Number Of Adverse Drug Reactions Research Articles

An observational study of adverse drug reactions reported in a rural tertiary care hospital

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.

Tools for Community-Based Pharmacist Patient Care Services to Support Optimal Opioid Use

Tools for Community-Based Pharmacist Patient Care Services to Support Optimal Opioid Use

Putting in harm to cure: Drug related adverse events do not affect outcome of patients receiving treatment for multidrug-resistant Tuberculosis. Experience from a tertiary hospital in Italy.

RationaleTreatment of multi-drug resistant Tuberculosis (MDR-TB) is challenging because it mostly relies on drugs with lower efficacy and greater toxicity than those used for drug-susceptible TB.ObjectivesAim of the study was to describe the frequency and type of adverse drug reactions in a cohort of MDR-TB patients and their potential impact on treatment outcome.MethodsWe conducted a retrospective study in a cohort of MDR-TB patients enrolled at a tertiary referral hospital in Italy from January 2008 to December 2016. The records of patients were reviewed for epidemiological, clinical, microbiological and adverse drug reactions data.ResultsSeventy-four MDR-TB patients (mean age 32 years, 58.1% males, 2 XDR, 12 pre-XDR TB) were extracted from the Institute data base and included in the retrospective study cohort in the evaluation period (January 2008—December 2016). Median length of treatment duration was 20 months (IQR 14–24). Treatment outcome was successful in 57 patients (77%; 51 cured, 6 treatment completed); one patient died and one failed (2.7% overall); 15 patients were lost to follow-up (20.3%). Sixty-six (89.2%) presented adverse drug reactions during the whole treatment period. Total number of adverse drug reactions registered was 409. Three hundred forty-six (84.6%) were classified as adverse events (AEs) and 63 (15.4%) were serious AEs (SAEs). One third of the total adverse drug reactions (134/409; 32.8%) was of gastrointestinal origin, followed by 47/409 (11.5%) ototoxic drug reactions, thirty-five (8.6%) regarded central nervous system and 33 (8.1%) affected the liver. All 63 SAEs required treatment suspension with 61 SAEs out of 63 (96.8%) occurring during the first six months of treatment. Factors associated with unsuccessful treatment outcome were smoking (p = 0.039), alcohol abuse (p = 0.005) and homeless condition (p = 0.044). Neither the number of antitubercular drugs used in different combinations nor the number of AEs showed significant impact on outcome. Patients who completed the treatment experienced a greater number of AEs and SAEs (p < 0.001) if compared to lost to follow-up patients.ConclusionsOur data demonstrate that, despite the high frequency of adverse drug reactions and long term therapy, the clinical management of MDR-TB patients in a referral center could reach successful treatment according to WHO target, by implementing active and systematic clinical and laboratory assessment to detect, report and manage suspected and confirmed adverse drug reactions.

Biodegradable and injectable hydrogels as an immunosuppressive drug delivery system

Cyclosporine A (CsA) is an extremely hydrophobic immunosuppressive drug, whose systemic administration to suppress the activity of T cells and T cell-based immune responses is frequently associated with a number of adverse drug reactions. Local delivery of CsA focused on a specific target organ has been proposed as a possible solution to this problem. In this study, we developed biodegradable sol-gel drug delivery systems, consisting of HA-Ca-Alg hydrogels combining hyaluronic acid calcium complex (HA-Ca) and sodium alginate (Alg-Na) components, for the local sustained delivery of CsA. A HA-Ca complex with very high degree of substitution was prepared by the acid-base reaction of hyaluronic acid and calcium acetate. The gelation was completed within about 2–45 min without external addition of calcium salts such as CaSO4 and CaCl2, indicating the high potential of the present hydrogel systems for drug delivery by injection in vivo. The HA-Ca system was characterized by high-resolution inductively coupled plasma-optical emission spectroscopy, 1H NMR, FT-IR, and thermogravimetric analysis methods. Moreover, the scanning electron microscopy analysis of the HA-Ca-Alg hydrogels showed an irregular porous morphology, with interconnected pores of 50–300 μm width. The sol-gel transition and the maximum viscosity (about 10,000 cP) of the HA-Ca-Alg hydrogels were characterized by examining the time evolution of the viscosity at 37 °C. The hydrolytic degradation of the HA-Ca-Alg hydrogel was also examined at 37 °C. CsA-encapsulated HA-Ca-Alg hydrogels exhibited sustained in vitro release of CsA over 14 days, which was confirmed through in vitro measurements of the activity of murine T cells over 2 weeks. These results show that the present injectable HA-Ca-Alg hydrogels can be used effectively for the sustained delivery of extremely hydrophobic immunosuppressive drugs, including CsA.

