A comparison of renal-related adverse drug reactions between rofecoxib and celecoxib, based on the World Health Organization/Uppsala Monitoring Centre safety database

2001 ◽  
Vol 23 (9) ◽  
pp. 1478-1491 ◽  
Author(s):  
S Zhao
Keyword(s):  
World Health Organization ◽  
Adverse Drug Reactions ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Drug Reactions ◽  
Safety Database ◽  
Monitoring Centre ◽  
The World ◽  
Health Organization ◽  
Uppsala Monitoring

scholarly journals An overview of the worldwide master key for pharmacovigilance and its role in India

2021 ◽  
Vol 2 (2) ◽  
pp. 19-26
Author(s):  
Janmejay Pant ◽  
Harneet Marwah ◽  
Ripudaman M Singh ◽  
Subhajit Hazra
Keyword(s):  
World Health Organization ◽  
Adverse Drug Reactions ◽  
Marketing Authorisation ◽  
World Health ◽  
Drug Reactions ◽  
Regulatory Authorities ◽  
The World ◽  
Health Organization ◽  
Positive Results ◽  
Uppsala Monitoring

Introduction: Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. Methods: In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. Results: The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this. Conclusions: The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.

scholarly journals Pharmacovigilance programme of India: revival of the renaissance

2018 ◽  
Vol 7 (11) ◽  
pp. 2281
Author(s):  
Jyoti B. Gadhade ◽  
Rajesh S. Hiray ◽  
Rekha Y. Aherkar ◽  
Kalpana U. Shah
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Drug Reaction Reporting ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Family Welfare ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
The World ◽  
Health Organization

Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.

scholarly journals ALLOPURINOL-INDUCED STEVENS–JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS: A CASE REPORT

2019 ◽  
pp. 5-7 ◽  
Author(s):  
MANIK CHHABRA ◽  
ANKIT GAUR
Keyword(s):  
Toxic Epidermal Necrolysis ◽  
World Health ◽  
Stevens Johnson Syndrome ◽  
Uppsala Monitoring Centre ◽  
Self Medication ◽  
Monitoring Centre ◽  
Johnson Syndrome ◽  
Chief Complaints ◽  
Health Organization ◽  
Uppsala Monitoring

Allopurinol is used for the treatment of gout and related conditions; it is associated with various adverse drug reactions (ADRs) such as Stevens– Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). A 50-year-old female was presented to the emergency ward with chief complaints of reddish pinpoint lesions over the back, chest, abdomen, and lower limb-upper limb for the past 6 days. She was diagnosed with SJS. On medication interview, it was revealed that she was on allopurinol therapy, which she took 5 days back as a self-medication. The World Health Organization - Uppsala Monitoring Centre (WHO) scale was used to access the causality assessment, ADR was found to be probable. The drug was withdrawn from the therapeutic regimen of the patient. The patient was discharged after 25 days from the hospital. Allopurinol has the strongest association with SJS with TEN. There should be a screening of HLA-B 5801 antigens before commencing the allopurinol therapy to the patients.

scholarly journals Incident adverse drug reactions in geriatric inpatients: a multicentred observational study

2017 ◽  
Vol 9 (1) ◽  
pp. 13-23 ◽  
Author(s):  
Amanda Lavan ◽  
Joseph Eustace ◽  
Darren Dahly ◽  
Evelyn Flanagan ◽  
Paul Gallagher ◽  
...  
Keyword(s):  
Observational Study ◽  
Adverse Drug Reactions ◽  
Feasibility Study ◽  
Median Number ◽  
Economic Consequences ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
P Value ◽  
Drug Reactions ◽  
Monitoring Centre

Background: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study’s objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. Methods: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. Results: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4–6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions ( r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5–25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. Conclusion: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.

scholarly journals Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
M. Süsskind ◽  
P. A. Thürmann ◽  
C. Lüke ◽  
E. Jeschke ◽  
M. Tabali ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Community Hospital ◽  
Safety Data ◽  
Uppsala Monitoring Centre ◽  
Anthroposophic Medicine ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Medical Wards ◽  
Design And Methods ◽  
Uppsala Monitoring

Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use.Objectives. We aimed to assess adverse drug reactions (ADRs) caused by anthroposophical medicines (AMEDs) in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code), causality (according to the Uppsala Monitoring Centre WHO criteria), and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6%) experienced 211 ADRs (CTCAE grade 2/3n=191, 90.5%, CTCAE grade 4/5n=20, 9.5%) of which 57 ADRs (27.0%) were serious. The median age of patients with ADRs (62.1% females) was 72.0 (IQR: 61.0; 80.0). Six patients (0.2%) experienced six ADRs (2.8% of ADRs) caused by eight suspected AMEDs, all of which were mild reactions (grade 2).Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms.

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