Knowledge, beliefs, and practice of pregnant women regarding medication use during pregnancy: a hospital-based cross-sectional study.

The purpose of this study was to assess the knowledge, beliefs, and practice (KBP) of pregnant women on medication use during pregnancy, and to identify the factors influencing KBP. A cross-sectional study was conducted in the Department of Obstetrics & Gynaecology of a tertiary care hospital over a period of nine months. Pregnant women receiving at least one medication were included in the study. A 19-item questionnaire was developed, validated, and used for assessing the KBP of pregnant women. Logistic regression analysis was used to identify the factors influencing the KBP. A total of 422 pregnant women with a mean (SD) age of 24.6 (4.05) years were included in the study. Pregnant women were having less knowledge on 'unsafe medications' and 'important medications' during pregnancy, wrong belief on 'stopping all medications during pregnancy', and less practice of 'asking Pharmacist how to take medications'. It was identified hat the age, education, occupation, and area of living were the factors influencing the knowledge and practice of pregnant women on medication use. This study identified the need for improvement in knowledge and practice of pregnant women who are young, having nil or low level of education, no occupation, and living in rural areas.IMPACT STATEMENTWhat is already known on this subject? Knowledge and beliefs on medication use play a vital role in medication adherence among pregnant women. Crisis in rural healthcare along with socio-demographic conditions and literacy status of Indian women may have contributed to the lack of understanding about use of medications during pregnancy.What the results of this study add? The knowledge of pregnant women was found to be insufficient on 'unsafe medications' and 'important medications' during pregnancy. Majority of the pregnant women believe that it is better for the foetus if they 'stop taking all medications during pregnancy'. 'Not asking Pharmacist how to take medications' is one important practice in India contributes less knowledge on medication use.What the implications are of these findings for clinical practice and/or further research? There is a need for improvement in knowledge and practice of medication use among pregnant women who are young, having nil or low level of education, no occupation, and living in rural areas.

Implementation and evaluation of medicine and therapeutic information service by clinical pharmacists in oncology care setting.

BACKGROUND: This study was conducted to explore the role of clinical pharmacists in providing medicine and therapeutic information service in oncology care setting. METHODS: It was a prospective study conducted for a period of three years after implementation of medicine and therapeutic information service as an integral part of oncology pharmacy services. The medicine and therapeutic information queries were received during ward rounds, at ambulatory care and via telephone by clinical pharmacists. All the medicine and therapeutic information requests were reviewed and answered to the concerned requester(s). Answered medicine and therapeutic information requests were electronically documented in the hospital drug information database and analyzed further. RESULTS: A total of 484 medicine and therapeutic information requests were received by clinical pharmacists during period of August 2013 to June 2016. Majority of medicine and therapeutic information queries were requested by radiation oncologists (27.2%) followed by medical oncologists (26.4%), general physicians (14.04%), resident medical officers (11.7%), ambulatory care nurses (8.6%), in-patient nurses (5.1%) and patients and care takers (6.6%). Majority of the medicine and therapeutic information queries were asked for the purpose of improving patient care (48.3%) followed by to update knowledge (30.9%) and training sessions to nurses (6.6%). The most common categories of medicine and therapeutic information were adverse drug reactions and its management (21.4%) followed by dosage adjustments of chemotherapy and biologicals (15.5%), supportive care related (14.6%), contraindications (14%), drug-drug interactions (11.9%), management of co-morbidities (7.8%), chemotherapy selection in special populations (4.5%). CONCLUSION: The provision of medicine and therapeutic information was found to be useful in providing medicine information to improve patient care and to update knowledge of health care professionals at the study hospital.

Implementation of clinical pharmacy services in an academic oncology practice in India.

