen significantly from 33.8% of the
sample in 1990 to 42.1% in 1997. Self-treatment with
herbal medicines was one of the therapies showing the
greatest increase over this period (2.5% of sample in
1990 compared with 12.5% in 1997).
Reliable estimates of CAM use among adults in
England come from a postal questionnaire survey involving 5010 adults (response rate = 59%) carried
out in 1998 by Thomas et al (2001). The study found
that within the previous 12 months, approximately
10% of the sample had used at least one of six complementary therapies (acupuncture, chiropractic,
homoeopathy, medical herbalism, hypnotherapy or
osteopathy), and that approximately 22% had purchased over the counter (OTC) homoeopathic or
herbal medicines in the previous year.
Market research carried out by Mintel Inter-
national (2005) estimated that retail sales of herbal
medicines alone were worth £87 million in 2004,
representing growth of 16% since 2002, whereas total
sales of herbal medicines, homoeopathic remedies
and essential oils have risen to £147 million by
2004. Around 50% of sales of herbal medicines and
homoeopathic remedies are made in pharmacies.
Mintel have estimated that 33% of the UK population
have taken CAM during 2004, but only 4% have visited a CAM practitioner for their medicine. Selftreatment using CAM remedies raises the issue of
the cause of any beneficial effects, as many of these
are practiced as holistic therapies, which is not the
case when simply purchasing medicinal products.
The use of CAM is not limited to the private sector
– in some cases, the NHS funds access. For example,
there are five NHS homoeopathic hospitals in the
UK to which GPs can refer their patients. Also, GPs
can prescribe homoeopathic preparationson NHS pre-
Table 20.1 Trends in homoeopathic prescribing on the NHS
Year Number of items Net cost (£)
1998 150 000 927 000
2004 94 500 661 400
2005 83 000 593 000
2006 63 000 442 700
http://www.ic.nhs.uk/statistics-and-data-collections/primary-care/
prescriptions
scriptions. In 1998, over 150 000 homoeopathic items
were dispensed against NHS prescriptions; data from
the Prescription Pricing Authority show that the net
ingredient costfor these was £927 600. Sincethat year
there appears to have been an unexpected downward
trend in NHS dispensing (Table 20.1). Furthermore, a
survey reported by Thomas et al (2001) estimated that
in 1998 there were over 2 million visits to complementary therapists funded by the NHS, and that the NHS
expenditure on CAM was £50–£55 million per year.
However, it has been claimed that many people who
might like to take advantage of a wide range of CAM
are prevented from doing so by lack of resources, as
only 10% of CAM is currently provided by the NHS
(Foundation for Integrated Health 2007).
Reasons for use of CAM
Symptoms and conditions
Complementary medicines are used by the general
public and by patients both for general health maintenance and for the relief of minor, self-limiting conditions. For example, studies involving pharmacists
and consumers have suggested that herbal products
to help relieve stress and sleep problems are those
most frequently requested by pharmacy customers
and ‘recommended’ by pharmacists to consumers
following consultations regarding symptoms.
Use of complementary medicines is not necessarily
limited to symptoms or conditions suitable for OTC
treatment. Indeed, many patients use complementary
medicines and complementary therapies for symptom relief in, or treatment of, serious chronic
illnesses, such as cancer, HIV/AIDS, multiple sclerosis, rheumatological conditions, asthma, depression,
203
SECTION THREE Pharmacy prescribing and selection of medicines
Table 20.2 Levels of use of a number of herbal and nutraceutical products for treating a range of medical conditions
Medical condition Use among participants (%) Herbal/nutraceutical product
Prostate cancer 4.5 Saw palmetto
1.2 Lycopene
0.7 DHEA
Enlarged prostate 18.3 Saw palmetto
1.6 Lycopene
1.4 Cranberry
Osteoarthritis 28.7 Glucosamine
19.9 Chondroitin
6.2 MSM
Bladder infections 5.8 Cranberry
Neck, back or joint pain 16.6 Glucosamine
10.5 Chondroitin
4.5 MSM
Depression 5.8 St John’s wort
Lactose intolerance 0.9 Lycopene
Degenerative eye conditions 4.2 Lutein
Perimenopause 4.9 Black cohosh
1.7 Dong quai
6.7 Soy products
Stress 3.2 St John’s wort
Memory loss 9.6 Ginkgo biloba
7.1 Fish oil
6.0 Coenzyme Q10
Insomnia 3.6 Melatonin
Diabetes 0.2 Dong quai
0.3 Lycopene
High blood pressure 0.3 Dong quai
Reprinted from Gunther S, Patterson RE, Kristal AR, Stratton KL, White E 2004 Demographic and health-related correlates of herbal and specialty
supplement use. Journal of the American Dietetic Association 104(1):27–34, with permission from American Dietetic Association.
