The physician attitude to notice the adverse drug reactions during post-marketing surveillance assessed by a simulated clinical case

590 Background: Cetuximab (ERBITUX) was approved in Jul 2008 in Japan with indication for EGFR-positive and unresectable metastatic or refractory colorectal cancer. Post-marketing surveillance is required by Japanese Health Authority to collect, obtain, verify or validate information on the safety, efficacy and quality of medicines. We conducted this surveillance in all patients treated with cetuximab to access in practical use since clinical data on Japanese patients are limited. Methods: The target number of patients was 1,800. Following adverse drug reactions were investigated: infusion reaction, skin disorders, interstitial lung diseases, electrolyte abnormalities (including hypomagnesemia), heart toxicities, gastrointestinal disorders, thrombosis/embolism, delayed wound healing, and eye disorders. Results: Between Sep 2008 until Jan 2010, 2,126 pts registered, 2,006 pts were evaluable for safety (safety population), 1,687 pts for efficacy (efficacy population). Of the 2,006 pts, 1,975 pts (98.5%) were EGFR-positive. Patients characteristics: male/female; 1,234/772 (61.5%/38.5%), median age; 64 (range 18-87), site of primary tumor; colon/rectal/others (multiple selection); 1,235/775/3 (61.6%/38.6%/0.2%), PS0/PS1; 1,370/630 (68.3%/31.4%), combination chemotherapy; cetuximab monotherapy/CPT-11/FOLFIRI: 460/1,255/256 (22.9%/62.56%/12.8%). Of the 2,006 pts, 133 pts (6.6%) and 1,869 pts (93.2%) were treated in second-line and in third-line or later treatment, respectively. The adverse drug reactions incidence was 89.9%. Incidence of skin disorders, gastrointestinal disorders, electrolyte abnormality including hypomagnesaemia, and infusion reaction were 83.7%, 23.1%, 11.5%, and 5.7%, respectively. Efficacy result: Of the 1,687 pts, 658 pts (39.0%) were evaluated to be effective. Of the 658 pts, 614 pts (93.3%) experienced skin adverse reactions. Conclusions: This post-marketing surveillance confirms the safety and efficacy of cetuximab in the Japanese population treated in clinical practice. The outcome of this surveillance with Japanese 2,006 pts would be useful for clinical use of cetuximab. [Table: see text]

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POST-MARKETING SURVEILLANCE OF ADVERSE DRUG REACTIONS

InPharma ◽

10.1007/bf03289402 ◽

1977 ◽

Vol 110 (1) ◽

pp. 4-5

Keyword(s):

Adverse Drug Reactions ◽

Drug Reactions ◽

Post Marketing Surveillance ◽

Post Marketing

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Safety and effectiveness of bevacizumab in Japanese patients with malignant glioma: a post-marketing surveillance study

Japanese Journal of Clinical Oncology ◽

10.1093/jjco/hyz125 ◽

2019 ◽

Vol 49 (11) ◽

pp. 1016-1023 ◽

Cited By ~ 2

Author(s):

Nagane Motoo ◽

Yasuko Hayashi ◽

Ayaka Shimizu ◽

Masako Ura ◽

Ryo Nishikawa

Keyword(s):

