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.

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.

 

IMG_4465 (1)
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.

IMG_4473 (1)
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.

The New Community Pharmacist

In the past three years, I have seen more changes occurring in healthcare and, in particular, pharmacy, then I have seen in my entire career which now spends almost 30 years.  The changes are coming rapidly and frequently to the point where it is becoming scary, challenging, and intimidating to pharmacists in all settings. One of the more significant changes is in how healthcare is being reimbursed.  The old fee-for-service is no longer the standard.  We have quickly moved to a system that utilizes value-based purchasing as the new standard.  In this system, payers purchase services based on value and the performance of providers.  Payers are looking to reduce their overall healthcare spend while simultaneously improving healthcare quality.  This includes sharing the risk of healthcare costs with providers, including pharmacists.  This also means new opportunities for pharmacists, including community pharmacists.  With these opportunities, though, will come new responsibilities.  Community pharmacists will have the responsibility to ensure that their patients are achieving therapeutic outcomes through the use of safe and effective medications.  This is not a responsibility to be taken lightly, nor is it one that will allow community pharmacists to stay passive.  We must change our practice setting, and what we do day-to-day for our patients.

From a practice setting perspective it means several things.  First, community pharmacies need to make sure that they are being freed up to provide patient care services, and not just dispensing a product to the patient.  This may require additional staff, and training of existing staff.  Community pharmacists should move to a technician-driven, pharmacist-managed dispensing process.  Also, it may require investment in technology whether it be a “state of the art” pill counter, or a more sizable investment in a robot for automated dispensing.  Another area to look at is what is allowed under state board of pharmacy rules in regards to a tech-check-tech system.  As mentioned previously, the intent of these changes is to make sure the pharmacist is freed up to review patient medication profiles, identify and resolve drug therapy problems, and document their activities.

Community pharmacists may need to make an investment in clinically oriented and/or residency trained pharmacists, especially if the current practice does not have a clinically oriented pharmacist on staff.  Being responsible for therapeutic outcomes is an extremely important role for pharmacists.  It requires current therapeutic knowledge, clinical skills, problem solving, and critical thinking.  Pharmacists need to become interventionist, meaning that once the drug therapy problems is identified, they also provide solutions to resolve these problems. This requires communicating clinical recommendations regarding drug therapy changes to other providers.  Community pharmacists should ask themselves the following questions with each patient, and every medication the patient is taking:

  • Is the patient achieving their therapeutic outcome?
  • Is the patient’s medication effective?
  • Is the patient’s medication safe?

If the answer to any of these questions is no, then a drug therapy change may be warranted.

Re-engineering a practice also means critically evaluating the physical layout of the practice.  Community pharmacists need to think about where they will counsel patients during the dispensing process, and if the space provides some level of privacy.  Also, a patient care area to perform Medication Therapy Management Services (MTMS) and other clinical services is important.  This space should allow a more intimate discussion where the patient does not feel rushed or concerned about privacy.  These patient care areas are where patients and pharmacist can have more in-depth discussions regarding the patients medication regimen, questions/concerns the patient may be having, or providing clinical service such as immunizations.

Lastly, the new community pharmacists needs to be documenting their patient care activities including the drug therapy problems found during the dispensing process when pharmacists are performing their prospective drug utilization review (pDUR) now referred to as continuous medication monitoring (CMM) services, or while providing MTMS or other clinical services.  This documentation needs to be completed real time. Drug therapy problems identified should be documented along with an action taken, and the results of the actions taken.  Patient charts, electronic or hard copy, should be kept for all patients, and these charts should includes all interventions pharmacists have made to improve their patients’ therapy.

The new community pharmacist has a lot of responsibility, but also becomes a more integrated healthcare team member.  With healthcare change will come a plethora of new opportunities, but community pharmacists need to by ready to accept them. The new community pharmacist needs to make every encounter with their patients count.