title: Drug safety reports on complementary and alternative medicines (ayurvedic and homeopathic medicines) by a spontaneous reporting program in a tertiary care hospital.
abstract: OBJECTIVE
  The objectives of this study were to initiate a pharmacist-coordinated program to improve the adverse drug reaction (ADR) reporting on complementary and alternative medicines (CAM) in a tertiary care hospital and to evaluate the pattern of the reported ADRs.
  
  
  METHODS
  A targeted approach was taken in increasing the ADR reporting to CAM in a tertiary care hospital in South India. Suspected ADRs to CAM spontaneously reported over a period of 24 months were selected for evaluation. Reported ADRs were evaluated for patient demographics, reaction and drug characteristics, causality, severity, and outcome.
  
  
  RESULTS
  A total of 12 ADRs to CAM were reported, which included 9 to Ayurvedic and 3 to homeopathic medicines, which accounted for 1.5% of the ADRs reported to the ADR reporting unit. ADR resulted in hospitalization in 5 patients. The system organ class most commonly involved included skin and appendage disorders (58.3%). Only four of the reactions were previously reported in the literature. The mean time for onset of the ADR after the administration of the drug was 27.8 +/- 36.1 days. The suspected drug was withdrawn in all the reports that resulted in recovery, with mean time for recovery 5.9 +/- 3.6 days. The majority (66.6%) were moderate in severity and 2 were severe in nature. On causality assessment, 6 were probable in nature and the remaining were possible.
  
  
  CONCLUSIONS
  Even though there were fewer ADRs reported by this spontaneous reporting system, it gave valuable information regarding the potential for adverse effects with these agents. The study has reinstated the potential role of spontaneous reporting in identifying lesser reported ADRs, including those to CAM. Such hospital-based programs can contribute much in increasing the safety-related data of these agents.
authors.affiliation: Department of Pharmacy Practice, International Medical University, Bukit Jalil, KL, Malaysia. jimmy_jose2001@yahoo.com
authors.forename: Jimmy
authors.initials: J
authors.lastname: Jose
authors.forename: Padma G M
authors.initials: PG
authors.lastname: Rao
authors.forename: M S
authors.initials: MS
authors.lastname: Kamath
authors.forename: Beena
authors.initials: B
authors.lastname: Jimmy
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000529:Complementary Therapies / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions; D006705:Homeopathy; D006760:Hospitalization; D006801:Humans; D007194:India; D008515:Medicine, Ayurvedic; D008517:Phytotherapy / Q000009:adverse effects*; D010936:Plant Extracts / Q000009:adverse effects*; D012017:Referral and Consultation
chemical_list: D010936:Plant Extracts