Objectives:Spontaneous reporting is an important tool in pharmacovigilance. However, its success depends on cooperative and motivated prescribers. Under-reporting of adverse drug reactions (ADRs) by prescribers is a common problem. The present study was undertaken to evaluate the knowledge, attitude, and practices (KAP) regarding ADR reporting among prescribers at the Civil Hospital, Ahmedabad, to get an insight into the causes of under-reporting of ADRs.Materials and Methods:A pretested KAP questionnaire comprising of 15 questions (knowledge 6, attitude 5, and practice 4) was administered to 436 prescribers. The questionnaires were assessed for their completeness (maximum score 20) and the type of responses regarding ADR reporting. Microsoft Excel worksheet (Microsoft Office 2007) and Chi-Square test were used for statistical analysis.Results:A total of 260 (61%) prescribers completed the questionnaire (mean score of completion 18.04). The response rate of resident doctors (70.7%) was better than consultants (34.5%) (P < 0.001). ADR reporting was considered important by 97.3% of the respondents; primarily for improving patient safety (28.8%) and identifying new ADRs (24.6%). A majority of the respondents opined that they would like to report serious ADRs (56%). However, only 15% of the prescribers had reported ADRs previously. The reasons cited for this were lack of information on where (70%) and how (68%) to report and the lack of access to reporting forms (49.2%). Preferred methods for reporting were e-mail (56%) and personal communication (42%).Conclusion:The prescribers are aware of the ADRs and the importance of their reporting. However, under reporting and lack of knowledge about the reporting system are clearly evident. Creating awareness about ADR reporting and devising means to make it easy and convenient may aid in improving spontaneous reporting.

Objective:To detect incidence of adverse drug reactions (ADRs) in hospitalized patients and to assess their causality, seriousness, preventability, and the possible economic impact.Materials and Methods:This was a prospective study carried out in two medical units at a tertiary care, teaching hospital, for about 18 months. All the admitted patients who developed an ADR after admission (group A) or who were admitted primarily for the treatment of an ADR (group B) were included. Descriptive statistics with 95% CI, χ2, χ2 for the trend and kappa test were used.Results:Out of 6601 patients, 140 patients developed 154 ADRs with an incidence of 2.12%. Causality of the majority of the ADRs in group A was ‘possible’ while those in group B was ‘probable’. Among 109 ADRs (34 serious) in group A, 38 were preventable. On the other hand, out of 45 serious ADRs in group B, 19 were preventable. The total cost of 154 ADRs in 140 patients was Rs. 1,49,803 with an average of Rs. 1070 per patient. The preventable cost for 57/154 ADR was Rs. 96,310.Conclusion:Around 2% of the hospital patients develop ADRs. A large number of these ADRs were preventable. A substantial saving can be made if adequate caution is exerted.

Introduction: Skin is one of the major target organ for adverse drug reactions (ADRs). The incidence of dermatological ADRs among indoor patients in developed countries ranges from 1–3%, whereas in developing countries such as India, it is 2–5%. Aims: To analyze the clinical spectrum, seriousness, outcome, causality, severity, and preventability of the cutaneous ADRs. Material and Methods: All cutaneous ADRs reported at the Regional Adverse Drug Reaction Monitoring Center between January 2013 to May 2016 were identified and evaluated. A retrospective analysis was carried out for clinical presentation, causality (as per the WHO–UMC scale and the Naranjo’a reactions (ADRs) Severity (Hartwig and Seigel scale), and preventability (Schumock and Thornton criteria) of a said drug. Results: Out of 2171 ADRs reported during study period, 538 were cutaneous ADRs (24.78%). The most common clinical presentation was maculopapular rash (58.92%) followed by itching (10.59%), and Stevens–Johnson syndrome (4.83%). The time relationship of cutaneous ADRs to drug therapy revealed that they can develop within 1 week to 1 year of treatment. Most common causal drug groups were antimicrobials (46%), non-steroidal anti-inflammatory drugs (NSAIDs) (18%), and antiepileptics (10%). Polypharmacy was observed in 7% of the cases. Most of the cutaneous ADRs were non-serious (91%), however, 10 were life-threatening and 1 was resulted in death due to the Stevens–Johnson syndrome. Causality category for majority of cutaneous ADRs was possible. Although majority of cutaneous ADRs were moderately severe (81%), however, not preventable (89%). Conclusion: The occurrence of cutaneous ADRs is common and they developed within 1 week of therapy. Antimicrobial agents and NSAIDs are the most common implicated drug class. Hence, physicians should closely monitor the patient in the first week while using such therapy for early detection and prevention of cutaneous ADRs.

Drugs account for 1–2% of all cases of pancreatitis. A 58-year-old man was prescribed atorvastatin 10 mg for 6 months for hyperlipidemia. He developed acute abdominal pain and vomiting with epigastric tenderness. Serum lipase and CT scan of the patient suggested the presence of acute pancreatitis. The patient was hospitalized; atorvastatin was stopped and treated symptomatically. He recovered completely within 10 days of drug withdrawal. The causality of the adverse drug reaction according to Naranjo and WHO-UMC Scale was probable. The exact mechanism of pancreatitis due to atorvastatin is not known. It may be a class effect of HMG CoA reductase inhibitors as it had been reported with other statins too. The definite causal relationship is difficult to establish, as rechallenge with the suspected drug was not done due to ethical consideration.

