Drug Reaction Monitoring Research Articles

AN ANALYSIS OF CASES OF DRUG-INDUCED LIVER INJURY REPORTED TO AN ADVERSE DRUG REACTION MONITORING CENTER

Objectives: Drug-induced liver injury (DILI) is a frequent cause of liver injury and acute liver failure .We aimed to analyze the cases of DILI reported over a period of 8 years to the adverse drug reaction (ADR) monitoring center (AMC) at our institution.
 Methods: This observational retrospective study was conducted at the ADR monitoring center of a tertiary care hospital. Cases reported to the AMC, Pharmacovigilance Programme of India during the year 2011–2018 were analyzed as per the criteria used to analyze the ADRs.
 Results: A total of 5448 ADRs were reported during the study period, of which 105 (2%) were suspected to be DILI. The mean age of the patients with DILI was 39.26 years. Men (66.66%) were more commonly affected than women (33.34%). The most common drug groups causing DILI were antiretroviral (ART) (42.85%) and antitubercular (ATT) (40%). Most common single drug responsible for DILI was isoniazid (44.44%) followed by atazanavir (28%) and pyrazinamide (22.22%). Increase in serum bilirubin was the most common DILI (64.75%). About 79% of cases had a possible causality and 21% of cases had probable causal association with the suspected drugs. Majority of the ADRs (83%) were not preventable and mild in severity (21%). All ADR forms were complete in accordance with National Coordinating Center scale.
 Conclusion: DILI is commonly observed in patients taking ART and ATT drugs for more than a month. Regular monitoring and assessment in these patients may help in preventing DILI and manage these ADRs.

A STUDY TO ASSESS KNOWLEDGE ATTITUDE AND PRACTICES OF PHARMACOVIGILANCE AMONGST SECOND YEAR MEDICAL STUDENTS OF A TEACHING HOSPITAL IN NORTH MAHARASHTRA.

Pharmacovigilance (PV) plays a vital role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Medicines do come with their respective adverse effects. Therefore it is imperative to do Adverse Drug Reaction (ADR) monitoring while they are being marketed. PV is a part of the second MBBS curriculum, but often given less importance by the students. If this Knowledge Attitude & Practice of PV can be made effective during the MBBS course itself, it may make the students better aware about ADR monitoring.
 Aims & Objective: Our purpose was to find out the knowledge, attitude & practices amongst the second year medical students in a tertiary care hospital in North Maharashtra.
 Methods: This was an observational based study which had predesigned questions. After seeking the approval from the Institutional Ethics Committee, questionnaire was given to second year students of a tertiary care hospital in north Maharashtra. MS Excel was used for data analysis.
 Results: The overall response rate was 76%. 30% answered knowledge question correctly whereas 70% answered the attitude questions correctly. Only 4 % had reported an ADR and majority felt that busy duty hours and fear of legal action was the reason for underreporting.
 Conclusion: Our study revealed that in spite of PV being part of 2nd year MBBS, it still needs more emphasis and attention. The student feedback regarding ADR after they visit wards may help in improving the general awareness.
 Keywords: Pharmacovigilance, Knowledge, Attitude, ADR.

PHARMACOVIGILANCE: AN INEVITABLE PATH TOWARDS DRUG SAFETY IN INDIA

Thalidomide disaster is one of the overturn jolt in the field of allopathic medicine that attracted the attention of practitioner all over the world towards adverse effects of drugs, then only the actual concept of monitoring of adverse drug reactions came into limelight. Pharmacovigilance is t he science and activities relating to the detectio n, assessment, understanding and prevention of adverse effects or any other p ossible drug - related problems . Pharmacovigilance not only allopathic drugs; but also include herbals, traditional medicines, blood products (Haemovigilance) , biological (biovigila nce), medical devices (materiovigilance) & vaccines. United Kingdom firstly introduced the yellow card for adverse drug reaction reporting. In India pharmacovigilan ce came into existence in 2010. Indian pharmacopoeia commission (IPC) is the national coordi nating centre for pharmacovigilance program of India, responsible for collection, assessment of reported ADRs from the various adverse drug rea ction monito ring centers & pharmaceutical co mpanies, also consulting central drug standard control organization (CDSCO) in generation of signal. IPC is also collaborating with World health organization (WHO) drug safety program. Main source of data collection of ADRs is spontaneous reporting method & mainly from healthcare professionals. For drugs, IPC - suspected ADRs reporting form for healthcare Professionals is used for reporting ADRs by doctors. IPC - has currently availed the ADRs reporting form for patie nt in english & local languages . National institute of b iologicals - has availed the form for Haemovigilance . Pharm acovigilance target to wards signal detection , creating warning, restricting drug use, sometimes withdrawal of drug from market & finally decreasing mortality & risk of ADRs in patients.

