Prakruti Patel

Intensive monitoring of adverse drug reactions in hospitalized patients of two medical units at a tertiary care teaching hospital

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.

An evaluation of knowledge, attitude and practices about prescribing fixed dose combinations among resident doctors

Background: Fixed Dose Combinations (FDCs) improve patient compliance and decrease pill burden. However, irrational prescribing of FDCs is a major health concern. As resident doctors are primarily involved in patient management at tertiary care hospitals, knowledge about prescribing FDCs is of paramount importance. Objective: To evaluate knowledge, attitude and practice, regarding use of FDCs by resident doctors at a tertiary care teaching hospital. Materials and Methods: The study was carried out among resident doctors working at Civil Hospital, Ahmedabad, a tertiary care teaching hospital. One hundred resident doctors from the departments of medicine, obstetrics and gynaecology, surgery, paediatrics, skin and psychiatry, who gave their informed consent, were enrolled. A prevalidated questionnaire regarding knowledge, attitude and prescribing practice of fixed dose combinations was filled up. Data was analyzed with suitable statistical tests. Results: Out of the 100 residents recruited for the study, 34, 33 and 33 residents were selected from the 1st, 2nd and 3rd year respectively. The resident doctors were not aware about all of the advantages and disadvantages of FDCs. On an average, only 31% of the residents (lowest 16% among 1st year residents) had knowledge about the Essential Medicine List (EML). Knowledge about rationality of given FDCs was lacking in 81% of the residents. Only 47% could name a single banned FDC in India. Common sources of information about FDCs were medical representatives, colleagues/peers, the Monthly Index of Medical Specialities (MIMS) and Continuous Medical Education (CMEs). A majority of residents (96%) agreed that FDCs should be allowed to be marketed. The residents opined that most commonly prescribed FDCs were of antimicrobial drugs, amongst which amoxicillin + clavulanic acid was the most frequent. Conclusion: There is need to improve knowledge about rationality, EML, usage and banned FDCs in post graduate medical students to promote the rational use of drugs.

A study of use of fixed dose combinations in Ahmedabad, India

Objective: The aim of this study was to evaluate the pattern of fixed dose combinations (FDCs) in Ahmedabad, a city in western part of India. Materials and Methods: Over a period of 24 months, prescriptions were collected from 24 pharmacy stores across 6 zones of Ahmedabad city. The information was recorded in pre-formed Data Record Form after written consent from the patients (or relative (s) of the patients). The pattern of use of FDC, rationality and seasonal variation in their use were analyzed. At the end of study, results were analyzed using Chi-square test. Results: Out of the total 1170 prescriptions, 941 (80.3%) contained 1647 FDC formulations. The average number of FDCs prescribed was 1.41 ± 1.04 (mean ± SD). The FDCs were more frequently prescribed in the age group of 31 to 40 years (23.7%) and in males (54.4%). FDCs were most commonly prescribed by oral route (92.7%). As per drug category analysis, a higher number of FDCs containing nutritional supplements (20.2%), and those for CNS (18.1%) complaints were prescribed. A seasonal analysis showed that FDCs were commonly prescribed for respiratory complaints (23.4%), central nervous system (CNS) complaints (20.3%) and as nutritional supplements (22.4%) in winter, monsoon and summer months, respectively. Only 5.8%, 9.8% and 10.9% FDCs prescribed were included in WHO (2010), National (2011) and Gujarat State (2011) Essential Medicines Lists (EML), respectively (P < 0.0001). Irrational FDCs that are banned or FDCs containing irrational active ingredients were 1343 (81.5%) and 203 (12.3%), respectively. Conclusion: FDCs are widely prescribed with seasonal influence in their use. FDCs containing banned or controversial ingredients are prescribed widely.

An evaluation of impact of educational interventions on the technique of use of metered-dose inhaler by patients