Objective This study was conducted to investigate medication-related problems after implementation of clinical pharmacy services at a speciality oncology care setting. Methods It was a prospective interventional study conducted for a period of three years at a private academic oncology care setting. Paper-based medical records and medication orders were reviewed and patients and care givers were interviewed to understand the treatment plan. All the medication-related problems were identified by clinical pharmacists by performing drug therapy review. Patients were also followed up at ambulatory care and in-patient units to ensure appropriate administration of anti-cancer drugs by nurses. All the medication-related problems were discussed with the concerned clinicians and then were resolved with the interventions of clinical pharmacists. Clinical significance of these interventions were assessed and classified as "Major", "Moderate "and "Minor". Educational, clinical and system-based interventions were developed and implemented to minimize medication-related problems at the study site. Results A total of 1359 medication-related problems were identified from 2120 medication orders reviewed of 1362 patients followed during the study period. The most common medication-related problems were lack of suboptimal supportive care (17.95%), inappropriate administration of medications (14.56%), untreated indication (14.20%), wrong dosing calculations (12.21%), drug-drug interactions (11.62%) and sub-therapeutic dose (11.11%). Clinical pharmacy interventions were made to resolve all the medication-related problems. Clinical significance of majority (n = 504, 37.08%) of medication-related problems was "Moderate" followed by "Major" (n = 434, 31.93%) and "Minor" (n = 421, 30.97%). Conclusion The study has demonstrated the importance of clinical pharmacy services in improving quality and safe use of medicines in oncology practice. Positive feedback of clinicians on clinical pharmacy services was a reflection of acceptance of clinical pharmacy interventions by clinicians.

Impact of medical conditions and medications received during pregnancy on adverse birth outcomes: A hospital-based prospective case-control study.

Purpose: In view of the raising rate of adverse birth outcomes (ABOs) across the globe, this study was conducted to assess the impact of medical conditions and medications received during pregnancy on ABOs. Materials and Methods: A prospective case-control study was conducted at the Department of Obstetrics and Gynecology of a tertiary care hospital over a period of 3 years from July 2015 to June 2018. Liveborn and stillborn neonates included in the study were categorized into cases and controls based on the presence or absence of composite ABOs, respectively. Binary logistic regression analysis was used to identify the risk factors for ABOs among medical conditions and medications received by mothers during their current pregnancy. Results: Among 1214 neonates included in the study, 556 (45.8%) were identified with composite ABOs, the majority were low birth weight (320 [26.4%]) and preterm birth 300 (24.7%). After adjusting for confounding factors, it was identified that hypertension (adjusted odds ratio [aOR] 7.3), oligohydramnios (aOR 3.9), anemia (aOR 3.2), nifedipine (aOR 10.0), nicardipine (aOR 5.3), and magnesium sulfate (aOR 5.3) were the risk factors for overall and specific ABOs like preterm birth and low birth weight. It was also identified that the early detection and management of hypertension with antihypertensives like labetalol and methyldopa can reduce the risk of preterm birth by 93% and 88%, respectively. Conclusion: Medical conditions such as hypertension, oligohydramnios, and anemia and medications such as nifedipine, nicardipine, and magnesium sulfate during pregnancy were identified as the risk factors for overall and specific ABOs like preterm birth and low birth weight.

Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study.

