Adverse Drug Reaction Monitoring In Psychiatric Outpatient Department Of A Tertiary Care Hospital
Adverse Drug Reaction Monitoring In Psychiatric OPD
Keywords:
Adverse drug reaction, Causality assessment scale, Psychotropic drugs, Severity assessment scaleAbstract
Background:Pharmacovigilance in psychiatry units can play vital role in detecting adverse drug reactions (ADRs) and alerting physician to such events, thereby protecting the user population from avoidable harm. Objective: To assess the suspected ADRs profile of psychotropic drugs in psychiatry OPD of a tertiary care hospital and its comparison with available literature data as well as to create awareness among the consultant psychiatrists to these ADRs profile. Materials and Methods: A prospective study was conducted in the psychiatry OPD. Thirty five consecutive patients per day were screened irrespective of their psychiatric diagnosis for suspected ADRs on 3 fixed days in a week from January 2011 to December 2011. CDSCO form was used to record the ADRs. Causality was assessed by WHO causality assessment scale while severity was assessed using Hartwig and Siegel scale. Results: Out of 4410 patients were screened, 383 patients were suspected of having at least one ADR. Thus, 8.68 % of our study population reported ADRs. Of 407 events recorded, 369(90.60%) were “probable†and rest “possible†according to WHO-UMC causality assessment scale. According to Hartwig and Siegel scale, 268 ADRs (65.85%) were “moderate†category. Twenty one different kinds of ADRs were noted. Conclusion: This study enables to obtain information on the incidence and frequency of ADRs in the local population that allows opportunity for education to the physicians to improve the patient’s quality of life.
References
2. Hamer S, Haddad PM. Adverse effects of antipsychotics as outcome measures. BJP 2007; 191:64-70.
3. Faich GA US adverse drug reaction surveillance 1984-1994. Pharmacoepidemiol Drug Saf 1996; 5:393-8.
4. Sengupta et al. Adverse drug reaction monitoring in psychiatry outpatient department of an Indian teaching hospital. IJP 2010; 43:36-39.
5. The use of the suspected adverse drug reaction reporting form. Available from: http://www.cdsco.co.in. [last accessed on 2012 Aug 15]
6. The use of the WHO-UMC system for standardized case causality assessment [monograph on the Internet]. Uppsala: The Uppsala Monitoring Centre; 2005. Available from: http://www.who-umc.org/graphics/4409.pdf. [last accessed on 2012 Aug 15]
7. Naranjo CA, Busto U,Sellers EM, et al. A method for estimation the probability of adverse drug reactions. Cli Pharmacol Ther 1981; 30:239-45.
8. Hartwig SC, Siegel J,Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49:2229-32.
9. Schumock GT, Thornton JP. Focusing on the prevetability of adverse drug reactions. Hosp Pharm 1992; 27:538.
10. http://cdsco.nic.in/pharmacovigilance_intro.htm. [last accessed on 2012 September 20]
11. Carlini AE, Nappo AS. The pharmacovigilance of psychoactive agents in Brazil. Rev Bras Psiquiatr 2003; 25:200-5.
12. Castberg I, Reimers A, Sandvik P, Aamo TO, Spiqset O. Adverse drug reactions of antidepressants and antipsychotics: Experience, knowledge and attitudes among Norwegian psychiatrists. Nord J Psychiatry 2006; 60:227-33.
13. Michele Thomas et al. Adverse drug recations in hospitalized psychiatric patients. Ann Pharmacother 2010; 44:819-25.
14. Baumann P, Heimke C, Ulrich S, Eckermann G, Gaertner I, Gerlach M, et al. The AGNP-TDM expert group consensus guidelines: Therapeutic drug monitoring in psychiatry. Pharmacopsychiatry 2004; 37:243-65.
