HIPAA–What Can Pharmacists Say?

I have been inundated with HIPAA cases recently.  Of these, only a few had merit.  It seems like someone gave the public a bad lesson in this law and it is being mis-interpreted so badly that every word spoken by a pharmacist is considered a HIPAA violation.

This is not helped by employers whose HIPAA  training takes the same tone.  Most of these programs take the attitude that words spoken in the pharmacy should be few and so innocuous that those hearing them might not even understand what is being addressed.

The Health Insurance Portability and Accountability Act was enacted to, among other things, protect patient privacy.  Many states had highly differing laws regarding the privacy of medical information in different settings, and there was no federal example or precedent to follow.  Several provisions address what and how much Protected Health Information (PHI) can be obtained, passed along to other parties, and used in counseling.  It even goes so far as to specify the destruction of PHI—specific garbage cans, who can have access to it, etc. However, while well meaning, the law has created a number of issues, among the top being verbal HIPAA violations in the pharmacy.

These usually arise because most pharmacies, while not physically accessible, are so open that words spoken in the prescription area can be easily overheard by the visiting public.

This discussion does not include counseling.  HIPAA acknowledges that counseling may well be overheard as many states do not mandate private counseling areas but rather understand that pharmacies are public forums.  Counseling is vitally important to proper and timely health care.  Therefore, counseling is generally acknowledged to have NO privacy or privilege or confidential nature.

What the public does not realize is that there are three primary HIPAA exemptions.  For these, health care providers are under only one constraint in the use of PHI.  These exceptions are 1) communications  with  the patient, 2)  billing and3)  communications between healthcare providers providing direct care to the patient.

The latter is often misconstrued as being communications between two or more entities at different locations: pharmacy and doctor’s office, doctor’s office and hospital, etc.  BUT this also includes persons in the same space, such as a prescription area of a pharmacy, such as discussions between two pharmacists, a pharmacist and a technician, and a pharmacist and a pharmacy intern.

These conversations may be overheard and someone may become aware of some PHI regarding a patient of the pharmacy.  However, these conversations are important and essential to proper and timely medical care—weighing the public hearing a piece of PHI against the patient’ s health and well-being—there is no doubt which way this needs to come down.  That is why these discussions are exempted from HIPAA.

I mentioned above that there is one constraint.  This is the Minimum Necessary Information (MNI) standard.  Basically, HIPAA does provide that when PHI is discussed, this standard be the basis of the conversation.  Some legal commentators say the MNI standard even follows the three exemptions and most employers train their pharmacy staff in this manner.  Other commentators, myself included, believe the MNI standard does NOT follow the three exemptions, that these exemptions should be conversations as full and frank—as detail oriented—as the health care providers sees fit in her exercise of professional judgment.  A legitimate fear is that a health care provider following the MNI standard might, in the interests of protecting privacy, inadvertently or deliberately omit something the patient or other provider would have seen as important.

Further, there is a fourth exception recognized by the feds and the states: the educational exception.  When there is a pharmacy student or intern in the pharmacy, conversations seeking to expand and fulfill the education experience should also be unfettered.  Patient privacy is protected by the college of pharmacy which teaches and trains its students in respecting patient privacy and following applicable law.  Most employers additionally have interns and rotation students take that company’s HIPAA training before letting them into the pharmacy environment. Thus, students come prepared to learn but not to share.

There are two rules to follow in pharmacy conversations about patients

  1. Is the conversation necessary? Does the comment or question really need to be made?
  2. Does the conversation follow the MNI standard? While I do not like nor agree with this standard, some Boards and employers do.  Pass along everything you consider necessary, but stop there.

Some employers also want their employers to ask before speaking: Is it appropriate?  While this may seem like a restatement of the “necessary” rule above, some HIPAA cases arise because pharmacy employees do give inappropriate information as part of a discussion.  Some comments are easily determinable as inappropriate—the patient is divorced, the patient’s father is an alcoholic, his son take amphetamine sfor school—but may become necessary with the patent history (was alcohol the only drug misused/abused) or drug regimen.  Here, the pharmacist’s professional judgment should dictate what words to say and what facts to relate.

Some employers also like the adage, “When in doubt, leave it out.”  This is not good patient care.  The opposite should be followed; “when in doubt, include.”

One thing in which there is no doubt, wading through the waters of HIPAA is quite tricky and is full of traps.  A violation or breach of HIPAA opens the person who does so to huge fines from the federal government, exclusion from federally funded programs, as well as Board action and a permanent black mark on their record.  However, pharmacists’ primary goal must continue to be providing the highest quality of health care, and having whatever discussions needed to provide it.

What Do I Do If…?

What do I do when

I get a forged or altered prescription ?

The first thing is to think of your safety.  Giving back the Rx is not a desirable solution, as it merely pushes this issue off on another pharmacist at another store.  But you should make a decision to give it back or retain based initially on any possible danger to yourself and the staff.  Do so if it seems the safest thing.
If you keep the Rx, you must ascertain that it truly is forged or altered within a reasonable time.  Once this is done, you must call the police.
A couple of notes:  what is a reasonable time?  If during office hours, usually no more than a couple of hours.  If after, waiting until the next day is usually reasonable.

 

If you feel the danger is substantial and you think the safest choice would be to fill the Rx, will the Board punish you?  No, as long as doing this is not a habit.  And if you do this for a safety reason, call the police after the “patient” leaves.

What do I do if

I catch someone in the pharmacy stealing/diverting CS?

