complementary and alternative health care: the other ... · chiropractic services, massage therapy...

NHPs and CAHC

A Survival Guide

Policy Challenges and Solutions: An Interview

Utilization Patterns and Trends

Natural Doesn’t Equal Safe

Finding the Balance

Innovative Regulations

Standards of Evidence

A Tool for Policy Analysis

Mark Your Calendar

Complementary and Alternative Health Care:The Other Mainstream?

Research shows that, over the past several years, more and more

Canadians have been turning to complementary and alternative

health care (CAHC) and natural health products (NHPs) to treat

illness and promote health. Now, legislators and policy makers are facing

some difficult questions about how to assure the safety and effectiveness of

such products and practices, while not unnecessarily restricting consumer

access. This in turn raises questions about what constitutes an acceptable

level of evidence for safety and effectiveness.

This issue of the Health Policy Research Bulletin explores these and

other questions by:

• defining CAHC and NHPs and exploring how they are positioned among

the array of health services and products available to Canadians

• presenting key utilization data on CAHC and NHPs and examining how

and why consumers are using them

• discussing the evidentiary challenges that governments face in balancing

safety and effectiveness needs with concerns about consumer access and

informed choice

• chronicling how Health Canada addressed these concerns in developing

the new regulatory framework for NHPs, which comes into effect in

January 2004

Finally, the authors question whether, by addressing these challenges, CAHC

and NHPs will become more integrated with conventional health care or

whether they will remain the “other mainstream.”

In this Issue

I S S U E 7 , N O V E M B E R 2003S T R E N G T H E N I N G T H E P O L I C Y – R E S E A R C H C O N N E C T I O N

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HEALTH POLICY RESEARCH BULLETIN — Issue 72

Health Policy Research BulletinThe opinions expressed in these articles, including interpretationof the data, are those of the authors and are not to be taken asofficial statements of Health Canada.

This publication can be made available in alternative formatsupon request.

Permission is granted for non-commercial reproduction provided there is a clear acknowledgment of the source.

Published under the authority of the Minister of Health.

© Her Majesty the Queen in Right of Canada, represented by the Minister of Public Works and Government ServicesCanada, 2003

ISSN 1496-466 X ISSN 1499-3503 (Online)

Editing, design and layout by Allium Consulting Group Inc.

Publications Mail Agreement Number 4006 9608

Return if undeliverable to:Health Canada2750 Sheffield Road, Bay #1Ottawa, ON K1B 3V9

About the Health Policy Research BulletinHealth Canada’s Health Policy Research Bulletin is pub-lished three times a year. The Bulletin is part of a largerpolicy research dissemination program designed toenhance Health Canada’s policy-relevant evidence base.

A departmental steering committee guides the devel-opment of the Bulletin. The committee is chaired byCliff Halliwell, Director General of the Applied Researchand Analysis Directorate (ARAD) of the Information,Analysis and Connectivity Branch. The ResearchManagement and Dissemination Division (RMDD)within ARAD coordinates the Bulletin’s developmentand production. RMDD would like to thank the steeringcommittee members for their contributions, as wellas Nancy Hamilton, Managing Editor, Jaylyn Wong,Assistant Editor, and Tiffany Thornton, Coordinator.Special thanks go to the Guest Editor of this issue,Philip Waddington, Director General of the NaturalHealth Products Directorate, Health Products andFood Branch.

We welcome your feedback and suggestions. Pleaseforward your comments and any address changes [email protected]. Electronic HTML and PDFversions of the Bulletin are available at:http://www.hc-sc.gc.ca/arad-draa

Our mission is to help the people of Canadamaintain and improve their health.

Health Canada

Some Commonly Used Terms

Complementary and alternative health care (CAHC);complementary and alternative medicine (CAM): diagnosis,treatment and/or prevention that complements mainstream medicineby contributing to a common whole, by satisfying a demand notmet by conventional approaches, or by diversifying the conceptualframework of medicine.1 Some common CAHC practices include:chiropractic services, massage therapy and traditional Chinesemedicine. While CAM is the term most often used internationally,CAHC recognizes the diversity of practice areas, including medicine,and is the term most commonly used by Health Canada in a policy context.

Health: a state of complete physical, social and mental well-being,and not merely the absence of disease or infirmity.2

Health care: refers to all services, products and activities used byindividuals for the purpose of promoting, maintaining, monitoringor restoring health.3

Health promotion: the process of enabling people to increasecontrol over and to improve their health.4

Holistic health: physical, mental, emotional and spiritual compo-nents of health, and their interrelationship.

Informed choice: the ability of individuals and groups to makechoices about their health based on their understanding of theevidence, facts, benefits and risks related to the issue, productor behaviour.5

Natural health products (NHPs): NHPs include herbs, vitamins,minerals, essential fatty acids and homeopathics, etc.These productsare used to prevent, diagnose or treat disease, restore or correctfunction, or maintain or promote health. NHPs may be derived fromplants, animals or micro-organisms.6

Self care: the decisions and actions that individuals take in theinterest of their own health.7

Click here for references.@For More Information . . .For more information on natural health products, the new Natural HealthProduct Regulations, or complementary and alternative health care,please go to the Natural Health Products Directorate (NHPD) website at:http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/index_e.html or e-mail theNHPD at: [email protected] or call toll free 1-888-774-5555.

Note: The information contained in this issue is accu-rate as of October 2003.

3Issue 7 — HEALTH POLICY RESEARCH BULLETIN

Canadians are faced with a sometimes overwhelming choice of health careoptions. In addition to the many choices offered as part of conventionalhealth care, they can also choose from among a range of CAHC thera-pies and NHPs. However, the choice is not always as simple as pickingbetween option A — the conventional, or option B — the alternative.Increasingly, consumers are regarding CAHC and NHPs as useful toolsin a comprehensive health care “toolbox” and are looking at ways tocombine conventional and alternative therapies and products to achievethe best results.

What Is CAHC?CAHC is an umbrella term used to describe numerous individual thera-pies and health care approaches (see page 2). As many as 4,000 differentpractice or discipline areas have been catalogued, including chiropractic,therapeutic massage, homeopathy and herbalism.1 Until recently, CAHCwas frequently defined as alternative to con-ventional health care. However, the definition

of CAHC is evolving to betterreflect Canadians’ increasing useof these therapies, especially ascomplements — rather than

alternatives — to conventionalhealth care.2

CAHC therapies rangein complexity from entire

systems of medicine, suchas Aboriginal healingand traditional Chinesemedicine, to specificphysical/spiritual/pharmacological interventions,

such as reflexology, relaxation therapy and herbal-ism.3,4 The majority of CAHC therapies do not

follow the biomedical model of conventional healthcare; instead, they are often based on paradigms of

health and healing that are considered “outside thenorm” in developed countries.

Although many people are

familiar with the terms

“complementary and alter-

native health care” (CAHC) and

“natural health products” (NHPs),

they often mean different things to

different people. The authors provide

definitions for both terms and discuss

how consumers’ understanding and

use of these products and practices

have been key factors in the quest

for “integrated health care.”

Alternative Practices and Products:

Michael J. Smith and Joan E. Simpson, Natural Health ProductsDirectorate, Health Products and Food Branch, Health Canada

A Sampling of CAHC Therapies

Alexander technique

Aromatherapy

Ayurvedic medicine

Bach flower therapy

Craniosacral therapy

Iridology

Kanpo medicine

Reiki

Rolfing

Tibetan medicine

A Survival Guide

situating a specific product or practice along it, anumber of factors should be considered, including:

• the potency of the pharmacological/therapeuticaction

• the nature of the evidence base• the degree of regulation• the extent of cultural acceptance

Taking these factors into account, drugs are oftenplaced at one end of the product continuum: their useis typically supported by rigorous scientific evidence;the products are of high quality; and access is generallyrestricted to mitigate any potential risk. Food productswould fall at the opposite end of the continuum

because they pose low health risksand there is little need for supportingevidence of their effectiveness. Foodquality is assured through regulationand consumer guidance (providedthrough informative labelling), andproducts are widely available.Generally, NHPs fall between foodand drugs on the product continuum.The continuum approach ensuresthat specific categories of productsare not classified as superior to oneanother, but are measured againstappropriate parameters and standardsof evidence (see article on page 23).

Where a product or practice isplaced on the continuum would varyfrom country to country. For example,reflexology is a relatively minor ther-apy in North America, but is a majorpractice in Scandinavian countries.5

Similarly, while the evidence base forhomeopathy is the same the worldover, the therapy enjoys a much higherprofile in Britain than in NorthAmerica because of its widespreadacceptance by British medical practi-tioners.6 In some countries, certaintypes of CAHC or NHPs are consid-ered a dominant healing practice, forexample, traditional Chinese medicinein China and Ayurvedic medicine onthe Indian subcontinent.7

While the concept of a continuumis informative, it is also useful to


Alternative Practices and Products: A Survival Guide

Although CAHC encompasses a diverse range oftherapies (see box on page 3), they share some commoncharacteristics. For example, they:

• work in conjunction with the body’s own self-healing mechanisms

• are “holistic”— i.e., treat the whole person• involve the patient as an active participant • focus on disease prevention and well-being

These characteristics are not exclusively the domainof CAHC.3 In fact, many CAHC therapies havemore in common with conventional care than with other forms of CAHC. For example, massagetherapy is more similar to physiotherapy than it is tohomeopathy.

Natural Health ProductsNatural health products (NHPs) isa general term (see page 2) used to describe a variety of products,such as herbal medicines, homeo-pathic remedies and nutritionalsupplements. NHPs should not beconsidered a subset of CAHC thera-pies, as there are some importantdistinctions between the two. Forexample, NHPs are generally self-selected by the consumer, whilepractitioners typically play a keyrole in the use of CAHC therapies.Moreover, NHPs — like other healthcare products — are regulated by thefederal government, while primaryresponsibility for CAHC — as forother health care services — restswith the provinces and territories.

Continuum of Product and PracticeIt is useful to consider CAHC andNHPs on a continuum that posi-tions specific products and practicesin relation to each other, as well asto those in conventional care. Forexample, a product continuum couldgo from drugs to NHPs to food. Inconstructing such a continuum or

NHPs should not be

considered a subset

of CAHC therapies,

as there are some important

distinctions between the two.

For example, NHPs are

generally self-selected by the

consumer, while practitioners

typically play a key role in

the use of CAHC therapies.

Moreover, NHPs — like other

health care products —

are regulated by the federal

government, while primary

responsibility for CAHC —

as for other health care

services — rests with the

provinces and territories.


Alternative Practices and Products: A Survival Guide

keep in mind basic definitions,which are often influenced byregulations. For example, if newevidence supports a specific healthbenefit of a particular food, it is notautomatically classified as an NHP.This particular food might be closerto the middle of the continuumthan some NHPs, but it would stillbe a food. In the same way, CAHCtherapies that are supported byscientific evidence — for example,acupuncture to treat nausea8 orchiropractic services for uncompli-cated acute low back pain9 — arenot necessarily regarded as conven-tional care.

Integrative Health CareSince many of the same peoplewho are using CAHC therapies andNHPs are also using “mainstream”medicine, links need to be establishedbetween the two types of health careoptions. Consumers have identifiedthis need and are the driving forcebehind the current move toward“integrative health care.” Integrativecare is more than using CAHC/NHPsand conventional care together. It isrooted in the belief that consumersshould have the ability to make in-formed choices about all their healthcare options. This concept of inte-grative health care was explored ata recent workshop sponsored byHealth Canada’s Health PolicyResearch Program (see page 35).10

Fundamental to integrative careis the notion that there must beeffective communication amongall involved parties, including thepatient, the conventional healthcare provider, the complementaryhealth care provider and govern-ment. Enhancing communication isparticularly important as consumers

appear to be reluctant to discussCAHC and NHPs with membersof their conventional health careteam. Until recently, it has fallento consumers themselves to bridgethe divide between alternative andconventional health care practi-tioners. However, as more andmore people turn to alternativeinterventions to complement theirconventional health care, practition-ers from both sides are starting tocommunicate with each other,individually and through theirorganizations. Health Canada isfacilitating such linkages by work-ing with community groups,non-governmental organizationsand educational bodies on initia-tives aimed at better preparingfamily physicians to counsel patientson the use of CAHC and NHPs,and increasing research literacyamong CAHC practitioners.11

A Final WordMany of the health care productsand practices that consumersonce considered to be alternativetherapies are now viewed as complementary to conventionalapproaches. Moreover, consumersare recognizing the need for CAHCand NHPs to be “integrated” withmainstream health care optionsand are calling for action on thisfront. It has yet to be seen whetherthis vision of integrated use willbe realized, or if CAHC and NHPswill remain distinct as the “othermainstream.”

Click here for references.@

Since many of the same

people who are using

CAHC therapies and NHPs

are also using “mainstream”

medicine, links need to be established

between the two types of health care

options. Consumers have identified

this need and are the driving force

behind the current move toward

“integrative health care.” Integrative

care is more than using CAHC/NHPs

and conventional care together.

It is rooted in the belief that

consumers should have the ability to

make informed choices about all their

health care options.


An interview with

Philip Waddington,

Director General of the

Natural Health Products

Directorate, Health Products

and Food Branch, Health

Canada, conducted by Nancy

Hamilton, Managing Editor

of the Health Policy Research

Bulletin.

An increasing number of people appear to be turning to comple-mentary and alternative health care (CAHC) and natural health

products (NHPs) as a way of treating illness and promoting health.Does the evidence support this observation?

Yes, as pointed out in the article on utilization trends (see page 9), theresearch shows that the use of CAHC therapies and NHPs has been onthe rise over the past several years. However, the evidence also shows thatwhile sales of NHPs increased substantially four or five years ago, saleshave now levelled off and, in some cases, even declined.

To what do you attribute this recent decline?

While some of the decline is probably due to general economic down-turn, the feedback we’ve received indicates that the decline may alsobe due to growing consumer dissatisfaction with the outcomes of

products that have been available in a relatively unregulatedmarketplace. In other words, it could be a result of what we call

“under-regulation.” For example, if consumers tried a productbased on a specific health claim and then found it did not deliver

the expected effects, they may have turned away from NHPs entirely.I must add, however, that many manufacturers are making NHPs

that work well and meet consumer expectations.

