Narcotics, Mail Order and the 90-Day Supply

Okay, maybe it seems that I am obsessed with writing about the 90-day supply. I have long maintained that our ability to care for a patient is directly correlated with the frequency we see them. Only seeing a patient every 90 days is often not frequent enough to enable quality care. But today, I hope, even strong proponents of mail order and the 90-day fill will agree that 90-day mail order fulfillment of narcotics is a really bad idea. Let’s begin today’s edition of Tales from the Counter.

Recently, while working to fill a prescription for generic Percocet (Oxycodone / Acetaminophen), the insurance rejected the claim. The claim response indicated that the prescription was filled by a mail order pharmacy about 40 days ago. Like most mail order prescriptions, it was filled for a 90-day supply.

Seeing this reject made my blood boil. The anger I felt was not because I lost business to an out of state pharmacy that provides a drugs as a commodity instead of providing personalized patient care. We see medications offered as an inexpensive commodity far to often, and getting angry about it doesn’t help. I was angry because of the  implications of mail order, 90-day supplies of narcotics.

Maintenance Therapy

The most common argument for the use of mail order pharmacy and 90-day supplies is that they are appropriate for maintenance medications. Once a patient’s therapy has been optimized and is stable, longer periods between monitoring by both the prescriber and the pharmacy may be acceptable. Medications for high cholesterol, for example, would be reasonable 90-day candidate.  Once the patient has been dosed on the appropriate statin intensity level and labs have been checked (e.g. liver function tests), then it may be appropriate for the pharmacist to assess the patient for adverse drug reactions every few months.  Other medications commonly promoted for mail order and 90-day supplies, though, may be less clear cut. Medications for diabetes and blood pressure, for example, certainly can benefit from more frequent monitoring by the pharmacist, and may not fit the 90-day model as well.

But are narcotics maintenance medications? I argue that while a patient might be dependent on opioid pain medications, and chronically using them, the treatment of even chronic pain should always be regularly monitored by both the prescriber and the pharmacy. The 90-day supply, quite frankly, isn’t conducive to this level of monitoring, and the lack of oversight is a significant concern.  Also, there are major concerns that opioids are overprescribed and overused and the 90-day supply increases the potential risk of this medication-related problem.

Besides monitoring issues, the potential for diversion also becomes a significant concern. This ties in with the epidemic of narcotic abuse both here, in the United States, and worldwide.  Narcotics delivered by the mail or currier services are at significantly higher risk of diversion. Unlike a retail pharmacy, where the patient and their caregivers are often known, a mail carrier or currier is at a significant disadvantage. HIPAA rules mean that the currier cannot know what the medication is or even that this is a narcotic. And while they may have to secure proof of delivery, the person accepting the delivery is generally unknown to the currier. Add to this the large quantities involved with extended day supplies, and the opportunities for diversion become even more significant.

Previously, we wrote about narcotic diversion and the responsibilities of the pharmacist in a blog entitled Pharmacy Street Blues (Link). Most of the methods pharmacists use to detect forged or counterfeit narcotic prescriptions rely on the pharmacists relationship with both local prescribers and the patients. A narcotic prescription doesn’t have to be forged to be illegal, either. There are prescribers writing for narcotics that are not following the DEA guidelines. Being a local provider makes it much easier to recognize this type of behavior. Any pharmacy without a local storefront, is going to be at a significant disadvantage in spotting both forged and illegally prescribed controlled substance prescriptions.  Patients with pain issues need to have a team of providers who are communicating closely with each other to ensure appropriate patient outcomes.

The other side of the narcotics epidemic is what is sometimes called fringe prescribing. These are narcotic prescriptions that are legally prescribed but probably not fully compliant with the prescriber’s responsibilities according the DEA. Spotting these problems and addressing them is very difficult when you are dealing with a local prescriber and patient. State run Prescription Monitoring Programs are an important tool, but these documents, which show the patient’s controlled substance history at all state pharmacies and from all prescribers, are difficult to interpret due to frequent inaccuracies. Having a local relationship with the providers makes the process of spotting real and potential issues possible.

Obviously, controlled substances prescriptions are being mailed, and this practice is legal. Pharmacies participating in this practice are certainly aware of the issues and likely have some safeguards in place to minimize issues. The problem is that distance creates a large impediment to performing all of the necessary due diligence. With the large volume of prescriptions mail order pharmacies process, it is not hard to imagine that problems are more likely to slip through. It is my opinion that the risk associated with mail order narcotics outweighs the convenience of the service. Your comments are welcome below.

Reducing Total Health Spend

One of the more interesting and important findings from a pilot we recently participated in was the financial impact pharmacy can have on a payor’s total health spend. Spoiler alert: it can be very significant. But teasing out exactly what a pharmacy is doing to decrease health spend is difficult, and one of the only ways to do this is to look at what differentiates a high-performing pharmacy from those not saving the payor money. In our case, our pharmacy offers a variety of uncommon and even unique services, and we suspect that this is one of the driving forces of our impact on total health spend, but finding concrete examples requires thinking in a different way. This weekend, while taking care of a patient, I had an epiphany. I realized that what I was doing was saving the system a lot of money.