Immediately remove the person from the pharmacy.  Terminate the person.   Check your state law–it may require you call the police and have the person prosecuted
Inform the Board of Pharmacy.  Most states have a requirement that such acts be reported.  The Board can act against the license or registration to prevent the person from being employed at another pharmacy.
Do a CS inventory to determine just how many CS doses have been stolen/diverted.  Fill out a Form 106 and provide to the DEA, Board and any other entity required by your state law.

What do I do if

There is a doctor who continually OKs early fills on CS Rxs?  Listen to your professional judgment and then listen to me.  Refuse to fill.

When a doctor OKs early fills more than one time, get a reason and document on the hard copy.  If the prescriber continues and you see no legitimate reason, refuse to fill early.   When the doc sends the patient elsewhere, notify whatever state entity you need to.

Remember, there are lots of legal cases out there that state pharmacists have liability for continual early fills

What do I do if

I forget to get all my required continuing education?

Self-report to the Board as soon as you realize your mistake.  Pay the fine and do the additional CE.  Most states will, after a period of time, permit you to get this pharmacy law violation expunged from your Board record.

Don’t try to hide it.  Your CE goes to a national database today and discovering your lack of required hours is not hard.  And the punishment for hiding it is much worse in most states and THAT does not get expunged.

What do I do if

I want to be a PIC at two locations?

Most states permit this, but usually only for a limited period of time.

Make a written request to your Board.  Nmae both locations and addresses, acknowledge you will be spending the required number of hours at each location, state why you need to be PIC at both locations, and provide a time period, at the end of which you expect the second location to have its own PIC.

Some state Boards require an appearance before the Board to discuss this.  But Boards are reasonable and they almost always allow this under reasonable circumstances

What do I do if

I am licensed in three states and one of the states punishes me for a pharmacy law violation.  Do I inform the other two state Boards?

It would not hurt to do so, and they might see your coming forward in a better light.  But punishments by Boards these days go into a national database.  The other two states will become aware no matter what.

And be prepared.  Almost all the time, the other two states will match the punishment of the original violation state.

What do I do if

My PIC quits and the other pharmacist does not want the position?

PICs in most states must be onsite 10 hours a week.  Boards overlook those weeks when a pharmacist is on vacation, ill, on a business trip, etc, so long as this does not go over 30 days.

Most Boards will allow a pharmacy to go without a PIC for up to 30 days, but check with your state Board.  Make sure you inform the Board within the required time that your PIC has left.

30 days is considered enough leeway for you to find a new pharmacist who will be your PIC.  Within the required time, inform the Board that your new PIC is in place.

What do I do if

The sole pharmacist on duty becomes ill?

Of course, the primary goal must be to go to the aid of the sick pharmacist.

I am guessing here that you mean sick enough to be unable to function professionally.  In this case, all states pretty much have law that says all pharmacy business must cease.  Even the verified prescriptions in the waiting bins cannot be sold.  If the pharmacist leaves, all pharmacy personnel must leave the pharmacy area and the pharmacy must be closed off.  If this cannot happen, the entire store must close.

What do I do if

The local doctor’s nurse leaves one voicemail but with multiple Rxs for each patient, and she talks 100 miles an hour.

Erase them.

You want to take a chance on getting something rwrong from somebody who is through spouting prescriptions before you can get your inkpen out of your pocket?  This is like bad handwriting—only one case has held a doctor responsible.  Otherwise, it is the pharmacist’s fault for not clarifying the handwriting, or the voicemail.

I listen to voicemails 3 times.  If I have any questions, I then call and have the nurse give me the prescription again, all of it.

If I have an issue like you mention (and I have), I fax a protocol to the doctor’s office and give them a couple of days to conform: no more than two patients per call, no more than a total of five prescriptions per call, birthdays must be included, no voicemails for CS after office hours, etc.  When they do not follow these protocols (and after having been warned in the fax) I

Erase them.

 

Got a “What do I do if…?” question.  Submit it to pharmacylawsource@gmail.com  When enough come to me, I will do a Part II to this blog

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.

“On The Premises”/”On Call”

“On The Premises”

Phyllis Pharmacist and Mary Pharmacist are working at their respective chain pharmacies when the Board of Pharmacy inspector comes in.  When the inspector asks to see their current licenses, Phyllis goes to the back room and gets her purse from her locker.  Mary runs out to her car where she leaves her purse while on duty.  Board Inspector writes up one of the pharmacists for not being “on the premises.”

Who did BI write up?  Pharmacy law requires pharmacists while practicing to have their license “on their person” in most states; neither one here did.  The answer is: BI wrote up Mary for leaving the premises.  Boards have acknowledged that purses may be used to divert prescription medications and they are OK that purses may be stored outside the pharmacy per company policy.  The important note here is that in order to get to her license, the pharmacist may NOT go outside the premises.

For a pharmacy to conduct the usual and customary business that a pharmacy performs, a pharmacist must be “on the premises.”  When a pharmacist is not present, ALL pharmacy business must cease.  No sale of previously verified prescriptions, no new prescriptions or refills being prepared, no information being fed into a computer.  Indeed, if the pharmacist is truly off the premises, all pharmacy personnel must leave and secure the pharmacy area.

On the premises was once defined as “under one roof.”  As long as the pharmacist was in the building, business could continue even if the pharmacist was outside the pharmacy area.  To a degree, this continues today.  If Phyllis or Mary makes a quick trip to the bathroom or goes out front into the OTC area to counsel a patient on an OTC drug, or merely runs up front to buy a snack, she is still on the premises.

