The number of people age 60 and older will be approximately 2 billion people by 2050.

Faced with that number, it is imperative that pharmacists and healthcare professionals arm themselves with tools to recognize and address the complexities and healthcare challenges that come with age, including frailty. 

Theoretically, frailty can occur at any age. The significance of frailty in the geriatric population lies not only on the frequency with which it occurs, but also its association with underlying illnesses, and that it is often a precursor to other adverse events in aging patients.

Because standardized and validated screenings to diagnose frailty are lacking, all healthcare providers must educate themselves about frailty. Community pharmacists, in particular, can use their frequent patient contact and accessibility to identify, screen, and refer patients who are frail or at risk for becoming frail. 

A frailty index to screen patients exists, but there is no consensus on how to define or screen for frailty. One definition of frailty is a condition that reduces an individual’s chances of recovering from a traumatic or stressful event.

 Unable to return homeostasis or the previous baseline, these stressors put these patients at risk for falls, hospitalizations, disability, delirium, and death.

 Physiologically, resilience declines with age, and as the hypothalamus-pituitary-adrenal (HPA) axis begins to fail over time, so does one’s ability to recover from stress.

 Furthermore, illness accelerates the aging process, and aging itself compromises one’s ability to recover from stress and return to one’s original functional state.

Pharmacist Intervention Helps Elderly Patients

According to one study, frail subjects have a mortality risk six times that of non-frail subjects.

 The degree to which an individual exhibits signs of frailty may help forecast poor prognosis and the risk for adverse events.

Another clinical definition of frailty is a catch-all that not only refers to gait and muscle tone, but also signs and symptoms associated with mental health, including cognition and social behaviors.

 Under this definition, frailty can be broken down into three categories: physical frailty, cognitive frailty, and psychosocial frailty.

A patient who is physically frail has three to five of the following signs and symptoms:

They may also have a shrinking in physical size.

 Patients classified as pre-physically frail exhibit one to two of these traits, but the importance of early identification and referral of patients who are pre-frail cannot be understated. Weakness is often the first symptom for pre-frailty, and caught early, can prevent the rapid progression to full-blown physical frailty.

More Older Patients Have Medication Troubles Than You Think

The earlier patients with signs of frailty can be guided to treatment, the greater the chances of improvement, and reducing the likelihood and/or severity of complications. In some cases, frailty can be reversed. Cognitive Frailty class="text">Cognitive frailty is a more complex category and can be more difficult to identify. Several factors contribute to the potential for misdiagnosis or missed diagnosis: Cognitive frailty often mimics signs of dementia and is best distinguished through biomarker testing for beta-amyloid plaques and neurodegeneration, along with evaluating the patient for signs of cognitive impairment.

Some experts embrace the idea that cognitive frailty, like physical frailty, often emerges because of pre-existing disease states, many of which predominate in older populations, such as heart disease, hypertension, stroke, chronic kidney disease, or viral infectious such as HIV/AIDS and hepatitis C.

Pharmacists take MTM to seniors in their homes

Despite the nebulous definitions, cognitive frailty is important because of its association with physical frailty and its reversibility, unlike dementia, which tends to be irreversible. Like physical frailty, cognitive frailty can also mark poor outcomes.

Even less understood and perhaps less studied is psychosocial frailty, which includes decreased or poor social interactions, and which can be the result of the patient’s frustrations with his or her declining physical state. These signs and symptoms may be consequences of societal challenges and manifest as depression, loneliness, anxiety, and reduced social interactions.

As the evidence demonstrating the effect of mental health on the physical body grows, it is important to understand how the isolation caused by being widowed, living alone, or having poor social support can exacerbate the consequences of frailty. The unique relationship community pharmacists form with their patients gives them some special insight into these risk factors that a standard medical evaluation might miss.

Because of their frequent and continuing patient contact, community pharmacists have tremendous opportunities to identify certain risk factors for frailty, which can include:

 Women may have poor nutrition and are more likely to live alone.

 Women with lower body mass are at greater risk.

 This can reduce access to care and to a social environment conducive to receiving care and emotional support.

 that can weaken or debilitate the body and mind.

: These can interfere with normal HPA axis activity which can accelerate physical and mental decline by reducing a patient’s ability to recover.

Certain medications and medication regimens:

 These may increase the risk of frailty especially for anyone on a complicated medication regimen, subject to polypharmacy, and at risk for prescribing cascades.

