Monthly Archives: January 2017

Interns and Legal Issues

Interns.  At one time—for some of us a long, long time ago—we were all pharmacy interns.  Working for pitiful wages back in my day, but hourly rates that jumped considerably when the shortage got significantly worse, gathering hours necessary for licensure, developing relationships that led to opportunities,  jobs and lifelong friendships.

Today, internship requirements have evolved form they were back in my school days.  Some duties and restrictions created by the Boards of Pharmacy have come and gone while others remain in effect.  The end result is that interns, like their pharmacist preceptors, in the face of expanding duties and responsibilities, also face increasing liabilities.

The legal doctrine towards professional students in the experiential part of their education is that these persons are expected to make mistakes.  Errors are part of the learning process, and thus the patient who consents to be treated, diagnosed, or counseled by a student is usually assuming  a risk not taken with the licensed professional. However, there  are a growing number of exceptions to this philosophy, the main one being the corresponding responsibility rule.

But first let’s remind the person seeking to become a pharmacy intern of his/her responsibility.  In most states, you must be actively enrolled or have been accepted to a college of pharmacy (CoP) before you can become an intern.  Contact the state Board of Pharmacy or look on their website to see what the requirements are for becoming an intern.  Depending on the state where you seek to be an intern, the CoP must be either approved, accredited or—in at least one state—“recognized” by the state Board of Pharmacy; check with the Board to make sure your CoP is acknowledged by the Board.  An application must be filled out and filed with the Board.  Some of these will require a background check and drug test.

When you get your intern registration, keep in mind how often it must be renewed.  File your collected intern hours in a timely manner—some states require monthly, others longer periods of time.  Also review the intern rules to see when your registration is good: for most states it is good while you are enrolled in a CoP, on a scheduled break from school, awaiting licensure exam and awaiting licensure results (the latter two are called “graduate intern” in most states but there is usually no difference in status or duties you can perform).  There may be circumstances where you will need to contact the Board to continue active registration.  For example, a CoP student leaves early in the semester due to the death of a parent.  Usually, contacting the Board and assuring them you will return to school the following semester or academic year suffices to continue active status.

Finally, make sure your pharmacist is a registered preceptor.  Having a non-preceptor sign papers that you worked 200 hours of internship and seeing those hours lost is something I see a little too often and nothing I can do about.  Those hours are lost.  At the beginning of your internship, preceptor and intern need to discuss fully those duties the intern may perform, both as seen by the Board and the pharmacist-preceptor.  Employers and preceptors may further limit what the law allows but the intern should question this when the limitations get to the point of negating the educational experience.  I have heard stories of pharmacists who hire interns but then do not let them do anything delegable, instead turning them into cashiers.  That is not learning how to be a pharmacist.

Pharmacists, if you are not a preceptor, become one the minute your state permits you to do so.  We need you to help provide the experiential part of the pharmacy student’s education, as important as any class that student has sat or slept through.  Most states will require an association as a community based faculty member and this means some extra training.  Usually this is accredited and can fulfill continuing education requirements. Make sure you are acquainted with the CoP’s experiential goals.

  1. Time to move on to legal issues. Interns can and do have legal issues.  Quite often, this is when they step over a line.

Performing a duty that is not recognized as a pharmacist delegable duty, even if the preceptor tells the student to perform the duty, is acting outside the scope of the pharmacy intern.   This is why most CoPs have students take their pharmacy law class before they embark on rotations—they have a knowledge of what the law permits.  Acting without authority opens up the student to liability and sanction by the Board.  Do not perform the final verification of a prescription.  Depending on whether your state allows it, do not counsel a patient or do not counsel a patient outside the range of the preceptor.

Ignoring a duty is also actionable.  Refusing an order from a preceptor or refusing to perform a delegated duty provides a basis for ending the internship at the pharmacy level and possibly open the student to Board and CoP sanctions.

One duty that some pharmacy students ignore raises the ire of state Boards.  And that is reporting the preceptor for acts that are illegal.  Even in the 21st century, some pharmacists will tell the intern to fill prescriptions, even doing the final verification.  After this, some pharmacists actually leave the pharmacy—go to lunch, get a haircut, go check on the husband, etc.  Hard to believe this still occurs today, and the number of incidents is decreasing, but it does.  The preceptor who does this usually intimates the student with fear of failing the rotation (if a rotation student) or ruining their school career.

Another example here is when the pharmacy intern, again out of fear, does not report an impaired preceptor.  The pharmacist who takes advantage of having an intern or rotation student to drink or take drugs is also a dying, but not quite dead yet, breed.  Patient lives are at stake; act accordingly for them.

In both of the above, the intern should report the preceptor to the director of intern rotations at the CoP and to the Board of Pharmacy.  Do not be in fear.  Report it.  Having dealt with these issues, I can pretty much categorically state both entities will rally round the intern.   And keep in mind that permitting these acts to occur and not reporting them places the intern  in peril.  Should a Board discover that a pharmacist left an intern alone at a pharmacy or that the preceptor was impaired AND the intern did not report—that is likely to be the end of the intern’s career.

Other issues that some interns still face, despite our being such an advanced society:

–discrimination.  Whether gender, sexual orientation, race, religion, or national origin, you do not have to put up with acts or words that insult your status.  In the pharmacy, we are expected to work and act together as a team for the betterment of the patients.  Intolerance of any sort should be quickly reported.

–sexual harassment.  This is hard to believe but it still exists in the workplace where the personnel are mainly licensed professionals.  Inappropriate language and/or touching, demands for sexual favors—whether for a good grade, a passing grade, or not—should be immediately reported to the CoP, the Board, and, if appropriate, to the next highest official at the place of employment or rotation.

Finally, the question: “Should I, as an intern, get malpractice insurance?”  Especially before fourth year rotations, my answer is “yes.”  Under the corresponding responsibility rule, interns can be included as a party to liability where the intern’s action contributed to the harm to a patient or a violation of pharmacy law.  Besides, it is pretty cheap.

Becoming a pharmacist is a daunting task, a challenging curriculum in a CoP, and internship that can be as tasking as it is rewarding.  Interns should make themselves aware of the requirements, find a good preceptor, and acquaint themselves with the possible pitfalls.

Drugs to Watch

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.