Periodic Safety Update Reporting of Newly Launched Drugs through Hospitals–Need of the Hour: A Drug Controller General of India Initiative

A Periodic Safety Update Report (PSUR) is comprise of most complete safety experience of drug submitted to the competent drug regulatory authorities at defined period of time. In India, PSURs for all newer drugs must be submitted every six month for first two years followed by annually for next two years to the Drug Controller General of India [DCG(I)], New Delhi. So far, it’s been mandatory only to Marketing Authorization Holders (MAHs) to submit PSURs periodically to DCG(I), New Delhi. But, since 28 August 2012 DCG(I) has made it mandatory for hospitals in India to implement PSUR system for newly introduced drugs. In country like India where, lots of irregularity seen in safety surveillance of patients. We have very less active Adverse Drug Reaction (ADR) monitoring centers in function and a lot of determination is needed in order to collect drug safety data which may be carried out through active safety surveillance of therapeutic agents. Thus it has become important to comply with the requirement of DCG(I) and address the safety concern of our hospitalized patients. PSUR is the need of the hour to in our hospitals. We have to take steps for monitoring patients who are on newly introduced drugs and generate data for the reporting of PSURs to the DCG(I). This pioneering hospital based PSUR setup will create an environment for healthy safety reporting and helps the regulatory authorities for drug safety related decisions.

Study of analysis 1 390 adverse drug reactions cases of parenterally administered Dengzhan Xixin based on China’s spontaneous response system

Adverse drug reaction (ADR) monitoring of spontaneous reporting system (SRS) data to detect signals, is the main method of pharmacovigilance by China food and drug administration (CFDA). This study conducted a data analysis of 1 390 ADR cases of parenterally administered Dengzhan Xixin based on China SRS data collected between Jan, 2009 and Dec, 2012. The proportional reporting ratio method (PRR) and Bayesian confidence propagation neural network method (BCPNN) were used for data mining analysis. The results showed that 71 cases of serious ADRs accounted for 1 390, 5.11% of cases reported. There were more men than women (613/593), and people over the age of 60 accounted for 64.03%. The most common ADRs were itching, rash, dizziness, chills, and palpitations. With damage to skin and its accessories 55 forming the highest percentage of ADRs. When propensity score method to control for confounding factors, PRR method and BCPNN methods were applied, headache, dizziness, palpitation, and chills were ADRs warning signals. Due to the limitation of the SRS data, the results still need to be combined with other research to form a comprehensive body of safety evidence, and to guide the rational clinical use and reduce risks.

Knowledge assessment in adverse drug reactions and reporting

Objectives: In India, adverse drug reaction (ADR) monitoring activity is in infancy. This study was conducted to determine the pattern and extent of occurrence of ADRs in the hospital, to analyze the ADRs reporting behaviors in healthcare professionals (HCPs), to analyze the knowledge about ADRs in HCP, to analyze and compare the ADRs reported by HCP and to analyze the barriers involved in nonreporting of suspected ADRs. Materials and Methods: The study was carried out at Kovai Medical Center and Hospital (KMCH). A questionnaire containing 19 questions was distributed to the teaching faculties of pharmacy college, physicians, nurses, and students of the study setting. Results and Conclusion: The response rate of faculties, physicians, nurses, and students for the questionnaire in phase-I were found to be 66.67%, 40.00%, 66.67%, and 73.33%, respectively. But the response rates remarkably increased in phase-II when compared with phase-I study viz., 100% from faculties and students, 93.33% from physicians, and 86.67% from nurses. Almost all the participants said that ADR monitoring is done in their institution. Majority of the participants said that ADR should be reported if it causes both inconvenience and death to the patients. In our study, physicians (93%) knew the objectives of ADR monitoring very well in phase-II, when compared with phase-I study (75%), which was followed by faculties (83%), nurses (77%), and students (73%). Spontaneous reporting of ADRs is denoted by all faculties, 93% physician, 80% students, and 77% nurses in phase-II study. All participants in the phase-II survey knew any one method to monitor ADRs but in phase-I, 10% nurses and 9% students did not know about any method of monitoring ADR. Lack of knowledge about ADR reporting center is the mainstay in under-reporting or nonreporting of observed ADRs noted by only 6.67% of faculties, 19.23% nurses, and 10% students. The reason for underreporting was very much reduced in phase-II than in phase-I.