Your last point suggests a relationship between what you call“under-regulation” and consumer confidence.

To optimize consumer confidence, I believe governments need tofind a balance between “under-regulation” and “over-regulation.”With under-regulation, there are fewer barriers restricting consumeraccess, so consumers have access to a wider array of products andservices. However, some of these are likely falling short in delivering

expected outcomes to consumers. In the case of over-regulation,the market is more restricted. There are fewer products available, but

these are supported by a very strong evidence base. Our consultationshave shown that what people really want is a balance between these twoextremes. They want assurances that products are safe and effective, butthey also want access to as many options as possible.

A Policy Challenge:

InnovativeSolutions

Q

Q

Q


A Policy Challenge: Innovative Solutions

How are CAHC practices and NHPs regulatedin Canada?

CAHC practices are regulated at the provincial level,so I’ll only make a few comments about them. Perhapsthe most important point is that the provinces andterritories are all moving forward at different speeds.Also, the regulatory environment varies from onepractice to another. For instance, while some practi-tioners, like chiropractors, are regulated consistentlyacross the country, others, like naturopaths, areregulated differently in each province.Although the federal government is not responsible for practitionerregulation, we are consulting withpractitioners and provincial govern-ments as they address issues related to scope of practice, training andaccreditation.

Currently, NHPs must fit intoeither the “food” or the “drug” cate-gory under the federal Food andDrugs Act (FDA). According to theFDA, NHPs sold for their nutritionalvalue are regulated as food whilethose making other health claims areregulated as drugs. However, there iswidespread concern that the Foodand Drug Regulations (FDR) areinappropriate for NHPs (see articleon page 19) and that their applica-tion might lead to the removal ofmany NHPs from the marketplace.

What approach did HealthCanada take to resolve what

appears to be a regulatory dilemma?

The House of Commons StandingCommittee on Health recognizedthat application of the FDR to NHPsserved neither the consumer nor the industry. In its 1998 report, theCommittee recommended that a newregulatory approach be developed.The Office of Natural Health Products— which later became the NaturalHealth Products Directorate — wasestablished within Health Canada tooversee the development of a new

framework that would be more appropriate to therange of products in this sector.

A pivotal factor in this regulatory initiative hasbeen the extensive consultations held with all majorstakeholders, including consumers, manufacturers,practitioners and importers. I believe the time investedin the consultative process has paid off well. As ameasure of its value, the new regulatory frameworkwas approved with few amendments and will comeinto force in January 2004. It is important to clarify

that this framework will apply only toNHPs sold over the counter. Productsthat require practitioner interventionor have a narrow safety margin willcontinue to be regulated as beforeunder the FDR.

What are the main pillars of thisnew regulatory framework and

what makes it unique?

The two main pillars of the frameworkare, first, the good manufacturingpractices (GMPs) and site licensingarrangements and, second, the standardsof evidence (SOE) (see articles onpages 19 and 23). What makes theframework unique is that the GMPsand SOE have been developed with thespecific characteristics of the industryin mind. Our goal was to ensure thatthe GMPs would maximize the bene-fits and minimize the negative impactsof the new Regulations. Unlike thepharmaceutical industry, which tendsto be dominated by large-scale manu-facturers, our Business Impact Testshows a relatively large number ofsmall- to medium-sized NHP manu-facturers. We also know that much ofthe innovation in this industry occursin smaller companies because theyare able to adapt more rapidly as newmethods of processing or new productsare developed. Imposing unnecessarilystrict GMPs could have shut down manyof the smaller operations, therebylimiting innovation.

The two main pillars

of the framework

are, first, the good

manufacturing practices

(GMPs) and site licensing

arrangements and, second, the

standards of evidence (SOE).

What makes the framework

unique is that the GMPs and

SOE have been developed with

the specific characteristics of

the industry in mind. Our goal

was to ensure that the GMPs

would maximize the benefits

and minimize the negative

impacts of the new

Regulations.

Q

Q

Q


A Policy Challenge: Innovative Solutions

How have the SOE been tailored to this sector?

Two points are key. First, the SOE for NHPs call for an examination of the “totality of evidence.” Forexample, two Canadian randomized control trialsare typically conducted before a new drug can bebrought into Canada. But, under the new SOE, anNHP may not be considered new in Canada if it hadbeen in use somewhere else. In that case, data fromthe other country could be used to substantiate safetyand health claims for the product.

The second point relates to the different levels ofevidence that are allowed under the SOE. The Com-mittee recommended that the SOE be appropriatefor a range of health claims. For instance, if a productmakes treatment claims for a scratch or cut, then onelevel of evidence is required.However, if the claims apply to amore serious condition, a higherlevel of evidence is necessary.

What are some examples ofthe different levels of evidence

provided for under the new SOE?

As I mentioned, we consider thetotality of evidence, including howthe product is made and sold, thesafety profile of the ingredients andhow it is marketed in other coun-tries, as well as evidence from thosejurisdictions. We take into accountboth the traditional and scientificliterature. If there are clinical trials,we look at those. We also considernon-randomized trials, as well asexpert opinion reports (see articleon page 23).

Another level of evidence focuseson whether there has been a historyof traditional use. By this, we meana practice of using that product whichhas been passed down within a com-munity from one generation to thenext. Under the new SOE, a minimumof 50 years is required to make a claimfor traditional use. At the other endof the spectrum are products that are“globally” new — they have never

been used anywhere. In the case of a new product wherethe company provides insufficient evidence that theproduct can be used safely for the indicated conditions,additional testing or clinical trials are required.

What will happen after the new NHPRegulations come into effect in January 2004?

It will take six years to fully implement the newRegulations. During the first two years, we’ll focus onproduct safety by making sure that all manufacturershave site licences and are using the approved GMPs.Approximately 10,000 NHPs (of the estimated 50,000to 60,000 on the market) currently have Drug Identi-fication Numbers (DINs) issued under the FDR. These

products will have six years to transitionto the new framework. The NHPD will betargeting compliance and enforcementactions on a risk-based approach to gradu-ally bring the remaining products into fullcompliance throughout the first four yearsthat the Regulations are implemented.

There is some uncertainty and a lotof work associated with implementingsuch a novel regulatory approach, butwe’re committed to being vigilant in ourfollow-up activities so that consumerscan realize the maximum benefits.

In closing, how would you respondto potential critics who might say

that support for CAHC and the newregulatory approach for NHPs is notsufficiently science based?

I believe we are science based. In my view,science is the practice of observation,recording, making observation-basedchanges and then moving forward. Thisis the approach that has been taken byresearchers, regulators and others work-ing in the field to ensure that consumershave access to products and practices thatare safe and effective. Our bottom lineis about enabling consumers to makeinformed choices about their healthcare options.

Q

Q

Q

Q

Approximately 10,000

NHPs (of the estimated

50,000 to 60,000 on

the market) currently have Drug

Identification Numbers (DINs)

issued under the FDR. These

products will have six years to

transition to the new framework.

The NHPD will be targeting

compliance and enforcement

actions on a risk-based approach

to gradually bring the remaining

products into full compliance

throughout the first four

years that the Regulations are

implemented.


The popularity of complementary andalternative health care (CAHC) andnatural health products (NHPs) is

well documented. Drawing largely fromrecent studies prepared for Health Canada,1-3

this article highlights current utilizationpatterns and trends, and examines howand why consumers are using these therapiesand products. It also explores the challengesof gathering comprehensive informationon consumer utilization.

The Big PictureThere is strong supporting evidence that CAHC and NHPs are a largeand generally increasing part of the Canadian health care reality.4 Forexample, the Berger Population Health Monitor recently reported thatthe proportion of Canadians using one or more NHPs in the previoussix months rose from 70 percent in 1999 to 75 percent in 2001.5

Millar’s 2001 analysis of National Population Health Survey data esti-mated that 19 percent of Canadians made use of CAHC practitionersin 1998 to 1999 (an increase of four percentage points from 1994 to1995) for services ranging from chiropractic, yoga and massage toacupuncture, homeopathy and meditation.6,7 A 1998 survey by theFraser Institute estimated that Canadians spent $3.8 billion on CAHC

and NHPs between 1996 and 1997.Although utilization of NHPs increased

significantly in the mid- to late 1990s,according to some measures there has

been a slight decrease in the past fewyears. For instance, Figure 1 indicates

that while the use of herbal reme-dies more than doubled during

the period 1996 to 1999, therehas been a subsequent levelling

off since then. This drop maybe due to lessened product

demand (see interview onpage 6), overall market

reductions, or some com-bination thereof.

Figure 2 presentstrends in Canadians’

use of different types of CAHCpractitioners from 1994 to 2001.

UtilizationJoan E. Simpson, Natural Health Products

Directorate (NHPD), Health Products and FoodBranch, Health Canada

Special thanks for the input provided by SariTudiver, Women’s Health Bureau, Health Policy

and Communications Branch; David Hoe,HIV/AIDS Policy, Coordination and Programs

Division, Population and Public Health Branch;Nancy Lloyd, Centre for Chronic Disease

Prevention and Control, Population and PublicHealth Branch; and Isabelle Caron, NHPD.

Patternsand Trends

Note: These data do not include vitamin and mineral usage.

Source: Nonprescription Drug Manufacturers Association ofCanada, updated to 2002 from Hay Health Care ConsultingGroup’s Berger Population Health Monitor, Survey #23 (R. Marles).

Figure 1: Use of Herbal Remedies, 1996-2002



Overall, Canadians are making significant use of healthcare approaches that, until recently, were consideredoutside the scope of mainstream health care inNorth America.8

About Consumer Utilization DataInformation on consumer utilization offers insightsinto CAHC product and practice issues, and can helpdetermine the agenda for future policy research. In hisreports to Health Canada, De Bruyn1,2 describes relevantdata sources and groups consumer utilization studiesinto three categories: research studies,9-12 studiesbased on data from Canadian health surveys6,13-15

and public opinion polls.16

Gathering comprehensive information on the useof CAHC and NHPs presents many challenges, somerelating to survey methodologies and others to thedefinitions of CAHC and NHPs employed in thestudies. For instance, reports of CAHC use are affectedby respondents’ understanding of the terms, as wellas their reasons for using a particular product ortherapy. For this reason, researchers usually decide toask about specific CAHC products, practice areas andpractitioners in their surveys and define these clearlyfor respondents. Utilization responses can also beaffected by consumers’ views about whether a partic-ular product or practice (e.g., prayer, meditation, use

of herbal teas) is a component of health care or justpart of daily living. Another significant challenge isthe need to appropriately represent Canada’s ethno-cultural diversity in survey databases — clearly anarea requiring further attention.1,17

Similar to enhanced utilization studies, gatheringinformation about the health outcomes of using NHPsand CAHC therapies has not been a major focus ofhealth policy research to date.

Why the Widespread Use?A number of factors may account for the increase inpopularity of CAHC and NHPs, such as the risingprevalence of chronic diseases, greater public accessto global health information, reduced deference forthe decision-making role of conventional health careproviders, and an increased sense of entitlement toquality of life.3

The reasons people give for using CAHC andNHPs range widely, from maintaining health andimproving quality of life and well-being, to preventingdisease, reducing stress, treating a condition or disease,and easing symptoms.3 Eisenberg et al.10 reportedthat 58 percent of CAHC treatments were used, atleast in part, to prevent future illness or to maintainhealth and vitality, while 42 percent were used to treatexisting illness.

Figure 2: Use of CAHC Practitioners, 1994–1995 to 2000–200170

60

50

40

30

20

10

01994–1995 1996–1997 1998–1999 2000–2001

Massage therapist Acupuncturist Homeopath Herbalist

Note: These data do not include visits to chiropractors, the most extensively used CAHC practitioners in Canada.Source: National Population Health Survey, 1994–2000.

Perc

enta

ge



Normally, consumers themselves select an approach,with perceived effectiveness as the major reason forchoosing between therapies. CAHC and NHPs tendto be used more often for chronic conditions, suchas back pain and allergies, than for acute or life-threatening conditions.17,18 Moreover, most peoplecite positive reasons for choosing CAHC and NHPs,such as a desire to take control over their health, orcompatibility with their belief systems, rather thannegative reasons such as a fear of or disillusionmentwith conventional care.18 While CAHC and NHPs aresometimes used as an alternative to conventionalmedicine, they are generally employed as an adjunctto other therapies. According to current estimates,only 6 percent of Canadians use CAHC and NHPs tothe exclusion of conventional medicine.17

Who Uses CAHC and NHPs?Many consumer populations are using CAHC andNHPs, including:3

• the concerned well (who aim to enhance their healthfor the long term)

• people with specific health problems, ranging fromminor to major (e.g., mental health concerns,infectious disease, acute illness or injury, mentalillness, long-term disability, chronic disease)

• people with a life-threatening illness• the terminally ill

Utilization can also vary by specific population groupsor among people with different health problems.

WomenAs Table 2 shows, women make greater use of CAHCand NHPs than men. In part, this is likely due towomen’s unique physiology and reproductive roles,which may lead them to seek alternative or comple-mentary treatment, for example, to relieve nauseaduring pregnancy, induce or decrease lactation andrelieve menopausal symptoms. As the “gatekeepers” offamily health, women also tend to play a key role indecisions about the type of practitioner to be consultedand under what circumstances. Findings such as theseindicate that women and men may have differing CAHCand self-care information needs.

People Living with Chronic IllnessesThe use of alternative therapies by chronically ill pop-ulations has been the focus of several recent surveys.

Use of NHPs is highest in British Columbia

and lowest in the Atlantic provinces: Forty-one

percent of respondents in British Columbia

reported using three or more NHPs in the previ-

ous six months, compared with 15 percent of

respondents in the Atlantic provinces.

Pharmacies and health food stores are the

main source of NHPs: Fifty-eight percent of

respondents purchased their last NHP at a

stand-alone pharmacy, 22 percent at a health

food store and 7 percent at a supermarket or

discount store pharmacy. Few NHP purchases

were made on the Internet.

