Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers

Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. Methods: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. Results: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs. Conclusion: Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.

Prescribing pattern and pharmacoeconomic analysis of antidiabetic drugs

Background: Diabetes Mellitus is a worldwide growing problem causing threat to patient's health because of its association with various complications and comorbidities. It is a chronic disease requiring lifelong medication which further adds to the economic burden. The objective of this study was to evaluate the prescribing pattern and to do pharmacoeconomic analysis of prescribed antidiabetic drugs.Methods: This observational cross sectional study was conducted for 12 months duration in Outpatient Pharmacy of tertiary care hospital. Prescriptions with antidiabetic drugs were captured and evaluation of prescribing pattern along with pharmacoeconomic analysis of antidiabetic drugs was done.Results: A total of 611 prescriptions with antidiabetic drugs were analyzed. There were total 4034 drugs in all prescriptions with a mean of 6.6 drugs per prescription. 4.28% of drugs were prescribed by generic name and 58.9% of prescribed drugs were from essential drug list. Dual drug therapy was prescribed in maximum number of patients (42.2%) followed by monotherapy (28.8%). More commonly prescribed class of antidiabetic drugs was biguanides as monotherapy (n=119) and its combination with sulfonylureas was prescribed maximally among dual drug therapy (n=158). Cost of monthly therapy for antidiabetic drugs prescribed as monotherapy was least with Biguanides (? 98.89/ month) whereas combination of biguanides and thiazolidinediones was least expensive among dual drug therapy (? 216/ month).Conclusions: Biguanides was the most common prescribed class of antidiabetic drugs among monotherapy and its combination with sulfonylureas was most prescribed as dual drug therapy and both of these therapies were economical.

A prospective observational study to assess compliance and factors influencing compliance with antiepileptic drugs among patients with epilepsy

Background: The primary treatment for epilepsy is Antiepileptic drug (AED) therapy. Non-compliance to AEDs can result in break-through seizure, emergency department visits, hospitalizations, fractures, head injuries and increased mortality. Thus, compliance to AEDs is crucial to be studied. Objective is to study compliance and factors influencing compliance with AEDs among patients with epilepsy.Methods: This observational study was conducted in 105 patients with epilepsy on AED therapy in community in Ludhiana (Punjab) after approval from Institutional Ethics Committee. Demographic data and drug history was collected. Monthly follow up for 6 months was done by paying home visits and data regarding type, dose, frequency of administration of AED was recorded on a semi-structured performa. Pill count was done by recording number of pills dispensed and number of pills remaining with patient. Response to Morisky’s Medication Adherence Scale (MMAS) was also recorded. Results were correlated with patient demographics, type, frequency and number of AEDs.Results: Out of 105 patients, 65 were males and 40 were females. Fifty-four patients were non-compliant with both pill-count and MMAS. Non-compliance was high in first month and decreased gradually. Poly-therapy, lower socio-economic status and multiple dosing regimens were most commonly associated with non-compliance.Conclusions: Under-dosing was more common among non-compliers, which explains the high reporting of forgetfulness to take medicine in MMAS. Both pill count and MMAS are effective non-invasive tools to study compliance.

Spontaneous adverse drug reaction monitoring in oncology: Our experience.

BACKGROUND: Adverse drug reaction (ADR) monitoring is slowly developing as an important aspect of healthcare. The aim of the study was to study the pattern of adverse drug reactions in the Oncology department of a tertiary care hospital. MATERIALS AND METHODS: This was a prospective study conducted in the Oncology department of a tertiary care hospital in which ADRs were reported spontaneously. The ADRs were noted from 1st January, 2007 to 30th June, 2011. Following were noted: demographics, premedication (if any), diagnosis, chemotherapy (regimen, cycles), medication history, and alteration in the treatment or co morbidities, ADRs (severity and management). Adverse drug reactions were noted by patient interview, collaborating with information on file, recording changes in the prescribing chart and investigations, consulting the doctor on duty. RESULTS: During this study period, there were total of 14,475 visits of patients from which 2500 ADRs were recorded. Maximum number of ADRs were noted with platinum compounds (25.52%) followed by pyrimidine antagonists (19.88%). The most common malignancy reported in our hospital was Carcinoma breast (20%) followed by leukemia (12%) and Ca ovary (12%). Alopecia (27.76%) was the most common ADR followed by anemia (7.48%), thrombocytopenia (6.96%) and constipation (6.16%). CONCLUSION: Alopecia is the most common ADR and platinum compounds were responsible for the maximum number of ADRs. The most common carcinoma reported during this period was carcinoma breast.

Dimethyl fumarate: a novel drug for multiple sclerosis.

