Adverse Drug Reactions In Patients Research Articles

Chemotherapy-Related Adverse Drug Reaction and Associated Factors Among Hospitalized Paediatric Cancer Patients at Hospitals in North-West Ethiopia.

BackgroundOne of the prevalent treatment modalities for cancer is chemotherapy. Adverse drug reactions, however, are becoming the world’s major public health problem. More than half (54.5 percent) of cancer patients need hospitalization for further management, in addition to the increased health-care costs of treatment. The aim of this study was to evaluate adverse drug reactions associated with chemotherapy and related factors in hospitalized paediatric cancer patients in Ethiopia’s north-west hospitals.MethodsFrom July 1, 2017, to August 13, 2019, a cross-sectional study was carried out among 311 paediatric cancer patients at Gondar Comprehensive University, Specialized Hospital and Felegehiwot referral hospital. The data were entered into Epi Info version 7 and exported for further analysis to Statistical Product and Service Solutions (SPSS). To identify associated variables, both the bi-variate and multi-variate logistic regression analyses were computed. Variables with a P-value of less than 0.05 were considered statistically significant in the multivariate logistic regression analysis.ResultsThe overall adverse drug reaction in this study was 41.5 percent ((95% CI: 35.8–47.2%)). Patients who received concomitant medications were at higher risk of experiencing adverse drug reactions (AOR: 2.60 (95% CI: 1.54–4.40)), according to the multivariate logistic regression analysis. Similarly, there was a risk of developing adverse drug reactions in patients taking four or more chemotherapy agents (AOR: 2.67 (95% CI: 1.52–4.68)). In addition, regimens based on etoposide (AOR: 1.99 (95% CI: 0.93–4.27)), mercaptopurine (AOR: 3.91 (95% CI: 1.06–14.46)) and doxorubicin (AOR: 2.32 (95% CI: 1.30–4.15)) were at higher risk for adverse drug reactions in patients.ConclusionAdverse drug reactions developed in a significant proportion of the study patients (2 out of 5 patients). Therefore, for pediatric cancer patients on concomitant medications and for patients on etoposide, mercaptopurine and doxorubicin drug regimens, efficient prevention and management of adverse drug reactions should be sought.

Cohort study on adverse drug reactions in adults admitted to the medical wards of a tertiary hospital in Nigeria: Prevalence, incidence, risk factors and fatality.

Intensive monitoring of medical patients for adverse drug reactions (ADRs) to assess prevalence, incidence, risk factors and fatality of ADRs leading to hospital admission or occurring in the hospital. Prospective cohort study on 1280 adult patients admitted to the medical wards of a tertiary institution over 12 months. Patients were assessed for ADRs during and throughout admission; causality and preventability of ADRs were assessed. Sixty-seven (5.2%) patients had ADRs, 51 (3.9%) caused hospitalisation while 17(1.3%) occurred during hospitalisation, and 42 (62.7%) of total ADRs were preventable. Nonsteroidal anti-inflammatory drugs, 14 (20.3%), antidiabetics, 12 (17.4%) and antibacterial, 11 (15.8%) were the most implicated drug classes. Gastrointestinal tract (37%), central nervous system (30.2%), and skin (24.7%) were the most affected organ/systems, while upper gastrointestinal bleeding and hypoglycaemia were the most observed ADRs. ADRs led to deaths in 7 (10.4%) patients, with an overall case fatality rate of 0.5%. The highest number of deaths were among patients with Stevens-Johnson syndrome 2/7 (28.6%) and hepatotoxicity 2/7 (28.6%). Risk factors, adjusted odds ratio (AOR [95% confidence interval, CI]) for ADRs leading to hospitalisation was male sex 3.11 (1.11, 8.73) while for ADRs during hospitalisation were number of drugs used before admission (AOR [95% CI] = 6.67 [1.16, 38.47]) and comorbidities (AOR [95% CI] = 3.0 [1.13, 8.01]). Patients admitted with ADRs had prolonged hospital stay (AOR [95% CI] = 3.37 [1.11, 8.71]). Preventable ADRs are common and important causes of hospitalisation and inpatients' morbidity and mortality among medical patients in Nigeria. Upper gastrointestinal bleeding and hypoglycaemia, resulting from nonsteroidal anti-inflammatory drugs and antidiabetic drugs were the most observed ADRs.