OBJECTIVES: The objective of this study is to evaluate the impact of two educational interventions that are demonstration versus pictorial Leaflet in patients using metered-dose inhaler (MDI). MATERIALS AND METHODS: This interventional study was done in patients who were prescribed drugs through MDI at Tuberculosis and Chest Department. The patients were enrolled in Group A or Group B as per random number table method. The method of use of MDI was assessed using a checklist based on the technique described in the WHO Guide to good prescribing. Patients in Group A were taught the use of MDI by demonstration of the technique by the investigator. Patients in Group B were educated about the technique by a pictorial leaflet based on the technique. Patients were followed up after 15 days and assessed for correct technique for use of the MDI. RESULTS: A total 100 patients were included in the study and were allotted to Group A (47) and Group B (53). Ninety-five percent of the patients had been taught by the treating physician about the method of use of MDI. All the patients at the baseline placed the lips tightly around the mouthpiece and held the aerosol as indicated in the manufacturers instructions while the step least followed was coughing up the sputum before inhalation. The average steps correctly followed by the patients in Group A and B at baseline were 5.17 ± 2.07 and 5.11 ± 2.04, respectively. These improved significantly to 9.19 ± 0.67 and 6.67 ± 0.63 in Group A and B, respectively, postintervention. The five essential steps of using MDI were followed by 25.53% and 26.41% patients preintervention. An improvement in the technique of use of MDI was observed in 85.11% and 49.06% patients (P = 0.003) postintervention. All the ten steps of the technique were followed by 34.04% patients from Group A and none from Group B at postintervention evaluation (P = 0.0001). CONCLUSION: The inhalation technique for the use of MDI used by the patients is inappropriate. Educational interventions such as demonstration or pictorial leaflet help ensure a better use of the MDI.

A study of medication errors in a tertiary care hospital

Objective: To determine the nature and types of medication errors (MEs), to evaluate occurrence of drug-drug interactions (DDIs), and assess rationality of prescription orders in a tertiary care teaching hospital. Materials and Methods: A prospective, observational study was conducted in General Medicine and Pediatric ward of Civil Hospital, Ahmedabad during October 2012 to January 2014. MEs were categorized as prescription error, dispensing error, and administration error (AE). The case records and treatment charts were reviewed. The investigator also accompanied the staff nurse during the ward rounds and interviewed patients or care taker to gather information, if necessary. DDIs were assessed by Medscape Drug Interaction Checker software (version 4.4). Rationality of prescriptions was assessed using Phadke′s criteria. Results: A total of 1109 patients (511 in Medicine and 598 in Pediatric ward) were included during the study period. Total number of MEs was 403 (36%) of which, 195 (38%) were in Medicine and 208 (35%) were in Pediatric wards. The most common ME was PEs 262 (65%) followed by AEs 126 (31%). A potential significant DDIs were observed in 191 (17%) and serious DDIs in 48 (4%) prescriptions. Majority of prescriptions were semirational 555 (53%) followed by irrational 317 (30%), while 170 (17%) prescriptions were rational. Conclusion: There is a need to establish ME reporting system to reduce its incidence and improve patient care and safety.

Prescribing pattern and appropriateness of drug treatment of diarrhoea in hospitalised children at a tertiary care hospital in India.

Objectives: To analyze the prescribing pattern and appropriateness of drug treatment of diarrhoea in hospitalized children. The economic burden of the disease and adverse drug reactions (ADRs) occurring during the course of treatment was also studied. Materials and Methods: It was a prospective, observational, single center study undertaken in pediatric inpatients of diarrhea, aged one month to twelve years over a period of eighteen months at a tertiary care teaching hospital in western India. Modified Kunins criteria along with the guidelines set by the Indian Academy of Pediatrics (IAP) and WHO were followed for assessing the appropriateness of the antimicrobials prescribed. The adverse drug reactions occurring during course of the treatment were noted and the economic burden of the disease was calculated as direct and indirect costs. Results: A total of 103 patients were enrolled, of whom 45% were in the age group of one month to one year. Diarrhoea with some dehydration was diagnosed in 50.5% patients followed by severe dehydration (34.9%) and no dehydration (14.6%). The number of drugs and antimicrobials prescribed per patient were 7.53±1.87 and 1.92±0.67, respectively. Rehydration fluids (31.6%) and antimicrobials (25.5%) were the commonest drug groups prescribed. Among the antimicrobials, cefotaxime, cotrimoxazole and amoxicillin with clavulanic acid were frequently prescribed. Appropriate antibacterial therapy was given in only 13% of the cases. Only one ADR due to cotrimoxazole was observed. The economic burden of the disease was calculated to be Rs. 3164.81 per patient. Conclusion: Inappropriate use of antimicrobials was seen in the study. Emphasis on proper diagnosis and treatment, education and availability of locally effective guidelines may help in a better and judicious use of drugs in children.

