Here’s a question often posed by veterinarians and clinic managers: “I have a box that automatically dispenses our drugs. Doesn’t that make my practice compliant?”
The short answer is no. Just because you invested — and it’s a significant investment — in fancy automated dispensing machine (ADM) technology doesn’t mean all your compliance issues are solved.
ADMs can be a great first step in securing your drug inventory and an important tool in an overall controlled-substance compliance strategy. If used correctly, these systems provide computer-controlled drug storing, dispensing and tracking right in your practice. They can improve security and efficiency, minimize errors, and help you capture lost billing.
But they are not a one-stop compliance solution for your business, and an ADM alone does not make you DEA compliant. Not even close. Even the savviest of software systems can be undone by machine inaccuracy and human intent or error.
Here’s a real-life example from human medicine: In Massachusetts, a pharmacy technician responsible for loading automated dispensing machines was charged with stealing nearly 18,000 pills and vials of medication, including opiates, over many months. According to court documents, the technician exploited a feature of the system by wrongly marking pills as “outdated” and removing them from the ADM.
A robust compliance system would have detected such actions. Which is why, when it comes to compliance, it’s important to think outside the box.
ADMs Are Not a Cure-All
Here are a few more critical things an ADM simply can’t do:
- Train employees. Staff who are not computer-savvy can struggle if they aren’t thoroughly trained. This can result in inaccurate dispensing.
- Stop all drug theft. An employee looking to divert can find ways around the ADM.
- Educate employees. ADMs can’t teach personnel about complicated regulations or provide ongoing education
- Prevent incorrect programming. Humans and software are not foolproof. Improper input can result in critical mistakes or even diversion.
- Ensure patient safety. Critical mistakes can have critical consequences.
- Provide security outside the box. While your ADM can analyze data, it can’t be relied on to monitor interior and exterior drug-diversion threats.
- Prevent overrides. Internal drug theft often begins with administrative access to controlled-substance supplies.
- Track waste. ADMs can’t manage proper waste disposal.
- Create SOPs. ADMs can’t create internal operating strategies and procedures, something many practices lack most.
- Screen employees. Preventing drug diversion starts with a thorough hiring process.
- Install security. Cameras and video surveillance should be installed by an expert who knows where to place the equipment based on U.S. Drug Enforcement Administration requirements.
Your Reputation Is at Stake
To be fair, the salesperson who sold you the ADM probably had a solid understanding of the product and a good idea about how the box should comply with compliance standards. But the salesperson probably wasn’t a DEA-compliance expert. Or a former DEA agent or investigator. Or ever been involved in a formal DEA inspection or audit.
If you think your ADM has your back, it might be time to rethink how you protect your business and reputation.
Since the opioid epidemic began, many DEA employees have left comfortable government jobs to work for the same pharmaceutical companies now under legal scrutiny for their roles in the drug crisis. However, few DEA investigative experts left government service to train and educate those in the part of the supply chain most impacted by the crisis: health care practitioners, especially in the veterinary industry.
When I retired from the Drug Enforcement Administration five years ago, I contemplated how to use my knowledge and skills to bridge the controlled-substance compliance gap between the health care industry and criminal justice organizations. From my perspective, finding solutions for opioid abuse shouldn’t fall solely on law enforcement. The entire supply chain has a collective social responsibility to do everything possible to stop the diversion of drugs. But what does that look like?
When Veterinary Clinics Fail
In 2018, my company conducted onsite inspections of 78 veterinary hospitals and practices from New York to Hawaii. Each had at least five DEA-compliance violations, and the average was 11. Without remediation, the average fine per facility would have been more than $165,000 ($15,040 per infraction).
Here were the most common violations found:
- Poor recordkeeping: Not having a DEA readily retrievable file, not keeping signed and dated records of controlled substance invoices, lack of authorized user logs, missing DEA 222 forms and lack of or inadequate standard operating procedures.
- Inadequate security: Failure to conduct background checks, a lack of employee screening statements, improper camera surveillance in required areas, and a lack of alarm systems or building-access systems.
- Reconciliation issues: A lack of or inadequate biennial reporting, a lack of or inadequate usage logs, and missing inventory records.
- Improper waste disposal.
Almost none of these violations could have been prevented by an ADM. Of even greater concern, many of these facilities had previously hired a “compliance expert.” Most of these individuals had a comprehensive understanding of compliance regulation from experience in pharmaceutical or veterinary practice management, but they had no practical experience in compliance law enforcement.
Experience Counts
Compliance requires more than a comprehensive understanding of regulation. True expertise requires a working knowledge in multiple disciplines, the most important being an in-depth understanding of DEA regulations.
To say someone without real-life experience in compliance law enforcement can provide a total compliance solution is like saying a podiatrist can perform brain surgery because he is a doctor. Certainly, a podiatrist could become a brain surgeon with a lot more training, but if you need neurosurgery, you’re not going to choose a podiatrist.
In addition to remediating internal and external solutions with regulators, a legitimate compliance expert will have expertise in:
- Risk management.
- DEA audits.
- DEA investigations.
- Education and training.
- Policy development.
- The law.
DEA-compliance experts will first evaluate your protocols, then develop and engineer the appropriate compliance program for your unique controlled-substance inventory. They will construct a “compliance box” around your storage box that will provide the proper security, training, education, legal assistance and peace of mind that your hospital can stand up to a real compliance inspection.