Pharmacy Policy: January 2025

Lawmakers Introduce Act to Reduce Frequency, Severity of Drug Shortages

A bipartisan group of federal lawmakers recently introduced the End Drug Shortages Act, designed to reduce the frequency and severity of drug shortages in the United States.

Image credit: Supatman | stock.adobe.com

The bill focuses on improving communication among drug manufacturers, the FDA, and pharmacies, mandating that drug manufacturers notify the FDA when there is a surge in demand that could lead to a drug shortage. Additionally, the bill requires the FDA to consider information from patients and health care professionals, including pharmacists, when designating a drug shortage.

This improved communication could provide earlier warnings of potential shortages, allowing health care providers and pharmacies to collaborate and better prepare to mitigate the impacts on patient care. By addressing the root causes of drug shortages and streamlining information sharing, the End Drug Shortages Act aims to ensure that patients have continuous access to essential medications.

“When Americans are consistently unable to fill a prescription at their local pharmacy or when hospitals are rationing lifesaving medications, it’s clear that there is a breakdown along our pharmaceutical supply chain,” said Abigail Spanberger, representative from Virginia, in a news release. “By requiring drug manufacturers to notify FDA when demand for a drug is surging, pharmacies and health systems can more quickly prepare for a potential shortage.”

REFERENCE

Kaine, Cotton, Spanberger, & Smith Introduce Bipartisan, Bicameral End Drug Shortages Act. News release. Tim Kaine. November 21, 2024. Accessed December 5, 2024. https://www.kaine.senate.gov/press-releases/kaine-cotton-spanberger-and-smith-introduce-bipartisan-bicameral-end-drug-shortages-act?utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-8mgc-yhi5vtVydLbpXtjq-Oq7Xo31tEFsA9LU_AwcWHfdnqZG1A0nsF0hKrQ6KkjGue8Jb

Debates Continue Over GLP-1 Compounding

Manufacturers, compounding pharmacies, and the FDA are continuing to debate the feasibility and necessity of compounded glucagon-like peptide 1 receptor (GLP-1) medications. Although the FDA has walked back its decision to disallow compounding pharmacies to produce tirzepatide (Mounjaro, Zepbound; Eli Lilly & Co),¹ manufacturers are still pushing back against compounded versions of their medications.

Novo Nordisk has nominated its semaglutide products (Ozempic, Wegovy) to be included on the FDA’s Demonstrable Difficulties for Compounding lists, which would prevent pharmacies and other health care providers from compounding semaglutide based on the argument that it is too risky and complex to manufacture outside of FDA-approved facilities. In particular, Novo Nordisk argues that compounded semaglutide may have different impurity profiles and stability issues, leading to compromised patient safety.²

Importantly, off-label semaglutide products have been associated with deaths and hospitalization, according to Novo Nordisk’s own data. The company released a report in October 2024 supporting its argument that the FDA should prohibit compounding.³

However, organizations such as the Alliance for Pharmacy Compounding have pushed back, saying that semaglutide and other GLP-1 medications are in fact not difficult to compound and pointing out that Novo Nordisk has itself been cited by the FDA for “quality lapses” at 2 of its manufacturing facilities.^4,5 Regardless, as of December 5, 2024, Novo Nordisk’s request for the FDA to limit or ban compounding of semaglutide does not affect pharmacies and only furthers the ongoing debates.

REFERENCES

1. Gallagher A. FDA To Reevaluate Removal of Tirzepatide From Drug Shortage List. Pharmacy Times. October 23, 2024. Accessed December 5, 2024. https://www.pharmacytimes.com/view/fda-will-reevaluate-removal-of-tirzepatide-from-drug-shortage-list

2. Lewis CA, Rich LA. Novo Nordisk Pushes for FDA Listing of Semaglutide Products. Venable LLP. November 18, 2024. Accessed December 5, 2024. https://www.venable.com/insights/publications/2024/11/novo-nordisk-pushes-for-fda-listing-of-sema

3. Gerlach A. Off-Label Semaglutide Linked to Deaths, Hospitalizations Calling for Compounding Regulation. Pharmacy Times. November 8, 2024. Accessed December 5, 2024. https://www.pharmacytimes.com/view/off-label-semaglutide-linked-to-deaths-hospitalizations-calling-for-compounding-regulation

4. Full of sound and fury, signifying nothing. News release. Alliance for Pharmacy Compounding. October 25, 2024. Accessed December 5, 2024. https://a4pc.org/2024-10/full-of-sound-and-fury-signifying-nothing/

5. Did someone mention glass houses? News release. Alliance for Pharmacy Compounding. November 1, 2024. Accessed December 5, 2024. https://a4pc.org/2024-11/did-someone-mention-glass-houses/

HHS Implements Final Rule Discouraging Health Care Providers From Information Blocking

The US Department of Health and Human Services (HHS) released a final rule penalizing health care workers for information blocking, or interfering with the access, exchange, or use of electronic health information except for when justified by law or regulation. The policy aligns with the 21st Century Cures Act.¹

The rule establishes disincentives for providers who knowingly engage in information blocking, including reduced Medicare payments, lower scores in the Merit based Incentive Payment System for the promoting interoperability performance category, and potential exclusion from the Medicare Shared Savings Program.¹

According to the American Medical Association, information blocking can take several forms, including restrictive and unfair contractual limitations, excessive fees to create electronic health record (EHR) interfaces, and nonstandard methods of implementing EHRs and other health information technology. Patients can also experience information blocking when trying to access their own medical records or when transferring records to another provider.²

The 21st Century Cures Act, enacted in 2016, includes provisions to promote health information interoperability and prohibit information blocking.² The new, final HHS rule is therefore intended to promote more coordinated and efficient patient care while still abiding by patient privacy.¹

REFERENCES

1. 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking. Federal Register. July 7, 2024. Accessed December 5, 2024. https://www.federalregister.gov/documents/2024/07/01/2024-13793/21st-century-cures-act-establishment-of-disincentives-for-health-care-providers-that-have-committed

2. What is information blocking? American Medical Association. January 2021. Accessed December 5, 2024. https://www.ama-assn.org/system/files/2021-01/information-blocking-part-1.pdf