Overall Survival ◽

Survival Rate ◽

Malignant Glioma ◽

Adverse Drug Reactions ◽

Median Overall Survival ◽

Surveillance Study ◽

Newly Diagnosed ◽

Drug Reactions ◽

Post Marketing Surveillance ◽

Post Marketing

Abstract Objective This surveillance study was conducted to verify the post-market safety and effectiveness of bevacizumab, which was approved in Japan in 2013 for the treatment of patients with newly diagnosed and or recurrent malignant glioma. Methods This was a prospective, observational, multicenter post-marketing surveillance study. Patients with newly diagnosed or recurrent malignant glioma scheduled for bevacizumab treatment were enrolled. The incidence and severity of adverse drug reactions were calculated. The effectiveness of bevacizumab was assessed by the 1-year survival rate and the overall survival rate. Results The safety analysis set and the effectiveness analysis set each comprised 258 of the 268 enrolled patients: tumours were newly diagnosed in 80 patients (31%) and recurrent in 178 patients (68.9%). The incidence of grade ≥ 3 adverse drug reactions was 15.1%. Adverse drug reactions of special interest included 14 cerebral bleeding events and 11 infections. Of the 80 patients with newly diagnosed malignant glioma, 44 (55%) were alive throughout the 18-month observation period. The 1-year survival rate for patients with newly diagnosed glioblastoma was 78%. Median overall survival was not calculated, but 51.2% of patients were alive at the last date of observation of the last observed patient. In patients with recurrent glioblastoma, the 1-year survival rate was 38.9%, and the median overall survival was 10.2 months. Conclusions The results suggest no new safety concerns, and the effectiveness might be similar to previously reported data in clinical trials. Therefore, bevacizumab is considered as one of the treatment options for patients with malignant glioma in real-world clinical practice.

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Study of adverse drug reactions associated with antiepileptic drugs: a pharmacovigilance study using spontaneous reporting system

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20213368 ◽

2021 ◽

Vol 10 (9) ◽

pp. 1125

Author(s):

Sudha K. Mukhyaprana ◽

Siddiraju Devipriya ◽

Meenakshi Thirumalaiappan

Keyword(s):

Antiepileptic Drugs ◽

Adverse Drug Reactions ◽

Spontaneous Reporting ◽

Reporting System ◽

Spontaneous Reporting System ◽

Maculopapular Rash ◽

Similar Efficacy ◽

Drug Reactions ◽

Post Marketing Surveillance ◽

Post Marketing

Background: More than 25 antiepileptic drugs (AEDs) are available in the Indian market to treat epilepsy of which many have similar efficacy but differ in their tolerability and are associated with many adverse drug reactions (ADRs). ADRs are one of the most common causes of death and clinical trials are not sufficient to uncover all the ADRs, hence post-marketing surveillance or pharmacovigilance is necessary. The aim of the study was to analyze the ADRs of AEDs by spontaneous reporting system under Pharmacovigilance Program of India (PvPI).Methods: Suspected ADR reporting forms provided by PvPI were used to collect the data from healthcare professionals of Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai.Results: A total of 77 ADRs from 61 reports were analysed of which 34 were male and 27 were female patients and maximum were in the middle-aged adult group (N=44). Majority of the ADRs were related to skin and subcutaneous disorders (N=55) and most implicated ADR was found to be maculopapular rash (N=12) associated with phenytoin. Most of the ADRs were non-serious (N=42) and were probable category (N=45) as per WHO-UMC scale.Conclusions: Monitoring ADRs in patients using antiepileptic drugs is a matter of importance; hence a robust pharmacovigilance practice is essential.

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Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i46a32867 ◽

2021 ◽

pp. 276-288

Author(s):

S. Narmada ◽

M. P. Gowrav ◽

Akhilesh Akki ◽

Vishakharaju Motupalli ◽

V. Balamuralidhara ◽

...

Keyword(s):

Adverse Drug Reactions ◽

Adverse Reactions ◽

Healthcare Providers ◽

The United States ◽

Reporting Rate ◽

Global Perspective ◽

Drug Reactions ◽

Paediatric Patients ◽

Post Marketing Surveillance ◽

Post Marketing

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

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Adverse reactions: getting the best from the yellow card system

Drug and Therapeutics Bulletin ◽

10.1136/dtb.18.19.75 ◽

1980 ◽

Vol 18 (19) ◽

pp. 75-76

Keyword(s):

Adverse Drug Reactions ◽

Adverse Reactions ◽

Drug Reactions ◽

Yellow Card ◽

Post Marketing Surveillance ◽

Post Marketing ◽

Card System ◽

The Many ◽

Source Of Information

Yellow cards provide the Committees on Safety of Medicines (CSM) and Dental and Surgical Materials (CDSM) with their major source of information on the occurrence of adverse drug reactions. Of the many forms of post-marketing surveillance now in use, it is the most widely applied and probably the cheapest. Three-quarters of the 23,000 reports received by the Committees in 1978 and 1979 were through the yellow card system. However, probably only 10% of serious adverse reactions are reported to the Committees.1 Why is reporting reactions important, and how can doctors help to make the system work better?

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