For chronic pain and spasticity patients, opioid medication can be a path to a higher quality of life. However, oral opioids can also be highly addictive and, when overprescribed or abused, can cause serious harm. In 2016, opioids were involved in more than 42,249 overdose deaths in the United States.1
Targeted drug delivery (TDD) offers an alternative to oral opioids. Because the medication is administered through an implanted pump that infuses medication into the patient’s intrathecal space, there’s no opportunity for the patient to independently increase the dose, or for anyone else to take the medication. In clinical studies, TDD has been shown to be a viable and relatively safe option for the treatment of chronic pain.2
TDD therapy can also lead to reduced healthcare utilization—and reduced costs. In a recent study of patients with cancer-related pain, use of TDD therapy was associated with fewer emergency department visits, fewer inpatient visits and shorter hospital stays than with conventional medical management alone, and led to average cost savings of more than $60,000 in a one-year period.3
Because of these benefits, more and more physicians are choosing TDD therapy for their patients. There are an estimated 140,000 implanted pump patients across the country, and the market keeps growing.4
“Many physicians are seeing the benefits of TDD therapy for chronic pain and spasticity patients,” says Anish S. Patel, Chief Medical Officer of AIS Healthcare. “For patients with comorbid conditions or who are at high risk for opioid abuse and addiction, TDD can provide a safer alternative to conventional medical pain management.”
Many pharmacies across the country offer patient-specific, compounded TDD therapies. When selecting among these pharmacies, quality has to be top of mind for prescribers. Because TDD involves infusing medication directly into the patient’s spinal fluid, all providers should ask what potential pharmacy partners do to ensure quality and sterility.
All 503A specialty compounding pharmacies, which prepare patient-specific prescriptions, must meet industry standards, as well as state and local regulations, to ensure minimum cleanliness and quality standards are met.
AIS Healthcare Targeted Drug Delivery, the leading TDD solutions provider, goes above and beyond these requirements to advance patient safety. Licensed in all 50 states, AIS Healthcare Targeted Drug Delivery has two state-of-the-art 503A pharmacies that adhere to higher quality standards, including third-party testing of all stock solutions,* and more rigorous quality processes.
Industry standards require 503A pharmacies to use aseptic processing to sterilize patient-specific prescriptions, resulting in sterility assurance levels of 1:1,000. AIS Healthcare Targeted Drug Delivery uses a proven, proprietary process that combines aseptic processing with terminal sterilization to achieve 1:1,000,000 sterility assurance levels and Beyond-Use Dates of 21 to 45 days at room temperature.†
Outside of the pharmacy, AIS Healthcare Targeted Drug Delivery does more to enhance the care experience for patients and providers. Three distinct care services provide in-home and in-clinic pump refills and maintenance, and a care coordination program offers 24/7 nursing and pharmacist support to patients. These services are designed to reduce unnecessary trips to clinics and physician offices, reducing costs and freeing up physicians’ staff to care for more patients. These programs not only support patients but also empower providers and allow them the time and flexibility to grow their practices.
“At AIS Healthcare Targeted Drug Delivery, we’re committed to doing more of what matters to advance quality throughout the care continuum,” says Simon Castellanos, Chief Executive Officer of AIS Healthcare. “We’re proud to do what’s right, not just what’s expected, at every care touchpoint.”
* Third-party testing for pH, sterility, potency, endotoxins and particulate matter
† All patient-specific dispenses within maximum concentrations (based on AIS Healthcare in-house data for 120,000 aseptically processed and terminally sterilized patient-specific prescriptions in 2019)
Two hundred years ago, a group of physicians, concerned about medication quality and safety, published the United States Pharmacopeia (USP), a set of national, uniform guidelines for drugmakers to help protect patients from dangerous or ineffective medicines.
Now, as USP celebrates its bicentennial, these guidelines remain the pharmaceutical industry standard, ensuring medication quality for patients across the country.1 The U.S. Food and Drug Administration (FDA), as well as state boards of pharmacy and other oversight organizations, use these guidelines to evaluate safety and quality practices.2
It’s critical to have accepted, proven guidelines to regulate the production of compounded medications, particularly for targeted drug delivery (TDD) medications. Quality failures at TDD pharmacies can have devastating consequences for patients. In 2012, a Massachusetts pharmacy distributed prescriptions that were contaminated with a fungus, resulting in more than 60 patient deaths.3
In 2013, Congress passed the Drug Quality and Security Act (DQSA), giving the FDA more authority to regulate the manufacture of compounded medications.4 This act incorporates USP standards, offering robust, comprehensive guidelines for every part of the compounding process, and requiring all U.S. pharmacies to follow them.