Evaluation of the community pharmacists' performance in the screening of non-steroidal anti-inflmmatory drugs risks in Saudi Arabia.

Objectives:To assess community pharmacists’ knowledge and practices regarding screening risk factors and providing safety information about the use of non-steroidal anti-inflammatory drugs (NSAIDs) to patients.Methods:Cross-sectional and a self-administered questionnaire-based study was conducted over a 4-month period (May-August 2019) with selected community pharmacies in Jeddah, Saudi Arabia. The questionnaire composed of demographic data and the pharmacist’s role in supplying NSAIDs.Results:The majority of participating community pharmacists dispense NSAIDs. However, many did not apply relevantly good communication skills such as seeking information about concomitant drugs (42.5%) or providing advice on managing any adverse side effects of taking NSAIDs (39.1%). Most of the community pharmacists also did not provide relevantly good communication about risk factors. The most common screening risk factors mentioned were a history of pregnancy and breastfeeding (84.2%) followed by being at an older age (74.5%) or a history of a gastrointestinal ulcer (71.5%).Conclusion:Community pharmacists in Saudi Arabia need to appropriately screen their patients for adverse drug reactions and effectively communicate the risks of using NSAIDs. The Saudi Regulatory Authority could endorse several approaches to apply a good strategy for improving the dispensing practices in community pharmacies, communication and awareness of risk factors especially in high-risk patients who are taking NSAIDs.

Adverse Drug Reactions in Patients with CKD.

Little is known about the burden of adverse drug reactions in CKD. We estimated the incidence of overall and serious adverse drug reactions and assessed the probability of causation, preventability, and factors associated with adverse drug reactions in patients seen by nephrologists. The Chronic Kidney Disease-Renal Epidemiology and Information Network cohort included 3033 outpatients (65% men) with CKD and eGFR<60 ml/min per 1.73 m2, with follow-up for 2 years. Adverse drug reactions were identified from hospitalization reports, medical records, and participant interviews and finally assessed for causality, preventability, and immediate therapeutic management by experts in pharmacology. Median (interquartile range) age was 69 (60-76) years old; 55% had eGFR≥30 ml/min per 1.73 m2, and 45% had eGFR<30 ml/min per 1.73 m2. Participants were prescribed a median (range) of eight (five to ten) drugs. Over 2 years, 536 patients had 751 adverse drug reactions, 150 (in 125 participants) classified as serious, for rates of 14.4 (95% confidence interval, 12.6 to 16.5) and 2.7 (95% confidence interval, 1.7 to 4.3) per 100 person-years, respectively. Among the serious adverse drug reactions, 32% were considered preventable or potentially preventable; 16 caused death, directly or indirectly. Renin-angiotensin system inhibitors (15%), antithrombotic agents (14%), and diuretics (10%) were the drugs to which the most adverse drug reactions were imputed, but antithrombotic agents caused 34% of serious adverse drug reactions. The drug was discontinued in 71% of cases, at least temporarily. Adjusted hazard ratios for serious adverse drug reaction were significantly higher in patients with eGFR<30 versus ≥30 ml/min per 1.73 m2 (1.8; 95% confidence interval, 1.3 to 2.6), in those prescribed more than ten versus less than five medications (2.4; 95% confidence interval, 1.1 to 5.2), or in those with poor versus good adherence (1.6; 95% confidence interval, 1.4 to 2.4). Adverse drug reactions are common and sometimes serious in patients with CKD. Many serious adverse drug reactions may be preventable. Some specific pharmacologic classes, particularly antithrombotic agents, are at risk of serious adverse drug reactions. Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN), NCT03381950.

