Consultant pharmacists brace for tough challenges ahead


ASCP reviews its upcoming legislative plate.



Consultant pharmacists brace for tough challenges ahead

Not bothering to mince words, the American Society of Consultant Pharmacists declared the legislative outlook for pharmacists in the long-term care area bleak. Speaking at the ASCP's recent annual meeting in Anaheim, Calif., Leigh Davitian, J.D., legislative counsel for ASCP, said pharmacy is under attack.

The recent mid-term elections may have worsened the outlook for pharmacy, with "some serious implications for the long-term care industry that are not going to be pretty," Davitian said. ASCP lobbyists had made progress working with the Democrats on a number of legislative initiatives, and their loss of the Senate leadership represents a giant step backwards for ASCP.

Medicare givebacks, proposed as a way to take the financial sting out of the draconian reimbursement cuts of the 1997 Balanced Budget Act, will probably not continue to be implemented by the Republican-controlled legislature. This will result in a significant negative impact on the financial health of nursing home facilities, and the effect on the consultant pharmacy industry could be infinitely worse, Davitian said.

Following are other issues at stake:

• The Medicaid federal upper limits (FUL) program was established under the Omnibus Budget Reconciliation Act of 1987 as a way to limit Medicaid drug payments for qualified generics. Qualified generics must be therapeutically equivalent (A-rated) to a branded drug; there must be three or more versions of the drug; and the drug must have three or more suppliers. The list of generics has grown to more than 150 drugs, and not all satisfy the criteria for inclusion. Furthermore, the established upper price limit was sometimes lower than the wholesale purchase price. ASCP is working with the Centers for Medicare & Medicaid Services (CMS) to reduce the ambiguities of the FUL guidelines, and it has received approval to review the FUL list before it is released.

• Average wholesale price as a benchmark for Medicare reimbursement for drugs continues to be a subject of controversy. The working definition of AWP varies, and in some cases there can be as much as a 100-fold difference between the AWP and the actual acquisition cost. New benchmark reimbursement prices were established, first for Medicare Part B drugs and then for the reimbursement of pharmaceuticals in all publicly financed programs. However, infighting in the legislature continues.

• Controlled substances. ASCP has designated a Drug Enforcement Administration (DEA) task force to work on regulatory issues related to controlled substances. Prospective DEA rules would cover automated dispensing systems in long-term care facilities, electronic orders, central fill pharmacies, and "cyber-prescribing" via Internet/e-mail. Other DEA issues involve establishing the chain of responsibility for dispensing controlled substances in long-term care facilities. According to current DEA opinion, nurses in long-term care facilities are not the legal agent of the prescribing doctor, but instead answer to the nursing facility. Therefore nurse-to-pharmacist communication of patient information is not an appropriate chain. DEA has also established that chart orders for controlled substances are permitted in long-term care facilities only if there is an on-site pharmacy in the facility. If not, controlled substance prescriptions must include all the elements of an Rx, such as the specific quantity, the patient's name and address, and the doctor's signature and DEA number. Emergency kits containing controlled substances are also subject to new DEA guidelines.

• OSHA. The primary changes occurring in the Occupational Safety & Health Administration involve ergonomics guidelines. Proposed guidelines for nursing homes involve the use of flip-top cartridges rather than blisterpacks to dispense medication; ergonomics related to patient handling; exposure to blood and other potentially infectious material; and dealing with slips and trips. For pharmacy, the emphasis in OSHA is on compliance with hazard communication standards.

• Assisted living. Tom Clark, R.Ph., M.S., the director of professional affairs for ASCP, discussed the issues of quality care in assisted living. Senate hearings have resulted in the formation of a coalition of 51 organizations charged with putting forth recommendations on specific topics. ASCP has been involved in the discussions on medication management. Final recommendations are expected within the next few months (see Ten nursing home quality measures are already publicly reported ( Nhcompare/home/asp), and medication use impacts almost all of those quality areas. Clark believes the role of pharmacists in assisted living facilities should expand as efforts to improve quality continue.

• Home health. Home health agencies with Medicare patients are required by CMS to conduct a drug regimen review for every client, but the review does not have to be done by a pharmacist. A six-month pilot will begin in six states this spring using draft quality measures for home health agencies, and CMS plans to publish quality measures of home health agencies on its Web site later in the year. One of the quality measures being considered is the patient's ability to manage his own medication. Another is urinary incontinence, which is often managed by medication. Clearly, pharmacists could contribute their expertise in these areas.

Diane Etchison, Ph.D.

The author is a writer based in southern California.


Diane Etchison. Consultant pharmacists brace for tough challenges ahead. Drug Topics 2003;1:61.

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