More people are consulting their physician or

pharmacist about NHPs: Between 1998 and

2000, there was a substantial increase in the

number of people discussing the use of NHPs

with their physician (from 31 percent to

38 percent) or pharmacist (from 22 percent to

38 percent). Women were more likely than men

to discuss NHPs with a conventional health

care professional.

*Based on Hay Health Care Consulting Group’s Berger Population HealthMonitor, 2001.

Table 1: Use of NHPs*

58%22%

7%13%

Stand-alonepharmacy

Health foodstore

Supermarket ordiscount store

pharmacy

Other



More Canadians are using

APs than ever before: The use

of APs among Canadians aged

18 or older increased from

15 percent in 1994–1995 to

19 percent in 1998–1999.

Since use of chiropractors

remained stable during that

period, the overall increase

may be attributed to the

growing popularity of other

types of APs (e.g., massage

therapists, acupuncturists,

homeopaths or naturopaths).7

Use of APs increases with

education and income:

People with some post-

secondary education are

more likely to consult an

AP than people with less than

a high school diploma. People

with a household income of

$50,000 or above consult an

AP more often than those

with a household income

under $20,000.7

Women are more likely than

men to consult APs: Nineteen

percent of women reported

consulting an AP in the previ-

ous year, compared with

14 percent of men. However,

men and women are equally

likely to consult a chiropractor.7

Residents of Western Canada are

more likely to use APs: The use

of APs increases from east to west,

with the highest rate of use in

Alberta. Between 3 percent and

9 percent of people in the Atlantic

provinces report consulting an

AP, compared with 15 percent in

Québec and Ontario, and 21 per-

cent to 25 percent in the western

provinces. The higher use in

Western Canada may be a reflec-

tion of provincial health care

plans, which offer some coverage

for chiropractic services.7

Use of APs is greater among

people with chronic conditions

or chronic pain: 2001 survey

data indicate that 59 percent of

Canadians suffer from one or

more chronic conditions.19 In

1998 to 1999, 25 percent of people

with three or more chronic con-

ditions consulted an AP, compared

with 11 percent of those reporting

no chronic conditions. Twenty-six

percent of people who reported

chronic pain consulted an AP,

compared with 15 percent of those

with no chronic pain. Use of APs

was highest among people suffer-

ing from back problems.

*Based on the 1998–1999 National PopulationHealth Survey.

Table 2: Use of Alternative Practitioners (APs)*

Use of APs increases

with education and

income: People with

some post-secondary education

are more likely to consult an AP

than people with less than a high

school diploma. People with a

household income of $50,000 or

above consult an AP more often

than those with a household

income under $20,000.



For example, surveys of peoplesuffering from arthritis andrheumatism report prevalencerates ranging from 82 percent to94 percent.20-22 A British Columbiaself-care study on the use of alter-native therapies among adults aged50 and older with arthritis, heartdisease or hypertension concludedthat “the illness context is criticallyimportant in affecting the propensityof individuals to use alternativetherapies.”23

People Living with HIV/AIDSAs discussed in the article on page16, the use of CAHC and NHPs isparticularly high for people livingwith HIV/AIDS.24 Multiple reasonsfor this use are cited by consumers,most particularly to gain controlover their health, boost immunefunction, delay and treat symptomsof the disease, help with side effects,relieve stress and improve generalwell-being.

People Living with CancerThe 1998 National Population HealthSurvey indicates that 10 percent ofCanadians with cancer reportsome use of alternative health care,while the related medical literaturesuggests that upwards of 60 percentof cancer patients use some formof CAHC.25 The most commonlyreported reasons are to boost theimmune system, improve quality oflife and prevent recurrences.Among those living with cancer,people with breast cancer, gastroin-testinal cancer and lung cancer arethe most frequent users of CAHCand NHPs (see “Who’s Doing What?” on page 28). Aswell, CAHC is commonly used for children with can-cer; in one study, almost 60 percent of childpatients were reported to have used one type of com-plementary or alternative medicine (CAM) during theircancer treatment.6

Assessing Products andPractitionersCanadians using CAHC and NHPsmay be doing so with or without theinvolvement of mainstream healthcare providers or any other practi-tioner.8 For this reason, it is criticalthat tools be provided to help con-sumers make informed decisionsabout how to access and use thevarious health care options (as dis-cussed in the following article).Tables 1 and 2 highlight specificpatterns and trends concerningaccess to and utilization of NHPsand CAHC practitioners, based onanalyses of Canadian national pop-ulation survey results.2 Althoughnot presented here, more in-depthanalysis of user characteristics, forexample, use of NHPs and CAHCby various ethnic groups, would bea valuable area for further study.

Moving ForwardStudies are needed to determine withgreater detail the extent to whichCanadians are opting for CAHCand NHPs. Enhanced studies on theutilization and health outcomes ofthese products and practices wouldassist in evaluating the potentialfor substantial health gains acrosspopulation groups.

The demand for NHPs andCAHC has implications for healthcare delivery in Canada. As dis-cussed throughout this issue, HealthCanada’s attention has been directedat several key policy areas: developing

an appropriate regulatory framework for NHPs;assessing CAHC health system impacts; and exploringthe needs of specific consumer populations for accessto and utilization of holistic health care approaches.


The 1998 National

Population Health

Survey indicates

that 10 percent of Canadians with

cancer report some use of

alternative health care, while the

related medical literature suggests

that upwards of 60 percent of

cancer patients use some form of

CAHC. The most commonly

reported reasons are to boost the

immune system, improve quality of

life and prevent recurrences. Among

those living with cancer, people

with breast cancer, gastrointestinal

cancer and lung cancer are the most

frequent users of CAHC and NHPs.

complementary or conventional). As a result, theircondition may deteriorate.

Intrinsic Procedural RisksThese are problems that arise directly from using aproduct or practice. Because the body’s organ systemsand metabolic processes are complex and interactive,any health product is likely to have side effects. Thereis also the risk that NHPs may be adulterated withother substances (e.g., drugs), contain the wrong herb,or be contaminated as a result of poor manufacturingpractices. NHPs may also interact with other sub-stances, including conventional drugs, other NHPs oreven foods.

Situational AmplificationsIn this case, the condition worsens — usually tem-porarily — as a result of taking the “correct” NHPor CAHC. An example is the temporary and minormuscle aches some people experience after chiropracticmanipulation.

Different Strokes (and Doses) for Different FolksNot everyone responds the same way to conventionalmedications or NHPs. For example, children experiencedifferent growth and development characteristics asneonates (< 1 month), infants (1–12 months), toddlers

(12–42 months), preschoolers(3.5–6 years), children (6–12 years),and adolescents (12–18 years).These stages of development affecthow children absorb, distribute,metabolize and excrete drugs,as well as the product’s actions.Children are also more susceptiblethan adults to the effects and toxi-city of some products, but are betterable to tolerate others.2-4

For many NHPs, documentsdescribing traditional use providelittle or no specific information ondosage for children, leaving parentsand practitioners to either guess ator calculate the appropriate amount.(The situation is not much betterfor conventional drugs, since their


Did You

Did You Know? is a regular column of the HealthPolicy Research Bulletin examining aspects of

health information, data and research that may besubject to misconceptions. In this issue, we investigatethe perception that all natural health products andcomplementary and alternative health care therapiesare safe.

It’s Natural, So It Can’t Hurt Me — Right?Michael J. Smith and Robin J. Marles, Natural Health ProductsDirectorate, Health Products and Food Branch, Health Canada

Many consumers and even some practitioners believethat natural health products (NHPs) and complemen-tary and alternative health care (CAHC) therapies arealways safe, no matter what the dosage is or how theyare used (see Figure 1). Is this perception accurate? Ifnot, how can we help people make informed, healthychoices, bearing in mind that the typical consumerof NHPs and CAHC is proactive about health care,inquisitive and well educated?

Natural Does Not Necessarily Mean SafeLike most other things in life — including drugs, foodand even motorcycle riding — the safety of NHPsand CAHC therapies depends on the amount ordosage, the characteristicsof the user and the contextin which they are used.More specifically, manyof the risks associatedwith NHPs and CAHCfall into the followingthree categories:1

Errors of Omission Put simply, this means thatby not doing the rightthing, you are doing thewrong thing. For example,taking a herbal medicinethat is inappropriate maycause consumers to ignoremore proven or appro-priate care (either Source: Canada Health Monitor, 1998. Price Waterhouse Coopers National Survey Centre.

Figure 1: Perception of the Potential Risks Associatedwith the Misuse of NHPs, 1998

10%

26%

46%

18%

All NHPs Most NHPs Some NHPs Not very many NHPs

Can NHPs be harmful if not taken properly?


Did You Know?

use in children is commonly “off-label” as well dueto the lack of clinically-derived information on chil-dren’s dosage and pharmacology.) A number ofdosing formulae for children have been proposed foruse by health care practitioners, none of which isregarded as completely reliable.5,6

Similarly, seniors often have special safety issuesbecause of low body weight, coexistinghealth conditions and the use of multi-ple medications, including bothconventional drugs (over-the-counterand prescription) and NHPs. As NHPuse is not generally recorded in apatient’s history, it is difficult to watchfor NHP-drug interactions in seniors,or in other groups with infectious orchronic diseases.7 Physicians areencouraged to start medications at alow dose and to monitor for sideeffects while increasing the dose to thelowest effective level, which may alsohelp to minimize interactions.8,9

Ginkgo Leaf Extract — An ExampleGinkgo leaf extract is an excellentexample of how NHP use and dosagevaries by population. Ginkgo extractcontains a blood-thinning agent andhas been clinically shown to reducecognitive impairment in geriatricpatients by improving blood flowthroughout the brain.10 However, ginkgomay interact with other blood thinnersto increase the risk of hemorrhage,emphasizing the importance of goodpatient–physician communication aboutthe use of NHPs.

Advertisers have falsely extrapolatedthe benefits of ginkgo products by pro-moting them to young people as a way of improvingtheir memory and cognitive functioning. Althoughthese products are unlikely to help young people (asmost have normal blood flow in the brain), ginkgoextract does have a potential use in children. Clinicalevidence supports its use as an adjunct in the treat-ment of bacterial blood infections.11 However, aschildren are not generally included in clinical trials,practitioners can only guess at an appropriate dose.

A Question of CommunicationEffective communication between consumers, con-ventional and complementary health care providers,and government is critical in ensuring consumersafety. Results from several surveys12 suggest that twothirds of people who use NHPs and CAHC do nottell their physicians they are doing so. Health Canada

is collaborating with partners such asthe Association of Canadian MedicalColleges to improve physicians’knowledge of CAHC and NHPs sothey can better counsel their patients.

When something does go wrong,consumers are less likely to report theproblem with an NHP than a drug,and are more likely to tell a neighbouror family member than their doctoror pharmacist.13 Effective reportingof adverse events is a major researchpriority and Health Canada is workingwith domestic and internationalpartners to ensure proper reportingprocedures, provide for effective riskcommunications with CAHC providers,and determine when an adverse eventresults from an adulterating sub-stance or other factor rather than theNHP itself.

Communication between CAHCproviders and conventional health careproviders is a two-way process in whichthe responsibility lies equally with bothgroups to establish a good workingrelationship. For instance, conven-tional providers may not always befamiliar with a specific NHP or CAHCtherapy and, thus, they need to knowwhen to refer a patient to a CAHCpractitioner. Similarly, CAHC providers

may not always have the necessary training to makethe best decision for a patient and must know whento make a referral to a conventional practitioner.Increasing consumer and practitioner understandingof the potential risks (and benefits) associated withCAHC and NHPs is vital in helping Canadians usethem safely, effectively and respectfully.


When something

does go wrong,

consumers are

less likely to report the problem

with an NHP than a drug,

and are more likely to tell a

neighbour or family member

than their doctor or

pharmacist. Effective reporting

of adverse events is a major

research priority.

Safety, Effectiveness and Access


Individual Balancing ActsCanadians’ considerable use of NHPs and CAHC suggests that they viewthese products and practices as an important complement to conventionalhealth care and a valuable opportunity to improve their health.

When deciding whether to use a CAHC therapy or an NHP, eachperson performs a risk/benefit analysis. Among other factors, individualsmust consider the product’s or therapy’s effectiveness and safety. Althougha wealth of information exists about many products and practices, thereare accuracy and reliability concerns. Furthermore, decisions must oftenbe made without the assistance of an adequately informed practitioner.Consumers must also consider the financial costs because they pay “outof pocket” for the majority of products and practices. Currently, onlyselected practices are covered by third party insurers, most of them for alimited period.

While consumers of conventional health care interventions also performrisk/benefit analyses, mainstream health care has a well-established systemor “orthodoxy” for balancing risk with benefit for an expected outcome.This orthodoxy encompasses components to help consumers assess thequality and safety of products and practices, and ensures training andstandards for practitioners themselves, as well as for their use of drugsand medical devices. It is designed to assist consumers in making informedhealth care choices based on the best available evidence and to help

practitioners provide safe andeffective interventions.

Although the absence ofsuch a comprehensive ortho-doxy for CAHC and NHPsallows consumers access to awide range of practices and

products, it also has a varietyof negative impacts. For example,

consumers may not be fully informed,information about interventions may

not be accurate or reliable, claims foreffectiveness may not be justified and practi-

tioner training may not be adequate. Manyproducts and practices are well known and widelyaccepted; however, others give rise to a number ofquestions concerning their safety and effectiveness

David Hoe, HIV/AIDS Policy, Coordination and Programs Division,Population and Public Health Branch, Health Canada

For some time, individual

Canadians have been trying to

balance concerns about safety,

effectiveness and access as they use

complementary and alternative health

care (CAHC) and natural health

products (NHPs) to maintain and

improve their health. This article

suggests that comprehensive frameworks

and standards for the delivery, devel-

opment and monitoring of CAHC and

NHPs could promote consumer confi-

dence by helping to ensure the safety

and effectiveness of these products and

practices. One case in point illustrates

how people living with HIV/AIDS have

successfully integrated CAHC and

NHPs into their health care regimes.

Finding the Balance:


Finding the Balance: Safety, Effectiveness and Access

(see box). Even though CAHCand NHPs may not pose someof the risks associated withcertain mainstream health careinterventions, such as surgery,these interventions cannot beassumed to be risk free (see“Did You Know?” on page 14).