Evaluation of Adverse Drug Reactions and their Management in Psychiatric in-Patients

Objective: To identify the adverse drug reactions caused by psychotropic drugs and to evaluate the causality, severity, preventability and management of those Adverse Drug Reactions (ADRs). Methods: A prospective observational study was carried out in hospitalised patients with psychiatric disorders. All the in-patients prescribed with psychotropic drugs were enrolled in the study and followed regularly for the identification of ADRs. Identified ADRs were assessed for causality, severity and preventability using various scales. Approaches towards the management of the ADRs and the patient outcomes were analysed. Results: A total of 200 patients were monitored, of which 79 ADRs were identified from 56 patients. The most commonly reported ADRs were tremor (18.98%) followed by drowsiness (17.72%). Olanzapine was found to be associated with more number of ADRs (29.11%) followed by Clozapine (12.65%). Causality assessment using World Health Organisation- Uppsala Monitoring Centre (WHO-UMC) scale showed that most of the ADRs were probable (62.02%) and possible (37.97%). Severity assessment revealed that 54.42% of ADRs were found to be moderately severe. 48.10% of ADRs were definitely preventable and 44.30% were probably preventable. Assessment on the management of ADRs says that most of them were resolved by specific treatment approach to the reaction. Conclusion: The end results of the study created the evidence on the incidence of ADRs in patients prescribed with psychotropic drugs. The study emphasises on monitoring of those drugs that are considered to have high risk in developing ADRs. Thus, it can influence to a chance of preventing or reducing an unwanted reaction.

Pharmacovigilance Study of Antituberculosis Drug Regimens in Adult Patients

The success of pulmonary tuberculosis (TB) treatment in Indonesia was 81, 3%. Meanwhile, this number has been not reached the WHO target number of 85%. It was because patients experiencing Adverse Drug Reaction (ADRs) of antituberculosis drugs. Therefore, the government launched a pharmacovigilance program to monitor the ADRs of antituberculosis drugs to improve successful treatment. This study aimed to observe regimens of antituberculosis drug that often caused ADRs and the number event of ADRs. It was non-experimental numerical and analytical descriptive that conducted in outpatient Installation one of Hospital in Klaten, Central Java, Indonesia. Data were collected by interviewing and observing the patients’ medical records for two months starting from January to February 2018. The sample was obtained by using purposive sampling method. Then, the data were analyzed by the Liverpool algorithm that interpreted in 4 scales: unlikely, possible, probable, and definite. This study focused on 30 patients, which 23 patients with positive smear and seven patients with negative smear tuberculosis. The result showed that Fix Dose Combination (FDC) of rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) regimen was the most causing side effects. The number of ADRs were 3–7 in one patient. The most common side effects were reddish urine (90, 74%), nausea (90, 74%), vomiting (83, 33%), shortness of breath (70, 37%), and dizziness (22, 22%). Almost all antituberculosis drug regimens caused ADRs.

Evaluation of adverse drug reactions in dermatology department of a charitable hospital in India

Background: Adverse drug reactions (ADRs) can be confined to either skin or be a part of systemic reaction such as drug hypersensitivity syndrome or toxic epidermal necrolysis. Objective: The objective is to evaluate the incidence, causality, severity, preventability, and risk factors of ADRs in the dermatology department of a charitable hospital in India. Patients and Methods: A prospective observational study was carried out over a period of 8 months in the dermatology department. The WHO and Naranjo's scales evaluated the suspected ADRs for causality assessment, severity by Hartwig and Siegel Scale, and preventability by modified Schumock and Thornton Scale. Results: A total number of 200 eligible patients were enrolled in the study. Out of 200, 18 patients developed ADRs. The incidence of dermatological ADRs in the study was 9%. The most commonly manifested ADRs were Stevens–Johnson syndrome (SJS) (22.2%) followed by skin rashes (16.7%) and others. The maximum number of ADRs were observed with antibiotics (33.5%), followed by antiepileptic drugs (16.7%) and nonsteroidal anti-inflammatory drugs (NSAIDs) (16.7%). According to the WHO and Naranjo's scales, most of the reactions were probable with 61.1% and 55.6%, respectively. Most of the ADRs were moderately severe (66.6%) and were not preventable (55.6%). Conclusions: SJS and rashes were the most commonly observed clinical pattern of ADRs. The most common drug class responsible for ADRs was antibiotics, followed by antiepileptic drug and NSAID's. Dermatological ADRs varied in their causality, severity, and preventability.