But this rule is no longer 100%.  When the pharmacist leaves the pharmacy for an extended period, especially if this is for a planned event—such as a meeting with the supervisor or a lunch break—even though the pharmacist is still under the same roof, the pharmacy should be closed.

Be careful here.  The rule does not go 100% in the opposite direction.  A quick outside-the-pharmacy private talk with a pharmacy supervisor need not require a closure; a pharmacist eating in the pharmacy need not close the pharmacy if she can be interrupted to conduct business.

Whether or not to close during a pharmacist absence from the pharmacy area?  Let us look to three criteria: time outside the pharmacy, intent to leave, and availability.  While there is no hard and fast number of minutes that determines whether a pharmacist is “off the premises,” pharmacists should always seek to minimize time out of the pharmacy area.  I would guess that up to ten minutes would not necessarily call for closure, but I would start leaning strongly toward doing so for any absence longer than 15 minutes.  Intent is the same; if the pharmacist intends to be outside the pharmacy for any purpose longer than 15 minutes, closure should be strongly considered.  Finally, a pharmacist outside the pharmacy area who desires that business be ongoing should be immediately available to return to the pharmacy for such acts as she is required to complete.

And a pharmacist can actually step outside the building and still be “on the premises.”  She must be outside for a minimal length of time and she must be conducting pharmacy business.  I have stepped outside for a minute or two to give a vaccination to a patient who had trouble with mobility.  I have taken prescription medications out front to patients with mobility problems that would not fit through the drive-thru window drawer.  Boards find such acts acceptable.

An area where issues have arisen with being “on the premises” is in the hospital setting, especially in the new mega-hospitals with the Women’s Hospital connected to the Children’s Hospital connected to the Heart Hospital.  Boards of Pharmacy have had issues with a pharmacist going from one type of hospital to another (while never going outside, mind you) and still being considered “on the premises.”  Even in some of the single larger hospitals, Boards have shown reluctance to acknowledging being on the premises when the pharmacist is some distance away from the pharmacy.  Usually this is of little concern as larger hospitals have more than one pharmacist on duty at a time.  Hospital pharmacists need to be 1) immediately and easily communicated with (eg, via cell phone) and 2) able to return to the pharmacy when required within a few minutes at most, immediately if needed.

Another “on the premises” question Boards face somewhat regularly: is a pharmacist still on the premises if part of the pharmacy is separate from the main prescription area?  I have seen pharmacies where a compounding room is separate from the prescription area but under the same roof.  The Board was fine with that.  In another matter, a pharmacy had two sections, separated by a public corridor.  The pharmacist had to cross the corridor, locking one door behind her and unlocking the other.  The Board agreed that she was still on the premises so long as there was instant and easy communication—intercom, cell phone—and an ability to immediately return across the hallway.

“On Call”

Kentucky (and every other state that I am aware) requires its hospitals to provide 24 hour service, having a pharmacist on call when the pharmacy is closed.  While on call situations almost always refer to hospital pharmacies, these can be easily relatable to the home health or other pharmacy that seeks to provide 24 hour service through an on call pharmacist when the pharmacy is closed.

Two cases pretty well sum up the on call issue: Tom Pharmacist and Joe Pharmacist are on call pharmacists at two different hospitals.  One night they both receive calls to come in and prepare medications for extremely ill patients.

Tom gets in his car and makes the 45 minute drive to the hospital.  He is too late ; the patient has died.

Joe gets in his car and drives his usual route.  At a train track, where Joe has never encountered a train before at night, there is now a train, and it is stopped.  Knowing the alternate route to the hospital would add 20 minutes to his drive, Joe waits a few minutes, then a few minutes more after he hears noise that sounds like the train was starting.  Then he gives up and drives the alternate route.  He arrives at the hospital too late; the patient has died.

Both families of the patients learn that if the pharmacist had arrived earlier, the patient might well still be alive.  Both sue the hospital and the pharmacist for undue delay in providing the medication needed to save their loved ones.

Joe is able to show that his usual 10 minute drive was lengthened by the train and that trains at night along that roadway were rare.  As it turns out, the train 1) was unscheduled for that time and 2) the engine had broken down, causing the stop across the roadway.  The court granted summary judgment for Joe and his hospital.  Joe had made every reasonable effort and the train being there, and broken down, was unforeseeable.

Tom and his hospital were found liable.  The court held that on call services were generally of an emergency nature; therefore, the hospital pharmacist should be able to respond in an undue amount of time.  Living 45 minutes away was too far, the court held.  While the court refused to say how close to the hospital an on call pharmacist should be, it brooked no argument that 45 minutes was simply and clearly too far.

To determine the questions relating to being “on the premises” and “on call,” pharmacists should refer to their state law.  Most pharmacies, retail and institutional, usually have adequate policies in place that match the law.  Where there is any doubt, be cautious and conservative in considering whether an absence from the pharmacy is acceptable.  If a situation looks to be ongoing, such asrequiring so many minutes to reach the hospital or crossing a corridor, write the Board and get a written opinion as to whether this is acceptable in their opinion.

–sponsored by Pharmacy Law Source, PLLC

THE RIGHT TO REFUSE TO FILL A PRESCRIPTION

In 1978 the New York state court of appeals rendered a decision: pharmacists have no right to refuse to fill a prescription.  Of course, in this same time period, other courts held forth in cases like MCLAUGHLIN V SUPERX, LESLEY V SHRAKES, MCKEE V AMERICAN HOME PRODUCTS, and so on.  These cases did not directly address the right to refuse, but they laid duties and responsibilities upon pharmacists not previously attached to the profession.  The NY CA had belittled the profession in its decision, trying to hold the profession to the same standard as a SCOTUS justice once did: “no more important than a sales clerk.”

