Articles related to PHARMACY OPERATIONS & MGMT

Attorneys speaking at a specialty pharmacy meeting warned that increased federal attention to fraud, waste, abuse, controlled substances, and reimbursement practices is driving greater scrutiny of pharmacies. The discussion focused on compliance preparedness rather than new regulatory requirements.

The FDA classified a recall of thyroid tablets USP 30 mg as Class I after identification of a superpotent product lot. The recall affects 1,955 bottles and carries risk of serious adverse health consequences, making prompt inventory review and product removal necessary.

HRSA’s revised 340B rebate pilot could require covered entities to purchase selected high-cost drugs at full price and recover discounts through manufacturer rebates beginning in 2027, prompting hospitals to evaluate data infrastructure, vendor readiness, and reimbursement workflows while legal and congressional challenges continue.

The FDA expanded approval of Capvaxive, a pneumococcal 21-valent conjugate vaccine, to children and adolescents aged 2 to 17 years with at least one chronic medical condition increasing pneumococcal disease risk, based on STRIDE-13 trial data showing noninferiority to PPSV23 across 12 shared serotypes and statistically significantly higher OPA GMTs for 9 serotypes unique to Capvaxive.

ASHP urged HRSA in a June 2 letter to take immediate enforcement action against Eli Lilly after the manufacturer gave an initial group of 340B-covered entities five business days to submit detailed claims-level data or lose access to discounted pricing across its full drug portfolio, including in-house hospital pharmacy dispensing and medically administered products; as of mid-June, the threatened cutoffs had not yet taken effect for many affected entities.

Pediatric pharmacists recorded 1,130 antithrombotic-related interventions involving 26.4% of 2,264 critically ill children across 9 U.S. children’s hospitals during 697 shifts from July 2023 to November 2024, with 74.7% of those interventions occurring in the pediatric cardiac ICU and 90.4% of initiation and management interventions involving anticoagulant agents.