To ensure patients in North Carolina receive transparent and advance disclosure of critical medication safety risks, we are demanding statewide legislation in North Carolina 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 patients receive critical safety information as listed on all FDA approved drug labels, section 17 “Patient Counseling Information”. This counseling includes vital information of potential adverse drug reactions, side effects, drug-drug interactions, dosage, and other information necessary for safe and effective use of the medication.

This mandate is important because many patients may not receive this information in advance, are unlikely to read this specific section of labeling information before spending money to buy their prescriptions, and may not understand the specific information listed in section 17. 

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

This is not fair. 

In North Carolina, current legislation (NCAC 46 .2504 Patient Counseling) requires pharmacies to offer counseling to patients, but does not require that patient counseling is delivered. Prescribers (examples: physicians, nurse practitioners, physician assistants) are not even required to offer patient counseling on prescribed drugs, as specifically noted in the FDA-approved label section 17. 

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 and, ideally, the prescriber would have a conversation with their patient, providing counsel on the prescription and ensuring that the patient understands all purported benefits and potential risks, including how to properly use the medication per the FDA-approved drug label section 17. This would also allow a patient to ask for a different medication before a prescription is sent to the pharmacy if they do not feel comfortable with the medication recommended, making the process more efficient for each of the patient, prescriber, and pharmacist. 

In 2019, the number of retail prescription drugs filled at pharmacies by payers in North Carolina totaled over 100 million (128,771,895) equating to more than $15 billion ($15,179,518,612) in sales. During that year, retail prescription drugs per capita was 12.3. Research shows that 93% of the unintentional poisonings in North Carolina are caused by biological products and the majority of them are prescribed substances. Between 2000 and 2007, the unintentional overdose death rate more than doubled (106.3% increase). 

A study from 2017 displays that the majority of individuals dying from unintentional drug overdoses had a prescription for a controlled substance within the year leading up to their death.

Looking at the increase in prescription rates and alarming statistics about prescription drug-related deaths, it is safe to say that mandating patient counseling will help the 10.5 million people that reside in North Carolina and depend on medications to heal or treat, not cause harm. 

Sign this petition to demand that the state of North Carolina makes patient safety a greater priority with mandatory patient counseling. Let’s demand that North Carolina 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.