Efficacy of febuxostat versus allopurinol and the predictors of achieving target serum urate in a cohort of Thai people with gout.

The objectives of our study were to compare the efficacy of febuxostat with allopurinol in Thai subjects with gout, as well as to determine the predictive factors of responsiveness to urate-lowering agents and to evaluate the safety of febuxostat in a real-world setting. The study was a retrospective cohort study; a total of 354 gout patients were recruited from February 2015 to November 2018. The patients were categorized according to prescription of allopurinol or febuxostat. Demographic data, comorbidities, concomitant medications, gout-related clinical parameters, and the laboratory results were collected. The serial serum urate (sUA) levels were recorded at the beginning of the treatment (baseline), and after treatment at 12weeks, 18weeks, and 27weeks. The primary efficacy endpoint was the achievement of target urate of < 6mg/dl in people taking febuxostat, compared with those taking allopurinol. The secondary endpoints were the predictive factors of achieving target urate level and adverse drug reactions in patients taking febuxostat. Multivariable regression analysis was used to determine factors associated with achieving target serum urate. After the treatment, the febuxostat groups had significantly lower mean sUA compared with the allopurinol groups across all follow-up periods. The proportion of people who achieved target serum urate was also higher in the febuxostat groups compared with the allopurinol groups throughout the follow-up periods. The multivariable regression analysis showed that febuxostat 40mg (OR = 10.96 (95% CI 4.32-27.80); p value < 0.001), febuxostat 80mg (OR = 9.54 (95% CI 3.91-23.28), smoking (OR = 2.35 (95% CI 1.13-4.91); p value = 0.023), and low baseline serum urate (OR = 0.62 (95% CI 0.52-0.74); p value <0.001) were associated with the achievement of target serum urate. No adverse drug reaction from febuxostat was observed even among people with renal insufficiency. In a Thai cohort, people receiving febuxostat are more likely to achieve target serum urate level, compared with people receiving allopurinol. Febuxostat (40 or 80mg), smoking, and low baseline serum urate were associated with the achievement of target serum urate. • Febuxostat showed superior urate-lowering efficacy compared with allopurinol in an Asian population. • In addition to febuxostat, lower baseline serum urate level and history of smoking were associated with achieving target serum urate in gout patients.

A comparative assessment of daily dosage regimen versus intermittent treatment regimen of tuberculosis at the RNTCP centres in Chitradurga district

The treatment of pulmonary tuberculosis is quite challenging. The national tuberculosis programs are shifting the trend to adopt daily regimen than the intermittent regimen. Hence, this study was undertaken to study the effectiveness and adverse drug reactions of the daily and intermittent regimens.A retrospective study was conducted in the department of Chest and TB in Basaveshwara Medical College and Hospital, Chitradurga and District Tuberculosis Centre, Chitradurga, India. About 55 patients on daily regimen and 50 patients on intermittent regimen constituted the study sample. The details regarding the age, sex, initiation and termination of the treatment, outcome and adverse drug reactions were collected using a predesigned proforma.Majority of the patients in daily regimen were 56 – 65 years and intermittent regimen was aged between 26 – 35 years. More number of the cases in both the regimen were males. Vomiting was the main adverse drug reaction in patients on daily regimen and Abdominal pain in intermittent regimen. About 54.5% of the patients on daily regimen and 62% on intermittent regimen were cured. The death and defaulter rate was higher in patients on intermittent regimen.Even though the cure rate is good in intermittent regimen, the adverse reactions are quite high in this study.

DRUGPATH: The Drug Gene Pathway Meta-Database.