A Role forGovernmentsIn fact, concerns about therisks of using CAHC andNHPs have been associatedwith a possible decrease inconsumer confidence that hascontributed to recent declinesin utilization (see the inter-view on page 6). If consumersare to be assured of the safety,quality and effectiveness ofthese practices and products, governments have a validrole to play in informing the consumer’s decision-making process by helping to identify the risks andbenefits of CAHC and NHPs.

As with mainstream health care, governments’primary tools for balancing access with assurances ofsafety and effectiveness are the regulation of productsand practitioners, and the application of common lawprinciples to practitioners. Jurisdiction in this area isdivided, with the provinces and territories responsiblefor regulations concerning practitioners and thefederal government overseeing product regulation.At this early stage, however, all levels of governmentcan demonstrate leadership by guiding discussionson how CAHC and NHPs can be integrated effectivelywith mainstream health care. Specifically, governmentscan collaborate with each other, the scientific commu-nity, consumers, manufacturers, CAHC practitionersand policy developers to:

• develop standards of evidence for the safety andeffectiveness of products and practices

• develop appropriate models of regulation that donot unnecessarily limit choice or access

• determine the role that CAHC and NHPs can playin helping Canadians maintain and improvetheir health

• put in place necessaryframeworks to preventharm while respecting citizen autonomy

• strengthen professionalbodies of CAHC practi-tioners to maintaintraining and other stan-dards, and to conductresearch designed toincrease the effectivenessof their practices

• protect the environmentalsustainability of naturalresources used for healing,such as wild herbs used byAboriginal healers

Government ActionUntil recently, individuals andconsumer organizations, such

as people living with HIV/AIDS (see box on page 18),have been trying to balance concerns about safety, effec-tiveness and access in the absence of comprehensiveframeworks and standards. However, governmentsat all levels have started to take action in this area.The article on page 19 highlights new federal activityaimed at providing a safe, evidence-based and appro-priately regulated field for the production, consumptionand monitoring of NHPs. Some provinces and terri-tories have recognized education and practice standardsfor specific types of CAHC practitioners, though theseapproaches are not identical across the country. Forexample, chiropractic services and massage therapy arecommonly recognized through regulation or registration,although many other CAHC practice areas are not.1

Research Is KeyAlthough governments have made significant progress,there is still some distance to go to ensure that accessto CAHC and NHPs is balanced with safety andeffectiveness. Much work remains on expanding theevidence base to determine whether these productsand practices achieve their intended health outcomes,which methods are the most effective, whether specificproducts and practices are safe, and under what circum-stances they may not be safe and/or effective.

Some NHPs and CAHC practices are widelyused, well accepted and raise few questionsconcerning their safety and effectiveness. Forexample, massage therapy is regarded as a credibletherapy for helping to reduce stress and healcertain physiological conditions, while vitaminsare widely used to improve nutritional balance.Many people turn to traditional Chinese medi-cine to treat a broad range of diseases. Similarly,Aboriginal people often integrate traditionalhealing methods with their health care regi-mens. It must be cautioned, however, that thefield encompasses a vast array of products andpractices, not all of which enjoy the same levelsof use, evidence and consumer confidence.

What Do We Know About Different CAHC Therapies and NHPs?

Over the past 20 years, people living with HIV/AIDS(PHAs) in Canada have developed substantialexpertise in the use of CAHC and NHPs. Based ontheir experiences, PHAs have become vocal criticsof this field, as well as of mainstream health care.

Greater Reliance on CAHC and NHPs When the HIV/AIDS epidemic began, the conven-tional health care system did not have medicationsfor the treatment and care of PHAs. On the otherhand, alternative health care systems and providersoffered literature on care of the immune systemand suggested treatment options that could beaccommodated into the daily lives of those affectedby the disease. CAHC and NHPs provided reliefthrough touch and energy work, addressed theissues of stress and pain reduction,and raised hopes of prolongedsurvival through improved self carein nutrition, physical movement,spiritual health and healing theimmune system. The continuinguse of CAHC and NHPs and theirintegration into the health careplans of many PHAs has led to acritical examination of the fieldand increased expectations foreffective products and practices,and new frameworks that positionCAHC and NHPs alongside con-ventional health care strategies.

While results vary across the country, severalOntario studies report that from 67 percent to over90 percent of PHAs use complementary and alter-native medicine.2 This rate is approximately twiceas high as that cited in a 1997 CTV/Angus Reid pollon the use of alternative medicines and practicesby all Canadians (42 percent).

Integration with Conventional CareIt is very common to find CAHC as part of the arrayof services available in community-based AIDSorganizations. Massage therapy, Reiki therapy,nutritional counselling, relaxation and stress reduc-tion are among the services offered to maintain and

improve the health of people affected by the dis-ease. In their work to ensure Canadians living withHIV/AIDS have access to effective products andtherapies, the Canadian Treatment Action Councilplaces CAHC on an equal footing with conventionaltreatments and therapies. Moreover, NHPs — includingnutritional supplements, vitamins and minerals —are widely used to help people manage the impactsof HIV and the medications used to treat the disease.

Although research on the use of CAHC by PHAsis limited, one in-depth qualitative study concludedthat: “complementary therapies represent differentthings for these individuals — a health maintenancestrategy, a healing strategy, an alternative to westernmedicine, a way of mitigating the side-effects of drug

therapies, a strategy for maximisingquality of life, a coping strategy,and a form of political resistance. . . .These meanings are neither mutuallyexclusive nor fixed. The therapiesoften appeal to individuals on dif-ferent levels and their appeal maychange over time.”3

An Impetus for ChangeIn integrating CAHC and NHPsinto their health regimes, PHAs andtheir organizations have focused onhow to ensure access to a range ofoptions while providing the infor-mation needed to make informed

choices. As a result, the experience ofPHAs has become the impetus for further examina-tion of this field and its place in the lives of peoplemanaging a serious health condition. Furthermore,it has highlighted a number of key issues such as: theimportance of CAHC and NHPs to Canadians; thebarriers that prevent access to informed choice ofboth products and practices; and the need for com-prehensive systems that fully integrate CAHC andNHPs with contemporary health care approaches.

HIV/AIDS: A Case in Point


Finding the Balance: Safety, Effectiveness and Access


42% 67% 90%

While results vary across thecountry, several Ontario studies

report that from 67 percent to over90 percent of PHAs use complemen-tary and alternative medicine. Thisrate is approximately twice as highas that cited in a 1997 CTV/AngusReid poll on the use of alternative

medicines and practices by allCanadians (42 percent).

A Regulatory DilemmaAs pointed out in the interview on page 6, new NHP Regulations willcome into effect in January 2004. Until then, NHPs will continue to beregulated as either food or drugs under the federal Food and Drugs Act(FDA) and Food and Drug Regulations (FDR). Under these Regulations,some NHPs are classified as foods, while other products carrying healthor therapeutic claims are classified as drugs.

Neither of these classifications is appropriate for NHPs, however. Forexample, products classified as food cannot make health claims,* norare they required to have full product use information on their labels or

to undergo any type of pre-market approval. This has raised con-cerns about product safety and effectiveness, and the adequacy

of information for decision making.On the other hand, NHPs that are regulated as drugs

are required to meet a very rigorous set of requirements. Asan example, the standards of evidence for drugs consist of a

framework based on clinical trials that does not readily recog-nize evidence based on a “history of safe use,” which many NHPs

have enjoyed.† As Figure 1 illustrates, Canada’s NHP industry isdominated by small and micro firms with fewer than 20 employees.1

Many of these firms could not support the considerable cost ofrandomized control trials. Furthermore, while the FDR use

Canada’s patent system to encourage innovation, the majorityof NHP findings cannot be patented because themedicinal ingredients are found in nature, ratherthan being proprietary formulations. This limits theability of NHP manufacturers to recoup the costsof developing new products or holding clinical trials.


In response to growing concerns

about the regulatory environ-

ment for herbal remedies,

Health Canada has developed a

new regulatory framework for

natural health products (NHPs).

Scheduled to come into effect on

January 1, 2004, this innovative

framework is the product of

extensive consultation with

a range of stakeholders.

N a t u r a l H e a l t h P r o d u c t s

Sinéad Tuite, Natural Health ProductsDirectorate, Health Products and Food

Branch, Health Canada

An

RegulationInnovative Approach to

*Recent changes to the FDA now permit a limited range of health-related claims for certainfoods — for example, claims that position the food as part of healthy eating, or claimsregarding the function or biological role of recognized nutrients.

†The Traditional Herbal Medicines Policy and Labelling Standards for Single DilutionHomeopathic Medicines do not require clinical trial evidence for these products.


NHPs: An Innovative Approach to Regulation

(For information on how the new regulatory frame-work encourages innovation through intellectualproperty rights, see page 27.)

The current regulatory environment has led toconfusion in the marketplace as consumers attemptto choose between a substance labelled as a food(without health claims or full product use informa-tion) that sits on the shelf next to a similar oridentical substance labelled as a drug (with healthclaims and adequate directions for use). As shown inFigure 2, this situation has not encouraged a highlevel of consumer confidence in the quality of NHPs.

A Catalyst for ChangeBy 1997, the growing dissatisfaction among consumersand the NHP industry had resulted in calls to re-examine the regulation of herbal remedies. Althoughmany stakeholders viewed the regulatory regime fordrugs as too rigorous for NHPs, there was also con-cern about whether all NHPs should be regulated asfood products. Industry and consumers urged that thehealth benefits of NHPs be reflected in their labelling,while consumers also pressed for assurances aboutproduct quality and information on the health

Figure 1: Number of Firms by Number of Employees

Num

ber o

f firm

s

1–4 5–19 20–49 50 or more Unknown

40

35

30

25

20

15

10

5

0

Number of employees

Figure 2: Confidence of Canadians in the Quality of NHPs50

40

30

20

10

0

Very confident Somewhat confident Not very confident Not at all confident

Perc

enta

ge

Source: Health Canada, Business Impact Test on the Natural Health Product Regulations, 2003.

Source: Hay Health Care Consulting Group, Berger Population Health Monitor, Overview Report March 2001.

Label Purity of ingredients Product safety Same ingredients for all bottles

benefits of individual products. Moreover, consumersindicated to Health Canada that they were willing toaccept reasonable price increases in order to obtainthese assurances.1

Health Canada responded by establishing anAdvisory Panel on NHPs and the Minister of Healthannounced a full public review of the regulatoryregime for NHPs by the House of Commons StandingCommittee on Health. The Committee heard frommore than 150 individuals, associations and coalitions,and made 53 recommendations for a new regulatoryframework. The Committee’s final report, NaturalHealth Products: A New Vision,2 was presented to theHouse of Commons on November 4, 1998.



In March 1999, the Government accepted therecommendations as the basis of a broad policyframework for NHPs. In response, the Minister ofHealth created the Office of Natural Health Products— now the Natural Health Products Directorate(NHPD) — to oversee development of a new regula-tory regime that would provide consumers withassurances of safe, effective and high quality products,while respecting Canadians’ freedom of choice, andphilosophical and cultural diversity.

Best Practices in StakeholderConsultationsThe regulatory framework for NHPs was developedin extensive consultation with more than 2,100 stake-holders in 11 cities, including industry representatives,health care providers, academics and consumer groups.Once the Regulations were drafted, a series of workinggroups or “town halls” were convened to examinespecific issue areas. Throughout the process, anexpert advisory committee and industry workinggroup provided input on relevant scientific, policyand operational matters.

A New Regulatory FrameworkThe new framework outlines standards of evidencethat are more appropriate for NHPs than the stan-dards of evidence in the FDR and sets out innovativeapproaches for achieving the Regulations’ objectives.

What the Regulations Address

The new Regulations, which will also be underthe Food and Drugs Act, provide direction in thefollowing areas:

• definitions

• product licensing

• site licensing

• good manufacturing practices (GMPs)

• clinical trials

• labelling and packaging requirements

• adverse reaction reporting

Effectiveness Safety QualityEffectiveness Safety Quality

Standards of EvidenceProduct Licences

Standards of EvidenceProduct Licences

Figure 3: Specific Components Address Particular Concerns

Good ManufacturingPractices

Site Licences

Good ManufacturingPractices

Site Licences



Under the new regime, NHPs canmake claims related to structure andfunction, risk reduction, treatmentand general nutrition. As outlinedin the following article (page 23),the level of evidence required tosupport a product claim is graduated,based on the level of health claim.As proof of product effectiveness,Health Canada will accept a rangeof corresponding evidence, includ-ing traditional references, priormarketing experience, observationalstudies and clinical trials.

If applicants wish to conduct aclinical trial on an NHP, they mustobtain authorization from HealthCanada. To ensure that reviewershave the appropriate expertise, theResearch Ethics Board that examinesthe clinical trial must have at leastone member knowledgeable in com-plementary or alternative medicine.

Applications forMarketing NHPsUnder the new regulatory regime,all NHPs sold in Canada willrequire pre-market assessment andauthorization of their safety andeffectiveness. Using the standardsof evidence, Health Canada willevaluate applications based on thetotality of evidence available.

The new NHP Regulations alsorequire product licence applicantsto submit a listing of each product’smedicinal and non-medicinal ingre-dients. To assist consumers inmaking informed choices, non-medicinal ingredients must appearon product labels along with medi-cinal ingredients.

Health Canada is developinga Compendium of Monographsoutlining known safety and effec-tiveness information for the most

commonly used ingredients on themarket (see also page 26). Applicantswill not be required to submitadditional supporting data if theirproduct’s active ingredients meetthe monograph specifications. TheRegulations commit Health Canadato processing applications within60 days, a timeframe that is designedto allow for efficient processing ofa large volume of applications.

The regulatory framework alsorequires the manufacturer, pack-ager, labeller and/or importer ofeach NHP to have a site licence.This will enable Health Canada toensure that the products appearingon Canadian markets are of highquality and are made according togood manufacturing practices(GMPs) in licensed facilities (seealso page 26).

As shown in Figure 3, the mainframework components, such as thestandards of evidence and GMPs,each address a need for safety, qualityand effectiveness.