It was a dark, and stormy Saturday night. Well, not really stormy, just dark. One of our patients was scheduled for an appointment on the previous Friday. The appointment was to administer an injection of haloperidol, a medication used to treat the patient’s mental illness. The patient missed their appointment, and our pharmacist called to remind the patient’s helper by phone that afternoon. By closing time on Saturday, the patient still had not presented to the pharmacy to receive their injection.

So on Saturday night, well after our pharmacy closed, I received a call from the patient’s service coordinator. They had just recognized that the patient missed their appointment and the medication. To make matters worse, the patient’s behavior was becoming a problem. If the patient could not get the dose soon, they were instructed to go the the emergency room where they would have administered the medication. Based on previous history, it was likely that if the patient did go to the ER, they would likely also be admitted for observation or even admitted.

I found myself at my pharmacy after 9 pm giving the patient the medication they required. Sometimes, because we are so involved in what we are doing, we fail to recognize the bigger picture. It was not until later in the weekend, while taking care of another patient after hours, that I had my epiphany; by taking the after hours call, I undoubtedly created a significant savings for the payor. I have since started thinking about the impact of many of the day-to-day activities I do as a pharmacist in a different light. It doesn’t take a lot if imagination to see the value in the services we offer.

At this point, however, pharmacists are not reimbursed for their time. This must and will eventually change.  By sacrificing 30 minutes of my Saturday night, I earned the gratitude of the patient and their advocate. My sacrifice also created a significant impact on healthcare costs. I can truly say that I made that encounter that count. I challenge everyone here to start thinking differently, and be sure to make every encounter count. 

What is Special about a Pharmacy?

I am seeing more and more drugs that are being moved from traditional retail status, meaning that you can get them from your local pharmacy, to specialty-drug status, available only from a designated pharmacy. According to Specialty Pharmacy Times:

specialty drugs or pharmaceuticals usually require specialty handling, administration, unique inventory management, a high level of patient monitoring, and more intense support than conventional therapies.

If one accepts the definition above, cost alone should not be enough to limit the product’s availability in the retail sector. However, the assignment of specialty status appears increasingly arbitrary, regularly focusing on drug cost. The arbitrary nature of the specialty moniker is most apparent when comparing different insurance plans. The same drug can be considered specialty in one plan, but not special in another.

Tales from the Counter

The state of Iowa recently switched its Medicaid recipients from a fee-for-service program to a for-profit managed care model. Originally, these plans were not going to be allowed to limit mediations to specialty status, but this stipulation was dropped in the 11th hour before implementation. It took less than 24 hours for one of our patients to be affected by this change.

One of our Medicaid patients has been receiving Invega Sustenna from our pharmacy. This patient was switched to one of the three MCOs now managing our Medicaid population.  Like many of our patients receiving medications by intramuscular injection, our pharmacy actually administers the medication to the patient. The prescribers in our area, for a variety of reasons, often do not want administer medications in their offices. These practitioners rely on us to administer the medication. We order the medication, schedule the administration appointment, and administer the injection.

On April 1st, however, the new MCO returned a rejection for the Invega Sustenna. They require that the medication be filled at a specialty pharmacy. Going back to the definition above, the medication exhibits few, if any of the attributes listed. Cost alone appears to be the primary consideration.

A call to the MCO simply confirmed that they required the medication to be filled at a specialty pharmacy. When asked what was special about this medication, they replied that it was an injection. That answer did not impress me; I dispense a lot of not-very-special medications that just happen to be in an injectable form. When asked how they can provide the medication in a timely fashion, they offered to overnight ship it to the patient.  I asked the MCO who was going to give the medication. They told me the patient would self-administer it or that a doctor would give it in their office. It is at this point I broke the bad news to the MCO representative: giving oneself a deep IM injection is not something most want to do, and the prescriber doesn’t give these injections in their office. I informed him that our pharmacy gives the injection to the patient.

After spending some time explaining these realities to the plan, I was able to secure a one time override for the medication because the injection was already scheduled and due to be given. This bought the patient some time, but it does not solve the problem. The medication is still arbitrarily designated as specialty-only. The plan, after learning that our pharmacy both provides and administers Invega Sestina to nearly a dozen similar patients, promised to follow-up and offer us a specialty pharmacy contract. I am not holding my breath. I expect to have the same problem again in a few short weeks.

Specialty pharmacy should be about more than the medication cost. As ASP’s definition states, it should require special equipment, expertise, or something above and beyond simply dispensing the medication. I have no doubt that for some drugs, the designation is warranted. Here, however, I am skeptical. Compared to a standard retail pharmacy, what the plan’s specialty pharmacy could do differently is not immediately apparent. There is nothing special about Invega, it is just an expensive, injectable medication. On the other hand, what we are providing is special. We are providing care.

 

Not Documented? Not Done!