Description of Adverse Drug Reactions in a Multi-specialty Teaching Hospital

Adverse drug reaction (ADRs) monitoring is an ongoing and continuing process used by health care professionals to enhance effective patient care and to improve quality of life. The present study was carried out to monitor the incidence of ADRs in a multispecialty teaching hospital in India. A prospective reporting study was conducted including both in-patient and outpatient departments. The Naranjos Algorithm Scale was used for the casualty assessment and a Modified Hartwig and Siegel Scale was used for the severity assessment. Confirmed ADRs were classified according to the Wills & Brown method. The economic burden of ADRs was also measured by calculating the average cost incurred in treating the ADRs. During the study period, a total of 208 adverse drug events were reported, in which 183 reports from 172 patients were confirmed as ADRs. Out of 183 ADRs, 171 reactions were reported in in-patient departments and the remaining 12 from the outpatient department. Of all the ADRs, 132 (72.1%) reports during the hospital stay and 27.9% of ADR-related admissions were observed. The causality assessments of 92 cases were observed to be probable (50.3%). The severity assessment revealed that mild type (57.8%) reactions were most common. The majority of the reactions were of Type H (119, 65.0%), they were not predictable. In the management of ADRs, the suspected drug was discontinued in 61 (33.3%) cases. An ADR monitoring programme was found to be useful and beneficial to the patients and health care professionals for a better therapeutic outcome.

Involvement of private players in pharmacovigilance program of India: Data reliability will be under question

Pharmacovigilance or Adverse Drug Reactions (ADRs) monitoring is the pharmacological science related to the collection, detection, assessment, monitoring, and prevention of adverse effects or any other drug-related problem. India is fast growing as a hub of clinical trials. This is reflected in the fact that the total number of applications received and processed at Central Drug Standard Control Organization (CDSCO) New Delhi has doubled from around 10,000 in the Year 2005 to 22,806 in Year 2009; with increase in New Drug Applications, global clinical trials, and market authorization of vaccine and biotech products from 1200, 100, and 10 in Year 2005 to 1753, 262, and 137 in the Year 2009 respectively.

Provision of clinical pharmacy education and services by RAK college of pharmaceutical sciences, Ras Al Khaimah, UAE

Objectives: Internationally, the role of pharmacist has now been extended from the provision of traditional services to patient specific care services. Unlike other developed countries, clinical pharmacy services are very rare in the health care settings of United Arab Emirates (UAE). Hence, clinical pharmacy based education and training is the need of the hour. Materials and Methods: RAK College of Pharmaceutical Sciences (RAKCOPS) through its innovative undergraduate pharmacy curriculum with a practice-oriented training, is enabling the students to acquire knowledge, skills, and practice to apply in a healthcare set up. RAKCOPS established a clinical pharmacy department in the year 2009 at Ibrahim Bin Hamad Obaidallah Hospital of Ras Al Khaimah, UAE, which is a 330 bedded tertiary care medical specialty hospital. In the year 2007, RAKCOPS initiated undergraduate pharmacy program of 4.6 years (B. Pharm) with a one semester of practice school training in the last semester. Results: Practice school training as a part of B. Pharm program is mainly designed to help the students to gain confidence in their ability to be an active and useful participant in the healthcare. Clinical pharmacy related services such as drug and poison related information, adverse drug reaction (ADR) monitoring, and reporting are also provided by the department of clinical pharmacy. Conclusion: Pharmacy practice related education and practice-based training provided for the undergraduate pharmacy students will be definitely a major contribution towards bringing up quality clinical pharmacists in UAE, who will be a major asset for the healthcare team.

