The pharmacist’s role is expanding as the healthcare arena moves from fee-for-service to value-based payments.

“Physicians are warming to the idea of working alongside pharmacists in their practice settings. In fact, not only are they warming to it, many physicians are carving out a pharmaceutical piece of part of their risk-sharing agreements,” says Susan Cantrell, RPh, CEO of the Academy of Managed Care Pharmacy (

Medicare accountable care organizations (ACOS) do not directly include pharmacists and medications, but appropriate medication management is necessary to ensure success of value-based arrangement, Cantrell explains. “Therefore, we are seeing a trend where physicians are trying to integrate pharmacists and medication management to achieve good outcomes,” she says.

Related article: How to Manage Medication Risks

Medication therapy management (MTM) is one of the biggest areas in which physicians increasingly rely on pharmacists, says Lucinda Maine, PhD, RPh, executive vice president and CEO of the American Association of Colleges of Pharmacy (

). “As physicians need to meet expectations around quality-based metrics, they are finding they can move those quality needles when a pharmacist provides MTM.”

In some cases, pharmacists embedded in practices or hospital pharmacists are meeting with patients prior to physician visits and conducting thorough medication reviews and assessments. “This relieves the physician of doing that part of the care plan,” she says. “Once physicians sees the value of the pharmacist, they don’t want to practice any other way.”

Community pharmacists are also experiencing role changes, as they too are providing medication management across the continuum of care. Some community pharmacists are partnering with nearby hospitals to more thoroughly counsel patients regarding medication and adherence. The expanding role of pharmacy technicians and robotics should also liberate these pharmacists to take on more of these tasks, says Maine.    

Here's more on how the role of pharmacists is changing in various practice settings.

Community pharmacy is the biggest area in which pharmacists can be better used because they have such frequent interactions with patients, says Marilyn Stebbins, PharmD, vice chair for clinical innovation, University of Southern California San Francisco (UCSF) School of Pharmacy. “Most people visit a retail pharmacy more than 20 times a year; this is where the pharmacist’s impact is the greatest,” she says.

Pharmacists are offering vaccinations, blood pressure screenings, and counseling on specific disease states such as diabetes. “In the retail setting, MTM, and not dispensing, should be the priority,” says Stebbins. “In this way, pharmacists can help improve outcomes and show their value.”

Related article: How Pharmacists Can Team Up with Physicians to Improve Care

Community pharmacists are also experiencing a growing role as hospitals look to them as a resource to improve adherence and reduce readmissions, a key metric in many value-based payment arrangements. One example is the “Meds to Beds” program at UCSF. Pharmacists from two retail pharmacies on the hospital campus meet with patients before they leave the hospital. The pharmacists explain their discharge medications and then follow up with patients to ensure they are compliant. The program has had good results, says Stebbins.

In both the retail and the hospital setting, specialty pharmacy is another model in which pharmacists are expanding their skills. Specialty pharmacies focus on high-risk patients who need intensive monitoring and intervention, explains Gary Matzke, PharmD, professor, Virginia Commonwealth University School of Pharmacy. Walgreens, for example, has pharmacies dedicated to oncology and HIV, where pharmacists perform extensive medication reviews and work closely with the patient to ensure compliance. The specialty pharmacy “contracts with pharmaceutical companies to ensure the providence of product care,” Matzke adds.

 reports that 3,257 pharmacists are currently certified as ambulatory care specialists. The specialty ranks third in numbers, behind geriatric pharmacy (4,432) and pharmacotherapy (21,771).

Related article: It's Time for Pharmacists to Carve Out a New Role

Ambulatory care encompasses pharmacy practice in clinical settings that could include ambulatory care clinics, physicians’ offices, retail pharmacies, and pharmacies affiliated with long-term care facilities, says Ernest Wright, senior manager of operations-BPS. In long-term care, pharmacists may also be certified through BPS as Geriatric Pharmacy Specialists.

“When the ambulatory care specialty certification was first offered in 2011, it went through a season of growth and resulted in many pharmacists being rapidly certified,” says Wright. Today, growth is still “pretty steady.”

Pharmacists are also finding new roles in hospitals and physician practices as these organizations take on value-based models such as 

). PCMHs are models of care that put patients at the forefront and build relationships between patients and their healthcare team. The end goal is to optimize outcomes as payers look to reward value.

