HERBAL AND ALTERNATIVE SUBSTANCES

The Illinois Council of Health-System Pharmacists (ICHP) supports FDA regulation of the herbal product industry with adequate resources to do so effectively.  ICHP also recommends that manufacturers of herbal and dietary supplements be required to provide substantial proof of efficacy and safety prior to marketing approval; that standards for manufacturing are met regarding identity, strength, quality, purity, packaging, and labeling; and that post-marketing reporting of adverse events, including drug interactions, be mandatory. 

ICHP encourages pharmacy practitioners to become adequately educated about herbal and dietary supplements. Such supplements should be included in documenting medication histories, during pre-surgery planning and as part of comprehensive patient counseling. ICHP also supports the regular use of the FDA Safety Reporting Portal for routine monitoring and reporting of herbal and dietary supplements defects, adulteration, identified interactions, and adverse effects.

ICHP recommends that the criteria used to evaluate herbal and dietary supplements for inclusion in health system formularies should be as rigorous as those established for non-prescription drugs reviewed for formulary status.  The increased risks of non-FDA regulated dietary supplements in hospitals and other health-system settings should be recognized by pharmacists and other healthcare providers.  ICHP urges pharmacists and other health care practitioners to integrate awareness of herbal and dietary supplement use into everyday practice and encourages pharmacists to increase efforts to prevent interactions between these supplements and drugs.

www.safetyreporting.hhs.gov


Revised 10/2015