Author: Michael Deninger

Mike graduated from the University of Iowa with a BS in Pharmacy in 1991 and completed his Ph.D. in 1998. He has over 20 years of practice experience, over half of which is as a pharmacy owner. Areas of expertise also include technology in practice, including integration with data sources.

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.

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.

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.

Baby Maximus Arrives

Several weeks ago, this blog discussed our use of a Parata Pass robot and our implementation of SuperSync. At that time, we announced (somewhat like proud parents) that our Parata Pass (named Phyllis) was going to be a big sister. Well Maximus (a Parata Max) entered our pharmacy almost 2 weeks ago and this blog post will address the details of preparing for and implementing automation in our retail pharmacy space. We will discuss the results of the implementation as they relate to improvements in workflow and our MedSync program in a later post.

The Purchase Details

Before finalizing the purchase, several decisions were made with respect to features that would be shipped on the machine. A couple of these decisions were made without a complete understanding of implications. And while a better understanding might not have changed the decisions made, I believe that these questions deserve a bit of discussion as it might benefit someone else down the road.

Vial Sizes. The Parata Max has the ability to label, fill, and cap, and sort prescriptions (start to finish). It is truly a marvelous example of modern automation. The machine can be equipped to use two different vial sizes. Our machine shipped with the standard 13 dram / 30 dram vial size combination. This is well suited for most retail implementations. The other option is the 20 dram / 40 dram vial size combination. This combination may be better suited for pharmacies that deal in a significant 90 day fill business. Be sure your choice of vial sizes matches your needs as changing the vial configuration is not something  that is easily accomplished after the machine ships.

Standard vs. Locking Cells. The second item that was discussed prior to placing the order was the option of locking cells. The sales person emphasized the use of locking cells as being important for scheduled (e.g. narcotic) medications. While locking cells are useful for this, they also offer an additional safety feature. With locking cells in the machine, the user (often a technician) can only have ONE cell open at any given time, minimizing the chance that a mistake is made during the filling process. Proper training, of course, also minimizes this risk, and ultimately the added cost was not worth this for us.

The Delivery Game Plan

Like any major addition to a pharmacy workflow, a lot of work was required after the purchase of the equipment but before the delivery and installation. This is very similar to parents preparing a nursery for a new arrival. A lot of attention is paid to details beforehand knowing that after the delivery there will be a lot going on. Parata, of course, has a detailed handbook of requirements that needs to be followed. These included:

  • Adding a dedicated power outlet on its own breaker for the robot
  • Network access near the installation point
  • proper space around the installed robot (three feet of open space around three of four sides and one foot on the end)
  • consideration of workflow

In our case, a small remodel was necessary to make space for the machine. The delivery crew visited about 1 week before installation to be sure the equipment could be brought into the space and all installation requirements would be done by the time they arrived for installation. I’m not sure they were confident that everything would be done in time, as the “nursery” looked far from complete at that point. Like most remodeling projects, this one finished the night before the installation was to occur.

The Arrival

After much anticipation and preparation, the big day finally came. As this was our second delivery, we were likely a bit more prepared and relaxed. Unlike the delivery of Phyllis 2 years earlier, which involved the equivalent of a c-section, Max breezed into the pharmacy without any problems. It was not until after delivery that a few problems surfaced. The “doctor” in the delivery room (the Parata technician) quickly discovered that Max had a birth defect. He was wired incorrectly at the factory for our installation (the power and network access points were on  the top of the machine instead of the bottom). Dr. Zach, however quickly created a temporary fix and scheduled a minor surgery the next day to fix the problem. Outside of this, installation and training occurred without any significant difficulties, and within a few days we were up and running. Like any new parents, we spent the next several days getting to know our new arrival.

 

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Preparing for delivery

The installation technician taught us how to change the labels, add vials and lids, and (of course) how to “feed it” (load) medications. Boy, can this boy eat! By the time the installation technician left us (three days later), we had only filled about 100 of the 186 different cells. At one week, we were filling about 50% of our total prescription volume on the Parata Max.

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Max in the “nursery”

Coming soon, we will share our experiences with now automation has improved (hopefully!) our workflow and our Medication Synchronization program.

Letting the Patient Update your Records

Recently I spent several weeks navigating a small health issue that involved outpatient surgery. When checking in at the clinic, the receptionist handed me a tablet and asked me to complete a History of Present Illness (HPI). I did not think too much about this until a week later, when one of my colleagues asked me what our I considered to be the most common intervention our pharmacists made when working with patients. The answer, for us, is a general form of medication reconciliation. We do it every day, though the form the intervention takes varies from case to case.

In our practice, and I am sure many others are not any different, we deal with a significant number of patients that are taking their medications according to the instructions provided by the prescriber. The problem is that these directions don’t necessarily match what was written on the most current prescription. We are routinely the last to know about changes that are made in our patient’s therapies. What starts out looking like an issue with compliance really becomes an exercise in medication reconciliation.

The thought that occurred to me was this: what if we could have the patient review their own medications from time to time and alert us to any changes that have occurred? Using a tablet type device that the pharmacy staff could configure to perform this query would be an excellent use of this type of technology, but even using a simple paper copy of the patient’s profile would be a step forward.

During the time that the patient reviews the accuracy of their profile, they could also be queried about other information related to their drug therapy. Example might include recent lab values (e.g. INR or A1C) or possible Adverse Drug Reactions (ADRs). The possibilities are almost limitless!

The Implementation

Using PharmClin (our clinical software package), a medication snap-shot of the patient’s profile can quicky be printed. By attaching this to a clip board, the patient can review the list while they wait. During the process of generating the medication list, the pharmacist can also review other desired data they wish to collect, and print these for inclusion with the profile. Many common items we use are pre-populated within PharmClin (for many important drug classes) to allow quick data entry by the pharmacist.

The goal is to provide a quick review and data collection period during the patient waiting period. When the medications are ready, the pharmacist can quickly review the information for additional questions and the patient can be on their way.

This workflow would not necessarily work in all situations. If a patient calls ahead, for example, they may be in a hurry to leave (not expecting to review their profile or answer additional questions). The workflow for medication synchronization patients, likewise might need some adaptation. For this reason, any implementation needs to be fluid, and the records to be presented to the patient should be able to be generated quickly and on demand. In cases where the patient is not currently available to perform a review, simply asking them if they might have time for a quick review at a later date (maybe the next time they pick up) could plant the seed and encourage them to make time at their next visit.

Conclusion

Taking the initiative to perform medication reconciliation is a valuable service, and this can be facilitated by leveraging the pharmacists access to the patient. Invariably, discrepancies will be discovered, leading to new interventions with both the patient and the prescriber. An implementation like this one is yet another example of making every encounter with the patient count!

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.