The other morning, before my staff arrived to work for the day, I took a phone call from one of the group homes we service. They wanted to know if we had received an order for a dose change on a patient’s sertraline. I looked in our systems and concluded that we had not yet received an order. It turns out that I was mistaken. Deconstructing my mistake illustrates a time honored saying: If you didn’t document it, you didn’t do it!

Where’s Waldo?

Like any busy work environment, knowing where to look for information is the key to success. There are limited ways the  order in question, a prescription, can arrive:

  • A faxed in prescription
  • A mailed in prescription.
  • An electronic prescription
  • A phoned in prescription
  • A hand-written prescription brought in by the patient

Once an order has been processed, documentation should be found on the pharmacy management system (PMS). At our pharmacies, the old prescription would be discontinued, and a new prescription would be entered with the new directions. This is what I expected to find if we had processed the order.

Our pharmacy also uses a clinical documentation system, PharmClin, to document all activities as they relate to drug therapy. Any notes or pending issues related to a dose change should be documented in this system. This additional documentation is very valuable to us as it allows us to document many of the important details that complete the clinical story as they relate to the patient’s drug therapy.  PharmClin makes this information easily accessible and retrievable.

I went searching. I found no unprocessed orders. The original order on our PMS still active, and no new prescriptions for sertraline were present. There were also no notes in PharmClin related to a dose change of sertraline. In other words, I did not find Waldo. Based on a lack of evidence, we did not appear to have the order yet.

When my staff pharmacist arrived, I mentioned the call and was informed that she was aware of the order and that it had already been addressed and picked up. I was flummoxed! How could this be? As it turned out, the situation was a lot more complicated than the phone call suggested.

The Details

The patient was taking 200 mg of sertraline daily. The previous day, prescriber decided to switch the patient to escitalopram. My pharmacist correctly identified that the patient should not simply stop taking the sertraline without some attempt to taper the dosage over time and contacted the prescriber’s office. She was told that the prescriber did indeed tell the house staff to taper the dose of the sertraline and provided a flow sheet of the taper. In other words, there was no prescription written to decrease or taper the sertraline. As Homer Simpson says, DOH!

Continuous Quality Improvement

Multiple mistakes were made here. My first mistake was not asking additional questions of the house staff that called. I made the assumption that we were looking for a dose change for sertraline and failed to see the new Rx for the escitalopram. The other omissions were made before I received the call: the sertraline order was not discontinued in the PMS, and the communication with the prescriber was not documented in PharmClin.

The scenario above an epidemic in today’s healthcare environment. The patient is told something by a primary provider, and other providers do not receive notice. The communication from the prescriber to the pharmacy, a form of documentation, was missing. Despite this, my staff pharmacist who dealt with the problem discovered all of the details after they spent time on the problem the previous day. But like the first omission, her documentation was incomplete and largely missing.

Having an tool like PharmClin to document clinical interventions is a great asset to a pharmacy. But if the tool is not used, the benefits are lost. Pharmacists across the country make outstanding interventions every day. The fact is, however, that they largely fail to document their work. In a small pharmacy with few employees, mentally keeping track of issues like this might be manageable, but eventually the system will fail. In a larger pharmacy with many more employees and patients, a systematic documentation system is a must. Remember…Do It. Document it. Done! This is how you can make every encounter count!

 

 

When Therapeutic Duplication Isn’t…

Modern pharmacy management systems screen therapeutic duplication using third party databases, and these systems are not capable of exercising the necessary professional judgement to separate an actual duplication from a rational duplication. Duplication alerts, because they are so frequent, become almost a nuisance, and alert fatigue is a real concern.

Normally, therapeutic duplication alerts in our pharmacy are documented as:

Duplication Appropriate: Different mechanisms of action required to achieve therapeutic outcome(s)

The above is typically added to intervention notes in cases like the use of metoprolol (a beta blocker) with losartan (an ARB). When we create this note, we typically will flag the problem for re-evaluation in 6 months or 1 year.

Duplication Appropriate: Different courses of acute therapy.

This designation is often used for antibiotics or other acute therapies (prednisone, NSAIDs etc) that have been completed before the next course is started. These are typically flagged for re-evaluation with the next fill of the medication.

Case Study (An Exception)

Today’s Tales from the Counter story starts with a therapeutic duplication; sotalol 120 mg in the AM / 80 mg PM with metoprolol ER 25 mg QD in the AM. One prescription was ordered by the patient’s primary care provider and the other a cardiologist. Both of these drugs are in the same therapeutic class of beta blockers. In this case, the duplication alert is not necessarily a nuisance; it represents a potential problem.

In the case of this patient, the refill history made the problem more difficult to evaluate. Metoprolol was filled in April for 90 days, sotalol in June, and both filled in August. At first glance, it appeared that the medication was changed from sotalol to metoprolol and then back again. To be sure, the patient was approached and asked if they were taking both. The unexpected response was that they were taking both medications (they had just accumulated an excess of sotalol and did not need to refill it until that supply had been depleted).

