Critics say bureaucracy on meds gets in the way of patient care

Providence, R.I. – End of life care is often about managing pain ensuring that elderly patients are comfortable in the final months or years of their lives. But some advocates for the elderly say federal regulations are making that job more difficult than necessary and as a result, the elderly are suffering without reason.

Nurse Candace Foisy experienced the problem first-hand last fall at the Summit Commons Nursing Home in Providence.

"We had a patient in assisted living who had some severe back pain, I was on call that evening," she said. "I got called out to assess her."

Foisy works in Summit Commons hospice, so she's used to seeing people in pain. But this patient was unusual.

"Basically she was just screaming that everything hurt her," Foisy said. "She was crying, she had the handrails clenched, she would not let them go. She had grabbed me, as soon as she could and would not let go. And just was screaming that her back and body was killing her. Her face was actually distorted because she was in so much pain."

The patient had a prescription filled for morphine, but the pills weren't working. So Foisy planned to give her a shot of the same drug from Summits emergency drug kit. But her nursing director stopped her.

"The director came up and told me it was absolutely against regulation, and we could not open it," Foisy said. "Even though we had the key, we could not open it."

That's because federal regulations require several steps before caregivers like Foisy can administer the pain medication. First, she needed a prescription from the on-call doctor, which the patient had.

But, in addition to that, the doctor needed to fax the prescription to an offsite pharmacist, and then the pharmacist needed to call Foisy back.

Only then could she open the emergency kit. So she waited and tried to explain the situation to the patient's daughter.

"I said, I have the medication here, and as soon as I get that call we'll be able to open the kit and give it to her, and I had to keep telling her this for two hours straight," Foisy said. "And her response was, Well, why haven't they called back yet? Why, if you have it here, can't you give it to her?' And I said, Because we can't.'"

Three hours later, the pharmacist finally sent Foisy a fax, and she was able to give her patient the shot of morphine. It relieved her pain within 15 minutes. A half hour later, the patient was dead.

"I've never seen anyone in pain like that for such a long amount of time in my entire life," Foisy said.

Foisy's experience is an extreme example of a common complaint from nursing homes, that bureaucratic steps required by the Federal Drug Enforcement Agency the DEA are wasting time and leaving patients waiting in pain.

It wasn't always like this.

"Once the nurse got the doctor on phone, they would have been able to immediately go to the (emergency) kit and give you the medication," Dr. Paula Carmichael recalled.

Carmichael lives in Lincoln, Rhode Island, but she works for three nursing homes in Massachusetts. For Carmichael's entire career it worked that way. Doctors could order prescriptions over the phone, and provide written prescriptions later.

Gradually, over the past year, the DEA started enforcing the need for written prescriptions and extra contact with a pharmacist before nursing home patients could receive certain medications. Carmichael started getting into fights with her pharmacist.

"I said, This rule doesn't apply to this drug,' and the pharmacist is like, No it applies to these,'" Carmichael explained. "When I actually looked at the laws, I realized he was right, I was wrong."

Carmichael discovered these weren't new regulations. They'd been on the books for her entire career, but no one had really enforced them.

The stricter enforcement is the result of a DEA investigation in Ohio that found nursing homes distributing medication without the required oversight of a doctor.

That same investigation found that many nursing homes around the country were unknowingly breaking the law. The DEA decided it was time to be perfectly clear about the regulations.

The DEA's deputy assistant administrator, Joseph Rannazzisi, explained the policy in a U.S. Senate hearing last March chaired by Senator Herb Kohl of Wisconsin.

"Though the responsibility for proper prescribing and dispensing (of) the controlled substance rests with the practitioner, it's the pharmacist that is the final gate keeper," said Rannazzisi, at the hearing.

That means the pharmacist must also sign off before a nursing home can dispense narcotics. That's the law, whether a patient is writhing in pain or not.

But at this hearing, a representative of the National Pharmacy Boards had an idea: why not allow nursing homes to apply for the power to act like hospitals? Everyone liked that idea, including the DEA, the president of the American Geriatrics Society and Kohl.

"I think that's great," Kohl said at the hearing. "We could've had you all working on health care; we would have done it in a month without all the animosity."

But that didn't solve the problem.

"As the regulations currently stand, a nursing home does not meet the definition or qualifications to get a controlled substances license," said Anne Marie Beardsworth of the Rhode Island Department of Health.

Beardsworth said that for nursing homes to dispense narcotics like hospitals they would need a controlled substance license from the state. That would require new legislation by state lawmakers, an unlikely possibility.

Several other states are trying to find ways to give nursing homes controlled substance licenses, but not Rhode Island. So nursing homes in Rhode Island and hospice nurses like Foisy are stuck with the strict rules.

"You know, it's tough, it's very, very frustrating to know that this may not come to an end," said Foisy. "It may still present a problem with us, and this situation may arise again."

Rhode Island Senator Sheldon Whitehouse is considering national legislation to change the DEA regulations, but that's uncertain. So, for now, local nursing homes will remain stuck in a web of bureaucracy and some of their elderly residents will pay the biggest price.