When prescription drugs are distributed to pharmacies and providers, included is a packet of prescribing information from the pharmaceutical manufacturer. The packets, required by the FDA, describe the safe and effective use of the product and include technical scientific information intended to assist the prescriber and pharmacist in dispensing the drug. Of note, these labels are included for physicians and pharmacists and are not labels patients receive on their prescription packages.
Often up to 45 pages, these paper inserts account for hundreds of billions of pages that are printed each year and frequently discarded by providers and pharmacists. They can often become quickly outdated as labels and FDA approved indications can frequently change. To increase access to timely information, enhance patient safety, and reduce paper waste, Viatris supports the modernization of prescription prescribing information.
In 2014, the Food and Drug Administration (FDA) proposed updating regulations to move to electronic transmission of this information, but they have not been able to finalize the rule and bring this practice into the 21st century.
Modernization has already occurred throughout other parts of the prescription prescribing process. In 2019, 98.7% of prescriptions were sent to the pharmacy electronically, 79% of prescribers used electronic prescribing, and 79 billion e-prescriptions were filled. Additionally, Medicare already requires providers to bill electronically, and most pharmacists and healthcare practitioners are Medicare providers.
Viatris has partnered with the Alliance to Modernize Prescribing Information (AMPI), to develop a consensus proposal for electronic approved labeling information and to develop and execute a strategy to implement that proposal.
Learn more about AMPI and efforts to make prescribing information real time, reliable, and environmentally sustainable here.