Thank you for the Board’s consideration in adopting regulations to regulate “brown” and “white” bagging within the State of Virginia.  I am in support of these efforts, and appreciate the opportunity to submit further comments for consideration by the Board. 

Overall, “brown” and “white” bagging through the utilization of specialty pharmacies has placed a significant burden on sites of care and patients.  There is confusion on the differences between these two practices and the proper method of conducting business and treatment of patients.   In addition, patients are becoming frustrated at a process that seems convoluted, impersonal, and a burden to receiving safe and effective care within established patient-provider locations.  These established locations, if they choose to continue treatment for a patient forced to utilize a specialty pharmacy, are accepting the burden of risk for treatment with a medication procured outside traditional channels, and are spending significant resources in coordination of care. 

Thank you for your consideration of the following comments:
 

1.       Brown bagging should not be allowed.  These medications require special storage and handling considerations and there is no validated method to ensure it is a safe to administer.  This places an organization at high risk of liability, and the patient at high risk for adverse outcomes.  Many organizations have already restricted use of brown bagging within their sites of care due to the safety risks.

2.       I am in support of proposals to improve communication and chain of custody of white bagging. Often product is sent without any notification, and there are significant resources that are spent on determining who the medication is for, and when the administration is due. This results in patients showing up for administrations prior to the medication being procured, or the medication is sent to the wrong site of care.

3.       Please consider modification or inclusion of 18VAC110-20-275, which requires a written contract or agreement for delivery of a filled prescription to another pharmacy for patient pickup.  Specialty pharmacies has refused to sign these agreements in the past.  In addition, please consider the implications of this practice on DSCSA Federal Regulations.

4.       Consider the impact of white bagging on patients.  In rural settings, we have patients that are driving past infusion centers for which they receive other medications.  They are driving over an hour in some cases to an infusion center located in a “strip” mall, because that location has a contract with their specific insurance company.  Patients do not understand why they cannot receive their medications in established, and in their opinion, safe sites of care.  They are often apprehensive about the locations of these infusion centers.  This practice is degrading trust in safe medication management, and reducing sites and access of care for patients. 

5.       Access to care may also continue to decrease as some infusion sites are receiving no reimbursement for resources and supplies used to administer these medications to patients.  As specialty pharmacy continues to grow, the economic burden will continue to increase, and thus decisions will be made to discontinue treatment of these patients at previous sites of care.  Organizations may also deem it too high of liability to continue.

6.       Please consider language to remove restrictions to the pharmacies that patients may obtain these specialty medications.  The pharmacies that serve current infusion centers, procure the same products through safe and validated supply channels. It also allows pharmacies that already take care of patients to continue to make safe decisions on care as they have access to the full patient medical record.

Thank you again for your time and consideration!