At this point, we let the patient know that we were going to contact the prescriber to clarify the therapy. A SOAP note was created and faxed that day to the primary care provider. The note simply stated:

Subjective / Objective: KB came into the pharmacy today to pick-up her meds. Pharmacist noted patient is taking both metoprolol ER 25mg QD (Dr. One) and sotalol 80mg 1.5 tabs QAM and 1 tab QPM (Dr. Two).

Assessment / Plan: 

Should KB be taking both metoprolol and sotalol? ___Yes ___No

If not, should metoprolol be D/C’d? ___Yes ___No ___N/A

Less than 24 hours later a reply was received. The response was unexpected by this pharmacist: KB should be on both medications — confirmed with cardiology.

Therapeutics Revisited

I was not expecting this response, and took some time to investigate the possible rationale for this decision. Sotalol is somewhat unique in the class of non-selective beta blockers as it also exhibits cardiac action potential duration prolongation (Vaughan Williams Class III) anti-arrhythmic properties. It is well documented that beta blockade can significantly decrease mortality and improve outcomes in several types of cardiac disease. In the case of a patient with an implantable cardioverter-defibrillator (ICD) and or a biventricular pacemaker, the combination of anti-arrhythmic and betalocking properties of sotalol can be beneficial, making it an excelent choice. Sotalol, being non-selective, may not offer enough beta blockade by itself, and the addition of a low dose selective beta blocker like Metoprolol Succinate 25 mg is therefore rational therapy.  For a good review, see Chaki ALCaines AEMiller ABSotalol as adjunctive therapy to implantable cardioverter-defibrillators in heart failure patientsCongest Heart Fail. 2009 May-Jun;15(3):144-7.

This is a great time to re-emhasize the importance of documentation. This intervention was addressed as Duplication Appropriate – an exception to the normal “like mechanisms” duplication that would normally be a problem. The intervention and SOAP note, including the physician’s response, was documented and linked to the problem. The next time this problem is assessed in 3 months, the pharmacist will already know the story.

Monitoring

Just because the duplication problem has been addressed does not mean that the pharmacist’s responsibility is complete. In this case, the patient is at risk of the effects of too much beta blockade. This would manifest as a low resting pulse rate. The pharmacy should now regularly ensure that the patient’s pulse is being monitored and/or monitor the patient’s pulse periodically. Both activities should be documented in the patient’s record.

Every day I worry about the future of pharmacy as a profession. The current reimbursement climate continues to resemble a walk through Death Valley, California, without any water in sight. Despite some of the grim realities pharmacists face daily, finding problems (and even non-problems like the one above), and managing the care of patients still excites me. It makes my days enjoyable. And the added benefit of the patient’s gratitude for taking the time to look into the potential problem doesn’t hurt, either. It reenforces the fact that every encounter really does count.

Being Proactive

Previously, I discussed complacency as it relates to pharmacy practice. But this is not the only challenge a dedicated pharmacist faces. Even a great interventionist struggles with being reactive from time to time.

Reactive |rēˈaktiv|
adjective: acting in response to a situation rather than creating or controlling it: 

To be fair, there is no way that anyone can avoid being reactive all of the time. Pharmacy is littered with opportunities for situations to arise that the pharmacist cannot reasonably predict and properly prepare. A common example might be receiving prescription electronically for a patient you have never seen before moments before (or even as) the patient walks through your door.

Strive for Proactive

Our pharmacy regularly struggles with this exact type of situation. In one regard, it is nice to be the place many providers refer patients. But a poorly handled referral  (because you were not prepared) does nothing to help you grow your business. You only get one chance to make a first impression with a new patient. But a proactive approach will do wonders for your business image and your first impression.

A large part of being proactive is simple common sense, and most of it distills down to one thing: excellent patient and provider communication. The trick is to create a workflow that allows any unexpected order or issue to be initially addressed in an efficient manner. Note that I wrote addressed, not completed. Being proactive really means letting the patient know where you are with the issue, what is needed, and what to expect will happen next.

A Reactive Case Study

Recently, we received an unsolicited order for wound supplies from a local prescriber’s office for a patient we had never seen. The order was received by fax at 4:30 pm, and the office regularly closes at that point and no patient information (phone number, address etc) was included on the faxed order.

Because nothing was known about the patient or the order, and because the office was already closed, the pharmacist or technician places this order on the counter for the next day’s staff to address. The pharmacist’s shift ends at 5:00 pm and the pharmacist fails to let the others working know about the new order.

About 45 minutes after receiving the order, the patient presented to the pharmacy for the wound supplies that they are expecting to be ready.

When the patient arrives, the staff are confused and do not know about the order. They search around, and eventually find the order. At this point, the pharmacy staff is completely out of control of the situation and is entirely reactive to the problem. To make matters worse, the items that the patient needs are not ones stocked by the pharmacy, and the patient needs them now. The situation spirals from bad to worse, and the image of the pharmacy and pharmacist is tarnished in the eyes of the patient, who fully expected this to be done and ready.

