Government Briefs: Herbal and Homeopathic Products: Ensuring Safe Choices for Canadians

To: Standing Committee on Health
By: Dr. Jeff Poston, Nœlle-Dominique Willems
Date: February 5, 1998

Introduction

The Canadian Pharmacists Association (CPhA), representing over 9,000 pharmacists in all areas of practice submits the following comments to the Standing Committee on Health as it embarks upon its important study of herbal and homeopathic products.

The regulation of herbal and homeopathic products has always concerned community pharmacists, more so recently because more and more pharmacists are being asked by their patients to explain the value of those products.

Some stakeholders who will appear in front of the committee will allege that pharmacists are trying to increase their market share by integrating herbal products to the wide array of health products they already provide. Data from the Canada Health Monitor indicates that 65% of consumers already purchase their complementary medicines in a pharmacy. There is little for them to personally gain by advocating for stronger regulations.

However, as front line health care professionals, pharmacists are extremely interested in providing safe optimal drug therapy. Since herbal remedies are being used more and more, they need to be considered as part of the continuum of pharmaceutical care. Pharmacists need to know the pharmacological properties and effective uses of common herbal products, they need to be able to recognize the potential for any drug interactions, or allergic reactions and be assured of the quality of the products they provide

Recommendations:

• The Canadian Pharmacists Association recommends that herbal products be treated as self-medication products and be considered an integral part of the products covered under the Drugs Section of the Food and Drugs Act.
  
• CPhA further recommends that herbal remedies be submitted to the principles of the Drug Schedule Harmonization as defined in the final report of the National Drug Scheduling Advisory Committee of August 1997 which determines the conditions under which drugs in different schedules must be sold.
  
• The Canadian Pharmacists Association recommends that the framework developed by the Therapeutic Products Directorate for cost-recovery should apply across the board to all manufacturers of herbal and homeopathic products in Canada.

We commend the government on the convening of the Advisory Panel of Herbal Remedies chaired by Dr Frank Chandler, and support in principle, the framework for regulation being developed by that committee.

 In our presentation today we wish to focus on the traditional three areas of concern with respect to therapeutic products derived from natural sources: safety, efficacy and quality.

Safety

Herbal products like all forms of self-treatment present a potential risk to human health. Self-medication may delay a patient from seeking professional advice.

In the Canadian health care system people who do not receive appropriate treatment from the onset may eventually cost more to the system. It is therefore important that clear and complete information about complementary treatments be available to people who choose to self-medicate with these products.

Many aspects of safety of herbal products need to be assessed by the government when proceeding with the regulation of those products, for example: acute and chronic toxicity of various dosage forms and the impact of long-term use.

Recommendation:

• Therefore the Canadian Pharmacists association recommends that where possible herbal products are subjected to the same safety standards as those required for other therapeutic products.

While a number of herbs have traditional established uses it is important that consumer safety is protected by appropriate labelling.

Recommendation:

• The Canadian Pharmacists Association recommends that clear warnings appear on herbal product labels where excessive ingestion has been found to provoke adverse effects. Similar warnings should be mandatory for products that may provoke hypersensitivity or phototoxic reactions. In addition the active ingredients must be specified on the label, in specific quantities, and labels must bear appropriate warnings as to side-effects and potential intereaction with other foods and medications.

Having said that, documented information on the interaction of herbal products with conventional medicines is limited.There is a need to identify herbal ingredients that may potentially interfere with specific categories of conventional drugs based on known phytochemical and pharmacological properties of certain herbs and on documented side effects.

Recommendation:

• The Canadian Pharmacists Association recommends that Health Canada encourage research on the interactions of herbal products with conventional medications and broadly disseminate such information to health care professionals and consumers.

We also have concerns with respect to adverse drug reactions. There are no mechanisms in Canada for reporting adverse effects from self-medication products unless the effects are so severe that the patient has to go to a health professional or a hospital.

Recommendation:

• The Canadian Pharmacists Association recommends that the government investigate an adverse drug reaction reporting process whereby a consumer could file a report on untoward events that may indicate reactions or side effects to self-medication products.

Efficacy

Claims of efficacy leading to increased use have contributed to the current need to review herbal products and evaluate their inclusion in the arsenal of remedies available. As with all other remedies being assessed in Canada, there is a move toward evidence-based decision making, and herbal products should be subjected to the same rules as required for other therapeutic products, particularly if they are to be considered for inclusion on drug benefit lists.