How Pharmacists Can Team Up with Physicians to Improve Care

Inpatient and outpatient status also contribute to frailty. As one study points out, historically, frailty was only studied in patients in the hospital or living in nursing homes. This is an important consideration when reviewing literature because patients who are either hospitalized or in long-term care facilities are more likely to be extremely frail. This also further highlights the need for additional studies on frailty, as well the need for healthcare professionals to reach a consensus on how to define it and screen for it.

Pharmacists who suspect a patient is frail or at risk of becoming frail should review the patient’s medication records and identify medications that could amplify the effects of frailty, increase the patient’s fall risk, or escalate cognitive decline. Because patients may use more than one pharmacy, a patient interview might be warranted. Community pharmacists who have frequent contact with patients and their caregivers and/or family members might consider employing tactful discussions to engage those involved in the patient’s care in efforts to prevent falls. Depending on the circumstances, concerns about frailty, declining health, and any associated potential health risks might warrant a call to the patient’s doctor.

Pharmacists who screen, identify, and refer patients in preliminary stages of frailty will help decrease healthcare costs, improve the patient’s quality of life, and increase patient survival.

Buckinx F, Rollard Y, Reginster JY, Ricour C, Petermans J, BruyÃ©re O. Burden of frailty in elderly populations: perspectives of a public health challenge. Arch Public Health. 2015;73(1):19. Available at: https://www.nbi.nm.nih.gov/pmc/articles/PMC4392630

Current Global Population. The Worldometers website. Available at: http://www.worldometers.info/world-population/. Accessed on March 13, 2018.

https://www.merriam-webster.com/dictionary/frail. Accessed on March 3, 2018.

Clegg A, Youn J, Illiffe S, Older Rikkert M, Rockwood K. Frailty in older people. Lancet. 2013:381(9868):752-762. DOI: 10.1016/S0140-6736(12)62167-9

Fried LP, Tangen CM, Waltson J.Fraiilty in older adults: evidence for a phenotype.J Gerontol A Bio Sci Med Sci. 2001:56A(3):M146-M156.

Gupta D. Morley JE. Hypothalmalmic-pituitary-adrenal (HPA) axis and aging. Comorbid Physiol 2014 Oct;4(4: 1495-510. DOI: 10.1002/cphy.c130049.

Qingwei R, Zhuouwei Y, Ma C, Zhijun B, Jin L, Wei H. Cognitive frailty, a novel target for the prevention of elderly dependency. Aging Res Rev. 2015(20)1-10DOI: 10.1016/j.arr.2014.12.004.

Mulasso A, Roppolo M, Giannotta F, Rabaglietti E. Associations of frailty and psychosocial factors with autonomy in daily activities: a cross-sectional study in Itailian community-dwelling older adults. Clin Interv Aging 2016; 11:37-45. DOI:10.2147CIA.S95182.

Articles

Pharmacists are in a unique position to screen patients for frailty. Here are the top risk factors to look for, and what to do when you encounter them.

How Pharmacists Can Help Frail Patients

My daughter Gretchen Garofoli, PharmD, a clinical assistant professor at West Virginia University, invited me to lecture to her pharmacy class about insurance and billing claims, and their impact on community pharmacy.

I tried to explain AWP (average wholesale price), WAC (wholesale acquisition cost), and direct costs, and help them understand with some examples, such as how the AWP for Aripiprazole 30 mg is $1362.26, and the WAC is $50.45. I thoroughly enjoyed my interaction with these future pharmacists. I have a passion for community pharmacy, and never miss an opportunity to interact with student pharmacists. 

The one challenge I did have was explaining the concept of 

 and shared that explanation. The students seemed confused, so I changed my tactics.

I asked the class if anyone worked for an independent pharmacy. One student raised his hand and said he worked for Waterfront Pharmacy in Morgantown. I asked him to work with me on this example: “My grass needs to be cut, I live on about half an acre, would you be willing to cut my grass for $40?” I told him it takes about 1.5 hours to cut the grass. He agrees to my offer and accepts it. So, in our scenario, he finishes cutting the grass and I hand him only $20. He complains that we agreed on $40.