), for example, the Pharmacy Department and the Department of Family Medicine, developed prototype PCMH models within two already-established primary care offices. Pharmacists at both sites, Care Point Gahanna and Care Point Lewis Center, work in the physicians’ offices as members of the healthcare team. “The pharmacists have separate appointments with the patients where they obtain medication history, conduct patient interviews, make medication adjustments, order labs, if necessary,” says Bella Mehta, PharmD, professor of clinical pharmacy and family medicine at OSU.

“While the original prototypes didn’t set out to measure long-term clinical outcomes, both sites found the pharmacists valuable and went on to hire full-time pharmacists,” says Mehta. “This is the highest compliment you can get.” 

Related article: Automation Drives New Role for Hospital Pharmacists

, a seven-hospital health system, brought together hospital pharmacists, clinical pharmacists, community pharmacists, and physicians. The project, Improving Health of At-Risk Rural Patients, sought to “improve the clinical status of the patients as well as reduce health service utilization, such as hospitalizations and emergency room visits,” explains Matzke.

A grant from the CMS Center for Medicare and Medication Innovation supports the placement of pharmacists in clinics on the hospital campus. The project was a collaboration between Carillon and Virginia Commonwealth University.

The pharmacists working in the clinics identified high-risk patients at hospital discharge, and from that point, coordinated among the clinic, the patient’s primary care physician, and the community pharmacist. High-risk patients were those with multiple disease states who were taking four or more long-term medications.

Related article: Telepharmacy: New Jobs, Expanded Opportunities

“We saw significant improvement in all clinical and utilization end points,” says Matzke. In looking at end points, blood pressure improved in participating patients, as well as cholesterol levels and A1c levels. “And many of the clinical results as well as the degree of hospital utilization were significantly better in the pharmacist group than in the retrospective control group that received usual care,” he adds.

Senior care is another area in which pharmacists are using their MTM skills to improve patient outcomes. “With the current demographics-with the baby boomers getting older and living longer-this generation is remaining a vital active member of the community,” explains Lynette Bradley-Baker, RPh, PhD, vice president for public affairs and engagement at AACP. “Subsequently, pharmacists are being asked to provide care in nursing homes and long-term care facilities.” In these settings, “MTM is critical to controlling chronic disease management,” she says.

A program at UCSF called “Care at Home” has the pharmacist addressing the needs of the older homebound patient via an e-visit. “It isn’t home healthcare, per se, but involves elderly, frail patients at higher risk who receive most of their healthcare in their home,” Stebbins explains. The program is a collaboration between the School of Pharmacy and the School of Nursing. “Through videoconferencing, the patient can receive a pharmacy consult at home,” she explains. “Additionally, the pharmacist may visit the home with the nurse practitioner, examine the patient’s medications and where they’re kept, and make recommendations.

In the managed care setting, more pharmacists are getting involved in utilization management programs for patients covered by Medicare Part D, says Cantrell. Ensuring proper usage can help curb costs, therefore helping organizations reach cost-based metrics in value-based arrangements.

Broken down further, pharmacists may be involved in population health management initiatives, in which healthcare organizations attempt to improve outcomes and reduce costs of care associated for groups of patients within specific disease states and demographics. “Pharmacists are involved in evaluating trends, evidence, and data to determine appropriate treatments, including medications, or preventative measures that will improve health among the patient population at a macro level to be implemented by individual clinicians, says Cantrell.”

Related article: Precision Medicine: A New Role for Pharmacists

In addition to offering these services in traditional managed care settings, such as ACOs, the managed care pharmacist is finding a new site in the in the physician’s office, says Cantrell. Placing these pharmacists in a doctor’s office, “allows them to be visible and lets the public see how they can improve patient care,” she says.

Reimbursement for the provision of pharmacy services has long been a concern.  Although, Cantrell says, “as the healthcare arena is moving toward paying for value, we’re seeing things move in the right direction for pharmacists.”

Currently, pharmacists may bill for MTM services under Medicare Part D, but, says Stebbins, it is not automatic. “Not every Medicare Part D Plan allows pharmacists to bill; it is on a contractual basis.” In individual states, billing for services is contingent upon provider status, but Stebbins notes that while California is one of the most progressive states in recognizing the value of pharmacists, “pharmacists aren’t being paid, in most cases. The payment models need to be worked out.”  

Related article: How to Get Paid for Pharmacy Services

One innovative payment model in California was established by Inland Empire Health Plan, a Medicaid managed care plan. Inland Empire implemented a pharmacy network, designed to provide targeted care to patients with chronic illness and allows pharmacists to bill for MTM services. This pay-for-performance program evaluates pharmacies on a set of seven quality metrics and provides bonuses to high quality pharmacies.