Ivermectin and albendazole (IA) combination preventive chemotherapy to all at-risk populations is deployed to eliminate lymphatic filariasis. Although safety monitoring is imperative, data from Sub-Saharan Africa is scarce. We conducted a large-scale active safety surveillance of adverse events (AEs) following IA mass drug administration (MDA) to identify the type, incidence, and associated risk factors in Tanzania. After recording sociodemographic, clinical, and medical histories, 9640 eligible residents received single-dose IA combination preventive chemotherapy. Treatment-associated AEs were actively monitored through house-to-house visits on day 1, day 2, and day 7 of MDA. Events reported before and after MDA were cross-checked and verified to identify MDA-associated AEs. 9288 participants (96.3%) completed the seven-day safety follow-up, of whom 442 reported 719 MDA-associated AEs. The incidence of experiencing one or more type of MDA-associated AE was 4.8% (95% CI = 4.3−5.2%); this being significantly higher among those with Pre-MDA clinical events than those without (8.5% versus 4.1%, p < 0.001). AEs were mild (83.8%), moderate (15.9%), and severe (0.3%), and most resolved within 72 h. The incidence of experiencing one, two, ≥ three types of AEs were 2.8%, 1.3%, and 0.6%, respectively. The most common AEs were headache (1.23%), drowsiness (1.15%), fever (1.12%), and dizziness (1.06%). A chronic illness, or clinical manifestation of lymphatic filariasis, or being female or pre-existing clinical symptoms were independent significant predictors of AEs. IA combination preventive chemotherapy is safe and tolerable, and associated AEs are mild-to-moderate and transient, with few severe AEs. Safety monitoring during MDA campaigns in individuals with underlying clinical conditions is recommended for timely detection and management of AEs.

Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring.

Preventive chemotherapy (PC) with praziquantel and albendazole co-administration to all at-risk populations is the global intervention strategy to eliminate schistosomiasis and soil-transmitted helminth (STH) from being public health problems. Due to weak pharmacovigilance systems, safety monitoring during a mass drug administration (MDA) is lacking, especially in sub-Saharan Africa. We conducted large-scale active safety surveillance to identify the incidence, types, severity, and associated risk factors of adverse events (AEs) following praziquantel and albendazole MDA in 5848 school children (5−15 years old). Before MDA, 1484 (25.4%) children were prescreened for S. mansoni and STH infections, of whom 71.8% were infected with at least one parasite; 34.5% (512/1484) had S. mansoni and 853 (57.5%) had an STH infection. After collecting the baseline socio-demographic, clinical, and medical data, including any pre-existing clinical symptoms, participants received single dose praziquantel and albendazole MDA. Treatment-associated AEs were actively monitored on days 1 and 7 of the MDA. The events reported before and after the MDA were cross-checked and verified to identify MDA-associated AEs. The cumulative incidence of experiencing at least one type of MDA-associated AE was 13.3% (95% CI = 12.5−14.2%); 85.5%, 12.4%, and 1.8% of reported AEs were mild, moderate, and severe, respectively. The proportion of experiencing one, two, or ≥ three types of AEs was 57.7%, 34.1%, and 8.2%, respectively. The cumulative incidence of AEs in S. mansoni- and (17.0%) and STH (14.1%)-infected children was significantly higher (p < 0.001, χ2 = 15.0) than in non-infected children (8.4%). Headache, abdominal pain, vomiting, dizziness, and nausea were the most common AEs. Being female, older age, having S. mansoni or STH infection were significant predictors of MDA-associated AEs. In summary, praziquantel and albendazole co-administration is generally safe and tolerable. MDA-associated AEs are mostly mild-to-moderately severe and transient. The finding of few severe AEs and significantly high rates of AEs in helminth-infected children underscores the need to integrate pharmacovigilance in MDA programs, especially in high schistosomiasis and STH endemic areas.

Impact of indirect education on knowledge and perception on cervical cancer and its prevention among the parents of adolescent girls: an interventional school-based study.

BACKGROUND: India has almost 225 million adolescent girls and they seem to be at a disadvantage, both economically and by their lack of knowledge on human papilloma virus (HPV) vaccine, when compared to adolescent girls of other Asian countries. AIM: To assess the prevalence of HPV vaccination and to identify the impact of education in improving the knowledge and perception about the HPV infection and vaccination among the parents of adolescent girls. METHODOLOGY: The prospective interventional study was conducted in four schools within a South Indian City, Mysuru. The informed consent form and the questionnaire were sent home with the identified adolescent girls during the pre-interventional phase. Educational sessions were conducted for the students in their school and an education leaflet was distributed to their parents. Three weeks later, questionnaires were re-administered to the parents via the enrolled girls and their responses were collected. RESULTS: The prevalence of HPV vaccination in the study population was 4.4%. There was a statistically significant improvement in knowledge in the post-interventional phase of the study (p = 0.001), but could not identify a significant change in their perception (p = 0.479). Parents belonging to the socioeconomic class of upper middle and upper lower showed better improvement at the end of the study, with a percentage improvement of 58.93% and 48.44%, respectively. CONCLUSION: The study proved that the healt care professional can target school children to communicate effectively to their parents on the importance of HPV vaccine as the study clearly observed a positive behavioral change among the study population.

Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study.

Preventive chemotherapy with diethylcarbamazine citrate (DEC) and albendazole (ALB) is the core intervention strategy to eliminate lymphatic filariasis (LF). We conducted a large-scale prospective active safety surveillance study to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass drug administration (MDA) of single-dose DEC and ALB in 10,010 participants from Kilifi County, Kenya. AEs were actively monitored and graded at 24 h, 48 h, and on day 7 Post-MDA. Out of 10,010 enrolled study participants, 1621 participants reported a total of 3102 AEs during a seven-day follow-up. The cumulative incidence of AEs was 16.2% (95% CI, 15.5-16.9%). The proportion of participants who experienced one, two, or ≥three types of AEs was 9.2%, 4.6%, 2.4%, respectively. AEs were mild (87.3%), moderate (12.4%), and severe (0.3%) and resolved within 72 h. The five most common AEs were dizziness (5.9%), headache (5.6%), loss of appetite (3.3%), fever (2.9%), and drowsiness (2.6%). Older age, taking concurrent medications, ≥three tablets of DEC, and type of meal taken before MDA were significant predictors of AEs. One in six participants experienced systemic mild-to-moderate severity grading and transient AEs. DEC and ALB co-administration for the elimination of LF is generally safe and well-tolerated.

Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa-Ethiopia, Kenya, Rwanda, and Tanzania.

Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.

Prevalence, Intensity, and Correlates of Schistosomiasis and Soil-Transmitted Helminth Infections after Five Rounds of Preventive Chemotherapy among School Children in Southern Ethiopia.

Preventive chemotherapy (PC) is a WHO-recommended strategy to control and eliminate schistosomiasis and soil-transmitted helminths (STHs). We assessed the prevalence, intensity, and correlates of schistosomiasis and STH infection after five rounds of PC in southern Ethiopia. A total of 3162 school children from four schools in Wondo Gennet and Hawella Tula districts were screened for Schistosoma mansoni and STHs infection. The overall prevalence of S. mansoni infection was 25.8% (range between schools 11.6% to 54.1%), with light (19.1%), moderate (5.3%), and heavy (1.4%) infection intensities. A total of 61.6% S. mansoni-infected children were STH co-infected. The overall prevalence of STHs infection was 54.7% (range between schools 30.6-71.0%), with moderate-to-heavy intensity infections being 16.3%. Ascaris lumbricoides was the most prevalent 45% (95% CI, 43.5-47) followed by Trichuris trichiura 25.3% (95% CI, 23.8-26.9) and hookworm 6.1% (95% CI, 5.3-7). A total of 33.7% of STHs-infected children had A. lumbricoides and T. trichiura co-infections. S. mansoni infection was significantly associated with school and STHs co-infection (p < 0.001). STH infection was correlated with school and younger age (p < 0.001). Despite repeated PC, S. mansoni and STH infection remain significant health problems, and the WHO target to control schistosomiasis and eliminate STH by 2020 may not be achieved. Intensified control and prevention measures, including drug efficacy surveillance, is recommended.

Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania.

