Innovations in pharmacovigilance studies of medicines in older people.
Lisa Kalisch EllettJack Luke JanetzkiRenly LimTracey-Lea LabaNicole L PrattPublished in: British journal of clinical pharmacology (2024)
Pharmacovigilance is defined by the World Health Organization as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem". Pharmacovigilance studies are critical for detecting and assessing adverse events of medicines that may not have been observed in clinical trials. This activity is especially important in older people who are often excluded from clinical trials as they have multiple chronic conditions and use multiple medicines for longer durations than the clinical trials. In this narrative review we describe innovative methods in pharmacovigilance studies of medicines in older people that leverage the increasing availability of digital health technologies, electronic health records and real-world health data to identify and quantify medication related harms in older people.
Keyphrases
- adverse drug
- electronic health record
- clinical trial
- drug induced
- public health
- healthcare
- case control
- clinical decision support
- mental health
- phase ii
- health information
- open label
- phase iii
- randomized controlled trial
- double blind
- health promotion
- climate change
- study protocol
- sensitive detection
- quantum dots
- placebo controlled