DALLAS, June 26, 2024 — SpotSee, a global leader in condition-indicating and monitoring solutions, today announced that pharmacy operators can comply with a new Texas rule to ensure prescription drugs have been safely delivered by using five of its accurate and cost-effective temperature indicators.
Texas is the first U.S. state to require that any prescription drug delivered by common carriers to a patient’s home be packaged in a way that maintains the temperature range appropriate for the medication.
On June 10, the Texas State Board of Pharmacy adopted Rule 291.12. It requires the use of temperature tags, time-temperature strips, insulated packaging, gel ice packs, or a combination of these, as necessary.
“The rule will have a wide-reaching effect; an estimated 10 million prescriptions are home-delivered each year in Texas,” said Tony Fonk, president and CEO of SpotSee. “We are already working with a number of large and small ship-to-home pharmacies, helping them to easily comply for less than $1 per prescription package. Our solutions help to ensure that life-saving medications reach the people who need them in a safe and effective condition, as intended by the regulation.”
Pharmacies (Classes A, A-S, E and E-S) based in Texas are now responsible for monitoring the conditions of prescription drugs during delivery to patients. The rule also applies to Texas-based pharmacies delivering drugs to patients in other states, as well as pharmacies in other states delivering to patients in Texas.
Under this new rule, pharmacists must maintain records on any temperature excursion that occurs in transit and are responsible for replacing any prescription drugs compromised during delivery.
Small- and medium-size pharmacies as well as enterprise-size pharmacy companies can achieve compliance with the new Texas rule using SpotSee temperature indicators, which are easy to use, Fonk said.
When a prescription drug has been exposed to temperatures that are hotter or colder than the ranges specified by the drug manufacturer, the SpotSee indicators change color. Patients and pharmacists can see at a glance when the home-delivered medications have been compromised and need to be replaced. Five SpotSee single-use temperature indicators available today can help pharmacists comply with the new Texas rule:
- ColdMark® indicators provide irreversible evidence of exposure to unacceptable conditions. They change color from clear to violet when the temperature goes below a predetermined threshold.
- WarmMark® time-temperature indicator stickers turn red when they reach the temperature threshold selected by the pharmacy. Three dots change color to indicate brief, moderate or prolonged exposure.
- Thermax® labels permanently record the highest temperature reached. A series of temperature-sensitive elements change color to provide a temperature history of the package being monitored.
- ColdChain Complete indicators monitor for cold and hot temperature excursions and can easily be inserted into a shipping box or insulated container.
- FreezeSafe temperature indicators provide accurate, irreversible evidence of a below-threshold temperature excursion. They turn from clear to magenta when the temperature falls below threshold.
“The new Texas rule is designed to protect the safety and efficacy of prescription drugs delivered to patients. Pharmacists are now responsible for ensuring that. SpotSee can help them immediately comply with best-in-class temperature indicators that are proven for last-mile deliveries of medications upon which patient health depends,” Fonk said.
Visit https://shop.spotsee.io/temperature_indicators/cold_chain_indicators for more information and to order the products. To see live product demonstrations, visit SpotSee in Booth #117 at the 2024 Texas Pharmacy Association (TPA) Conference & Expo, July 26 to 28 in Allen, Texas.