Of course, pharmacists are more important than sales clerks, and the NY holding faded into obscurity.  No other substantial interference with the right to refuse arose until 2004 when Illinois governor Rod Blagojevich issued an executive order directing the state’s pharmacists to fill all legitimate prescriptions.  This arose out of the conscience/moral/religious objections some pharmacists had to dispensing certain medications in the early 2000s.  The state’s pharmacists chose to file a lawsuit challenging the order; little came of the lawsuit but the definition of just what is a “legitimate prescription” again saw the order fade into almost oblivion.

However, the question of a right to refuse to fill a prescription has not, in and of itself, faded totally away.  Pharmacists are still having issues that arise.

Can a pharmacist refuse to fill an opioid prescription for a chronic pain patient if the fill is several days early?  Absolutely.  The casebooks are replete with examples of pharmacists being held liable for not doing so.  May the same pharmacist refuse to fill a prescription for a child because the child’s race or religion?  Absolutely not.

What criteria are essential for a legitimate refusal?  1)  The refusal must have a sound basis.  Don’t say that you refused to fill your ex-girlfriend’s new boyfriend’s prescription just because you think he is a son of a —–.    He may be, but that is no basis for refusing.

2)  The refusal must be based on professional judgment (PJ) and/or a scientific reason.   However, the basis for the PJ or science need not be 100%.  A reasonable suspicion of harm, abuse, etc is all you need.  And let’s define “reasonable” once again as “more likely than not,” or 51%.  Be 51% sure and act.

Example: Joe Pharmacist gets a phone call from Peter Patient.  Peter has determined that his insurance will pay for his oxycodone five days before it is due and he wants it filled then.  Joe says no, as he is aware of the cases mentioned above.  A legitimate  refusal?  Sure.

Example: Joe Pharmacist checks Patty Patient’s profile.  Patty is taking her estrogen hormone replacement therapy irregularly.  Joe talks to Patty, who says she takes the estrogen only when the hot flashes are “intolerable.”  Joe checks the literature which states the chance for cancer from HRT goes up exponentially with intermittent use.  Joe refuses to refill Patty’s prescription.  A legitimate refusal?  Obviously, this is a harder one.  Let’s make it more difficult: what if the prescriber tells Joe to fill it anyway?  I still hold that this is a legitimate refusal, though not of the same level as the first example.

In the second example, cases vary.  Some have held pharmacists liable, due to our superior knowledge of medications, while others have held that patients have “assumed the risk” after being counseled by the  pharmacist.  The second example is occurring more and more often.  I recently had a pharmacist contact me with a patient who had a heart attack and yet wanted to stay on his Adderall XR 30mg, 2 caps QD dose.  The patient’s prescribers all wanted to have the patient stop the drug but the patient claimed that the Adderall was the only way he could get out of bed and face the day (it was adjunctive therapy for depression).  I had the pharmacist refuse to fill until the patient signed a “Memo of Understanding and Waiver of Liability.”

As I wrote above, this scenario is occurring more and more often with medicines and their interactions, as well as interactions with medical conditions, state rules, CDC guidelines, etc.  Pharmacists dispense dangerous medications (“that’s why they are prescription only!”) but the fact that they are prescription only or are being legitimately prescribed is not enough today to protect the pharmacist from liability.  As a profession, we have a duty and responsibility to act or refuse to act when the necessity exists.

An issue with refusals that creates problems for pharmacists that occurs frequently is when another pharmacist—partner, PIC, pharmacy supervisor—steps in and fills a prescription after it has been refused.  For a while (it has fallen off recently), I had regular complaints of prescriptions being refused and a pharmacy supervisor coming to the store and filling the disputed Rx.  This is, way more often than not, purely and completely wrong.

Yet, many employers hesitate to turn down any prescription, especially in these days of shrinking reimbursement.  Numbers do help make up where fee per prescription are half of what they used to be.  But this is understandable only to a degree.  Patient health, preventing abuse and misuse, and professionalism must supercede.

To step in and do what another pharmacist has refused to do is an interference with PJ.  It undermines the pharmacist-patient relationship, it undermines the PJ of the first pharmacist, it provides those who complain with an outlet for dis-satisfaction with a pharmacist (OK if the act was wrong but wrong if the refusal was correct, as it often seems to be as described to me).

What do you do if another pharmacist steps in and fills a prescription you denied?  Talk to this person first and see if the matter can be resolved between you.  Stress that a basic precept of professionalism is respect for the acts of other pharmacists.

Consider contacting your Board of Pharmacy.  State Boards generally protect PJ like a grizzly bear protects her cubs: strongly, ferociously, and quickly.  Look for a pattern of abuse of PJ before doing so—don’t bother a Board over one incident—the Board will rightfully tell the two of you to work it out between you.  But if there are repeated incidents do what you need to act.

The right to refuse to fill a prescription is not under massive attack by corporate masters, employers, patients and prescribers these days but the right is still being challenged, and often.  Pharmacists should take appropriate steps to protect not only their professional status but also their license to practice.

 

NOTE: this article only touched on the right to refuse for reasons of conscience or morals.  Readers interested in this aspect of refusing to fill a prescription are referred to my earlier blog on this topic.