An analysis of seriousness, predictability and preventability of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective observational record based study

Background: Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. An attempt has been made in this study to analyse the seriousness, predictability, preventability, severity and outcome of ADRs occurring in a tertiary care hospital.Methods: This was a retrospective observational study based on the data collected from ADRs reported to an approved ADR monitoring centre (AMC). Data collected was evaluated for seriousness, predictability, preventability, severity and outcome using appropriate scales. Simple descriptive statistics was used for analysis.Results: The total number of ADRs reported was 300. Among this 39% reactions were serious. The commonest reason for considering as serious reaction was prolongation of hospitalization. The overall predictability was 40.4%. Total preventability was found to be 18.3%. Assessment of severity showed 55.3 %, 41.7%, 3% reactions in mild, moderate and severe grades respectively. 64.3% patients had recovered from the reaction and 30% were recovering at the time of reporting ADR. Only 0.3% ADRs caused death.Conclusions: Authors hope this study will foster the culture of reporting and analysing ADRs among health care professionals and students. The findings from the study can create awareness among health care professionals regarding the impact of ADRs on the treatment course.

TMFUF: a triple matrix factorization-based unified framework for predicting comprehensive drug-drug interactions of new drugs

BackgroundA significant number of adverse drug reactions is caused by unexpected Drug-drug interactions (DDIs). The identification of DDIs becomes crucial before the co-prescription of multiple drugs is made. Such a task in clinics or in drug discovery usually requires high costs and numerous limitations, while computational approaches are able to predict potential DDIs effectively by utilizing diverse drug attributes (e.g. side effects). Nevertheless, they’re incapable when required to predict enhancive and degressive DDIs, which change increasingly and decreasingly the pharmacological behavior of interacting drugs respectively. The pharmacological change of DDIs is one of the most important factors when making a multi-drug prescription.ResultsIn this work, we design a Triple Matrix Factorization-based Unified Framework (TMFUF) to address the above issue. By leveraging a group of side effect entries of drugs, TMFUF achieves the inspiring result (AUC = 0.842 and AUPR = 0.526) in the case of conventional DDI prediction under the traditional screening task. In the comparison with two state-of-the-art approaches, TMFUF demonstrates it superiority by ~ 7% and ~ 20% improvement in terms of AUC and AUPR respectively. More importantly, TMFUF shows its ability in the comprehensive DDI prediction under different screening tasks. Finally, a utilization TMFUF reveals the significant pairs of side effects, which contribute to form enhancive and degressive DDIs, for further clinical validation.ConclusionsThe proposed TMFUF is first capable to predict both conventional binary DDIs and comprehensive DDIs such that it captures the pharmacological changes caused by DDIs. Furthermore, it provides a unified solution of DDI prediction for two screening scenarios, which involves newly given drugs having no prior interaction. Another advantage is its ability to indicate how significantly the pairs of drug features contribute to form DDIs.

Central nervous system-active drug abused and overdose in children: a worldwide exploratory study using the WHO pharmacovigilance database.

Recent epidemiological studies have reported an increase in central nervous system (CNS)-active drug abuse rates in paediatric settings, raising several public health concerns. No study to date has explored this issue worldwide. We performed an extensive analysis of drugs abuse/overdose reported for children in the last decade by using the largest pharmacovigilance database, i.e. the VigiBase, collecting adverse drug reaction reports that involved at least one suspect drug belonging to the Anatomical Therapeutic Chemical code "Nervous System" through the Standardised Medical Dictionary for Drug Regulatory Affairs Queries for Drug abuse. 8.682 reports matched our criteria. An increase in reporting activity was observed, starting from 2014; an intentional overdose was reported more frequently than an accidental one, with a difference between age groups. We retrieved 997 reports with death outcome. These referred more to adolescents (n = 538) than subjects of any other paediatric age group. Paracetamol and opioid analgesics were the most common suspect drugs in deaths across all age groups due to hypoxic-ischaemic encephalopathy, brain death, and cardio-respiratory arrest.Conclusion: The number of reports associated with drug abuse and overdose is increasing (for opioid and paracetamol-containing products) and a considerable number of adverse drug reactions are serious. Data on the patterns of use of such medicines from each country may help in implementing strategies of risk-minimisation and renewing healthcare recommendations worldwide. An increased clinical awareness of drug abuse and overdose is warranted, while continuing to provide effective treatments. What is Known: • The large increase in paediatric prescriptions for CNS-active drugs in the last 20years has recently raised public health concerns about drug abuse and overdose. • No study to date has examined this issue in paediatric patients worldwide. What is New: • The number of paediatric reports associated with CNS drug abuse and intentional overdose is increasing, including those with fatal outcome; over 4years; more than 35% of the reports was entered from European countries. • Opioid and paracetamol were most frequently suspected for ADRs with fatal outcome across all age groups, due to hypoxic-ischaemic encephalopathy and cardio-respiratory arrest, suggesting the need to implement strategies of risk-minimisation.