The complexity of modern-day diseases often requires drug treatment therapies consisting of multiple pharmaceutical interventions, which can lead to adverse drug reactions for patients. A priori prediction of these reactions would not only improve the quality of life for patients but also save both time and money in regards to pharmaceutical research. Consequently, the drug-gene-pathway (DRUGPATH) meta-database was developed to map known interactions between drugs, genes, and pathways among other information in order to easily identify potential adverse drug events. DRUGPATH utilizes expert-curated sources such as PharmGKB, DrugBank, and the FDA’s NDC database to identify known as well as previously unknown/overlooked relationships, and currently contains 12,940 unique drugs, 3933 unique pathways, 5185 unique targets, and 3662 unique genes. Moreover, there are 59,561 unique drug-gene interactions, 77,808 unique gene-pathway interactions, and over 1 million unique drug-pathway interactions.

P136 Adverse reaction with intravenous immunoglobulin (IVIG) therapy and management of symptoms: a single centre experience

Abstract Background IVIG is a therapeutic preparation comprising of pooled blood donated from large numbers of healthy people. There are different preparations of IVIG available. All should have high levels of IgG (&amp;gt;95%) but vary in concentrations, pH, stabilizing agents and IgA content. In inflammatory conditions, IVIG is often used as an adjunct therapy in patients with poor response to first line therapy and in general well tolerated. However adverse reactions can occur and vary in severity from mild constitutional symptoms to aseptic meningitis. The aim of this study was to identify patients who required IVIG within the paediatric rheumatology department at Great Ormond Street Hospital, the underlying diagnosis of these patients and the indication for starting treatment. The study also looked at the number of adverse drug reactions of patients requiring IVIG, the symptoms they presented with and the management of these symptoms. Methods A retrospective case review, of patients under the care of the paediatric rheumatology team who received IVIG between July 2013 to August 2018. We collected demographics including, age, sex, diagnosis of patients and indication for commencing IVIG, symptoms of any adverse drug reaction and management of symptoms. Results We identified 43 patients who required IVIG over the last 5 years as part of their treatment plan, of which 23 patients had a diagnosis of Juvenile dermatomyositis (JDM). Of the remaining patients 5 had a diagnosis of SLE, 4 with SRP positive mysositis, 2 with necrotising myositis and 2 with atypical systemic onset JIA. The main indication for starting treatment was for active or worsening skin disease, muscle weakness or both. From the 43 patients that required IVIG, 21 patients had an adverse drug reaction and 15/21 patients had a diagnosis of JDM. 5/21 patients had symptoms associated with aseptic meningitis (headache, photophobia and neck stiffness), 2 of which were unable to continue treatment. The remaining 16 patients had milder constitutional symptoms. Symptoms were managed by premedicating patients prior to subsequent IVIG treatment with a combination of paracetamol, chlorphenamine, ondansetron or by reducing the rate of IVIG infusion or reducing the dose of IVIG from 2g/kg to 1g/kg. Conclusion We identified from the study, that half the patients requiring IVIG as part of their treatment plan had an adverse drug reaction of which half had a diagnosis of JDM. However, the majority of patients who had an adverse drug reaction had mild constitutional symptoms, relieved by premedication or by adjusting IVIG rate of infusion or dose. Only 2 patients were unable to continue IVIG treatment. Disclosures S.H.A. Wildman None. M. Al-Obaidi None.

Assessment of adverse drug reactions in patients on cardiovascular drugs: A prospective study

Objectiv: To quantify ADRs in patients on cardiovascular drugs and to assess their severity. Materials and Methods: Based on inclusion and exclusion criteria, 265 inpatients on cardiovascular drugs from a tertiary care center were included in this prospective study. All patients were assessed for occurrence of ADR and followed up till the recovery of the ADR. Causality assessment of ADR was done, severity of ADR was graded, and preventability of ADR was assessed. Results: In the present study, descriptive statistics were used to analyze the data. Out of 265 patients screened, 137 (51.69%) had 245 ADRs. About 175 (71%) ADRs were due to antihypertensives, 175 (71%). On causality assessment of these ADRs, 230 (94%) were found to be possible and 15 (6%) probable. Two hundred and nine (85%) ADRs were mild, 34 (14%) were moderate, and 2 (1%) were severe. The most common ADR encountered in the study was giddiness due to various classes of antihypertensives in 26% about patients. Conclusions: Among the cardiovascular system drugs, antihypertensives were the most common group of drugs to cause giddiness as ADR. Majority of the ADRs had a score of “possible” because of concomitant medications.

