Study : Adverse drug reactions among inpatients in a north Indian referral hospital.

Uppal R , Jhaj R , Malhotra S

Natl Med J India. 2000 Jan-Feb; 13(1):16-8

Period: 3 years

Methodology : Spontaneous Reporting

ADRs reported: 317

Major organs system affected: Skin (38.8%) and Gastrointestinal tract (28.4%)

Common causative drugs: Antimicrobial agents, including ATT (47.3%).

Others - Radio contrast dyes, anti-neoplastic and psychoactive agents

Study : Adverse drug reactions in a south Indian hospital-their severity and cost involved.

Ramesh M , Pandit J , Parthasarathi G

Pharmacoepidemiol Drug Saf. 2003 Dec; 12(8):687-92.

Period: 7 months

Methodology: Spontaneous Reporting

ADRs reported: 270

Major organs system affected: Gastrointestinal system (36.3%)

Common causative drugs: Cardiovascular drugs (18.3%)

Statistics:

•  0.7% of the admissions were due to ADRs

•  3.7% of the hospitalized patients experienced an ADR

•  1.8% had a fatal ADR

Study : Pattern of adverse drug reactions notified by spontaneous reporting in an Indian

tertiary care teaching hospital.

Jose J , Rao PG .

Pharmacol Res. 2006 Sep;54(3):226-33

Period: 12 months

Methodology: Spontaneous Reporting

ADRs reported: 408

Major organs system affected: Dermatological system (23.5%) Skin rash (10.5%) -most frequently reported reaction

Statistics:

•  The suspected drug was withdrawn in majority (56.6%) of the reports

•  Causality assessment majority were probable (53.7%).

•  Mild and moderate reactions accounted for 50.5 and 43.9%, respectively

•  In 28.7% of the reports, the reaction was considered to be preventable.

•  At least one predisposing factor was present in 79.9% of the reports

•  Type A reactions were more common among elderly adults (85.92%) and

•  Type B reactions more common in adults (35.01%)

Study: A pharmacovigilance study in the department of medicine of a university

teaching hospital.

Sharma H, Aqil M, Imam F, Alam MS, Kapur P, Pillai KK.

Pharmacy Practice 2007; 5(1): 46-49.

Period: 4 months

Methodology: Intensive ADR monitoring of patients in Medicine OPD by a registered

pharmacist and voluntary reporting of ADRs by physician.

ADRs reported: 122

Major organs system affected: Gastrointestinal (24.7%) followed by skin (22.2%)

Common causative drugs: Antihypertensive therapy (39.3%), antimicrobials (31.1%) and antidiabetics (10.7%).

Statistics:

•  Causality - Certain 4.9% ,Probable 29.5% , Possible 33.6%, Unlikely 21.3%,

Conditional 4%, Inaccessible 6.6%.

•  Severity - Mild 41.0%, Moderate 40.2%,Severe 18.2%

Study: Adverse drug reactions in pediatrics with a study of in-hospital intensive

Surveillance.

Dharnidharka VR , Kandoth PN , Anand RK .

Indian Pediatrics. 1993 Jun;30(6):745-51

Methodology: A two-part prospective study of adverse drug reactions (ADRs), using in-hospital intensive surveillance scheme (IISS) for the detection of ADRs in two units of the pediatric ward (1 unit serving as a control group).

ADR's reported:

1 st Part - 6 months- 6 cases reported (1 fatal)

2 nd Part - 2 years- 40 cases

Statistics:

•  The frequency of ADRs (p < 0.001) and their resultant mortality in Indian children was less than that in a western prototype study

•  Though IISS showed a marked increase in ADR reporting, it was too cumbersome for routine use in our country

•  Antimicrobials, especially sulphonamides, accounted for a high percentage of cases mostly as skin rashes and fairly severe reactions were common.

•  Patients on anti-tuberculous and anti-convulsant drugs required prolonged supervision for late onset reactions.