Prescribers, Pharmacists Prepare for Tamper-Resistant Prescriptions

CINDY SANDERS

Prescribers, Pharmacists Prepare for Tamper-Resistant Prescriptions
After a six-month reprieve, federal legislation is set to go into effect April 1, 2008, requiring Medicaid outpatient prescriptions to be presented to pharmacists on tamper-resistant pads containing at least one security measure.



In Tennessee, this new mandate impacts written prescriptions for TennCare patients. Exceptions to the tamper-resistant requirement include electronically transmitted prescriptions such as an e-prescription or a fax from a physician’s office, as well as prescriptions called in to the pharmacy by a physician or other recognized prescriber. Drugs administered on site at skilled nursing facilities and some other institutional and clinical settings are also exempt.



The legislation, which was slipped into the Iraqi War Supplemental Appropriations Bill, took many in the healthcare industry by surprise. After it became clear that it would be impossible to meet the original October 2007 start date, affected stakeholders were given an extra six months to gear up for compliance.



Official correspondence from the Centers for Medicare & Medicaid Services (CMS) to state Medicaid directors, said that, “The CMS strongly supports state program integrity measures and wants states to be aware that both e-prescribing and use of tamper-resistant prescription pads may reduce instances of unauthorized, improperly altered, and counterfeit prescriptions.”



While it might seem the easiest answer would be to rely strictly on electronically transmitted prescriptions, it’s important to note that a supply of tamper-resistant prescription pads should still be kept on hand as prescriptions for schedule II controlled substances cannot legally be transmitted electronically.



Baeteena M. Black, DPh, executive director of the Tennessee Pharmacists Association, said her chief concern is for patients. While the law will heavily impact TPA members, the bigger worry is that patients might see a disruption in receiving necessary medicines.



Once the law goes into effect, she explained, “Pharmacists are given no leeway. It’s very important for the entire prescriber community to learn about this.”

Although the federal mandate was limited specifically to Medicaid patients, the scope of the law is expected to be considerably broader in actual practice.

“It is for TennCare only, but realistically someone isn’t going to carry two prescription pads in their pocket,” pointed out Russ Miller, CAE, senior vice president of the Tennessee Medical Association.



Of the attempt to reduce fraud, he added, “It doesn’t hurt as long as it doesn’t unduly burden medical practices. You have to factor in that it’s an unfunded mandate.”



Dave Beshara, chief pharmacy office for TennCare, noted that, “There’s certainly a need for programs within the medical arena that help reduce fraud.”



He added that this program does put an additional layer of security into the prescribing process but said he’s taking a “wait and see” stance on effectiveness. As he pointed out, those bent on committing fraud often find ways around the technology, as has been seen with counterfeit money even in the wake of heightened security measures.



In an effort to lessen the chances for prescription abuse, Beshara said that CMS has focused on three broad security elements to make a prescription “tamper resistant.” Prescription pads must include the following characteristics for compliance:


  • A design to prevent unauthorized copying of a completed or blank prescription form;

  • elements to prevent erasure or modification of information written by the prescriber; and

  • a design that prevents the use of counterfeit prescription forms.


“For April 1st, you need to have one feature from one of those three characteristics,” he explained. “For October 1st, you’re going to need to have one element from each,” he continued, regarding the second phase of requirements coming later this year.



Beshara said that TennCare staff has reviewed industry-recognized guidelines and surveyed stakeholders including pharmacists, representatives from the printing industry and other healthcare trade organizations.



“We’ve coalesced this (information) into what we think are both practical and feasible recommendations,” he said, adding that security measures must not only be applicable but must also be easy to implement and monitor if they are to be effective. The suggested guidelines have already been sent to thought leaders for input. The projection was to have practical information posted online at http://state.tn.us/tenncare/pro-pharmacy.html by the time this issue of Nashville Medical News was released.



Beshara said that a number of suggestions are being explored in each of the categories. To prevent unauthorized copying, one option is to have the word “void” embedded, to show up only if someone tried to copy the prescription or blank pad. Watermarks and microprinting technology are other options that would fulfill this first criterion.



In the second category, which calls for deterrents to prevent erasure or modification, some simple measures include turning quantity and refill information into pre-printed boxes that are check-marked by a prescriber. Instead of having the word “refill” followed by a blank line, a tamper-resistant pad might have a check box beside the numbers “1,” “2,” et cetera. That way, Beshara said, it prevents someone from adding an extra numeral to turn a handwritten “1” into a “12.”



The third area, which requires elements to prevent the use of a counterfeit form, utilizes similar technology to that employed in printing money. Options include a security back print that would require a pharmacist to hold the prescription at a certain angle to see a security marking or the use of thermochromatic ink that would change colors if copied.



Black said printing a list of security features used on the pad is crucially important so that pharmacists know the elements for which they are screening. It’s also a key concern in maintaining good customer service.



“You can see how that would really slow down a practice if every time someone comes in, I have to go down the list of 20 or 25 different possible characteristics that would qualify for making it meet the CMS criteria for being considered tamper resistant,” Black pointed out. “Please don’t make us try to be the super detective to figure out which feature is embedded in this piece of paper.”



Undoubtedly, the new federal law will cause increased administrative burden. Pharmacies will have to have quick access to copiers, magnifying glasses and other tools needed to test prescription pads.



However, impacted organizations are trying to lessen that load for their members. Miller said the TMA has already negotiated with several preferred vendors to offer some discount for printing new prescription pads. Black said that TennCare and prescriber organizations have been very receptive to hearing pharmacists’ concerns.



Beshara was also quick to praise stakeholders and said that healthcare organizations have offered a lot of useful insight. “They make our lives a whole lot easier because they understand the legal, medical and business ramifications.”







April 2008