Looking AheadThe NHP Regulations will comeinto force on January 1, 2004. Atwo-year transition period for sitelicensing and a six-year transitionperiod for product licensing willallow the industry to adjust gradu-ally to the new requirements (seethe interview on page 6). HealthCanada will conduct a full reviewof the regulatory framework at the end of this period and makeadjustments based on experienceand stakeholder and consumerfeedback.


NHP Regulation in Other Countries

Regulation practices for NHPs

vary considerably from country to

country. Similar products are

generally labelled as “drugs” in

countries in the European Union.3

Australia recently classified many

of these products as “comple-

mentary medicines” and made

legislative and regulatory changes

to regulate them as a subclass of

“therapeutic goods.”4 In the

United States, many NHPs

are regulated as “dietary

supplements,” which do not

require pre-market review or proof

of safety by the manufacturer

and are not permitted to make

treatment-cure claims.5 In Canada,

NHPs will be classified as drugs

under the FDA; however, they will

be regulated separately under the

new NHP Regulations.


Regulating NHPsOne of the challenges in developing new Regulations for natural healthproducts (NHPs) was to achieve an appropriate balance between generalityand specificity. On one hand, the Regulations must be general enough to:

• encompass the more than 50,000 NHPs currently being sold• allow for industry innovation in bringing

new products to market• respect freedom of choice, and philosophical

and cultural diversity

On the other hand, the Regulations should bespecific enough to:

• ensure that Canadians have access to NHPs thatare safe, effective and of high quality

• enable consumers to make informed choicesabout personal health care

Responsible regulation requires that this balance be determined following athorough examination of the evidence concerning NHPs.

Benefits of an Evidence-Based ApproachAn evidence-based approach to regulating NHPs is expected to have anumber of benefits:

• NHPs that fail to meet Health Canada’s standards, or whose manufacturersdo not apply for a product licence, will be removed from the market.

• Consumers will experience the health benefits of NHPs whose safety,effectiveness and quality are established by an evidence-based, pre-marketapproval system.

• Boosting consumer confidence that “what is on the label is in the bottle”will help create an increased demand for NHPs.

• Practitioners and pharmacists will be increasingly confident in makingrecommendations about NHPs.

• With a clear set of regulations specific to NHPs, industry participantswill have a level playing field in which all products are required to meetthe same set of standards.

Health Canada has developed

standards of evidence for

evaluating licence applica-

tions for natural health products

(NHPs). These standards were

developed after extensive stakeholder

consultation and harmonize well

with international criteria. Applying

these standards to the regulation

of NHPs will allow consumers access

to products that are safe and effective,

and will facilitate consumers in

making informed choices.

Gene

ralit

y

Specificity

The Evidence Base for

Evaluating Evaluating Robin J. Marles, Ph.D., Natural Health Products Directorate,Health Products and Food Branch, Health Canada

Natural Health ProductsNatural Health Products


The Evidence Base for Evaluating NHPs

A Flexible FrameworkAn important feature of the new SOE approach is therecognition that a gradient of evidence strength existsand varying strengths of evidence can be used tosupport the claims of safety and effectiveness in aproduct licence application. As Table 1 indicates, thenew regulatory framework incorporates a range ofevidence levels. This is designed to allow considerableflexibility in the claims that manufacturers are per-mitted to make about an NHP. Simply put, the strongerthe claim, the stronger the supporting evidence needsto be.

EffectivenessSome of the major categories of health claims aredescribed briefly in Table 2. To be allowed, a claimmust correspond to the level and totality of the

In addition, the cost of maintaining Canadians’ healthmay decrease as consumers are better able to safelyand effectively self-medicate. If this proves to be true,governments will benefit as well.

Standards of EvidenceOnce the Regulations are in force in January 2004,every NHP sold in Canada must be issued a productlicence, which registers it with Health Canada. Asdescribed in the article on page 19, the regulatoryframework will outline newly developed standards ofevidence (SOE) specific to the needs of NHPs. SOEare clearly defined criteria concerning the amountand type of evidence required to support each claimfor safety, effectiveness and quality.

International HarmonizationSince Canada has active trade relationships with theUnited States, Europe, Asia, Australia, Latin Americaand Africa, Canadian NHP Regulations were alsodeveloped within the context of the internationalregulatory environment. Furthermore, Agricultureand Agri-Food Canada, the Canadian Forest Serviceand their provincial counterparts are exploring thepossibility of expanding domestic production ofNHPs to help diversify Canada’s farm and forestproduct industry. Keeping these points in mind,Health Canada has established an evidence evaluationframework based on categories developed by theUnited States Agency for Healthcare Research andQuality1 and adopted with minor modifications bythe World Health Organization,2 the European Agencyfor the Evaluation of Medicinal Products3 and theAustralian Therapeutic Goods Administration.4

Table 1: Evidence LevelsLevel Types of Evidence

well-designed systematic reviews and meta-analyses of randomized controlled trials (RCTs)or at least one well-designed RCT (preferablymulti-centred)

well-designed clinical trials without randomiza-tion and/or control groups

well-designed descriptive and observationalstudies, such as correlational studies, cohortstudies and case control studies

expert opinion reports, peer-reviewed publishedarticles, or conclusions of other reputable regu-latory agencies

references to traditional usesV

IV

III

II

I

Table 2: Types of Claims

Treatment

Risk reduction

Structure/Function

diagnosis, treatment or cure, mitigation, or prevention of disease, disorder, abnormal physiological state or its symptoms

reduction of a major risk factor for a chronicdisease or abnormal physiological state

effects on a human body structure, a physiological or mental function

treats upset stomach, relieves crampingand bloating due to indigestion, curesstomatitis

helps prevent infection and inflammation,promotes healing of wounds

aids digestion

Claim Type Explanation Examples



are few reports of problems resulting from consump-tion of German chamomile tea other than cross-reactivity in people allergic to other members of thedaisy family.7,8 Levels I and III evidence support arisk reduction claim that German chamomile extractsapplied topically “can help prevent infection andinflammation and promote healing of wounds.”9

Peppermint LeafLevel V evidence about peppermint leaf tea supportsthe treatment claim that it is “traditionally used torelieve indigestion” and the structure/function claim,“traditionally used to aid digestion.” Furthermore,peppermint leaf oil in enteric-coated capsules couldbe marketed with a highest level treatment claim,

evidence of effectiveness which is available, meaningthat higher level (i.e., stronger) evidence contradictinglower level (i.e., weaker) evidence will take precedence.As an example, scientific reports indicating that somecomfrey products are toxic when taken internally wouldoverride claims about traditional uses of comfrey tea,unless evidence is presented that the product is free ofthese toxins.

As discussed in the interview on page 6, productclaims may be traditional or non-traditional. Thewording “traditionally used” may be applied to any ofthe claim types shown in Table 2 (except for conditionsnot appropriate to self care), if two independent ref-erences document at least 50 years of continuoustraditional use within a particular culture or healingparadigm.

The herbs Roman chamomile, German chamomileand peppermint leaf can be used to illustrate how theSOE allow a variety of health claims to be made for asingle NHP, based on the level of evidence supportingthe product’s effectiveness and safety for each proposedpurpose.

Roman ChamomileRoman chamomile tea has long been “traditionallyused to treat upset stomach” in Europe. Hence, thiswould be an acceptable claim supported by Level Vevidence.5 As there is no clinical data (Levels I or II)to either support or contradict the claim,6 a strongerclaim cannot be made. Texts on herbal safety (Level IVevidence) suggest that Roman chamomile is generallya safe product, except for pregnant women or peoplewho are allergic to other members of the daisy family,7,8

a risk that can be mitigated by cautionary labelling.

German ChamomileThere is also Level V evidence that German chamomile,a distant relative of the Roman herb, is “traditionallyused to treat upset stomach.” Moreover, there is clinicalevidence (Level II) and further experimental animaland in vitro evidence (Level IV) supporting the treat-ment claim that it can be used effectively “for relief ofcramping and bloating due to indigestion.” However,a claim that it can cure inflammations such as stomatitiswould not be acceptable as there is only suggestiveevidence (Level II) to support it, not conclusive evi-dence (Level I). Data on previous market experiencecould be used as additional sources of Level IV evidence.For example, despite a long history of high sales, there

Assessing Product Safety

• Are individualized instructions, practitionersupervision or routine lab monitoring requiredto ensure the safety or effectiveness of the sub-stance?

• Is the substance used in treatment of a diseasethat is not appropriate for self care, e.g., a seri-ous disease easily misdiagnosed by the public?

• Does use of the substance mask other ailmentsor their development?

• Does it have known adversereactions at the recommendeddose?

• Is there a narrow margin ofsafety between therapeuticand toxic doses, especially inseniors, children, and pregnantor nursing mothers?

• Has it demonstrated potentialfor addiction, abuse or severedependency?

• Have experimental data shown that the sub-stance induces toxicity in animals? Longenough to establish a pattern of toxicity inhumans?

• Does it have known interactions with otherNHPs, drugs or foods?

• Is it known to affect results of standard labo-ratory or other diagnostic tests?

• Is it likely to contribute to the development ofresistant strains of microbes?

• Does the substance possess a high level of riskrelative to expected benefits?



“clinically proven to provide symptomatic relief inirritable bowel syndrome,” because it is supported bya meta-analysis of clinical trials (Level I evidence).9

SafetyEvaluating the safety of NHPs is challenging becausethe full range of safety and toxicological data is oftennot available. Thus, it is particularlyimportant that different types ofevidence are recognized in the SOE,meaning that available information,such as history of use, can be usedin evaluating product safety issues.

Some of the questions that willbe used to assess product safety arepresented in the box (page 25). Foreach “yes” response, Health Canadawill assess whether the potentialrisk can be mitigated using suchrisk management tools as labelling.

All full product licence applicationsfor NHPs must contain a “safetysummary report” highlighting anysafety issues identified in a thoroughreview of published scientific litera-ture. For products that have neverbeen used in humans, repeat-dosetoxicity, genotoxicity and reproductivetoxicology testing will be mandatory.Depending on the results of thesebaseline tests, further toxicity testingmay be required.

QualityQuality is a key issue in consumer protection. Manyadverse effects initially attributed to NHPs have beentraced to quality control problems such as contami-nation, adulteration or substitution with the wrongherb (e.g., contamination of the safe herb plantainwith the heart drug digitalis leaf10,11). To counter thisconcern, manufacturers, importers, packagers andlabellers of NHPs will be required to submit evidenceof compliance to NHP good manufacturing practices(GMPs),12 in order to obtain a site licence.

GMPs set out requirements for places (premises,equipment), people (personnel, quality assurancestaff), processes (sanitation program, operations) andproducts (specifications, stability, sterile productpreparation, samples, records and recall reporting).

General specifications include tolerance limits forcontaminants, while specifications unique to a partic-ular substance may include chemical tests for markersto identify a particular species or variety of herb, or forlevels of active or toxic constituents to support partic-ular claims of effectiveness and safety. The variabilityinherent in products produced from nature makes

quality control more challengingfor NHPs than for conventionaldrugs. However, without someassurance about the product’squality (e.g., crop quality, potency),there can be no certainty about thequality of the evidence, for example,from a clinical trial.

SOE in ActionUnder the new Regulations, NHPscan obtain a product licence in oneof two ways:

• attestation — the NHP con-forms to the specifications of aproduct monograph in HealthCanada’s Compendium

• full assessment — the NHP issubmitted for a complete assess-ment, together with evidence tosupport its safety, quality andhealth claims

Product MonographsA Compendium of Monographs is

being prepared to assist in registering the safest andmost commonly used NHPs on the Canadian market.Sources include monographs published by the WorldHealth Organization,13,14 the German Commission E,6

the European Scientific Cooperative on Phytotherapy,15

the British Herbal Compendium,16 the AmericanHerbal Pharmacopoeia,17 and other standard texts andpeer-reviewed articles. As discussed in the article onpage 19, Health Canada is evaluating almost 300 sub-stances for possible product monographs, whichwill include the proper and common names of thesource organism, source part (e.g., leaf, stem), recom-mended method of administration, dosage form, useor purpose, dose, duration of use, risk informationand references.

Evaluating the safety of

NHPs is challenging

because the full range of

safety and toxicological data is

often not available. Thus, it is

particularly important that differ-

ent types of evidence are

recognized in the SOE, meaning

that available information, such

as history of use, can be used in

evaluating product safety issues.



Full AssessmentAs all supporting evidence must be assessed accordingto the SOE, Health Canada will require considerablymore time to process a full submission for a productlicence application than to determine whether a prod-uct conforms to a monograph. However, one of thebenefits of the full assessment procedure is that it willallow for industry innovation in the development ofnew single ingredient and combination products (see“Protecting Intellectual Property,” below).

While many NHPs have only one medicinal ingre-dient, almost 60 percent of NHPs currently sold containa combination of medicinal ingredients. Moreover,this proportion may be on the rise as manufacturersvie for shares of a growing market. Although somecombination products have a long market history andare therefore eligible to be monographed, there are analmost infinite number of possible combinations ofmedicinal ingredients. To address these concerns, a“Combinations Policy” has been developed that estab-lishes clear industry guidelines concerning substancesthat can and cannot be combined, how medicinal andnon-medicinal ingredients should be listed, how toadjust dosages, what evidence is required to supportthe combination of ingredients, and the rationale insupport of the safety and effectiveness of a particularcombination of substances.

Protecting Intellectual PropertyConventional drugs are generally given 20 years ofpatent protection so that manufacturers can recoupthe considerable expense of preclinical and clinicaldrug development. Generic manufacturers wishing tomake the same claim as the original patented drugmust demonstrate the bioequivalence and/or pharma-ceutical equivalence of their product. As most NHPsdo not have the level of patent protection availablefor synthetic drugs, other incentives are needed toencourage industry innovation. To protect the intel-lectual property rights of the licence holder, proprietarydata such as clinical trials submitted in support of aproduct licence application for an NHP will not beincorporated into monographs or otherwise released.Moreover, as the new NHP Regulations do not con-tain a bioequivalency clause, competitors makingthe same claim must submit their own evidencesupporting the safety, effectiveness and quality oftheir product.

