Pharmacists are an integral part of the conventional health care team within the context of the North American health care system. There is some variability of regulations governing pharmacists among Canadian provinces and American states; however, all are bound by national drug regulations. The role of pharmacists generally includes “the custody, compounding and dispensing of drugs, the provision of non-prescription drugs, health care aids and devices and the provision of information related to drug use.” (1
) The introduction of new categories of products – natural health products (NHPs) in Canada and dietary supplements (DS) in the United States and has created new challenges for pharmacists striving to provide comprehensive patient-centred pharmaceutical care for patients.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) came into effect in the U.S.A (2
). In it, a DS is defined as “a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients”. More recently, in 2007 the U.S. Food and Drug Administration introduced good manufacturing practices (cGMP) for DS (3
). This regulation “ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labelled”, thus strengthening the pre-existing regulations.
Similarly, a new category called NHPs has been recognized in Canadian legislation since January 1, 2004.(4
) The definition of NHPs is: natural source “substances which are manufactured, sold or represented for use in: i) the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans; ii) restoring or correcting organic functions in humans; or iii) maintaining or promoting health or otherwise modifying organic function in humans” (p. 1536). Medicinal ingredients to be regulated under the new regulations are listed in an inclusion list (e.g., plant or plant material, algae, fungus or non-human material, vitamins, amino acids, essential fatty acids, minerals, homeopathic preparations and traditional medicines). All products covered by the new regulations must be in dosage forms (i.e., bulk herbs are not included) and must have a wide margin of safety. By definition, NHPs are safe for over-the-counter sale directly to consumers.(5
Although NHPs and DS are widely available in pharmacies across North America, there has been relatively little discussion among members of the profession about what professional responsibilities pharmacists have with respect to these products. Pharmacists’ responsibility to detect and prevent interactions between NHPs/DS and conventional medications has consistently been identified in the literature as important,(6
) and a recent North American study suggested that use of prescription drugs in conjunction with NHPs/DS is high enough (16%) to raise concerns about unintended interactions.(10
Several information papers suggest that pharmacists should provide objective information to help patients make informed choices about DS/NHP use.(11
) These reports seem to imply that there is relative agreement within the profession of pharmacy, not only that pharmacists have professional responsibilities with respect to NHPs/DS, but also with respect to key aspects of what those responsibilities are (or should be). However, there is evidence that this is not an accurate portrayal of the opinions and practices within the profession. For example, a study of US pharmacists reported that although almost three-quarters of the pharmacists surveyed worked in a retail setting where herbal medicines were sold, almost half agreed with the statement, “herbal medicines are not
accepted by the majority of my colleagues” and only a quarter agreed with the statement “herbs are efficacious.”(13
) A recent Canadian study reported that only 2% of pharmacists felt they had adequate information about complementary and alternative health care.(14
) Furthermore, we know from a systematic review of surveys of pharmacists that opinions within the profession are mixed, with roughly half reporting positive attitudes toward NHPs/DS, and the other half reporting negative attitudes.(13
) Pharmacists’ practices also lag behind at least some of expectations outlined in the information papers, since most pharmacists do not routinely document, monitor, or inquire about patients’ use of NHPs or DS.(13
The purpose of this study was to complete a comprehensive, systematic assessment of the pharmacy literature to identify how the pharmacist’s role with respect to NHPs and DS is portrayed. This work forms the first step in a larger study which aims to develop core competencies for undergraduate pharmacy students with respect to NHPs and DS that can be implemented at pharmacy schools across North America.