Safe Medications Use By FDA

Safe Medications Use By FDA

Institute of Medicine’s (IOM’s) roundtable discussed health literacy in April gathered a group to talk about how they can help Food and Drug Administration (FDA) in increasing the medical adherence and United States citizen medications use safety.  The main focus of that meeting was to share the ideas with FDA. One of the ideas was the idea about Safe Use Initiative launched last fall. The main goal of this initiative is the reduction of adheres events from misuse of medications. FDA principal deputy commissioner Joshua M.  Sharfstein said they were just starting with that effort.

You can read about the consequences of the misuse in this article.

The FDA is planning to decrease the misuse and low adherence by improving dosing devices for liquid medications which are available over the counter and make instructions with consumer medication information (CMI) more relevant and easy to understand for customers. Assistant professor of pediatrics at the New York University School of Medicine, H. Shonna Yin, presented the report about study information of labels and packages of about 200 liquid pediatric nonprescription cold, allergy and cough medications. He said about one-quarter of all the packaged didn’t include any dosing device, and this leads to the misuse of the medication.

He added, that 81% of the devices (most of which were plastic caps) had superfluous volume marks, which weren’t related to the information in the medication instruction. Almost 90% of those devices had markings for units of measurement that wasn’t indicated in instruction, 53% had numeric values, that didn’t match the instruction and other 22% were missing the marks needed to take the medication properly.

The other major problem, noticed by Yin, was nonstandard abbreviations on the same dosing devices: teaspoons, milliliters and others, the use of nonstandard units and the lack of a leading zero on dosage instructions. He pointed out it to be a new issue.

The most widely used supplemental documentation are CMI leaflets, thinks Gerald McEvoy, ASHP’s assistant vice president for drug information, who have a presentation on CMI leaflets. (ASHP is a commercial database of CMI provider).  However, Food and Drug Administration states, that documents didn’t meet the agency’s criteria for containing useful and relevant information, which would be used by patients. ASHP will collaborate to improve CMI content, simplicity, and the consistency. McEvoy also suggested FDA work with the state boards to check, if CMI products reach out the expectations for content at the point of dispensing.

Another approach needed?

In the opinion of Sharfstein, the best way to increase the proper use of medications is to choose another approach for Safe Use Initiative program. The main idea of this approach is to take one medication at a time. Daniel Budnitz, director of the Centers for Disease Control and Prevention’s (CDC) medication safety program, thinks, that chose the injury-based approach. CDC analysis of ER visits for unintentional overdosages in patients who are five and fewer years old identified a cough, cold products, and nonsteroidal anti-inflammatory medications are the leading reasons for the visits. Most of the overdosages were attributed to the ingestion, making this possible target for medication use improvement.  McEvoy also proposed that FDA starts a list of products with boxed safety warning and focus its Safe Use initiative on those medications. If the medications have that kind of warning by FDA, it should be considered a high-risk medication. The list will not be long because a huge amount of medications includes a boxed warning.

The Save Use Initiative as the part of the agency’s focus on public health said Sharfstein. He added, that he hoped FDA will save a lot of lives and prevent a lot of illnesses. In this case, the FDA will save a lot of costs and prevent suffering. He added, that partnerships to improve public health can assist FDA in implementing Risk Evaluation and Mitigation Strategies (REMS). Such tools, in his opinion, will affect the work of health care providers and pharmacists, which will cause the reduction of drugs benefits along with its risk. Pharmacy specialists have a very important role in the improvement of medication adherence and proper usage. “In some cases, they could be more effective than REMS,” he added. Pharmacies, for example, could send text messages to the patients to help them to dispose of expired or unused narcotics. He asked if it would be hard for the pharmacy to send and instant message to somebody saying something, like “if you still have any medications lying around the house, maybe it’s time to get rid of it?”.

FDA needs to work with other stakeholders, simply because a lot of different unsafe drug practices were taking place outside of FDA’s competence, said a medical officer in FDA’s Office of the Commissioner Karen Weiss. She added, that everyone has his own important role in medication safety.

Dmytro Nikolayev

Dmytro Nikolayev spent many years working in the field of healthcare, especially in its technical part. Gained much experience in Open Data and Machine Readable Formats used in the industry. Also, built several IT projects that were designed to help people with their healthcare decisions. Now he is an editor and author of Pharmacy Near Me

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