Seeba Zachariah

Coxibs Refocus Attention on the Cardiovascular Risks of Non-Aspirin NSAIDs

Non-steroidal anti-inflammatory drugs (NSAIDs) were differentiated from steroidal anti-inflammatory medicines to help clinicians who needed to use anti-inflammatory agents that were safer than steroids. With market entry of rofecoxib in 1999, NSAIDs were then further classified into traditional NSAIDs and cyclooxygenase (COX)-2 inhibitors (coxibs), the latter posing potentially fewer gastrointestinal risks. In 2005, rofecoxib was withdrawn from the market because of concerns about the risk of heart attack and stroke with long-term use, and clinical practice began focusing more on the cardiovascular versus gastrointestinal safety of coxibs. Since then, many coxibs have remained unapproved by the US FDA or have been removed from the market. This article explains how coxibs refocused attention on the cardiovascular safety of NSAIDs and the general implications of that. COX-2 activity/specificity is one factor associated with increased cardiovascular risks; however, these risks cannot be attributed to coxibs alone. The traditional NSAIDs (i.e., meloxicam, etodolac, and nabumetone) have significant COX-2 specificity, but naproxen and ibuprofen have less specificity. All NSAIDs, whether traditional or a coxib, pose some cardiovascular risks. It is possible that clinicians continue to focus more on decreasing the immediate gastric risks than preventing the later cardiovascular risks. The cardiovascular risks posed by NSAIDs should not be disregarded for the sake of achieving gastrointestinal benefits. Current recommendations suggest NSAIDs should be considered a single class of non-aspirin NSAIDs. Preferred NSAIDs are ibuprofen and naproxen. Coxibs are preferred in patients with low cardiovascular risk and high gastrointestinal risk who are intolerant to anti-dyspepsia therapy.

High prescription of antimicrobials in a rural district hospital in India

Background The World Health Organization (WHO) recommends surveillance of antibiotic use as part of the strategy to fight against antimicrobial resistance. However, there is little information about the antibiotic consumption in developing countries, especially in rural areas. Objective The objective of this study was to describe the antimicrobial consumption in a rural hospital in India Methods The study was performed in a district hospital situated in Anantapur, Andhra Pradesh. In accordance with WHO recommendations, we used the defined daily dose (DDD) methodology to measure the antibiotic use during one year (from 1st August 2011 to 1st August 2012). The antibiotic use was measured using DDDs/100 admissions and DDDs/100 patient-days for inpatients, and DDDs/100 visits for outpatients. Results During the study period, there were 15,735 admissions and 250,611 outpatient visits. Antibiotics were prescribed for 86% of inpatients and 12.5% of outpatients. Outpatient prescriptions accounted for 2/3 of the overall antibiotic consumption. For inpatients, the total antibiotic use was 222 DDDs/ 100 patient-days, 693 DDDs/ 100 admissions and the mean number of antibiotics prescribed was 1.8. For outpatients, the total antibiotic use was 86 DDDs/ 100 outpatient visits and the mean number of antibiotics prescribed was 1.2. The most common antibiotics prescribed were aminopenicillins and 3rd generation cephalosporins for inpatients, and tetracyclines and quinolones for outpatients. In a sample of patients with diarrhoea or upper respiratory tract infections (URTI), the proportion of patients who received antibiotics was 84% (95% confidence interval [CI], 67-93) and 52% (95% CI, 43-62), respectively. Conclusion In this rural setting, the use of antimicrobials was extremely high, even in conditions with a predominantly viral aetiology such as diarrhoea or URTI.

An interventional study on intensive care unit drug therapy assessment in a rural district hospital in India

Background: Intensive care unit is a potential area for drug-related problems. As many of the patients treated are complex patients, clinical pharmacy intervention could find drug therapy problems. Materials and Methods: Drug information liaisons daily attended ward rounds with intensivists and screened the patient for drug therapy assessment using the American Society for Health-System Pharmacists clinical skills competition DTA format. This was a prospective study done for 6 months from August 2012 to January 2013. Simple statistics were used to tabulate the drug-related problems assessed. Results: A total of 72 patients were screened for drug therapy problems, for which 947 drug doses were prescribed in the study period. The total number of prescriptions was 148. The average number of drugs per prescription was 6.39 and the average number of drugs per patient was 13.15. A total of 243 problems were identified; on an average, 1.67 problems were present per prescription. The total number of drug interactions identified was N = 192 (78.2%); majority of them (61.4%) were of type C (not serious). So, 55.73% of them were monitored and not stopped or substituted. The second type of problem was a correlation between drug therapy and medical problem (7.4%). Appropriate drug selection and drug regimen was the third problem, and the adverse drug reactions and therapeutic duplications accounted for approximately 2% of the drug-related problems identified. Conclusion: Drug interactions constituted the major problem of ICUs, but not many were serious or significant. Consensus in assessment of drug-related problems and convincing intensivists with good quality evidences are required for better acceptance of interventions.

