Drug Utilization Study at Tertiary Care Hospitals in Punjab

Drug utilization (DU) or Drug use evaluation (DUE) studies is an ongoing, authorized and systematic quality improvement process. These studies designed to review drug use and prescribing patterns of drug with current recommendations or guidelines for the treatment of a certain disease. DUE provide feedback of drug utilization data to prescribers related to number of cases of adverse effects adverse drug reactions, specific drug-drug, drug-food interactions and medication errors. This study shows the evaluation of current prescribing pattern to identify different adverse drug reactions, specific drug –drug, drug -food interactions and medication errors at tertiary care hospitals in Punjab.


Introduction
Drug utilization (DU) or Drug use evaluation (DUE) studies is an ongoing, authorized and systematic quality improvement process. These studies designed to review drug use and prescribing patterns of drug with current recommendations or guidelines for the treatment of a certain disease. DUE provide feedback of drug utilization data to prescribers related to number of cases of adverse effects adverse drug reactions, specific drug-drug, drugfood interactions and medication errors [1]. This study shows the evaluation of current prescribing pattern to identify different adverse drug reactions, specific drug-drug, drug-food interactions and medication errors at tertiary care hospitals in Punjab. Drug interaction is defined as the modification of the effects of a drug (object drug) by the prior and/or the concomitant administration of another drug (precipitant drug). Drug interaction may either increase or decrease the intended effect of one or both drugs. It may transform the diagnostic, preventive or therapeutic activity of any drug [2]. Drug interactions can be an extremely main contributory factor for the incidence and occurrence of adverse drug reactions and adverse drug events. This article contains one part of the study which is accompanying with the adverse drug reactions, drug interactions, medication error reported during study period.

Materials and Method
The study was carried out on after obtaining approval and clearance from the Institutional Ethics Committee. The study was conducted at Department of Medicine in three different hospitals setting in the Moga, District of Punjab, India. Based on the inclusion and exclusion criteria the patient's after signing the Informed Consent Form data was collected from the patient case file, case reports, and laboratory reports. The study included patients with both type1 and type2 diabetes and suffering from hypertension with diabetic and hypertensive complications. Sample size is calculated through Software "Statcal Epiinfo" which is designed by US Department of Health and Social Services Centre for Disease Control and Prevention (CDC) for prospective observational studies [3]. Population size of the study was found to be = 1613254 as per census (2011). Sample of the study was found to be=1098 Patients. Study was conducted for a period of one year. The aim of this study was to study the pattern, drugs involved, severity, outcomes and preventability of adverse drug reactions using intensive monitoring approach as well as to observe drug interactions and medication error.

Results
Total 1208 patients of both genders were enrolled in study who were under treatment of diabetes and hypertension with their comorbidities and complications. During the study following ADR's10 were detected and reported. The present study showed that females experienced higher incidence of ADRs when compared to males. In most of the ADR cases immediately drug responsible for the causes of reaction were stopped & management therapy were initiated as per guidance and guidelines. Type A reactions accounted for most of the ADRs. Using the Naranjo algorithm, (61.19%) ADRs were assessed as 'probable' whereas (37.86%) were assessed as 'possible' and 3 (1%) were classified as 'definite' in relation to the suspected drug. Gastro-intestinal system was the most common organ system affected.

Drug Food Effect
Naproxen Fatty food Upset stomach [2] Celecoxib Milk Upset stomach [2] Benzodiazepine Grapefruit Inhibit the enzyme involve in BZD metabolism [2] Warfarin Vitamin K Reduce the effect of drug [5] Tetracycline Calcium food Reduce the absorption of drug [6] Acetaminophen Alcohol Liver damage [20] Digoxin Oatmeal Decrease the absorption of drug [21]

Discussion
During the study it was found that dispensing type of error is the common followed by indenting error. It is important to understand that an analysis of medication errors can help healthcare professionals and pharmacist to identify why medication errors can occur and make improvements to prevent or reduce them. Future research into the development of a clinical framework to prevent clinical errors is required. More data in regards to medication and other clinical errors and what causes them is essential. In addition, data concerning potential solutions is also recommended and the articles could be analyzed further based on location of the medical error incident (e.g. hospital, primary care, etc).
In most of the ADR cases immediately drug responsible for the causes of reaction were stopped & management therapy were initiated as per guidance and guidelines. Type A reactions accounted for most of the ADRs. Using the Naranjo algorithm, (61.19%) ADRs were assessed as 'probable' whereas (37.86%) were assessed as 'possible' and 3(1%) were classified as 'definite' in relation to the suspected drug similar results were found in study conducted by [16]. Gastro-intestinal system was the most common organ system affected. Sign and symptoms related to gastro-intestinal system were vomiting, diarrhea, constipation, nausea, Gastritis, peptic ulcer, and gastric pain. When organ systems affected were studied, Gastro-intestinal system was the organ system most commonly affected by the ADRs with vomiting as the most common individual reaction. This study showed the level of gastric intolerance of patients to this class of drugs [22].
These findings substantiate previously reported studies on gastric ADRs [23]. In most of the ADRs cases drug were withdrawn instead of dose alteration or alternative therapy. The present study showed that females experienced higher incidence of ADRs when compared to males which is similar to the results of [24] Cardiovascular drugs were the second most common drug class with furosemide being the most commonly implicated drug. These findings are consistent with the findings of [25]. During the study it was found that percentage of the reactions was severe in nature and mostly skin reactions accounted for that. Preventable ADRs were less in this study compared to available reports [14].

Conclusion
With this study it was concluded that there is an alarming rate of prevalence and incident of adverse drug reactions, drug interactions, medication error which is much higher in patients receiving combinations of drugs or poly pharmacy or suffered from co-morbidity of diseases such as diabetes, hypertension which require prolong and multi treatments and the risk of drug interaction will increase as they are treated with multi-therapies. The intensive monitoring of ADRs in medicine wards helped to assess the incidence and pattern of ADRs.
It is well reported that diabetic patients are suffering because of higher risk of diabetic complications may encounter higher rate of drug interaction as they receive combination of therapies, and hence the rate of occurrence of drug interaction is rapidly increases. In this study, we have found that the patients receiving diabetic medication are at higher risk of drug-drug and drug-food interactions as they are receiving multi therapies for the treatment of diabetic complications and other related disorders. So that the physician and other medical staff should aware and guide the patient about the medication, drug related problems, interaction with food and other drugs or with medication.
This will help to avoid and stop the rate of the drug-drug and drug-food interactions associated to anti diabetic therapy. This study summarized and highlights the various drug interactions likely drug-drug and drug-food interactions as well as reports unwanted effects of other treatment associated with diabetic and hypertensive patients suffering with their complications.
Clinical pharmacists design pharmaceutical care plan, identify problems, establish outcome goals, provide patient counseling, monitor pharmacokinetics and therapeutic drug level, report adverse drug reaction (ADRs), evaluate treatment outcome, and drug information to health care professionals.

Limitations of the Study
Rechallenge was not performed for many ADR cases and this might alter the causality if such information is available for all the cases.