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Lifting a Regulatory Burden Could Create Dangerous Consequences

 |  By cclark@healthleadersmedia.com  
   November 17, 2011

When the Centers for Medicare & Medicaid Services last month proposed a rule to relax some Medicare conditions of participation for hospitals seeking federal reimbursement, we heard that leaders of acute care facilities jumped for joy.

Instead of dishing out tons of new regulatory paperwork, the payers in chief were finally deleting some that were thought to be unnecessary. In doing so, CMS officials said, they would be saving hospitals an estimated $942 million a year and allowing providers to spend more time at the bedside. 

This announcement "is welcome news for hospitals and patients, providing much-needed regulatory relief to a health system choked with paperwork," the American Hospital Association's President and CEO, Rich Umbdenstock said in a statement.

That’s all well and good... except for one thing.

The 76-page CMS proposal seeks to eliminate one requirement that could cause more in time and harm – in headaches and adverse events, not to mention true disasters and damage to family relationships – than it prevents.

The agency proposes to allow hospitalized patients, or their caregivers, or 'support' persons, the ability to administer some medications themselves, eliminating the requirement that a hospital employee (i.e. a nurse) perform those functions.

Here's the language of the proposed rule: "We also propose additional revisions at proposed §482.23(c)(6) that would allow hospitals the flexibility to develop and implement policies and procedures for a patient and his or her caregivers/support persons to administer specific medications (non-controlled drugs and biologicals).

"This proposal would be consistent with the current practice of giving patients access at the bedside to urgently needed medications, such as nitroglycerine tablets and inhalers, and selected non-prescription medications, such as lotions and rewetting eye drops. These proposed changes would apply to the self-administration of both hospital-issued medications and the patient’s own medications brought into the hospital."

After all, the reasoning goes, the patient brings these medications with him or her into the hospital, why not let him or her take them while they're there instead of making them wait, and letting those drugs go to waste?

Although the comment period ends Dec. 23, objections are already starting to come in.

On the federal website regulations.gov, Stephanie Hutchins, a former hospital nurse who is now a nursing instructor in California, said she is in support of most of the proposed modifications.  "However," she wrote, "I DO NOT SUPPORT allowing the patient or a 'support person' to administer medications to hospital patients.

"Currently studies have shown that 30-50% of patients ignore or otherwise compromise instructions concerning their medication," she wrote. "If a person other than the nurse administers medications in the hospital, the potential for lack of adherence and therefore lack of crucial therapeutic benefit from the prescribed meds in the hospital is high."

Hutchins continued, "if nurses are required to monitor meds given by a person other than the nurse to ensure adherence, it would create a time backlog for the nurse, negating much of the benefit of having them given by another person."

As someone who has visited family members and others in the hospital, I also can envision the problems relaxing this rule could present.  A son, a daughter, and a wife all know about Tom Smith's need for a certain daily pill. And when they all visit him in the hospital, they all make sure he gets it.  But they all visit him at different times. Then the nurse comes to administer it again.

Mr. Smith might object, but hospitalized patients often get confused over the shock of their new surroundings, even if they otherwise would have the capability of remembering what their dosage should be.

And in any case, physicians evaluating his care may ultimately discover those medications might be the very ones causing some of his medical problem, or are contraindicated.

Richard Bankowitz, MD, chief medical officer for the quality and purchasing healthcare network Premier Healthcare Alliance, sees both sides.

On one hand, he says, the rule "is "meant to balance the fact that as patients are admitted to the hospital, many of them are on chronic medications that need to be taken at a certain schedule," he tells me in an interview. "There's been some concern that as soon as patients come into the hospital their medications get taken away and then they've got to wait for the orders to be written and the medications to come up from the pharmacy. ... It could be very frustrating."

Providing better medication continuity would be a good thing, he says.

On the other hand, allowing patients to keep and administer their own medications comes with some risk, he acknowledges. "The flip side is that there's a documentation issue, so even if it's just one family member, what happens then if the nurse comes by with the medication, and it's not documented in the chart because the family hasn't accessed the medication record and recorded that the medication was given?"

The real solution, Bankowitz says, is for hospitals to have a process in place to assure efficient delivery of the medication, "so that it becomes a non- issue."

That brings us back to the proposed CMS rules. They require the hospital to meet all of the requirements specified below before allowing medication self-administration:

• Assure that a practitioner had issued an order, consistent with hospital policy, permitting self-administration of medications
• Assess patient and caregiver/support person's capacity to self-administer specific medications
• Provide patient and caregiver support person instructions regarding the safe and accurate administration of the compounds
• Ensure the security of medications for each patient
• Identify a patient's own medications and visually evaluate those medications for integrity
• Document the administration of each medication in the patient's medical record.

When all these parameters are met, CMS writes, the new rule "may provide hospitals with a means to make care more patient-centered and adaptable to patient and caregiver/support person needs."

In a commentary published this week in the Journal of the American Medical Association, CMS administrator Don Berwick, MD, and CMS chief medical officer Patrick Conway, MD, wrote that this portion of the burden-lifting proposal served to promote greater patient-centered "culture and engagement."

Surely the intention in reworking this regulation is a good one. But the added workload and risks for healthcare personnel to enable patients and their support teams to administer their medications – even if it's just supposed to be an aspirin or an eye drop – could outweigh any benefit or added convenience to the patient and their families.

Relaxing regulations to promote better patient-centered care is an admirable goal, but it shouldn’t come at the expense of patient safety.

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