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(https://townhall.virginia.gov/L/ViewStage.cfm?stageid=8947)

May 21, 2021

Caroline D. Juran, RPh

Executive Director

Virginia Board of Pharmacy

9960 Mayland Drive, Suite 300

Richmond, Virginia 23233

Re:  Regulations Governing the Practice of Pharmacy [18 VAC 110 ? 20]

Dear Ms. Juran:

On behalf of the Virginia Hospital & Healthcare Association’s 26 member health systems – with 110 community, psychiatric, rehabilitation, and specialty hospitals and more than 125,000 employees – thank you for the opportunity to provide comment to the Board of Pharmacy regarding 18VAC110-20 and the practices commonly referred to as “white bagging” and “brown bagging.”

When the Notice of Intended Regulatory Action (NOIRA) was issued on December 11, 2017, the intent of the updated regulations was to protect the public by codifying rules to ensure infrequently white bagged drugs are handled appropriately.  Three and a half years have passed since that NOIRA, and the practice of “white bagging” has proliferated to a level not foreseen in 2017.

The newly added Subsection F of 18VAC110-20-275 contains important safeguards for patient safety in situations when white bagging of drugs from a pharmacy to an alternate delivery site is needed in an urgent, and non-routine circumstance.  Communicating basic logistical details such as arrival date, shipping information, and delivery address are common-sensical steps that should be taken by any responsible pharmacy, even without regulations.

White bagging in any circumstance is inherently risky for safe, timely patient care because it breaks down the normal distribution process by removing the direct relationships between manufacturer and clinics/hospitals for provider-administered medications.  Potential implications of white bagging include, but are not limited to: delays in patient care; reduced patient access to the right medication; limited site of care flexibility for patients; compromised drug integrity and efficacy; drug wastage; inappropriate shifting of liability to providers; and administrative inefficiencies.

The practice of white bagging should be limited only to those truly rare cases in which a patient has no other way to obtain a needed medication.

Short of white bagging being banned – or at least significantly curtailed – in Virginia, we advocate for the strongest patient protections possible in regulations.  The existing regulations in Subsections B through E of 18VAC110-20-275 provide reasonable safeguards because they require pharmacies that engage in white bagging as a matter of “routine” practice to establish mutually agreed-upon contracts and policies and procedures with the partner pharmacies and providers that treat patients and are ultimately responsible for administering the drugs.  Such guiding documents establish processes and associated non-compliance provisions that put patient safety on the forefront – and they are mutually agreed to between two collaborating entities.  Accordingly, subsections B through E of 18VAC110-20-275 should firmly apply when white bagging policies and programs are standardized across patients.

“Brown bagging,” the practice of delivering dispensed drugs that require administration in a healthcare setting directly to a patient’s residence, is also risky and potentially dangerous.  Brown bagging should be banned except in cases where patients have inherited bleeding disorders and the drugs are needed for emergency, lifesaving treatment.  We therefore support the new Subsection G of 18VAC110-20-275 and recommend it be implemented as planned.

Considering our comments above, we recommend the Board of Pharmacy:

1. Issue guidance that clarifies the applicability of the new Subsection F of 18VAC110-20-275 – specifically what the provision on “routinely receiving deliveries” means in light of high-volume white bagging policies being implemented by insurers and pharmacy benefit managers.  If the Board cannot issue such guidance quickly, then we recommend the Board suspend this regulatory action, reaffirm the requirements in the existing regulations, and develop new regulations that account for the proliferation of insurer-mandated white bagging policies.
2. Implement the new Subsection G of 18VAC110-20-275 as proposed.
3. Hold additional stakeholder workgroup meetings on the practice of white bagging to learn more about new programs that have been implemented since previous discussions were held and assess whether even more stringent regulations governing these practices are needed.

On behalf of VHHA and its members, thank you for your consideration of these comments and recommendations.

Sincerely,

Craig Connors

Senior Director, Payor Relations