Pending federal legislation would allow pharmacists to bill for services under Medicare Part B. Once that is approved, pharmacists will be able to embrace their new roles, says Mehta.

Some private insurers are also allowing pharmacists to bill, in some instances, says Matzke. But, he adds that adequate reimbursement doesn’t have to be dependent on billing for services. In a clinic, for example, “payment to the pharmacist is carved out of the payment that comes to the practice as a whole.” If the pharmacist is valued and can increase efficiency, Matzke says, the pharmacist will be appropriately compensated. Lack of provider status shouldn’t hold pharmacists back from stepping up to the plate and providing optimal patient care.

1. National Committee for Quality Assurance. Overview of PCMH. Available at http://www.ncqa.org/programs/recognition/practices/patient-centered-medical-home-pcmh/why-pcmh/overview-of-pcmh. Accessed April 19, 2018.

2. University of North Carolina Eshelman School of Pharmacy. Achieving Better Quality and Lower Costs in Medicaid through Enhanced Pharmacy Services. Center for Medicaid Optimization through Practice and Policy. Available at https://pharmacy.unc.edu/files/2015/03/Achieving-Quality-and-Lowering-Cost-in-Medicaid-through-Enhanced-Pharmacy-Services_CMOPP-white-paper_April-2017.pdf.  Accessed April 20, 2018.

Articles

Physicians are looking to pharmacists to help satisfy value-based metrics. Here’s how it’s changing pharmacists’ roles.

Top Ways Pharmacists’ Roles Are Changing

Slideshows

Easy-to-swallow bits of news from the past month, tailored for the busy pharmacist.

Small Doses News for Pharmacists May 2018

Now in its 20th edition, the ultimate medical guide looks (and weighs) a lot different than it did over 100 years ago.

Five Ways the New Merck Differs from the 1899 Edition

Observant Muslims fast from sunup to sundown during Ramadan, a practice that can be complicated if they must take medications. Pharmacists should know how to make adjustments in medication regimens that can help them and how to counsel their Muslim patients.

This year, Ramadan is between May 15 and June 14. Muslims who observe the fast will refrain from consuming anything by mouth between dawn and sunset, including food, water, and oral medications. Non-oral meds-injections, inhalers, suppositories, and eye or ear drops-are generally permissible.

“The general rule is if you can safely fast, then you do it,” explains Wasem Alsabbagh, PhD, a pharmacist and assistant professor at the School of Pharmacy at the 

, Ontario, Canada. “The safety assessment usually falls on the shoulders of healthcare professionals who should approach the issue from a shared-decision point-of-view.”

The ban on oral medications can create a dilemma for patients who take part in the fast. Pharmacists can play an integral role by recommending medication adjustments and by counseling their patients on ways to avoid the potential hazards of fasting.

The Ramadan fast can be particularly challenging for people with diabetes due to the risk of hypoglycemia. The American Diabetes Association (

) recommends against prolonged fasting for patients with multiple diabetes complications. The ADA’s complete recommendations can be found at its website.

“Patients on insulin should measure glucose before, during, and after fasting,” advises Mohammed Jalloh, PharmD, assistant professor at 

. “I strongly encourage patients to know the hallmark signs and symptoms of low blood sugar.” 

Related article: Adult Patients Could Be Misdiagnosed with Wrong Form of Diabetes

Any condition that requires medications taken several times a day or that is affected by food and drink intake (such as hypertension and thyroid disease) may require therapy adjustment. Alsabbagh says pharmacists can suggest adjustments to their medication regimens and to lifestyle to avoid any adverse effects of fasting.

Patients should be advised to consume enough water before and after fasting begins to prevent dehydration, he says. Patients should avoid too much activity and exposure to sun and high temperatures. If they become dehydrated, they should immediately break the fast and rehydrate, he says.

Jalloh says pharmacists can also adjust the times medications are taken. Once-daily formulations should be taken when patients break the fast or begin eating food after sunset, he notes.

Finally, Alsabbagh urges pharmacists to be proactive with their patients. “It is important for pharmacists to ask patients if they are considering fasting and engage in the conversation about safety and necessary adjustments, rather than restricting their intervention to patients who ask,” he concludes. Above all, pharmacists should be respectful of patients’ personal wishes and religious beliefs when offering counseling.

Here are some things you can do to help your patients who will be fasting.

