Youngstown Daily Legal News

Plan would end cancer drug 'brown bagging'

TIFFANY L. PARKS
Special to the Legal News
Published: January 22, 2014

A bill jointly sponsored by Sens. Gayle Manning, R-Ridgeville, and Scott Oelslager, R-North Canton, would eliminate a cancer drug dispensing practice known as “brown bagging.”

Senate Bill 230 would generally prohibit pharmacists and pharmacy interns from dispensing certain non-self-injectable cancer drugs by delivering or causing them to be delivered directly to a patient, a patient’s representative or a patient’s private residence.

“To understand the great need for this legislation, it is important to understand that these oncologic drugs are fragile and complex,” Manning said in sponsor testimony Wednesday.

Brown bagging describes the practice of an insurer requiring patients to receive volatile, non-self-injectable cancer medication at a location separate from where the drug is to be administered, often by mail-order pharmacy via commercial carrier.

Manning said patients must then transport the medication to a medical facility for infusion.

“The extended trip to the medical facility required by this type of insurance contract creates unnecessary risk for compromised patient safety and drug effectiveness,” she said, adding that the drugs should be stored in a proper environment to deliver their maximum effect to patients.

SB 230 defines non-self-injectable medication as a dangerous drug that is indicated for the treatment of cancer or a cancer-related illness and must be administered intravenously or by subcutaneous injection and cannot reasonably be self-administered by a patient to whom the drug is prescribed or by an individual assisting a patient with any self-administration.

“If a patient brings chemotherapy drugs to a medical center that were delivered to his or her doorstep, the oncologist is unable to determine if the drugs have been subject to extreme temperatures or exposed to other elements that may alter their effectiveness,” Manning said. “Many patients required to use the brown bagging process are thus turned away by oncologists. This presents significant challenges to both patient safety and efficient healthier delivery.”

Manning said the safest and most efficient handling method for these types of drugs is for an oncologist to order the drug from an oncology drug distributor that maintains the appropriate storage prior to injection.

“To ensure drug quality and patient safety, SB 230 aims to modify the insurance companies’ delivery requirements so that patients do not directly receive or obtain their non-self-injectable drugs from a retail mail-order pharmacy.”

The proposed legislation specifies that the dispensing prohibition would not apply if a patient’s private residence is an institutional or health care facility or, if certain notifications have been provided, when a patient is a hospice patient or home health agency client.

In addition to concerns regarding proper drug storage, Manning said the brown bagging practice contributes to a variety of chemotherapy reimbursement problems with respect to both Medicare and other third-party payers.

“SB 230 is therefore designed to protect patient safety and promote better health outcomes, while reducing unnecessary waste in the state’s healthcare system.”

In the last legislature, Oelslager championed the bill’s provisions as Senate Bill 194.

That measure, which also sought to create equity in a patient’s out-of-pocket costs for orally-administered cancer medications compared to IV-based medication, stalled after two committee hearings.

In breaking down the previous bill, Oelslager partnered with Manning on SB 230 and reintroduced the oral cancer medication provisions as Senate Bill 99.

Oelslager previously said that if a patient brings a medication that was dropped off to his or her doorstep to the hospital, an oncologist cannot tell if the chemotherapy drug has been altered.

“Visual inspection alone will not inform the oncologist of compromised medicine in many cases. This uncertainty presents dangerous situations for patients,” he said.

“The unknown variables of exactly where that drug has been, how it has been handled and who handled it takes the quality control of drugs out of the hands of the oncologists and pharmacists and puts it in the hands of the patients and mail couriers.”

In crafting the revamped proposal, Manning said she and Oelslager worked with interested parties such as The Ohio State University Comprehensive Cancer Center, the American Cancer Society, the Ohio Pharmacists Association and the Ohio Hematology Oncology Society.

“Cancer patients have incredible battles with which to cope,” Manning said. “SB 230 will eliminate one obstacle in patient access to the most effective treatments in the fight against cancer.”

SB 230 is co-sponsored by Sens. Shannon Jones, R-Springboro, Peggy Lehner, R-Kettering, Tom Patton, R-Strongsville, and Capri Cafaro, D-Warren.

The bill has not been scheduled for additional hearings.

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