I am in overall support of the NOIRA related to brown bagging and white bagging of medications.  I support the use of the NABP definitions as presented.  I am in overall support of the proposed regulations, but would like to submit some additional comments for considerations:

1.  The brown bagging of drugs requiring special storage, reconstituion or compounding prior to administration should not be allowed from a patient safety and administering organization liability perspective.  There is no method to ensure that the medication has been maintained at appropriate temperature and conditions prior to administration.  Even if kept in a refrigerator at the patient home, the is no confirmation that the medication was maintained between 36-46 as required by standard.  For RT medications, there is no confirmation that the medication was maintained at controlled room temperature. This not only puts the patient at risk, but puts the organization administering the medication at risk.  For the most part, this practice is being driven soley for the financial benefit of insurance vendors, not for the benefit Ior safety) of the patient or healthcare provider. 

2.  There are similar concerns related to storage for white bag medications.  There is not the same assurance of integrity as if the organization had provided the medication and stored the medication as required by board of pharmacy regulation and requirements of other accrediting organizations (The Joint Commission, DNV, etc).  Even with special packaging, there is not assurance of maintenance of temperature, putting the patient and administering organization at risk.  Again, this practice is being driven soley for the financial benefit of insurance vendors. 

3.  Coordination of care with medications provided through a "white bag" process is challenging for both the healthcare provider and the patient, resulting in delays in care in many cases.  The burden is put back on the patient and administering organization, while the financial benefit resides with the insurance vendor and out-of-state dispensing pharmacy.  At a minimum, the burden should be placed back on the dispensing pharmacy to take ownership of coordination of shipping and receiving of medication.  Ideally, regulations that pertain to any willing provider and other limitations of provision of services by payers (e.g. site of service limitations) could be strengthened to allow health systems to provide medications through normal procurement and distribution systmes.

Thank you in advance for your intent to draft regulation to control a process that lacks control and oversight today, and to improve the care and safety for our patients.

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!

I believe that brown bagging should not be allowed for the simple reason of that the pharmacy has to control of the medication to ensure the appropriate storage and integrity of the medication.  We cannot delegate this responsibility, not even to the patient.

As for white bagging, I also do not support the use of white bagging for a facility that is capable of providing the medication for their patients.  The reasons for not supporting this practice based on a variety of quality and patient safety issues.  My concerns are:   

• Patients receive a call from a pharmacy that is unknown to them and may be asked to provide credit card information to a company not associated with facility providing the care (difficult to differentiate from a phone scam).  This may cause a delay in treatment.
• Before a shipment is sent out, the mail order pharmacy requires the approval and full copay remittance from the patient: no monthly payments or bills after the treatment as you would find at a healthcare facility.  Due to the high cost and co-pays for these medications, this may cause a significant financial burden and/or result in a delay in treatment. 
• The patient’s next treatment becomes dependent on a delivery, not an established schedule. Coordinating ordering, receipt and administration drains a facility’s resources and may test the staff’s (and the patient’s) patience.
• The mail order pharmacy will not have the entire medical record for the patient which may lead to issues with continuity of care between the ordering provider, the pharmacy and the facility infusing the medication. 
• The patient’s condition may change before the shipment is received. The patient may have to pay for another medication (in addition to the one that was sent originally).  Because the drug arrives at the facility, but is the property of the patient, the pharmacy cannot use the drug on another patient and is now responsible for disposal of a hazardous product.
• Most mail order pharmacies are not willing to sign alternate site delivery contracts as required by Virginia law. 
• The origin of drugs cannot be traced further back than the mail-order company. Where, when and from whom were the drugs purchased?
• Mail order pharmacies may take longer to fill backorders causing delays and cancelling treatments that may be perceived by the patient as a facility issue. 
• A delivery may sit for hours in extreme heat or cold conditions.  So, a box full of sensitive drugs sitting outside for hours may result in compromised contents….how does the facility ensure that it was handled appropriately and safely at all times if they are not controlling the supply chain?
• Is the facility legally responsible for any product injected into the patient even when they have lost control of the process? Will malpractice insurance cover such claims? Whose fault is it in the case of a negative outcome?
• The pharmacy preparing the drug receives no reimbursement for their time and supplies used to get the drug ready for administration.  In addition, the facility may not be able to get reimbursement/denied reimbursement for the administration if there is no drug charge on the bill. 

Dear Ms. Yeatts:

The Virginia Association of Hematology and Oncology (VAHO) appreciates this opportunity to comment on the Virginia Board of Pharmacy’s (the “Board”) Notice of Intended Regulatory Action to amend 18VAC110-20, Regulations Governing the Practice of Pharmacy, regarding the “white bagging” and “brown bagging” of drugs. VAHO represents over 150 oncology physicians and other oncology healthcare professionals practicing in Virginia.  VAHO seeks to improve the quality of oncology care available to the people of Virginia. VAHO members are committed to ensuring that safe, evidenced-based practices for the prevention, diagnosis and treatment of cancer are available to all Virginians. 

