Off-label prescribing of antipsychoric drugs in depressive disordrs in general pratitioner's settings from Karachi, Pakistan; a pilot study

Date of Award


Document Type


Degree Name

Master of Science in Epidemiology & Biostatistics (MSc Epidemiology & Biostats)


Community Health Sciences


Pharmacological treatment is a critical part of much of psychiatric practice round the globe; in patients from a wide age range and across many diagnostic groups. Despite the availability of varying psychotropic drug groups, an eloquent proportion of patients will remained troubled by distressing and disabling symptoms even after succession of licensed pharmacological treatment/s. The situation will aid an ascending weightage to the existing state of mental health with special emphasis on developing regions of the world which are accountable with more than half of the total global burden of common mental health disorders. In terms of drug regulation and control FDA has a limited role in monitoring the practice of a medicine, although new indications are timely revised in drug monographs. In countries like Pakistan; where almost 70% of the total health care is provided by the general practitioners' there, is an awful requisite to study their psychopharmacological practices systemically. Aims: We designed this survey to analyze the proportion of off-label prescribed Antipsychotics drugs in depression among patients' with common mental health disorders at general practice. We also ascertained for associated factors. Methods: An analytical cross sectional study was designed on pilot scale to determine the extent of off-label prescribing at general practice. The study followed a multi-stage cluster sampling technique. Out of the total 18 towns 4 of the towns of Karachi city were taken as PSU (primary sampling units). From each town, 1-2 union councils were taken as SSU (secondary sampling units). General practitioners' clinics were mapped from SSU's as per eligibility criteria. A short interview was conducted from the physician at first stage whose clinic was selected as study site to ascertain about their competencies in terms of clinical management of common mental health disorders. Within each of the respective clinics adult patients (18-65) years of age who sought medical care for CMD's (common mental health disorders) were then approached toaccess them for depression screening by SRQ-20 scale and prescription record review on a pre-designed questionnaire by the trained research staff. GEE (Generalized estimating equation) technique through binary logistic regression analysis was used to determine the co-relation between general physician's clinical expertise and his / her prescribing practices. Results: The study estimated an overall proportion of off-label prescribing of Antipsychotic drugs in depression as 19% among clinic attendees. The factors independently associated with off-label prescribing among clinic attendees at general practice were gender (OR adj -7 2.908, 95% Cl= 1.027- 8.2377) and SRQ-20 scoring for Depression (OR adj= 0.1266, 95% C1= 0.0309- 0.5184). Furthermore we have received 37.5% response rate from the mapped general practitioners' clinics located in selective towns of Karachi. Among these almost 96% (n= 24) were practicing as private clinicians, 80% (n=20) reported a proportion of almost 10% cases of common mental health disorders in their clinical practice, 68% (n=17) of them were unaware for diagnosing depression as per DSM-1V criteria, 44% (n=11) were familiar with the concept of off-label use of a drug in clinical practice. In addition to it 76% (n=19) of them were agreed with the notion of experiencing difficulties in clinical management of psychiatric patients in their clinical practice. Concerning about preferred choice of drug in depression the utmost response was for SSRI's (selective serotonin re-uptake inhibitors) by the physicians. Conclusion: The study was designed and conducted as a first baseline pilot scale survey in our regional settings. The results of this study will be guiding us in designing and planning a larger scale epidemiological study to explore the novel concept of off-label prescribing of drugs systematically at each health care level of our country. Besides the findings of this small scale survey will be speculated as obligatory for all those stake holders (Drug Regulatory Authority‘of Pakistan and Health Care Professionals) who are linked with Drug monitoring and regulation at national level.

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