Objective: To analyze the rationality of antimicrobial (AM) and respiratory (RP) fi xed dose combinations (FDCs) available in Indian market. Materials and Methods: Antimicrobial and RP FDCs enlisted in Indian Drug Review 2010 and 2013 respectively were analyzed by a pretested validated 8 point criteria tool. Each FDC was assessed for number of active pharmacological ingredients, approval by regulatory authority, listing in World Health Organization (WHO) essential medicine list (EML) or National List of Essential Medicine. While effi cacy, safety, pharmacokinetic and pharmacodynamic interactions and advantages of each FDC were analyzed by evidence based literature search. Each criterion was scored one for positive and minus one for negative or unfavorable observation. The total score for the tool was 12 and score ≥7 was considered rational. Results: Of 209 FDCs, 108 were AMs and 101 were RPs. The mean rationality score was 5.41 ± 1.63 (95% CI, 2.15-8.67). Majority of FDCs were irrational (174) while 35 were rational, and only 12 of these were listed in WHO EML 2013. Out of 108 AM FDCs, 21 (19%) were rational while 87 (81%) were irrational. Out of 101 RP FDCs, 14 (14%) were rational while 87 (86%) were irrational and 24 (24%) with unfavorable pharmacodynamic interactions. Majority of the rational AM FDCs were antiretroviral (6) agents while RP FDCs were indicated for chronic obstructive pulmonary diseases. While majority of irrational FDCs were AM plus steroids, β 2 agonists plus antihistaminics/expectorants/anticholinergics/mast cell stabilizers/leukotriene receptor antagonists. Conclusion: Rationality assessment of AM and RP FDCs reveals that a substantial number of these FDCs in Indian market are irrational. This calls for a close scrutiny of marketed FDCs and educating prescribers to use them with great care and caution. This also indicates a serious review of the regulatory framework for drug manufacturing and marketing.

A-24 year-old male was prescribed prednisolone (60 mg/day) for left sided facial palsy. After three days of therapy, the patient complained of black spots in his vision in right eye. Fluorescein angiography of right eye showed evidence of central serous retinopathy (CSR). Prednisolone dose was withdrawn gradually and the patient improved within a week. There were no other systemic or ophthalmic diseases reported by the patient, which could have caused this condition. An improvement after dechallenge confirmed steroid-induced CSR. Recurrent CSR is known to cause permanent loss of vision. Hence, awareness regarding this adverse drug reaction (ADR) with steroids and its reporting can minimize this complication and help in better patient management.

Objective:The comparison of the effect of antidepressants on psychomotor functions in patients with endogenous depression.Materials and Methods:This prospective interventional study was carried out at a tertiary care teaching hospital on 95 literate patients with newly diagnosed endogenous depression matching inclusion and exclusion criteria. Patients were prescribed either desvenlafaxine (50 mg) or fluoxetine (40 mg) or sertraline (50 mg). Psychomotor functions were assessed by digit letter substitution, six letter cancellation, choice reaction time, hand steadiness and flicker fusion test at the baseline 1st month and 3rd month. Efficacy of drugs was also measured by Hamilton rating scale for depression. Data were analyzed by using ANOVA and P < 0.05 was considered as statistically significant.Results:A total of 95 patients were enrolled. Fluoxetine, desvenlafaxine, and sertraline were prescribed in 32, 32, and 31 patients, respectively. At the end of 3 months, a significant improvement in psychomotor functions was observed in patients treated with sertraline (P < 0.05), while desvenlafaxine-treated patients did not show any significant change in any of the tests. Surprisingly, fluoxetine-treated patients showed deterioration in all psychomotor tests (P < 0.05). Hamilton rating score improved at the end of 3 months treatment as compared to baseline. Most commonly observed adverse reactions in all three drug groups were nausea (n = 20), dizziness (n = 3), headache (n = 20), and diarrhea (n = 3).Conclusion:Sertraline significantly improves psychomotor function as compared to desvenlafaxine while fluoxetine impairs.

To compare the efficacy and safety of different oral and parenteral iron preparations in patients with anemia. Methods: An observational, prospective study in patients of anemia in pregnancy and chronic kidney disease (CKD) receiving iron sucrose, oral ferrous ascorbate and ferrous sulfate were included. Demographic details, clinical history, baseline hemoglobin, anemia indices data were recorded in a case record form. The patients were followed up monthly for 12 weeks and observed for clinical and haematological improvement and adverse drug reactions (ADRs). The data was analyzed using paired t-test, unpaired t-test and Fisher`s exact test. Results: Out of 232 patients, 84 received iron sucrose, 62 ferrous ascorbate and 86 ferrous sulfate. Oral and parenteral iron preparations significantly (P<0.0001) improved mean hemoglobin, anemia indices and serum ferritin at the end of study. However, mean increase in hemoglobin and anemia indices were significant (P<0.0001) with iron sucrose (4.42 ± 0.17gms/dL) as compared to ferrous ascorbate (3.45 ± 0.1) and sulfate (3.3 ± 0.4). Increase in serum ferritin was more and rapid (at 4 weeks) with iron sucrose as compared to ferrous ascorbate in CKD patients. Surprisingly, ADRs were more in patients treated with oral ferrous sulfate (86%) and ascorbate (71%) compared to iron sucrose (63%). Conclusion: Parenteral iron sucrose improves hemoglobin. anemia indices and replenish iron stores rapidly and is well tolerated than oral iron preparations.