I told the class that is exactly how DIR fees work; we pharmacists have no control of what we will be paid after we dispense the drug. We get “whacked” for the DIR fees. DIR fees are assessed against the pharmacy when the invoices arrive. We don't know until the check arrives, that a DIR fee was taken out. Pharmacists can’t budget for these takebacks because they are driven by Star Ratings and 

Pharmacy Community Reacts to Cigna/Express Scripts Deal

No one in any community pharmacy provides the level of healthcare that our independent pharmacies do to take care of our patients. If anything, we need government protection from the predatory practices of the PBMs and major chains. Seems to me that the only ones in healthcare making money are the ones who never interact with a patient! 

My preceptor Louie Rinovato told me once: “You have to pay attention to the business side as much as the clinical side. You can go out of business filling 30 prescriptions a day; you can go out of business filling 300 prescriptions a day. One is a lot easier than the other!”

In those days in the late 1970s, when many pharmacies were still using “40% fair trade markup,” pharmacists would never have envisioned the ridiculous reimbursement system that we have 40 years later.

I often serve as a preceptor and my latest pharmacy student is William Thompson IV, the son of the owner of Thompson Pharmacy, where I work. He represents the future generation of independent pharmacy owners. Billy is in his last rotation, and will graduate this April from the 

University of Pittsburgh School of Pharmacy

He has done several community pharmacy rotations this year, and shared with me his belief is that DIR fees are the number one concern of independent pharmacies. He said that like his father’s stores, these other independent pharmacies struggle with the uncertainty of the whole DIR process. Every aspect of running a pharmacy is impacted by these fees, from inventory management to payroll and staffing. Billy reflected, "If this profession is to be sustainable someone needs to put an end to these unfair clawbacks.”

Peter Kreckel recently tried to explain DIR fees to students. Here’s how it went.

Explaining the Flawed DIR System to Student Pharmacists

Pharmacists in almost every setting are pushing for provider status. While provider status is the most direct and transparent way to get paid for clinical services, it’s not the only way. Pharmacists who learned how to navigate the reimbursement system have been getting paid for clinical services for years.

“We started our first pharmacist-managed ambulatory care clinic in 1996 and have been getting paid for our services from day one,” says Dean T. Parry, RPh, assistant vice president for clinical informatics at 

. “Today we have about 60 pharmacists working full time in ambulatory disease and medication management. Getting paid is a matter of figuring out where in your specific administrative and financial system you can fit in. Provider status would be nice, but it is not a prerequisite to getting reimbursed for clinical services,” says Parry.

Like many other integrated networks, Geisinger covers only about 40% of members through its own insurance program. The remaining 60% are covered by standard commercial payers. The key to convincing commercial payers to reimburse clinical pharmacy services is to provide a reasonable return on the payer’s investment, says Parry.

Payers have seen all the data on the health and financial outcomes of clinical services. Parry says that they know just as well as pharmacists that the appropriate pharmacy interventions can improve health outcomes and reduce overall costs of care-over time.

“Payoff time is the obstacle for payers,” he explains. “They need to see a payoff in reduced total cost of care in less than one year. That might be possible in some disease states, but the return on investment for anticoagulation, asthma, COPD, cardiovascular disease, and most chronic diseases is too long term for most payers to work with.”

The current wave of consolidation among payers, 

s, pharmacies, wholesalers, and providers may ease the ROI problem. With far fewer payers in the system, each payer is more likely to retain patients for a longer period of time, Parry suggests. The longer patients remain with a single payer organization, the longer that payer’s time horizon for a return on its clinical pharmacy investment.

Integrated networks like Geisinger seldom worry about whether their pharmacists can bill payers directly, Parry said. Clinical pharmacists are part of the overall patient care team working to control costs, reduce admissions, improve adherence and provide more effective care. When pharmacists are part of the patient care team, the health system looks to the total cost of care versus the total reimbursement for care. Whether services are reimbursed directly or through some other provider becomes an accounting exercise for the integrated health network. The key to convincing commercial payers to reimburse clinical pharmacy services is to provide a reasonable return.

Getting Reimbursed for Services Rendered: It’s no Magic Trick

For now, closed systems like Kaiser, where a network is exposed to patients’ entire cost of care over multiple years, have an easier time justifying the financial investment in clinical pharmacy services. Pharmacists in other settings must find an appropriate work-around. Closed system pharmacists don't get reimbursed individually because the system is responsible for everything: insurance coverage, cost of care, quality of care, patient and provider satisfaction. If a third party payer is involved-Medicare, Medicaid, or some other public system-the system gets reimbursed, not the provider.