DHEA, dehydroepiandrosterone; MSM, methylsulfonylmethane
*Angelica sinensis root
gastroenterological disorders, skin conditions and so
on. Use of CAM is usually (but not always) to supplement conventional health care, rather than to replace it. Special patient groups also use CAM,
including the elderly and women who are pregnant
herbal products and nutraceuticals in over 60 000
elderly patients revealed extensive use for a range of
medical conditions, a number of which would normally be expected to be treated by conventional medicines (Table 20.2).
*
*
*
or breastfeeding. It is also used by some parents/
guardians for children in their care.
A number of surveys of CAM users have been
carried out; frequently females have been shown to
Beliefs, perceptions and
attitudes
have higher use than males, and usage tends to be
greater between 35 and 64 years, and in higher social
classes (Ernst & White 2000). A survey on the use of
There are numerous reasons why people choose to
use complementary medicines and therapies. They
204
Complementary/alternative medicine CHAPTER 20
include dissatisfaction with conventional medicine in
terms of effectiveness and/or safety, satisfaction with
CAM and the perception that it is ‘safe’. There are
also more complex reasons that are associated with
cultural and personal beliefs, views on life and health
and experiences with conventional healthcare professionals and CAM practitioners.
An individual’s choice to use CAM approaches is
tied in with ‘healthcare pluralism’ – people may use
any of several treatment options, such as taking advice
from family and friends, consulting a CAM practitioner and consulting a pharmacist, GP or other healthcare professional. Related issues include whether
individuals disclose CAM use to conventional healthcare professionals and whether there is better compliance with CAM treatment regimens than with
conventional drug regimens.
Regulation of CAM
CAM practitioners
There are around 40 000 complementary practitioners in the UK, according to a 1997 survey of
CAM organizations commissioned by the Department of Health (Mills & Peacock 1997). These practitioners are using either medicinal products,
alternative techniques, or both.
With the exception of osteopaths and chiropractors (the General Osteopathic Council and the General Chiropractic Council were established by acts
of parliament to regulate their respective disciplines), CAM practitioners are not legally required
to undertake any training before practising. While
most CAM practitioners will have trained in their
chosen therapy, others may not, or they may have
trained in one complementary therapy but practise
several. Furthermore, there is wide variation in
the level of training and methods of assessment.
For the major therapies – acupuncture, homoeopathy, herbal medicine, osteopathy and chiropractic
– training is generally highly developed, with many
institutions having university affiliation and offering
courses at degree level. However, training for other
complementary therapies is less intensive and more
disparate.
TheestimateofnumbersofCAMpractitioners
given above is based on membership of CAM
organizations, but cannot be precise as some practitioners are registered with more than one organization and some are not registered at all. Generally,
practitioners are members of a registering or accrediting body, although criteria for membership vary
widely. Also, many complementary therapies have
several registering organizations, although some disciplines are taking steps to become unified under
one regulatory body.
The practice of complementary therapies is not
limited to CAM practitioners – some conventional
healthcare professionals, including pharmacists, practise CAM. Some institutions offer specialized courses
for conventional healthcare professionals, and there
are registering organizations which represent stateregistered healthcare professionals who have undertaken training in and practise certain complementary therapies. For example, the British Medical
Acupuncture Society represents medically qualified
individuals with training in acupuncture.
