Nothing happens in a vacuum. In economics, healthcare, labor markets — even in our bodies. The past four years demonstrated this with painful precision.
So, it should come as no surprise that the spike in telehealth in early 2020, and the push by U.S. medical insurers to reduce costs have spurred a spike in home-delivered prescription drugs. Guess what is likely to happen when millions and millions of temperature-sensitive prescription drugs are shipped by common carriers?
A spike in consumer complaints related to delivery, packaging, tampering, incorrect prescriptions, and – most notably – temperature-sensitive prescription drugs. The sort of thing that keeps pharmacists up at night. Especially in states with extreme summer climates, such as Texas.
The benefits of home-delivered drugs are immense. From accessibility for home-bound, elderly, or disabled patients to better medication adherence for chronic disease sufferers to safety for contagious or immunocompromised people to basic convenience for all.
But those benefits did not and will not mitigate the downsides — the real and ever-present risks — most notably: patient safety. As complaints kept piling up, patient concerns kept growing, and compliance resources were stretched thin, multiple state boards of pharmacy began discussing regulation as a means of prevention and accountability.
The Texas State Board of Pharmacy (TSBP) was the most recent to advocate for additional safety measures. As early as August 2023, the Board began discussing the need to institute rules for prescription drugs delivered by common carriers.
Texas State Board of Pharmacy Rule 291.12
On June 10, 2024, Rule 291.12 was adopted “to improve the health, safety, and welfare of patients by ensuring the safety and efficacy of prescription drugs that are delivered to a patient or patient’s agent” by Class A, Class A-S, Class, E, and Class E-S pharmacies. The rule applies to Texas-based pharmacies delivering drugs in or outside Texas as well as pharmacies in other states delivering to patients in Texas.
Rule 291.12 reiterates standard stipulations applicable to all types of prescription drug fulfillment, but additionally requires that home[1]delivered drugs be packaged in a way that maintains the temperature range appropriate for the medication (according to the United States Pharmacopeia or drug manufacturer). Maintaining the proper temperature requires the use of temperature monitoring indicators (temperature tags, strips, labels, etc.) and insulated packaging, gel ice packs, or a combination of these, as necessary.
Pharmacists are also required to maintain records of any temperature excursions that occur in transit and are responsible for replacing any prescription drugs compromised during delivery.
Considerations for Compliance with Texas Rule 291.12
If Rule 291. applies to you, either as a Texas-based pharmacy or one that ships to patients in Texas, but you have not heard about it, you might be considering a mail order of nitroglycerin or a beta blocker. After all, June 10 was months ago, and the penalties for noncompliance range from a verbal warning to license revocation.
In my experience helping pharmacists, heads of logistics and supply chain, and procurement and compliance managers at mail-order pharmacies nationwide, their primary concerns about Rule 291.12 (and other rules like it) are four-fold:
- Compliance: They need to know, specifically and clearly, what compliance requires of them.
- Expense: Any compliance solution needs to be as economical as possible since pharmacies are assuming the immediate cost.
- Degree of Difficulty: Compliance cannot cause a huge disruption in their compounding workflow or fulfillment/ shipping timetables.
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- Scale: The solution must be applicable, from compliance to cost to simplicity, to every prescription. If it works well for up to ten prescriptions but is complicated to use for more than that, it is just another impediment.
Most pharmacies are already abiding by the majority of Rule 291.12, since its stipulations are simply reiterations of retail pharmacy regulations. The compliance outliers are usually: 1) a dependable temperature-regulating packaging solution and 2) a quality temperature monitoring indicator solution.
They will both need to be:
- Cost-effective: Reusable packaging and temperature monitoring indicators are impractical. Single-use solutions are much more economical (and less stressful) in the long term.
- Easy: If you need an advanced degree to use or interpret either solution, then “solution” is a misnomer.
- Scalable: Even small- and medium-size pharmacies should be conscious of scalability. One frustrating, cumbersome task repeated just 20 times a day will result in exponential lost time. (And the detrimental effect on your pharmacists/pharmacy technicians’ well-being is just as important.)
- Immediate: If you are ordering temperature indicators from a remote location halfway around the world, there are bound to be compliance gaps.
- Flexible: Can the gel packs fit easily in your standard packaging? Does the foam mold around different-sized medications? Do the temperature indicators take up a lot of space? Would either solution necessitate changing your packaging or workflows altogether, or do they fit seamlessly into your best practices?
A temperature monitoring indicator requires one additional, obvious attribute: accuracy.
Similar Prescription Drug Delivery Rules in Other States
Texas is one of the first U.S. states to require that any prescription drug delivered by common carriers to patients’ homes be packaged in a way that maintains the temperature range appropriate for the respective medication. Oklahoma adopted a similar rule following Arkansas’ Board of Pharmacy's adoption of prescription delivery standards (Rule 07-05) in May 2022 and Georgia’s updates to Rule 480-48 in June 2017.
This is a growing (and needed) trend. I anticipate the adoption of many similar or identical rules in the coming years. For pharmacies looking to get ahead, both in terms of compliance and patient safety/satisfaction, there is no harm in preparing now.
How to Prepare for Rules in Your State
The best-case scenario is a future rule adoption that changes nothing for your pharmacy’s daily operations, by virtue of the fact that you are already compliant — your temperature-regulating packaging and temperature monitoring indicators solutions are well in hand.
The next-best scenario is a smooth transition to compliance due to your research and logistics preparations beforehand. Search for solutions that fit the descriptions above, run through the cost and workflow impacts, and create standard operating procedures beforehand. Even if there is turnover, a compliance master plan will be ready to execute whenever your state board of pharmacy follows suit.
Additionally, make good use of your state board of pharmacy’s resources. Regarding Texas Rule 291.12, pharmacies can:
- Call the TSBP Rules Queue hotline for live help at (512) 305-8070.
- Read Rule 291.12 in its entirety on the TSBP website.
- Visit the TSBP website to read a wealth of online resources, including pharmacy rules and laws, continuing education, training/informational videos, and licensing renewals.
- Subscribe to the TSBP newsletter, published monthly with information about law and rule changes, news, and other updates relating to the practice of pharmacy in Texas.
- Attend or watch upcoming board meetings live, submit a public comment request to address the board during a meeting, or view archived meeting recordings/materials.
Though not all states have as robust a website/online resources as Texas, reaching out to your respective state’s board of pharmacy by phone or email is a better option than guesswork or operating out of a sense of isolation and frustration.
Texas Rule 291.12 Has Compounding Benefits
It is easy to view compliance as a stressor. A sunk cost. An impediment to what you are really trying to get done. But patient safety, just like everything else, does not exist in a vacuum.
When patient health is protected, the ultimate goal of medicine is met. When patient safety is protected, your professional safety is guarded. When patient welfare is protected, your own well-being is too.
Because nothing exists in a vacuum. For worse — and better.
Author Details
Billy Sanez- Global Marketing Director, SpotSee
Publication Details
This article appeared in Pharmaceutical Outsourcing:Vol. 25, No.4 Oct/Nov/Dec 2024Pages: 22-23