Dimethyl fumarate (DMF) is a novel oral immunomodulatory and neuroprotective drug that was approved by FDA for relapsing forms of multiple sclerosis (MS). The initial use of DMF was for the treatment of psoriasis where its long-term use was safe and efficacious, and it also got German approval for the same. It was found that the anti-inflammatory actions of DMF contributed to its efficacy in psoriasis. This anti-inflammatory action of DMF created interest using DMF in other auto-immune or inflammatory diseases, including MS. DMF acts by decreasing production and release of inflammatory molecules. DMF also activates the nuclear factor-erythroid 2 related factor pathway which induces the transcription of various genes, including anti-oxidative ones, reduces oxidative neuronal death and helps maintain myelin integrity. Thus, DMF acts via two pathways: by down-regulating oxidative stress and corresponding cellular injury, as well as by inhibiting pro-inflammatory cytokines. DMF is an orally administered, enteric-coated microtablet preparation. There was a 44-53% reduction in annualized relapse rate with the use of DMF in patients with relapsing form of MS. The most common adverse reactions reported are flushing, abdominal pain, diarrhea, and nausea, which are more prominent during initial treatment and usually decrease over time. No serious adverse events were seen during the phase II and III trials, including no increased risk of opportunistic infections or cancer. DMF seems to approach the ideal combination of safety, efficacy and welltolerability to other approved oral therapies for MS.

Phentermine and topiramate combination for chronic weight management: a review.

Obesity is a major public health concern and one of the leading preventable causes of death worldwide. It has manifold adverse health consequences, potentially involving all major organ systems thus leading to a reduced life expectancy. The long-term successful management of obesity remains a herculean task and invariably requires a multifaceted approach including lifestyle and behavioral modification, increased physical activity, and adjunctive pharmacotherapy and bariatric surgery. However, effective pharmacological options are limited because of the previous history of several failed agents as well as the fact that presently available agents are few, and utilized only as monotherapy. The recent Food and Drug Administration (FDA) approval of the fixed drug combination of phentermine and extended release topiramate marks the first FDA approved combination pharmacotherapeutic agent for obesity. This review details the various pharmacological aspects of the use of phentermine and topiramate combination along with the results of clinical trials done so far and also the present role of this combination in the management of obesity. Beyond the significant improvement in weight, the findings from various clinical trials also show improvement in metabolic and glycemic parameters, blood pressure, and lipid profile suggesting its added utility in cardiovascular risk modification. The acceptability of this combination would usher in a new era in the pharmacotherapy of obesity that utilizes combination therapy to improve efficacy, enhance synergism and concurrently minimize the risk of adverse effects. As with any newly marketed drug, there may be yet-unknown benefits and risks associated with this combination, which would be known only after its long-term use.

A Drug Utilization Study of Antimicrobial agents (AMAs) in the Intensive Care Units (ICUs) at Medical College Hospital of North India.

The APACHE (Acute Physiology and Chronic Health Evaluation) is a prognostic scoring system for classifying patients in Intensive Care Unit (ICU) on the basis of physiological scores and chronic health status. The chances of survival increase with a decrease in score. AMAs play a major role in management of such illnesses and dramatically improve patient outcome. This study has been undertaken to study the AMA utilization patterns in ICUs. Data was collected from 49 patients admitted in Surgery and Neurosurgery ICUs after IEC approval. The average number of AMAs used was 3.36 per patient. The highest use of AMAs was 4.3 in group VI of APACHE scoring system. Cephalosporins was the most commonly prescribed AMA group. The preferred route of administration was intravenous route. Feedback from this study would help both the prescribers and institutional authorities to review their prescribing practices and modify if necessary to facilitate better health care delivery.

Prescribing Pattern & Cost-Identification Analysis of Antimicrobial Use in Respiratory Tract Infections.

The objective of an observational study was to evaluate the drug prescribing pattern in the pediatric population in a tertiary care teaching hospital. The most common illness, which warranted admission to PICU, was bronchopneumonia (33.3%) followed by bronchiolitis (17.5%) and bronchial asthma (7.9%). Average no. of Antimicrobial Agents received per patient was 3.9. Parenteral drugs accounted for 86.1% of the total drugs prescribed. The most common AMAs prescribed were cephalosporins (26.1%), aminoglycosides (20.9%), beta-lactams (excluding cephalosporins) (17.4%) and fluoroquinolones (11.1%). Beta-lactams contributed to 44% of the total AMA cost followed by cephalosporins (31.8%) and miscellaneous AMAs (8.5%). The total number of preparation encounter per prescription was 9.7±4.8 per patient. The total number of single drug prescription was 88.4% and fixed drug combinations were 11.6%. Among the total drugs prescribed, 45.26% were generic and 54.73% constituted branded drugs. Overall 51% of the total drugs prescribed were from the WHO List of Essential Medicine 2010. There should be more emphasis on prescribing generic drugs and in case of similar efficacy the drug with lesser cost should be preferred.

