Bulletin Today
Only 47% of pharmacies gave proper instructions on how to dispose of antibiotics, and only 34% gave correct instructions for opioids, according to a small survey conducted in California pharmacies.
Researchers at the University of California San Francisco (UCSF) posed as parents of children who had recently had surgery. They phoned roughly 900 pharmacies in California and spoke to employees, asking them what to do with two leftover medications, an antibiotic—sulfamethoxazole-trimethoprim—and an opioid—hydrocodone-acetaminophen. The telephone surveys were conducted in 2018.
“This clearly points to the need for better dissemination of information on proper medication disposal,” said senior study author Hillary Copp, MD, an associate professor of urology at UCSF, in a press release. “The FDA has specific instructions on how to dispose of these medications, and APhA has adopted this as their standard. Yet it’s not being given to the consumer correctly the majority of the time.”
In the absence of a take-back program, FDA said antibiotics should be mixed with an unpalatable substance, such as coffee grounds or kitty litter, and disposed of in a sealed container in the trash to keep them from getting into the water supply or inadvertently ingested.
For opioids, FDA recommends flushing them down the toilet to avoid any potential abuse or misuse.
Copp said in the press release that improving disposal practices will require educating patients more thoroughly as well as expanding disposal programs.
“A pharmacy is a place where medications are dispensed, so it is natural for people to look to this same location for advice on how to dispose of unused medications,” Copp said. She added that managing leftover medication is complex, however, and shouldn’t be the sole responsibility of the pharmacy but instead addressed from multiple angles.
The study was published December 30, 2019, in Annals of Internal Medicine.
FDA suspects metformin may be tainted with NDMA
The popular diabetes medication metformin is the latest to come under scrutiny from FDA for possible contamination with the suspected human carcinogen N-nitrosodimethylamine (NDMA). The agency is testing samples of metformin sold in the United States but has not announced any recalls to date and said patients should continue to take their treatment as prescribed.
NDMA has already been found in popular blood pressure and heartburn medications. Recently, FDA asked manufacturers to voluntarily recall ranitidine and nizatidine medications because they contain unacceptable levels of NDMA.
On December 4, FDA announced that it asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA “to include all lots of the medication before making them available to consumers.”
FDA stated that if testing shows NDMA above the acceptable daily intake limit of 96 ng per day or 0.32 ppm for ranitidine, “the manufacturer must inform the agency and should not release the lot for consumer use.”
Throughout 2019, recalls for valsartan as well as losartan, irbesartan, and combination medications have been ongoing since FDA began an investigation into the foreign manufacturing process for active pharmaceutical ingredients in these drugs, which have caused impurities in the form of NDMA and N-nitrosodiethylamine—another suspected human carcinogen.
FDA’s investigation into valsartan dates back to June 2018.
CDC: Number of young adults receiving HPV vaccine almost doubled between 2013 and 2018
Newly released CDC data indicate that the percentage of U.S adults aged 18 to 26 who received any dose of the human papillomavirus (HPV) vaccine nearly doubled between 2013 and 2018. It increased from 22% in 2013 to 40% in 2018 for these young adults who received one or more doses of HPV vaccine.
The HPV vaccination requires multiple doses. CDC recommends two HPV vaccine doses given 6 to 12 months apart if the series is started before age 15. Three doses, to be completed within 6 months, are recommended for those who started vaccination at age 15 or older.
According to the 2013 to 2018 survey data, women were more likely than men to have received one or more doses of the HPV vaccine (the vaccine was first recommended for girls in 2006 and for boys in 2011). However, the percentage of men who received one or more doses more than tripled, from 8% in 2013 to 27% in 2018. The percentage of women who’d ever received one or more doses of HPV vaccine increased from 37% in 2013 to 54% in 2018.
Among adults aged 18 to 26 who ever received one or more doses of HPV vaccine, the majority received the first dose between the ages of 13 and 17 years.
Vaccination is routinely recommended at ages 11 to 12 years and can be started at age 9. For those not vaccinated at age 11 to 12 years, CDC said vaccination is recommended for all persons through age 26.
PBMs to face major scrutiny as Supreme Court agrees to hear Arkansas case
The U.S. Supreme Court will hear Rutledge v. Pharmaceutical Care Management Association, a case involving Act 900, an Arkansas law that allows the state’s Insurance Department to regulate and license PBMs throughout the state and permits the state insurance commissioner to review and approve how PBMs compensate pharmacies.
Supreme Court Justices have granted a writ of certiorari petition from the U.S. Court of Appeals for the Eighth Circuit. Pharmaceutical Care Management Association (PCMA) is the professional association representing PBMs. Arkansas challenged the circuit court’s ruling in favor of PCMA’s claim that the Employee Retirement Income Security Act (ERISA) preempts state regulation of reimbursement and payment practices of PBMs.
The U.S. Solicitor General subsequently filed a brief with the Supreme Court disagreeing with the Eighth Circuit’s decision. Many states have laws or have attempted to pass laws to regulate PBM practices, and the lower courts are split on whether ERISA bars state action and activities related to PBMs.
“We’re pleased with the Supreme Court’s decision to hear this case,” said Ilisa Bernstein, PharmD, JD, FAPhA, APhA senior vice president of pharmacy practice and government affairs. “PBM business practices have been putting significant strain on pharmacies in the United States by pulling financial resources that were once applied to patient care into unproductive administrative layers and profits for the middlemen. This in turn affects patient access to the services and patient care delivered by pharmacists every day in communities across the country.”
“Many Arkansans rely on pharmacies as their frontline health care provider,” Arkansas Attorney General Leslie Rutledge said in a statement. “These same pharmacies are experiencing financial losses at the hands of middlemen PBMs that set pharmacy reimbursements so low that local pharmacies operate at a loss or are forced out of business.”
Act 900 is intended to provide fair access to generic drugs in Arkansas and transparency in PBM industry practices. The law regulates PBMs and protects patient access to generic medicines by requiring PBMs to reimburse pharmacies for generic drugs at a price at least equal to what the pharmacy had paid for the drug. Before the law, PBMs provided below-cost or negative reimbursements for a significant number of prescriptions, contributing to the closure of 12% of Arkansas’s independent pharmacies since 2006.
This case has broad implications on PBM regulation across the country.
“The Court’s decision demonstrates how important this issue is. State regulatory oversight plays an important role in curbing PBMs. A ruling from the Supreme Court will provide clarity in the U.S.,” Bernstein said. “APhA fully supports pharmacists in seeking fairness and protecting patient access to care.”