Analysis of Prescribing pattern and Adverse drug reactions of Anti-diabetic drugs in patients of Type 2 Diabetes Mellitus in a tertiary care teaching hospital - A prospective observational study.

This study will be designed to analyse the pattern of anti-diabetic drugs prescribed to the patients. Details of patient related information such as demographic profile, prescribed drug, dose, route of administration, frequency of administration will be recorded on the patient information form. Other drug related information such as number of anti-diabetic drugs per prescription, drugs prescribed by generic name vs branded name, Mono therapy vs Combination therapy, number of anti diabetic drugs prescribed from National List of Essential Medicine (latest) and details of concomitant medications will also be recorded and analyzed.

The rationality of prescriptions will be assessed using the WHO

core prescribing indicators which include :

a)Average number of drugs prescribed.

b)Percentage of encounters with an antibiotic prescribed.

c)Percentage of encounters with an injection prescribed.

d)Percentage of drugs prescribed from National List of Essential Medicines (NLEM).

e)Percentage of drugs prescribed by generic names.

Patients on anti-diabetic drugs will also be screened for suspected Adverse Drug Reactions (ADRs). These ADRs will then be reported using Suspected Adverse Drug Reaction Reporting Form (version 1.4).

The causality assessment of the suspected ADR will be done using “WHO-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale” which categorizes causality of an ADR into 6 categories: certain, probable, possible, unlikely, conditional/unclassified,unassessable/unclassified.

Severity of the ADRs will be assessed using “Modified Hartwig and Siegel Severity Assessment scale” which categorizes severity of ADR into 7 levels (Mild= level 1 and 2, moderate= level 3 and 4, severe= 5, 6 and 7).

Preventability of ADRs will be assessed by using “Modified Schumock and Thornton scale” which categorizes the preventability of an ADR into “Definitely preventable”, “probably preventable” and “not preventable”.

Statistical Analysis of the data will be done using Microsoft Excel and SPSS software. Categorical variables will be presented as numbers and percentages and quantitative variables as mean ± SD.