Proactive Case (Version).

Being proactive in the case above is going to be difficult. Our first order of business would be to contact either the prescriber or the patient to assess the urgency of the order and to gain insight in to what their expectations were for our pharmacy. With the prescriber’s office being closed, the pharmacist could have the prescriber paged to gather additional information. The only other option would be to use a local phone directory to try to establish contact with the patient to determine their needs and expectations. Note that SOMETHING needs to be done shortly after the order is received, and whatever is done needs to be documented in a manner that the next person to deal with the situation will be able pick-up and immediately know what the situation is.

The pharmacist asked the technician to call the office and finds the office closed (as expected). Rather than page the prescriber, the technician attempts to look-up and contact the patient using the phone directory. They call what they believe to be the patient’s home number and get no answer, so they leave a general message for the patient indicating that they wish to speak with the patient about a new order received. Both of these calls are documented and placed into a pending queue for the pharmacy, and an action item is created and added to initiate a call to the office in the morning.

The pharmacy has done very little at this point, but they have been reasonably proactive. While do not have any additional information needed to proceed with the order, it is officially “pended” awaiting a call back from the patient and a call is scheduled for the morning to call the prescriber. The pharmacy now has documentation that they can share with the patient that will demonstrate a proactive approach.

This patient arriving shortly after the unexpected order is received is possibly the worst possible scenario, and the fact that the patient has an expectation that things will be ready aggravates the situation considerably. Two things, however, make this situation more manageable:

  1. The readily retrievable pended issue that can be matched to the new patient’s requests and
  2. The documentation of what was already done by the technician.

The above items demonstrate to the patient that the pharmacy is vested in solutions. Little time needed to be spent by the pharmacist or technician to get up to speed on the situation. Despite now being in a reactive position with this patient, the pharmacy handled the situation in the best possible way.

Being proactive applies to anything that could reasonably be anticipated. An common example might be counseling the patient on potential adverse drug reactions (ADRs) when they first receive the medication. Recently, a patient came into the pharmacy and received a shingles vaccination. The pharmacist that gave the immunization failed to proactively mention the possibility of a local rash (ADR) at the injection site that takes several days to appear and then disappear. The patient did have this local reaction and came into the pharmacy concerned. Proactively counseling would not have prevented the patient from coming to the pharmacy (when I counsel Zostavax, I ask them to come in if they have a reaction so I can assess the rash and further counsel on signs and symptoms of cellulitis for them to watch for), but it does prevent the patient from a moment of panic.

Conclusion

In business, image is everything. Being proactive can make a huge difference in all aspects of a pharmacy practice, and it is not limited to simple transactions. A proactive pharmacist will look for possible issues that are not currently issues. Things like the price of a medication might not be a problem for a 64 year old patient with excellent commercial insurance now, but thinking proactively, addressing the possibility of a less expensive medication now, before cost becomes an issue, is something that will make your pharmacy stand out. Think Proactive. Be Proactive. It can help you make every encounter count!

Handling Sticky Situations

In our day-to-day CMM (Continuous Medication Monitoring), we regularly are making interventions and documenting the clinically relevant outcomes of our patients. One of the advantages of having a clinically oriented system like PharmClin is that it allows the pharmacist to see what has been done about an issue before, and schedule a follow-up assessment in the future. But not all pharmacists handle situations the same way. Sometimes a problem comes to you that should have already been addressed (and apparently was not). This creates a situation where we are dealing with a lack of inertia. The process SHOULD have already started, but because it hasn’t yet, where do I start? This is one such sticky story.

Origin of a Problem

Every story has a start, and this story starts out with a drug-drug interaction. Every drug-drug interaction has a first dispense of the second (and therefore triggering) drug. This story starts out with a patient taking Bupropion SR 150 (dating back many years). Later, a cardiologist added flecainide 50 mg  to treat an arrhythmia. At this point, the pharmacy management system undoubtedly flagged an interaction, and the pharmacist springs into action.

Facts and Comparisons classifies this interaction as significant (1) with a delayed onset, and potentially significant severity. The documentation referenced is rated as suspected. The pharmacologic effects of flecainide may be increased by the bupropion, caused by an elevation of plasma concentrations (mechanism of CYP2D6 Inhibition) resulting in potential toxicity (QT prolongation/Torsades de Pointes). In a nutshell, this is a potentially big deal.

The Easy Case

If you happened to be the pharmacist checking the first fill of the flecainide, then your job is the easiest. But is it any less sticky? Consider some possible interventions the pharmacist might make:

  1. The pharmacist alerts the cardiologist of the interaction
    • Possible Outcome: Cardiologist is concerned but considers this therapy most appropriate for patients cardiac related disease process. Requests that the pharmacist contact PCP to change antidepressant.
    • Possible Outcome: Cardiologist is aware of the interaction and not concerned. Will be monitoring EKG for QT prolongation and titrating dose to the desired clinical response. Wants the drug dispensed.
  2. The pharmacist alerts the Primary Care Physician (PCP) of the interaction
    • Possible Outcome: PCP changes medication for depression to Sertraline or other non-interaction medication and undertakes new monitoring for depression due to change in therapy.
    • Possible Outcome: PCP satisfied with patient response to current antidepressant and does not want to risk any change. Is not concerned with the interaction as cardiologist will be monitoring the EKG for QT prolongation.
  3. The pharmacist could elect to do nothing, or fail to completely follow-thru with one or more of the above interventions.
  4. The pharmacist could complete the intervention and fail to document what was done and when to follow-up with this issue.

