Monthly Archives: June 2016

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.