Demand Mandatory Patient Counseling on Prescription Drugs for Californians

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To ensure patients in California receive transparent and advance disclosure of critical medication safety risks, we are demanding statewide legislation in California 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 labeling section 17 “Patient Counseling Information”. This counseling would include the sharing, from provider-to-patient, of vital information of known 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 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 California, the current Pharmacy Lawbook requires pharmacists to counsel a patient upon request or when a prescription drug has not previously been dispensed to the patient. While drug-drug interactions, self-monitoring for side effects, and special directions for use and/or storage are incredibly important factors in drug safety, those are currently not a requirement for pharmacists to disclose. No consultation is required, unless, as described in Section 4074 of the California Pharmacy Lawbook, the drug has been deemed dangerous to use with alcohol or while operating a motor vehicle by the Board of Pharmacy. Even then, only a warning and not a full consultation is required. 

Pharmacists serve an important role in educating patients about their prescriptions and their role in delivering patient counseling shouldn't change but shouldn't prescribers be involved too?

Prescribers, other than pharmacists themselves (physicians, nurse practitioners, etc.), are not even required to provide thorough patient counseling on the drugs they prescribe. 

A common theme in the California laws on patient counseling is clear: much of it is left up to the discretion of the pharmacist, and, less commonly, the prescriber.

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. 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 safety risks), making 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 California pharmacies by payers totaled over 300 million (333,906,521). This totaled over $30 billion ($32,525,850,723) in sales. During that same year, retail prescription drugs per capita was 8.5. Mandating patient counseling in California, from prescriber to patient, will help the 40 million people that live in California.

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

To contact Safest Drug, to 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.



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