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Press Release

ASHP Leads Opposition to Proposed Medicare Regulations that Would Deprive Patients of Pharmacist Protection

Proposed changes to the Health Care Financing Administration (HCFA) conditions of participation (COPs) that hospitals must follow to be eligible for Medicare and Medicaid reimbursement could mean bad news for patient care if they are adopted. ASHP is spearheading efforts to battle provisions that would (1) remove requirements for pharmacists to be involved in the medication use process and (2) establish a 2% allowable medication error rate for participating hospitals.

Pharmacists' Role In Medication Use Process Ignored. The proposed revisions, which were issued in the December 19, 1997, Federal Register, would eliminate almost all reference to pharmacists from the hospital standards for Medicare and Medicaid, including the requirement that a pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy's services. The COPs also would remove the necessity for a pharmacist to review medication orders, stating instead that "before medications are administered, a licensed nurse...or doctor of medicine or osteopathy must review the individual patient's information , and the orders of the practitioner who prescribed the medication." 

In a comment letter sent to the agency, ASHP noted that the proposal would seriously compromise patient care and remove a link vital to patient safety. The Society strongly asserted that responsibilities such as medication review and supervision of compounding and dispensing of drugs should belong to hospital pharmacists, who have the most in-depth training on medication use of any health care profession. "Not requiring pharmacists to be involved in the medication-use process would be equivalent to not requiring that the diagnosis of disease be under the control of physicians or not requiring that implementation of treatment plans be under the supervision of nurses," ASHP's letter states. In addition, ASHP's comments called for a requirement that would make pharmacists available in hospitals 24 hours a day and urged HCFA to require that pharmacy directors be graduates of accredited pharmacy residencies or have comparable experience. 

Cap on Medication Error Rates Proposed. The proposed revisions to the HCFA COPs also would establish an allowable medication error rate of 2%. ASHP recommended in its comments that the regulations should foster a public policy standard that medication errors should be eliminated and focus instead on error prevention. The 2% threshold could hinder reporting and create the impression that HCFA sanctions a certain level of errors. The Society suggested an alternative five-point approach that would address both prevention and active follow-up of serious errors. 

ASHP has also taken the lead in organizing a collaborative response to the medication error provisions. Three nationally recognized leaders in the field of adverse drug events and quality improvement have joined ASHP Executive Vice President and Chief Executive Officer Henri R. Manasse, Jr., Ph.D., Sc.D., in signing a letter that encourages HCFA to adopt regulations leading to the elimination of medication errors rather than institute the proposed 2% threshold. Lucian Leape, M.D., Associate Dean of the Harvard University School of Public Health; Donald M. Berwick, M.D., President and Chief Executive Officer of the Institute for Healthcare Improvement; and Michael R. Cohen, M.S., FASHP, President of the Institute for Safe Medication Practices, all signed the letter; and the following organizations endorsed it: the American Academy of Pediatrics, the American Federation of Health Systems, the American Medical Association, the Association of Operating Room Nurses, and the National Consumers League. 

Reason to Rally the Troops. If the proposed rule is finalized, it would have an immediate impact on the approximately 1,400 small, rural hospitals that do not seek JCAHO accreditation. JCAHO-accredited hospitals are automatically granted eligibility for Medicare and Medicaid reimbursement without having to prove they meet the COPs. However, HCFA views the COPs as minimum requirements, which would require JCAHO to make its standards consistent with any changes in the COPs. 

ASHP mailed a "call to action" to pharmacy directors in hospitals and health systems informing them of the proposal and requesting they submit comments directly to HCFA. More than 1,000 affiliated state societies and individual members have rallied to protest the unfair treatment of pharmacists, sending letters to the agency expressing dissatisfaction with the revised regulations. Pharmacy students were particularly active, and several student societies organized letter-writing campaigns. 

ASHP also organized a unified professional response to the proposed COPs from the Joint Commission of Pharmacy Practitioners (JCPP). Each of the regular JCPP member organizations signed a letter that expressed concern about the potential for compromised patient safety as a result of the proposals. "Throughout the hospital industry, pharmacists are recognized as the drug therapy experts and are called upon millions of times each day to review, recommend, and monitor patients' safe medication use," the JCPP letter states. 

ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of health care systems. ASHP believes that the mission of pharmacists is to help people make the best use of medications. Assisting pharmacists in fulfilling this mission is ASHP's primary objective. The Society has extensive publishing and educational programs designed to help members improve their delivery of pharmaceutical care, and it is the national accrediting organization for pharmacy residency and pharmacy technician training programs.