Brown bagging and inherited bleeding disorders

On behalf of the federally funded Virginia comprehensive hemophilia treatment centers (HTCs) at the University of Virginia, Virginia Commonwealth University, Children's Hospital of the Kings Daughters and the Children's National Hospital, we are requesting an modification to the exception for 18VAC110-20-275, section G to read:

"An exception to this requirement may be made for patients with inherited bleeding disorders¹ who may require therapy² to prevent or treat bleeding episodes³."

Our rationale for the request is the following:

1) The term "hemophilia" is sometimes restricted to just Factor VIII and Factor IX Deficiencies whereas "inherited bleeding disorders" captures other inherited factor deficiencies.

2) Most factor concentrates are not blood products.  Some newer hemophilia treatments are not factor concentrates.

3) Hemophilia medications are given in non-emergent outpatient settings, as a part of best practice.  Most hospitals do not carry factor concentrates; HTCs do not carry all of the products used by patients to meet their specialized needs. Pharmacokinetic studies in clinic are completed in clinic to monitor home therapy and prevent bleeding episodes.  Outpatient reimbursement often requires prior authorization which can delay treatment.  Teaching home therapy to patients and families in the outpatient setting ensures that policies and procedures are followed for patient safety.

Thank you for the opportunity to share our concerns

The Virginia Society of Health-System Pharmacists (VSHP) supports the Board’s actions to improve the integrity of the supply chain regarding drugs delivered through the white bagging process. The lack of notification and logistical information of receipt of drugs through this process has been a longstanding point of frustration for our members who have to allocate additional resources to track down shipments and follow the trail of information to connect these drugs with the intended patient.

VSHP would like to ask the Board to consider exemptions to the 4^th proposed regulation prohibiting delivery of drugs that are delivered to the patient’s residence for self-administration that require special storage, reconstitution, or compounding prior to administration. There are some drugs, such as factors for the treatment of hemophilia which requires the patient to bring their drugs to the clinic or the emergency department for assessment of self-administration and/or drawing of labs prior to observation of administration. This process is critical to ensuring positive outcomes for patients as the observation of administration technique or demonstration of administration technique is part of ensuring that the drug is received by the body in the indicated manner. This is very similar to asking a patient to bring their inhaler to a physician’s office to demonstrate their inhalation technique as part of evaluation for efficacy. The way the proposed regulation is written does not account for this unique population.

We recommend the following: “Prohibiting delivery to a patient's residence of any drug that requires special storage, reconstitution, or compounding prior to administration is intended and that will be subsequently transported by the patient for administration. Drugs that may require compounding or reconstitution, but either are self-administered or that the patient must possess because the drugs are for emergent use for rare conditions and are not stocked in the facilities who would treat the patient, are exempted from this prohibition.”

Thank you for your time and consideration.

Thank you for the opportunity to comment on proposed regulation related to the practice of white bagging/brown bagging.  Many insurance providers/pharmacy benefit managers are disrupting the traditional patient-provider relationship, adding increased burden to the provider and patient, and potentially jeopardizing the integrity of medication and provision of timely patient care through the mandate to have medications supplied through a "white bag" or "brown bag" process.  Overall, I agree with the regulation language, and specifically with the changes that allow for exemptions for certain circumstances. 

Within many health systems, the pharmacy department routinely provides purchasing oversight for hospital owned clinics.  For health systems, such as ours, where there is a specialty pharmacy presence, we attempt to practice "clear bagging" where the medication is filled through an organization owned pharmacy and delivered to the provider location using organization resources and tracking.  Based on the language under (F) related to "the alternate delivery site does not routinely receive delivery form the pharmacy, I wanted to make sure that this practice of "clear bagging" would not be at risk nor would require that we register every physician clinic with a BOP CSR or practitioner of the healing arts license to sell controlled substance registration. 

Additionally, I would suggest some type of phase in period for the regulation to allow adequate time for notification to providers, patients and payers in order to not disrupt care.

Thank you