The need for additional data on safety and efficacy of medicines both new and old that assess all potential risk factors is ever present, with health system pharmacists at the front lines.
Many medicines are known to have cognitive consequences for patients during and after use, but the extent and severity of those consequences are not always well understood. Specifically, certain drugs have been found to have varying cognitive effects based on certain risk factors, one of which can be sex. Although there have been extensive efforts to generate more data on how sex may impact the effects of a drug on a patient, it wasn’t until 1993 that the US Congress made the inclusion of women and minority populations in clinical research a law. In fact, the FDA had a policy in place in 1977 recommending the exclusion of women of childbearing potential from all clinical trials.1
On page 28, authors Deja Neal, a class of 2024 PharmD candidate; and Jolene Bressi, PharmD, PMP, BCMAS, discuss the cognitive consequences of benzodiazepines, a commonly prescribed class of medications used to manage conditions such as anxiety, insomnia, alcohol withdrawal, muscle spasms, and seizures. Although benzodiazepines have been available for more than 60 years—coming to market for the first time in 1960 with chlordiazepoxide (Librium; Hoffmann–La Roche) and 1963 with diazepam (Valium; Genentech, Inc)—many of the findings that led to the FDA approval of these drugs were not assessed in women.2 In their article, Neal and Bressi explain how more data are showing that sex may be a risk factor for cognitive effects of benzodiazepines.
Additionally in this issue, author Gary Hopkins in the cover story on page 8 explains the value of using a pharmacy to fill a prescription at the same health system in which the prescription was written. However, this is not always possible, as some insurance companies require prescriptions to be filled at large, offsite mail-order pharmacies. According to Hopkins, the associated challenges for patients that can arise, primarily around communication, can be considerable and can delay the initiation of treatment.
On page 24, Diandra Ruidera, PharmD, BCPS, BCIDP; and Stuart Greaser, PharmD, BCIDP, discuss new evidence showing the benefit of tonsillectomy for recurrent acute tonsillitis, the treatment of which contributes to the highest antibiotic-prescribing and overprescribing rate in adult populations.3 In addition, on page 32, Jeff Bruni, a 2024 PharmD candidate; Anne Dang-Vo, a 2024 PharmD candidate; and Ron Welch, PharmD, BCPS, BCIDP, discuss the role of tirofiban hydrochloride (Aggrastat; Medicure Pharma, Inc) in acute coronary syndrome, noting that further data areneeded before tirofiban treatment for ischemic strokes can be deemed safe and effective.
The need for additional data on safety and efficacy of medicines both new and old that assess all potential risk factors is ever present, with health system pharmacists at the front lines—shedding light on these data by contributing and adding to the depth of the literature.