Notice that several scenarios create a sticky situation going forward, with the cardiologist electing to monitor the patient. This creates difficulty for the pharmacist later as eventually the PCP will assume responsibility for the flecainide as the specialist’s involvement wanes. How does one continue to ensure that this problem doesn’t later evolve into a real issue, with potentially deadly consequences.

Inertia

Consider the possibility that the pharmacist failed to complete or document an intervention above. The next pharmacist that sees this interaction (the first refill) may assume that something MUST have been done and that this interaction is acceptable. Because nothing was changed, we don’t need to change now. This is a problem of inertia, and this type of problem is not uncommon. Getting the pharmacy train back on track and moving forward takes effort!

Sticky Fingers

Now consider what your options to regain inertia with the problem are when, for whatever reason, this interaction appears in front of you months or even years down the road. The patient has been receiving the medications together for a prolonged amount of time. Based on your discussions with the patient, their depression and rhythm appear to be well managed without any significant issues. What should you do now?

A lot depends on what (if any) documentation the pharmacist has from the origin event discussed above. If there is documentation, the next steps are easier (though still non-trivial). If monitoring of the EKG was originally being used to manage the interaction, the pharmacist can assess (through the patient and / or the current prescriber) if regular EKGs are still being done and if any QT elongation has been observed. The intervention made now will simply be an extension of the previous intervention(s). It is important if these medications continue to be used together after the intervention, that there is a specified follow-up date associated with it so that the pharmacist can revisit the issue at a later date.

If nothing was done (or no documentation exists), the options available to the pharmacist are the same as they were before, with one significant difference: the patient is currently (likely) stable on both medications. Changing the antidepressant now will result in the patient needing to be evaluated for effectiveness of the new antidepressant AND eliminate the CYP2D6 inhibition, effecting the flecainide steady state in the blood (requiring a potential change in the dose of the second drug).

Documentation is Key

This is where pharmacists tend to fall down. Without a well-documented history, it is very difficult to regain inertia on a problem. Once you decide to take the time and effort, be sure that you leave a paper trail. Document what was done, who was involved, and what their responses were. Before you finalize your intervention, be sure to assign a follow-up date for the problem. Revisit the problem to be sure that it has not evolved into something more challenging.

Take Action!

Regardless of how the situation arises, it is not acceptable to let a lack of inertia prevent patient care. Doing nothing is not an option. Even if you inherit a sticky situation, it is up to you to be sure to make every encounter count.

Why Transitions of Care and PBMs Don’t Mix

My step-father, who has been deathly sick for the past 6 1/2  months due to an aortic valve replacement surgery that did not go well, is being discharged from the skilled nursing facility where he has resided at for the past month and a half.  Before this, he was in the ICU for over 3 months, were he required a tracheostomy, gastric tube, urinary catheter, and oxygen.  To be honest, there were several times when we didn’t know if he would make it through the night.  But, he slowly started to make progress, and now he is ready to be discharged to go home.  I am not only his step-son, but I am also his pharmacist, his pharmacy, and his POA for both health and financial matters.  Because I have been a pharmacist for almost 30 years now, I know the challenges that occur during transitions of care, especially as they relate to medications.

In my step-father’s example, he is being discharged on a Sunday.  I had been working with his social worker, nursing supervisor, and prescriber to make sure that I have an updated medication list.  I reviewed this list, noted the discrepancies, and sent a follow up note to all three providers.  They indicated that they will only fill the medications that he has been taking while in the facility and, if there are any discrepancies, I should follow up with his PCP and specialists that he sees (which include a pulmonologist, neurologist, and cardiologist).  So I did this, and received new prescriptions for the medications that they want him to take following his discharge.  Obviously, this was a multi-step process that occurred over several days.  Now that I have his prescriptions, things should go smoothly, right?  Wrong!  When we went to fill the prescriptions, they, of course, got rejected as “refilled too soon” because the long term care pharmacy that fills for the facility (not our pharmacy) has already filled and billed medications.  I confirmed with the facility that they will not be sending him home with any mediations, so,  next step was to call the Pharmacy Benefit Manager (PBM) to get an override. This is where the frustrations and problems escalated.

