Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

In old age the organs will become damaged and the drug therapy in the elderly is further impacted by changes in the geriatric pharmacodynamics and pharmacokinetics. Elderly  patients require chronic medication with multiple drugs which will result in polypharmacyCompliance, is defined as “the extent to which the patient’s behaviour matches the prescriber’s recommendations. Compliance is a passive behaviour in which a patient is following a list of instructions from the doctor.” While “adherence is an active choice of patients to follow through with the prescribed treatment while taking responsibility for their own well-being.

The drug interaction is defined as a modification of the effect of a drug when it is administered with other drug. When a therapeutic combination of drug could lead to an unexpected change in the condition of the patient, this would be described as an interaction of potential clinical significance.[6] Potential drug-drug interactions can be a very important ancillary factor for the occurrence of adverse drug reactions (ADRs) and adverse drug events. DDIs are a subset of ADRs, accounting for about 3-5% of all ADRs, and ADRs can of course be harmful or fatal. [6,7] Drug-drug interactions (DDIs) are significant but avoidable causes of iatrogenic morbidity and hospital admission.[8]

Numerous studies have been done in many developed countries to assess the problem and prevalence of poor compliance in geriatric patients [5]. However, few studies have been done in Indian population to assess the problem and the extent of medication compliance and drug-drug interaction in geriatric patients.

Hence, this study will be conducted to study the medication compliance and potential drug-drug interactions in geriatric patients attending outpatient department of a tertiary care teaching hospital in Maharashtra.

1) To study of potential drug-drug interaction by using Medscape drug interaction checker (MDIC).

2) To study of medication compliance by using Morisky Medication Adherence Scale (MMAS).

Secondary Objectives: 

To Study drug utilization pattern in geriatric patients attending OPD.

Inclusion criteria

1. Patients above 60 yrs. Of age

2. Patients of either gender.

3. Patients suffering from non-communicable diseases.

4. Patients willing to participate in study with written informed consent.

Exclusion criteria

1. Patients not willing to consent.

2. Those with serious/acute illness such as acute myocardial infarction, acute left ventricular failure, and diabetic ketoacidosis.

2. Selection of study participants will be done on the day of examination after it has been established that the participant fulfilled all the inclusion criteria.

3.Patients attending the Medicine OPD will be screened by the physician and principal investigator. Diagnosis will be made on the basis of patients’ chief complaints, history, and clinical assessment.

4. Afterwards written informed consent will be obtained and patients will be enrolled in the study. A patient information sheet will be given to all prospective participants.

5.Patients will be assessed for medication adherence and potential drug- drug interaction between the drugs after seeing the prescriptions of the patients.

6.The medication adherence will be assessed by Morisky medication adherence questionnaire where mild(<6), moderate(6-8) and high(8) medication adherence will be assessed on basis of score(0-8).

7.After seeing the prescription of the patient, Potential drug- drug interaction will be seen by using MEDSCAPE Drug interaction checker. To analyze drug interactions, software namely Medscape drug interaction checker (URL- http:// reference.medscape.com/drug-interaction checker) freely available on the website www.medscape.com was used.

8.The clinical relevance of potential drug- drug interaction was defined by a software programme namely Medscape drug interaction checker, which classifies PDIs as mild, significant and serious. This software, based on clinical and pharmacological documentation, gives a reasonably fair idea of potential adverse event risk and efficacy of drugs.

9.Following data will be collected and analyzed from the prescription given to the patients.

Data collection:

1.Data will be collected in self-designed proforma and will be analyzed according to following parameters—

2.Demographic profile: Name, Age, Sex, Address, Education and Occupation Diagnosis

3.Weight of patient

4. Lab investigations

5. Drugs prescribed

6.Formulation and dose of drug

7.Duration and frequency of drug administration

8.Route of drugs administration

9.Generic/brand name

10.Drugs from essential drug list

11.Adverse drug reactions seen after therapy, its duration and treatment.

Confidentiality of the information will be assured throughout the study.

Statistical Analysis:

1.Descriptive statistics will be used to analyse data for demographic parameters.

2. Results will be expressed as percentage frequency and Mean ± SD or median, depending on whether the data is parametric/non-parametric.