Do independently owned pharmacies, medical offices, etc., need to reconcile their inventories of controlled substances (i.e. Vicodin, Valium) with any governmental or other outside agencies? I can understand how a major pharmaceutical chain, such as Walgreens or CVS, or the medical center at a teaching hospital would have oversights in place that would make unauthorized use very difficult for even their highest ranking employees. However, what’s preventing the pharmacist/owner at an independently owned pharmacy, or a physician who owns his/her medical practice from doing so?
In both instances, all of the other employees that would be able to detect and report misuse are employees of the person in question, who would have the sole authority to dictate how these employees carry out their duties. Plus, the pharmacist or physician would own, or at least have unrestricted access to the entire facility, and I would assume be the legal owner (subject to legal constraints) of the drugs. Obviously it would be difficult for them to turn their business into a full scale drug dealing operation, because they need to purchase these drugs from legitimate outside sources, but I’d think that it would be easy for someone with both access to both the room where the drugs are stored as well as the inventory and financial records to feed their own personal addiction without setting off any alarms.
Do the governmental authorities responsible for these types of drugs conduct any type of oversight over independent entities, or do they just rely on professional ethics on the part of both owners and employees to at least curtail abuse? And no, I’m not a pharmacist or a doctor mulling the pros and cons of raiding their own stash. My curiosity was piqued after I read a newspaper article this morning while visiting relatives about an update on the situation of a local dentist who, among other things, was caught abusing Fentanyl from his own supply.
The people with the teeth are the licensing boards for those that handle the medications. Threatening someone who handles high level controlled substances with 6 months in county is a trivial threat. They get out and go right back to work. Suspension or revocation of their license is a serious threat.
IIRC all pharmacies have some kind of relationship with DEA or a similar regulatory body that has the authority to inspect them and or audit their inventory.
Yes and no. Yes, in that Ohio Law (Ohio Revised Code 3719.07) and Administrative Rule (Ohio Administrative Code 4729-9-14) pretty clearly delineates that every single step along the way, from acquisition, to dispensing, to destruction, has to have a paper trail when dealing with controlled medications. Part of those requirements state that, at the time the person in charge takes over, a complete controlled substance inventory must be performed, which then has to be repeated every 2 years or whenever the person in charge changes. However, unless the Board of Pharmacy sends in an agent to do a random audit, those records aren’t viewed by the Board at all. It’s largely an honor system with the threat of a random audit to keep practitioners in line.
Professional ethics should prevent it in most cases. Fear of getting caught/audited and losing one’s license to practice in the rest (given how time consuming and expensive it is to acquire a pharmacy/medical license). Though you might be surprised at how long an individual diverting/misusing/abusing narcotics can get away with it, even in a chain retail pharmacy like CVS or Walgreen’s. The retail company I work for had to let a pharmacist go earlier this year because said individual had been stealing certain narcotics for at least 6 months before finally being caught.
The Ohio Board of Pharmacy has told us (in law class in Pharmacy school, and again in CE’s they sponsor) that they take seriously any report of potential diversion, including anonymous tips, so a concerned employee in Ohio would merely need to contact the Board, who could do anything from sending in an agent for a “random” audit, to a “sting” to catch the person in question in the act.
Controlled substances records are kept by both the selling entity (Wholesaler or another Terminal Distributor) and the buying entity, under Ohio law, so alteration of those records by a pharmacist/physician would very quickly show discrepancies if the Board decided to compare the two. Further, once the drugs are in the possession of the terminal distributor (be it a pharmacy or a physician’s office), every single thing that could happen to the drugs has to be documented. Given to a patient? There’s a doc for that. Returned to the wholesaler unused and in date? Doc for that. Sent to be destroyed? Doc for that. Missing (in “substantial” quantities)? Document for that which has to be faxed to both the local DEA office AND Board of Pharmacy as well as be kept on file locally.
But yes, in theory, if the person in question wasn’t going crazy with it, they could get away with drug diversion for quite a long time before getting caught.
I remember reading a very long discussion on a pharmacy blog way back that came to the same essential point. Meaning if for whatever reason the pharmacist or owner whatever wanted to divert drugs as a one time thing it would be easy to get away with.
What isn’t easy to get away with is making it a habit, once it happens several times and becomes a pattern that is when the DEA or licensing board will become interested and you’ll be under the microscope.
Back when I worked at a pharmaceutical company over a decade ago, I was in charge of our entire drug inventory, which included a number of controlled substances. We would get bi-yearly visits from the DEA that wanted to see our record keeping system and conducted very detailed interviews with me and the main users of the drugs for research. While I can’t recall everything they asked, they did want to see records of what we ordered, and when, where it was stored under lock and key, who had access to those keys, etc. Then they would ask random questions like: tell me how much di-hydro testosterone you have on hand, where it is stored, and who the last person was that accessed it.
While exact amounts could not always be accounted for due to spillage, failed experiments that weren’t recorded, etc., the amount we were off was never more than about 50mg. It was always way less than an amount that could account for any kind of real abuse, and we always passed with flying colors.
Interestingly, in the early days of punitive drug regulations it was often the state pharmacy boards who led the rough work of investigations. raids. and arrests. At least, that’s how it was in California so I assume it was similar in other states as well. Given that traditional LEOs at that time usually had little or no experience enforcing the new drug laws, perhaps it seemed to make more sense to have it done by the state boards.
DEA tracks Schedule 1 and 2 drug transactions (high potential for abuse, little or no legitimate medical use). They send Diversion Investigators out to perform audits (in some cases, with little or no warning), compare them to the DEA-222 forms required for a provider to purchase, and note discrepancies. Back when I worked for DEA, there were several pretty high profile cases (organized crime diversion of things like Oxycontin and such). Sending in undercover agents to buy restricted pain meds with weak stories (usually just saying “my back hurts… I want Oxycontin”) and surreptitiously recording the whole affair, sans any meaningful examination, would do the trick. These docs are commonly referred to as “scrip mills.”
Same in Canada; most countries probably do this. Inventories are tracked. All inventory in and out must be accounted for. If you dispense X you must have a doctor’s prescription for it. A friend of mine worked a while ago on a program which put all prescriptions in one province into a database. Among other things, it allowed pharmacists to catch people doctor shopping for multiple or fraudulent prescriptions, but it not only allowed the authorities to track drugs prone to abuse - they also used the results to “consult with” doctors who appeared too lax in their screening or criteria for prescribing that sort of medication. The Doctors’ College would issue warnings and discipline from time to time if it appeared some doctor seemed too easy a mark for drugs. Sometimes they were banned form prescribing these drugs.
Also, remember the L&O episode where the pharmacist faked a “flood” (failed sprinkler system) to create the excuse to dispose of inventory and order new inventory. The implication in that show was that prescription medications were tracked going in and going out.
I suppose a pharmacist could dilute their supply to siphon off a portion; but there’s a limit to how much you can dilute medication before it becomes noticeably ineffective (the premise of the L&O show). However, with many medications now in prepackaged pills, that becomes trickier to do. The premise of the show was that the pharmacist was diluting non-narcotic expensive medications for money.
My curiosity was piqued after I read a newspaper article this morning while visiting relatives about an update on the situation of a local dentist who, among other things, was caught abusing Fentanyl from his own supply.