INTRODUCTION: The increased access to medicinal products in Africa is not well-matched with the pharmacovigilance capacity to monitor drug safety. The objective of this study was to assess the functionality and identify the strengths and limitations of the national pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania, and compare these systems. METHODS: Legal and statutory documents governing the pharmacovigilance systems of each participating country were examined by assessors prior to on-site review. The staff of the pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using the East African Community Harmonized Pharmacovigilance Indicators tool, supplemented with indicators from the World Health Organization (WHO) Global Benchmarking Tool. Responses were recorded, and data were analyzed. RESULTS: The pharmacovigilance systems were supported by law and regulations in line with international standards. Standard operating procedures for receiving, processing, and communicating suspected adverse event reports were in place, but reporting of suspected medicine-related harm from stakeholders was inadequate in all countries. The number of Individual Case Safety Reports (ICSRs) received by NMRAs in Kenya, Ethiopia, and Tanzania (mainland) were 35.0, 6.7, and 4.1 per million inhabitants, respectively, in the last calendar year. At the time of assessment, Rwanda did not have an operational system. Overall, ≤ 1% of the total number of health facilities per country submitted ICSRs. Only Kenya and Tanzania had a designated budget for pharmacovigilance activities and an electronic ICSR reporting system. The national pharmacovigilance systems in all four countries did not have access to data on drug utilization. CONCLUSIONS: The national pharmacovigilance systems in the four East African countries have policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the four national pharmacovigilance systems are at different levels of capacity and performance with respect to conducting pharmacovigilance activities. Targeted interventions are needed to strengthen the pharmacovigilance systems to enable evidence-based decision making for patient safety.

Prevalence and Correlates of Lymphatic Filariasis Infection and Its Morbidity Following Mass Ivermectin and Albendazole Administration in Mkinga District, North-Eastern Tanzania.

Lymphatic filariasis (LF) is a neglected tropical disease targeted for elimination as public health problem through morbidity management and preventive annual mass drug administration (MDA). This cross-sectional community-based surveillance assessed the prevalence and correlates of LF infection in Mkinga district, Tanga-region, Tanzania. A total of 4115 individuals (49.7% males, 35.2% children) were screened for circulating filarial antigens (CFA), microfilaremia (mf) and disease manifestations in 15 villages between November 2018 and January 2019. MDA uptake in the previous year was assessed. Overall prevalence of CFA-positivity was 5.8% (239/4115; 95% CI: 5.1-6.6), with significant heterogeneity between villages (range 1.2% to 13.5%). CFA-positivity was higher in males (8.8%) than females (3.3%), and correlated with increasing age (p < 0.001). Prevalence of mf among CFA-positives was 5.2%. Only 60% of eligible inhabitants in the study area took MDA in the previous year, and CFA-positivity was 2-fold higher in those who missed MDA (p < 0.0001). Prevalence of scrotal enlargement, hydrocele, arms or legs swelling, lymphoedema and lymphadenopathy was 6.4%, 3.7%, 1.35%, 1.2% and 0.32%, respectively. Compared to baseline data, 16 years of MDA intervention significantly reduced LF transmission and morbidity, although the intended elimination target of <1% mf and <2% antigenemia to level where recrudescence is unlikely to occur by the year 2020 may not be attained. The finding of hotspots with ongoing transmission calls for intensified control measures.

Improving medication safety in oncology care: impact of clinical pharmacy interventions on optimizing patient safety.