Adverse drug reactions in patients taking anti tuberculosis therapy from directly observed treatment short course centre at Mandya Institute of Medical Sciences, Mandya: a cross sectional study

Background: Ending the tuberculosis (TB) epidemic by 2030 is among the health targets of the sustainable development goals. Side effects to anti-TB drugs are common and may lead to reduced compliance to treatment. These adverse effects must be recognized early to reduce associated morbidity and mortality. Objective of this study was to determine the adverse drug reactions (ADR) to anti-tubercular therapy among patients visiting directly observed treatment, short-course (DOTS) centre MIMS, Mandya.Methods: A cross sectional study was conducted at DOTS Centre MIMS, Mandya. TB patients registered at DOTS Centre during the year 2018 were selected for the study. Verbal informed consent was taken from the TB patients and interviewed using pretested semi-structured questionnaire. Data analysis was done using descriptive statistics and chi square test.Results: Among the study population (n=90), 67 (74.4%) experienced ADR among which 47.7% took treatment for ADR and the remaining 52.3% patients were given reassurance. In this study, gastrointestinal manifestations (42.3%) were the most common adverse drug reaction (ADR). Of the TB patients who experienced ADR, 9.0% of them had interrupted ATT, however they completed full course of ATT.Conclusions: A considerable number of TB patients taking ATT experience ADRs and some of them may have to interrupt treatment. However, they need to be counselled or supervised with caution to complete their course of treatment to reduce the chances of treatment default and also reduce the occurrence of drug resistance.

The Incidence of Adverse Drug Reactions in Patients Treated with Statins in the Emirates: A Retrospective Cohort Study.

We investigated the incidence of adverse drug reactions (ADRs) in patients treated with statins for cardiovascular (CV) risk among the United Arab Emirates (UAE) population. This is a retrospective cohort study conducted among statin users attending 2 tertiary care centres: Al Ain and Tawam hospitals in Al Ain city, UAE. We retrieved the clinical profile of all the patients taking statins from January 2011 to January 2015 using our electronic database (Cerner®). Among 556 patients (418 men; 138 women) taking statins, 237 ADRs were reported (186 men; 51 women). The incidence of ADRs was 40.7%, and was more frequent among patients at "high CV disease (CVD) risk" and "moderate CVD risk" than other risk categories. High CVD risk (odds ratio, 1.67; 95% confidence interval [CI], 1.19-2.34), vitamin D deficiency 1.45 (95% CI, 0.89-2.38), type 2 diabetes 1.22 (95% CI, 0.84-1.77) and hypertension 1.13 (95% CI, 0.70-1.83) are some of the factors that were associated with statin ADRs. The incidence of ADRs among statin users was 42.6%, and frequent ADRs (49%) were noted in patients with high CVD risk. Early identification of these ADRs should improve patient adherence to life-saving statin treatment.

Potential of Drug Interactions as a Cause of Adverse Drug Reactions in Patients with Kidney Diseases.

Objective:Adverse drug reactions (ADRs) are one of the major causes of mortality. One of the major causes of ADR is drug–drug interactions. The purpose of this study was to evaluate the prevalence and characteristics of ADRs caused by the drug interactions in the nephrology departments.Methods:This cross-sectional prospective study was carried out in the nephrology department on 117 patients who received at least two medicines. Drug interactions were determined, and the patients were evaluated for the presence of a drug complication.Findings:A total of fifty ADRs were observed in 39 patients, whereas 26% of total ADRs (13 drug complications) were due to drug interactions. About 69% and 31% of complications were classified in terms of severity, in the category of “severe” and “moderate” complications, respectively. Warfarin had the highest contribution to major interactions (33.33%).Conclusion:ADRs, which specially occurred due to drug interactions, are particularly important for patients taking multiple medications (e.g., patient with renal insufficiency). Therefore, special attention should be paid to preventing and reducing ADRs in these patients' population.

