The Ministry of Health released a regulatory update on February 5 regarding label changes for existing biological drugs. While seemingly a positive step toward modernizing the health care system, this move exposes a severe, overlooked flaw: the total lack of oversight once a biological drug leaves the pharmacy. There is no supervision or documentation at the critical moment when the medication is handed to the patient.
Biological drugs are not stable products. Because they are based on complex protein molecules, they are highly sensitive to environmental conditions. Any minor deviation in temperature or handling can cause them to lose their medical efficacy—even if they appear visually perfect.
This is not a theoretical concern. Industry reports show that up to 20% of sensitive drugs are discarded annually due to improper storage, and the World Health Organization estimates that 50% of vaccines are destroyed due to cold chain failures. While the U.S. and Europe document billions in losses, Israel remains in the dark, lacking a public measurement system or a standard of accountability for post-delivery drug integrity.
While the United States utilizes rigorous standards such as USP <1079> to define requirements for the storage and distribution of temperature-sensitive pharmaceuticals, the practical gap remains alarming. Although the FDA requires manufacturers to provide stability data, oversight at the terminal point—the transition from the specialty pharmacy to the patient’s home—remains the weakest link. Without adopting similar mandates and enforcing these standards technologically through the final delivery, the system continues to gamble on the efficacy of its most expensive and critical therapies.
Today, biological drugs are delivered via self-pickup, couriers or home delivery without mandatory temperature monitoring or integrity control. Most are packed in basic cooling materials and may spend hours outside standard ranges. Most worryingly, there is no system to verify if a drug is still fit for use once it reaches its destination.
Effective solutions already exist. Smart temperature monitoring systems using portable digital sensors can provide continuous documentation throughout the transport route and alert to any deviations. Furthermore, interactive thermal stickers can provide patients with an immediate visual indication if a drug has been compromised. However, technological solutions alone are insufficient. The Ministry of Health must adopt a binding standard requiring all distributors—HMOs, pharmacies and couriers—to be fully responsible for drug quality until delivery.
Furthermore, patient education must be addressed. Many patients are unaware of how to properly store their medications or how to identify signs of spoilage. Medications are frequently left in hot vehicles or unstable home refrigerators without clear guidance. The health care system fails to provide the average patient with the necessary tools or basic documentation upon delivery to ensure safety.
To solve this crisis, we require a combination of regulation, technology and education. The Ministry of Health must mandate digital temperature monitoring for sensitive drugs throughout the entire distribution chain, including the “last mile” to the consumer’s home. Simultaneously, HMOs must be required to provide clear guidance for safe storage and signs of defects.
Israel is a leader in adopting advanced medicines, but without closing the gap in quality maintenance until the moment of use, this massive investment is wasted. A drug stored incorrectly is not a drug; it is a fragile and expensive medical illusion.
Ron Nagar is the CEO of TempraMed