High-cost specialty pharmaceuticals have become an attractive target for bad actors. A former Veterans’ Administration pharmacy technician, for example, was recently charged with allegedly stealing $8.2 million worth of HIV drugs and re-selling them.
Drug diversion and misuse are also costly problems. For example, the cost of diversion to public and private medical insurers is more than $72 billion per year, according to the U.S. Department of Justice National Drug Intelligence Center.
The patient safety implications of drug theft, diversion and misuse are even more concerning than the economic impact. If products are tampered with and this abuse goes undetected, patients may receive diluted medications or worse yet, drugs that are contaminated with dangerous substances or viruses that could cause dangerous infections.
In response, health systems are developing drug safety strategies with multiple programs and protocols. Becker’s Hospital Review recently spoke with Dave Sandberg, RPh, pharmacy director of CHI St. Alexius Health Williston (ND), about this topic. He shared his organization’s approach to drug safety which includes a variety of product and process innovations, in combination with monitoring, reporting and analytics.
Product safeguards are the first defense against drug diversion and misuse
CHI St. Alexius Health Williston has adopted several tamper-evident products to support its drug safety strategy. In the operating room, the organization uses anesthesia syringes manufactured by a 503B compounding pharmacy. These devices include tamper-evident locks at the end of the syringes, so it’s very noticeable if someone has compromised the product integrity.
For controlled substances, the health system uses syringes with tamper-evident seals. “This is very important, because it’s very easy to withdraw controlled substances from a non-tamper-evident vial or syringe, fill it up with saline and put a new seal on it,” Mr. Sandberg said.
For intravenous drugs, CHI St. Alexius Health Williston has developed a multistep approach to safety. Once pharmacists have injected medications into IV bags, they apply seals over the ports. If these seals are broken, the team knows the product has been tampered with.
Once IV bags reach patients, the clinical team may follow certain protocols, depending on the nature of the medication. “For epidural pumps and PCA pumps, we use lock boxes,” Mr. Sandberg said. “The IV bag with controlled substances is secured in the box and the nurse is the only person with a key to it. This limits who can access and potentially tamper with the IV bag.”
The organization also uses IV smart pumps to administer intravenous drugs. These devices monitor administration rates. Any unusual readings may be a red flag pointing to possible drug diversion or misuse.
“Looking ahead, we hope to deploy IV smart pumps that integrate seamlessly with our electronic health record system,” Mr. Sandberg said. “Those will automatically record administration rates and further improve patient safety.”
Processes in combination with technology add another layer of patient protection
Track and trace is a major component of health system drug safety strategies. Ideally, organizations should be able to track drugs from the manufacturer all the way to the patient bedside.
“With prices for specialty pharmaceuticals running as high as $40,000, you have to be very careful about stolen goods, counterfeit drugs and gray market products,” Mr. Sandberg said. “If you aren’t sure of the source, that’s a big concern.”
Mr. Sandberg noted that pharmaceutical manufacturing technology has almost advanced to the point where radio-frequency ID (RFID) tags can be placed in medication vials to track drugs all the way to the bedside with the lot number and expiration date.
For non-intravenous drugs, CHI St. Alexius Williston has implemented automated dispensing cabinets which serve as drug safes on the nursing units. These technology-enabled devices work hand in hand with automated processes to ensure patient safety.
When a provider enters a prescription order into the EHR, the order is sent to the pharmacy system. After the pharmacist verifies the order, it is then transferred electronically to the automated dispensing cabinet and attached to the patient’s profile.
“The nurse goes to the automated dispensing cabinet and pulls up the patient’s name,” Mr. Sandberg said. “The medications ordered for that individual appear on the screen. When the nurse touches the screen, the drawer pops open with the exact medication for the patient. This is an important aspect of our drug safety strategy.”
The safety process doesn’t end with the automated dispensing cabinet, however. The nurses then barcode scan every medication at the bedside before administering it to the patient. If it’s not the right medication or the right time, the nurse receives an alert. CHI St. Alexius Williston is approaching 95 percent to 100 percent barcode scanning at the bedside to protect patients from the wrong medications.
“We have a daily code scan report that I share with the nursing staff and leadership,” Mr. Sandberg said. “If something doesn’t scan properly, we work closely with our IT department, pharmacy and nursing to find out why. When issues arise, we work as a team and try to solve problems in near real time. Our goal is to drive automation all the way to the bedside.”
Reporting and analytics identify areas where further investigation is warranted
The third component of CHI St. Alexius Williston’s drug safety strategy is ongoing monitoring and reporting. Every month, the organization monitors controlled substance usage patterns to look for potential diversions.
Another tool is incident reports. Nurses, pharmacy staff or other employees can initiate these reports whenever they witness errors that have occurred in the drug administration or medication management process.
Conclusion
Drug security is a complex challenge and requires a multilayered solution. Leading health systems like CHI St. Alexius Health Williston are taking a 360-degree view and surrounding their pharmaceutical inventories and medical devices with robust processes and technologies to enhance patient well-being.
“Patient safety is our top priority and we want to monitor possible tampering very closely,” Mr. Sandberg said.
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