Initiation of a pharmacovigilance programme at a tertiary care hospital in South India

Abstract Objective India is a country with the availability of a large number of pharmaceutical preparations as branded generics. At the time of this study there was no established pharmacovigilance system at the national level except a co-ordinating centre at the national capital. The study site was a tertiary care teaching hospital with a bed capacity of 500 and with an average of 200 outpatient visits and 50 inpatient admissions per day. The hospital did not have any system of monitoring and documenting adverse drug reactions. The objective of the study was to introduce an adverse drug reaction (ADR) monitoring programme at a tertiary care teaching hospital and assess ADR-related issues in both inpatient and outpatient departments. Method All departments willing to report ADRs were included in the study, which was carried out for one year. Physicians and nurses filled in the notification forms when they encountered suspected ADR cases. These cases were then assessed by a panel of four judges. According to Naranjo's algorithm, the ADRs were assessed and classified based on World Health Organization (WHO) classification. Key findings A total of 288 suspected cases were reported and 264 ADRs were confirmed by the panel. According to Naranjo's probability scale, 83 cases were categorized as ‘probable’, 181 cases were classified as ‘possible’, and none were classified as ‘unlikely’ or ‘definite’. The most common classes of drugs involved were antibiotics (25%), psychotropics (20%), analgesic and cardiovascular agents (14% each). Generalised itch and rash, tremors, urticarial drug reaction, oral ulcer, gastritis and akathesia and extrapyramidal symptoms were found to be the most common ADRs observed; 2.1% of the patients in the studied departments had ADRs. Conclusion The ADR reporting system was initiated at the hospital and was well received by the physicians. Appreciable participation of physicians was noted during the study in reporting ADRs. The study also gave an insight into the awareness of physicians about ADR-related issues. The number of ADRs reported was reasonably comparable with the findings of other authors from India.

Pharmacovigilance on olanzapine

Pharmacovigilance on olanzapine

Monitoring of Adverse Events and Reporting

Monitoring adverse events is recognized as one of the major safety measures of current pharmacotherapeutics. Although the concept of a formal system for adverse drug reaction (ADR) monitoring has existed for many years and some countries have more than 30 years of experience with such systems, monitoring is still far from perfect.Since the early 1990s, when the political systems of the central European countries changed and their economies began moving toward a free market system, the approach to drug safety had to be changed. At present, in Poland and Hungary ADR monitoring systems are undergoing major changes. In the Slovak and Czech republics the system was previously well organized and continues to be effective. In Poland, a number of new initiatives, and a new pharmaceutical law that obliges the industry to monitor and report ADRs, changed the approach to drug safety. There is a considerable effort to adopt proven concepts, for example, a decentralized monitoring system similar to the one created in ...

Adverse Drug Reactions: Communications and Reporting — Hospital and Home Health Care Perspectives

Emphasis on adverse drug reaction (ADR) monitoring and reporting in the hospital setting has spawned a number of model ADR programs across the country. Although the pharmacy department usually becomes the caretaker of such programs in the hospital, a multidisciplin ary approach may be the cornerstone to an effective and efficient program. In contrast, little information is available regarding ADR monitoring in the home setting. Developing and implementing an ADR monitoring program in the home health-care setting presents unique administrative and clinical challenges to home infusion providers. The decentralized nature of formalized home care emphasizes the need for open communication channels in all aspects of care, but particularly for the monitoring and reporting of ADRs. Establishing an effective ADR program in the home setting may optimize patient safety, and provide valuable information regarding the nature and significance of reactions that occur in this population. The University of Kansas has established a dedicated phone line which enables home health care professionals to monitor and report ADRs. The data collected in this pilot project is reviewed, with respect to the type of reaction and its degree of severity, patient outcome and the United States market life of drugs associated with these reactions.