Commenter: Bryant Thomas on behalf of Children's Hospital of The King's Daughters

June 8, 2021

Caroline Juran, RPh, Executive Director

Board of Pharmacy

9960 Mayland Drive, Suite 300

Henrico, VA 23233

Delivered via email to: Caroline.Juran@dhp.virginia.gov

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

Dear Ms. Juran:

I am writing on behalf of Children’s Hospital of The King’s Daughters (CHKD) and appreciate the opportunity to comment on the proposed changes regarding 18VAC110-20 governing the practice of “white bagging” and “brown bagging” by the Board of Pharmacy. The practice of “white bagging” has recently been drawing more attention nationally over the proliferation of the practice by payers. These new practices and changes in regulation have the potential to have an immense impact on the way that healthcare is delivered in the Commonwealth. Our pharmacy at CHKD provides pharmaceutical care to our pediatric patient population and is a critical part of the comprehensive continuum of services that we offer to our patients and their families. These proposed regulatory changes as well as growing concerns over the propagation of “white bagging” practices by payers have made this conversation both timely and necessary.

As you may know, CHKD is the only freestanding children’s hospital in Virginia and one of fewer than 50 in the United States. It serves the medical and surgical needs of children throughout greater Hampton Roads, the Eastern Shore of Virginia, and northeastern North Carolina. Our Health System operates primary care pediatric practices, surgical practices, multi-service health centers, urgent care centers, and satellite offices throughout our service region.

Pharmaceutical care at CHKD not only involves medication therapy, but also decisions regarding medication selection, dosages, routes, methods of administration, and therapeutic drug monitoring. Patients’ medications, diseases, and doses are reviewed for safe and effective treatment. Pharmacists also provide drug information to other health care professionals and counseling to patients and/or their caregivers. In addition, pharmacists at CHKD are responsible for documenting clinical interventions and reporting adverse drug reactions, and they play an important role in formulary management, medication safety, and error prevention.

The CHKD Pharmacy Department manages the pharmaceutical supply chain for all inpatient and ambulatory centers that fall under the hospital umbrella, to include our two ambulatory infusion centers and hematology/oncology infusion center.  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.

We are in support of the proposed changes to 18VAC110-20, specifically the additions of subsections F and G. These additions contain 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. This additional regulation of “white-bagging” helps ensure that appropriate coordination of patient care is being followed.  

We respectfully request that the Board be sensitive to any potential unintended consequences that may affect our health system as we continue to navigate this new landscape of expanded “white-bagging” practices in the Commonwealth. Further, CHKD urges the Board of Pharmacy to implement the recommendations proposed by VHHA with respect to the Final Regulation. 

Our hospital appreciates the longstanding partnership that we have enjoyed with the Virginia Department of Health and the Board of Pharmacy. CHKD would welcome the opportunity to participate in future conversations regarding updating and modernization of current practices in the provision of pharmaceutical services the Commonwealth and these future policy considerations.

Sincerely,

Jim Dahling

President and CEO

Children's Hospital of The King's Daughters