Prescribing pattern of antimicrobials and adverse drug reactions in children suffering from lower respiratory tract infection in tertiary care hospital

Background: Acute respiratory tract infections are leading cause of mortality in children in India. Further, indiscriminate use of antimicrobials has led to increased drug resistance and large number of adverse drug reactions (ADR). Therefore, aim of study was to study antimicrobial prescribing pattern and record incidence and causality assessment of ADRs in pediatric in-patients having lower respiratory tract infection (LRTI).Methods: In this prospective and observational study total of 300 children aged 2 months to 12 years suffering from LRTI and hospitalized for minimum 48 hrs duration were included. A descriptive analysis was carried out to determine frequency and combinations of antibiotics prescribed and causality and number of ADRs.Results: Out of 300 subjects, 70.3% of patients were males and 54.6% of cases with LRTI belonged to 2-6 months age group. The most frequently prescribed antibiotic was ceftriaxone alone in 67 (22.3%) patients while ceftriaxone and amikacin was the most common 2 drug combination in 60 (20%) patients. Ceftriaxone, ampicillin and gentamicin was most common 3 drug combination in 7 (2.3%) patients. There were 49 cases (16.3%) of ADRs and maximum were in 2-6 months age group and ceftriaxone with amikacin was associated with maximum number 10 (20.4%) of cases. Diarrhoea was most frequent adverse effect associated with antibiotics in 36 (76.6%) cases.Conclusions: The use of cephalosporins (single or combination) are most commonly used drug and associated with maximum number of ADRs in 2-6 months male children with LRTI so clinicians should use them judiciously and rationally.

Assessment of Adverse Drug Reactions Associated with Cardiovascular Agents and Antibiotics at a Tertiary Care Hospital

The assessment of Adverse Drug Reactions (ADRs) has become increasingly significant because of the introduction of a large number of potent toxic chemicals as drugs in the last two or three decades. Therefore, it is important that continuous monitoring of adverse drug reactions in hospitals could prevent serious consequences and unexpected effects of the drugs and improve the quality of treatment in patients. Antibiotics and cardiovascular agents are the most commonly prescribed drugs which are also involved with the highest number of adverse drug reactions in the hospitals. The objective of this study was to monitor and evaluate the adverse drug reactions caused by cardiovascular agents and antibiotics at a tertiary care hospital in Bangalore, for a period of 12 months between March “2017 to March 2018”. All in-patients of both genders who experienced an ADR during their hospital stay were enrolled for the study and exclusion criteria were patients admitted to hospital and did not experience an ADR. Out of 110 Adverse drug reactions, 57 (51.81%) were caused by cardiovascular agents and 53 (48.18%) were caused by antibiotics. Among the cardiovascular agents ADRs the most frequently reported ADRs were caused by furosemide 19 (33.33%) followed by telmisartan 5 (8.77%). Out of 53 (48.18%) ADRs caused by antibiotics, 8 (15.09%) were induced by ceftriaxone, followed by 7 (13.20%) piperacillin/tazobactam, 6 (11.32%) cefoperazone, 5 (9.43%) levofloxacin. The most common organ system affected was the gastrointestinal system with 31 (28.18%) followed by fluid and electrolytes 28 (25.45%), dermatological 21 (19.09%) and cardiovascular 7 (6.36%). The causality assessment of the ADRs was carried out using the Naranjo’s Scale algorithm and the majority of the ADRs were found to be possible 44 (40%). Antibiotics and cardiovascular agents are the most commonly prescribed medicines in hospitals, so it is important to notice the physicians with latest adverse drug reactions of these medications. This approach consequently reduces the chances of patient harm and also improves the patient's quality of treatment, reduces the cost burden and hospital stay and minimizes the antibiotics resistance due to unresponsiveness of medications in patients.