Ramadan, Medications, and the Pharmacist

In 2000, HHS reported that a serious shortage of pharmacists was looming. But for the last few years, there has been talk that there are too many pharmacists for the number of available jobs.

 (PDI), which reports perceptions of the demand for pharmacists, was 3.05 on a 1-to-5 scale, for the first quarter of 2018, the most recent data available. A PDI of 5 means there is a critical demand for pharmacists, while a 3 means that supply and demand are balanced. The population adjusted PDI is 2.98. The PDI is a bit higher in the Midwest and West (2.99 and 3.55, respectively), and a bit lower in the South (2.74).

Related article: Job Market Shifting for Pharmacy School Grads

“My and the AACP’s position is that it doesn’t appear to be [a glut], and I realize that is not the universal position,” says Lucinda Maine, executive vice president and CEO of the American Association of Colleges of Pharmacy (

). But regionality, demographics, and economics may play roles in why a perception of too many pharmacists exists, she says.

Some regions of the country have greater need for pharmacists than other parts due to an older population with greater healthcare needs. Rural areas are more likely to have job openings than urban or suburban locales, she added.

In 2000, when HHS issued its report, the economy was booming. Pharmacists could work 20 hours a week and get full benefits from the pharmacy chains, Maine notes. “Clearly, many things have changed since then.”

Though the economy has picked up greatly since the recession hit, the explosive growth seen in the 1990s in pharmacy did not return, Maine says.

“Some would say the economy is sizzling and the stock market is sizzling, but Walgreens isn’t opening a new store every 17 hours anymore,” she points out. Pharmacy chains now grow by buying existing pharmacies rather than opening new ones, which doesn’t add job openings, she notes.

“In 2000-ish, we had a very well defined national shortage, but we were graduating less than 8,000 pharmacists a year at that time,” Maine says. About 15,000 people graduate with a pharmacy degree annually now. “I ask our members pretty consistently, ‘How’s the job market for your graduating class?’ and the job market is by and large absorbing almost a doubling of the graduation cohorts,” she says. “The balance in supply and demand is likely best for the profession and the patients we serve.”

There may be an oversupply of pharmacists, but it might not be across the board for all of pharmacy, says David J. Fong, PharmD, a retail pharmacy consultant. “I think the simple answer is ‘to be determined,’” he says. “It is not clear today whether there is a glut.” Fong is a member of the Editorial Advisory Board of Drug Topics.

Maine notes that future job growth in pharmacy will likely be coming as pharmacists work more collaboratively with other healthcare professionals. “I just see a world of opportunities opening up for the profession. And I think one of the next ones that’s going to happen quickly is the integration of pharmacists into physician group practices.”

Related article: Report: Supply of pharmacists outnumbers jobs

Fong agrees. There are expanding roles with new types of jobs for pharmacists, and there is a need for pharmacists who are qualified for those new roles, he says. “We are trying to bring value to the healthcare supply chain and demonstrate what we do to make a difference.”

But not every pharmacist has pursued advanced qualifications, such as board certification in a specialty or in diabetes education. There is a need for individuals with specfic qualifications, Fong says. Whether there are too many qualified people for such positions is unclear because the roles of pharmacists are continuing to evolve. 

It may depend on where you are and where you are in your career.

Are There Too Many Pharmacists?

The delivery and financing of U.S. healthcare is changing rapidly. Pharmacists and other healthcare professionals have to reinvent themselves as healthcare becomes more of a retail business. With the threat of new competition, the pressure for pharmacists to add value in healthcare is mounting.

Ensuring the appropriate use and management of specialty pharmaceuticals is one area in which pharmacists can offer unique and necessary expertise. These medications will have a profound impact on the practice of pharmacy over the next ten years as they consume more of the healthcare dollar. They will affect all pharmacy practice settings-e.g., community, hospital, long-term care, etc.-accelerating the importance of medication management to ensure the appropriate use of these therapeutic agents.

Related article: Specialty Pharmacy Will Gain a Bigger Chunk of U.S. Pharmaceuticals

Retail, mail-order, and specialty pharmacies account for the distribution of about 45% of specialty drugs that are covered under the pharmacy benefit.  The majority of specialty pharmaceuticals are distributed and administered in the physician’s office, an outpatient setting, or as home infusion. All are covered under the medical benefit.

The role of the pharmacist in the physician’s office will emerge as a way to manage patients taking certain specialty medications. Currently, patients taking specialty pharmaceuticals represent only 1% of the patient population, yet, amazingly, they represent 30% of total drug spend.