NOTE: got an idea or question you would like to see the subject of my blog?  You can email me at pharmacylawsource@gmail.com  Your name will not be mentioned and dates, names, places will be changed.  Facts of the case will be altered but only enough that the basic issue of the case/question remains intact.

ILLEGAL/INAPPROPRIATE PRESCRIPTIONS

In the early 1980s I was working relief a day every week in a small town in western Kentucky.  I would occasionally get HCTZ and Lopressor prescriptions from a prescriber.  The name on the top of the Rx blank stated “Dr.John Smith.”  There was no designation after the name, so I filled these several times before I was made aware that the prescriber was a dentist.  The techs where I was working said the dentist “helped out” the local docs by treating hypertension when he saw it in his office.

These prescriptions were illegal in that they were outside the scope of practice of the prescriber.  Dentists are not trained to diagnose or treat hypertension.  And pharmacists who fill the prescriptions can get into a LOT of trouble. (see below)

There are two basic types of illegal prescriptions.

The first is the forged, altered or unlawfully possessed prescription.  KRS 217.214 addresses this in Kentucky.  When a pharmacist has a reasonable suspicion that a presented prescription is forged, altered or unlawfully possessed, the pharmacist MAY retain the prescription.  I capitalized “MAY” because the pharmacist makes the decision whether or not to seize and retain.  The main consideration here is the pharmacist’s safety—if retaining may compromise safety, the pharmacist can return the prescription to the customer.  First and foremost, keep yourself safe in these situations.  (in an extreme case, if you feel that not filling an obviously forged Rx would endanger you, fill it.  As long as you don’t have a handful of these Rxs in your files, the Board is unlikely to sanction your action)

Let us take a moment and define “reasonable.”  If another pharmacist with similar education, skills, and experience would consider the likelihood of forgery or alteration to the same degree you do, you are acting reasonably.  Another way to look at it is to view it under the legal phrase “more likely than not.”  If you believe—not 100% but at least 51%–that more likely than not that an Rx is forged, you may seize and retain.  Seizing and retaining under reasonable circumstances and belief cannot result in liability, even if it turns out the Rx was legitimate.

The second type of illegal prescription is the inappropriately prescribed medication.  The scenario at the beginning of this blog is a perfect example.  Here are some more provided to me by Kentucky Drug Control:

-A dentist prescribing large prescriptions of narcotics for his mother (he was taking them)

–An APRN prescribing alprazolam with multiple refills (pharmacists fill these scripts all the time, uggh)

– An APRN without a CAPA-CS (left practice,they terminated her CAPA-CS, she kept writing controls)

-A doctor prescribing himself Ambien

-A PA calling himself in Ambien under doctor’s name

-A dentist requiring patients bring in their controlled substance prescriptions for him to keep and dispense as needed from office (he is in prison)

-Several cases of providers calling in medication for “patients” and picking it up themselves for “some reason”   HUGE RED FLAG

-Lots of cookie cutter prescribing or “no-exam” Don’t be afraid to ask the patient if anyone took medical history/performed medical exam and what their diagnosis is!

-OB/GYN prescribing to men

-A pediatrician prescribing to ADD meds to adults

-A psychiatrist prescribing Lortab/alprazolam/carisoprodol combinations

-Stolen blanks from an orthopedists in L-ville and pharmacists keep filling the month of Xanax 2 mg rx they wrote, no questions asked- RED FLAG!!!

-Lots of cases where the provider fails to KASPER patient prior to prescribing controlled substance

100s of promethazine w/cod scripts (>300ml) from docs states away for made up patients and person picking up lives in another state – all forgeries and Rph fill them all the time

 

Let me add anorexiant prescriptions where the patient does not meet the manufacturer or legal BMI requirement.  (In my previous blog on Controlled Substance issues, I already touched on postdated CS Rxs)

When a prescriber writes an inappropriate prescription, too many of us ignore this and fill it.  What I thought was a problem of the past is quite prevalent today, and these Rxs lead to a number of lawsuits every year.

What the pharmacist should do is two things: 1) retain the prescription or return it to the patient after writing on the face of the blank the reason that the prescription is inappropriate, then contact the prescriber and explain; and 2)if the prescriber persists in writing these Rxs,  report the prescriber to the appropriate administrative board and/or Drug Control.

If problems arise from these prescriptions being filled, the pharmacist should expect the punishment from the Board to be of greater degree than for a misfill or other error emanating from a legitimate prescription.  Is a jury or the Board going to just look askance because the prescription was inappropriate and illegal?  Hardly.  Under the doctrine of corresponding responsibility, if not already established as a principal duty, a pharmacist should know the prescriber at the very least well enough to determine the legitimacy of the prescription written.  What kind of prescriber?  What is the scope of practice?  Does this Rx fit within that scope? are the questions you must ask.

One of the many dangers here is that malpractice insurance does not cover “criminal acts” and insurers consider filling illegal prescriptions a criminal act.  So, if you fill digoxin for a patient with CHF and the prescription comes from a dentist, and then the patient suffers harm from the drug, the award or settlement to the patient (or family) from the ensuing lawsuit will come from the wallet in your back pocket.

But a lawsuit may not be your biggest worry.  The Board of Pharmacy can sanction you for the harm to the patient under KRS 315.121.  The Board has the right to revoke your license for life and they have shown that they are not afraid to use this right.  And it does not stop there.  The Board can provide evidence of filling an illegal prescription to the state attorney general’s office.  Since filling an illegal prescription is considered to be a criminal act in itself, you can then be prosecuted by the AG.