Up next: Collaborative agreements and how to get started

A work-around usually means teaming up with another provider who has the necessary reimbursement status, most often a physician or nurse practitioner. Many states have collaborative practice agreements that make it relatively straightforward for pharmacists to provide clinical services under protocol with another provider and bill for services through that provider. The billing provider shares reimbursement under terms agreed to by both provider and pharmacist. If pharmacy is part of an SSP, reimbursement is simply part of health plan revenues that go to pay all providers.

Geisinger started with a single pharmacist, Parry, and a collaborative practice agreement with a single neurologist to handle anticoagulation. Today, Geisinger pharmacists are covered by a network of overlapping collaborative agreements with multiple providers to ensure that clinical pharmacy services are eligible for reimbursement.

These agreements may not be the ideal reimbursement solution, but it’s a workaround that can work for an entire career.

“I’ve been prescribing and adjusting drug therapy almost since the day I got out of pharmacy school,” says pharmacy consultant Fred Pane, RPh, former hospital pharmacy director. “Granted, I worked mostly in hospital pharmacy, but there is always a way to work around not having provider status. You do it by solving clinical problems for providers who do have the right reimbursement status.  When you become an indispensable member of the patient care team, there are always ways to get paid for your services,” says Pane.

The key to building collaborative practice and reimbursement is creating a concrete plan that solves provider pain points, says Parry.

The first step is to evaluate published outcomes and cost data against your own practice and project returns locally. Once the program has local buy-in, pharmacy creates standardized work flows for interventions, data collection, and data reporting on patient and financial outcomes. Standardized clinical procedures and data collection makes it easier to document both interventions and outcomes.

“One of our programs worked with difficult-to-manage diabetes patients with elevated hemoglobin A1c levels,” Parry says. “Clinical pharmacists brought more than half of them to A1c goal in less than one year. That kind of data sells itself.”

Pharmacists are finding ways to get reimbursed for clinical services. See what you can do to get paid.

How to Get Paid for Pharmacy Services

	Direct and indirect remuneration (DIR) fees are the bane of many pharmacists’ lives. Now, changes may be coming. At last.

	“DIR fees have been disastrous for community pharmacy in part because of how much money they are clawing back, but just the uncertainty, the unpredictability of it is also a problem,” says Bradley J. Arthur, RPh, co-owner of two independent pharmacies in Buffalo, NY, and past president of 

. DIR fees originated when Medicare Part D was created in 2006, Arthur says, but the fees charged by plans or pharmacy benefit managers (PBMs) have become more prominent-and more detrimental to pharmacies-in recent years.

 that asserted its authority to require a portion of DIR fees to be assessed at the point of sale. The rule doesn’t actually make the change, but opens the door for further discussion about how the fees are assessed. According to the rule, any formal changes to DIR fees “would be proposed through notice and comment rule-making in the future.”

	Pharmacy officials see this move as a step in the right direction.

	 “In this rule, CMS hints strongly that it is concerned about retroactive pharmacy DIR, that it has the statutory authority to address the issue, and that there may be further rule-making to deal with it in the months ahead,” said NCPA CEO B. Douglas Hoey, RPh, MBA, in a release. “That’s very promising. This rule simply telegraphs the next step in the process.”

	This change comes months after CMS solicited comments on a suggestion within the proposed 2019 rule that the DIR fees be assessed at the point of sale rather than retroactively.

	“We are gaining traction,” says Ronna Hauser, vice president of regulatory affairs for the NCPA.

	CMS’ rule change also comes after bills were introduced into the House and Senate in February 2017. These identical bills would bar retroactive DIR fees and improve transparency by requiring that DIR fee assessments be made at the point of sale. Both bills remain active at press time and have earned support from legislators.

Pharmacists Are the Vitamins of Healthcare

	Some in the pharmacy industry are optimistic that these efforts could eliminate retroactive Medicare Part D pharmacy fees that cause reimbursements to shrink well after a sale has been made.

	“I think a lot of folks didn’t fully appreciate the impact of DIR fees until they were up to an amount where it was starting to affect their cash flow,” says Arthur. “If you quietly take a couple hundred bucks from me in a month, it’s probably not going to rise to the level where I am going to react to it, but when it started getting into the thousands and tens of thousands-and I hear of single stores now where it’s $60,000 a year in DIR fees-now you are talking about amounts of money that are deal breakers for some small, single store pharmacies.”