Association of Drug Metabolic Enzyme Genetic Polymorphisms and Adverse Drug Reactions in Patients Receiving Rifapentine and Isoniazid Therapy for Latent Tuberculosis.

Weekly rifapentine and isoniazid therapy (3HP) is the most frequent treatment for latent tuberculosis infection (LTBI). However, the association between major adverse drug reactions (ADRs) and drug metabolic enzyme single-nucleotide polymorphisms (SNPs) remains unclear. In this study, 377 participants who received the 3HP regimen were recruited and examined for genotyping of CYP5A6, CYP2B6, CYP2C19, CYP2E1, and NAT2 SNPs. In our study, 184 participants (48.4%) developed ADRs. Moreover, CYP2C19 rs4986893 (TT vs. CC+CT, odds ratio [OR] [95% CI]: 2.231 [1.015–4.906]), CYP2E1 rs2070676 (CC vs. CG+GG, OR [95% CI]: 1.563 [1.022–2.389]), and CYP2E1 rs2515641 (CC vs. CT+TT, OR [95% CI]: 1.903 [1.250–2.898]) were associated with ADR development. In conclusion, CYP2C19 and CYP2E1 SNPs may provide useful information regarding ADRs in LTBI patients receiving the 3HP regimen.

Incidence of adverse drug reactions in patients taking anti-tuberculosis treatment

Background: High incidence of infection has caused a large number of morbidity and mortality which is partly due to serious adverse reactions induced by Anti-Tuberculosis (Anti-TB) drugs. In present prospective study an attempt is made to estimate the incidence and risk factor for ADRs among patients treated for tuberculosis.Methods: All the new patients starting their treatment with selected six DOT center were enrolled in study. All patient's complete clinical history was recorded. They were followed regularly for occurrence of ADR till end of their treatment.Results: Total of 108 patients (67 male and 41 female) had taken and completed their treatment during the study period (March 2007 - April 2008) and were observed for occurrence of ADR during their treatment period. Out of total108, 28 patients (25.9%) experienced one of the ADR, out of 28 patients, 12 (42.85%) patients developed GIT intolerance, and hepatitis was seen in 8 (28.57%) patients, while 4 (14.48%) patients developed skin reactions. Only 3 (7.14%) patient developed dizziness and loss of balance, which was relieved by reduction of dose of streptomycin.Conclusions: With close monitoring and on time action, RNTCP DOTs regimens can be safely and successfully administrated.

Clinical relevance of the lnc-HNF1B-3:1 genetic polymorphisms in Western Chinese tuberculosis patients.

BackgroundTuberculosis remains a global public health problem. Genetic polymorphisms may affect the susceptibility, clinical characteristics, and adverse drug reactions of patients with TB. The present study aimed to examine the association of single nucleotide polymorphisms of lncRNA‐HNF1B‐3:1 with the clinical manifestation of TB in a Western Chinese population.MethodA total of 526 tuberculosis patients and 561 healthy subjects were recruited in Western China. The correlation between lnc‐HNF1B‐3:1 polymorphism and tuberculosis susceptibility was investigated. Moreover, the influence on adverse drug reactions following treatment was explored. A total of 7 SNPs within the lnc‐HNF1B‐3:1 locus was genotyped by the improved multiplex ligation detection reaction method.ResultsNo significant associations were noted between TB susceptibility and the presence of all 7 SNPs of the lnc‐HNF1B‐3:1 as determined by single‐locus analysis (All P > .05). The AA genotype of rs12939622 (in the dominant model) and the AA genotype of rs4262994 (in the recessive model) caused increased susceptibility of the subjects to fever (P < .001 and P = .008, respectively). The Rs2542670 G allele was associated with increased risk of thrombocytopenia, leukopenia, and chronic kidney damage following drug administration (P = .007, .029, .003, respectively).ConclusionThe present study reported for the first time that the rs12939622, rs4262994 and rs2542670 genotypes in lnc‐HNF1B‐3:1 locus may influence the clinical manifestations of tuberculosis.