Prescribers writing inappropriate/illegal prescriptions is more prevalent today than most of us think.  As pharmacists, we need to be aware of the ability of a prescriber and what he/she can actually legally prescribe.  The consequences of failing to do this can be devastating to a career.

CONTROLLED SUBSTANCE ISSUES Part 2

The last blog reminded pharmacists that these days we need a CS policy in place.  CS issues belong to the pharmacist on duty, as does the liability.  An agreed upon, settled policy between pharmacists in a pharmacy benefits not only the professionals but also the public.   The policy makes it plain to customers/patients, owners, managers, supervisors, etc., how CS Rxs are going to be treated at your location.

Now let’s move on to those issues that are commonly seen and provide some guidelines for dealing with them.

–What can you change, not change, or modify on a C-II prescription?  Since June of 2005, I have suggested that you print out page 4 of that month’s Kentucky Board of Pharmacy newsletter.  It details what you can change or modify and what cannot be changed or added.  June 2005, reprinted Sept 2010 newsletter.  Print out and post it

–A seemingly big issue right now is whether or not the patient’s address on the sticker placed on the back of the CS Rx meets the requirement for the patient’s address being added to the Rx before filling.  Actually, this is the prescriber’s responsibility.  I am seeing  more computer generated Rxs that have addresses on them, but there are plenty of prescribers who do not put them on the Rx.  The address is required, so if the prescriber does not add it, we must.  What the law states about the address or the prescriber’s DEA being on a sticker on the back versus being added to the front of the Rx blank actually does NOT matter at this point.  Everybody has been doing the stickers for upwards of two decades with no one being sanctioned by the Board or any other entity.  Thus, the government has accepted this practice and WAIVED its right to enforce the law, IF it actually requires the address on the front of the blank.  If the Board told you tomorrow that you were being fined for not meeting the law, a first year law student could get you off.  However, keep in mind that the Board or DEA could announce that they were going to start enforcement at some specific time in the future and then start punishing those who failed to conform after such notice.

–No CS Rxs for a practitioner writing for himself.  No CS Rxs for family members only in case of emergency—going to have to exercise your professional judgment to determine if it is an emergency.  Document your reason if you do fill

–On a partial fill for a CS Rx, can you go over the prescribed amount?  No, a partial fill is less than the prescribed quantity

–Days supply limit on a CS Rx.  The Board opined a couple of years ago that a 90 day supply was OK, even on a C-II.  The law does not address this specifically

–This has been described as a “can of worms.”  The DEA came out with provisions stating that a properly “populated” refill request form can serve as a new Rx for a CS.  Since these forms do not conform to the KY CS security prescription blank of 902 KAR 55:105, can we really use them?  Under a strict interpretation of the law, I would have to say “no” but once again, this is something pharmacies have been doing and the Board has not acted against any pharmacist for doing so.  If the Board gives notice that after a certain date, this practice must be stopped, then stop.  Until then, hard to say that following these DEA provisions is truly illegal.

–Phoned in C-IIs are not permitted in KY.  What if you know the prescriber and have a relationship with the patient and the prescriber is in a state that follows the federal law that states phoned in C-IIs are legal?  No.  If the same type of prescriber inside KY cannot do this, then you cannot accept such an Rx from outside KY

–What about methylphenidate from an APRN in a neurology practice for treatment of MS induced fatigue?  Not more than a 72 hour supply in KY.  The APRN was not associated with a psych doctor or facility, which is required for more than a 72 hour supply of psychostimulant drugs in KY.

–E-prescribed CS Rxs.  Not as bad as you think.  They are legal.  The Rx must have a security statement or notice on the Rx when it prints out.  All required information that should be on a written Rx must be here.  No, there is no prescriber signature required.  Like a phoned in Rx, you must sign all e-prescriptions for CS.  And when you put the sticker on the Rx, do not cover the security statement or notice.  A C-II and you don’t have the drug in stock—you don’t give the Rx to the patient to take elsewhere—have the prescriber issue a new Rx to the other pharmacy

–Can we sell pseudoephedrine products based on our professional judgment and skip Methcheck?  No.  Let me put it this way: when the Board catches you doing this, don’t even call a lawyer.  Just say “bye-bye” to your license to practice.

–CS Rxs “For Office Use.”  NO!  Make an invoice (date, buyer name & address, seller name & address, drug name & strength, quantity, price, etc) and use a Form 222 id C-IIs drugs are involved.

— Post dated CS Rxs remain a problem.  The Board considers these to be illegal Rxs.  I was once told that the Board would probably severely punish any pharmacist caught filling a postdated CS Rx AND then turn the evidence over to the Attorney General’s office to have the pharmacist prosecuted by that entity.  Not worth it. Confiscate the Rxs, inform the prescriber a new Rx must be issued, and if there is an ongoing  problem, call the phone number below

–While we are on the subject, you cannot modify, ignore, or change a “Do Not Fill Until” date, even if the prescriber says you can.  New Rx.

–KASPER reports can now be shared or given to prescribers and the patient

–To dispense a CS Rx, you need the patient’s SSN.  If they do not have one, a driver license number.  If neither, all zeroes.  If a child’s first ADD/ADHD Rx and they have no SSN, fill the Rx but tell the parent/caregiver they have a month in which to get the SSN.  For pets, all zeroes, NOT the owner’s SSN.

