By Michael R. Cohen, President Institute for Safe Medication Practices
Although it’s not within our purview as a federally certified patient safety organization (PSO), healthcare consumers sometimes send us complaints about their pharmacy shorting them on the number of tablets or capsules they’re supposed to get when a prescription is dispensed. It seems like we’ve gotten a lot of these recently so I thought I’d share some thoughts. Of particular concern is that reported episodes often involve federally listed controlled drugs such as prescription opioid narcotics like Oxy-Contin, Vicoden and Lortabs or sedatives like Xanax or Ambien.
Consumers tell us that when they identify missing pills they call the pharmacy to inform or complain about being short and the pharmacy insists it dispensed the proper quantity. Neither party believes the other. The pharmacy thinks the patient or someone in their home removed some tablets (either for themselves or for the black market) and the patient thinks the same about the pharmacist and/or their staff. So it basically winds up being a “he said, she said” situation. So where are these drugs going? What are can be done to provide better control?
Recently an ISMP staff member attended a pharmacy continuing education presentation that was organized by a high school principal. During the program three high school students urged pharmacists to warn patients picking up narcotic and other addictive prescriptions about the potential for abuse and theft by teenagers visiting their homes. They relayed countless stories about how easy it was for them to obtain these drugs to support their habits. One brave teen recounted the lowest moment in his addiction- when he visited his grandfather, newly diagnosed with cancer, not to comfort him, but to steal his pain medication! In the Partnership Attitude Tracking Study (PATS) Teen 2008 report, 58% of teens indicated they get their prescription drugs from their own family’s medicine cabinets and 42% said prescription drugs are available everywhere. How scary is that?!
We make it way too easy for kids who want to take on the risks of drug abuse. In the U.S., community pharmacists dispense almost all oral solid drugs, including narcotics and sedatives, as loose tablets/capsules in a plastic vial that is labeled for the patient. This manner of dispensing makes it easy to understand how diversion of a few tablets here and there is possible. In truth it can and does happen at either end of the dispensing chain. If you as a consumer truly believe there is a problem, then, as hard as it may be, you need to expect the worst. If hopefully you can assuredly rule out home diversion, then you need to report incidents to chain pharmacy headquarters or the pharmacy owner so that investigation, tracking and appropriate action can be taken. However, know that my pharmacy colleagues almost uniformly tell me that complaints about possible pharmacy diversion are rarely substantiated.
As a former hospital pharmacist, I know that hospitals are certainly not immune from diversion by staff. Still, controls are much better than in pharmacies because each dose of controlled drug must be accounted for separately. Special packaging called “unit dose” is employed, where each tablet or capsule is packaged in a tiny individual envelope or blister. These are in strips and usually are numbered to make it easy for nurses to maintain inventory counts. Otherwise there’s a running count kept on the nursing unit through a computerized drug control system. As each patient’s unit dose is removed from a drawer in an automated dispensing cabinet, the inventory count changes. At any time, a nurse or pharmacist can account for every single dose.
Drug control is also far better outside the US where unit dose or unit of use packaging (a sealed patient package containing a quantity that is typically prescribed) is widely used by pharmacies. This past week I checked with some colleagues in Europe who use patient packs almost exclusively, and not just for those that are federally controlled. They have worked with manufacturers, doctors and computer system vendors to standardize the available quantities. This gives manufacturers a critical mass of standard sizes, which makes it financially viable. Pharmacists no longer have to count pills and they rarely ever hear from a patient about missing doses.
It seems to me that if unit dose or patient packs were used by US community pharmacists, a lot of the disputes that patients have could be eliminated and we could enjoy much better control. Manufacturers could produce sealed packages of unit dose packages that dispense a numbered strip once opened. Patients and pharmacists would be able to readily identify the quantity of pills being dispensed and the patient could be asked to sign for and agree to the amount at the point of sale (as per amount printed on outside of the sealed container). End of these ongoing disputes! Such packaging would also help consumers in detecting home diversion by a teen or other person who has access to their home because the quantity remaining would be readily identifiable.
There are important safety reasons for unit dose or unit of use packages too. It could help prevent medication errors. Rather than just going by tablet or capsule appearance, you will see the drug name on the label for every dose. That can help you spot a dispensing error, especially on renewals. There is also the redundancy of having the complete drug name and strength on each unit dose package or blister as well as on the pharmacy's label. Controlled drugs like Lortabs and Vicoden also contain acetaminophen. All too often patients do not know this and they often take an acetaminophen product in addition to what’s in these drugs. Too much acetaminophen, though, can cause liver damage. Greater recognition of acetaminophen content could go a long way to reducing the problem of double dosing. ER physicians would also have a readily available way of knowing what drugs have been taken since they won’t only have loose pills to identify in emergencies.
To me, the “patient pack” idea makes a lot of sense. Yet sadly, in speaking to pharmacy owners about this idea I find that they are not all that receptive. They argue that it would cost more (it might – maybe a few pennies for each dose but surely it would be worth it) and patient packs also take up more storage space on pharmacy shelves. Doctors would also have to be trained to prescribe only in quantities available in patient packs or in multiples of available package sizes. These are all specious arguments in my opinion, given the crisis we’re seeing with prescription drug abuse. I see this as not only completely doable but also as a critically needed change in the way we’ve been doing things all these years.
Even the White House has recognized there’s a public health crisis. They recently unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the US. Just last month the FDA announced that they’ve sent letters to manufacturers of certain long-acting controlled drugs because of ongoing abuse, misuse, addiction, and overdose resulting in fatalities. They informed the companies that they’ll have to develop training tools for prescribers to assure safe use and also educate patients in the safe use, storage, and disposal of opioids. I wish they would have asked manufacturers to look into patient packs for controlled drugs but that didn’t happen. However, as they plan to address the REMS, I do hope repackaging of these drugs will be on the radar screen.
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