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Sunday July 13, 2008

Regulating traditional medicine

By DR MILTON LUM

The use of traditional and complementary medicine is becoming more
widespread. There needs to be clear regulations to address the many
issues surrounding such practices.

TRADITIONAL and complementary medicine (T/CM) is used by many people
throughout the world. Its use varies between countries, with about 60%
of the Hong Kong population reporting its use and 10% in the United
Kingdom, 20% in Canada and 76% in Singapore.

In countries like Vietnam and China where T/CM is an integral part of
the healthcare system, about a third of patients receive traditional
medicine.

Traditional medicine has maintained its popularity in the developing
world and its use is rapidly spreading in developed countries. It is
estimated that more than 50% of the population in Europe and North
America have used complementary and/or alternative medicine at least
once.

The global market for herbal medicines is estimated to be US$60bil
(RM192bil) annually and is growing steadily. Traditional herbal
preparations account for 30% to 50% of the total medicines consumed in
China.

Popular interest

There are several reasons for the increasing popularity of T/CM. The
middle- and high-income groups of the population are more health
conscious and have adopted a proactive approach to their own health by
seeking out different forms of self-care. Aggressive marketing,
particularly with the tagline that T/CM products are “natural”, have
generated its use.

The lower income group has resorted to T/CM for different reasons i.e.
availability, relatively lower costs, cultural and peer influences. A
major reason is that modern medicine has generated expectations that
cannot be delivered consistently.

The global market for herbal medicines is estimated to be RM192bil
annually and is growing steadily. - Reuters photo There is very
limited global data on the number of T/CM practitioners. In some
countries like South Africa, they exceed significantly the number of
doctors. The number of practitioners is comparable to that of doctors
in some countries like China and India, while they are a minority in
Europe and North America.

Data from a survey conducted by the Malaysian Health Ministry in 2005
revealed that 69.4% of respondents had used T/CM in their whole life
and 55.6% in the preceding 12 months. Of those who used T/CM products
for health problems, the modalities used were viz:

·Biologically-based therapy e.g. herbs, vitamins supplement - 88.9%

·Manipulative and body-based e.g. massage, reflexology, chiropractic -
27.0%

·Mind-body medicine e.g. hypnosis, prayer, meditation, yoga, taichi -
11.1%

·Whole medical system e.g. acupuncture, ayurveda, homeopathy, Chinese
medicine - 1.9%

The Health Ministry’s Drug Control Authority reported that, as at
December 31, 2007, the cumulative number of registered products
comprised 18,200 traditional medicines (46.5%) compared to 11,805
prescription medicines (30.2%) and 9,098 over-the-counter medicines
(23.3%).

The National Health and Morbidity Survey in 2006 provide additional
information. It reported that the out-of-pocket expenditure for those
above 18 years of age in 2006 was RM3.76bil, of which a whopping
RM2.97bil (79%) was for health promotion, as compared to RM0.54bil
(14.4%) for ambulatory care and RM0.17 bil(4.5%) for hospitalisation.
Of the expenditures, 88.1% were spent at private facilities, 8.5% at
government facilities and 3.4% at both.

Terminologies

The terminologies used to describe conventional (or Western) medicine
and traditional and complementary medicine (T/CM) is variable. Some
terms have additional meanings depending on whether they are used by
the proponents or critics of T/CM.

The terms “traditional medicine” and “complementary medicine” are
relatively recent terminologies for a range of healing practices that
have been practised for hundreds of years, in some instances. Such
practices were previously referred to as “primitive medicine” and
“fringe” or “marginal medicine”.

The World Health Organization (WHO) has defined traditional medicine
“as including diverse health practices, approaches, knowledge and
beliefs incorporating plant, animal, and/or mineral based medicines,
spiritual therapies, manual techniques and exercises applied
singularly or in combination to maintain well-being, as well as to
treat, diagnose or prevent illness.

“The terms complementary/alternative/non-conventional medicine are
used interchangeably with traditional medicine in some countries.”

The term “complementary and alternative medicine” (CAM), which refers
to the use of treatments as an adjunct to, or supplementary to,
conventional medicine, is widely used. It has been defined by WHO as
“a broad set of healthcare practices that are not part of that
country’s own tradition and are not integrated into the dominant
healthcare system.”

Some CAM practices are adaptations of traditional medicine. As CAM is
a relative concept, its knowledge and practices vary between countries
and are time-specific.

The Health Ministry defined T/CM (in 2001) as a form of health-related
practice that excludes the medical or dental practices utilised by
registered medical or dental practitioners.

The T/CM practices in Malaysia include acupuncture, aromatherapy,
ayurveda, chiropractic, homeopathy, Malay medicine, naturopathy,
reflexology, traditional Chinese medicine, traditional Indian medicine
and yoga.

