Pramote Tragulpiankit

Attitudes among healthcare professionals to the reporting of adverse drug reactions in Nepal

BackgroundHealthcare professional’s knowledge and attitudes to adverse drug reaction (ADR) and ADR reporting play vital role to report any cases of ADR. Positive attitudes may favour ADR reporting by healthcare professionals. This study was aimed to investigate the attitudes towards and ways to improve adverse drug reaction (ADR) reporting among healthcare professionals working at four Regional Pharmacovigilance Centres (RPCs) of Nepal.MethodsA cross sectional study was done by survey using a self-administered structured questionnaire. The questionnaire was distributed to 450 healthcare professionals working at four RPCs.ResultsThe overall response rate was 74.0%. There were 74.8% of healthcare professionals who had seen patient experiencing an ADR; however, only 20.1% had reported. Reporting form not available (48.1%) and other colleagues not reporting ADR cases (46.9%) would significantly discourage the ADR reporting among healthcare professionals working at four RPCs. Healthcare professionals perceived that seriousness of the reaction (75.6%); unusual reaction (64.6%); reaction to new product (71.2%); new reaction to existing product (70.2%); and confidence in diagnosis of ADR (60.8%) were important factors on the decision to report ADR. Awareness among healthcare professionals (85.9%), training (76.0%), collaboration (67.0%), and involve pharmacist for ADR reporting (63.1%) were mostly recognized ways to improve reporting. Regular newsletter on current awareness in drug safety (71.2%), information on new ADR (65.8%), and international drug safety information (64.0%) were the identified feedbacks they would like to receive from the Nepal pharmacovigilance programme.ConclusionHealthcare professionals working at four RPCs of Nepal have positive attitudes towards ADR reporting. Awareness among healthcare professionals, training and collaboration would likely improve reporting provided they would receive appropriate feedback from the national pharamcovigilance programme.

Knowledge about adverse drug reactions reporting among healthcare professionals in Nepal

OBJECTIVE To investigate the knowledge about ADRs and ADR reporting among healthcare professionals working at four regional pharmacovigilance centers (RPCs) of Nepal. METHODS It was a cross sectional study, done by a survey using a validated self-administered structured questionnaire. The questionnaire was distributed to 450 healthcare professionals working at four RPCs. RESULTS The overall response rate was 74%. Only 53% and 38% of respondents knew about the existence of National Pharmacovigilance Centre (NPC) and RPC, respectively. Among the respondents, 29% and 33% did not know what a Type A and Type B ADR was. Similarly, 30% and 45% were not aware of the common types of ADRs or the thalidomide tragedy. Only, 9% knew about Uppsala Monitoring Centre (UMC) and only 10% answered correctly about the Naranjo algorithm as a causality assessment tool for ADRs. Of the respondents, only 19% knew about spontaneous reporting system and only 18% were aware about its drawbacks. The overall mean score on knowledge about ADR among healthcare professionals was 7.64 ± 2.38 out of the maximum possible score of 12. Whereas, the overall mean score of knowledge about ADR reporting was 3.95 ± 1.78 out of maximum possible score of 11. CONCLUSION Healthcare professionals working at four RPCs of Nepal have some knowledge about ADRs themselves but limited knowledge about ADR reporting. There is an urgent need of action to be taken by RPCs at the regional level and NPC at the national level to improve knowledge and ADR reporting by healthcare professionals.

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients

We aimed to determine the prevalence and characteristics of adverse drug events (ADE) in rheumatoid arthritis (RA) and (osteoarthritis) OA patients.

A prospective, randomized, double dummy, placebo-controlled trial of oral cefditoren pivoxil 400 mg once daily as switch therapy after intravenous ceftriaxone in the treatment of acute pyelonephritis

OBJECTIVES To compare the clinical and bacteriological effectiveness of intravenous (IV) ceftriaxone followed by oral cefditoren pivoxil or IV ceftriaxone for acute pyelonephritis. METHODS A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis was performed. Daily 2g IV ceftriaxone was initially given to all patients. After day 3, patients who satisfied the criteria for switch therapy were randomized to either group A (IV ceftriaxone) or group B (oral cefditoren pivoxil 400mg once daily). RESULTS Eighty-two patients were enrolled; 41 (50%) patients in group A and 41 (50%) patients in group B were evaluated. There was no statistically significant difference in baseline characteristics between the two groups. Clinical cure was observed in 39 of 41 (95.1%) patients in group A and 41 of 41 (100%) patients in group B (p=0.15, 95% confidence interval (CI) -0.12 to 0.02). Urine bacteriological eradication was found in 63.4% in group A and 60% in group B (p=0.75, 95% CI -0.18 to 0.25). There was no statistically significant difference in adverse effects between the two treatment groups. CONCLUSION These data suggest that IV ceftriaxone followed by oral cefditoren pivoxil is highly effective and well-tolerated for the treatment of acute pyelonephritis, even for uropathogens with a high proportion of quinolone-resistant strains.

Comparison of genetic variation in drug ADME-related genes in Thais with Caucasian, African and Asian HapMap populations

The objectives of this study are to investigate allele frequencies of drug absorption, distribution, metabolism and elimination (ADME)-related genes in the Thai population and to compare these genes to HapMap populations including Caucasians (CEU), Africans (YRI) and Asians (CHB/JPT). Genetic variations of drug ADME-related genes in 190 Thais were investigated using drug metabolizing enzymes and transporters (DMET) plus genotyping system. We examined 1936 single nucleotide polymorphisms (SNPs) of 225 genes that have documented functional and clinical significances in phase I and phase II drug metabolism enzymes, drug transporters and other genes involved in ADME processes. Distributions of genotyping data from Thai were compared with other HapMap populations including Caucasian, African and Asian populations. The analysis demonstrated 43 SNPs with statistical significance comparing among five populations. However, only 26 SNPs showed statistical significance in pair-wise comparisons between Thai versus CEU and Thai versus CHB/JPT. These 26 SNPs belong to 13 groups of drug ADME-related genes which are CYP2A6, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, VKORC1, COMT, NAT2, TPMT, UGT1A1 and SLCO1B1. These genes demonstrated clinical significances as previously observed in many studies. The results could explain clinical variability in pharmacokinetics and pharmacodynamics of drugs in Thais based on genetic variations in drug ADME-related gene emphasized in this article.

Carbamazepine-induced Stevens-Johnson syndrome/toxic epidermal necrolysis overlap in a Filipino with positive HLA-B75 serotype

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are two related mucocutaneous disorders with different severities. Although the incidence is low, SJS and TEN are life-threatening and predominantly drug-induced conditions. There is a strong relationship between the HLA-B*1502 allele and carbamazepine-induced SJS and TEN in different Southeast Asian populations. Here, we report a case of Filipino with SJS/TEN overlap probably induced by carbamazepine. The condition was treated with hydrocortisone followed by prednisone. The HLA-B*1502 allele was not found in this case. The patient tested positive for the HLA-B75 serotype, suggesting that carbamazepine-induced SJS/TEN may be serotype specific. Establishing the genotype before initiation of the drug may be advantageous for some patients and will aid physicians in determining the optimal drug therapy. Prevention of adverse drug reactions (ADR) may be done if pharmacists and other healthcare professionals work as a multidisciplinary ADR team to ensure that safe medication practices are realised.