By Matt Devino, MPH
Insurer mandates requiring patients to have their therapies dispensed via “brown bagging” or “white bagging” are becoming increasingly common. Oncologists treating patients whose insurers require these methods of pharmaceutical procurement have identified problematic issues with them, including concerns about patient safety, proper care coordination, potential treatment delays, and drug waste.
The National Association of Boards of Pharmacy (NABP) defines white bagging as “the distribution of patient-specific medication from a pharmacy, typically a specialty pharmacy, to the physician’s office, hospital, or clinic for administration.” NABP defines brown bagging as “the dispensing of medication from a pharmacy (typically a specialty pharmacy) directly to a patient, who then transports the medication(s) to the physician’s office for administration.” A third term, “clear bagging,” refers to when a cancer program or practice maintains its own specialty pharmacy that provides prescribed medication directly to the clinic.
These practices often apply to supportive care drugs such as filgrastim and pegfilgrastim products, which are used to reduce the incidence of neutropenia in patients with cancer. Insurer-mandated practices may also call for the “bagging” of therapeutic drugs, and providers worry that these models will expand to apply to more anti-cancer drugs.
To learn more about these practices and their impact on patients and cancer programs and practices, Kristin Ferguson, ACCC senior director of cancer care delivery and health policy, sat down to talk with Jorge Garcia, PharmD, MS, MHA, MBA, FACHE, assistant vice president at Baptist Health South Florida. Dr. Garcia has responsibility for Baptist Health South’s system-wide acute and ambulatory oncology pharmacy services and its non-oncology infusion pharmacy services. A member of the 2021-2022 ACCC Board of Trustees and an Advisory Committee member of the ACCC Oncology Pharmacy Education Network (OPEN), Dr. Garcia says he is seeing a steady increase in the number of patients treated at his health system’s cancer program who are covered by insurers mandating white and brown bagging.
ACCC: What are your concerns about brown bagging?
Dr. Garcia: The unique concern with brown bagging is that the drug comes to the patient directly and is in the patient’s custody. From a quality standpoint, our worry is that if a drug is delivered to a patient’s home, it may sit in a mailbox for some time before it is retrieved, perhaps in high temperatures. We know that it is not appropriate for medications to be kept in these conditions. While it may seem convenient for patients to receive their drugs at home, it is not as convenient—or safe—as having the drug available at a practice when a patient arrives for treatment. There is also the added risk of patients not remembering to bring their drugs with them to their infusion appointments.
ACCC: What are your concerns about white bagging?
Dr. Garcia: White bagging refers to when a drug is delivered from the insurer’s preferred pharmacy to our practice. This also requires a high level of coordination. The insurer’s pharmacy needs to know where to send the medication, and our team must know when to expect it, since some of these medications require refrigeration. If a drug is sitting in a box on a loading dock, it may sit there for a while outside of appropriate temperature requirements. I saw this happen with a drug called Neulasta. A box was found two days after shipment in the wrong clinic. We had already provided the drug to the patient from our own supply because we did not want the patient to go without it, so the drug intended for the patient had to be wasted. White bagging requires additional resources on both the payer and provider sides. We do not have the resources to incorporate the workflow required of a large number of our patients to receive their therapies this way.
Some white bagging practices, depending on the drug, require a nurse to go to a patient’s home under a home health arrangement to administer the medication. In my experience, home health services have not always been consistently reliable in the community. There are not enough home health services to be able to support white bagging on a large scale, and there are not enough nurses available in this care setting. We have seen during the COVID-19 pandemic several barriers in both the reliability and availability of home health nurses, who may also not be trained in oncology practices. For example, in one patient case I saw, a growth factor was given to a patient outside the window of indication due to the lack of nursing availability and lack of understanding as it relates to the timing of the therapy relative to chemotherapy administration. There can be many quality risks when you involve home health staff with no expertise in oncology.
From a patient’s standpoint, white bagging poses the risk that the medication will not arrive at the clinic in time for their scheduled appointment. This has happened where the patient comes for an appointment, but the drug never arrived from the payer. This may delay patient care and lead to long wait times. When a medication does make it to us, we may not know its storage conditions at all, or we may not have temperature records for the entire delivery journey.
