The Pharmacovigilance of Complementary Medicines (CAMs) M. Dheda & S Banoo Civitas Building, Pretoria Feb 2014
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1 The Pharmacovigilance of Complementary Medicines (CAMs) M. Dheda & S Banoo Civitas Building, Pretoria Feb 2014
2 Historical Perspective Thalidomide tragedy It was an effective tranquilizer & painkiller & was declared a "wonder drug" for insomnia, coughs, colds & headaches --- morning sickness. Deformation called Phocomelia, shortened limbs etc
3 Introduction Pharmacovigilance began with thalidomide. Do not need CAM Thalidomide to wake the Pharmacovigilance stakeholders. Policy makers, Pharmaceutical Co, Physicians, Pharmacists, Patients -- allow for the successful safety monitoring of CAM More than 100 countries have regulations for CAM
4 Key facts Use for thousands of years. Myth that natural = safe Use of CAMs is growing. Poor accessibility to modern drugs Shortage of physicians Cost of drugs Many depends on CAM for primary health care. CAM generating billions of dollars.
5 Key facts Don't think that these are also drugs Availability- Over the counter/ internet False but attractive claims by prescriber and manufacturers Health tonics and food supplements Lack of Good Manufacturing Practices (GMPs)
6 Monitoring of CAM The worldwide use is enormous, - imp. to identify the risks associated with their use. used in conjunction with other medicines, interaction of combination. Regulatory status consequently determines the access Safety influenced Regulated/ not regulated Prescription/ non-prescription Regulate / un-regulated providers and distributors Qualified / unqualified providers
7 Monitoring of CAM vs Drugs Drugs - clinical trials and spontaneous reports - physicians, dentists, pharmacists, and nurses CAM - all providers of traditional, complementary, and alternative medicineinvolvement of consumers. -non-prescription medicines - substantial proportion - come directly without pre or postmarketing safety monitoring.
8 Reporting of ADRs Clinical practice Informa tion Patient ADR Reports MCC Routine Clinic visit Cluster Possible ADR reported to PV Committee Suspicion of ADR Possible ADR documented and reported
9 Unique Challenges lack of uniformity in identification lack of information on adverse effects inadequate studies of ADRs, such as frequency and causes, Natural = safe. % of ADRs to CAM in our database is small
10 Quality control Quality control - more complex than pharmaceuticals. quality of the raw material/ product agricultural practices collection practices - plant selection and cultivation
11 Quality Poor quality control may result in a high incidence of adverse reactions Quality of the product itself adulteration - potent substances contamination other substances.
12 Remember You need not not be be certain Just Just be be suspicious
13 St. John s Wort ( Hypericum perforatum ) Eg of Adverse Effects: Photosensitivity, Insomnia, vivid dreams, headache, dizziness Drug Interactions: ( through induction of the Cytochrome P450 enzyme CYP3A4, but also CYP2C9 and induction of the P-glycoprotein (P-gp) efflux transporter Examples of interaction Decreased levels Warfarin : Decreased Oral contraceptives or hormone replacement therapy, Decreased levels of PI protease inhibitors (ARV)
14 Kava Kava (Piper methysticum ) Anxiolytic, assist with insomnia Hepatotoxicity: liver failure withdrawn from the market from SA (Feb 2004)
15 Information Flow in NPC NPC MCC Regulatory changes Medicine alerts DHCPL HCP Cohort Request for cohort studies on specific problems (CEM) Patient Rational use of drugs in progammes Evaluate the impact of programmes Inform guidelines Re-education/training of staff Analysis
16 CONCLUSION CAM are widely used in health care. Pharmacovigilance for CAM, in its infancy - essential monitoring the safety - presents unique challenges Reporting ADRs for must be encourage
17 benefits >>> risks greatest achievable margin the individual patient population as a whole risk risk benefit risk benefit risk benefit Thank you for your attention!
18 References Dheda, M, Decentralized HIV/AIDS pharmacovigilance in South Africa: Mpumalanga as pilot province for national roll-out. Journal of AIDS and HIV Research 5(9), pp , September, DOI: /JAHR Geneva: World Health Organization; 2004 WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems Dr. R. K. Dixit, MD Professor Pharmacology & Therapeutics King George s Medical University, Lucknow.November "Herbal DrugsImportance of Regulatory Affairs Ushma Mehta, Mukesh Dheda, Gavin Steel, Marc Blockman, Augustin Ntilivamunda, Gary Maartens, Yogan Pillay, Karen Cohen. Strengthening Pharmacovigilance in South Africa. SAMJ pending publication
JUNE 2011 Vol.29 No.6 CME 247
: the devastating consequences of not thinking about adverse drug reactions The burden of adverse drug reactions (ADRs) on patient care has been found to be high globally and is particularly high in South
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