Bulletin Today
APhA Staff
FDA said it is temporarily halting its risk evaluation and mitigation strategy (REMS) program for clozapine, a treatment for schizophrenia.
FDA noted that health care professionals had difficulty trying to adhere to the program’s original November 15, 2021, deadline. The agency confirmed that pharmacists can dispense clozapine without a REMS dispense authorization and wholesalers can continue to ship clozapine to pharmacies and other health care settings.
“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” FDA stated.
In July 2021, FDA approved modifications to the clozapine REMS. The drug can be effective in some patients, but it can also potentially decrease a person’s neutrophil count, which can lead to severe neutropenia, serious infections, and possibly death. Patients who take the drug need to have their absolute neutrophil count monitored.
FDA said medical professionals informed the agency about ongoing challenges such as a high call volume and long call wait times for stakeholders. FDA recommended the use of “clinical judgment” with respect to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range. In September 2021, the American Psychiatric Association and other groups asked FDA in a letter to delay the implementation of a new REMS program until after January 1, 2022.
Many patients not receiving statins after lower-extremity revascularization
A new study in JAMA Network Open analyzed data from more than 125,000 patients who received lower-extremity revascularization between 2014 and 2019.
Researchers found that rates of statin prescription at discharge increased overall, but only 30% of patients who did not have a prescription before their procedure were discharged with a new prescription.
The researchers focused on a cross-section of data from the Society of Vascular Surgery’s Vascular Quality Initiative, a large, multicenter national registry. The data included 172,025 procedures in 125,791 patients with a mean age of 67.7 years. Roughly 63% of patients represented in the data were men.
The study found that, generally, rates of statin prescriptions at discharge from this procedure grew from 75% in 2014 to 87% in 2019. When looking at patients not taking a statin prior to revascularization, the research team found that only 12,790 of 42,020 patients (30%) were newly discharged with a statin medication.
Fentanyl deaths spike in parts of the U.S.
Between 2019 and 2020, illicitly manufactured fentanyl-related overdose deaths increased substantially in western, southern, and midwestern states, CDC reported.
According to the report, fentanyl-related overdose deaths exceeded 1,800 in western states in the second half of 2020, a nearly 94% increase compared with the same period a year earlier.
The second half of 2020 saw more than 4,300 deaths involving illicitly manufactured fentanyl in southern states, a nearly 65% increase from the previous year, while such deaths in midwestern states topped 2,000 for that period, up 33% from the second half of 2019.
In the northeast, illegal fentanyl-related overdose deaths increased 3.5% from the second half of 2019 to the same period of 2020.
CDC called for improved overdose prevention, harm reduction, and response efforts, saying the measures are “urgently needed to address the high potency and various routes of use” for illicitly manufactured fentanyl.
Pharmacy techs can now be certified in MTM
The Pharmacy Technician Certification Board (PTCB) announced the launch of a new certificate in MTM for pharmacy technicians.
“The MTM certificate formally recognizes trusted pharmacy technicians for their advanced understanding of medication uses and MTM administration,” said Angela Faszczewski, CPhT-Adv, vice president of the PTCB Certification Council, and Chair of the PTCE Exam Development Committee, in a news release.
“With this designation, technicians engaged in high levels of patient care have another opportunity to move one step closer to earning the Advanced Certified Pharmacy Technician (CPhT-Adv) credential, the ultimate differentiator for those with expertise and experience. Pharmacists and employers can be assured that technicians earning specialty certificates and the CPhT-Adv credential are among the most dedicated, competent and valuable members of the pharmacy team and can be relied upon to provide exceptional patient care.”
PTCB said that its MTM Certificate will help continue to advance pharmacy technician skills.
New HIV PrEP guidelines call for clinicians to talk with patients about prevention meds
CDC now advises all clinicians to talk to their patients who are sexually active, including adolescents, about HIV preexposure prophylaxis (PrEP) at least once and to prescribe the prevention medication to anyone who requests it.
“PrEP is part of good primary case,” said Demetre Daskalakis, MD, CDC’s director of the Division of HIV/AIDS Prevention. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”
The new CDC recommendations are part of the updated U.S. Public Health Service’s PrEP prescribing guidelines, marking the third revision since FDA approved the first HIV prevention medication in 2012.
The guidelines also discuss how to prescribe and monitor an injectable version of PrEP. Additionally, the guidelines streamline monitoring lab levels for the current daily regimen by checking creatinine clearance levels twice per year in people aged 50 years and older, and once a year in those younger than age 50 years who take the oral medication.
Hundreds of prescriptions expected to have higher prices this year
Drug companies raised the prices of more than 400 drugs on January 1, with prices up 5% on average.
The increases are comparable with those of recent years. The beginning of the new year is when most drug companies favor raising prices. Several major drugs were included in this set of price increases.
Gilead Sciences increased the prices for its HIV drugs bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) and emtricitabine/tenofovir alafenamide (Descovy) by 5.6%.
Pfizer set 6.9% increases for its breast cancer drug palbociclib (Ibrance) and its pneumococcal 13-valent conjugate (Prevnar). The company also raised the prices of its heart drugs tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) by 4.4%. Meanwhile, Purdue raised the price of its opioid analgesic oxycodone hydrochloride (OxyContin) by 5% and Vertex set a 4.9% increase for its cystic fibrosis medication elexacaftor/tezacaftor/ivacaftor (Trikafta), which has no competition and an annual list price exceeding $311,000.
The increases affect the drugs’ list prices, but PBMs can negotiate lower drug prices via rebates so that drugmakers collect lower net prices. However, uninsured individuals typically must pay list prices, and deductibles and coinsurance rates are often based on a drug’s list price.