Regulation Versus AccessSince health care practice is subject to provincialrather than federal jurisdiction, the Regulations willnot cover NHPs that physicians and complementaryand alternative health care providers (e.g., Aboriginaltraditional healers) prepare for their patients on anindividual basis. Thus, the Regulations will not alterpractitioners’ access to health products already withinthe scope of their practice. Furthermore, enforcing theRegulations may increase practitioners’ confidence inthe safety, effectiveness and quality of registered NHPsand encourage them to recommend these products totheir patients.

The NHP Regulations apply only to substances safefor over-the-counter use. Access to NHPs will be moreuniform when the evidence-based approach to riskmanagement is applied to exclude high risk productsand to recommend mitigation strategies for self-careproducts. If Health Canada were to create a list ofprescription NHPs, the right to prescribe them wouldvary from province to province. A registered healthprofession, such as naturopathy in Ontario, Manitoba,Saskatchewan and British Columbia, could be giventhat right by the provinces, but as yet no province hasgiven naturopaths prescribing rights.

A Concluding NoteHealth Canada’s evidence-based approach to regulat-ing NHPs gives industry substantial flexibility in howthey bring NHPs to the marketplace and also allowsconsumers ready access to a variety of products forself care. Harmonizing the SOE framework with theregulatory environment in other countries will helpfacilitate Canada’s international trade in NHPs. At thesame time, consumer and practitioner confidencewill likely increase as claims for safety, effectivenessand quality are evaluated according to clear criteriaestablished with broad stakeholder input.

Thanks to Melissa Johnson, Yad Bhuller and Cicely Gu of the NaturalHealth Products Directorate for their assistance in assembling theinformation for this article.



Who’s Doing What?Who’s Doing What?

Who’s Doing What? is a regular column of the HealthPolicy Research Bulletin profiling key players,

including Health Canada, involved in policy researchin the current theme area. This issue profiles a sampleof governmental and non-governmental organizationsworking in the field of complementary and alternativehealth care and natural health products.

Isabelle Caron and Joan E. Simpson, Natural Health ProductsDirectorate, Health Products and Food Branch, Health Canada

Health Canada ShowcaseThe following activities illustrate the diversity ofHealth Canada’s involvement with complementary andalternative health care (CAHC) and natural healthproducts (NHPs). The following program areas areparticipating in an intradepartmental initiative to definepolicy issues and Health Canada’s role in this area.

• CAM in Medical CurriculaThe Department’s Health Human Resource StrategiesDivision, Health Policy and CommunicationsBranch, is working with the University of Calgaryand the Association of Canadian Medical Collegeson a curriculum-related research initiative tofacilitate the physician’srole with respect to com-plementary and alternativemedicine (CAM). Havingagreed to include CAMcontent, Canadianundergraduate medicaleducation programs arecurrently identifyingand developing capacity-building tools in the areasof knowledge, skills andattitudes. With assistancefrom Health Canada, anational team of educatorsis working on curriculumimplementation issues andheld a workshop in thefall of 2003. Policy researchissues include the recogni-tion of CAM within the

conventional health care system and the role ofphysician information in decision making. For moreinformation, e-mail: [email protected] [email protected]

• Health Promotion and CAHCThe Health Policy and Communications Branchinitiated policy research on a variety of CAHChealth systems issues, including information, informedchoice, educational approaches and product/practiceissues. Building on this work, the Health Productsand Food Branch incorporated health promotionas a component of the Natural Health ProductsDirectorate’s responsibilities in implementing anNHP regulatory framework. Current policy researchactivities include enhancing information providedto the public and practitioners, developingpractitioner research capacity and contributing todepartmental policy development (see: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/research_e.html).

• Informing the PublicThe Canadian Health Network, Population andPublic Health Branch, provides multiple sources ofcredible and practical electronic health promotionand disease and injury prevention information to

Canadians, including infor-mation on CAHC and NHPs.Policy research questionsfocus on, for example, assess-ing information source andquality, and balancing diverseperspectives (see: http://www.canadian-health-network.ca).

• NHP Research ProgramFollowing up on the recom-mendations made by the1998 Standing Committeeon Health in its report onNHPs, the Natural HealthProducts Directorate willwork with other HealthCanada jurisdictions, theCanadian Institutes forHealth Research and externalpartners to invest $5 million

Practitioner-deliveredhealth care

(provincial/territorial)

Information(all levels)

Self care(individuals)

Product-specificaspects(federal)

Maintainingand improvingthe health ofCanadians

Joan E. Simpson, July 2003.

Integrative Health Care


Who’s Doing What?

over the next five years to support a variety ofresearch initiatives in the area of NHPs. The researchwill focus on themes such as support of originalproduct research, building research capacity, devel-oping community infrastructure and partnerships,and enhancing knowledge transfer (see: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/research_e.html).

Highlights of External Activities• Interdisciplinary Capacity Enhancement Network, Funded

by the Canadian Institutes for Health ResearchThe goal of the Complementary and AlternativeMedicine — Interdisciplinary Capacity EnhancementNetwork (CAM ICE) is to create a sustainable, well-connected research community in Canada that isinternationally recognized for its excellence andcontributions to understanding CAM and its use.Led by researchers from the University of Torontoand the University of Calgary, theteam will include professionalsfrom various disciplines, includingmedical sociology, pharmacology,epidemiology, medicine, chiro-practic, naturopathic medicineand ethics. Among the issues CAMICE will focus on are: building asustainable network that supportsresearchers studying CAM from ahealth services and policy per-spective; developing researchpriorities, agenda and capacity;promoting knowledge transferamong researchers, health carepractitioners, policy makers,research funders and the public;and linking with other relevantnetworks, organizations and edu-cational institutions. For moreinformation, contact: Dr. HeatherBoon ([email protected])or Dr. Marja Verhoef ([email protected]).

• Use of Complementary Therapies by Cancer Patients,Funded by the National Cancer Institute of CanadaThere are indications that interest in and use ofcomplementary therapies is increasing among can-cer patients. A new study led by the University of

Saskatchewan in conjunction with researchers fromfive other provinces will examine the prevalence,characteristics and use patterns of complementarytherapies by cancer patients in six Canadianprovinces during the first two years after diagnosis.The study, which aims to generate data currentlyunavailable in Canada, will provide informationrelevant to patients and their families, healthprofessionals and the health care system. Formore information, contact: Dr. Anne Leis([email protected]).

• CAM and Children and Youth: Legal, Ethical and ClinicalIssues, Funded by the Hospital for Sick Children FoundationAlthough the use of CAHC and NHPs is growingrapidly in Canada, little is known about their useamong children. Because of the vulnerability of thepaediatric population, this application raises spe-cific legal, ethical and clinical concerns. Plans are

currently under way for an inter-disciplinary research project thatwill develop the basis for a poli-cy framework for considerationby hospitals, relevant profes-sional organizations andgovernment bodies. Led byOsgoode Hall Law School atYork University, TorontoHospital for Sick Children, theUniversity of Toronto and theUniversity of Alberta, the projectwill involve researchers fromthe University of Alberta, YorkUniversity, Toronto Hospital forSick Children, Canadian Collegeof Naturopathic Medicine andHarvard University. In the firststage of the study, researchers willcollect and analyze Canadian andAmerican data on legal, ethicaland clinical issues raised by theuse of CAHC and NHPs forchildren. In the second stage, case

scenarios will be developed to help identify gaps ininformation and generate recommendations forfuture health policies. For more information, con-tact: Dr. Joan Gilmour ([email protected])or Dr. Christine Harrison ([email protected]).

Little is known about the use of CAHC

and NHPs among children.

Because of the vulnerability of

the paediatric population, this application

raises specific legal, ethical and clinical

concerns. Plans are currently under way

for an interdisciplinary research project

that will develop the basis for a policy

framework for consideration by hospitals,

relevant professional organizations and

government bodies.


Microsimulation models are becoming increasinglypopular among policy makers because they signifi-cantly enhance the evidence base for decision makingby demonstrating the implications of policy optionsbefore they are put in place. The models work byimposing a policy change on individuals and house-holds, and comparing the results to the status quo.The impacts are then “rolled up” to a level of aggrega-tion useful for policy analysis. A sensitivity analysiscan determine the “winners and losers,” that is, whichtypes of households are better or worse off as a resultof the policy change. These impacts are displayed intables and graphs organized according to varioussocioeconomic factors, such as income level, educa-tion level and family type (e.g., seniors, two-parent,single-parent).

The PHARMASIM Microsimulation ModelBoth the final report of the Commission on the Futureof Health Care in Canada1 (the Romanow report)and the Senate Committee Report, The Health of

Canadians — The Federal Role2 (the Kirbyreport), drew attention to rising drug

costs in Canada. The Kirby reportobserved that many Canadians

are becoming at risk forfinancial hardship due to thehigh cost of prescriptiondrugs. To assess this hard-ship, policy analysts needinformation about theextent and degree of drugcoverage in Canada. Health

Canada’s PHARMASIMmicrosimulation model not

only provides this information,it also enables analysis of the

fiscal and distribution effects of awide range of options for enhancing

drug insurance benefits.

Models Need Sound DataOne of the problems in building a reliable micro-simulation model is the lack of a single data sourcecontaining information about all the necessary “realworld” variables, for example, socioeconomic status,

Using Canada’s Health Data is a regular column ofthe Health Policy Research Bulletin highlighting

some of the methodologies commonly used in analyzinghealth data. This issue focuses on microsimulationmodelling and illustrates how it can be used to deter-mine the potential impact of various policy options.

Microsimulation Modelling: A Tool forPolicy Analysis

Vishnu Kapur and Kisalaya Basu, Applied Research and AnalysisDirectorate, Information Analysis and Connectivity Branch, HealthCanada

Policy makers are often faced with the task of choosingthe most appropriate policy from an array of possibleoptions. Typically, policy analysis tools such as macro-models help to inform decision makers about theimpact that policies are likely to have on governmentfinances and “average” Canadians. In many cases,however, decision makers also want information thatwill help them gauge how policies will affect differentsubgroups of the population including, forexample, seniors, low-income familiesand single-parent families.

What Are Microsimulation Models?Microsimulation models usemicro data — i.e., household orindividual level data — to showthe distributional impact of poli-cy changes on individuals orindividual households, as well ason government finances. They dothis by using a simplified repre-sentation of “real world” individualsor households to simulate the effect ofpolicy changes. The data underlying themodels — which can include hundreds orthousands of observations — embody a built-inpopulation that often has the same distribution ofcharacteristics as the actual population. Models suchas these can also incorporate the rules of differentexpenditure and/or tax programs, allowing researchersto calculate the financial impact of policy changes onhouseholds or individuals in the database.


Using Canada’s Health Data

1. Survey of Consumer Finances (SCF)

2. Survey of Household Spending (SHS)

3. Personal Income Tax System

4. National Population Health Survey

5. Private Insurance Claims Data

6. Public Plan Claims Data

Newfoundland and Labrador

Prince Edward Island

Nova Scotia

New Brunswick

Québec

Ontario

Manitoba

Saskatchewan

Alberta

British Columbia

All provinces

Table 1: Data Sources and Available Variables

Detailed

Summary

Some

Summary

Some

Some

Variables Available

Source Data Socioeconomic Drug Coverage Tax Deductions Drug Expenses

No

Partial

No

Yes

Not explicitly

Not explicitly

No

No

Yes

No

No

No

No

Out-of-pocket only

No

No

Yes

Yes

Table 2: Extent of Coverage in Canada (% of Population)

Province Conventional Conventional Plansand Catastrophic Plans

(%) Total (%) Public (%) Private (%)

67.8

71.5

78.1

75.1

100.0

100.0

100.0

100.0

80.1

100.0

96.1

67.8

71.5

78.1

75.1

100.0

83.3

69.0

67.3

80.1

76.8

84.5

20.5

24.4

19.7

17.9

43.3

22.8

8.8

15.3

16.5

21.6

26.1

47.3

47.1

58.4

57.2

56.7

60.4

60.2

52.0

63.7

55.2

58.4



Understanding Current Patterns of CoverageAs indicated in Table 2, the new database can be usedto illustrate the extent of drug coverage in Canada.5

Drug coverage can be analyzed along two dimensions— whether or not a household has any coverage at all,and the degree to which each household is covered.The data show that more than 96 percent of Canadianshave some form of drug coverage. Almost 85 percenthave a conventional (non-catastrophic) plan thatcompensates to varying degrees for a considerable

gross drug outlays, drug insurance coverage andout-of-pocket expenses. In the case of PHARMASIM,Health Canada researchers synthesized data from sixdifferent sources to develop a comprehensive databaseon drug expenditures and coverage. As Table 1 shows,each data source contains a unique “slice” of theinformation required for the PHARMASIM database.A number of statistical techniques were employed tomeld data from these diverse sources, including statis-tical matching and imputation.3,4

Figure 2: Impacts of Proposed Drug Subsidies

Figure 1: Comparison of Provincial Drug Benefits for a Typical Senior Couple with Annual Drug Costs of $1,000

$1,000

$800

$600

$400

$200

0Nfld. P.E.I. N.S. N.B. Qué. Ont. Man. Sask. Alta. B.C.

Total family income of $24,000Total family Income of $50,000

Number of prescriptions = 20

80

60

40

20

0

Total benefits as a proportion of drug expensesWinner families as a proportion of all families

Perc

enta

ge

Family income< $10,000 $10,000–$20,000 $20,000–$30,000 $30,000–$40,000 $40,000–$50,000 $50,000–$60,000 $60,000–$80,000 $80,000+



portion of prescription drug expenses. One quarter(26 percent) of Canadians are covered by a provincial(public) plan, compared to 58 percent that have apurely private plan (such as an employer-providedplan). In some cases, there is overlap between publicand private plans.

Modelling the Status QuoUsing the new database and informationon provincial drug plans, PHARMASIMcan model existing provincial drug benefitsfor various Canadian sub-populations.Figure 1 illustrates the considerableprovincial variation in drug insurancecoverage for senior couples with lowand average incomes. All provincescover the drug costs of low-incomehouseholds, for example, those on theGuaranteed Income Supplement (GIS)or social assistance. However, seniors withhigher incomes are not provided withprovincial coverage in New Brunswick,Newfoundland and Labrador, Manitobaor Saskatchewan (although the latter twoprovinces offer catastrophic coverage).

