GOVERNMENT and LAW

California launches pharmacy quality assurance program

California pharmacists shouldn't worry about the state's new mandatory quality assurance program—not yet. Pharmacy board inspectors will be focusing on education, not enforcement, through mid-2002.

"Until July or August, our role will be primarily educational," state board of pharmacy supervising inspector Robert Ratcliff told R.Ph.s attending the California Pharmacists Association (CPhA) annual meeting in February. "Our goal is to give a compliance meeting and nobody comes."

Pharmacists statewide have expressed concern that board inspectors would begin enforcing the new program when it took effect in January. Under a law passed in 2000, every pharmacy in California must establish a formal quality assurance program to track, report, and reduce medication errors.

"Quality costs, but poor quality costs even more," board member Stan Goldenberg told a standing-room-only audience at the CPhA meeting. "If you put a rock in a bottle, patients will swallow it. Prevention is the key to reducing errors."

California's QA program is one of the most ambitious medication error reduction efforts in the nation, said CPhA general counsel John Cronin. Every pharmacy, inpatient and outpatient, must have written policies and procedures to deal with medication errors. The policies and procedures must be readily accessible to pharmacy employees.

If an error is found, it must immediately be reported to both the prescriber and to the patient. The pharmacist must also suggest ways to avoid or mitigate any potential harm that could result from the error. Every error must be investigated within 48 hours of discovery, Cronin continued, and every investigation must produce a formal report. QA reports must be kept in the pharmacy for at least 12 months.

The report must review the participants who contributed or may have contributed to the error, the circumstances, and all pertinent data and documentation. QA reports must also include formal findings of the review process and recommend changes to prevent a similar error from occurring in the future. All pharmacy personnel must be notified of changes resulting from the review.

"You have to investigate, review, and act," Cronin said. "The upside is that your compliance with QA requirements is a mitigating factor in any board investigation of the error."

Goldenberg explained that the goal is to reduce errors, not to punish the pharmacists who make them. "We need a method to learn from our mistakes so we don't repeat them," he said. "Prevention is the key to safety, and data are the key to prevention. Only data can tell you if you have a problem with the system or a one-time event."

Board member Don Gubbins also emphasized data collection. Every industry except health care collects data on errors, he noted. From autos to aerospace, the goal is not to punish individuals but to find weak points in production and delivery systems. Improve the system and errors decline. "QA is not a punitive process," he said. "It's a learning experience. The whole purpose is to recommend to pharmacy practice changes that can eliminate errors."

Gubbins suggested that changes could be as simple as checking NDC codes or comparing medications in the vial with a product picture on the computer screen before dispensing.

Cooky Quandt, pharmacy compliance manager at Longs Drugs, said her chain has found that many errors occur because pharmacists and pharmacy technicians don't ask basic questions. Every patient should be asked his or her name and the physician's name, she said. "These are significant questions to ask," she explained. "They assure you the correct script is being provided to the correct patient."

Handwritten prescriptions are another significant source of errors, she said. Requiring prescribers to type or use computerized order entry would eliminate many medication problems.

Steven Gray, California professional affairs leader for the Kaiser Permanente Medical Care Program, said patient counseling is the most effective change a pharmacy can implement to reduce errors. "I strongly recommend that you document who provided the final consultation with the patient," he said. "It's the last best step in preventing that error from happening."

But QA documentation should not go into the patient's own profile, he added. That's because California law allows patients to see their own medication profiles. The state's QA statute protects QA program data from discovery. But any QA data in a patient profile can be made public by the patient. "You don't want the patient and his or her attorney to get to all the other records for that pharmacy or that specific pharmacist, Gray warned. "That could have a chilling effect" on data collection.

Gray added that while QA is a blame-free program, pharmacy managers need to analyze error data by individual employee. "We've learned over 25 years of collecting error reports that there are human factors at work," he said. "Some people are simply more error-prone than others. You've got to find system changes to make that protect you and the patient from that human factor."

Fred Gebhart

Fred Gebhart. California launches pharmacy quality assurance program.

Drug Topics

2002;6:47.