SPONTANEOUS ADVERSE DRUG REACTION REPORTING IN A TERTIARY CARE HOSPITAL IN CALICUT

Objective: The study was conducted to assess the adverse drug reactions (ADRs) reported in a tertiary care hospital in Calicut.Methods: Spontaneous ADR reporting method was followed for the study. The ADRs reported by the health-care professionals, or the patients were confirmed with the physician-in-charge. Further, the assessments of type, severity, and preventability of reported ADRs were done using Wills and Brown classification, modified Schumock and Thornton severity scale, and modified Hartwig and Siegel preventability scale.Results: A total of 30 ADRs were reported. A study found that the incidence of ADRs was more in males (1.14%) when compared to females (0.79%). Geriatric patients showed more incidences of ADRs (1.04%) when compared to pediatrics (0.69%) and adults (1.02%). More number of ADRs was associated with antibiotics (23.33%) and anticonvulsants (23.33%) than another category of drugs. Based on type or mechanism involved 80% of ADRs were pharmacologically related (Augmented) ADRs. Severity assessment showed that 50% were mild, 46.67% were moderate, and 3.33% were severe. Assessment of preventability showed that 63.33% of ADRs were not preventable, 30% were preventable, and 6.67% were probably preventable.Conclusion: The study was useful in finding the age category and drugs that were more prone to ADRs. This will render precautions and monitoring in the future. The importance of ADR monitoring unit and aid of clinical pharmacist in the monitoring and assessment were very well considered during the study.

A retrospective analysis of adverse drug reactions reported at a tertiary care hospital in South India

Background: Adverse drug reactions (ADRs) have a major impact on public health. Pharmacovigilance has become an integral part of pharmacotherapy. This study has been undertaken to retrospectively analyze the various adverse drug reactions and to promote the reporting of ADRs among the healthcare providers.Methods: A retrospective analysis of the reported ADRs over a period of 3 years at a tertiary care hospital, in Chennai was done. Data related to the number of adverse drug reactions, the demographic particulars, details on the drugs administered, type of ADRs, serious events and prevention strategies undertaken was analyzed. ADRs were assessed for their causality, severity, and preventability as per the standard criteria.Results: A total of 128 suspected ADRs were found to be reported over a period of 3 years. 81.25% ADRs were found to be of mild severity using the Hartwigs scale of assessment, 71.09% were classified as possible using the Naranjo’s causality assessment, the outcome of 63.28% were found to be recovering from the ADR and 41.40 % were under the probably preventable category. The most common ADRs were the skin reactions. The antimicrobial agents were found to have caused the highest number (58.59%) of ADRs followed by NSAIDs (14.84%) and the antihypertensive drugs (14.06%).Conclusions: The antimicrobial agents were associated with ADRs in majority of the patients. The commonly reported ADR s were the skin reactions.

Final Results of National Surveillance of Childhood Tuberculosis in Canada: 2013–2016

Abstract BACKGROUND There is little detailed epidemiologic and clinical data about tuberculosis (TB) disease in children in Canada. OBJECTIVES This study characterizes the epidemiologic, clinical, and treatment data for all cases of TB in children under age 15 in Canada surveyed through the Canadian Paediatric Surveillance Program’s (CPSP) Childhood Tuberculosis Study from October 2013 to September 2016. DESIGN/METHODS New active TB cases were identified through a monthly form sent by the CPSP to approximately 2500 active paediatricians, paediatric subspecialists, and select non-paediatricians who manage childhood TB. For cases meeting inclusion criteria, a detailed questionnaire was sent to the treating physician to collect clinical, epidemiological, and treatment data, followed by 6-month follow-up surveys until 6 months after treatment completion. Cases were reviewed by at least one TB specialist for inclusion and classification of disease. RESULTS Of 285 unique incident cases reported, 188 cases met inclusion criteria, returned a detailed questionnaire, and were classified. Selected demographic data are shown in Table 1. 92% of cases had intrathoracic involvement (N=172, 91%), but a minority were confirmed by culture or nucleic acid amplification (62/172, 36%). The most common sites of intrathoracic involvement were lymph nodes (N=118, 69%) and lungs (N=54, 31%). There were 143 attempted respiratory microbiological studies, with 32 (22%) yielding a positive culture or NAAT in sputum and 33 (23%) in gastric aspirate. Highest yield was in the 10+ age group with 54% (20/37) positivity. 31 cases of extrathoracic TB were recorded, with 19/35 (54%) having simultaneous intrathoracic TB. The most common forms of extrathoracic TB included CNS or meningeal disease (N=13) and extrathoracic lymphadenopathy (N=11). Miliary or disemminated disease (2 or more non-continguous sites involved) was found in 15 cases (8%). 16 cases reported at least one adverse drug reactions, with pyrazinamide (N=10) and isoniazid (N=5) being most common. 4 children were hospitalized and the most common ADR was hepatotoxicity. There was one case of multi-drug resistant TB. CONCLUSION This study suggests a high incidence of TB in Inuit and First Nations children, as well as a higher proportion of extrathoracic TB and greater success in culture positivity in children aged 10+. It also shows a significant number of adverse drug reactions to anti-TB treatment. Further analysis of this data will serve to refine practice in monitoring, detecting, and treating this infection.

