Pharmacovigilance for evaluating adverse drug reactions: value, organization, and methods

Assessment of Knowledge, Attitude and Practices of Adverse Drug Reaction Reporting among Doctors and Pharmacists in Primary Healthcare

“…It encompasses all drugs and patient populations, including special groups. However, under-reporting and an inability to calculate the incidence of ADRs are the inherent disadvantages of this method [6][7][8]. Worldwide, 95% of serious ADRs do not get reported to the health authorities [9].…”

Cutaneous Adverse Drug Reactions-A Study of Clinical Patterns, Causality, Severity & Preventability

“…[10] WHO defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.ADR burden the health system by not only increasing the mortality & morbidity but also the expenses. Science of Pharmacovigilance is accountable to identify, appraise, comprehend and avert ADRs with the eventual mean to develop secure and coherent utilization of medication [11][12][13] [14].Current methods of Pharmacovigilance possess certain constraints reminiscent of under reporting, inability to find the incidence rate, size of the population exposed and bias in collection of drug exposure [11][15] [16] [17]. Pharmacovigilance gives a vital measure of the burden of drug induced morbidity and approximately half of ADRs could be averted with better prescription care [18] [19] [20].…”

Utilization and Safety of Hepatoprotective Drugs: A Retrospective Pharmacoepidemiology Study on Two Databases of China

“…Among the 916 ADEs, 733 (80.02%) were general, mainly involving the skin and its appendages, central and peripheral nervous systems, cardiovascular system and gastrointestinal system, and 24 (2.62%) were serious, mainly including allergy (especially anaphylactic shock), fainting, erythema, dyspnea, hyperpyrexia, and chest tightness. Rash or pruritus (18), palpitation or chest tightness (9), fever of chills (7), dyspnoea (7), anaphylactoid reaction(6), phlebitis (5), dizziness (4), night sweats (4), nausea and vomiting (3), rash erythematous (3), flushing (2), anaphylactic shock (2), stomach discomfort (2), larynx oedema (2), anaesthesia local (2), pain (1) Rash or pruritus (15), palpitation or chest tightness (15), chills or fever (11), nausea or vomiting(9), anaphylactoid reaction(5), phlebitis (4), dizziness (4), rash erythematous (4), injection site pruritus (2), stomach discomfort (2), headache (2), dyspnoea(2), diarrhoea (2), anorexia (1) Rash or pruritus (14), palpitation or chest tightness (12), nausea or vomiting (7), chills or fever (5), anaphylactoid reaction(4), rash erythematous (4), dizziness (2), anaphylactic shock (2), anasarca (2), peripheral oedema (2), oedema (2), injection site pruritus (2), injection site pain (1), rash maculopapular (1), flushing (1), phlebitis (1), night sweats (1), facial oedema (1), abdominal pain (1) Anaphylactoid reaction (41), nausea or vomiting (38), rash or pruritus (36), fever (7), diarrhoea (7), chest tightness (6), rash maculopapular (5), palpitation (5), dyspnoea (3), pain (3), rash erythematous (3), stomach discomfort (3), larynx oedema (2), injection site pruritus (2), chills (2), dizziness (2), flatulence (2), fatigue (2), anaphylactic shock (1), coma (1), increased stool frequency (1), hypotension (1) Total 916 100.00…”

“…In the USA, voluntary and mandatory reporting systems co-exist [17] . Unlike that of USA, Chinese ADR monitoring system adopts a decentralized management model with 34 regional centers as its main component [18] , and hospital-based monitoring is one of the major methods used to collect ADR. The data of drug utilization and ADEs in Hubei Province are all obtained from the above two databases.…”