Providers are more open to clear bagging. It doesn’t lead to delays, as practices can use drugs from their own inventory, and, most important, practices have full custody of the product and can guarantee good product integrity. Many practices adopt clear bagging reactively, in an attempt to retain full control of patient care and prevent the further fragmentation of care that occurs when an external pharmacy dispenses one drug, and an internal pharmacy dispenses others. All types of bagging lead to fragmentation of care, and as we know, we already operate in an extensively fragmented healthcare system.
ACCC: Is white bagging or brown bagging mandated by your patients’ insurers? Do you track this practice?
Dr. Garcia: White bagging and brown bagging are insurance mandates for some of our patients. But sometimes whether patients are affected by these mandates is unclear. While a plan may not require white bagging, an employer that is contracting with that plan may decide to mandate white bagging as part of a formulary to achieve cost savings. Bagging mandates can come from both insurance plans and employers.
We do track each time we are impacted by a bagging mandate, and an escalation process is followed to ensure we can identify an appropriate plan for the patient without compromising quality of care. Policies disallowing bagging practices are becoming more common, and in my experience organizations enforce these despite payer mandates.
ACCC: Is drug waste an issue with the increased use of white bagging and brown bagging?
Dr. Garcia: It boils down to the coordination required when more layers are added to the dispensing process. When a drug passes through multiple hands, it is more likely to arrive late or be exposed to environmental conditions that are not acceptable. This can lead to more waste.
ACCC: Does white bagging and brown bagging contribute to the likelihood of medical errors?
Dr. Garcia: Yes, definitely, specifically with the potential for duplication of therapy when multiple teams are involved in dispensing, receiving, and administering the drug. For example, if a patient receives a prescribed drug at home, providers may not be clear on how the patient obtained it. Was it mailed? Was it dispensed by an external pharmacy? Was it appropriately stored in transit or in the home? Under what environmental conditions? In some cases, drugs may be shipped to a clinic directly, even though patients are administered drugs at an infusion clinic. This causes confusion about where patients receive their medication. All of these factors can create confusion and delays in patient care.
The confusion caused by white and brown bagging can also disrupt the operations of a busy clinic. There can be numerous phone calls from practices and hospital teams to patients, patients’ insurers, and other members of the healthcare team to coordinate for patients whose insurance companies are requiring them to use white bagging or brown bagging, asking “Is the drug here yet?” “Do we change this patient’s appointment for tomorrow?” etc. When we dispense a drug furnished by an insurer, we must also remember to issue a credit to the patient, because, upon dispensation, EHRs will automatically issue a charge. So you run the risk of double-charging a patient. Doing all of this for every patient, for every administration, is very laborious, introducing more opportunities for errors.
ACCC: What do you think the future holds for white bagging and brown bagging mandates?
Dr. Garcia: The bottom line is that drugs should be dispensed as close to the point of care as possible. In an infusion setting, the infusion pharmacy is best suited for drug dispensation, far better than in a distant internal specialty pharmacy in the building, or at a different location in the health system, which would still be superior to making arrangements with an external pharmacy across state lines. Unfortunately, white and brown bagging are growing trends. We are currently organizing to advocate about this in Florida through professional organizations and state boards. We want to establish guidelines for promoting safer pharmaceutical procurement practices. A letter from the Florida Society of Health System Pharmacies is going to be presented at the Board of Pharmacy in Florida regarding our various concerns with these practices, specifically regarding quality and safety concerns. As a healthcare leader, I do not feel this practice is in the best interest of quality patient care, timely care, or patient safety.
To better understand how widespread the practice of white and brown bagging is becoming, and how it is impacting your cancer program or practice, ACCC’s Oncology Pharmacy Education Network (OPEN) would like your feedback to this brief (5-10 minute) survey. Results from the survey will be used to inform our education and policy teams on how best to move forward with this issue.
For further reading:
ACCC Oncology Pharmacy Education Network (OPEN)
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