Evaluation and appraisal of drug information services in a rural secondary level care hospital, Anantapur, AP

Background: Drug Information Center (DIC) is an information center which provides drug information (DI) to healthcare professionals. The aim was to evaluate the performance of DIC for improving the quality and quantity of information services provided to the healthcare professionals. The service was provided free of cost to the customers. Materials and Methods: This descriptive study was conducted for the period of 6 months from February to August 2011 excluding May due to vacation. Customers were asked: how did they find the service provided to them? Was it good, satisfactory, or need improvement? There were written feedback forms to be filled by the customers, including customer satisfaction questions. The official publication of the DIC, RIPER PDIC Bulletin was screened for its types of articles/number of drug news published. The bulletin is circulated for free to the healthcare professionals electronically. Results and Discussion: A total of 232 queries were obtained during the study period of 6 months. Average number of queried received to the DIC was 39 per month. Most preferred mode of queries was personal access (89%). Majority of queries were received from nurses, i.e., 162 (70%) queries and 81% of all queries were drug oriented for improving knowledge. There were only 19% of the queries for individual patients; doctors asked most of those queries. Only 3% queries answered were rated as need improvement by the healthcare professionals. Rest were considered as either Good (56%) or satisfactory (49%). Range of drug news published in each bulletin was 3–4 and most of the other articles include expert opinion to improve practice or training. Conclusion: The DI services were satisfactorily used for academic interests. Nurses used the service for the highest compared to other health care professionals. Future studies should plan to establish the usefulness of DI to improve healthcare practice.

Knowledge, Attitude, and Practice of Pharmacovigilance in Developing Countries

Abstract Pharmacovigilance (Pv) systems are gaining ground in developing countries. The knowledge, attitude, and practice (KAP) of Pv by different stakeholders are discussed in this chapter to identify challenges and recommend solutions. The study of Pv KAPs is a trend in developing countries. Healthcare professionals, including pharmacists, have poor to moderate knowledge, a positive attitude, and poor practice of Pv. Continuing education will improve their KAP of Pv; knowledge is easier to change than attitude and practice. The existing knowledge and attitude will be retained better if it is applied in practice. The increasing involvement of developing countries in the World Health Organization (WHO) Program for International Drug Monitoring (PIDM) is promising. Technology and financial challenges hinder Pv incorporated into the healthcare systems of developing countries. In a developing healthcare system, in addition to its inherent deficiencies, practitioners are afraid to use Pv, which is indicated as evidence of its flaws. An efficient healthcare system will facilitate a sustainable Pv practice. The development of locally relevant patient-centered practice demands a Pv culture.

Authors’ Reply to Urtasun et al.: “Coxibs Refocus Attention on the Cardiovascular Risks of Non-Aspirin NSAIDs”

We thank Urtasun et al. [1] for their interest in our article Coxibs Refocus Attention on the Cardiovascular Risks of Non-Aspirin NSAIDs, published recently in the journal [2], in which we emphasized the cardiovascular risks of nonaspirin non-steroidal anti-inflammatory drugs (NSAIDs). The answer to the question ‘‘can we consider celecoxib a cardiovascular safe drug?’’ is ‘‘no’’. No NSAID, except aspirin, is considered safe in terms of cardiovascular risks. Many issues raised by Urtasun et al. [1] regarding the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen) trial [3] warrant further discussion. Others have previously criticized the following aspects of the PRECISION trial:

Cost-analysis of the WHO Essential Medicines List in A Resource-Limited Setting: Experience from A District Hospital in India

The World Health Organization (WHO) has been publishing the essential medicines list (EML) since 1977. The EML includes the most efficacious, safe and cost-effective drugs for the most relevant public health conditions worldwide. The WHO performs a cost-effectiveness analysis within each therapeutic group, but very little is known about which therapeutic groups are costliest for hospitals that adopt the WHO EML concept. In this study, we have described the annual consumption of medicines in a district hospital in India, that limited the list of available drugs according to the WHO EML concept. Only 21 drugs constituted 50% of the hospital spending. Anti-infective medicines accounted for 41% of drug spending, especially antiretrovirals which were used to treat HIV infection. Among other therapeutic groups, insulin had the highest impact on the hospital budget. We identified medicines used in perinatal care, which included anti-D immunoglobulin and lung surfactants, that were used rarely, but bore a relatively high cost burden. The results of this study indicate that, in district that adopt the WHO EML, antiretrovirals and antibiotics were the top therapeutic groups for the drug hospital budgets.

Assessment of Adverse Events and Quality of Life of Cancer Patients in a Secondary Level Care, Rural Hospital in South India

OBJECTIVE To grade adverse events (AEs) occurring after chemotherapy in the cancer patients and to explore the quality-of-life (QOL) findings among posttherapy cancer patients in a rural, secondary level care Indian hospital. METHODS A cross-sectional study was carried out during a 6-month period in a rural secondary level care hospital situated at Anantapur district in South India. Patient and cancer demographics were collected from the cases treated in the study site. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 v 3.0 Telugu (regional language of the study site) module and Common Terminology Criteria for Adverse Events v 4.0 of Cancer Therapy Evaluation Program, USA, were used to assess the QOL and severity grades of AEs, respectively. RESULTS Most AEs were mild or moderate, with only a few being severe. Insomnia (27.98%), nausea (13.50%), vomiting (12.81%), fatigue (10.90%), and pain (11.68%) were common, with insomnia being the most frequent. The different scores of the QOL scale (functional, symptomatic, financial, and global health status scores) were assessed independently. Among the functional scale parameters, the cognitive and physical functioning scores were good (85.14 and 82.79, respectively) and the social, emotional, and role functioning scores were moderate (77.94, 72.30, and 71.65, respectively). The overall effect of symptoms on QOL showed that the pain score was higher and interfered to a higher extent in patients (36.02) and the dyspnea score was the least and occurred to a lesser extent (7.20). But certain variables such as anorexia, for example, showed a greater interquartile range and SD, which implied that it gave a lesser chance for the prediction of results for that particular condition. Financial burden existed to a moderate level on an average in all the patients. CONCLUSIONS The occurrence and severity of AEs was low, indicating that the patients tolerated and responded well to therapy. The survivorship is yet to be estimated and the life expectancy to be studied by further investigation of the subjects.