Mark W. Caverly, who was an investigator for 31 years, in charge of diversion policy with the Drug Enforcement Administration (DEA), was policy chief of diversion control when he retired from the DEA. He is now senior controlled substance compliance consultant with BuzzeoPDMA, a Cegedim Relationship Management company, consulting with manufacturers, pharmaceutical companies, hospitals, and other providers, including opioid treatment programs (OTPs), on compliance and regulatory issues.
With more than 1.5 million providers with DEA registrations (registrants) to handle controlled substances, the DEA has a lot of turf to cover. About 1,400 of these are OTPs. Not only does the DEA enforce drug law, but it is a regulatory agency, issuing licenses and registrations to individuals and companies that want to handle controlled substances.
The DEA conducts unannounced inspections for certain categories of registrants, OTPs among them. There are three main points for OTPs to remember about these inspections, said Mr. Caverly: 1) Expect an inspection every day, 2) Be prepared for it, and 3) Manage it when it happens.
- Expect the inspection: OTPs need to have a mindset of expecting an onsite inspection at any time. “You won’t get a call; they’re going to come, so anticipate them,” said Mr. Caverly.
- Prepare for the inspection: Know how your OTP will respond to an inspection, even starting from when the DEA investigators first walk through the door, recommends Mr. Caverly.Have a contact tree, starting with the receptionist. Determine who will sign the notice of inspection presented by the DEA investigators, and, if that person is absent, who the backup person will be.Arrange for a quiet place for the inspectors to work. Have a DEA “ready-book,” as some OTPs refer to it─a binder that includes copies of any federal and state licenses, corporate background information, names and titles of responsible individuals at the OTP─and keep that book up to date. The book should also contain building diagrams, specifications of vaults or safes, dispensing hours, and all the other information that the DEA may ask for.Any OTP that has already been subject to an inspection will have an easier time preparing. Not only does the “ready book” facilitate a smoother investigation, but “it tells the DEA investigators that the OTP is managed well from a human level,” said Mr. Caverly. “It presents a more professional presentation.”
- Managing the inspection: The key part of the inspection from the OTP’s point of view occurs at the end, when the DEA inspectors sit down with OTP staff and administration, and go through their findings, said Mr. Caverly. There won’t be any surprises: as the investigation took place, any problems the inspectors found would have been obvious. “If the OTP can correct whatever these issues are right away, before the inspectors leave, it will be better off,” he said.Usually, the problem is not a diversion issue: it’s recordkeeping. “It’s not stealing methadone, it’s that the staff gets overwhelmed by the number of clients, and they get sloppy,” said Mr. Caverly. Take notes when meeting with the inspectors, and pay close attention to recordkeeping issues. During an inspection, the DEA will take an inventory of the medication you have on hand, and look at your records to see what was purchased and what was dispensed. Without good records, you’re not going to be able to satisfy them.
One of the most important aspects of paperwork is documenting your shipments of methadone.
OTPs need to use Form 222 when they document receipt of methadone (or any other Schedule II medication). This paper form now has an electronic equivalent, called the CSOS (Controlled Substance Ordering System). The DEA has been encouraging providers, including OTPs, to use the CSOS instead of the paper Form 222.
“If you’re an OTP and you request supplies of methadone, you have the option of using the old style form on paper, Form 222,” said Mr. Caverly. This paper form has been in use since before the DEA replaced the Bureau of Narcotics and Dangerous Drugs in 1973─some older forms even still say BNDD on them. When CSOS came along, suppliers and providers had the option of using it instead of Form 222, said Mr. Caverly. “Most suppliers are using CSOS instead of form 222,” he said. If the methadone supplier is using CSOS, the OTP has to use it as well. The main difference is that CSOS is online, and there is a computer link between the OTP and the supplier, so the OTP can document the quantities received, and the date.
One problem OTPs frequently run into is the electronic nature of CSOS receiving, Mr. Caverly told AT Forum. “This catches a lot of registrants. I saw it in the DEA, and I still see it as a consultant─they frequently miss linking the receipts electronically with the order.”
Initially, when the DEA set up CSOS, they meant it to substitute for the paper 222 form. But what most registrants do is print out an electronic version of the 222 form, and use it to make physical notations, just as they would on a paper form. This isn’t legitimate: the DEA regulations are clear that the information must be electronically linked, said Mr. Caverly.
“I don’t think the CSOS software is particularly user-friendly,” he said. “That’s why they pick the paper copy in lieu of electronically linking─but they’re supposed to stay within the CSOS software.”
So what should OTPs do if they have problems electronically documenting received methadone? “The best thing is to contact the supplier,” said Mr. Caverly. “Sometimes the supplier of the methadone also supplies the software link.” For example, a pharmaceutical company that supplies methadone and sets up the OTP with the CSOS software could also “walk the OTP through” the linkage process.
Many providers are having problems with the CSOS linkage. “It is so very common,” Mr. Caverly said. “I was at a client this past week and they weren’t electronically linking their receipts with orders . . .”
The problem is endemic in health care─everyone is familiar with paper. But OTPs have to decide on one or the other─the paper 222 or the online CSOS. With pharmaceutical companies using the CSOS, providers need to use it too and make sure their receipts are electronically linked with the originating orders. Technically, not doing so is a recordkeeping violation, said Mr. Caverly. However, he cannot recall a single time when the DEA cited a registrant for this kind of violation.
One last comment on inspections: if the inspectors come during dosing, they are less likely to get the appropriate individuals to spend time with them, said Mr. Caverly. “In my experience as an investigator, I would try to wait until after dosing hours,” he said. “I would try to minimize the disruption to the OTP.”
Cegedim is a technology information and services company, working with pharmaceutical and medical device companies internationally, focusing on the commercial process. In 2005 Cegedim acquired BuzzeoPDMA, which focuses on compliance with the DEA and Food and Drug Administration (FDA). Mr. Caverly is a member of the BuzzeoPDMA team, which consults to providers within the supply chain of controlled substances.