Econometric analysis models5 canprovide further insights into patterns ofcoverage. For instance, the groups mostvulnerable for lack of coverage generallyinclude: people living in rural areas;young adults (under 35 years of age);adults aged 55–64; single people; peoplewith no post-secondary education;self-employed or part-time workers;households in lower income brackets($10,000–$30,000); and people livingin Atlantic Canada, Manitoba andSaskatchewan. People in the 55–64 agegroup tend to have the highest out-of-pocket drug expenses because they havehigh drug consumption rates and rela-tively low rates of drug coverage. Thisgroup is not as well covered as the youngerage groups because many people have leftthe work force due to early retirementor health problems. Neither is the 55–64age group as well covered as seniors, whoare eligible for provincial drug plans.

A Hypothetical Policy ChangeA hypothetical example helps to illustrate how a micro-simulation model works in practice. Consider a policyoption that would provide drug subsidies to familiesthat have high drug expenses relative to their income.Such a plan would provide supplementary benefits to

individuals or households in additionto the benefits provided by theirexisting provincial and/or privateplans. Capped at $1,500, the benefitswould equal family out-of-pocketdrug expenses above a progressivedeductible of 1 percent to 3 percent ofnet family income. (It should benoted that this proposal is not madein either the Romanow or the Kirbyreports, although some features fromthese reports were used to developthis example.)

According to PHARMASIM, theproposal would reduce family out-of-pocket expenses by a third (over andabove expenses that are currentlyreimbursed). As Figure 2 illustrates,the proposal is progressive because itfavours families with lower incomes.There are no “losers” under the proposedplan and the number of “winning”families declines with income, as doesthe average amount of gain.

ConclusionIdentifying the Canadians most likelyto suffer financially from high drug costscan help policy makers design phar-macare programs that best meet therequirements of those who need themthe most. By providing distributionaland fiscal estimates of the impact ofnew programs and changes to existingprograms, microsimulation modelssuch as PHARMASIM can help ensurethese programs balance affordabilityand effectiveness.

Ahypothetical

example helps to

illustrate how a

microsimulation model works in

practice. Consider a policy option

that would provide drug subsidies

to families that have high drug

expenses relative to their income.

Such a plan would provide

supplementary benefits to

individuals or households in addi-

tion to the benefits provided by

their existing provincial and/or

private plans. Click here for references.@


Modelling Human Resource NeedsWorking in collaboration with the Health Resourcingand Economics Branch of Alberta Health and Wellness,Health Canada’s Microsimulation Modelling andData Analysis Division (MSDAD) has built a HealthHuman Resources (HHR) demand model that calcu-lates the requirements for physicians and registerednurses in Alberta from 2000–2030. Completed inDecember 2002, the model simulates the relationshipbetween the health characteristics of the populationand the human resources required to meet its healthneeds. Such a model, when combined withMSDAD’s HHR supply models, can help HealthCanada examine the implications of populationaging for HHR supply and demand and identifypotential gaps. The information can then beused to develop focused and informed policyresponses at the national and provinciallevels. For more information, e-mail:[email protected]

Climate Change andHealthThe health and social impacts of climatechange on Canadians within the context ofthe Kyoto Protocol was the focus of recentdiscussion at an Expert Panel Workshop onClimate Change and Health & Well-beingin Canada. Organized by the University ofOttawa, the workshop will provide input toHealth Canada’s Climate Change and HealthOffice (CCHO) as it leads the developmentof the health component of the next NationalClimate Change Impact Assessment. Canadais scheduled to complete the Assessmentby 2005 as part of its commitment to the UnitedNations Framework Convention on Climate Change(UNFCCC). Updates on relevant policy researchactivities on climate change and health are availableat: http://www.hc-sc.gc.ca/cc

Improving the Health of CanadiansIn December 2003, the Canadian Population HealthInitiative (CPHI) of the Canadian Institute of HealthInformation (CIHI) will release a policy report entitledImproving the Health of Canadians. Part of CPHI’sstrategy to provide information on population healthissues and stimulate public dialogue on the determi-nants of health, the report will provide up-to-dateinformation on the health of Canadians. Major topicsinclude the health of Aboriginal people and the healtheffects of income distribution, early childhood devel-opment and obesity. More information can be foundat: http://www.cihi.ca

Support for Health Policy Research

Health Canada’s Health Policy ResearchProgram (HPRP) funds extramural,

peer-reviewed research that contributesto the evidence base for the department’s

policy decisions. HPRP supports a range ofinitiatives including: primary, secondary andsynthesis research; policy research workshops;developmental contributions; and federal/provincial/territorial partnerships to fundresearch of national significance. Since theprogram’s inception in 2000, 22 initiativeshave been funded; five of the projects com-pleted to date are summarized below. Formore information about the HPRP or toobtain summaries of the project reports,e-mail: [email protected]

• Informal Care Networks for Seniors This study tested policy assumptions aboutthe capacity of informal networks, such asfamily, friends and neighbours, to providesustained care to frail, elderly Canadians.Using data from the 1996 Canadian GeneralSocial Survey, the study examined the charac-teristics of informal care networks for peopleaged 65 and over living with a long-termhealth limitation. The findings show thatthese networks are generally small in size,

oteworthy

New and Noteworthy is a regular column of theHealth Policy Research Bulletin highlighting

“up and coming” policy research in the health field.


New and Noteworthy

female and kin dominated, and made up of youngto middle-aged people who live in separate house-holds from the care recipients. For more informationon this study, e-mail: [email protected]

• Integrative Health CareThere is evidence that complementary and alternativehealth care (CAHC) is being integrated with con-ventional medicine, at least at the consumer level.However, the wide range of perceptions aboutwhat constitutes integrative health care (IHC) hasmade policy decisions in this area difficult.This issue was the impetus for aworkshop entitled “IntegrativeHealth Care: Defining andOperationalizing theFundamental Elements,”which aimed to develop aworking definition of IHCand identify outcomes andindicators at the patient, prac-titioner and clinical levels. Areport summarizing the results ofthe workshop may be obtained bye-mail: [email protected]

• Enhancing Telehealth ServicesThe 2002 National TelehealthCoordinators Workshop assembledguidelines and tools to assist indecision making, promote best prac-tices and improve the consistencyand efficiency of telehealth servicedelivery. Sixty telehealth coordinatorsfrom across the country participatedin the workshop, which was held inOctober. A report summarizingrecommendations on such issues asoperational standards, skills andcore competencies may be obtainedby e-mail: [email protected]

• Health Care Settings and Public PolicyRecent health restructuring in Canadaand Sweden has increased the numberand type of settings in which care isdelivered. As a result of fiscal anddemographic pressures, technologicaladvances, globalization and changesin social attitudes, a broad spectrum

of health care services is now available in hospitals,homes, clinics, schools and the workplace. Under-standing the challenges posed by health care that isgeographically decentralized and technology mediatedwas the focus of a five-day research workshop at theUniversity of Toronto in June 2002. Participants fromresearch and public policy sectors in Canada andSweden explored research on health care, technologyand place, and the implications for diverse policysectors — such as housing, social services andinternational trade — of providing geographically

dispersed health care services. Severalinterdisciplinary, cross-professional,

cross-national and cross-sectoralresearch and knowledge trans-

lation activities were developedduring and after the workshop.To learn more about theseactivities or to access a copy

of the final workshop report e-mail: [email protected]

• Telehealth Research SummerInstitute Hosted by the Health TelematicsUnit at the University of Calgary,the Telehealth Research SummerInstitute (TRSI) is an annual eventthat focuses on advancing policyand research through evaluation oftelehealth programs and telelearn-ing initiatives in health care. Thethird TRSI was held in July 2002and issues concerning the socio-economic, technical and policyimpacts of telehealth provideda framework for developingrecommendations about futuredirections. Discussions at thefourth TRSI, which took placeJune 25–27, 2003, focused on adocument entitled Final Report for3rd Annual Telehealth ResearchSummer Institute. For more infor-mation, see: http://www.ucalgary.ca/telehealth or e-mail: [email protected]

Hosted by the

Health Telematics Unit at the

University of Calgary, the

Telehealth Research Summer

Institute (TRSI) is an annual

event that focuses on advancing

policy and research through

evaluation of telehealth

programs and telelearning

initiatives in health care.


November 22–24, 2003Montréal, Québec

http://www.ellisriley.on.ca/IHSPR

December 4–6, 2003Washington, DC

http://www.asaging.org/icadi/03/index.cfm

December 8–12, 2003Canberra, Australia

http://www.natsem.canberra. edu.au/

January 26–30, 2004San Diego, California

http://www.charityadvantage.com/chadwickcenter/2004Conference.asp

January 28–30, 2004Washington, DC

http://www.academyhealth.org/nhpc/

February 18–20, 2004Washington, DC

http://www.cdc.gov/nccdphp/conference/

February 18–22, 2004Orlando, Florida

http://www.preventivemedicine2004.org/

February 29–March 3, 2004Atlanta, Georgia

http://www.iceid.org/default.asp

March 17–20, 2004Washington, DC

http://womenmentalhealth.com/congress/default.htm

April 26–30, 2004Melbourne, Australia

http://www.health2004.com.au/

Strengthening Foundations:Health Services and PolicyResearch — CanadianHealth Care

International Conferenceon Aging, Disability andIndependence

International MicrosimulationConference on PopulationAging and Health: ModellingOur Future

San Diego Conference on Child and FamilyMaltreatment

2004 National Health PolicyConference

18th National Conference onChronic Disease Preventionand Control

Preventive Medicine 2004

International Conferenceon Emerging InfectiousDiseases

2nd World Congress onWomen’s Mental Health

XVIIIth World Conferenceon Health Promotion andHealth Education

Role of health services and policy researchin solving Canada’s most pressing health caresystem and delivery issues

Issues and key findings in research anddevelopment, practice, products, servicesand policies

Microsimulation models and other modellingapproaches used to examine populationaging and health issues

Prevention, diagnosis, treatment and prose-cution of child and family maltreatment

Health policy scan to identify key healthcare issues confronting policy makers

Investing in health: The dollars and senseof prevention

Forum for policy makers, health care pro-fessionals and physicians focusing on fourareas: public health care practices, clinicalpreventive medicine, health care qualityimprovement and prevention policy issues

Exchange of scientific and public healthinformation on emerging infectious diseasesaround the world, including infectious agentsin farming and food production, and antimi-crobial resistance

State-of-the-art developments in biopsy-chosocial aspects of women’s mentalhealth, psychology, psychopharmacologyand other treatments

Information in a range of areas, includinghealth promotion, methodological issues,population groups and health care settings

What When Theme

Mark Your Calendar


References

ReferencesReferences for “Some Commonly Used Terms”(p. 2)

1. Ernst, E., et al. (1995). Complementary medicine —a definition. Journal of General Practice, 45, 506.

2. World Health Organization. (1998). Health PromotionGlossary.

3. Achilles, R., Adelson, N., Antze, P., Biggs, C., Chabot, P.,Gilmour, J., Jensen, P., & Muldoon, J. (1999). Complemen-tary and Alternative Health Practices and Therapies — ACanadian Overview. Toronto, ON: York University Centrefor Health Studies.

4. World Health Organization. (1986). Ottawa Charter forHealth Promotion.

5. Definition adopted by consultant teams for Health Productsand Food Branch Health Promotion Initiative, 2002.

6. Health Canada, Health Products and Food Branch, NaturalHealth Products Directorate, Expert Advisory Committeeon Natural Health Products. (2001).

7. Health and Welfare Canada. (1986). Achieving Health forAll: A Framework for Health Promotion, Ottawa, ON: Author.

References for “Alternative Practices andProducts: A Survival Guide” (p. 3)

1. Jonas, W., & Levin, J. (1999). Essentials of Complementaryand Alternative Medicine. New York: Lippincott Williamsand Wilkins.

2. Astin, J. (1998). Why patients use alternative medicine.Journal of the American Medical Association, 279, 1548-1553.

3. Health Canada. (2001). Perspectives on Complementary andAlternative Health Care: a collection of papers prepared forHealth Canada. Ottawa, ON: Author.

4. Achilles, R., Adelson, N., Antze, P., Biggs, C., Chabot, P.,Gilmour, J., Jensen, P., & Muldoon, J. (1999). Complemen-tary and Alternative Health Practices and Therapies — ACanadian Overview. Toronto, ON: York University Centrefor Health Studies.

5. Launso, L. (1995). A description of reflexology practiceand clientele in Denmark. Complementary Therapies inMedicine, 3(4), 206-211.

6. Ernst, E., & Hahn, E. (1998). Homeopathy: A CriticalAppraisal. London: Butterworth Heinemann.

7. World Health Organization. (2001). Legal Status ofTraditional Medicine and Complementary/AlternativeMedicine. Geneva, Switzerland: Author.

8. Vickers, A. (1996). Can acupuncture have specific effectson health? A systematic review of acupuncture anti-emesistrials. Journal of Royal Society of Medicine, 89, 303-311.

9. Quon, J. (1998). Spinal manipulation therapy: A review ofrandomised controlled trials and possible biological effects.Paper presented at the Art and Science of Healing Conference,November 2001, Vancouver, BC: Tzu Chi Institute.

10. de Bruyn, T. (2003). Integrative Health Care: Defining andOperationalizing the Fundamental Elements — WorkshopReport.

11. Health Canada, Natural Health Products Directorate. (2002).Perspectives on Natural Health Products: A collection ofexecutive summaries from stakeholder consultation reports2001-2002. Ottawa, ON: Author.