Efficacy and safety issues

Without evidence of efficacy, it is hard to judge the safety of any
practice that impacts on health. This is simply because the risk of an
adverse effect, which might be acceptable for an effective treatment,
will be unacceptable for an ineffective treatment.

About 25% of medicines are made from plants that were initially used
traditionally. Herbal medicines which have demonstrable efficacy like
morphine, which is used for pain relief, and vincristine, which is
used in cancer chemotherapy, are important in conventional medicine.
Their use illustrates the principle that “natural” is not synonymous
with innocuous, as their safety margins are narrow.

In general, the evidence of the efficacy of T/CM is limited, as most
therapeutic claims remain unsubstantiated. The scientific evidence
from randomised clinical trials is only persuasive for many uses of
acupuncture, some herbal medicines and some of the manual therapies.

Acupuncture has been proven to be effective in relieving postoperative
pain, nausea during pregnancy, nausea and vomiting due to cancer
chemotherapy, and dental pain, with very few side effects.

More research is needed to determine the efficacy and safety of
several other T/CM practices and products.

The unregulated or inappropriate use of T/CM products and practices
has resulted in negative or dangerous effects. For instance, the herb
“Ma Huang” (ephedra), which is traditionally used in China to treat
respiratory conditions, and was marketed as a dietary aid in the
United States, resulted in at least a dozen deaths, heart attacks and
strokes.

Interactions with prescription and over-the-counter medicines have
also been reported with untoward effects for the user.

The quality of manufacturing may also pose serious problems. If plants
are used, the precise chemical content would depend on the variety and
the growing conditions, processing, and storage. The concentrations of
compounds in T/CM products may vary considerably. Although
commercially grown plants can be reliably identified, plants gathered
in the wild may not be. Toxic species may be substituted for innocuous
ones.

Another risk is the adulteration of T/CM products with prescription
medicines e.g. corticosteroids and toxic substances e.g. heavy metals
like lead, mercury and arsenic.

The Health Ministry’s Drug Regulatory Control Authority (DCA), as part
of its post-market surveillance programme to ensure continued
compliance to safety, efficacy and quality, subjects samples of
registered products to testing.

A total of 2,538 registered products were sampled in 2007. Six product
batches were recalled within 72 hours and 138 product batches were
recalled within 30 days, due to quality defects. The recalls involved
17 prescription medicines (12.8%), 13 over-the-counter medicines
(9.8%) and 103 traditional medicines (77.4%). It is noteworthy that
the recall rate for traditional medicines is disproportionate to its
segment of the products registered (46.5%) by the DCA.

The scientific evidence from randomised clinical trials is only
persuasive for many uses of acupuncture, some herbal medicines and
some of the manual therapies. - AFP photo
Regulation

Unlike T/CM, conventional medicine is heavily regulated. There are
more than 40 health laws that doctors and health administrators have
to be conversant with, depending on their practice situations.

One of the reasons for this is historical, as Malaysia inherited the
common law from the United Kingdom. The common law right to choose
one’s own treatment for illness has hardly been controlled by
statutory law. As long as one does not claim to be a doctor or
practise protected disciplines like dentistry, pharmacy and midwifery,
or supply prescription medicines, any one could set themselves up as a
practitioner in any aspect of healthcare.

This situation is unlike that in Europe or the United States where
there are few healthcare activities that are permitted without
authorisation by the state.

Because T/CM practitioners do not have to submit themselves to
authority, it has led to a situation where T/CM is practised without
recognisable training, qualification, professional standards or
indemnity coverage. In short, there is little or no accountability
with T/CM products and practices, until very recently.

The Health Ministry being cognisant of the need for a stronger
evidence base on the safety, efficacy and quality of the T/CM products
and practices, and the need to promote therapeutically sound use of T/
CM by providers and consumers, established a Standing Committee on T/
CM in 1998 and launched its national policy on T/CM in 2001. The Drug
Control Authority also started to register T/CM products to address
safety issues.

The much publicised T/CM Bill is eagerly awaited by many doctors and
health administrators. One aspect that is of interest is whether the
penalties for non-compliance are similar to that in the Private Health
Care Facilities and Services Act.

T/CM products

T/CM products have recently come under the purview of the Control of
Drug and Cosmetic Regulations 1984, Poison Act 1952, Sale of Drug Act
1952, Advertisement and Sale Act 1956 and Protection of Wild Life Act
1972.

T/CM products registered in Malaysia have to comply with the safety
requirements of the Health Ministry’s Drug Control Authority. However,
almost all T/CM products are registered as food supplements or
vitamins, which registration requirements are much less stringent than
that of prescription or over-the-counter medicines.

