Gairik Sengupta, Subhrojyoti Bhowmick, Avijit Hazra, Ananya Datta, and Musfikur Rahaman (2010), wrote on the “Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospital”. The topic as stated by the authors shows only a general possibility in the medical field. In this case, the authors do not seem to be specific in which drug is been studied. At this point the reader of the article is left guessing what could be the drug under investigation. The need to have a single or a range of particular drugs give the researcher specific objectives other than the blanket nature of the problem stated would be appropriate. Generalized research topics tend to give false results or inaccurate information on the subject under investigation.
- The number of out-patients who experience the ADR
- The type of drug reactions
- The levels of the ADR
Research design and methods
In one day, twenty consecutive patients were screened for possible ADRs irrespective of their diagnosis in two days a week with exception of holidays. Two days were not enough to establish a good trend. Three pharmacology residents and psychiatry participated in the interviewing and screening of the patients. Such a practice ensured that the best of the results were collected. A senior psychiatrist was also available for consultation in case of difficulties. To gather more evidence, family members accompanying the subjects or the patients were also interviewed to provide more insights on the ADRs and the history of drug reactions of the subject. To avoid errors in the collected data, patients who were not accompanied by their care givers, and those who abused drugs were excluded from the research. It is this activity that made the data collected more objective and authentic. The Indian National Pharmacovigilance programme was followed in recording of the details of the subject. It provided a common ground for the research reducing possible deviations ion the research results. Mild severity and confusion from diseases symptomatology were not considered in the research. The casualty event was assessed by the use of the World Health Organization-Uppsala Monitoring centre (WHO-UMC) criteria. The criteria made the results authentic and accurate since it provides specific guidance on the data collection.
A sample of 2000 patients was assessed for ADRs. Out of this, 21.45% i.e. 429 of them were suspected to have at least a single ADR with 84% of them having insufficient evidence and hence discontinued from further analysis. The authors found that out of all the subjects, with a confidence level of 95%, be3tween 15.59% and 18.91% had at least a ‘possible’ casualty in the WHO-UMC scale. 68% were males and the rest women. The following were the most common diagnoses:
- Twenty seven (27) percent was Bipolar affective disorder,
- Twenty four (24) percent Schizophrenia
- Twenty two (22) percent depression
Reactions to the drugs of the above diagnoses included the following:
Tremor was the leading with 69%
Weight gain came second with 54%
Constipation 51% was third
Dyspepsia 35% was fourth
Extrapyramidal reactions 29% was the fifth and
Amenorrhea was 22% among others.
Other non-anticipated ADRs were discovered such as diabetes mellitus were discovered.
The results shows a very broad reaction to medication, the research shows no any specific reaction of a particular medication as it was indicated earlier. The lack of a specific research drug or a particular diagnosis leads to these many generalized reactions. As the researchers note, these reactions may be a result of entirely other drugs such as those of coughing, hypertension among others. Therefore, based on this premise, the results may not be correct. Although the researchers established that ADRs may induce diabetes mellitus, there is no any specific link between the two.
The discussion indicates that the researchers did not take into account new drugs in the market. The reason provided is because such drugs are expensive and could not be found in the public hospital serving the poor. It is thus evident that, as indicated earlier, the results are biased on social economic basis since the study only covered the poor people. The researchers also note that the casualty assessment was mild to moderate severity. It is thus possible to confuse the ADRs with normal drug reactions in the body that does not require any serious attention. The researchers state that the post-marketing surveillance study does not provide a true prevalence rates but a general idea that can offer an insight to the drug reactions among patients in India. Such a conclusion leaves one wondering whether the original objectives were achieved. It further indicates the un-focused nature of the research.
Gairik Sengupta, Subhrojyoti Bhowmick, Avijit Hazra, Ananya Datta, and Musfikur Rahaman
(2010). Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospita. Department of Pharmacology,Institute of Postgraduate Medical
Education & Research (IPGME&R)
Glassman AH, Bigger JJ. Antipsychotic drugs, prolonged QTc interval, torsades
de pointes and sudden death. Am J Psychiatry 2001;158:1774-82.
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
2010 Mar 15].