	Total DIR fees grew about 22% per year since 2010, while the per-member per-month DIR grew nearly 14% per year between 2010 and 2015, according to a 2017 fact sheet from CMS [

For the past two years, NCPA members have identified retroactive pharmacy DIR fees as the top legislative and regulatory priority, with more than 37% choosing the issue as their top concern in 2018.

	Kala Shankle, director of policy and regulatory affairs for NCPA, believes one reason the fees are becoming more prevalent is because payers and PBMS are using them to work around the increasing number of state maximum allowable cost (MAC) transparency laws.

	MAC lists are created by payers or PBMs and give the upper limit a plan will pay for generic, or brand name drugs that have an available generic. Historically, payers or PBMs have had free rein to pick what’s on their list. Transparency laws seek to clear up how MAC is determined and compel PBMs to provide more information about their MAC list practices.

	“It is likely that the plans and PBMs have determined that utilizing DIR reconciliation processes after claim adjudication allows them to keep published MAC amounts high while ultimately reducing the aggregate reimbursement for generic drugs at the end of an established reconciliation period, further obscuring the true reimbursement amounts to pharmacies,” Shankle says.

	This obscuring of reimbursement raises problems for chains, specialty pharmacies, and independent pharmacies.

	“DIR fees are disconnected in time and this makes it difficult to manage our businesses. When the fees are finally collected, many are not provided with supporting claim detail which makes it difficult to determine if these fees are even accurate,” says Kathy Bryant, RPh, MS, vice president of pharmacy at 

. “Forecasting them becomes nearly impossible.” Price Chopper Supermarkets operates 86 pharmacies across six states in the Northeast.

	Bryant says sometimes the chain does not know how it will be reimbursed for a transaction until three to six months after it occurs. When the reimbursement does arrive, without claim detail, it’s impossible to understand what happened or when it might happen again, she adds.

	While DIR fees were originally created under the guise of pay for performance, the reality is very different, she says. “For the majority of plans, no matter how strong our performance is, the DIR fee will not be zero, let alone paying a positive amount for a strong performance.”

	The impact of DIR fees can be particularly significant for specialty pharmacy drugs that often carry a high price tag because the reimbursement is often based on a percentage of the drug cost.

	“In the specialty field, it is really difficult because you don’t know the amount of take backs, and the percentages can be high enough that it can make you negative in the reimbursement,” says Brian Komoto, PharmD, president and CEO of 

, a group of pharmacy companies that provides retail pharmacy services.

	Komoto says his specialty pharmacy was so challenged by the fees that they had to alter which plans they would accept. “Once we started getting a history of which Part D plans were taking percentages rather than fees, that’s when we said we have to exclude these plans until we know for sure what the upfront DIR fee is,” he says.

 weighed in on DIR fees in January. It sent a letter to CMS after the rule was proposed requesting clarification as to whether it could expect the negotiated price, including all pharmacy price concessions, be used for determining pharmacy reimbursement for prescription drugs at point of sale, or if CMS would expect such a negotiated price to be used solely for determining beneficiary payment at the point-of-sale. NACDS agrees there is a need for greater transparency between part D plans and pharmacies in the use of DIR fees and other post-adjudication fees and quality and performance-based network fees. 

Click to expand“[W]e would urge CMS to consider that the negotiated price be used solely for determining beneficiary payment at the point of sale and not for determining pharmacy reimbursement at the point-of-sale,” NACDS wrote in the letter.

	Before CMS’s rule change was issued, the agency sought further information on ways in which retroactive pharmacy DIR fees can be assessed at the point of sale.

	If the fees were assessed at the point of sale, pharmacies would be able to make better decisions on how they want to structure their business, better understand what impact DIR fees would have on their bottom line as they plan for the future, and make smarter choices regarding what plans to do business with, says Bryant.

	Arthur says he’d rather see the fees eliminated completely, but believes assessing the fees at the point of sale is a good starting point. “At least give the pharmacists at the point of sale [an opportunity] to make a decision. Maybe they decide, ‘I just can’t provide this service to you for this high dollar specialty,’” Arthur says. “It’s progress. It’s not the end-all, but it’s progress.”

	A positive benefit resulting from the fight against DIR fees is that it’s uniting pharmacists, says Bryant. “We are all here to serve our patients, that’s why we do what we do, so this really has us joining together in one voice in proposing and soliciting help on something that can help us, but ultimately help our patients.”

	While DIR changes are gaining momentum, experts believe meaningful change isn’t imminent. CMS has opened the door to further discussion on this issue through this rule change, but a more formal comment period and discussion are likely to follow.

