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New patient privacy rules may wreak havoc on pharmacy

Chaos is coming to a pharmacy near you. That's the prediction from a chain drug executive who said the nation's pharmacies will be overwhelmed trying to comply with lengthy and complex medical privacy regulations issued by the Clinton Administration in late December.

Of particular concern to community pharmacies is a requirement that by Feb. 26, 2003, patients must have a signed consent form on file before their prescriptions can be filled. "On Feb. 27, there will be chaos at our pharmacy counters," said Carlos R. Ortiz, director of government affairs for CVS Corp. Ortiz told a Congressional staff briefing that "at best" CVS could probably get 50% of its customers to sign a form before the deadline. In the form, which is the responsibility of the pharmacy to write, the patient consents to the use or disclosure of individually identifiable information for treatment, payment, or health-care operations.

As many read the regulation, a pharmacy cannot even begin to fill or refill an Rx until the patient signs a form. Adding to the problems facing pharmacies are the continuing escalation in prescription volume—one billion more Rxs forecast in 2004 than last year's 3.1 billion—and the vexing shortage of pharmacists. "The burdens on pharmacies are significant," Ortiz said, "but the burdens on consumers are going to be even greater."

There will be a significant impact on patients transferring an Rx to another pharmacy, "snow birds," Rxs being delivered or picked up by someone other than the patient, and Rxs for patients living and working in different states, Ortiz told the briefing, sponsored by the Health Leadership Council. The HLC, a coalition of health-care CEOs, has called on the Bush Administration to revisit the regulations. A 1996 law that directed the Department of Health & Human Services to come up with rules if Congress failed to pass a patient privacy law by the summer of 1999 required them. The rules also cover doctors, hospitals, other health-care providers, and insurers.

Last month, the National Association of Chain Drug Stores, the American Society of Consultant Pharmacists, the American Pharmaceutical Association, and the Academy of Managed Care Pharmacy, along with HLC and about 40 health-care and employer organizations, urged the new Administration to delay implementation of the rules (Drug Topics, Feb. 19). "How providers will obtain consent forms from over 200 million Americans by the compliance date is a staggering problem that could interfere with everything from refilling routine prescriptions to sending out reminder notices about appointments, conducting disease management programs, maintaining quality assurance programs, doing claims adjudication, medication compliance, and so on," they wrote HHS secretary Tommy Thompson.

Mary R. Grealy, HLC president, noted that HHS originally had dismissed a consent requirement as unworkable. She also said that Maine had repealed a similar requirement in 1999 just 12 days after it took effect because of "severe disruptions for family members trying to obtain prescriptions for elderly parents and other family members."

Michael F. Conlan

 

Mike Conlan. New patient privacy rules may wreak havoc on pharmacy. Drug Topics 2001;5:29.