–BMI.  You are not required to get a BMI to fill a prescription for an anorexiant.  However, if your professional judgment says to, do so.  I recently had two prescribers ignorant of the minimum BMI for writing phentermine Rxs; one of the patients had a BMI of 22!  The law requires a BMI of 27 for anorexiant Rxs, or down to 25 if there are co-morbidities.  (Manufacturer recommendations for the new drugs, Belviq and Qsymia, are a BMI or 30 or 27 if there are co-morbidities)  Keep in mind that while the Board does not require you to get BMIs, they also would have no problem punishing you if you filled a number of Rxs where patients did not meet the BMI requirements

–Doctors and other prescribers who are prescribing inappropriately or over –prescribing.  Contact DEPPB at 502-564-7985.  This is not the KY Board of Medical Licensure.  These people will investigate.

  1. That is It for now. I was submitted more than this to address and if you are interested and let me know, I will do a Part III in the near future.  Keep in mind that laws change—the above is, to the best of my knowledge, current.  And also remember that where I suggested acts of commission or omission, these are guidelines.  Your professional judgment should rule.

Many thanks to those who asked questions or provided ideas for this blog.

As I wrote at the beginning of the first CS Rx blog, the situation is now a fine balance between taking care of the legitimate patient—and there are a lot of them—versus meeting legal requirements versus unscrupulous prescribers and patients.  Err, even innocently, and you endanger your license.  Be overly cautious and the deserving patient suffers.  There is no easy answer.

CONTROLLED SUBSTANCE POLICY Part 1

Recently I blogged on the topic of who determine policy in a pharmacy, “Who’s The Boss?”  The response was positive and more than a few of you suggested I follow-up with some suggestions of forming policy.  Specifically, most of you want guidelines on making your own policy on Controlled Substance (CS) prescriptions.

I can understand why.  Opioids are epidemic in the US.  There is plenty of legitimate use of these drugs, but even that is overshadowed by the misuse and abuse.  State and federal governments, after such disasters as the two chains in Florida dispensing millions of CS tablets and the pain pill mills in Florida and Ohio, look over our shoulders (to a point, deservedly so) to an extent that we oft-times question our own professional judgment.  Kentucky recently handed down guidelines on the dispensing of buprenorphine products and the feds sent out new guidelines on prescribing CS.  The law on CS is not easy and neither is formulating a CS policy.

As in the “Who’s The Boss?” blog, the pharmacist on duty at the time is the pharmacist responsible for the CS policy.  It is not the Big Three chain, the regional vice-president, the district manager, pharmacy supervisor or PIC; it is you.  Obviously and often, these entities may hand down policies.  These are guidelines and should only be interpreted as such.  The final decision belongs to the pharmacist and his/her professional judgment.  However, recognize that these policies often reflect sound judgment themselves.  While ignoring them is the prerogative of the pharmacist, should the pharmacist do so in a manner detrimental to patients and/or the employer, the result of such action may be termination.

Here are a few suggestions:

  • Get all the pharmacists in your location to agree, at least for the most part, on how you address filling, refilling, dispensing CS. A large portion of the emails and calls I get are from pharmacists whose partners vary substantially in policy, one preferring a “fill only one day early” policy and the other “may fill 3 days early.”  This tends to have questionable patients seek the one pharmacist.  Corporate hierarchy may mis-interpret this as the stricter pharmacist not being customer-friendly.  And it may bring the attention of the Board to the early-fill pharmacist. If you cannot agree, then stand your ground.  It is one thing to compromise to a standard less than you consider appropriate, but if a jury or the Board later decides it was negligent or illegal, you are going to regret your decision all the more.
  • Follow this ranking for CS Rxs: a) applicable state and federal law, b) prescriber instructions/professional judgment*, c) company policy, d) third party restrictions, and, finally, e) patient wishes. If you want to reverse c and d, I am not going to argue.
  • Do not be afraid to question a prescription. Not every prescriber is scrupulous; not every prescriber keeps up with current law.  For example, look at the number of prescribers who continue to postdate CS Rxs; this has been illegal since 2009.  Also, I recently got a phentermine prescription for someone with a BMI of less than 23 (and no co-morbidities).  The APRN who wrote the prescription had no idea of the restrictions under 201 KAR 9:016.  Filling this could have gotten me into trouble comparable to the APRN for writing it.
  • Do not be afraid of customers. One of the popular pharmacy magazines recently printed an article about the ways customers are currently employing to get early fills of CS.  My policy is to respond to all of these by saying: “If your doctor okays the early fill, I will do it.”  However, unscrupulous customers, aware of the end of the pharmacist shortage, are now employing the tactic of threatening to call corporate on a pharmacist who  refuses to do an early fill.  In today’s corporate philosophy of “we apologize for everything,” even pharmacists acting correctly, the tendency is to favor the customer no matter how wrong they are.  Pharmacists fear for their jobs.  Sometimes the customer will even make the call, hoping the pharmacist who has been written up (and is one step closer to termination) will be afraid of being fired and will succumb to  threats of another call.  Some pharmacists are falling for this—do not join them.  The good customer/patient knows when a fill or refill is available and cooperates with you.
  • Set your limits and make sure the patients know them. Every patient who gets chronic CS Rxs should be told that that you only fill on the day due, only one day early, etc etc.  Stick by your limits. I used to suggest posting CS policy once it has been decided on by the pharmacists, but many pharmacies—indies and chains—thought doing so was exhibiting something too negative for public consumption.  I do recommend that you do write up your CS policy and keep it handy for argumentative customers.  Handing them a written policy more often than not impresses even the most recalcitrant. (See example below)
  • Buprenorphine: a) I now recommend for buprenorphine-only prescriptions for addiction that the pharmacist get documentation that the patient is pregnant or allergic to naloxone from the prescriber.  b) watch how the patient refills when the patient does partial fills.  If the quantity purchased over a week or two does not match up with prescription instructions—over or under prescribed dosage–inform the prescriber.  If adherence does not then conform to prescription instructions, cut off the patient. c) I continue to recommend requesting the prescriber for an update on the patient’s status when buprenorphine doses do not taper or maintain over time.
  • Do not fill more than 2 days early—I only do one day early. See 12 below
  • Do not fill prescriptions for two or more benzos without a documented reason
  • Do not fill prescriptions for two or more CS analgesics without a documented reason. If you consider “PRN for breakthrough pain” on one of the Rxs to be sufficient, I do not argue with that.
  • Set a limit in miles for which you will not fill a CS Rx unless a) you know the patient, b) know the prescriber, c) know the clinic or institution, or d) ou call and confirm the legitimacy of the Rx. Most pharmacies go with something like 40 miles but that should be varied to your location.
  • Catching up. If you consistently fill a CS Rx two (or more) days early, at the end of a year the patient has an extra three weeks of CS over what was intended for the patient.  Should you require a patient to “catch up”?  For example, if you fill two days early for three months, on the fourth month should the patient be made to wait an extra six days for the next fill?  States vary on this; some are pretty strict while others seem to shrug this off.  I suggest a conservative approach.  If you fill more than one day early each monthly refill, require a “catch up” every 3 to 4 months.  Make sure the patient is aware that you will be doing this.

