Drugs have prescription status because they have effects that are beneficial but sometimes dangerous, side-effects that are dangerous or have a strong tendency to be so, invite misuse and/or abuse, and a host of other reasons. Due to these effects, the educated pharmacist has a duty, along with potential liability, to ensure the “right dose, right patient, right medicine, right time.”
Some drugs demand a heightened attention, sometimes for a reason known at the time the drug comes on the market, sometimes only after the drug has been available for a period of time. This blog entry is going to list some drugs that require this heightened attention. Further, it is going to explain that there is legal liability from the unfettered dispensing of these medications. Failing to ask a question, failing to speak to the prescriber, failure to document when you do dispense, and, in growing numbers, a failure to refuse to fill when appropriate is leading to lawsuits and/or action by the Board of Pharmacy.
Do not for a second think this is the whole list, Feel free to respond to this blog with your additions.
Obviously, the first on any list is controlled substances. Heck, I just did a two-part blog on these in 2016. But let us look at a couple of examples.
First, in 2016, (20 years too late for a lot of pharmacists) the federal government issued a statement that combining opioid analgesics with benzodiazepines was not a good idea. Mental depression, CNS depression, respiratory depression. This combination, especially among chronic pain patients, has been a staple for years. Now, pharmacists are on notice that these patients should not just automatically receive their monthly fills. When needed and appropriate, the pharmacist should consult with the prescriber where a patient seems depressed, has trouble communicating or being mobile, etc. Ignoring symptoms in favor of the prescriber’s regimen is fast becoming a dangerous gambit.
Second, this is new to me in the last six months but I am seeing chronic pain patients on the opioid-benzo combination getting an ADD/ADHD C-II Rx added to the mix. Multiple drugs that depress the body now mixed with drugs that stimulate. I am no doctor and not even a pharmacologist, but I wonder at the long term effects of such a strong push-pull effect on the body. And if that effect is substantially detrimental…well, this one worries me, folks.
On the same tact as the previous paragraph, watch out for opioid-benzo patients getting prescriptions for phentermine. Unscrupulous docs are prescribing this to avoid adding a C-II ADD drug to the regimen (it makes the KASPER or other PDMP not look quite so bad, the thinking goes). Many states, KY included, do not require pharmacists to get a BMI for a phentermine Rx. Here, I would highly advocate taking a moment of your time to look further into the propriety of the prescription before dispensing.
Sleeping pills I: with only a couple of exceptions, sleepers are indicated “for occasional use only.” Yet, I would guess that most pharmacists reading this fill benzo sleepers and zolpidem monthly for a lot of patients. Research states that sleepers will put one to sleep but they actually rob the patient of the restful REM sleep, thus creating a vicious cycle of the patient feeling like she slept badly and wanting the drug even more. As this trend of regular use of a class of drugs meant only for occasional use nears 20 years, we should start seeing studies indicating what, if any, the long term adverse effects of such therapy are. From my early days as a lawyer, when I actually did a few automobile accidents and other “Have you been injured in some kind of accident?” cases (Yes, I even had a few Fen-Phen cases), I got to know some of the tort kings. These lawyers, I can tell you, are anxiously awaiting these studies.
Sleeping pills II: a little over a year ago, the federal government handed down dosing guidelines on zolpidem, mainly that women should not go over zolpidem 5 mg or zolpidem ER 6.25. As time has gone by, many prescribers ignored this or have relaxed their prescriptions on this. But the lawsuits from females over getting the higher dose are no longer few in number. Question the prescriber and document the response if you decide to dispense the higher dose.
Long term use of cough syrups containing codeine or hydrocodone: not only has this instigated lawsuits against pharmacists for failing to consult or interfere in some way, but both federal and state entities are looking into this. If this occurring in your pharmacy, check with the prescriber. A pulmonologist or oncologist, maybe 1 time a year. Family practitioner, no less than 2 times a year. And document.
And now a few non-CS drugs.
Gabapentin: abuse and misuse of this medication is expanding exponentially. KY has labeled this a “drug of concern” and is one of several states looking to reclassify the drug as a controlled substance. Until such time, I have advocated and still do that pharmacists treat gabapentin like it is already a controlled substance: no early refills, consult with prescriber when needed, etc.
Clonidine: this is a new one for me. As heroin abuse grows, clonidine abuse matches it, due to claims (true or not I do not know) that this medication enhances the heroin “high.” Many times, as I am hearing it, heroin users either seek to get themselves or their children diagnosed with ADD/ADHD so as to get an amphetamine to treat the condition and also clonidine to take at the end of the day Watch compliance on your patients taking this drug.
Anti-psychotics: as some states tighten their Medicaid formularies, sleeping pills are being deleted. A number of third party insurances are also eliminating these or cutting patients down to 10-15 tablets every thirty days. Some prescribers are replacing these with anti-psychotics, such as quetiapine. Adverse effects from these meds have spawned a small number of lawsuits. Counsel the patient getting these drugs for sleep as to the side effects and document.
Cyclobenzaprine: there are scattered reports of abuse and misuse. Also, in one of the popular pharmacy journals this last year, there was an article reiterating that cyclcobenzaprine is indicated for 21 days or less. Us eof this drug for long term therapy is not recommended. However, most of us see continual use well beyond this time period, many of us on a regular basis. Are to the point yet where we need to do prescriber consults due to the possibility of abuse or due to the long term use? Not yet is my gut feeling here, but the day may not be far off.
Drugs on the Beers List: I have regular contact with both federal and state entities that deal with drugs in my practice. On the federal level, there is continuing , if not growing, apprehension over the casual manner in which the Beers List is ignored by prescribers. These drugs should be watched, doses adjusted, and ultimately discontinued in the elderly. At the same time, this is another class of drugs where the tort kings are watching with baited breath. Once the government lays the law down on prescribing these drugs, start watching for the TV commercials advertising whether your aged loved one has been harmed by a Beers List drug.
Pharmacists have long been aware of the need to exercise a heightened sense of awareness regarding the dispensing of certain drugs. This list, sadly and for varying reasons, is expanding all the time. With the above, and probably more, pharmacists must take the time to investigate, make calls, do consults, and document, document, document to protect themselves, though still not being able to be secure that this will provide a full shield against liability or sanctions.