Dixon Thomas

Effect of patient counseling on quality of life of hemodialysis patients in India

End stage renal disease (ESRD) is a growing problem. The effect of patient counseling is to be defined on health-related quality of life. Objective: The purpose of this study was to find out the impact of patient counseling in health related quality of life (QoL). Methods: In this prospective interventional study, the Karnofsky Performance Status (KPS) for QoL questionnaire was used in test and control groups for data collection. The same data collection method was used during six months to study the effect of patient counseling. Results: Health related quality of life in test group showed a consistent improvement of 2% in six months. Improvement of awareness by patient counseling was also improved. Conclusion: As part of medication therapy management (MTM), patient counseling focusing on dialysis compliance, diet and medications are an effective way to improve health-related QoL and awareness in ESRD. Such services should be made mandatory by law in India to improve outcomes in chronic illness.

Therapeutic failure of primaquine and need for new medicines in radical cure of Plasmodium vivax

Primaquine has been the drug of choice for the prevention of Plasmodium vivax relapse for more than 60 years. Primaquine tolerant strain of P. vivax was identified in 1944. Significant mortality and disease burden of P. vivax calls for the need of new drugs. Primaquine resistance is a complex issue, as the mechanism of resistance is not clear. Direct evidence of resistance to primaquine by hypnozoites has not yet been shown. There are some reports detailing risk of primaquine resistance in specific regions, but the overall distribution of primaquine resistance in P. vivax-infected people is largely unknown. Confounding factors contribute to treatment failures; such as inadequate doses, inappropriate dosing intervals, risk of reinfection, combinations with blood schizontocidals, and compliance. Therefore, primaquine resistance needs to be addressed along with additional important confounding factors. Tafenoquine is the most studied drug in replacing primaquine for the radical cure of P. vivax malaria. It has comparable efficacy with primaquine. The potential advantage of tafenoquine is better compliance with a single dose regimen. Rational use of primaquine can secure its effectiveness, but it is essential in the future to have better or similar alternatives to treat P. vivax.

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.

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.

Days lost due to disability of diclofenac-induced adverse drug reactions

Disability Adjusted Life Years (DALY) is a widely used measure to quantify the burden of diseases or illness. DALYs for a disease is calculated as the sum of the Years of Life Lost (YLL) due to premature mortality in the population and the equivalent healthy Years Lost due to Disability (YLD). The only difference from the YLD and Days Lost due to Disability (DLD) calculation is that instead of considering the duration of Adverse Drug Reaction (ADR) in years, it is calculated in days. Objective DLD was measured for diclofenac tablets to prepare the ADR profile. Methods The study was done on the patients (18-65 years old) attending the community pharmacy at Kasaragod district, South India, with prescription of diclofenac tablets. Patients reported ADRs on their next visit to the pharmacy or they had called to the provided phone number and reported it. Disability Weight (DW) was calculated in an analogue scale from 0-1. Zero represent complete health and 1 represent death or equivalent condition. DW was multiplied with occurrence and duration of ADRs in days. Results About 943 patients received diclofenac tablets in 1000 prescriptions were successfully followed up for possible, probable and definite ADRs. A total of 561 reactions reported in 2010 for diclofenac tablet in the study population. There were 34 different types of ADRs under 12 physiological systems/organs. Most common reactions were on gastrointestinal (GI) system (48%), followed by skin (14%), Central Nervous System (10%), renal (7%), and cardiovascular (7%). Abdominal pain, cramps or flatulence was the highest occurring GI ADR (107), followed by 43 rashes, 42 nausea/vomiting, 37 indigestion, 34 peptic ulcers, 31 edema etc. DLD for peptic ulcer was considerably high (0.078) per 1000 of the study population on diclofenac. The most damaging ADR were peptic ulcer with or without perforation, followed by rash 0.036 DLD and edema 0.027 DLD. There was considerable DLD by acute renal failure (0.012) Steven-Johnson syndrome (0.013) even though few cases were reported. Conclusions Diclofenac has a complex adverse drug profile. Around 34 types of reactions were reported. Diclofenac was widely prescribed because of the experiential belief of comparative safety with other NSAIDs. The study shows the importance of pharmacovigilance even on the most prescribed medicine. Most disabling ADR for the study population was peptic ulcer with or without perforation. YLD or DLD are useful measures of calculating disability caused by ADRs. Future studies could focus on improving the usefulness & precision of DLD.

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.

Quality Use of Quality Medicines

The use of medicines as healthcare interventions bring to the fore 2 important aspects of quality namely; ‘quality of medicines’ and ‘quality use of medicines’ (QUM). Governmental and non-governmental agencies in a regulatory and advisory role monitor medicines for quality production, distribution and proper use. Reports about substandard quality medicines suggest a need for further improvements in quality production and distribution of medicines.[1] QUM is not strictly monitored as is the quality assurance carried out in the production of medicines. The importance of ‘QUM’ has entered the scene rather late as compared to ‘quality of medicines’. Consumers owe themselves the responsibility in using their medicines appropriately. However it is the healthcare professional, who plays a pivotal role in assisting consumers in QUM. Wise collaborative decisions of prescribers, nurses, pharmacists, and consumers contribute greatly to QUM. [2] In this editorial, we discuss the aspects of quality and the use of quality medicines as a collective responsibility of pharmaceutical industries, healthcare professionals, and consumers with the support of other stakeholders in healthcare. Read more. . .

Higher Regulatory Control of Tramadol to Prevent its Abuse and Dependence

Abstract Tramadol abuse potential is not well studied. While some studies claim low abuse potential, others signal significant public health risks associated with tramadol abuse. This is a review on the abuse and dependence potential of tramadol. Tramadol was originally approved as non-controlled drug, but there is a trend to recognize tramadol as a controlled substance by regulators in many countries. Several factors contribute to abuse of tramadol. The leading reasons include history of drug abuse, geographical variation, and lessened regulatory controls. Tramadol abuse can cause increases in seizures and suicidal ideations. Abusers experience withdrawal symptoms and worsening of depression. Higher regulatory control of tramadol is warranted to avoid its misuse.

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: