Pharmacy Games

Recently, I have spent some time trying to lend some understanding of the inner workings of the pharmacy world to a financial reporter interested in DIR fees (among other things). The most recent discussion with this reporter left me thinking about how far the profession of pharmacy has been corrupted by outside interests. Pharmacy today is a lot like a game of Russian Roulette.

Narrow Networks and Choice

This blog has discussed the benefits and difficulties facing pharmacy with respect to access to lives. Consider a pharmacy invited to participate in a narrow network. The pharmacy has to make a decision on their participation. The idea with narrow networks is that not every pharmacy will be invited to participate, creating an illusion of exclusivity and access to the patient group represented by the narrow network. This exclusivity comes at a price: lower reimbursement to the pharmacy for servicing these patients.

If a pharmacy elects to participate in the network, they are forfeiting the current level of reimbursement for the services (medications) they provide and accepting a much more aggressive (lower) reimbursement in its place. The carrot, as it were, is the potential of this exclusivity to drive patients to come to your pharmacy. If a pharmacy rejects the lower reimbursement, the pharmacy risks losing most or even all of the patients (even current customers) in the narrow network. If a pharmacy elects not to participate, the patients then have to make a decision: pay more at their pharmacy, or switch pharmacies to one that is preferred by their plan. Make no mistake, many, or even all, patients will eventually succumb to the lure of a lower copay and leave the non-participating pharmacy. A preferred network is, metaphorically speaking, the Pharmacy Benefit Manager (PBM) placing a gun to the head of the pharmacy. Choose between lower reimbursement, or fewer patients (customers). 

The wild card in this choice is the reimbursement the pharmacy is going to receive. Reductions in the contract are usually specified as the lesser of either Average Wholesale Price (AWP) minus a percentage or Maximum Allowable Cost (MAC). This lower reimbursement may also be accompanied by Direct and Indirect Remuneration (DIR fees) taken from the remittance advice (withheld from the payment at a later date).

While a pharmacy might be able to estimate the impact of AWP – % or a simple DIR fee, without a clear definition of the MAC price (a price that the PBM considers to be a trade secret), there is no real way to know how participation in the narrow network will actually effect the bottom line before signing up.

Access to Lives

An optimistic pharmacy, chain, or PSAO might look at the numbers and decide to participate, hedging that with the published reimbursement rates, the pharmacy will maintain a profitable margin. The pharmacy will have to find other ways to generate revenue using the “access to lives” it has negotiated. Independent pharmacies using Pharmacy Service Administrative  Organizations (PSAOs) heard exactly this logic when preferred network contracts were signed for the 2015 year. Large chains undoubtedly made similar decisions.

A pessimistic pharmacy (or chain or PSAO) might elect to not sign the contract. In the end, they undoubtedly will lose customers. This is revenue that drops from the bottom line. And if the customer doesn’t come into the store, you cannot offer them services or other items to purchase.

The real question for any pharmacy, chain, or PSAO, is which chamber the bullet is in when the pharmacy pulls the trigger on the contract. And each year, the chamber rotates around, so if a pharmacy survived 2015 with a preferred network, it has to pull the trigger again in 2016.

Even a large chain (like WalMart), with some very smart lawyers and accountants, appear to have miscalculated for 2015. WalMart’s recent, lower than forecast financial disclosure blame, in part, pharmacy reimbursement for lower than expected profits. It is not an accident; WalMart participates more narrow network contracts than any other pharmacy chain.

Two Edged Sword Revisited

Earlier this year, I wrote about access to lives (see A Two Edged Sword), and in the end I wrote:

I don’t like the current landscape of pharmacy and healthcare, and it is going to take hard work to change it. Giving up access, to me, is simply wrong.   Micheal Lefoeuf once said “Every company’s greatest assets are its customers, because without customers there is no company.”  Access to our patients is our lifeline!