I explained to the PBM representative that my step-father is being discharged on Sunday and that I am not only his step-son, but his pharmacist and pharmacy.  I want to be proactive and have all his medications filled so when I pick him up on Sunday, he has all his medications there.  Sounds easy, right?  Wrong again?   The representative said that we cannot be proactive and that he cannot get an override until he is discharged.  I said that our pharmacy is closed and that I will be busy getting my step-father home, but she said there is nothing she can do.  I asked for the representatives supervisor, and this person reiterated said the same information.  The supervisor stated that they are “only the processor” for the plan, and that I would have to contact the plan to get an override before his discharge date. The supervisor was unable to give me a phone number to contact the plan, and said to look on the back of his card. I don’t have that information readily accessible.  The supervisors solution was to have me come into my pharmacy early on Sunday, fill the prescriptions, call the PBM to get overrides (one by one for 8 to 10 medications), fill the medications, then go see my step-father.  I asked her why we cannot be proactive, since we are only talking about 2 to 3 days and the supervisor said the plan will not allow them.  So, now instead of focusing on helping my mother (who is also ailing) and my step-father (who’s health is very fragile), I have to figure out how to fill his medications on the day of discharge–are you kidding me!

That is why I titled this blog “Why Transitions of Care and PBMs Don’t Mix”.   Supposedly payers are concerned about the quality of health care and that readmissions for the same diagnosis are frowned upon.  So, when you have a pharmacist proactively working closely with prescribers to get an accurate mediation list and making sure the medications are ready when the patient is being discharged, this should be a good thing, right?  Wrong, yet again.  Plan and PBMs are so worried about the kind and timing of the override that they have totally forgotten about the patient.

It is time to change the system.  Pharmacists are frustrated with the limitations that insurance plans and PBMs have place on patient care.  Doesn’t it make sense to ensure the patient, who has been hospitalized, should get their medications seamlessly to prevent a bad outcome?  And doesn’t it make sense that it should happen prior to the discharge?  I was unable to get the appropriate override, but it did move me to action, as I am writing a letter to my step-father’s insurance plan and the plan’s PBM to express my concern that their limitations will end up hurting patients.  Perhaps, they need to be educated about the challenges of transitions of care from a patient and caregiver perspective because, from my perspective, they know very little.

Mondays with Mike

Today’s edition of Tales from the Counter is about pharmacist interventions. Interventions are not a new concept in pharmacy. Pharmacists have been interventionists for decades, and it doesn’t take a clinical pharmacist or a clinical environment to be an interventionist. Our main pharmacy documents several thousand interventions every month. When some pharmacists hear about the number of interventions our pharmacies document, they are often skeptical of either the quantity or the quality of the interventions. I thought that it would be interesting to give an overview of several categories of interventions that I completed during the last Monday morning I worked the counter. During this 5 hour shift I documented 186 interventions. I have picked a few key areas to discuss today as examples of our interventions and processes.

Compliance

Using a Percent of Days Covered (PCD) calculation looking at the last 6 months worth of refills, our PharmClin software alerts the pharmacist to any impending compliance issues (for all patient medications, not just the one being filled). Non-compliance is defined as a PDC below 75% or are above 125%. During my last Monday on the counter, 123 different medications were flagged as non-compliant. As we have stated in previous posts on this blog, compliance is one of the most common issues we see. It also represent the basis of three different EQUiPP pharmacy performance measures. We assess PDC on every medication, and many acute or as needed drugs will eventually fall into a “non-compliant” (or, in the case of a PRN medication, a hyper-compliant) state. Each one needs to be evaluated on a regular basis to ensure there are not any real problems underlying the issue.  Of the 123 compliance issues evaluated:

  • 91 were deemed non-issues because they represented acute drugs or were “as needed” medications. Each of these were flagged as “continue to monitor” and will be re-evaluated in 90 days (to prevent Alert Fatigue)
  • 26 were explained by other evidence (recent dose changes)
  • 9 were flagged for face-to-face questions with the patient. Illustrative examples included:

Propafenone compliance at 72%. The patient was asked if the dose or instructions have changed (and we were not alerted). Patient denied any change and denied any missed doses. The follow-up evaluation for this drug was moved up from 90 days to 30 days to re-assess.

Omeprazole compliance dropped to 63%. Patient asked if still using or if it was discontinued. Patient reported that the medication was discontinued and that they are using OTC ranitidine with good relief of occasional symptoms.

Omeprazole compliance at 70%. patient reports “as needed” use of this medication. Wanted the Rx to be available in case symptoms reappeared. Note sent to prescriber requesting a new Rx with “as needed” directions.

Sertraline compliance dropped to 63%. When approached, the patient admitted that she had this filled at another pharmacy to take advantage of a new patient program. The importance of a “pharmacy home” was discussed with the patient.

Metformin compliance at 73%. Patient reported that the doctor was doing a 90 day trial. The medication was discontinued

Screening for Adverse Drug Reactions (ADRs)

We routinely look for ADRs on several drug categories including all diabetic medications, opioid pain medications, and warfarin. PharmClin alerts the pharmacist of a new problem or that it time to re-assess an old one. Like other interventions, once an ADR potential has been investigated, the intervention is scheduled for re-assessment in 30 to 90 days (depending on the medication or the seriousness of the potential issues) to prevent Alert Fatigue. This built-in timing also prevents the patient from becoming overwhelmed with constant queries. The periodic nature of the ADR queries also allows us to assess problems that develop with time.

