Bulletin Today
APhA Staff
What strategies do pharmacists use to identify and prevent adverse drug reactions?
In what is believed to be the first study of its kind, researchers examined the cognitive processes health care professionals use to detect, resolve, and monitor adverse drug reactions.
The research paper, published in the BMJ, points to the complexity of resolving problems regarding adverse drug reactions and also provides readers with implications to develop novel clinical decision support systems that more closely align with a health care provider’s cognitive workflow.
The researchers reviewed incidents reported at a single VA Medical Center with a focus on both inpatient and outpatient care. Within 2 to 4 weeks of select incidents, follow-up critical decision method interviews were conducted with 10 physicians and 10 pharmacists. Researchers then performed quantitative data analysis to identify key decision points and themes. They subsequently developed a descriptive model of how health care providers identify problems and make decisions related to adverse drug reactions.
The model incorporates 4 phases, including problem detection (e.g., through symptoms or information transfer from another health care provider). The other 3 stages are investigation of the root of the problem, risk-benefit considerations, and plan of action and follow-up.
The study authors believe the findings can help train future pharmacists and physicians about adverse drug event decision-making.
In addition, their results may inform the design of clinical decision support systems, which they recommend be fine-tuned to facilitate patient-provider communication in order to better detect and address adverse drug reactions, among other changes.
CDC makes the case for pharmacists’ reimbursement given expanding roles
The health care disruptions created by the COVID-19 public health emergency have revived interest in identifying opportunities to optimize pharmacists’ roles.
Pharmacies can no longer afford to work without reimbursement—especially since the COVID-19 pandemic, which has meant more responsibilities in the form of testing and vaccinations, but fewer employees to share the load.
After conducting a series of hour-long semistructured interviews with pharmacists and chronic disease experts in the summer of 2020, researchers with CDC’s Division for Heart Disease and Stroke Prevention and George Washington University drafted a white paper detailing 21 key findings. They report that community pharmacists can play an important role in delivering chronic disease management services, but only if adequate staffing, technology, and workflow procedures are in place. Reimbursement is also critical.
“Successfully demonstrating pharmacists’ value and making the case for reimbursement from payors, as well as optimizing pharmacy workflow, are critical to maximizing pharmacists’ impact in chronic disease prevention and management,” the researchers wrote.
FDA aims to develop nonaddictive alternative to opioids
FDA recently issued draft guidance about its plan to develop nonopioid analgesics for acute pain in an effort to spur the development of nonaddictive alternatives.
The guidance defines acute pain as lasting up to 30 days, often the result of tissue injury such as trauma or surgery.
“Opioid misuse and abuse remain a serious public health crisis facing the country,” said Patrizia Cavazzoni, MD, director of FDA’s Center for Drug Evaluation and Research. “Preventing new addiction through fostering the development of novel nonopioid analgesics is an important priority for the FDA.”
The draft guidance focuses on FDA’s current thinking about 3 facets of non-opioid analgesic drug development for acute pain: types of drug development programs that may be appropriate to generate data needed to support an indication for the management of acute pain, potential use of claims in labeling regarding the elimination or reduction of opioid use and the data needed to support those claims, and potential use of FDA’s expedited programs to spur the development program.
The guidance also supports the HHS Overdose Prevention Strategy, which focuses on primary prevention, harm reduction, evidence-based treatment, and recovery support.
New report shows 82% of patients still experience medication delays
A new report estimates that 82% of patients experienced medication delays in the last year because of COVID-19 restrictions, medications cost, communication challenges, insurance processes, and/or lack of transportation.
Of patients who experienced delays, 85% had to make monetary compromises to afford their prescriptions, such as forgoing other bills or medications or modifying treatment to stretch out a prescription. Many patients postponed medical visits in the past year, according to the CoverMyMeds’ 2022 Medication Access Report.
The industry report found that 84% of patients delayed or skipped in-person health care visits, mostly because of concerns related to COVID-19 or a lack of appointments. This contributed to an estimated 500 million fewer diagnostic visits and more than 15 million fewer new prescriptions.
The report also found that 79% of patients said they went to the pharmacy but found that the cost of a prescription was more than anticipated, up from 67% the year before. Among patients facing affordability issues, 56% sought to stretch out a prescription, 52% skipped paying bills or buying other essential items to afford medications, and 51% stopped taking their medications to pay bills and other essentials.
Meanwhile, 54% of pharmacists said they lacked time to complete their job effectively, with 81% citing inadequate staffing and 73% citing time-consuming administrative tasks. To improve affordability conversations with patients and provide them with specialty therapies sooner, 64% of providers said they need access to patient-specific benefit information, but only 25% of providers and 36% of pharmacists said they have in-workflow access to plan-specific pricing.