Even given the stark reality that the past 6 months have revealed (with reimbursement in some networks well below break-even), I am sticking with my previous assertion. The difference today, though, is the realization that one cannot necessarily generate enough new revenue to cover the losses realized by participation in some of these narrow networks. In order for my pharmacy to continue to service our patients, we are going to have to optimize every aspect of our care. This will be difficult to do while maintaining high quality service. The goal now is to survive long enough to see the end game, where pharmacy and pharmacists are reimbursed not for product, but for the value they provide to the system.

That time is coming, of this I am certain. A significant number of pharmacies will close before that time, and pharmacists not performing clinical services and adding value will find themselves in a difficult position. The pharmacy transformation is coming, and I am certain that we are ready. Ask yourself what you need to be doing to be ready in your practice, and work to make every encounter count.

Access to Lives and the Biggest Big Box Store

Walmart has long been a polarizing force in pharmacy. It is best known to pharmacists as the innovator of the prescription loss-leader. The goal of the loss-leader prescription (the $4 program) was to draw customers into Walmart store in order to drive non-Rx sales. Recently, Walmart’s financials were revealed, and the results were poorer than expected. Pharmacist frustrated with these tactics may have cracked a secret smile upon hearing these financial results. Analysis of these financial results implicated poorer than expected pharmacy reimbursement, at least in part, was responsible.

For an excellent analysis of the impact of preferred networks (and how Walmart may have miscalculated the benefits of these closed networks), follow this link to “Walmart Wrestles with the Reality of Preferred Networks” at AccessRx America

The DIR and the Pharmacy Rebate

Recently, I was discussing DIR fees with a journalist writing a story about DIR fees for a national financial publication. Among the things we discussed was one PBM’s description of the reason DIR fees exist today: to pass a part of the rebate savings pharmacies receive back to the payor. This is not a quote, of course, but the implication is clear: pharmacies are making money on rebates and some of that should be shared with the payor.

While I disagree with the sentiment above, I understand the payor’s desire to lower its costs. With that said, I figured it was time to go back to some actual numbers and see how our DIR fees compare to our rebates.

Methodology

The rebates are available to pharmacy are product specific. For a given generic drug, there may or may not be a rebatable product available to the pharmacy. Sometimes, the rebatable product is actually more expensive (after rebates are accounted for) than another product. Rebates for the purposes of this analysis were calculated based on the actual rebate available for the product submitted to the PBM. If a cheaper, non-rebatable product was submitted, no rebate was calculated. Pharmacies do not generally receive rebates on brand name drugs.

There are two flavors of DIR fees currently being used by PBMs: Flat Fee DIRs and what I refer to as voodoo DIR fees. The former is specified as either a percent of a claim or is a flat fee known to both parties before the transaction takes place. The latter is calculated by the PBM using a variety of variables and the pharmacy generally has no way to know what the DIR fee being assessed for a prescription is until much later.

A two week period of claims assessed a Flat Fee DIR fees for our pharmacy was analyzed to compare the total DIR fees returned to the payor. For each claim, the estimated rebate (assuming the rebate requirements were fully met) was calculated using on the after-rebate NET price per unit (tablet / capsule etc).  The sum of both the DIR fees and the per-claim matched rebates received by the pharmacy was calculated.

For the voodoo DIR fees, it was necessary to wait for a quarterly report compiled by our PSAO in order to match a DIR fee to each claim. This report represented DIR fees for 3 months. The sum of these DIR fees was then calculated along with the corresponding claim-matched rebates estimate.

Results: Flat Fee DIRs

There were 201 claims processed with Flat Fee DIR Fees in the most current remittance for our pharmacy. The total DIR fees withheld by the PBM to pass along to the payor was $546.51. After applying rebates to the products eligible for rebates, the total rebate the pharmacy will eventually see for these prescriptions was $545.39.