Against this background, the House of Lords
(2000) report on CAM included several recommendations regarding training and regulation of CAM
practitioners, including conventional healthcare professionals who practise CAM. In summary, these
recommendations were:
*
Regulatory bodies of healthcare professionals
should develop guidelines on competence and
training in CAM
*
Statutory regulation of C AM practitioners,
particularly acupuncture and herbal medicine,
and possibly non -medical homoeopathy; a Herbal
Medicines Regulation Working Group has been
set up to take the process forward for herbal
medicines
*
Training for CAM practitioners should be
standardized, independently accredited and
include basic biomedical science.
The issue of training also relates to staff employed
in retail outlets, e.g. health food stores which s ell a
vast range of complementary medicines, who sell
or advise on complementary medicines. A small
study has suggested that information and advice
given by health food store staff may not always be
appropriate.
Complementary medicines
The majority of complementary health products are
not licensed as medicines. Therefore, the competent
authority, which, in the UK, is the Medicines and
Healthcare products Regulatory Agency (MHRA),
has not assessed evidence of their quality, efficacy
and safety.
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SECTION THREE Pharmacy prescribing and selection of medicines
Herbal medicines
Herbal products are available on the UK market as
licensed herbal medicines, herbal medicines exempt
from licensing and unlicensed herbal products sold as
food supplements (Barnes et al 2007). In several
cases, the same herb is available in all three categories.
Potentially hazardous plants are controlled as prescription only medicines (POMs) and certain others
are subject to dose (but not duration of treatment)
and route of administration restrictions, or can only be
supplied via a pharmacy and by, or under the supervision of, a pharmacist.
Most licensed herbal products were initially
granted a product licence of right (PLR) because they
were already on the market when the licensing system
was introduced in the 1970s. When PLRs were
reviewed, manufacturers of herbal products intended
for use in minor self-limiting conditions were permitted to rely on bibliographic evidence to support efficacy and safety,rather than being required to carry out
new controlled clinical trials, so many licensed herbal
medicinal products have not necessarily undergone
stringent testing.
Herbal products exempt from licensing are those:
*
Compounded and supplied by herbalists on their
own recommendation
*
Consisting solely of dried, crushed or comminuted
(fragmented) plants (i.e. they must not contain any
non-herbal ‘active’ ingredients) sold under their
botanical name and with no written
recommendations for use
*
Made by the holder of a specials manufacturing
licence.
This was initially intended to give herbalists the flexibility to prepare remedies for their patients. However, manufacturers can legally sell products under this
exemption. Furthermore, at present, there is no statutory regulation of herbalists in the UK, although this
is under review.
The majority of herbal products are sold as food
supplements without making medical claims and are
regulated under food, not pharmaceutical, legislation.
In the UK, the MHRA has the statutory power to
decide whether a specific product satisfies the definition of a relevant ‘medicinal product’ and, therefore,
is subject to the provisions of regulations relating to
Medicines for Human Use Regulations (1994, 2000,
2005). If a product is determined to be a relevant
medicinal product, and if it does not meet criteria
for exemption, then the manufacturer is required to
submit an application for a full product licence and/or
remove the product from the market. The procedure
allows for the company to request a review of the
decision. In this case, the views of an independent
panel, the Independent Review Panel on Borderline
Products, are taken into consideration.
Manufacturers of licensed medicines, including
licensed herbal products, are required to satisfy the
MHRA that their products are made according to the
principles of good manufacturing practice (GMP).
While some established manufacturers of unlicensed
herbal products also manufacture their products to
GMP standards, others do not. There is no guarantee
that such products are of suitable pharmaceutical
quality. The quality of plant raw materials can be
affected by several factors and, therefore, it
is important that finished (marketed) herbal products
are of suitable quality. The European Pharmacopoeia
(5th edition, 5.1–5.8, 2005–2007) contains over 100
monographs on herbal drugs, and further examples
are in preparation.
‘Ethnic’ medicines available in the UK include traditional Chinese medicines (TCMs) and Ayurvedic
medicines (see Box 20.2). Such products are subject
to the same legislation as ‘western’ complementary
medicines. In the UK, there are further restrictions on
certain toxic herbal ingredients, namely Aristolochia
species, found in some TCM products, and on
other herbal ingredients that may be confused with
toxic herbal ingredients. In addition to containing
non-herbal ingredients such as animal parts and/or
minerals, some manufactured (‘patent’) TCM products have been found to contain conventional drugs
as listed ingredients, some of which (e.g. glibenclamide) may have POM status in the UK. Non-herbal
active ingredients of any type cannot legally be included in unlicensed herbal remedies, and inclusion of
drugs with POM status represents an additional infringement of UK medicines legislation. For some
ingredients, such as certain animal parts, restrictions
under the Convention on International Trade in Endangered Species (CITES) of Wild Fauna and Flora
also apply.
