Virginia Regulatory Town Hall
Department of Health Professions
Board of Pharmacy
Regulations Governing the Practice of Pharmacy [18 VAC 110 ‑ 20]
Action Brown bagging and white bagging
Stage Final
Comment Period Ended on 6/9/2021
Previous Comment     Back to List of Comments
6/9/21  6:32 pm
Commenter: John Lubkowski



    • My hospital provides a full range of oncology and infusion services with medications being acquired, prepared and dispensed through the pharmacy department for both inpatients and outpatients. 

    • A new trend in the healthcare insurance industry is for a PBM (pharmacy benefits manager) to require that their patients receive medications that are filled at the PBM’s contracted specialty pharmacy.  This is in contrast to the hospital acquiring the medications through our regular wholesaler distribution system.   We have an agreement with our contracted wholesaler that provides us assurance of drug storage and shipping conditions.  White bagging goes outside our supply chain and ships via common carrier, which could introduce the risk of compromised packaging or temperature excursions.  

    • The medications sent from specialty pharmacies are not always the same size, strength or presentation that we normally use, resulting in safety risks from using non-standard products.  This may bypass barcode scanning technology that we use in our IV room.   A change in product may require a new order from the patient’s physician which may cause additional delays.  Storage of these medications must be separate from the standard hospital inventory.  The space for storage presents a challenge as well.

    • Patient delays in treatment may result from processing time associated with obtaining medications from a required specialty pharmacy.  Care coordination is more difficult when an additional external entity is brought into the process.  Patient stress can be exacerbated, by being overwhelmed with this process.  It is not unusual for the coordination and management of one shipment to take several hours, potentially distracting the pharmacist from providing safe patient care. Follow up is imperative to ensure the product will be available when needed.  The time required for shipping impacts the ability to make same day treatment decisions based on laboratory findings, or changes in the patient's condition.  Additionally shipping delays may impact patient care.  

    • Insurance mandated White Bagging denies the patient’s freedom of choice in selecting their pharmacy provider.

    • As of July 1, 2015 the FDA requires pedigree information to accompany all drugs that we purchase.  Specialty pharmacies decline to send this information claiming to be shipping product to the patient, when in fact they ship to the hospital.  If indeed this is considered dispensing to the patient then Virginia Board of Pharmacy regulations would consider this “alternate site delivery” and require a contractual agreement with each specialty pharmacy, and there are many involved. 


I appreciate the opportunity to provide input into this potential risk to patient safety.


The contents of this letter are my own personal and professional opinion, not as a representative of my employer or facility.


CommentID: 99032