Where things get interesting is when one looks at brand name drugs. The pharmacy receives no rebates for these (though the PBM may actually receive a rebate from the manufacturer for having the medication on formulary). The pharmacy was still assessed a DIR fee on many brand name drugs. Of the 201 claims, 26 were brand name drugs without pharmacy rebates. 415.74 in DIR fees were assessed to the pharmacy on these non-rebatable claims.

I will let that sink in for a moment. For the period analyzed, all of the rebates that would eventually be received by the pharmacy for the drugs dispensed was wiped out by the DIR fees. Remember, the rebate won’t actually hit the pharmacy’s bank account for several months, so this is a real hit to the pharmacy’s cash flow.

As a point of reference, these 201 claims generated only $611.59 in profit for the pharmacy after DIR fees were subtracted and the rebate check was received. That is an anemic $3.04 per prescription.

Results: voodoo DIRs

Because this report represented a larger time span, there were 805 claims compiled. The total of the DIR fees withheld (which includes any negative DIR fees that are returned to the pharmacy because the MAC price was even more aggressive than the contract allows) was $12,512.23. The rebates that these sales will reap the pharmacy came in at $3985.88, It does not take a rocket scientist to figure out that the DIR fees not only have eliminated the rebates the pharmacy would eventually receive, but also have dragged the pharmacy’s bottom line significantly into the red. For reference, the 805 claims LOST the pharmacy $5741.55 (an average loss of $7.13 per prescription). Like the last DIR analysis done here, most of this was due to several drugs significantly underwater. Note that the PBM has not addressed these underwater claims despite 6 months worth of regular reporting done by our PSAO. 

Like the Flat Fee DIR fees above, the voodoo DIR fees also assessed DIR fees on brand name drugs. Brand Name drug claims were limited to only 60 claims and represented only $450.99.

Conclusions

In order to be included in the preferred networks, pharmacies have had to agree to very aggressive terms. The MAC Pricing being used today leaves very little profit to be made by the pharmacy on the product. In recent years, the primary driver for profit for pharmacies has been rebates. With the advent of DIR fees, rebates are effectively being completely absorbed in DIR fees as “provider savings,” leaving pharmacies with little profit to cover overhead, salaries, and a reasonable profit on their investment.

I have no problem with rationalizing DIR fees existence on the existence of pharmacy rebates. Unfortunately, just like MAC price schedules, the PBM’s grasp on reality appears to be questionable. The PBMs severely underestimate real-world acquisition prices, and their MAC prices are too often below actual the pharmacy’s acquisition price. Likewise, the PBMs appear to be severely overestimating the rebates pharmacies generate.

Post Script

At the end of my conversation with the reporter, he asked me if there was anything that I would ask the PBM (that he was scheduled to talk to next) about DIR fees. That answer was simple: Pharmacy sacrificing their own profits to generate savings to the payor through the acceptance of contracts with DIR fees. What is the PBM industry (as one of the more profitable industries in all of health care) sacrificing to provide savings to the payor? I doubt that question will get a serious answer, though.

“If it’s right for the patient, then its right for pharmacy”

“If it’s rights for the patient, then its right for pharmacy”.  I first heard this statement, or something very similar to this from an esteemed colleague, Bob Osterhaus.  Over the years, I have cited this statement in many venues convincing pharmacists to always put the patient first and do the “right thing” to ensure that they are achieving therapeutic outcomes through safe and effective medications.  This phrase was paramount to my business partner (Mike Deninger) and I as we re-engineered our practice to provide continuous medication monitoring (CMM) for all of our patients.   To put it simply, CMM was a process that we developed and implemented so that we became accountable to our patients.  Filling a prescription becomes more than just a dispensing process, but rather a meaningful encounter with the patient whereby pharmacists are reviewing the patients medications, identifying and resolving drug therapy problems, communicating with patients and prescribers, and documenting their activities in real time.  We firmly believed that this was the RIGHT thing to do for patients.

