Focus On Errors May Bring Changes to the Pharmacy
Pharmacists urged to take the lead in medication safety

from Pharmacy Today

Alex Otto

With the national spotlight focused on medical errors, pharmacist Michael R. Cohen, President of the Institute for Safe Medication Practices (ISMP), has no doubt that major changes are coming to the practice of pharmacy.

Politicians and health care administrators are scrambling to implement the recommendations made by the Institute of Medicine (IOM) in its groundbreaking study, To Err Is Human. After concluding that medical mistakes kill as many as 98,000 hospitalized patients each year, the study's authors suggested major system-wide changes to reduce medical errors. Many of these changes would affect how pharmacists handle drugs. Some recommendations could also, if implemented, make it more likely for pharmacists to be sued for mistakes made on the job.

Medication errors, the report argued, must be addressed as part of the overall strategy. The Institute estimated that approximately 7,000 patients both in and out of the hospital are killed annually by mistakes made in drug administration, but the actual figure may be much higher. Announcing his intention to develop a strategy to reduce medical errors, President Clinton said, "If there is one thing we have learned, it's that effectively managing the prescribing and dispensing of drugs is one of the best ways we can improve quality and hold down cost."

The focus on medication safety is likely to remain for some time. The General Accounting Office is expected to release its own report on drug safety in the first quarter of this year. A series of congressional hearings to address medical errors is planned in the coming months, as well, and a White House task force will present Clinton with an action plan based on the IOM report in February.

Attention from Regulators
The health care community has heard scores of concrete, practical tips on how drugs could be handled more safely in the pharmacy since the IOM report was released in November. Many come from Cohen's book, Medication Errors, which is published by APhA. Cohen presented a copy of his book to Clinton when the two met at the White House in December. Cohen's ideas also formed the backbone of an American Hospital Association quality advisory recently mailed to hospital pharmacists.

Regulatory bodies have been watching these developments closely, Cohen said, raising the possibility that compliance with at least some suggestions may eventually be required for pharmacy licensing, accreditation, and reimbursement. The Joint Commission on Accreditation of Healthcare Organizations, in fact, recently recommended special precautions when handling and administering heparin, insulin, and injectable potassium chloride, among other medications. Cohen believes pharmacists should seize the initiative and actively embrace the role of health safety officer by approaching physicians and administrators to implement safer pharmacy practices.

"These are things pharmacists have been writing about and wanting to do for years," Cohen explained, "but we have met with roadblocks from physicians and managers trying to save time and keep costs down. Now finally everyone has latched onto them and realized their importance. It's time to be proactive."

APhA President J. Lyle Bootman, PhD, concurred. "We have never been in such an opportune time as now to provide the leadership to solving this problem, the silent disease of America," he said.

Mandatory Reporting
The IOM report called pharmacists "an essential resource" for drug information."There is no question that this will increase the acceptance of pharmaceutical care," Cohen said. The recognition also makes it more likely that a Medicare drug benefit will include compensation for pharmacists' cognitive services. In fact, Clinton plans to add coverage for medication safety measures when he reintroduces his benefit proposal later this year.

But the report has a potential downside for pharmacists, as well. IOM has recommended mandatory, public reporting to state governments of medical errors that cause serious injury or death. In the case of a major error, the identity of both the pharmacy and pharmacist would be available. Pharmacists could also be held responsible for detecting incorrect dosages and other errors made by prescribing physicians, Bootman noted. A jury in Odessa, Tex. recently found a pharmacist, pharmacy, and physician liable after a handwriting mix-up on a prescription slip resulted in the death of a patient.

Reporting of less serious injuries would be voluntary and confidential under the IOM system, which could be modeled after FDA's MedWatch or the U.S. Pharmacopeia's Medication Error Reporting Program. Both systems analyze reports and alert practitioners and industry to emerging problems.

States would present aggregate data from their reporting systems to the Center for Patient Safety (CPS), a new federal body proposed by IOM to promote safe medical practices. The Center would use the information to identify safety issues that require more intensive analysis and broad response.

Court Battles
"Mandatory reporting would increase the likelihood of pharmacists winding up in court," Bootman said. "Lawyers have been paying very close attention, and they have little tolerance for error."As a result, malpractice insurance could skyrocket and automation could become more common. "There is a perception that robots cause fewer errors," Bootman explained. Traditionally, APhA has supported voluntary reporting with subsequent confidential analysis of data.

Many questions remain to be answered about mandatory reporting. For instance, would a preexisting standard need to be violated to trigger a report? Who would decide what injuries were severe enough to be reported? How would reporting work in the ambulatory setting? It is also unclear what state agency would receive the reports and how the information would be made available to the public. Despite these and similar unresolved questions, Sen. Edward M. Kennedy (D-Mass.) has announced a bill that would enact the IOM recommendations, including the reporting provisions. Sen. James Jeffords (R-Vt.) and Sen. Arlen Specter (R-Pa.) may soon introduce similar legislation.

"Once you know about a problem, you're under a moral obligation to deal with it," Clinton said when asked about liability in December. "Whatever the problems are, they are not as important as saving the thousands and thousands of lives that obviously are there to be saved, now."

	

Pharmacy Today 6(1), 2000. © 2000 American Pharmaceutical Association