WoW! 150,000 supporters and counting! Thank you to every single one who cared enough about the issues with forced mail-order pharmacy to sign and share the petition.
Patient’s lives depend on the choice to use the pharmacy that best fits their needs for life-saving medications. 3 PBMs, Optum RX CVS Caremark and Express Scripts handle the prescription benefits for 95% of Americans. Many whose lives are in their hands are forced to the PBM owned mail-order pharmacy for some of the most critical, temperature sensitive, and life-saving medications. Many patients have experienced life-threatening delays, wrong medications, medications shipped to the wrong address, lost and stolen medications. When we have the option to pick up our medications safely from the hands of our trusted pharmacists, many of these issues are 100% eliminated.
Next, the FDA doesn’t regulate the temperatures of mail-order pharmacy. The state boards of pharmacies are supposed to, but some don’t at all. It’s still alarming to me that we have discovered that something so loosely regulated is being forced upon the lives of millions of Americans.
In this video, I am updating everyone on the status of Florida’s State Board of Pharmacy’s attempt to be one of the first states to truly regulate the temperatures of mail-order pharmacy from the mail-order pharmacy to the patient's door.
While watching the video, please know that USP is not at all related to UPS the brown trucks. USP writes recommendations for best practices for the safe handling of medications. The FDA and State Boards of Pharmacy often uses USP's recommendations for writing laws to protect patients. The State Board of Pharmacy’s chairperson states that USP doesn’t have guidelines for shipping. That is not true. I reached out to USP myself. This was the reply that I received from USP. I wonder if the Florida State Board of Pharmacy even reached out them directly?
After reaching out to USP, here was part of the reply from USP.
"I reached out to Desmond Hunt, Principal Scientific Liaison, Science – General Chapters (whose listed at
the bottom of the document I sent you) about your question.
He said that the instructions you see on the packaging insert are exactly the same that appear on the
product label and carry the same weight. As you noted, the instructions say: “Store at 25°C (77°F);
excursions permitted to 15°C to 30°C (59°F to 86°F).” These instructions also apply to shipping, as stated
in the document we provided."
This as part of the document USP provided:
"USP General Chapter 659 Packaging and Storage Requirements specifically addresses standards for the temperature of medicines during storage in the following paragraph:
TEMPERATURE AND STORAGE
Specific directions are stated in some monographs with respect to storage conditions (e.g., the temperature or humidity) at which an article must be stored and shipped. Such directions apply except where the label on the article has different storage conditions that are based on stability studies. Where no specific directions or limitations are provided in the article's labeling, articles must be protected from moisture, freezing, and excessive heat, and, where necessary, from light during shipping and distribution.
Relevance to shipping medications:
- Shipping is a subset of storage (i.e., in the lifecycle of a drug product, shipping would be anticipated to occur under the applicable conditions of storage). Therefore all requirements for storage also apply during shipping, which includes every step of the medication’s journey from the manufacturer to the patient.
-Generally, all drug products marketed in the U.S. have storage instructions on the label, which always take precedence over USP requirements. USP’s standard sets a minimum level of protection that applies only when there are no storage instructions provided by the manufacturer."
Thank you, everyone! We also want to give a special thank you to USP and Change.org.
You may also help by sharing your story, donating to our nonprofit, Unite for Safe Medications, and by speaking to your legislators about these issues.
Thank you,
Loretta Boesing
loretta@uniteforsafemedications.com
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