Since implementing CMM, our pharmacists have improved their efficiencies in their patient care processes so much so that we are documenting approximately 3000 interventions every month.  But how did we get there?  This did require an investment of time, money, and resources.  Early one Mike and I realized that CMM can only be done if there is an effective and efficient documentation system.  Initially we developed a documentation system that allowed pharmacist to do final verification along with patient SOAP notes and we called it our “Quick Clinical” system.  Eventually, it became a comprehensive documentation tool that allows our pharmacist to provide final verification, create on-the-run interventions, identify potential drug therapy problems, and write SOAP notes.  This clinical documentation system is now called PharmClin and we have filed for a patent to the United States Patent and Trademark Office (USPTO).  This system has allowed our pharmacists to better manage our patients drug therapy.  It was the RIGHT thing to do for our patients.

We also hired more pharmacists to ensure that we could provide other clinical services in addition to CMM.  These services include immunizations, medication therapy management (MTM), consulting services for hospice and long term care, medication adherence program (MAP), durable medical equipment (DME) consults, medication synchronization, and health screening/promotion.  We invested in technology (e.g. Parata Pass and Parata Max), participated in the new practice model (tech-check-tech program) initiated in our state, and fully engaged in medication synchronization with the sole purpose to make sure pharmacists were freed up to provide patient clinical services.  Although a sizable investment, it is the RIGHT thing to do for our patients.

Mike and I fully understand that we have a sizable financial investment in our pharmacies, but we firmly believe that we have put our pharmacy on the right path for a bright future.  It is not without concerns, fear, or doubts.  But then I am reminded of the statement by Bob Osterhaus “If it’s right for the patient, it’s right for pharmacy”.  Then I know that we have done the RIGHT thing because our patients are benefitting.

It is time for all of us to critically evaluate our practices to determine if we are doing the “RIGHT” things for our patients.  It begins by creating efficiencies in the practice so that pharmacists are freed up to provide clinical services.  Dispensing should be technician driven.  Medication synchronization services should be the standard of community pharmacy practice as it improves dispensing efficiencies, inventory management, and the provision of clinical services.  Pharmacists need to become “interventionist” by identifying drug therapy problems, providing clinical recommendations to patients and/or prescribers, and documenting their clinical activities.  Pharmacists need to make sure they are practicing to the level of their degree.  If they are uncomfortable and incapable of doing this, then they need remedial education/clinical training.  Obviously this is not easy, nor can it be done without some type of investment (time, money, or resources).  But, ultimately, it is not about what is best for us, but rather what is RIGHT for the patient!

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!

Complacency

Over the last 8 months, I have worked hard to lose 50 pounds and become much more physically fit. This did not happen by itself. It took a lot of hard work and dedication. There was a point where I had to dedicate myself to fitness and set goal. Once I achieved these goals, another dedication (to maintain my level of fitness) was necessary. Unless this dedication becomes life-long, I risk a return to my much heavier, and less healthy self.

Dedication is an amazing thing. Over the course of the month of August, I ran more than 100 miles, a feat I did not think possible. I also managed to run a half-marathon (twice). Again, not something I reasonably thought I would be able to do. I even plan on attempting a marathon distance this fall. Dedication takes will power and perseverance.

The other morning, a day after I logged 12 miles of running, my alarm went off (as usual) at 5:20 AM. The little voice in my head rationalized that because I ran 5 of the last 6 days, I should sleep in and rest today. It was tempting to get a little rest, to let my sore muscles heal. I deserve some rest because I put all of that hard work in last month and achieved so much! All of a sudden, my mind was beginning to be complacent.

Complacent
adjective: showing smug or uncritical satisfaction with oneself or one’s achievements ORIGIN mid 17th cent. (in the sense ‘pleasant’): from Latin complacent- ‘pleasing,’ from the verb complacere

Needless to say, dedication prevailed, and I got up and put in my miles. After the run, I felt much better. But such is the battle with complacency. You know what you should do, but you still feel you don’t need to do it again because you have proven yourself.

The Thriving Pharmacist vs. the Complacent Pharmacist.

This little store above was not meant to publicly brag about my accomplishment in a national forum (though it does feel good!). It is, instead, a way to talk frankly about pharmacy and pharmacists becoming complacent. One of the first things my business partner tells our residents every year is to “not become complacent.”

It takes a lot of energy and commitment to be an active, patient-care-centered pharmacist. I know a lot of pharmacists that started out committed to patient care, only to slowly become complacent. Little financial benefit is seen by both the pharmacist and the pharmacy for quality pharmacy care. Complacency comes easy in this situation, and a pharmacist may gradually become a simple dispensing pharmacist, doing only the bare minimum required by the state board of pharmacy.

Dedicate Yourself

For me, complacency in my overall fitness came gradually over the last several years. My wake-up call to get fit came from my loving wife in the form of a gift certificate to a local gym. It sometimes takes a push to recognize that complacency has set in.

Fortunately, my dedication to my pharmacy career has been fairly constant over the years. While I regularly am challenged with complacency, I work in an environment that helps me stay dedicated to patient care. Occasional “wake up calls” come from my business partner and my employee pharmacists. We all work hard to challenge each other to stay dedicated to patient care. It is certainly not easy, and often reimbursement for quality care is non-existent.

The Thriving Pharmacist openly challenges every pharmacist to reaffirm their dedication to patient care. Strive to create a supportive work environment that helps everyone maintain a level of dedication to patient care. Become a dedicated interventionist, or re-affirm your dedication quality care. Be proactive, and not simply reactive in clinical recommendations for your patients. Pharmacists have ready access to their patients, seeing them far more often than most physicians see them. Use your access to make every encounter with your patients 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.

An Appetite for Inventory

Last Week we wrote about the new addition to our pharmacy, baby Maximus (a Parata Max). Today, I wanted to discuss our experience with inventory as we adapt to life with our new robotic child.

An Appetite of Inventory

The Parata Max, as it came configured for our pharmacy, has the capacity to hold 186 different medications. It has two different sizes of canisters; regular, and the “super cell.” A regular size canister can accommodate:

  • 300-500 larger tablets (e.g. atorvastatin 80 mg) or
  • 1000-1300 regular size tablets (e.g. metoprolol 50 mg) or
  • 2000-4000 small size tablets (e.g. levothyroxine or atenolol 25 mg)

The super cells, on the other hand are really best suited for larger tablets and capsules or very, very high volume drugs. Super cells hold roughly twice the capacity of the normal cell.

If it is not apparent, using an average cell capacity of more than 1000, the robotic dispensing apparatus has a capacity of more than 170,000 tablets or capsules, with a ceiling much, much higher than that. Even if the machine is filled entirely with inexpensive generics averaging $0.05 per dose, the inventory capacity is about $10,000. In our case, the actual inventory value is likely going to be higher.

Dual Edged Inventory Sword

One of our learning experiences has been with the re-stocking of the robot. The goal it to find a balance between too much stock (several months worth of inventory) and too little stock (requiring regular re-loads) in the robot. Our goal is to keep 2-3 weeks worth of inventory in the machine at any given time.  For fast-moving drugs (e.g. gabapentin 300 mg capsules), a single super cell only lasts a couple of days, using a second super cell with the same drug in it might be warranted.

The goal of restocking any given medication every 2 to 3 weeks is a significant change in our inventory patterns. In the past, we used a JIT (Just In Time) inventory model, keeping only several days worth of inventory on the shelves, and ordering each time a bottle was consumed. Because we receive deliveries 5 days a week, this model worked well to keep overall inventory down and to maximize the number of “turns” of our inventory every year. The new model, with the robot, is going to require additional inventory for many items, meaning that for medications in the robot, we will turn our inventory much less frequently.