	“That’s where you are going to see the real regulatory knives come out,” Shankle says, noting that the biggest opposition will likely come from the PBMs. “They would have to change up some processes in the way that they do things.”

	In the interim, experts say pharmacists can help continue to increase momentum in both the regulatory and legislative front by contacting their senators and representatives and sharing their stories about DIR fees and the challenges they pose. 

Meaningful changes to DIR fees are on the horizon-will pharmacies see an increase in reimbursements?  

Everything Pharmacists Need to Know About DIR Reform

Maybe it’s because it was the first country music concert I attended or maybe because the concert was at Lambeau Field, home to my beloved Packers, either way, I’ve come to really enjoy the music of Kenny Chesney.

One of his more recent songs is titled “

.” It’s a great tune, even if country music isn’t your preferred genre. The reason I mention this is that I really feel that for those of us dealing with the pressures of owning a community pharmacy, everything 

If you are like me, you’ve seen margins shrink, and shrink, and shrink some more. This month’s cover story on DIR fees underscores this growing challenge. Trying to decipher 

, and dealing with other frustrations such as restricted networks, is no easy task. Now we’re again hearing rumblings of drug reimportation as a potential fix to the rising cost of medicine. These are threats to our livelihood and are reasons to be worried about the future.

But haven’t there always been reasons to worry? I’ve been a pharmacist for a little over 15 years now and I’m not sure I can recall any particular time that there wasn’t at least one threat to what we do. But I also cannot remember a time where our resilience and belief in what we do each and every day did not get us through the tough times or make us stronger. And so here we are, facing more and more pressure on our businesses, and yet there is a light at the end of the tunnel.

A network of like-minded pharmacies is forming under the 

Community Pharmacy Enhanced Services Network

. My understanding is that one of the end-goals of this network is to change the reimbursement model to one that pays pharmacies for the care we provide, independent of dispensing prescriptions. That’s huge for our profession.

We’ve probably all read hundreds of studies that show the impact pharmacists can have, in pretty much every segment of healthcare. It’s obvious to us that we do more than put pills in bottles, and now it’s up to us to make it obvious to others. Along these lines, those of us in community pharmacy are now being measured (and graded) on the quality we provide via the 

 (a performance information-management platform).

While I admit that it’s frustrating to see some payers use these measures to penalize the low performers instead of rewarding the high performers, it still seems like a step in the right direction. I know that seeing a monthly report card has motivated me to keep putting effort and resources into improving my pharmacy’s scores-and I assume I’m not alone in the type-A pursuit for perfection. 

And so here we are, doing what we’ve always done, going that extra mile to help our patients in every way that we can. And even though we may be facing more challenges today than ever before, I believe that what we do matters. We will get through this together and we will be stronger for it. At the end of the day, everything is gonna be alright.

There is plenty for community pharmacists to worry about, but there is a light at the end of the tunnel.

The Future of Pharmacy Is Not All Doom and Gloom

The FDA approved apalutamide (Erleada, Janssen Biotech, Inc.) to treat patients with nonmetastatic castration-resistant prostate cancer.

Androgen-deprivation therapy (ADT) is an effective and integral part of care for patients with nonmetastatic prostate cancer. However, resistance to ADT is inevitable and develops in almost all cases of prostate cancer.

 Preventing metastasis to bone and other sites is an important goal in treatment. Apalutamide is a nonsteroidal antiandrogen agent that has been found to increase the time until metastasis in prostate cancer.

 It works by binding directly to the ligand-binding domain of the androgen receptor, and preventing processes such as receptor translocation, DNA binding, and transcription.

Approval of apalutamide was based on data from SPARTAN, a multicenter double-blind placebo-controlled phase 3 trial involving 1207 patients with nonmetastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time ≤10 months on ADT.

 Patients were randomly assigned in a 2:1 ratio to receive either apalutamide 240 mg orally once daily with ADT or placebo once daily with ADT.

The median metastasis-free survival was 40.5 months in the apalutamide arm and 16.2 months in the placebo arm (hazard ratio for metastasis or death, 0.28; 95% confidence interval [CI], 0.23 to 0.35; P<0.001).

 Additionally, apalutamide was associated with longer time to metastasis, progression-free survival, and time to symptomatic progression.