Under the definition of the National Associations of Boards of Pharmacies (NABP), VAHO recognizes “white bagging” and “brown bagging” as the following:

• “Brown Bagging” – Under this practice, a pharmacy dispenses a medication directly to a patient, who then transports the medication themselves for administration at their physician’s office. Often, this practice occurs at specialty pharmacies.
• “White Bagging” – Under this practice, the pharmacy dispenses a patient’s medication to the physician’s office for administration. This practice is often used for oncology patients to obtain medications that are not available at all non-specialty pharmacies.

Administration of drugs for cancer patients requires a great deal of care and sensitivity to ensure safety for the patient and provider. Due to the imperative needs of oncology drugs to be treated with certain handling, storage, and transportation requirements, VAHO is deeply concerned and opposes brown bagging to deliver injectable oncolytics to cancer patients in the state of Virginia. Both white bagging and brown bagging have the potential to put the patient and their provider at risk, as well as significantly impact a patient's treatment outcomes, and for that reason, VAHO stands in opposition of the NAIRO notice. Oncology drugs are delivered to patients specifically with adequate safety measures in mind, especially during administration. 

VAHO would like to voice concern over a waste issue that can arise with "white bagging" if a physician needs to make a timely decision to update a patient's dosage or adjustment of a patient's treatment. Administration of oncolytics for a patient can change rapidly, and "white bagging" has been proven to increase waster of expensive oncolytics for cancer patients and their providers across the country. 

Thank you for this opportunity to share the oncology provider perspective on your proposals in the Virginia Board of Pharmacy’s Notice of Intended Regulatory Action to amend 18VAC110-20, Regulations Governing the Practice of Pharmacy, regarding the “white bagging” and “brown bagging” of drugs. VAHO supports continued consideration of these regulations but is in strong opposition to “white bagging” and “brown bagging.” Please feel free to contact Dr. Richard Ingram, VAHO President, if you have any questions or need any additional information.  We look forward to working with you on this critical issue for oncology patients and their providers in the state of Virginia. Thank you again for your attention to this very important matter.

Respectfully Submitted, 

Richard Ingram, MD

VAHO President 

My company owns 3 sites in Virginia.  We are committed to helping each of sites provide the best care to all patients' while meeting all rules and regulations.  Recently, during a Board visit, one site who had received a refrigerated med from a specialty pharmacy for a patient scheduled in the next day was asked if they had a written contract with this pharmacy to do business.  Of course the answer was No, as this is viewed as a patient's own med and having it sent directly from the other pharmacy to the hospital pharmacy helps assure the integrity of the product prior to use versus having the med sent to the patient at home where proper storage requirements cannot be verified.  The time of notification that the patient was coming in for a refrigerated, injectable med and time of receipt was approximately one week which would not allow the hospital enough time to set up a contract or written agreement with the specialty pharmacy.  I would hate to have to turn this patient population away but given the quick turnaround times, there is no way to be compliant with the current guideline for contracting.  I want each of our sites to be able to care for Virginia residents so would appreciate your consideration to grant exceptions for these patients' that require a refrigerated medication that insurance dictates must be purchased through a specialty pharmay and allow them to be viewed as patients' own meds just temporarily stored in the hospital pharmacy until day of administration similar to inpatients' that must use their own med if it is not available on the hospital formulary.

VSHP is in overall support of regulation to regulate brown bagging of drugs requiring reconstitution or compounding prior to administration and the establishment of specific requirements for specialty pharmacies participating in white bagging, with the overall intent of public protection.

VSHP supports the use of definitions of brown bagging and white bagging as established by NABP.

In addition to the regulations under consideration as defined in the NOIRA, VSHP suggests expansion of regulations under consideration to include:

1. Not allowing brown bagging of medications that require special storage, reconstitution or compounding prior to administration due to the risk to the patient and the organization providing administration of the medication.

2. Leverage  current “Any Willing Provider” legislation to allow health systems that have specialty pharmacy/retail pharmacy capability to provide the needed medications for patients receiving care at health system owned locations. Alternatively, include provisions that would allow health systems to provide medications through normal procurement process versus through external specialty pharmacy providers. This would allow more robust coordination, reduce the risk of medication errors and patient harm, limit risk of improper storage of medications, and minimize delays in patient care.

3. Inclusion of requirement for coordination of shipment and arrival date to include physician-based practices and other locations of care since often the transfer is not pharmacy to pharmacy.

In addition, VSHP members have inquired about whether proposed regulations will impact the following scenarios, and we look forward to providing further comment:

• Patient Assistance Programs and Manufacturer Consignment Programs

• Patient request of provider administration of non-reconstituted, non-compounded medications (such as ready to inject syringes) brown bag medications due to concerns with self-administration at home

• Exclusions for emergent situations. Example: Patients with hemophilia admitted to emergency departments requiring emergent blood factor treatment that requires reconstitution that is not carried by pharmacy. These patients usually bring their own blood factor products to the Emergency Department as a result.