Documented clinical data do not exist for most herbal products; however, there is no reason why some traditional products should not be available for minor conditions, provided that they are consistent with traditional uses, that based on known pharmacological and toxicological data, appear rational, that the products are of suitable quality and safety, and that the appropriate warnings and contraindications appear on the label. However, significant therapeutic claims should not be made for these product unless they are evidence based.

Recommendation:

• The Canadian Pharmacists Association recommends that therapeutic claims of efficacy for herbal products be substantiated by available clinical data. We further recommend that Health Canada regulate and monitor the types of claims and advertising made by herbal product manufacturers.

Quality

Herbal remedies present unique problems that arise because of the nature of herbal ingredients usually a complex mixture of plant constituents that may vary greatly depending on environmental and genetic factors as well as the source or part of the plant from which the ingredients are obtained. Control of raw materials is essential to ensure that a standardized quality herbal product is being consistently manufactured.

Recommendation:

• The Canadian Pharmacists Association recommends that, to ensure safety through the manufacturing of standardized quality herbal products:
  • herbal products be submitted to quality control tests to develop quality finished products to defined specifications;
  • the stability and expiry date of herbal products be established by manufacturers and clearly specified on the labels;
  • the plant species and part of the plant from which the herbal ingredient was obtained and, when possible, the amount of active ingredient be clearly specified on the label.

Homeopathic Preparations

The Canadian Pharmacists Association has submitted comments to Health Canada on the labelling indications of homeopathic preparations and reiterates its concerns about labelling homeopathic products with indications

We believe that labelling with respect to indications should be consistent for all therapeutic preparations.

As with herbal products we believe that the labelling with indication could lead to unnecessary delays in treatment for some patients.

Recommendation:

• The Canadian Pharmacists Association recommends that, as an absolute minimum, the following warning label should be attached to homeopathic products:
  
  "The effectiveness of this product is based on homeopathic principles and is not supported by the usual scientific evidence required for nonprescription medications."

Besides the concerns for patient safety, we believe that allowing labelling with indication of homeopathic products would not be fair to manufacturers of pharmacologically active nonprescription medications, who are required to support products with scientific evidence.

The Role of the Federal Government

As more people try complementary medicines, the natural health products community is opposed to strong federal intervention in this field. It is important however to reaffirm the important role the federal government plays in ensuring the safety of Canadians in many domains: foods, drugs, consumer goods and transportation. No legitimate reason exists to forego this important role where herbal and homeopathic products are concerned.

The success of regulations under the Canadian Food and Drugs Act to ensure safety and efficacy of pharmaceutical preparations should not lull us into a false sense of security. We enjoy safe and effective drugs and consumer goods because the Government of Canada has had the foresight to adopt a regulatory framework that makes it so.

The Canadian Pharmacists Association agrees that as much as possible consumers must continue to be able to choose the types of products they wish to use. There is an onus on government however to ensure that the products from which they make their selection are safe.

Recommendation:

• The Canadian Pharmacists Association recommends that herbal products be submitted to the same standards in manufacturing as other products deemed fit for consumption in Canada.

We also have some recommendations with respect to advertising. The streamlining of the advertising process for self-medication products has lead to increased safety for Canadians by preventing false advertising and claims being made about health products. Those rules should also apply to herbal and homeopathic remedies.

Recommendation:

• The Canadian Pharmacists Association recommends that all herbal and homeopathic products advertising be pre-cleared by the agency that also monitors advertising of nonprescription medication.

Cases of promotion by association are common with certain herbal products. There is no claim on the bottle but one can find a leaflet nearby, or a recommendation can be made by a sales person or a health professional directly to the consumer or in readily available literature.

Recommendation:

• CPhA recommends that Health Canada address the issue of promotion by association through appropriate regulations.

Conclusion

The Canadian Pharmacists Association believes that the federal government through coherent regulation of herbal and homeopathic products will increase the capacity of Canadians to choose safe, and effective self-medication products of quality. We believe that it is the responsibility of this Committee and the Government it represents to perpetuate the long tradition of protecting the Canadian public by ensuring that all products and medications used in Canada correspond to established standards.

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Les produits homéopathiques et à base d'herbes médicinales : Assurer des choix sûrs aux Canadiens (PDF)