As specialty pharmaceuticals costs escalate-some in excess of $50,000 annually (e.g., Solvaldi, Olysio)-it makes sense to place pharmacists closer to the patient. Even home visits will have direct pharmacist involvement for patients when using these medicines.

Some community pharmacists can fill this role where appropriate, if they can help patients improve drug use, minimize waste and increase patient safety.

Systems will be developed to track patients across the healthcare system to ensure appropriate specialty medication use.

The most recent impact to the delivery of specialty drugs is “personalized medicine.” This term relates to the use of genetic testing-genomics-to guide the dispensing of the optimal type and dosage of a drug for a specified healthcare condition, through the identification of a patient’s individual cellular and genetic makeup. 

Related article: Considering Specialty Pharmacy? Make Your Move

For example, genetic testing can provide information about patients’ liver enzymes and predict the rate they metabolize specific drugs. This information provides guidance to the prescribing physician in the medical management of a patient.  This is an opportunity for the community pharmacist to work in collaboration with physicians

Clearly, healthcare will need a different approach to the optimal dispensing of specialty pharmaceuticals. We have known this for years. The industry will need creativity and focus to demonstrate just how far specialty pharmaceuticals can take us.

The role of the pharmacist will be critical as specialty pharmaceuticals consume more of the healthcare dollar. 

Specialty pharmaceuticals will have a growing impact on pharmacists. Here’s how it could change your role.

It's Time for Pharmacists to Carve Out a New Role

 about pharmacy technician staffing, I wrote: “In my 36 years on the bench I’ve found the difference between a great day and a challenging day isn’t the number of prescriptions, it is the level and quality of staffing.” Technicians in the pharmacy are indeed what keeps us pharmacists on task, so we can spend time helping the patients who seek our expertise, as well as verifying prescriptions.

The level of staffing unfortunately is left to those further up the food chain, usually district managers or someone sitting in a corporate office.  

More from Peter Kreckel: Pharmacists Are the Vitamins of Healthcare

For some reason they feel they have psychic powers that can determine the needs of a pharmacy that they don’t ever staff. Their formulas can’t possibly factor into account the health literacy of the population, which can require more “hands-on” work by the pharmacist and staff.  

Most of my patients can’t punch their prescriptions in on the interactive voice response (IVR). Instead, they dial our phone number and hit the “0” button to talk to a staff member. Writing down 12 prescription numbers takes us more time than processing 12 prescriptions directly off the IVR. Add to the mix lottery machines and drive-through windows, and staff can be spread mighty thin. In contrast, where my wife works in a university town, her patients are rather low maintenance, seldom calling for early refills and always using the IVR.

 uses the figure of 8.7 prescriptions per tech hour, which includes techs and cashiers on the pharmacy team. Fill 480 prescriptions in 12 hours, you get 55 hours to staff your pharmacy with cashiers and technicians. Another grocery chain allows 11 prescriptions per tech hour, not including the cashier (who is up front).  Fill 480 prescriptions at this pharmacy and you get 44 tech hours. Most chains just assign tech hours without any reasoning.

I find it amazing that the state boards of pharmacy, APhA, NACDS, and NCPA have provided little, if any, guidance about the levels of staffing, which is the community pharmacist’s number one complaint. That might be a good way to increase their membership by taking a stand on staffing and maybe the average community pharmacist might see value in joining the ranks of these three associations.

Thus far the only group that has taken a stand on pharmacy technician staffing is the 

. It wants to pass legislation that requires mandatory pharmacist breaks as well as 10-technician hours for every 100 prescriptions filled. Those levels would need to be adjusted for flu vaccinations as well as other promotions that pull pharmacists away from prescription verification and counseling. Fines range from $250 to $1,500 per day, also including whistleblower protection for the employees.

Related article: Pharmacy Tech Brings U.S. Guidelines Overseas

As far as the quality of technicians, that responsibility rests on the training programs. I have had amazing techs over the years, because I always take the time to train them, then “cut them loose” to develop their own skill set. The technician that keeps my store running like a well-oiled machine is Brad Wiegand. Brad came to us as a high school senior and worked as a stock boy. When he expressed interest in becoming a pharmacy tech, we taught him our pharmacy filling software program. As with any young kid, he excelled in operating the computer and is a “dream technician.”