An analysis of the pharmacological management of respiratory tract infections in pediatric in-patients at a tertiary care teaching hospital

Objectives: To analyze the pharmacological management of respiratory tract infections in hospitalized pediatric patients. The economic burden of the disease and the adverse drug reactions occurring during the course of treatment have also been studied. Materials and Methods: It was a prospective, longitudinal, and observational study, carried out over a period of one-and-a-half years. The patients, aged one month to twelve years, diagnosed with respiratory tract infections (RTI), as confirmed by a pediatrician, were enrolled. Modified Kunins criteria along with the guidelines set by the Indian Academy of Pediatrics (IAP) were followed for assessing the appropriateness of the antibacterials prescribed. The adverse drug reactions occurring during the course of the treatment were noted and the economic burden of the disease was calculated as direct and indirect costs. Results: A total of 201 patients were enrolled, of whom 46% were in the age group of one month to one year. The most common diagnosis was pneumonia (76%). The number of drugs and antibacterials prescribed per patient were 4.88 ± 1.57 and 1.85 ± 0.86, respectively. Antibacterials (37.7%), intravenous fluids (17.2%), respiratory medicines (16.6%), and analgesic/antipyretics (16.5%) were the common drug groups prescribed. Among the antibacterials, amoxicillin with clavulanic acid (47%) and cefotaxime (22%) were frequently prescribed. Appropriate antibacterial therapy was given in 42% of the cases. Salbutamol and a combination of Levosalbutamol and Ipratropium Bromide were the commonly prescribed respiratory medicines. Three adverse drug reactions (ADRs) were observed in indoor patients, all due to antibacterials. The economic burden of the disease was calculated to be Rs. 4925.14 or US

An evaluation of the impact of antidiabetic medication on treatment satisfaction and quality of life in patients of diabetes mellitus

109.9 per patient. Conclusion: An overuse of antibacterials and respiratory medicines was seen in the study. Emphasis on proper diagnosis and treatment, education and availability of locally effective guidelines may help in a better and judicious use of drugs in children.

KNOWLEDGE, ATTITUDE AND PRACTICE ABOUT DIABETES AND ITS TREATMENT IN PATIENTS ATTENDING THE SPECIALITY CLINIC

Aims: This study aims to measure the quality of life (QOL), treatment satisfaction, and tolerability of antidiabetic drugs in patients suffering from type 2 diabetes mellitus (DM). Methods: The prospective, observational study was conducted in consenting patients of type 2 DM attending the outpatient department of a tertiary care hospital in Western India. The QOL instrument for Indian diabetes (QOLID) patients questionnaire and the Diabetes Treatment Satisfaction Questionnaire were administered to all patients at baseline, 3 months, and 6 months of treatment. Tukey–Kramer comparison test was used to analyze the difference in QOLID scores in various domains at baseline, 3 months, and 6 months. WHO-UMC scale, Naranjos probability scale, Hartwig and Siegel, and Schumock and Thornton modified criteria were used to analyze the adverse drug reactions. Results: A male preponderance was observed in 200 patients enrolled in the study. The mean duration of diabetes was 10.96 ± 5.99 years. The patients received metformin alone (40), metformin and glipizide (47), metformin, glipizide and other oral hypoglycemic agents (OHAs) (78), and OHAs and insulin (35). A significant improvement in fasting and postprandial blood sugar was observed at 6 months as compared to the baseline (P < 0.05). A total of 39 (19.5%) patients suffered from adverse effects to metformin and insulin. Physical health and physical endurance improved in patients receiving metformin alone or in combination with glipizide as compared to patients receiving other OHAs and/or insulin. Treatment satisfaction, highest in patients receiving metformin and least in those receiving insulin, was unaltered during the study period. Conclusions: While polypharmacy is evident, using lesser medicines offers better treatment satisfaction and QOL in DM. Periodic assessment of QOL and treatment satisfaction are recommended in DM.

A study of the use of drugs in patients suffering from psoriasis and their impact on quality of life

Diabetes mellitus is a prominent healthcare problem in India. Emphasis on self management and active participation of the patients can help reduce its complications. This baseline study was conducted to evaluate the knowledge, attitude and practice about diabetes and its treatment among patients. A validated self-administered questionnaire was administered to diabetic patients attending the specialty OPD at a tertiary care, teaching hospital. The questions assessed the knowledge, attitude and views about diabetes, its complications and regarding prevention and treatment. Scoring of questions regarding knowledge was done (range 0 to 33). Latest fasting and postprandial blood sugar levels and HbA1C level were also recorded. The data was recorded in a Microsoft Excel 2007 spreadsheet and statistical analysis was done using Graph Pad InStat version 3.06. The study enrolled 200 patients (151 males and 49 females). About 75% patients knew the normal blood sugar levels, symptoms and complications of diabetes. Heart disease was considered to be a major complication and around 70% believed that these complications could be prevented. The mean knowledge score was 12.8±3.3 out of 33. The level of knowledge was better with greater age and duration of diabetes. The attitude of the patients was favourable with majority realizing the importance of lifestyle modifications, uninterrupted treatment and regular follow up. However, few patients actually partook in the lifestyle changes. Attitude of the patients was encouraging but the knowledge and practice was generally lacking among the patients. Motivation and importance of self management patient education regarding drugs, diet and regular exercise is important for decreasing mortality and morbidity due to diabetes.