DRUG UTILIZATION BASED ADRS MONITORING OF ANTIHYPERTENSIVE AGENTS PRESCRIBED IN AL-QUWAYIYAH GENERAL HOSPITAL, SAUDI ARABIA

Objective: To monitor drug utilization based adverse drug reactions (ADRs) of antihypertensive agents prescribed in Al-Quwayiyah general hospital, Saudi Arabia.Methods: An open, non-comparative, observational study was conducted on hypertensive patients attending the medicine outpatient department of Al-Quwayyah general hospital, Al-Quwayyah, Saudi arabia. Data were collected by conducting patient interviews. Data were captured for adverse drug reaction monitoring based on Narinjo scale and WHO format.Results: 25 ADRs were observed out of 212 hypertensive patients. Incidence was found to be higher in patients more than 40 y age, and females experienced more ADRs (n = 16, 7.54%) than males, 9 (4.62%). Combination therapy was associated with more number of ADRs (64.0%) as against monotherapy (36.0%). Calcium channel blockers were found to be the most frequently associated drugs with ADRs (n = 8), followed by diuretics (n = 6), and β-blockers (n = 5). Among individual drugs, amlodipine was found to be the commonest drug associated with ADRs (n = 8), followed by torasemide (n = 4). ADRs associated with the central nervous system was found to be the most frequent (48.0%) followed by musculoskeletal complaints (20.0%) and respiratory system disorders (16.0%).Conclusion: ADRs were experienced by taking the antihypertensive drugs prescribed in Al-Quwayyah general hospital, Saudi arabia. The findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with ADRs.

Suspected adverse drug reaction reports with oral anticoagulants in Portugal: a pharmacovigilance study

ABSTRACTObjective: In this pharmacovigilance study, we aimed to determine the incidence of spontaneously reported suspected adverse drug reactions (ADRs) related to oral anticoagulants: non-vitamin K antagonist oral anticoagulants (NOACs; apixaban, dabigatran, edoxaban, rivaroxaban) and vitamin K antagonists (VKA)Research design and methods: In this retrospective observational study, we extracted all the individual case safety reports related to oral anticoagulants recorded in the Portuguese Pharmacovigilance Database (January 2010 to April 2015). The annual incidence of suspected ADRs was estimated using drug exposure data. Disproportionality of reporting ADR was addressed through reporting odds ratio (ROR) and 99% confidence intervals.Results: We appraised 794 suspected ADR (78% related to NOACs). The annual number of ADRs increased overtime with 9 ADRs/million Defined Daily Dose (DDD) at the end of 2014. The incidence of NOACs ADRs decreased from 2012 onwards. VKA showed a disproportion in ‘Investigation’ (ROR 0.10, 99%CI 0.05–0.22) and ‘Injury, poisoning and procedural complications’ (ROR 0.36, 99%CI 0.19–0.69) ADRs compared with NOACs. NOACs had a higher significant disproportion of ‘Nervous system disorders’ related ADRs (ROR 3.98, 99%CI 1.50–10.53).Conclusions: Reporting of ADRs associated with oral anticoagulants (mainly NOACs), is increasing. Exploratory disproportion analyses showed an increase of reports of nervous system ADRs with NOACs, and INR-related ADRs with VKA.