As his senior year concluded Brad was considering enrolling in a local pharmacy tech program. I promised I’d train him in store and save him around $11,000. He has “rock star” status, because everyone in the store gave him the opportunity to learn and excel. If your technician is inadequate, I’ll bet it can be traced directly back to their training. We pharmacists are responsible for the training of our technicians. A well-trained technician is the difference between a great day and a challenging day; just make sure you have enough of them!

Chicago proposed legislation requiring minimum pharmacy technician hours. Should other municipalities follow suit?

It's Time to Rethink Pharmacy Tech Staffing

If you are struggling to engage and motivate your pharmacy technicians, making some small changes can help. Here are some tips.

Shane P. Desselle, RPh, PhD, FAPhA, professor at 

Touro University California College of Pharmacy

 in Vallejo, CA, says it’s important for pharmacists to “provide an organizational climate that allows for technicians to mentor one another, in addition to the pharmacist mentoring them.”

Related article: Standardization a Pressing Issue for Pharmacy Technicians

Desselle says mentoring gives the senior technicians pride and accomplishment and the desire to remain with the organization. At the same time, it allows the junior technician to learn more than just technical responsibilities, such as customer service, organization norms, and attitudes. Desselle is editor of 

Research in Social and Administrative Pharmacy

Pharmacy Management: Essentials for All Practice Settings

Pharmacy technicians want more responsibility and one of the most important things a pharmacist can do is “delegate any and every responsibility procedures that they are legally accorded to do. I can’t overstate the importance of that,” Desselle says.

Tiffany Bartlett, CPhT, CSPT, agrees. She has been a certified pharmacy technician for more than 20 years and a specialty pharmacy technician at 

 in Spring, TX, for almost three years. “I think there are many responsibilities that can be delegated to the technician, such as insurance specialist, educator, medication therapy management, and quality control. With each new opportunity, each role should be evaluated and minimum guidelines should be established relating to educational requirements and work experience in order to choose the right candidate for the position,” says Bartlett. “Pharmacy technicians are anxious to break out of their traditional roles in retail and hospital and use their skills and knowledge to practice in exciting new opportunities.”

Kilee Yarosh, RPh, MBA, market pharmacy director, Turnbull Memorial Hospital, Northside Medical Center, Hillside Rehabilitation Hospital, and Steward Family Hospital in Ohio, notes that technicians have more opportunities to expand their roles.

“As we continue to see the practice of pharmacy transform, it will be integral to our profession’s success that we indeed work hand-in-hand with our technician workforce to ensure adequate training, credentialing, and support to provide the best care possible to our patients, regardless of practice setting,” Yarosh says.

She recalls working with a technician who came into the field with a business background.

“Over the course of several years, I had the opportunity to work with this technician and help develop their skills, especially in the area of informatics. This tech had an opportunity recently to become a team lead for an informatics group.”

Bartlett, who has a national specialty certification in sterile compounding from the Pharmacy Technician Certification Board, creates continuing education content for the approximately 180 pharmacy technicians at the cancer center. She often seeks advice from clinical pharmacists on her team to troubleshoot problems within an online training module or receive constructive feedback on the best way to present a real-life scenario to trainees.

Related article: The Future of Pharm Techs

“On the other hand, the same clinical pharmacists on my team will seek advice from me on real-life scenarios experienced by technicians working in the clean room. Moreover, they may ask questions regarding inpatient work flow improvement options and gain insight from my work experience on preparing a patient-specific sterile compound,” Bartlett says.

Yarosh says that providing transparent feedback to technicians is one way to help them improve their job performance. Pharmacists should also set clear expectations, have goal-setting discussions, and “provide projects that capitalize on their strengths but also push their comfort zone,” he says.

Four Ways to Help Pharmacy Technicians Improve Job Performance

In March, the FDA approved ibalizumab-uiyk (Trogarzo; TaiMed Biologics USA Corp.) for use in combination with other antiretroviral agents in adult patients with multi-drug-resistant human immunodeficiency virus 1 (HIV-1) who have previously received multiple antiretroviral therapies and who are on a regimen that is unable to suppress viral load. Ibalizumab-uiyk is a recombinant humanized monoclonal antibody. It binds to CD4 cells and interferes with the post-attachment processes that allow entry of HIV-1 virus into a host cell. CD4-directed post-attachment HIV-1 inhibitors are a new class of antiretroviral drug therapy that offer a new option for patients with multi-drug-resistant HIV-1 infection.

Efficacy of ibalizumab-uiyk was established in a single-arm multicenter trial (TMB-301) of 40 participants.