The most common adverse events of any grade associated with apalutamide during the SPARTAN trial were fatigue (39%), hypertension (25%), rash (24%), diarrhea (20%), nausea (18%), arthralgia (16%), fall (16%), weight loss (16%), hot flush (14%), fracture (12%), and peripheral edema (11%).

Rash was the most common adverse event that led to discontinuation (3%). Macular or maculopapular rashes occurred at a median of 82 days of treatment and typically resolved within a median of 60 days for most patients. Management of rash included topical and systemic corticosteroids as well as oral antihistamines.

Hypothyroidism occurred in 8% of patients receiving apalutamide. In those already receiving thyroid replacement therapy, apalutamide worsened hypothyroidism. Hypothyroidism was managed with increases in or initiation of thyroid replacement therapy.

Apalutamide is not indicated in females and is contraindicated in pregnancy. Males should use effective contraception during treatment and for 3 months after the last dose of apalutamide.  Apalutamide may cause infertility.

The recommended dosing of apalutamide is 240 mg by mouth once daily. If a dose is missed, administer as soon as possible on the same day and return to the normal dosing schedule the following day. Apalutamide is supplied as 60-mg oral tablets which should be swallowed whole. It can be taken with or without food.

 The estimated price for a 30-day supply of 120 tablets is about $10,000.

. (Wolters Kluwer Heath, Inc. Riverwoods, IL). Available at: 

Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. 

. 2018 Feb 8. doi: 10.1056/NEJMoa1715546.

Erleada (apalutamide) Package Insert. (Janssen Products, LP, Horsham, PA). February 2018. Available at 

Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer [supplementary appendix]. 

Erleada prices and Erleada coupons. GoodRx Web site. Available at 

FDA approves apalutamide for castration-resistant prostate cancer.

Apalutimide for Prostate Cancer: What to Know

Pediatric pharmacotherapy is a dynamic and challenging profession. It is a field that requires extensive experience and an in-depth understanding of pharmacokinetics and pharmacodynamics in order to expertly navigate the complexities of treating patients where clinical data on the use of drugs is limited and often requires off-label use.

I pursued a future in the pediatric field of pharmacy because of its unique challenges, as well as its positive impact on patient care for the most vulnerable population.

Neonates, infants, children, and adolescents differ from adults anatomically, physiologically, immunologically, psychologically, developmentally, and metabolically. As a vulnerable population, pediatric patients present a unique challenge and have a higher risk for adverse drug events than adults. For example, medication dosing errors are more common in pediatrics than adults because of weight-based dosing calculations.

How Pharmacists Can Protect Kids from Dangerous Medications

Most medications are formulated and packaged for adults, which requires manipulation of the dosage form in order to administer the precise dose to the child. Additionally, pediatric patients often can’t communicate effectively to providers any adverse effects caused by medications. This provides an opportunity for the pharmacist with expertise in pediatrics to ensure optimal pharmacotherapy with desired outcomes and minimal adverse effects to pediatric patients in collaboration with the caregiver and other healthcare professionals.

Several national organizations such as the 

, ASHP, and APhA have advocated for recognition of pediatric pharmacy practice as a specialty.

Board-Certified Pediatric Pharmacotherapy Specialist

 (BCPPS) helps provide quality assurance that a pharmacist is specialized in care in pediatrics. Eligibility for the BCPPS exam includes graduation from an Accreditation Council for Pharmacy Education (ACPE) accredited program and active licensure, plus one of the following requirements:

Completion of four years practice (post-licensure) in the pediatric setting with at least 50% of time spent in pediatric pharmacy activities

Completion of a PGY1 residency plus two years of practice in the pediatric setting with a minimum of 50% of time spent in pediatric pharmacy activities

Completion of a specialty PGY2 residency in pediatric pharmacy.

The exam covers four domains of specialized functions in pediatrics: patient management, practice management, information management and education, and public health and patient advocacy.

Pediatric Asthma: An Update for Pharmacists

Board certification elevates the status of pediatric pharmacists. These pharmacists collaborate with ambulatory-care pharmacists and other healthcare providers to improve pediatric public health, including by improving health literacy, providing individual patient care plans, and ensuring optimal medication outcomes.

A BCPPS can serve important patient care functions in many different settings such as the community, ambulatory care, or hospital. With the quality assurance from the Board of Pharmacy Specialties, these pharmacists can make a significant impact for young patients who have unique needs.

Board-certified pharmacists are better prepared to deal with pediatric patients than others. Here’s why.