References for “Utilization Patterns and Trends”(p. 9)

1. de Bruyn, T. (2001). Taking Stock: Policy Issues Associatedwith Complementary and Alternative Health Care. In HealthCanada, Perspectives on Complementary and AlternativeHealth Care: a collection of papers prepared for HealthCanada (pp. II.21-II.23). Ottawa, ON: Author. Availableon the Natural Health Products Directorate website:http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/

2. de Bruyn, T. (2002). A Summary of National Data onComplementary and Alternative Health Care. Contractreport prepared for Health Canada, Health HumanResource Strategies Division (pp. 2-8). Ottawa, ON:Author. Available on the Natural Health ProductsDirectorate website: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/

3. Tataryn, D., & Verhoef, M. (2001). Combining Conventional,Complementary and Alternative Health Care: A Vision ofIntegration. In Health Canada, Perspectives on Complemen-tary and Alternative Health Care: a collection of papersprepared for Health Canada (pp. VII.87-VII.93). Ottawa,ON: Author. Available on the Natural Health ProductsDirectorate website: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/

4. Speaking notes prepared for Ian Shugart, Assistant DeputyMinister, Health Policy and Communication Branch, HealthCanada, for plenary session What Our Future DoctorsNeed to Know About CAM at the Annual Meeting of theAssociation of Canadian Medical Colleges, Toronto, ON,May 1, 2001 (unpublished).

5. Hay Health Care Consulting Group. (2001). BergerPopulation Health Monitor Overview Report March 2001.

6. Hay Health Care Consulting Group. (1999). BergerPopulation Health Monitor Overview Report March 1999.

7. Millar, W.J. (2001). Patterns of use — alternative healthcare practitioners. Health Reports, 13(1), 9-21.


References

8. Health Canada. (2001). Introduction. In Perspectives onComplementary and Alternative Health Care: a collectionof papers prepared for Health Canada (pp. ii-iii). Ottawa,ON: Author. Available on the Natural Health ProductsDirectorate website: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/

9. Eisenbery, D.M., Kessler, R.C., Foster, C., et al. (1993).Unconventional medicine in the United States: Prevalence,costs and patterns of use. New England Journal of Medicine,328(4), 246-252.

10. Eisenberg, D.M., Davis, R.B., Ettner, S.L., et al. (1998).Trends in alternative medicine use in the United States,1990-97: results of a follow-up national survey. Journal ofthe American Medical Association, 280(18), 1569-1575.

11. Ramsay, C., Walker, M., & Alexander, J. (1999). Alternativemedicine in Canada: Use and public attitudes. Public PolicySources, 21. Fraser Institute.

12. MacLennan, A.H., Wilson, D.H., & Taylor, A.W. (1996).Prevalence and cost of alternative medicine in Australia.The Lancet, 37, 569-573.

13. Millar, W.J. (1997). Use of alternative health care practi-tioners by Canadians. Canadian Journal of Public Health,88(3), 154-158.

14. So, J. (1997). Utilization of alternative therapies by theCanadian population: A preliminary study. In J. Muldoon(Ed.), Taking Charge of Health: Exploring AlternativeHealth Care. Conference proceedings sponsored by TrentUniversity, Peterborough, ON.

15. Blais, R., Maiga, A., & Aboubacar, A. (1997). How differentare users and non-users of alternative medicine? CanadianJournal of Public Health, 38(3), 159-162.

16. Angus Reid Group Inc. (1998). Use and danger of alterna-tive medicines and practices: Parts I and II. Consumer pollconducted by CTV/Angus Reid Group Poll in August 1997.

17. Achilles, R., et al. (1999). Consumer Use and Knowledge.In York University Centre for Health Studies, Complementaryand Alternative Health Practices and Therapies — A CanadianOverview (pp. 253-266). Toronto, ON: Author. Available onthe York University website.

18. Astin, J. (1998). Why patients use alternative medicine.Journal of the American Medical Association, 279, 1548-1553.

19. Health Canada. Documentation for Statistics Canada’sNational Population Health Survey, 2000.

20. Boisset, M., & Fitzcharles, M. (1994). Alternative medicineuse by rheumatology patients in a universal health caresetting. Journal of Rheumatology, 21, 148-153.

21. Kestin, M., et al. (1985). Medical Journal of Australia, 143,516-519.

22. Kronenfeld, J.J., & Wasner, C. (1982). The use of unortho-dox therapies and marginal practitioners. Social Scienceand Medicine, 16, 1119-1125.

23. Wister, A.V., et al. (2002). Using alternative therapies tomanage chronic illness among older adults. CanadianJournal on Aging, 21(1), 47-62.

24. Crouch, R., Elliott, R., Lemmens, T., & Charland, L. (2001).In Canadian HIV/AIDS Legal Network, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical andPolicy Issues in Regulation (p. 15). Toronto, ON: Author.

25. Data collected by Health Canada, Centre for ChronicDisease Prevention and Control, for Progress Report onCancer Control in Canada, for 2003 publication.

References for “Did You Know?” (p. 14)

1. O’Neill, A. (1994). Danger and safety in medicines. SocialScience and Medicine, 38(4), 497-507.

2. Rane, A., & Wilson, J.T. (1976). Clinical pharmacokineticsin infants and children. Clinical Pharmacokinetic, 1(1), 2-24.

3. Munzenberger, P.J., & McKercher, P. (1980). Pediatric dosing— the pharmacist’s dilemma. Contemporary PharmaceuticalPractice, 3(1), 11-14.

4. Anonymous. (2003). Pediatric considerations. Available at:http://www.cheos.ubc.ca/Pediatric.pdf

5. Reich, I., Schnaare, R.L., & Sugita, E.T. (2000). Pharmaceuticalcalculations. In A.R. Gennaro (Ed.), Remington: TheScience and Practice of Pharmacy (20th ed.), (pp. 110-111).Philadelphia: Lippincott Williams & Wilkins.

6. Cancer Care Ontario Drug Formulary. (2003). Appendix 4— Calculation of body surface area (BSA). Available at:http://www.cancercare.on.ca/formulary/bodysurface.html

7. de Bruyn, T. (2002). The Role of Natural Health Productsand Complementary and Alternative Health Care inHIV/AIDS — Developing a Research Agenda: An InvitationalRoundtable. In Health Canada, Natural Health ProductsDirectorate, Perspectives on Natural Health Products: Acollection of executive summaries from stakeholder consul-tation reports 2001-2002 (pp. 25-27). Ottawa, ON: Author.

8. Rochon, P.A., Clark, J.P., & Gurwitz, J.H. (1999). Challengesof prescribing low-dose drug therapy for older people.Canadian Medical Association Journal, 160, 1029-1031.

9. Rochon, P.A., Anderson, G.M., Tu, J.V., Gurwitz, J.H., Clark,J.P., Shear, N.H., & Lau, P. (1999). Age- and gender-relateduse of low-dose drug therapy: the need to manufacturelow-dose therapy and evaluate the minimum effective dose.Journal of the American Geriatric Society, 47(8), 954-959.


References

10. Le Bars, P.L., et al. (North America EGb Study Group).(1997). A placebo-controlled, double-blind, randomizedtrial of an extract of Ginkgo biloba for dementia. Journalof the American Medical Association, 278, 1327-1332.

11. Dhainaut, J-F.A., Tenailion, A., Tulzo, Y.L., Schlemmer, B.,Solet, J.-P., Wolff, M., Holzapeel, L., Zeni, F., Dreyfuss,D., Mira, J.-P., Vathaire, F., & Guinot, P. (1994). Platelet-activating factor receptor antagonist BN 52021 in thetreatment of severe sepsis: A randomized, double-bind,placebo-controlled, multicenter clinical trial. Critical CareMedicine, 22(11), 1720-1728.

12. de Bruyn, T. (2001). Taking Stock: Policy Issues Associatedwith Complementary and Alternative Health Care. In HealthCanada, Perspectives on Complementary and AlternativeHealth Care: a collection of papers prepared for HealthCanada (pp. II.1-II.39). Ottawa, ON: Author.

13. Barnes, J., et al. (1998). Different standards for reportingADRs to herbal remedies and conventional OTC medicines:face to face interviews with 515 users of herbal remedies.British Journal of Clinical Pharmacology, 45, 496-500.

References for “Finding the Balance: Safety,Effectiveness and Access” (p. 16)

1. Casey, J., & Picherack, F. (2001). The Regulation ofComplementary and Alternative Health Care Practitioners:Policy Considerations. In Health Canada, Perspectives onComplementary and Alternative Health Care: a collectionof papers prepared for Health Canada (pp. VI.65-VI.66).Ottawa, ON: Author.

2. Canadian HIV/AIDS Legal Network. (2002). Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical andPolicy Issues in Regulation. Toronto, ON: Author, p. 15.

3. Pawlich, D., Cain, R., & Gillet, J. (2002). Lay Constructionsof HIV and Complementary Therapy Use. In CanadianHIV/AIDS Legal Network, Complementary/AlternativeHealth Care and HIV/AIDS: Legal, Ethical and PolicyIssues in Regulation (p. 16). Toronto, ON: Author.

References for “Natural Health Products: AnInnovative Approach to Regulation” (p. 19)

1. Health Canada, Natural Health Products Directorate. (2003).Business Impact Test on the Natural Health ProductsRegulations. Ottawa, ON: Consulting and Audit Canada.

2. Volpe, J. (1998). Natural Health Products: A New Vision.Report of the Standing Committee on Health. Ottawa, ON:House of Commons. Available at: http://www.parl.gc.ca/InfoComDoc/36/1/HEAL/Studies/Reports/healrp02-e.htm

3. European Agency for the Evaluation of Medicinal Products(EMEA). (1999, November). Working Party on Herbaland Medicinal Products. See: http://www.emea.eu.int/htms/human/hmpwp/hmpwpfin.htm.

4. Government of Australia, Therapeutic Goods Administration.(2003, August 18). See: http://www.health.gov.au/tga/cm/cm.htm

5. US Food and Drug Administration. (1994). DietarySupplement Health Education Act of 1994. See:http://www.fda.gov/opacom/laws/dshea.html

References for “The Evidence Base forEvaluating Natural Health Products” (p. 23)

1. West, S., King, V., Carey, T.S., Lohr, K.N., McKoy, N., Sutton,S.F., & Lux, L. (2002). Systems to rate the strength of scientificevidence. Evidence Report/Technology AssessmentNumber 47, AHRQ Publication No. 02-E016. Rockville,MD: Agency for Healthcare Research and Quality.

2. World Health Organization. (2001). General guidelinesfor methodologies on research and evaluation of traditionalmedicine. WHO/EDM/TRM/2000.1. Geneva, Switzerland:Author.

3. European Agency for the Evaluation of MedicinalProducts (EMEA). (1999, January). Ad hoc WorkingGroup on Herbal Medicinal Products. Draft points toconsider on the evidence of safety and efficacy requiredfor well-established herbal medicinal products in biblio-graphic applications.

4. Government of Australia, Therapeutic Goods Administration.(2001, October). Guidelines for levels and kinds of evidenceto support indications and claims for non-registerable medi-cines, including complementary medicines, and otherlistable medicines. Canberra City, Australia: Author.

5. Wren, R.C. (1907). Potter’s Cyclopaedia of Botanical Drugsand Preparations. London: Potter & Clarke.

6. Blumenthal, M., Busse, W.R., Goldberg, A., Gruenwald, J.,Hall, T., Riggins, C.W., & Rister, R.S. (Eds.). (1998). TheComplete German Commission E Monographs. TherapeuticGuide to Herbal Medicines. Austin, TX: American BotanicalCouncil, and Boston: Integrative Medicine Communications.

7. Brinker, F. (2001). Herb Contraindications and DrugInteractions (3rd Ed.). Sandy, OR: Eclectic MedicalPublications.

8. McGuffin, M., Hobbs, C., Upton, R., & Goldberg, A.(Eds.). (1997). American Herbal Products Association’sBotanical Safety Handbook. Boca Raton, FL: CRC Press.

9. Blumenthal, M. (Ed.). (2003). The ABC Clinical Guide toHerbs. Austin, TX: American Botanical Council.

10. Health Canada. (1997, May 23). Warning not to use theArise & Shine product “Chomper.” Health CanadaAdvisory 1997-36.

11. US Food and Drug Administration. (1997, July 2). FDAwarns consumers against dietary supplement productsthat may contain digitalis mislabeled as “plantain.” Press


References

Office, Food and Drug Administration, US Departmentof Health and Human Services.

12. Health Canada. (2003). Draft Guidance Document GoodManufacturing Practices for Natural Health Products.Available at: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/gmp_guide_cp_e.html

13. World Health Organization. (1999). WHO Monographson Selected Medicinal Plants (Vol. 1). Geneva, Switzerland:Author.

14. World Health Organization. (2002). WHO Monographson Selected Medicinal Plants (Vol. 2). Geneva, Switzerland:Author.

15. European Scientific Cooperative on Phytotherapy.(1996–1999). Fascicles 1-6: Monographs on the MedicinalUses of Plant Drugs. Exeter, UK: ESCOP Secretariat,Argyle House.

16. Bradley, P.R. (Ed.). (1992). British Herbal Compendium(Vol. 1). Bournemouth, Dorset, UK: British Herbal MedicineAssociation.

17. Upton, R. (Ed.). (1999). American Herbal Pharmacopoeiaand Therapeutic Compendium: Willow Bark, Salix spp.Analytical, Quality Control, and Therapeutic Monograph.Santa Cruz, CA.

References for “Using Canada’s Health Data” (p. 30)

1. Commission on the Future of Health Care in Canada.(2002). Building on Values: The Future of Health Care inCanada (The Romanow Report). Ottawa, ON: NationalLibrary of Canada.

2. The Senate of Canada. (2002). The Health of Canadians— The Federal Role. Final Report on the State of HealthCare System in Canada. Volume Six: Recommendations forReform, M.J.L. Kirby, Chair. Ottawa, ON: Standing SenateCommittee on Social Affairs, Science and Technology.

3. Basu, K., & Kapur, V. (2003). Imputing a binary variablefrom donor to recipient dataset when recipient datasetholds restricted information on the variable. Forthcomingin Health Services and Outcomes Research Methodology.

4. Gupta, A., & Kapur, V. (2003). A Microsimulation modelfor Pharmacare: Development, Analysis and PolicyApplications. Paper to be presented at International Micro-simulation Conference, Canberra, Australia, December 2003.

5. Kapur, V., & Basu, K. (2003). Drug Coverage in Canada: Whoare at risk? Paper to be presented at International Micro-simulation Conference, Canberra, Australia, December 2003.

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