As we learn how much stock to keep in the robot, we have decided to keep the same level of stock on our shelves (several days of inventory). This has essentially doubled our inventory of these drugs. Until we have a better understanding of how much inventory to keep in the robot, we want to keep a safety net of inventory on hand. Fortunately, only a few of the medications we have chosen to put in the machine are costly.

Smarter Inventory?

With time, the Parata Max is supposed to get a feel for our inventory usage. The reports generated by the replenishment wizard are designed to give us notice of when it is time to re-order inventory, and then how much stock to put in the machine. This has the promise to help minimize the added inventory required to leverage the robot in our workflow.

The one difficulty, though, is the nature of today’s pharmaceuticals market. On any given day, it is a challenge to get several generic medications due to supply chain issues. If we depend on the replenishment reports to order stock, we risk not being able to get the product in a timely fashion and running our supply completely out.

The other side of this is the frequent substitution that occurs in the market today. Even though the cells in the Parata are not NDC specific, each change of product requires the cell to be re-configured and calibrated. The also means that the cell must be completely empty before replenishing it. Frequent changes in generic products are certainly not ideal.

Substitution Confusion

In our practice, we place a small warning sticker on the prescription vial letting the patient know that a change in generic occurred (and that the product looks different). We generally add these notices for up to 90 days after changing a product in order to alert all customers at least once. When the product was filled off of the shelf, knowing when a product was changed was a matter of a small label or note on the bottle. When coming out of the robot, however, this is much more difficult to track, and we have not yet determined a work-around for this.

Closing

Like any new program, the inclusion of a robot into our workflow is a learning experience. With some time, we hope to minimize the impact of this change on our overall inventory levels. Next week, we will discuss the impact the robotics are making on our workflow, especially as it relates to medication synchronization.

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.

An Ode to Empty Warfarin Bottles

Some pharmacists and most patients don’t immediately recognize that some prescriptions medications are hazardous materials. That is not the same thing as dangerous (necessarily), because prescription medications are safe as long as they are used in the manner that they are prescribed. The hazardous label comes not from the Food and Drug Administration (FDA), but the Environmental Protection Agency (EPA).

From time to time the news media will cover a story about ground water (streams etc) having measurable concentrations of antibiotics or steroids. These amounts generally are very, very small, but the implications to the population in general and the environment are real.

Proper disposal of unused medications, therefore, is important. Many pharmacies (in Iowa for example) participate in a Take-Away program for non-controlled drug disposal. This program helps divert unused medications from the landfill and possible infiltration into our ground water supply by incinerating the medications at an EPA registered waste facility to render them harmless.

Of course, some medications are more worrisome than others. Very few medications make the EPA’s list of acutely toxic substances. One common exception, however, is warfarin (the generic of Coumadin, a blood thinning agent). Warfarin is also used in commercial rodent poisons, and even a small amount can impact the blood clotting physiology of humans and other animals.

The Resource Conservation and Recovery Act (RCRA) is the regulation that defines hazardous waste in the United States. Warfarin appears on both the P and U lists of hazardous waste (depending on the concentration of warfarin in the product). And while the tablets of warfarin (once dispensed to the patient) are exempt from any special disposal requirements (as they have been used for their intended purpose), the residual (the dust that may remain in the container after all tablets are gone) has not been used for its intended purpose, and is therefore subject to the RCRA and its requirements.

This interpretation of 54 FR 31335-31336 (July 28, 1998) by the EPA means that pharmacies must comply with the requirements of the RCRA (see 40 CFR 261.2) when disposing of the empty warfarin bottles. This is where things get a bit more complicated. If a pharmacy generates enough waste (greater than 1 kg / month), it is subject to a host of extra rules. Fortunately, it is the weight of the residual powder (measurable in milligrams), not the weight of the bottles, that is considered. This makes all but the largest pharmacies most likely categorized as conditionally exempt generators.

