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Lifting a Regulatory Burden Could Create Dangerous Consequences

Cheryl Clark, for HealthLeaders Media, November 17, 2011

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.


Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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1 comments on "Lifting a Regulatory Burden Could Create Dangerous Consequences"


Mark Dominesey (11/30/2011 at 8:32 AM)
There clearly two very important sides to this issue. One issue is the patient is trusted to administer the medication (or have someone else administer it for them) while they are out of the hospital, and allowing them to continue that practice can help alleviate some of their anxiety and promote a sense of partial independence. The other issue is that now the hosptal and the clinicians may be required to take responsibility for something that they did not do, or have little control over. The article takes a negative tone for allowing patient administered medications after it does a wonderful job of laying out how clinicians and hospitals can alleviate some culpability. The CMS guidelines appear to be vague enough to allow the hospitals some flexibility in creating policies (in consultation with their Risk Management Dept) that will delineate when this pratice should be allowed and when it should not be. Patient and caregiver education is key to this practice and patient education was not mentioned in the article. Yes, there are very real possibilities of patient harm if certain medications are administered more than what is therapeutically efficacious, but hospitals can craft policies and procedures to mitigate those risks. At no time should patient self-administration be implemented to alleviate some burden on clinicians or for clinician convenience, but only as a vehicle to promote patient independence and wellness. I am in favor of this proposal by CMS. Patient self-administration does occur now, though not widespread, in many hospitals, with a properly [INVALID]d physician order and patient education. Many medications are not suitable for this proposal and it would behoove the hospitals to include such language in their ploicies and procedures along with assistance from their pharmacy staff.