 All participants have heavy treatment experience, a viral load greater than 1,000 copies/mL, and documented resistance to a minimum of one antiretroviral drug from each of the following three classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI).

For inclusion in the trial, participants received therapy for at least six months and were currently failing therapy or had failed within the last eight weeks. Throughout the trial, a participant’s baseline antiretroviral therapy was continued. The first week of the trial served as a screening period to establish baseline viral loads (control period). On day seven, all participants received a 2,000 mg infusion of ibalizumab-uiyk and were monitored through day 13. This “functional monotherapy period” was used to determine virologic activity of ibalizumab-uiyk.

A maintenance period that spanned from day 14 through week 25 assessed viral load changes. During the maintenance period, a participant’s background regimen was optimized to ensure viral susceptibility to at least one drug. Participants received 800mg of ibalizumab-uiyk every two weeks starting day 21 through week 25 of the trial. Within one week of initiating ibalizumab-uiyk therapy, 83% of participants demonstrated a significant decrease in viral load. At the conclusion of the study period, 43% of participants achieved HIV RNA suppression (HIV RNA <50 copies/mL). Studies have not demonstrated cross resistance between ibalizumab-uiyk and other antiretroviral therapies. A decrease in susceptibility to ibalizumab-uiyk therapy after multiple administrations of the drug have been observed. The development of cross-resistance to other classes of therapy has not been observed in cell culture studies.

Experience with ibalizumab-uiyk is limited. A total of 292 patients infected with HIV-1 have been exposed to ibalizumab-uiyk. The most common adverse reactions in TMB-301 were mild to moderate in severity and included: diarrhea (8%), dizziness (8%), nausea (5%), and rash (5%).  As with all combination antiretroviral therapies, use of ibalizumab-uiyk can result in immune reconstitution inflammatory syndrome (IRIS), which occurred in one participant in the TMB-301 trial.  There is insufficient data to assess differences in adverse effects by sex, race, or age. Ibalizumab-uiyk is a monoclonal antibody and would cross the placenta during pregnancy.

Ibalizumab-uiyk therapy is administered intravenously every two weeks. Therapy is initiated with a 2,000 mg loading dose and maintained with 800 mg doses administered every two weeks. Dosing modifications due to renal, hepatic, or concomitant therapies are not studied. Modifications are not anticipated to be required for renal impairment or drug interactions. Ibalizumab-uiyk is administered intravenously over 15 to 30 minutes in a clinical setting. All patients must be monitored for one hour after the first dose is administered. If no reaction has occurred, the patient may be monitored for 15 minutes after administration of subsequent doses.

1. Trogarzo [package insert]. Irvine, CA: TaiMed Biologics USA Corp. March 2018.

What pharmacists need to know about the new antibody approved for multi-drug-resistant HIV-1.

Ibalizumab-uiyk (Trogarzo) for Multi-Drug-Resistant HIV-1

 “You know, children are not small adults,” a preceptor once told me during an early pharmacy practice rotation. Nearly 10 years later, I sometimes still hear her voice in my head. However, my patient population falls on the opposite end of the life spectrum: They are members of the geriatric community.

Like children, advanced members of our community require special considerations. Some disease states affect elderly patients differently than younger individuals. Liver function changes with age, resulting in altered drug metabolism. Physiological changes such as thinning of the skin and increased body fat can greatly alter drug metabolism and affect how medications behave outside and inside the body. A prudent clinician may initiate therapy at a lower-than-normal starting dose and slowly titrate accordingly.

Pharmacy school alludes to some of the many differences seen in patients of advanced age. But providing a comprehensive overview of the circumstances that distinguish geriatric patients from younger patient populations is both arduous and impractical. Certification offers a solution.

One may have many motives for specializing in geriatrics-just as with any other therapeutic area. As with residencies and fellowships, many pharmacists  choose to pursue board certification to deepen their clinical skills while gaining a   leg up on the competition in the ever-tightening job market.

While these factors influenced my decision to become a board-certified geriatric pharmacist (BCGP), I ultimately chose geriatrics as a specialty because of my love for the elderly. I come from a culture in which its oldest members head the entire family, and caring for them is considered a community effort. I willingly forfeited sleeping late my senior year of high school to act as my grandfather’s morning chauffer, administer his medications, and take him to the barbershop every Saturday. I guess you could say the seed was planted early.