But being a conditionally exempt generator doesn’t mean these bottles can simply be thrown away. These bottles must still be disposed of in a manner consistent with RCRA guidelines. In order to discard the bottles into the traditional waste stream (for example, a landfill), the bottles must be RCRA empty (as defined by 40 CFR 261.3), requiring a triple rinse with a solvent documented to remove the hazardous materials. From a practical angle, this is not feasible, as the rinse material would then be a P-listed waste, and the simple act of rinsing would actually increase the amount of waste on hand.

There have been a couple of EPA guidances on this topic published in the past few years that are worth reading:

  1. October 2011 Letter (Boston Field Office)
  2. November 2011 Letter (Washington DC Office)

Concentration is the Key

The most important aspect of this problem is the dual nature of warfarin as it is classified by the RCRA. At concentrations of above 0.3%, warfarin is listed as acutely toxic and on the P-List. At lower concentrations, the same product becomes U-Listed. The “intended use” interpretation for the residue only appears to apply to P-Listed substances, and at lower concentrations, less stringent disposal rules would apply.

The second (November) guidance above does address some anecdotal evidence that the amount of warfarin residue might potentially be U-Listed. Limited testing referenced in the letter showed residue of warfarin in a single dose package was about 36 micrograms. This is in line with our estimates done with an analytical balance. The residual powder in a bottle of 1000 tablets averaged about 13 mg (equivalent to 650 micrograms warfarin).

The reporting of concentration as a percent, however, leads to difficulty in interpretation. For example, If an empty bottle of 1000 warfarin 10 mg tablets contains 13 mg of residue equivalent to 0.650 mg warfarin, the concentration of warfarin (reported  as a percent of the initial warfarin contained in the bottle) is 0.0026%. In other words, the bottle is 99.9974% empty. But the concentration of the residual powder would be still 5% w/w warfarin, identical to the tablets themselves.

This relative nature of percent has created some confusion. Consider the State of Florida’s own guidance, which uses the first calculation example above to calculate warfarin in the empty bottle as under 0.3% (of the initial warfarin concentration). The guidance states that the FDEP has determined that the containers are therefore identified as U-Listed. The November guidance from the FDA, however, clearly specifies the second calculation (the warfarin concentration (w/w%) of the powder residual itself). This guidance essentially relegates every strength of warfarin tablet (and the residual dust they generate) as P-Listed.

What is also not clear is if RSRA rules allow the dilution of the P-listed agent to attain U-listed status. If an “empty” warfarin bottle contains 15 mg of residue (containing 0.7 mg warfarin), adding an additional 200 mg of lactose ( or other pharmaceutical powder diluent) and mixing until homogenous would render the %w/w concentration of warfarin less than the 0.3%, making the bottle subject to U-listing procedures. For reference, 200 mg of lactose a small pile size of a dime. Without official guidance from the EPA, using a strategy like this would incur significant risk.

Best Practice

The rules created by the RCRA cover the industrial generation of waste. Procedures referenced within the rules talk about a variety of instances, but examples often illustrate a much larger scale of waste than a pharmacy would generate. For example, discussions referencing containers like railroad tanker cars, a scale that only a pharmaceutical manufacturer might approach. Empty bottles that formerly contained pharmaceuticals really should be subject to more specific and appropriate rules. The EPA guidance from October 2011 noted that they were currently evaluating certain aspects of the management of hazardous pharmaceutical wastes in healthcare settings, but no new guidances are available since 2011.

In the end, because each bottle contains (less than one milligram of) warfarin, pharmacies should continue segregate and send away empty warfarin bottles for incineration at an EPA licensed facility. Companies like Sharps Compliance Inc and others can help a pharmacy manage these wastes. One possible way to kill two birds with one stone is to use a program like Sharps Compliance’s Take-Away containers. These container can be used to dispose of unused, non-scheduled, patient medications, including warfarin tablets. Patient medications could be aggregated into an empty warfarin bottle, and when the bottle is full, the entire bottle (with patient medications AND the P-listed warfarin residue) can be placed in the Take-Away box for incineration according the EPA guidelines.