During my last Monday, almost 30 different potential ADRs were noted. Each of these resulted in a face-to-face with the patient. Some examples of these interventions:

  • Patient on Novolog: Confirmed with the patient they understood the signs and symptoms of low blood sugar. Also documented blood glucose testing frequency and date of the last drawn Hemoglobin A1C.
  •  Warfarin patient: Asked about any unusual bruising or bleeding. Also documented patient reported goal INR, draw schedule, and last INR (patient reported value)
  • Patient on Tramadol: Queried patient on possible constipation and confusion / drowsiness from the medication. Patient denies any problems at this time.
  • Patient on Metformin: asked about diarrhea and other potential ADRs. Patient reports that this medication caused them to “fall” and that the prescriber discontinued the medication. Note sent to the prescriber to confirm discontinuation as no other therapy for blood sugar noted in patient profile.

Other Interventions

  • During the 5 hour period, seventeen different new medications were flagged for counseling and patient education.
  • Fourteen new “therapeutic duplications” were evaluated.  None of these were deemed inappropriate.
  • Five prescriptions were flagged as “product is the same but may look different” to alert the patient to a generic product change
  • four different Lab values were recorded in the patient’s electronic chart. These included blood pressure, INR, TSH, and A1C

None of the above examples is above and beyond what an engaged pharmacist does on a daily basis. The primary difference, though, is the documentation done. By documenting what was done, and when it needs to be revisited, we can make every encounter with our patients count.

Computer ADR Screening and Real Life

Today’s post is yet another edition of  “Tales from the Counter.” This one is somewhat less clinical sciences and a bit more pharmaceutical sciences, with a measure of soapbox thrown in for good measure.

The other day, while performing CMM on a nursing care center patient being admitted, my technicians asked about a DUR Warning our pharmacy system flagged on the patient. These warnings are generated by software licensed from a third party vendor and are designed to bring possible issues to the attention of the pharmacist. The warning here read:

Prior Adverse Reaction Report

Prescribed Drug: Triamcinolone Nasal Spray

Adverse Reaction(s) have been reported with prior MORPHINE SULFATE 20 mg/ml.

Ethylenediamine Class Monograph

Essentially, the above warning is stating that the patient has had a prior adverse drug reaction (ADR) to morphine, and the newly prescribed drug (triamcinolone nasal spray) may also, therefore, cause problems with the patient.

I will let that sink in for a moment. Any pharmacists that immediately know why this was flagged are encouraged to comment below (giving yourselves a little pat on your own back), because this one is a little obscure (though there is a hint in the general description above).

The warning continues on as follows:

Discussion: Aminophylline is the ethylenediamine salt of theophylline. Hypersensitivity reactions to aminophylline including maculopapular rashes, dermatitis, exfoliative dermatitis and urticaria are thought to be primarily due to the ethylenediamine component…

Pharmacists who are still confused are thinking clinically and not pharmaceutically at this point. The ADR being flagged by the software is not due to either morphine or triamcinolone (in the nasal spray). The ADR being flagged is to an excipient (inert ingredient) that both products may share: EDTA (ethylenediamine tetra-acetic acid), which is a pharmaceutical chelating agent / preservative.

The science behind this Prior ADR Warning is sound and well documented in the primary literature, though the clinical relevance may be tenuous. The prevalence of EDTA in morphine injectable formulations is lower today, with many preservative free formulations available. Checking several references, ADR references to maculopapular rash with morphine were completely absent.

The Soapbox

In the end, it was easy to identify the prior ADR to morphine for this patient: confusion. Based on this, the triamcinolone nasal spray  represented no additional risk for the patient, and the warning was documented off as a false positive. And while this computer-generated warning was not relevant for this patient, the obscure nature of the issue is not something that most pharmacists would immediately recognize and therefore it is entirely possible that a warning like this might help prevent patient discomfort in someone down the road.

Software-aided screenings can be very beneficial, but they also complicate patient care tremendously. It takes a skillful and knowledgable professional to be able to decipher and evaluate the host of information available today. Yet, pharmacy benefit managers continue to cut reimbursement for product and this is leading to pharmacies using fewer and fewer pharmacists (because labor costs are one of the largest expenditures in pharmacy). The argument is that technicians and machines can take care of more and more of the work. Without a competent pharmacist evaluating the mountain of clinical information, though, healthcare will be taking a step backwards in safety.

It is not unlike today’s aircraft: modern computer driven avionics can take a plane into the air, to the destination, and back down for a safe landing without any human intervention. But what happens when something out of the ordinary takes place,and the computer cannot make the judgement? Would you fly in a plane capable of flying itself without a professional pilot on board just in case? Modern technology can move pharmacy into a new era of efficiency in dispensing, but in the case of actual patient care, we are still a long way from not needing a professional in the trenches.