GAITHERSBURG, MD – Safest Drug, a national nonprofit founded in 2019 to address medication-related injuries and deaths in America as a public health issue, has released multiple petitions to demand enhanced mandatory patient counseling on prescription drugs in at least six states.
Prescribers would deliver patient counseling to their patients at the point of care in Minnesota, California, Utah, New Jersey, South Carolina and North Carolina. The petitioning for mandatory patient counseling is starting in a small number of states, with hopes of adding more in the future. If changes are made, groundbreaking legislation will help protect patients by ensuring they consistently receive disclosure of known critical safety risks associated with their medicines, based on the information currently being advised to be shared by healthcare providers per section 17 of pharmaceutical drug product’s FDA-approved labeling.
Many states do not have any prescriber requirements to counsel their patients, much less per section 17, and counseling is often delivered as an option and at the discretion of a pharmacist. This oversight puts patients at risk of adverse drug reactions, side effects, and drug-to-drug interactions. “We know that some prescribers may not favor talking with patients about the safety guidance in section 17, but this type of mandate would be huge for patient safety,” said Mika Pollack, Executive Director of Safest Drug. “It would allow people to have conversations with their healthcare providers that they would have never had before about their prescription drugs.”
New prescription drug counseling rules would require the prescriber to have a conversation with their patient to ensure potential safety risks are always discussed. Informing patients would allow them to better understand major safety risks and lead to a more transparent prescribing process. “Pharmacists are too busy to talk to every patient who buys a prescription at their store,” Pollack said. “So, the mandate would allow the burden of educating and informing to be shared between prescribers and pharmacies.”
Nationally, in 2019, an estimated 4.38 billion prescriptions were filled to heal or treat various conditions and illnesses. In the same year, the FDA received over 2 million reports of suspected and confirmed pharmaceutical drug product safety issues.
Without advanced information sharing and more thorough counseling from prescribers, patients are not able to help monitor and detect safety issues and adverse drug reactions, contributing to nationwide medication-related injury and death statistics. Arming patients with information about potential safety risks could reduce the number of patients harmed.
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