Innovations-Magazine-April-2023 - 9

The practice enables patients to receive
medicine more quickly - including
people living in rural locations and other
" pharmacy desert " communities without
easy access to local pharmacies - but
at the same time, it may lead to several
negative impacts on patient care.
Each health system typically creates a limited number of specialty
pharmacies within its own network. At each location, they are able to
attract and employ highly trained pharmacists and technicians capable of
dealing with the clinical aspects of specialty drugs, helping those health
systems maximize quality control and minimize compliance issues for
these medications. In instances where a health care system does not
have its own specialty pharmacy, " white bagged " medications can be
dispensed and sent to the health care provider from a specialty pharmacy
outside the health system. White bagging is commonly referred to
as an arrangement between payers and selected pharmacies to ship a
patient's medications directly to the site of care, where staff must then
take whatever steps are needed to prepare and administer the products,
according to the American Society of Health-System Pharmacists.
Challenges may arise for health systems when PBMs require
medication delivery to take place via preferred pharmacies of the
PBM instead of through the IDN's own specialty pharmacy. Such
requirements may be due to the patient's insurance requirements or other
contractual agreements. In other words, a limited-distribution contract
for a given drug may require a prescription to be sent to an outside
pharmacy, even if a patient prefers to fill it at the IDN pharmacy.
In some instances, PBMs designate larger chain pharmacies to deliver
specialty medications to patients more quickly and efficiently and with
fewer hands involved. However, when pharmacies designated by the
PBM are not local to the patient, they must ship medications, including
high-dollar specialty drugs, to the patient's health system in order for
them to be administered to the patient.
In effect, the PBM is asking the health system to receive, mix,
and administer a drug to a patient, often without any contractual
agreement in place. In addition, the PBM is asking the pharmacy
within the health system to perform a function where it does not
have control over all aspects of the drug's oversight, maintenance, and
delivery, but it is legally responsible for ensuring that the medication is
safe to dispense and administer.
Communication breakdowns between a pharmacy designated by
a PBM and the health system may result in public health and patient
safety concerns. Though drug manufacturers may have stringent
requirements regarding how medications should be shipped, stored,
and administered to patients, there have been instances where drugs
have lost their efficacy when shipped by an outside specialty pharmacy
to the health system.
For example, a health system may not be aware that a drug shipped
to its facility by an outside specialty pharmacy resulted in the product
sitting on a loading dock for too long outside its required temperature
range and affecting its integrity; or, a pharmacist may be required to
prepare and/or reconstitute a drug received from a mail-order pharmacy
without knowing certain essential information, such as a patient's weight,
which is required for drug utilization review.
The practice of white bagging has expanded over the years, but it was
the coronavirus disease 2019 pandemic that accelerated the shift to this
model for many PBMs and health systems. The practice enables patients
to receive medicine more quickly - including people living in rural
locations and other " pharmacy desert " communities without easy access
to local pharmacies - but at the same time, it may lead to several negative
impacts on patient care.
With white bagging, patients may not be aware that the drugs being
administered do not come from the hospital and that the integrity of
their drugs cannot be verified. Other patient safety challenges associated
with white bagging include potential delays in care, disruptions in
the medication ordering process, inability to manage drug recalls, and
inability to leverage safety technologies, according to a report by the
California State Board of Pharmacy.
New Regulations Aimed at Increasing Transparency
Many states are currently pursuing legislation to regulate and impose
new requirements and standards on PBMs related to aspects such as
reimbursement and transparency around pricing and contracts. In
many cases, regulations are being targeted to central fill situations when
drugs are filled at one pharmacy and sent to another for dispensing to
the patient.
At this time, several states have put forward more than 20 pieces of
legislation related to PBMs for the current legislative session, including
Arizona, Florida, Maryland, Minnesota, Mississippi, New Jersey, New
York, Oklahoma, Oregon, Virginia, and Washington.
West Virginia also recently put forward House Bill 2429, designed to
protect patient access to physician-administered medication by prohibiting
certain actions, including the practice of white bagging altogether.
The proposed legislation to date indicates that states are keeping
patient safety and concerns at the forefront. Though it is too early to
tell, current state legislation and proposed regulations may ultimately
encourage greater coordination between PBMs and health systems
with regard to creating a contractually based, integrated care model
that ensures the integrity of the drug product from the manufacturer
to the patient, as well as the safe administration of drugs to patients. As
the IDN model expands, the boards of pharmacy and state legislatures
may also want to consider if (and how) rules developed specifically for
PBMs could also be applied to IDNs.
For more information, see NABP's 2018 White Bagging and Brown
Bagging Report in the News section of nabp.pharmacy.
APRIL 2023 | 7
https://nabp.pharmacy/newsroom/news/
Innovations-Magazine-April-2023

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