Evaluation of Drug Use Pattern in Dermatology as a Tool to Promote Rational Prescribing.

The present study was undertaken to evaluate the format, prescribing pattern and rationality of prescriptions of the patients attending Dermatology Out Patient Department of a tertiary care hospital for a period of one year. A total of 5,355 prescriptions were analyzed in which 17,459 drugs were prescribed with an average of 3.26 drugs per prescription. The patient's name and age was mentioned in all the prescriptions while superscription, dosage form, duration of therapy and prescriber's identity was written in 95.4%, 100%, 80.7% and 23.5% prescriptions respectively. Out of all drugs, 15.4% were from National Essential Drug List of India. Antihistamines (16.9%) were the most common group of drugs used, followed by corticosteroids (15.3%). Most of the drugs were given by topical route (60.2%). Dosage and dose schedule of drugs was written for 91.2% and 94.7% drugs respectively. The study showed a tendency towards polypharmacy and prescribing by proprietary names.

Efficacy and safety of pegylated IFN alfa 2b alone or in combination with ribavirin in thalassemia major with chronic hepatitis C.

Background Treatment of HCV infection in patients with thalassemia major (TM) is limited by the lack of large clinical trials and concerns about ribavirin-induced hemolysis. Methods We conducted a prospective, randomized, openlabel study to determine efficacy and tolerability of pegylatedinterferon alfa 2b (1.5 μg/kg/week) alone (group A) or with ribavirin (12–15 mg/kg/day; group B) in patients with TM and chronic HCV infection. Patients with genotype 1 or 4 HCV were treated for 48 weeks and those with genotype 3 or 2 HCV for 24 weeks. Early viral response (EVR; after 12 weeks of treatment), end-of-treatment virological response (ETR) and sustained virological response (SVR; 6 months after stopping therapy) were assessed. Results Of 40 patients, 20 each were allocated to the two treatment groups. EVR rates in group A and B were 15 (75%) and 18 (90%), respectively. ETR occurred in 17/20 (85%) patients in each group. SVR occurred in 8 (40%) patients in group A and 14 (70%) in group B. Blood transfusion requirements increased in one patient in group A and four patients in group B. One patient in group A had severe sepsis and one in group B had nephrotic syndrome. Two patients in each group required reduction in drug dose. Conclusions In patients with TM and chronic HCV infection, pegylated interferon alfa 2b and ribavirin combination therapy achieves a higher SVR rate than pegylated interferon alone, and is well tolerated except for an increase in blood transfusion requirement.

Safety and efficacy of clobazam versus phenytoin-sodium in the antiepileptic drug treatment of solitary cysticercus granulomas.

BACKGROUND: It is now agreed that the prognosis of seizure disorder due to solitary cysticercus granuloma (SCG) is generally good. However, the choice antiepileptic drugs (AEDs) remain empirical, with no comparative trials of different AEDs being available. AIMS: To determine the safety and efficacy (measured by the incidence of 'treatment failure') of clobazam in comparison to standard treatment with phenytoin-sodium for prevention of seizures in persons with solitary cysticercus granulomas (SCGs). SETTINGS AND DESIGN: This pilot study was conducted in a neurology department of a medical college hospital in the form of a prospective, randomized, open-labeled trial. MATERIALS AND METHODS: Forty-eight patients with seizures due to SCG were randomized in an open-labeled trial to either, clobazam (1 mg/kg oral loading followed by 0.5 mg/kg/d) (n=21) or phenytoin (15 mg/kg, oral loading in 3 divided doses over 24 h, followed by 5 mg/kg/d) (n=27). They were followed over 6 months with the primary outcome measure being treatment failure (either discontinuation or modification of AEDs) due to either adverse effects or breakthrough seizures. RESULTS: Treatment failures were noted to be significantly less common (P =0.03) in the clobazam-treated group (n=1; 4.7%) than in phenytoin-treated group (n=9; 33.3%). These included one patient (4.7%) in the clobazam-group who had breakthrough seizures and 3 (11.1%) who had breakthrough seizures and 6 (22.2%) in the phenytoin-treated group who had adverse effects requiring treatment discontinuation. CONCLUSIONS: Clobazam was well tolerated, safe and more effective than phenytoin in the AED treatment of patients with SCG.