|Action||Brown bagging and white bagging|
|Comment Period||Ended on 6/9/2021|
June 8, 2021
Caroline D. Juran, RPh
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 Pharmacists Association’s members, 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.
White bagging in any circumstance is inherently risky for safe, timely patient care; it also limits consultation with a pharmacist. Further, patients risk unexpected drug interactions due to the timing and handling of various medications. If the Board of Pharmacy is seeking cost saving solutions for patients, this is not it. Additionally, costs could be controlled, and patient access expanded by simply increasing pharmacy access to specialty contracts.
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. It should be a practice of last resort.
VPhA advocates for the strongest patient protections possible in regulations. The existing regulations in Subsections B through E of 18VAC110-20-275 provide some measure of 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. In the least, the regulations should be clear regarding “routine” practices. A guidance document is not adequate to offer clarity, as it will not have the enforcement strength that the teeth of regulations have.
We strongly urge the Board to revisit the regulations to limit the practice as to only those cases where there is no other means available to dispense and administer. On behalf of VPhA and our members, thank you for your consideration of these comments and recommendations. We stand ready to assist with any follow up questions.