Many Illinois consumers stopping by a drugstore to pick up a new prescription soon will be hearing a lot more from the pharmacist.
Pharmacists throughout the state are being required to counsel customers who seek to fill orders for new medications or need changes in their longtime prescriptions — a mandate that includes alerting patients to potentially dangerous drug interactions.
The higher counseling standard is the result of newly approved regulations that Gov. Bruce Rauner pushed after Tribune reporters found pharmacies frequently failed to warn customers about severe drug interactions.
Currently, pharmacies only have to offer to counsel customers, a standard so weak that drugstore workers often simply ask at checkout if a patient has questions for the pharmacist. Customers often reflexively say “no” and leave with their drugs without hearing about potential problems.
The new rules, expected to take effect as soon as Friday, will require pharmacists to engage in “verbal counseling” with the customer before they dispense drugs to a new patient, give an existing patient a new medication or fill a regular patient’s prescription with changes in the usual dosage, strength or directions.
Through the counseling, patients should receive information on common severe side effects and potential drug interactions, as well as basics such as how long to take the medicine and where it should be stored. Counseling also must be given to someone who picks up medicine for another person, officials said. Patients still have the right to refuse counseling.
The new regulations represent the first major change in government policies since the Tribune investigation, published in December.
In the largest and most comprehensive study of its kind, the Tribune found 52 percent of 255 chain and independent pharmacies tested in the Chicago area and nearby states failed to warn reporters when they picked up pairs of drugs that could be harmful or fatal if taken together.
The new rules in Illinois follow a series of significant improvements put in place in response to the Tribune investigation by CVS, Walgreens, Walmart, Costco, Kmart and locally based Mariano’s — chains that represent more than 23,000 U.S. drugstores with the potential to affect millions of consumers.
CVS, the nation’s largest pharmacy retailer by store count, said it would comply with the new counseling requirements. “Patient safety is CVS Health’s top priority, and we are committed to complying with all regulations that are applicable to our business,” a spokesman said.
Deerfield-based Walgreens, another major pharmacy retailer, said in a statement: “We support measures that help to promote a culture of quality and safety in the pharmacy setting, and are prepared to comply with the new state requirements.”
State officials are giving pharmacies two weeks to get into compliance before Illinois begins enforcement, a process that could lead to fines or other discipline for failing to follow the new counseling requirement and other standards, said Terry Horstman, spokesman for the Department of Financial and Professional Regulation.
Following the Tribune investigation, the Rauner administration determined that more than 40 states had tougher counseling regulations than Illinois and said deficiencies in the current pharmacy system “put patients at risk.”
“On a daily basis, we rely on pharmacists to serve as our medication experts — to safeguard the health and wellness of ourselves and our loved ones,” Rauner said following approval of the rule changes.
“Their extensive knowledge and skill set serve a vital role in providing prescription drug counsel, while ensuring we are not exposed to harmful drug interactions,” the Republican governor said. “When there is a breakdown in this protocol, it is imperative that the state take pro-active steps to address these gaps in care by ensuring meaningful pharmacist-patient relationship communications.”
The state’s stricter counseling standard is “needed and long overdue,” according to Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
Catizone, whose group is the leading organization of state pharmacy regulators, called the new standard a “critical step in assuring safe medication use.”
Garth Reynolds, executive director of the Illinois Pharmacists Association, said his group has “always felt that pharmacists should be counseling patients as part of best practices and appropriate care to the patient.”
“With this new rule,” he said, “this will just codify what pharmacists should already be doing.”
Talking with a customer can uncover additional information that could cause a pharmacist to re-examine whether a new medication would cause a patient problems, Reynolds said.
Further, Rauner plans to call for beefing up state oversight, including directing inspectors to check stores more thoroughly regarding adverse drug reactions and launching a “mystery shopper” program to test drugstore compliance. Details still are being ironed out, officials said, and no specific date will be disclosed for the launch so pharmacies won’t be tipped off.
More broadly, Rauner is seeking input from pharmacists and other health care providers on ways to protect patients at a time when many people use multiple prescription drugs obtained through various doctors and pharmacies. Retail drugstores also will have to post signs with a consumer hotline to complain if a patient believes a pharmacist’s counseling was inadequate.
Despite the government and industry moves, Democratic Rep. Mary Flowers of Chicago maintained “Rauner’s rules don’t go far enough, and what the industry has done also doesn’t go far enough.”
Flowers unsuccessfully sought far-reaching restrictions this spring on pharmacist hours and the number of prescriptions they could fill per hour. She now is placing her hopes in a state task force that would explore how to address what she fears are assembly-line working conditions forcing pharmacists to work so fast that they put patients at risk. The legislation creating that task force has been sent to Rauner, who has the matter under review.
In Chicago, Ald. Edward Burke, 14th, is pressing for a city-only version of the restrictions that Flowers wanted to put in place statewide.
Rauner recently won approval of the new counseling standard and other changes through the obscure Joint Committee on Administrative Rules, a bipartisan group of House and Senate lawmakers who oversee regulatory issues that address the finer points of state law. The changes become official when they are posted publicly, which is scheduled to occur Friday.
Before approval, pro-pharmacy lobbyists suggested a variety of tweaks to Rauner’s initial proposal, which he unveiled in January, as the rules traveled through the regulatory review process.
One suggestion accepted by state officials will exempt pharmacies serving residential patients in some long-term care settings from the new counseling requirements because, officials said, drugs are typically administered by nurses or other health care professionals.
Reynolds unsuccessfully sought to block the governor’s new rule to require that pharmacies post a new consumer hotline. Reynolds said it “was not like we don’t want the patient informed.” But he said his pharmacists association thought the new sign would “just become wallpaper” among the array of other mandated postings, such as explanations about privacy issues, controlled substances and Medicare Part D, Reynolds said.
Rauner staffers in his professional regulations agency disagreed, saying the hotline sign would be the size of a standard 8.5-by-11-inch piece of paper and would not be costly nor “unduly burdensome.”
“The signage,” the agency wrote in a letter to the rules committee, “will benefit the consumer, who will be encouraged to seek counseling from their pharmacist on medications.”