Pharmacy Board Considers Changing Old Law Causing Uproar

A 1961 Oklahoma Board of Pharmacy statute is just now causing tension between pharmacists and physicians.

The law prohibits physicians from receiving patient-specific prescriptions in the office setting. In other words, if a prescription has a patient’s name on it, then the medication must be delivered to the patient, not the physician, except in certain situations.

While some news outlets have reported that the pharmacy board is just now enforcing the law, it maintained to Pharmacy Times that this is incorrect.

Cindy Hamilton, DPh, who has been the chief compliance officer for the Oklahoma State Board of Pharmacy for 17 years, told Pharmacy Times that the law went into effect in 1961 and has been enforced for many years.

“This statute prevents pharmacies from shipping medications to physicians so that they are ‘forced’ to do business with a particular pharmacy, therefore allowing kickbacks to the physician and/or allowing the physician to mark up the drug further and getting his cut of the profit,” Hamilton said.

Another reasoning for the law is to prevent doctors from using medication for personal use, but some doctors are saying the law is causing issues.

News on 6 reported that one patient of George Monks, MD, is having trouble obtaining chemotherapy to treat skin cancer.

Another patient with psoriasis and psoriatic arthritis reported always having shots of Stelara administered at the doctor’s office. Now, the medication is delivered to the patient’s home, where the treatment needs to be kept refrigerated until the patient can go to the doctor’s office to have it administered.

“I really have no idea why it exists,” Dr. Monks told News on 6. “I think it’s a ridiculous law.”

In a letter obtained by Pharmacy Times, Woody Jenkins, MD, president of the Oklahoma State Medical Association, wrote to the board about his questions about the law. (Dr. Monks was also CC’d on this letter.)

In the letter dated November 3, 2015, Dr. Jenkins wrote, “We are trying to ascertain exactly what the state of the current law is and what changes, if necessary, are necessary to get back to the way things were and allow patients to receive their needed medication at their doctor’s appointment.”

It was his understanding that the law had been in place for many years but had not been enforced. He asked for insight on why the law was passed in the first place.

“As you well know, this law is going to impact numerous patients with a wide variety of ailments, ranging from psoriasis, to multiple sclerosis, to metastatic melanoma,” Dr. Jenkins wrote. “This is not simply an issue of convenience—it is an issue of making sure that patients have access to the crucial drugs that they need.”

John A. Foust, PharmD, DPh, executive director of the Oklahoma Board of Pharmacy, responded to Dr. Jenkins’ letter with assurances and explanations of why the law was passed.

For one, the law prevents diversion schemes that were popping up in the 1960s and 1970s. Dr. Foust explained that back then, prescribers could order medications, including narcotics, for a patient and have them delivered to his or her office. Meanwhile, the medication would be covered by the patient’s insurance, and the patient would not know about the medication because neither the pharmacy nor the insurance carrier would notify the patient about the existence of the prescription or the costs.

Secondly, there have been complaints that some prescribers have the medications delivered to their office and charge the patient a different price than the pharmacy, Dr. Foust pointed out.

“The regulation that does not allow filled prescriptions to be delivered to practitioners’ offices was originally enacted to protect the patient,” Dr. Foust wrote in an e-mail to Dr. Jenkins.

However, there have been many changes since the law was written. For example, the law was written before co-pays existed or other ways of verifying prescriptions, and before prescribers started to provide infusion services involving compounded sterile drugs or other high-tech drugs that required special temperature settings.

“It was not until the medical insurance business model began encouraging patients to get their sterile drug products filled at a specialty or mail-order pharmacy for prescriber office administration, rather than the original physician ‘buy and bill’ method, that this has become an issue,” Dr. Foust wrote.

As the “buy and bill” model became no longer viable, the pharmacy board started to work on pilot programs a few years ago that allowed some shipments of filled prescriptions to practitioners’ offices in certain circumstances. For example, if there were issues with cold storage, or if the patient did not have a secure mailing address, the physician could obtain the medication instead of the patient.

Patients who are in a hospice facility, at a hospital, or staying at a relative’s home should be able to have their medication shipped to these locations without issue.

Meanwhile, patients who in shelters or on the streets can have their medication delivered to a prescriber’s office or clinic through the pilot programs.

Hamilton told Pharmacy Times that the board is aware that these situations exist and have asked pharmacies to come before the board to ask for special dispensation.

“[Special dispensation] has been allowed in situations where the pharmacy serves a homeless population, or mentally ill patients, or even in situations where the medication is very unstable and the prescriber feels that it could be compromised if it isn’t shipped directly to him prior to administration,” she explained.

Dr. Foust said he guessed some pharmacies without pilot program status have tried to ship sterile infusions to patients’ prescribers and were then questioned by their insurance carriers and denied payment, which may be the reason for new questions about this law.

A committee is convening November 12, 2015, to review the pilot programs and make recommendations for updating the regulations, according to Dr. Foust.

“The pilot programs have always been the ‘temporary’ response to patient health until the board could carefully review the issues and recommend appropriate legislative changes,” Dr. Foust wrote.