To ensure patients in Minnesota receive transparent and advance disclosure of critical medication safety risks, we are demanding statewide legislation in Minnesota that will mandate all prescribers deliver patient counseling for prescribed drugs, per a medication's FDA-approved label section 17 "Patient Counseling Information".

Mandatory patient counseling would ensure that all patients receive critical safety information, as listed on FDA-approved drug labels section 17 “Patient Counseling Information”. This counseling would include the sharing, from provider-to-patient, of vital information on known potential adverse drug reactions, side effects, drug-drug interactions, dosage, and other information necessary for the safe and effective use of the medication.

This mandate is important because many patients may not receive this information in advance, they are unlikely to have an opportunity to read this specific section of labeling information before spending money to buy their prescriptions (or, know that it is exist), and, in some circumstances, may not be able to independently understand the specific information listed in section 17 "Patient Counseling Information".

Without these mandates in place, patients are more likely to unintentionally misuse medication or fail to self-monitor for potential safety issues as those may arise, leading to different results, injury, or even death. 

This is not fair.

In Minnesota, the current Minnesota Administrative Rules for Pharmacies and Pharmacists require pharmacies to determine procedures for patient counseling to patients, but does not require that patient counseling is actually delivered to every patient. In fact, before patients pick up their prescriptions at the pharmacy, prescribers of those medications (example: physicians, physician assistants) are not even required to offer patient counseling on the information noted in section 17 of the FDA-approved drug label.

Pharmacists should remain available to counsel patients, but how can the persons prescribing medications not be required to deliver patient counseling on those prescriptions too?

By the time a patient is at the pharmacy to pick up and pay for their prescription, the offer to counsel a patient is of little benefit. Ideally, the prescriber would have a conversation with their patient and provide counsel on the prescription(s). This would ensure patients understand potential safety risks, including how to properly use a medication, according to the FDA-approved drug label section 17 "Patient Counseling Information".

This would also allow a patient to ask for a different option, before a prescription is sent to the pharmacy, if they do not feel comfortable with the medication recommended (after learning about potential safety risks). Delivering patient counseling as noted in section 17 of the FDA-approved drug label would make the process more ethical, transparent and efficient for each of the patient, prescriber, and pharmacist. 

In 2019, the number of retail prescription drugs filled at Minnesota pharmacies by payers totaled over 54 million (54,196,324). This totaled over $5 billion ($5,866,165,654) in sales. During that same year, retail prescription drugs per capita was 9.6. Mandating patient counseling in Minnesota, from prescriber to patient, will help the nearly 5.7 million people that call Minnesota home.

Sign this petition to demand that the state of Minnesota makes patient safety a greater priority with mandatory patient counseling. Let’s demand that Minnesota legally requires mandatory patient counseling be delivered by prescribers of prescription drugs and at the point of care.

To contact Safest Drug, get involved on this issue, or to learn more about actions toward fighting against medication harms, visit our website at www.safestdrug.org. Safest Drug is a nonprofit organization with a mission to prevent and alleviate medication-related illness, disability, and death within the United States.