For TDD and other sterile compounders, the relevant guidelines are found in USP <797>.5 This chapter outlines the facilities and quality processes needed to produce patient-specific prescriptions that meet safety, sterility and potency requirements.
At AIS Healthcare, we’re proud to not only meet these requirements, but in many ways, we exceed them. Throughout our state-of-the-art compounding pharmacies in Dallas, Texas, and Ridgeland, Mississippi, we take extra steps and make extra investments to go beyond these requirements and produce medications of the highest quality and sterility.
All of our compounding is done by licensed pharmacists; USP does not require the compounder to be a pharmacist. We use enhanced contamination-control procedures, including full-body sterile garb for cleanroom personnel—USP just requires sterile gloves. We also get our cleanroom independently certified twice as frequently as required, and conduct environmental monitoring far more frequently than mandated by USP standards.
Additionally, we’re able to exceed USP’s Beyond-Use Date (BUD) requirements with a proven, proprietary process. By combining aseptic processing with terminal sterilization—a pharmaceutical industry standard—we are able to achieve sterility assurance of 1:1,000,000 and BUD of 21 to 45 days at room temperature.*
“The USP standards provide an essential framework for producing quality medications, especially for TDD and other high-risk compounding,” says Jonathan Hamer, Director of Pharmacy and Pharmacist in Charge, Dallas. “But at AIS Healthcare, we’re always looking for ways to do more to keep advancing quality and doing more for the patients and providers we serve. That’s why we’ve invested time and resources into building facilities and developing processes that do more to put quality first.”
Targeted drug delivery (TDD) prescriptions are usually labeled with a Beyond-Use Date, or BUD—the date or time after which the compounded sterile preparation shall not be administered, stored or transported.
BUDs help to protect patients. TDD medications are compounded and then stored in the closed system of a vial or syringe. BUDs tell clinicians when the integrity of that closed system may begin to be at risk, whether through chemical degradation, microbial contamination or proliferation, and therefore should not be administered to patients.1
BUDs can vary significantly among preparations and pharmacies based on the formulation, current scientific literature, risk of microorganism contamination and sterilization method used. For both TDD patients and providers, longer BUDs come with some significant benefits.
For many TDD patients, traveling to a hospital or clinic for a refill can be a challenge. These patients are at higher risk of missing or needing to delay an appointment. An extended BUD can reduce the stress of missed or delayed appointments, allowing more time to reschedule without needing to reorder the prescription.
For providers, extended BUDs can help reduce the financial liability when these appointments are missed or rescheduled. Under a buy-and-bill model, providers would be unable to bill for medication that was not administered prior to its BUD. A longer BUD allows more time to use the medication, and therefore more time for the patient to travel to the office or clinic. Under other billing models, re-ordering prescriptions for missed appointments can place an unnecessary burden on staff.
Extended BUDs at room temperature are especially valuable for providers. The clinic or hospital staff does not need to worry about having enough space in the refrigerator or freezer, and providers do not need to allow time for the medication to reach the required temperature before administering it to a patient.
*All patient-specific dispenses within maximum concentrations (based on AIS Healthcare in-house data for 130,000 aseptically processed and terminally sterilized patient-specific prescriptions in 2020).
At AIS Healthcare, our investment in an advanced terminal sterilization program allows us the sterility assurance needed to offer extended BUDs. Our formulary TDD prescriptions have a BUD of 21 to 45 days (average 34 days) at room temperature,* offering patients and providers more flexibility and safety assurance.
“Our proprietary process that combines aseptic processing with terminal sterilization—and our robust, independent testing—enables us to produce patient-specific prescriptions with extended BUDs,” says Jonathan Hamer, Director of Pharmacy and Pharmacist in Charge, Dallas.
AIS Healthcare has made a multimillion-dollar, multi-year investment in our terminal sterilization equipment and processes. Our proprietary terminal sterilization program is based on extensive research and was developed in conjunction with industry experts. We have conducted and continue to conduct rigorous and independent testing and validation studies, including extractable and leachable studies, of our program. We go above and beyond to meet and exceed USP <797> requirements and produce prescriptions with extended BUDs.
“We’ve made significant investments in our pharmacies and terminal sterilization program to be able to offer all the benefits of extended BUDs to our patients and providers,” says Hamer. “It’s one of the ways that our commitment to advancing quality helps to improve lives.”