Prior to 2004 it was widely considered that the
system of licensing for herbal medicines did not give
consumers adequate protection against poor-quality
and unsafe unlicensed products. Nor did it allow manufacturers to provide appropriate information to inform consumers’ choice of products. Against this
background, a new European Union (EU) directive
(2004/24/EC) was proposed which aims to establish
a harmonized legislative framework for authorizing
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Complementary/alternative medicine CHAPTER 20
the marketing of traditional herbal medicinal products. The directive requires EU member states to
set up a specified simplified registration procedure for
traditional herbal medicinal products which could not
fulfil full medicines licensing criteria. Under this EU
directive, all manufactured traditional medicinal
herbal products are required to be registered under
the Traditional Herbal Medicines Registration
Scheme (THMRS). This directive has been in force
from October 2005, but there is a transition period of
5 years from that date for manufacturers to meet the
requirements. Some of the main features of this
scheme are that manufacturers will be required to
provide:
*
Evidence that the herb has been used traditionally
in the EU for at least 30 years (15 years’ non-EU
use will be taken into account)
*
Bibliographic data on safety with an expert report
*
Quality dossier demonstrating manufacture
according to principles of good manufacturing
practice (GMP).
Under this directive, it is not possible to make claims
about the product’s efficacy, but only regarding its
traditional use. The new directive is not a route to
licensing for herbal POMs or for traditional herbal
medicines that can be licensed by the conventional
route. As it stands, the proposed directive would accommodate ethnic medicines that have been used in
the UK (or any other EU member state) for at least 15
years. This directive also lists problematic consequences of imported US products and restricted
herbs.
EU Directive 2004/24/EC also gives guidance on
permitted medicinal indications. L abelling may also
be covered by the Joint Health Claims Initiative
(JHCI), which restricts excessive claims.
Homoeopathic remedies
In the UK, homoeopathic remedies are subject
to medicines legislation. A simplified registration
scheme (Simplified Scheme) exists in the UK (and
the rest of the EU) for homoeopathic medicinal products which:
*
Are intended for oral or external use
*
Are sufficiently dilute (usually a minimum dilution
of 1 in 10 000)
*
No medical claims are made.
Since 1 September 2006, new homoeopathic products may be registered under the National Rules
Scheme. For such products, manufacturers are required to demonstrate quality and safety, and efficacy,
together with appropriate product labelling and literature. Manufacturers of homoeopathic medicinal products which are administered parenterally, are below
the minimum dilution, or make efficacy claims are
required to substantiate this in the same manner as
is required for conventional drugs.
Other complementary
medicines
Products marketed as food or dietary supplements
include non-herbal substances, such as glucosamine,
vitamins, minerals and fish oils. These products are
sold under food legislation and are marketed without
medical claims. Such products may be deemed by the
MHRAto be a relevant medicinal product (see ‘Herbal medicines’ above). Some ‘supplements’ are subject
to stringent restrictions on their use. Melatonin is a
POM, available on a ‘named patient’ basis only as
there are no licensed melatonin products in the UK.
However, in the USA, melatonin is sold as a food
supplement. A new draft EU directive is aimed at
harmonizing the marketing of food supplements in
member states.
Gamma linolenic acid (GLA), widely available as
unfractionated evening primrose oil, was widely
used as a supplement, principally for premenstrual
syndrome, but later obtained a full product licence
for the two conditions of psoriasis and mastalgia, although these were withdrawn in 1995.
Essential oils used by aromatherapists in their practice for medicinal purposes are considered to be medicinal products, but are exempt from licensing
provided they meet certain criteria (see ‘Herbal medicines’ above). Aromatherapy products sold through
retail outlets are not subject to licensing regulations
unless they are marketed as medicinal products.