SAMPLE CS RX POLICY

Controlled Substance Policy for X Pharmacy

X Pharmacy will fil/ refill controlled substance prescription no earlier than one day before the next fill is due.  Any earlier than that must be OK’d by the prescriber and is subject to our approval  We also reserve the right to have patients who consistently fill even one day early to have to “catch up”

X Pharmacy has the right to ask for as much personal identification as necessary to determine that a CS Rx is being dispensed legally and properly

X Pharmacy reserves the right to have your prescriber supply X Pharmacy with documentation as to the necessity of your CS Rx

X Pharmacy will not fill CS Rx written by prescribers more than 40 miles from X Pharmacy unless we know the patient or the prescriber.  Even then, X Pharmacy retains the right to check with the prescriber before filling the prescription

X Pharmacy reserves the right to refuse to fill any prescription—CS or not—at any time.

*I rank a doctor’s “Do Not Fill Before ___” above professional judgment of the pharmacist most of the time.  However, I ranked these two as equal because I get regular calls and emails about prescribers who continually OK early refills. However, there is a point where a practitioner’s prescribing must be subject to our professional judgment and refused.

TO BE CONTINUED

Who’s The Boss?

Question:  I work for $%^& Chain Drugs and I disagree with a couple of their policies.  I think one may even be in violation of the law.  Am I protected from Board action and/or liability if I obey these policies?

Question: I just started work at a new job.  The PIC laid down the law on the first day on such things as when CS refills can be filled, assigning techs to specific duties (on my day to work), counseling, even what computer I am to use.  Do I have any say or is the PIC that much my boss?

I get questions about pharmacy hierarchy almost on a regular basis.  It seems that there are numerous interpretations of how this hierarchy is defined.

In the 1980s, early in my career, and before the advent of the PIC position, the Board of Pharmacy made it clear that the responsible party in the pharmacy at any time was the PHARMACIST ON DUTY AT THE TIME.

This remains the case today.  When you are the pharmacist on duty, you are the final arbiter of decisions.  The results of the shift or day are your reward but they are also your responsibility and liability.  What goes right is not attributable to CVS or Rite Aid but your time, effort, education and experience.  What goes wrong—well, watch how quickly your employer will throw you under the proverbial bus.

So, let’s answer the above questions.  No, following a policy your employer has in place that is in conflict with applicable law will not prevent the Board from punishing you for violating that law.  You have the license to practice, not your employer.  The license is subject to your performance and the means you employ in following the law.  You are the person the Board will hold responsible.  If a conflict exists between law and employer, the law wins.

The PIC issue shows up regularly.  The PIC is in “full and actual charge” of the pharmacy, NOT the pharmacist.  Though the Board has carved out exceptions (some of which I do not agree with), the PIC is not responsible for the acts of other licensed pharmacy personnel.  If you misfill a prescription, if you dispense a prescription with a dangerous sig, if you permit an impaired person to work in the pharmacy with you, the PIC is not the person held responsible—you are.

Thus, if the responsibility is yours, policies laid down by PIC, owner, employer, etc are all subject to your professional judgment.  Do what you think is best, not what a company or your “boss” thinks.  If you can, sit down with your PIC or employer and explain your issues; firmly state that you will protect your license as well as patient safety over business policy.  If you need another opinion, call a pharmacist you trust.  Call me.

Some are going to cringe at the idea of telling an employer that a policy will be ignored.  Usually, employers are not unhappy when they discover a policy may be in conflict with the law.  They will quickly revise the policy to a non-violative status.  If your employer does seek retribution for not following a policy, or for any expression of professional judgment, boards of pharmacy are generally quick to act to protect professional judgment.

What is the hierarchy in the pharmacy?  In the final analysis, YOU as the pharmacist are the hierarchy when you are on duty.  Act accordingly.