Background Adverse drug reactions (ADRs) monitoring in cancer patients is important to ensure early detection, effective management and possible prevention subsequently. Objectives This study was conducted to detect and monitor ADRs to anti-cancer agents, and to assess impact of clinical pharmacists (CPs)' interventions in minimizing ADRs to anti-cancer agents. Setting Private, specialty oncology care hospital in South India. Methods CPs prospectively followed cancer patients admitted to inpatient wards and treated at ambulatory care in order to identify ADRs, for a period of 3 years. Identified/reported ADRs were discussed with concerned oncologists and/or nurses, documented electronically and assessed further for their causality, severity, preventability and grading. Based on study findings during year 1, interventions (educational, therapeutic and system based) were developed by CPs and implemented in order to minimize preventable ADRs. Impact of CPs' interventions was studied during year 2 and year 3. Main outcome measure(s) Preventable factors contributing to ADRs and percentage of preventable ADRs before and after CPs' interventions. Results A total of 1279 ADRs were reported in 1133 patients from a cohort of 1328 patients. Vomiting (23.22%), alopecia (9.53%), diarrhoea (8.67%) and myelosuppression (7.42%) were the common ADRs reported. Inappropriate administration frequency and regimen of anti-emetics (22%), lack of/suboptimal supportive care (18%) and administration errors (16%) were identified as common contributing (preventable) factors for ADRs in year 1. Percentage of preventable ADRs was 81% during year 1 (pre-intervention), and 45% and 34% in year 2 and year 3 respectively (post-interventions). Conclusion Interventions by CPs helped to minimize preventable ADRs to anti-cancer agents.

Active surveillance of adverse events following immunization (AEFI): a prospective 3-year vaccine safety study.

BACKGROUND: Vaccines used in national immunization programs are considered safe and effective but immunization safety has become as important as the efficacy of vaccination programs. The objective of the study was to detect adverse events following immunization (AEFIs) to all vaccines administered to a pediatric population in India. METHODS: The prospective active vaccine safety surveillance study enrolled eligible children in the age group 0-5 years receiving vaccination from the immunization center at JSS Hospital, Mysuru. Study participants were monitored at the site for 30 min following vaccination and a telephonic survey was made after 8 days to identify all AEFIs. Causality assessment of the AEFIs were done using a new algorithm developed by the safety and vigilance department of the World Health Organization. RESULTS: The incidence of reported AEFIs was 13.7%. The most frequently reported AEFI was fever (n = 3095, 93.2%) with an incidence of 109.7 per 1000 doses of vaccine administered, followed by persistent crying (n = 69, 2.4 per 1000 doses of vaccine) and diarrhea (n = 57, 2.0 per 1000 doses of vaccine). The majorly implicated vaccine for AEFIs was Pentavac® followed by BCG. Consistent causal association to immunization was observed in 93.4% of cases. CONCLUSIONS: A high incidence rate of AEFI was observed in our study population when compared with previous published studies. AEFI surveillance studies help to detect changes in the frequency of adverse events, which may be an alert to consider vaccine quality or identify a specific risk among the local population.

Impact of preterm birth and low birth weight on medical conditions, medication use and mortality among neonates: a prospective observational cohort study.

BACKGROUND: There is a paucity of studies conducted in India on neonatal outcomes of preterm birth and low birth weight. Hence, we aimed to assess the impact of preterm birth and low birth weight on medical conditions, medication use and mortality among neonates. METHODS: A prospective observational cohort study was conducted at the neonatal intensive care unit (NICU) over a period of 9 months. Neonates of either sex, admitted to NICU and who received at least one medication were enrolled in the study. Perinatal and demographic data, reason(s) for NICU admission, diagnoses, medications prescribed, medication-related problems, discharge status and the direct medical cost were documented and analyzed. RESULTS: Four hundred and five neonates were included in the study: 60.5% were boys, 32.7% were preterm and 44.2% were born underweight. Neonatal sepsis (n = 125, 16.7%), unconjugated hyperbilirubinemia (n = 83, 11.1%) and respiratory distress syndrome (n = 62, 8.3%) were the most common medical conditions and were significantly more common among preterm and underweight neonates. Nearly half of the medications prescribed were anti-infectives for systemic use (n = 1310, 47.4%). The mean number of medications received by neonates increased from term to extremely preterm (5.2-15.0) and normal birth weight to extremely low birth weight (5.0-14.9). Mortality rate was significantly higher among extremely preterm (66.7%), and very preterm (15.2%) neonates compared to term (2.9%) neonates. The median direct medical cost for NICU admission was INR 21,430 (USD 331). CONCLUSION: Medical conditions, medications prescribed and mortality rate were significantly higher among preterm and underweight neonates admitted to NICU.