Pharmacogenomics as a tool to prevent drug-related hospitalization of elderly cardiology-oncology patients receiving chemotherapeutic agents and multiple symptomatic treatments: a pilot study planned for the Italian health system.

Current precision medicine approaches offer powerful tools to optimize medication regimens; however, the potential impact of these tools in cancer patients with multiple drug treatments has not fully appreciated yet. Here we describe a planning project scheduled to start in the next six months. The overall endpoint of this project is to explore the potential association between the presence of individual genetic profile and severe toxicity rates in so-called "frail" cancer patients, using a nested case-control study design. The pilot study includes the detection of the individual pharmacogenetic profile of 150 (cases), prospect enrolled cancer "frail" patients, and 150 (control) retrospectively paired enrolled individuals. Methods for addressing the primary endpoint include: (a) Evaluation of cost-effectiveness analysis by recording QALY criteria; (b) Data recording by a brief self-administered questionnaire used to evaluate the adherence of a patient's tests and the impact of this genotyping on the patient's adverse drug reactions (ADR); (c) A sample size of paired (for age, gender, education, social status, geriatric syndromes, number of medications and comorbidities) 150 (cases) and 150 (controls); (d) Genotyping method choice by current widely diffuse platforms. The investigators believe that genotype screening and the management of the overall cost of health care personalized therapy has the potential to reduce the health care costs of the Italian national health system (SSN). Finally, the innovative issue of this project is to advocate the creation of a new model of the co-operative team (Physicians, pharmacist, geneticist and lab manager) that join for planning the most appropriated personalized therapy for their patient.

Prescription auditing and observational study in a tertiary care hospital

Background: Prescription is an important document written by a doctor which if not written properly can lead to various problems such as adverse drug reactions in patients, incompatibility to follow the instructions to take timely medications and sometimes over dosage due to improper prescription can even lead to death of the patient.Methods: This prospective observational cross-sectional study was conducted over a period of 6 months. The study was conducted in Rajendra Institute of Medical Sciences, Ranchi. Various prescriptions were collected from outpatient care facilities of a tertiary care hospital. Results were analyzed and assessed on 150 prescriptions collected.Results: Total 150 prescriptions were evaluated out of which 49.3% were males and 50.7% were females. Various parameters were assessed during the study which showed that there is still a scope of improvement in prescribing patterns in areas of writing complete prescriptions, prescribing generic medications and mentioning drug dosage forms as well as time of administration in each prescription.Conclusions: The results showed there is still a scope of improvement in writing practices of prescription. The doctor should incur the habit of writing generic names of drug in every prescription. They should adopt proper handwriting skills and no mistakes should be done in a prescription. A good prescription written by a doctor will help in legible practice and will also be very helpful in patient’s care.

Determination of good pharmacovigilance reporting practices in Quebec hospital pharmacies using a modified Delphi method.