Some essential oils are available as licensed medicinal
products, e.g. peppermint oil capsules, although such
products are conventional medicines, not aromatherapy products. These examples highlight the possible
confusion for both pharmacists and patients.
Pharmacy and provision of CAM
Pharmacies and pharmacists have several roles in the
provision of CAM. Community pharmacies are a major source of complementary medicines for people
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SECTION THREE Pharmacy prescribing and selection of medicines
who purchase and self-treat with these products.
Pharmacists may also be asked for information and
advice on self-treatment with complementary medicines. In addition, community pharmacists may be
presented with NHS (FP10) prescriptions for
homoeopathic medicines. Some independent pharmacies provide consulting rooms that are available
for use on a sessional basis by CAM practitioners,
and a similar initiative was recently adopted by some
branches of a large multiple, which offered consultations with practitioners of several CAM therapies,
including homoeopathy, herbalism and osteopathy.
Also, there are several community pharmacies
which specialize in CAM, e.g. homoeopathic pharmacies which offer professional homoeopathic pharmaceutical services.
Pharmacists’ involvement with CAM is not limited
to the community. Pharmacists employed in NHS
homoeopathic hospitals provide pharmaceutical services in the pharmacy and on the wards. Pharmacists
employed in conventional NHS hospitals may be involved with the supply of certain complementary
medicines.
Pharmacists’ training in CAM
edies. The majority of pharmacists are asked for and
‘recommend’ specific complementary medicines.
However, the extent of teaching on pharmacognosy
(the scientific discipline which covers the chemistry,
biological and clinical effects of natural products, particularly plants) and herbal and complementary medicines in the MPharm programme is limited and
varies between schools of pharmacy. Furthermore,
the majority of practising pharmacists have not undertaken or received training in areas of CAM, although
Centre for Pharmacy Postgraduate Education (CPPE)
training manuals are freely available in England.
Pharmacists’ training in CAM should not be limited to complementary medicines. It should include an
awareness of the background to, evidence for and
safety concerns with regard to complementary therapies such as acupuncture. This is because patients’ use
of such treatments may have implications for pharmaceutical care. For example, research involving
community pharmacists in the USA has suggested
that some patients with chronic conditions temporarily or permanently use complementary therapies instead of their prescribed medicines. This has also been
shown to have an effect during surgical operations
(Ang-Lee et al 2001).
In September 1999, the Science Committee of the
Royal Pharmaceutical Society of Great Britain
(RPSGB) set up a working group on complementary
and alternative medicine to examine issues in this area
of importance to pharmacy and pharmacists.
Pharmacists’ involvement in the provision of CAM
at any level raises several issues, particularly with regard to pharmacists’ knowledge of and training in
CAM, their professional accountability and the quality, safety and efficacy of complementary medicines
sold or supplied. The RPSGB Code of Ethics states
that pharmacists providing homoeopathic or herbal
medicines or other complementary therapies have a
professional responsibility:
*
To ensure that stocks of homoeopathic or herbal
medicines or other complementary therapies are
obtained from a reputable source of supply
*
Not to recommend any remedy where they have
any reason to doubt its safety or quality
*
Only to offer advice on homoeopathic or herbal
medicines or other complementary therapies or
medicines if they have undertaken suitable training
or have specialized knowledge.
Almost all pharmacies sell complementary medicines,
particularly herbal medicines and homoeopathic rem-
Pharmacists’ professional
practice
At present, pharmacists’ professional practice with
regard to complementary medicines is not optimal.
Many pharmacists do not routinely ask customers and
patients specifically about their use of complementary medicines, nor record such use on patient medication records. Pharmacists are encouraged to apply
principles of good professional practice with regard
to complementary medicines, and to be aware that
patients’ use of complementary medicines may have
implications for pharmaceutical care. For example, it
is possible that patients may use complementary
medicines in addition to, or instead of, conventional
medicines, without telling their doctor or pharmacist.
The concurrent use of complementary medicines,
particularly herbal medicines, and conventional drugs
is of concern as there is a potential for interactions to
occur. For example, important interactions have been
documented between St John’s wort and certain
prescribed medicines, including warfarin, digoxin,
theophylline, ciclosporin, HIV protease inhibitors,
anticonvulsants and oral contraceptives. Many other
examples have been reported.
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