Whilst registration of T/CM products has ensured that they do not
contain scheduled poisons and contaminants, efficacy issues have yet
to be addressed. This question needs to be addressed, particularly
when health promotion takes up about 79% of out-of-pocket health
expenditure.

How effective are T/CM products? Are claims reflected in the reality
of the situation in which the T/CM products are used? Are consumers
getting value for their money? This is of particular relevance when
the economic circumstances demand that there be belt-tightening.

Educational standards, registration and licensing

It is a fact that there are many T/CM practitioners who practise
without qualifications or without adequate training. Of those who are
trained, the length of training and the qualifications obtained vary
widely. Some continue learning as apprentices or through short courses
or correspondence courses.

There is a need for regulators to establish objectives of training and
define core competencies in T/CM. Although many T/CM practitioners are
not likely to face critical diagnostic issues or interact seriously
with conventional medicine, others may have patients who choose not to
consult a doctor, with some T/CM practitioners encouraging such an
approach.

This issue needs to be clarified. If T/CM practitioners claim
therapeutic autonomy, then they should have the benefit of a full
medical education to equip them to work independently of doctors.

Some T/CM disciplines like osteopathy and chiropractic have developed
and moved along the path of self-regulation in some countries, e.g.
the United Kingdom and Australia. There are university degree courses
in these disciplines with acts of parliament that protect their titles
and provide orthodox regulation of their activities.

There are currently no formal accredited courses in T/CM offered by
any institution of higher learning in Malaysia. However, there is
progress in that the National Accreditation Board of the Ministry of
Higher Education, in collaboration with the Health Ministry, has
drafted standards and criteria for the offering of such courses. The
standards recommended practices that are in tandem with
internationally recognised good practices.

There were 7,154 T/CM practitioners registered with the Health
Ministry as at December 2007. The criteria and implications of their
registration have not found its way into the public domain yet.

Some countries require T/CM practitioners to be registered or to
possess a licence to practise. Eligibility is usually determined by
evidence of qualification and/or safe practice. Some countries
automatically register a practitioner with a recognised qualification
while others require the passing of a licensing examination. A robust
and independent accreditation system is needed for automatic
registration.

T/CM practice

Many T/CM practitioners practise in multiple therapeutic areas. It is
important to address the issue of whether the regulations apply to the
practice of a single therapy or recognise a varied range of therapies.

Standards of practice and conduct are usually spelt out in a code of
conduct. The responsibility for setting standards is usually left to
the professional body. The problem arises if the standards are set too
low, for various reasons.

The public should be given the opportunity to pursue complaints
against T/CM practitioners with the provision of codes of conduct,
disciplinary procedures and sanctions. Although this is currently
absent, it is the responsibility of regulators to ensure its
implementation as soon as possible.

When there is an adverse event in conventional medicine, the patient
and/or his representative can complain to the Health Ministry and/or
Malaysian Medical Council and/or commence legal proceedings. What is
the recourse for the patient and/or his representative when there is
an adverse event following treatment by a T/CM practitioner? Worse
still, what is the recourse if the adverse event occurred after
treatment by a doctor as well as a T/CM practitioner?

The practice of T/CM by doctors is a question that some doctors have
raised. The Code of Professional Conduct of the Malaysian Medical
Council (MMC) prohibits doctors from employing or associating with
persons who are not qualified or not registered under the Medical Act.

Any doctor who uses a T/CM product or practice has to ensure that it
is evidence based and that they have been trained in the practice.
Involvement in questionable practices may expose a patient to risks,
and even danger, and the doctor to disciplinary proceedings by the
MMC.

With increasing societal expectations for greater professional
accountability in the medical profession, T/CM practitioners will need
to do the same by increasing public scrutiny of their affairs.

Conclusions

Many people consult T/CM practitioners at the same time they consult
their doctors. However, many do not inform their doctor for a variety
of reasons. As there are efficacy and safety issues with many T/CM
products and practices, it is in the interest of the patient for
communication between doctors and T/CM practitioners to be enhanced.

There are many aspects to be addressed in the regulation of T/CM which
have, to date, flourished without any accountability. It is hoped that
the regulation of T/CM will enable the Health Ministry to achieve its
objective of ensuring quality and safe use of T/CM practices and
products to attain optimal potential in healthcare delivery.

Dr Milton Lum is Chairperson of the Commonwealth Medical Trust. This
article is not intended to replace, dictate or define evaluation by a
qualified doctor. The views expressed do not represent that of any
organisation the writer is associated with. The views expressed are
those of the writer and readers are advised to always consult expert
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reliance on such information.

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