Many published guidelines are available for health care providers describing the best way to manage patient's adverse drug reactions (ADRs). However, there is a lack of guidance on the best way to promote and manage ADR reporting within hospitals. The goal of this study was to develop good pharmacovigilance reporting practices (GPRPs). This descriptive study used a modified Delphi method. The research team developed 41 statements, according to a modified Specific Measurable Attainable Realistic Timely (SMART) method and grouped them in six categories: organization (n=12 statements), pharmacovigilance committee (n=4), database (n=5), training (n=5), tools (n=3), and quality (n=12). The Delphi consultation (two online rounds, conducted in 2018) involved directors of pharmacy in Quebec hospitals. Of 30 directors of pharmacy invited to participate in the first round, 27 (90%) did so. Following this round, the wording of five statements was modified according to pre-established rules. Twenty-five (93%) of the original 27 participants responded during the second round. Of the initial 41 statements, 37 were selected (average score≥7); the other four were eliminated. Of the 37 statements selected, 22 had a "must do" formulation, 12 had a "should do" formulation, and three had a "may do" formulation. Using a modified Delphi method, we established a set of GPRPs for hospital pharmacy based on 37 statements. To our knowledge, these are the first GPRPs published in the hospital pharmacy literature.

Safety analysis of long-term phenazopyridine use for radiation cystitis.

Phenazopyridine is a urinary tract analgesic indicated for short-term treatment of irritation in the lower urinary tract. Despite the lack of evidence for extended use, it is often used in varying durations for supportive care for cancer patients with radiation-induced cystitis. The objective of this study was to compare the incidence of adverse drug reactions in patients with radiation cystitis receiving long-term phenazopyridine (>14-day supply) compared to a matched comparator group. This retrospective cohort study compared adverse events among cancer patients with and without phenazopyridine exposure. Included patients received radiation and at least one chronic medication between 1 July 2008 and 30 June 2017. The phenazopyridine group also received >14-day supply of phenazopyridine during the study period. Patients were matched based on gender, age (±5 years), cancer diagnosis, and palliative or curative treatment intent. Data collection occurred at baseline, during the time of presumed exposure, and through the end of the study period for surveillance purposes. A total of 272 patients received phenazopyridine for >14-day supply during the study period. Of these, 90 patients were included and matched to an equal number of patients in the comparator group. The included patients were similar between groups and were largely male with a diagnosis of prostate cancer. Most patients received between a 30- and 60-day supply of phenazopyridine. There were a total of 13 adverse drug reactions in the phenazopyridine group and 18 in the comparator group (p = 0.32). No differences were identified between the phenazopyridine and comparator groups for the incidence of individual adverse drug reactions, emergency department visits, hospitalizations, or new diagnoses of hepatocellular or colorectal cancer. There was no difference in adverse drug reactions among patients receiving phenazopyridine for >14 days compared to a matched comparator group. The overall incidence of adverse events in both groups was low.

Prescribing pattern and adverse drug reactions of cardiovascular drugs in out-patient department of a tertiary care hospital

Background: The main objective of prescription pattern analysis is to assess the rationality of drug use. It has been found that cardiovascular disease is the most frequent cause of morbidity and mortality throughout the world. This study is to estimate the prescribing pattern and adverse drug reactions in patients with cardiovascular diseases.Methods: This prospective observational study was conducted for a period of 2 months in cardiology outpatient department.100 patients who fulfilled the study criteria were observed. The central drug standard control organisation (CDSCO) reporting forms were used for the collection of adverse drug reactions. Causality assessment was done by using the World Health Organization Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (WHO-UMC) scoring system and severity assessment by modified Hartwig and Siegel scale.Results: The study group consists of 79% male and 21% females. Average number of drugs per prescription was 4.65. Most commonly prescribed drugs were antiplatelets (32%) followed by statins (18.27%) and the least common were calcium channel blockers (1.72%) and cardiac glycosides (0.86%). A total of 174 adverse drug reactions were reported out of which 24.7% were myalgia due to statins, 15.5% were cough due to angiotensin converting enzyme inhibitors and 14.3% were gastritis due to antiplatelets.Conclusions: Antiplatelets, statins and angiotensin converting enzyme inhibitors dominated the prescribing pattern. Myalgia, cough, gastritis, insomnia by atorvastatin, enalapril, aspirin, beta blockers respectively were found to be the most commonly reported ADRs among the cardiovascular drugs.