Virginia moves to limit mail-order specialty pharmacies following concerns of mishandling medicines for complex conditions
Shortly after Loretta Boesing’s son took medication delivered to the family’s home in Missouri on a hot summer day in 2012, he ended up in the hospital as the liver transplant he’d received at the age of 2 began to fail him.
Although the liver didn’t fail, he spent five weeks in the hospital. Boesing is convinced that the medicine, delivered to her door in a plastic bag, had been weakened by the heat in which it was transported, she said in an online petition she posted to Change.org that has gathered nearly 78,000 signatures from people in favor of tougher rules on mail-order specialty pharmacies and the insurance companies that require them.
These pharmacies, which focus on high-cost medication therapies to treat serious, complex conditions, such as cancer or rare diseases, are growing in popularity as insurance companies favor the cost savings that result from negotiations and personalization of the prescription to the patient.
As more people use the service, Virginia regulators are seeking greater control over the delivery of these medications from specialty pharmacies, either to a practitioner’s office — known as “white bagging” — or directly to the patient’s home — known as “brown bagging.”
The state’s Board of Pharmacy gave initial approval Wednesday to several rule changes aimed at reducing the chance of medication being mishandled due to delivery mishaps, including requiring delivering pharmacies to inform hospitals and doctors’ offices of expected arrival time and storage instructions for medicines, banning the delivery of drugs requiring special storage directly to the patient’s home, and mandating that the specialty pharmacy provide a return procedure for medications that are not delivered or administered.
Despite the associated risks, the prescription delivery model has gained traction in the U.S., at least in part due to reduced costs to insurance companies, which can negotiate prices with the pharmacies and are not generally subject to pharmacy regulations, according to a study published in April by the National Association of Boards of Pharmacy.
“Brown bagging” and “white bagging” can also save prescribers costs associated with purchasing and stocking medications and can spare them the process of billing for reimbursements, the study states.
Despite the benefits associated with the model, the NABP, as well as several health care providers who submitted public comment to the Virginia Board of Pharmacy, expressed concern about the potential for danger to patients, waste of expensive medications and unclear responsibility when something goes wrong with a delivery.
The Board of Pharmacy received five written responses during the public comment period following a public notice of intent to change regulations, which ended Sept. 5.
Cynthia Williams of Newport News-based Riverside Health System said that she supported the regulation and emphasized the lack of oversight to ensure that medications delivered in this way are not compromised.
“This not only puts the patient at risk, but puts the organization administering the medication at risk,” Williams wrote in a public comment. “For the most part, this practice is being driven solely for the financial benefit of insurance vendors, not for the benefit (or safety) of the patient or healthcare provider.”
Another commenter, Elizabeth Early, cited examples of medications sitting for hours in extreme temperatures when improperly delivered, waste when a delivered medication must be disposed of after a last-minute change to the prescription for the patient’s health, and delays in delivery endangering patients’ health and costing them financially when they must purchase new medicine.
Dr. Richard Ingram, president of the Virginia Association of Hematologists and Oncologists, wrote that his organization is “in strong opposition to ‘white bagging’ and ‘brown bagging,’ ” specifically for cancer medications, which he said require special care.
Just over a quarter of oncology drugs were distributed by delivery, according to the 2016 Genentech Oncology Trend Report, cited in the NABP report.
The proposed regulations will be subject to a 60-day comment period before the Board of Pharmacy holds an official vote, which would send them to Gov. Ralph Northam for final approval.
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Twitter: @bridgetbalch
Years ago there was a single test done on the mailing a prescription inhaler. It was mailed to an address in the SW USA IN THE SUMMER… and after it arrived.. its potency was tested and it LOSS ABOUT 50% OF THE LABEL POTENCY. If any entity has done any testing since… I have not seen any published data.
The FDA/USP has temperature storage requirement for most common meds somewhere between mid-50’s to mid-80’s. Some medications .. like Fentanyl patches have a much lower temp storage requirements.. they use to state 72F-75F upper limit .. now they say “room temperature”.
As the laws now function, the pharma, wholesaler and pharmacy are required to maintain those storage requirement, but once a pharmacy hands off a prescription to be mailed to the carrier ( USPS, UPS, Fed-X).. they are not held to those storage requirement.
Where is the FDA/USP on this issue… or … is this just another area that the insurance industry’s lobbying power is able to get the bureaucrats to “look the other way”… since the insurance industry own the vast majority of these mail order pharmacies ?
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