Pharmacist-Initiated Medication Error-Reporting and Monitoring Programme in a Developing Country Scenario.

Medication errors (MEs) often prelude guilt and fear in health care professionals (HCPs), thereby resulting in under-reporting and further compromising patient safety. To improve patient safety, we conducted a study on the implementation of a voluntary medication error-reporting and monitoring programme. The ME reporting system was established using the principles based on prospective, voluntary, open, anonymous, and stand-alone surveillance in a tertiary care teaching hospital located in South India. A prospective observational study was carried out for three years and a voluntary Medication Error-reporting Form was developed to report medication errors MEs that had occurred in patients of either sex were included in the study, and the reporters were given the choice to remain anonymous. The analysis was carried out and discussed with HCPs to minimise the recurrence. A total of 1310 medication errors were reported among 20,256 hospitalised patients and the incidence was 6.4%. Common aetiologies were administration errors [501 (38.2%)], followed by prescribing and transcribing errors [363 (28%)]. Root-cause of these MEs were distractions, workload, and communications. Analgesics/antipyretics (19.4%) and antibiotics (15.7%) were the most commonly implicated classes of medications. A clinical pharmacist initiated non-punitive anonymous ME reporting system could improve patient safety.

Access to anti-cancer drugs in India: is there a need to revise reimbursement policies?

BACKGROUND: The aim of this study was to examine the access of Indian cancer patients to optimum cancer care under selected government schemes by reviewing reimbursement schemes for cancer care in India. METHODS: All cancer care reimbursement schemes in India were identified and three highly utilized schemes (VAS, RAS, CMCHS) were selected. Quality of breast, colorectal, lung, head & neck, and gastric cancer care was reviewed with respect to NCCN guidelines. Direct medical costs and shortage of budget in reimbursed amounts were calculated for each listed chemotherapy regimen. RESULTS: Medical oncology practice following the schemes' formularies is inferior to recommendations by the NCCN guidelines. Innovative treatment (targeted therapies) like trastuzumab, pertuzumab (breast), bevacizumab, cetuximab, panitumumab (colorectal), erlotinib, gefitinib, crizotinib, and nivolumab (lung) are either not reimbursed (VAS, CMCHS) or partially reimbursed (RAS). Average shortage of budget was found to be 43% (breast), 55% (colorectal), 74% (lung), 7% (head & neck), and 51% (gastric cancer). CONCLUSIONS: Policy makers should consider addition of newer treatments, exclusion of sub-optimal treatments, increments in per patient budget and optimization of supportive care, which may contribute to improvements in survival and quality of life for Indian cancer patients.

A prospective observational study to evaluate safety reporting of antidepressants at a tertiary care hospital in India.

OBJECTIVE: This prospective observational study was carried out to identify the prevalence and Severity of ADRs of antidepressant in a tertiary care teaching hospital. MATERIALS AND METHODS: Patients prescribed with at least one antidepressant were randomly selected and monitored for adverse drug reactions (ADRs), irrespective of their age and gender. RESULTS: Of the 401 patients who received antidepressants, 170 patients (42.39%) experienced 204 ADRs. Selective serotonin receptor inhibitors (SSRIs) [110 (53.92)] was the most common therapeutic class of drugs associated with ADRs. Gastrointestinal system [54 (26.47)] was most commonly affected system organ class. Dry mouth (n = 30) and diaphoresis (n = 21) were the most frequently reported ADRs. As assessed by the World Health organization (WHO) probability scale, 61% of the ADRs were 'probable' causality. Among all the ADRs, 22.54% (46) were preventable. Majority of the ADRs [(n = 184) 90.17%] were 'mild' in their severity. CONCLUSION: In this study, incidence of adverse reaction to antidepressants was 42.3% were the most common SSRI inplicated drug group for the ADRs.