Drug overdose deaths from nonbenzodiazepine sleeping pills and anti-epilepsy gabapentinoids rises
A new study in The Lancet Regional Health—Americas found that the proportion of overdose deaths involving nonbenzodiazepine sleeping drugs (i.e., z-drugs) and gabapentinoids increased more than threefold between 2000 and 2018, coinciding with exponential prescription increases since their introduction into the market.
“These drug classes were introduced as less dangerous alternatives to opioids and benzodiazepines, creating perceptions among physicians and patients of their supposed increased safety, even without guidelines or data to back up such perceptions and leading to increases in prescribing,” said Silvia Martins, MD, PhD, senior author of the study, in a news release. “Approved for short-term treatment of insomnia, they were touted as safe alternatives to the popular benzodiazepines when introduced to the market as less prone to abuse or dependence. Yet, recent evidence suggests that this alternative may also be as harmful as the product it intended to replace.”
The research team wanted to further explore and determine the dangers of co-usage of the drugs. According to the research, more than 67% of those who died from overdoses with nonbenzodiazepine sleeping drugs and anti-epilepsy gabapentinoids between 2000 and 2018 also had opioids in their system.
Prescription opioids and benzodiazepines are the most common medication classes involved in drug-related ED visits and drug overdose deaths in the United States. When taken in excess, both benzodiazepines and prescription opioids promote respiratory decline.
According to the research, based on data from the National Center for Health Statistics, there were more unintentional overdoses and a greater proportion of women, whites, and those with higher educational background who died from an overdose.
“The rise in gabapentin prescriptions roughly accompanies the involvement of z-drugs and gabapentinoids in overdose deaths, which suggests they can be playing a role in those deaths. The literature also has shown increasing deaths with gabapentin co-using with other substances including alcohol,” said Martins, who is also a professor of epidemiology at Columbia University Mailman School of Public Health.
Could famotidine reduce COVID-19 symptoms?
According to outpatient clinical trial results recently published in Gut, the common heartburn medication Pepcid (famotidine) could improve the recovery of symptomatic patients diagnosed with COVID-19.
Adults with mild to moderate COVID-19 who took famotidine during the trial exhibited an earlier resolution of type-I interferon release from SARS-CoV-2–infected epithelial cells without reduced antiviral immunity. Patients self-administered 80 mg of famotidine or placebo orally 3 times a day for 14 consecutive days during the study period.
“We found that famotidine is safe at the higher doses used and see molecular and clinical evidence that it improves the recovery of symptomatic patients of diverse ancestries diagnosed with COVID-19,” said lead investigator Tobias Janowitz, MD, in a news release.
“We closely monitored patients in this fully remote clinical trial while protecting their safety and that of health care providers in pandemic conditions. We hope that the data we are sharing with this study guide future trials that are necessary to confirm famotidine as a treatment for patients with COVID-19,” said Janowitz, who is with Feinstein Institutes for Medical Research at Northwell Health and Cold Spring Harbor Laboratory in New York.
Previous studies have shown famotidine turns inflammation down by blocking a specific molecular pathway. These new findings confirm that famotidine leads to earlier resolution of inflammation in patients diagnosed with COVID-19 and alleviates symptoms of the disease, but the research team said additional randomized trials are required.
Needle-free epinephrine products could be available in 2023
Apprehension over using epinephrine autoinjectors has motivated research into other delivery methods for this medication, according to participants at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
Both San Diego, CA–based ARS Pharmaceuticals and Raleigh, NC–based Bryn Pharma are working on intranasal formulations, while Aquestive Therapeutics in Warren, NJ, is working on a sublingual film.
Both of the nasal sprays reached maximal plasma concentration in 20 to 30 minutes. ARS Pharmaceuticals compared its intranasal product (Neffy 1 mg) against manual intramuscular injection (0.3 mg) and two autoinjectors (EpiPen 0.3 mg and Symjepi 0.3 mg) by evaluation data from several randomized crossover Phase I studies that focused on pharmacokinetics and pharmacodynamics in 175 healthy adults.
In this comprehensive analysis, EpiPen was fastest (20 minutes) at reaching maximal concentration (Tmax), followed by Symjepi and Neffy (both 30 minutes) and epinephrine 0.3 mg I.M. (45 minutes).
In a human factors analysis, ARS Pharmaceuticals reported that untrained participants were able to administer the Neffy spray to themselves or another participant safely and effectively during a simulated emergency scenario.
Bryn Pharma compared pharmacokinetics of its nasal spray product (BRYN-NDS1C 6.6 mg) when self-administered or administered by trained professionals and found comparable Tmax values: 21.63 minutes (trained professional) and 19.82 minutes (self-administered).
Meanwhile, Aquestive Therapeutics is developing a product the size of a postage stamp that delivers epinephrine and begins dissolving when placed under the tongue, with no swallowing or water needed. The company found that the epinephrine reaches maximum plasma concentration in about 15 minutes, with a Tmax range narrower than that of the EpiPen.