PENGETAHUAN DAN PERSEPSI APOTEKER TERHADAP SISTEM PELAPORAN MONITORING EFEK SAMPING OBAT (MESO) DI APOTEK WILAYAH KOTA YOGYAKARTA

The importance of pharmacovigilance activity is the Adverse Drug Reaction (ADR) reporting system. Many pharmacists who do not report ADR incident and number of ADR indicated that more knowledge and good perception of ADR is needed. This study was aimed at investigating the knowledge and perception of pharmacists towards the ADR reporting system of Community Pharmacists in Yogyakarta City, Indonesia. Cross sectional study design was conducted to community pharmacists (n=275) in Yogyakarta City, Indonesia on the period of November 2016 to March 2017. All data were analysed by Statistical Package for Social Sciences (SPSS) software V.16.0. Results were reported as frequency, and we used cross tabulation. The questionnaire consisted of questions about the sociodemographic characteristics of the Pharmacists. Furthermore, questionnaire with nine and eight points for assessing knowledge and perception about ADR Reporting System in Indonesia was used. The response rate of community pharmacists reached 36% (n = 100). A majority of the respondent was female (81%) and respondents of age group 20–30 years were predominantly (55%). Most of the respondents was graduated as pharmacist (85%), in the graduation year of 2010-2016 (55%). Most of the pharmacist had 1-5 years of work experience (44%) and never get pharmacovigilance training (86%). Most of the pharmacists had fair knowledge ( 40%) and fair perception (65%) towards the ADR reporting system. Pharmacovigilance training and last education of community pharmacists could influence the pharmacists’ knowledge (p: 0.00 and 0.013, respectively). Moreover, there was no significant association between pharmacists’ knowledge and perception (p &gt; 0.496).

Study of drug utilization pattern and adverse drug reactions of psychotropic drugs in psychiatric inpatient department of tertiary care hospital

Background: Mental disorders are now widely recognized as a major contributor to the global burden of disease. The drug use in psychiatric illness is a complex process and because of this the optimal benefits of drug therapy in patient care is not achieved. This often leads to increased cost of medical care, drug resistance, adverse effects and patient mortality. Hence, this study is undertaken to study the drug utilization pattern and adverse drug reactions of psychotropic drugs in psychiatric inpatient department of a tertiary care hospital.Methods: A prospective, observational study was undertaken from 1st February 2015 to 31st July 2016. A total of 250 prescriptions were analysed. Defined daily dose of the drugs were calculated. ADR’s were recorded in the format of the National Pharmacovigilance Programme of India (PvPI).Results: In 250 prescriptions most, common drug prescribed was antipsychotics (48.5%). Total drug utilization in terms of DDD/100 bed days was 669. The total number of adverse drug reactions observed was 8%. Antipsychotics were the most common class of psychotropic drugs causing ADR’s.Conclusions: In conclusion, it has been found that the psychotropic drugs used in our psychiatry department was rational and was based on clinical knowledge, expertise and the guidelines available in the field of psychiatric practice.

Distinguishing adverse drug reactions, the noxious effects of medicines at a tertiary care hospital

Introduction: Adverse drug reactions (ADRs) are unavoidable and are considered as the fourth-to-sixth leading causes of death. It makes it essential to detect and monitor the ADRs. Hence, this study was aimed to identify the agents involved in the occurrence of ADRs and to identify and monitor the ADRs occurred in inpatients of a tertiary care hospital. Materials and Methods: It was a descriptive, prospective, observational study conducted for 2 years at a tertiary care hospital in Bengaluru, India. The ADRs were detected and monitored by interviewing the patients and reviewing the laboratory tests and medical charts. All the collected data were tabulated in Microsoft Excel 2016 and analyzed for possible results. Using Naranjo scale and Hartwig and Seigel's severity assessment scale, the probability and severity of the reactions have been identified. Results: In this study, it was observed that majority of ADRs occurred in females. Patients belonging to the age group of 21–50 years old experienced higher number of ADRs than the patients in other age groups. The most commonly reported ADRs were associated with antimicrobial and cardiovascular agents. The most commonly reported ADRs were elevated liver function test (LFT) (12.2%) followed by diarrhea (9.5%). The gastrointestinal system was the most commonly affected organ system followed by fluid and electrolytes. Majority of the ADRs (55.1%) were found to be probable. In addition, the majority of the reported ADRs (84.2%) were mild. Conclusion: The results of this study provide a database of ADRs, which aids clinicians in optimized and safer use of medicines and this, in turn, might lead to an enhanced level of patient care.