Objective: Traditionally, studies on the non-medical use of pharmaceutical products have focused on controlled substances; e.g., opiates/opioids; and benzodiazepines. Although both bupropion and venlafaxine have been reported as being misused, only anecdotal reports have been made available so far. Hence, the European Monitoring Agency (EMA) Adverse Drug Reactions (ADRs), misuse/abuse/dependenc...

Abstract Introduction. The use of medicines involves trade-offs between their therapeutic benefits and inherent risks. Several studies show that numerous adverse drug reactions (ADRs) could be avoided by increasing patients’ awareness medicine’s Even though labels enclose relevant information about risks benefits, this often requires patient education overall health literacy to improve medicati...

Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors are a recent targeted therapy approved for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2−) advanced breast cancer. Abemaciclib, palbociclib ribociclib demonstrated great efficacy safety during clinical studies. However, differences in their adverse-event profiles have been observed. Thi...

The promise of augmenting pharmacovigilance with patient-generated data drawn from the Internet was called out by a scientific committee charged with conducting a review of the current and planned pharmacovigilance practices of the US Food and Drug Administration (FDA). To this end, we present a study on harnessing behavioral data drawn from Internet search logs to detect adverse drug reactions...

In recent years, pharmacovigilance has undergone some major changes. First, the patient's active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT). Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now ...

BACKGROUND The description of adverse drug reactions (ADRs) by health care professionals (HCPs) can be highly variable. This variation can affect the coding of a reaction with the Medical Dictionary for Regulatory Activities (MedDRA(®)), the gold standard for pharmacovigilance database entries. Ultimately, the strength of a safety signal can be compromised. OBJECTIVE The objective of this stu...

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lake...

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration’s (FDA’s) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lake...

Generally the data on adverse reactions to drugs treatment have been recorded in clinical trials, post-marketing analyses and anecdotal reports; however such data are available only in well developed countries and it might not be an up-to-date. The Thalidomide tragedy around 1962 which resulted in the birth of more than 10,000 malformed children by women who took the drug at the early stage of ...

Background: In developing countries like India, the increased economic burden in healthcare system is due to adverse drug reactions (ADRs) related hospitalizations which turn are polypharmacy associated with potential of ADRs. World Health Organization (WHO) started program for international monitoring (WHO PIDM) year 1968. India one member under WHO PIDM using Vigibase analysis individual case...