In my first role as a licensed pharmacist, I served a predominantly older population. Almost immediately, I recognized that successfully managing these patients required a higher skill set than pharmacy school offered. Providing medication therapy management consultations further highlighted what I felt were deficiencies in my skill set that additional experience alone could not address. It was during this time I first began considering certifying in geriatrics. However,  with no residency under my belt, I needed several years of practical experience before sitting for the exam.

By the time I moved into managed care, I had become eligible to test. I was still consulting, but my patient population had become even more complex. I went from working with elderly populations in rural East Texas communities to serving a hybrid middle-aged/geriatric community that encompassed the gamut of cultural, racial, and ethnic diversity of New York City and surrounding areas. Special considerations required to manage this highly diverse demographic further amplified the need to upgrade my skill set.

My advice to pharmacists considering certifying in geriatrics: Don’t do it just to add extra letters to the alphabet soup of credentials after your name. Do it because you want to make a difference and build confidence in your ability to provide optimal patient experiences. In that lies the true reward.

Geriatric pharmacists can work in a variety of settings. Like me, many practice in community pharmacy or managed care settings. Some work in long-term care and assisted living facilities or do research, while others opt go on to start their own consulting practices. Like any credential, the BCGP increases your professional credibility. However, as our society becomes more heavily credentialed, the certification generally receives its greatest recognition from the pharmacy community and other geriatric specialists.

A board-certified geriatric pharmacist shares the benefits and special considerations required to manage this diverse patient population.

Why I Became a Board-Certified Geriatric Pharmacist

	Critics of “evergreening,” a tactic used by brand-name drug companies to extend a patent or regulatory monopoly, say the practice is getting worse.

	Chip Davis, president and CEO of the Association for Accessible Medicine (

), says the frequency of evergreening tactics has gone up, along with the creativity of delay strategies.

	“As patents on a product’s main ingredient and methods of use are getting close to expiring, what brand-name drug companies will do is make nominal changes. For example, they’ll change it from a tablet to a capsule or may say our dosing went from 20 mg to 30 mg and then secure a patent on the new dosing formula or formation.”

Why Health Systems Are Making Their Own Generics

	When the drug company receives the patent extension, it will use its sales force to switch patients to the new formulation, says Davis.

	There are high-profile cases, he notes, including renting the 

 when one of Humira’s principal initial patents expired in 2016, manufacturer Abbvie filed more than 75 late-stage patents.

	Davis says these tactics deny patients access to safe, effective, and affordable alternatives.‎ “It’s negative to patients and their providers because more options are better than fewer. More options lead to the price coming down as opposed to a monopoly where the brand manufacturer has unbridled discretion to take 9.9% price increases once or twice a year, which is what’s going on, particularly in the specialty medicines area.”

Ensuring the Future of Accessible Medicines in the U.S.,

 calls for ensuring that there are no “artificial barriers” to launching a new generic or biosimilar competitor.

	Davis says that there’s no magic single solution to evergreening because the number of different systemic ways drug companies are using to prevent competition from coming to the market is growing. "So we have to have multiple proposed solutions to deal with them.”

	AAM has an array of policy proposals including ensuring that generic companies can gain access to the number of samples needed for generic development and for filing applications with the FDA.

	At a speech in March, FDA Commissioner Scott Gottlieb, MD, explained that “pay for delay” involves branded drug manufacturers splitting monopoly rents with generic manufacturers who have 180-day 

. They can then delay entry of generic competition in return for cash or agreement by the innovator not to launch an authorized generic until after the six-month exclusivity expires.

	“Many insurers and PBMs have rightly spoken out against these practices, arguing that they’re anticompetitive and hurt consumers,” says Gottleib.

	Nicole S. Longo, senior manager for public affairs at 

, says many types of innovation are leading to valuable advances and improvements for patients. These include novel delivery mechanisms or new dosing schedules for previously approved medicines, which can result in increased patient adherence, improved health outcomes for patients, and fewer unnecessary hospitalizations, she says.

	“Having additional competitors in different disease areas expands treatment options for patients and providers, can result in improved outcomes for patients, and spurs competition.”

	Longo says it’s important to understand that added patents or exclusivities that cover new innovations relating to previously approved medicines do not extend patents or exclusivities on the earlier products or otherwise block FDA approval of generic copies of earlier versions.

	“There is a misconception that innovation stops the minute a medicine is first approved by FDA. The reality is that research is ongoing long past the initial approval of a medicine. Each innovation has the potential to improve the lives of patients.”

	That’s why biopharmaceutical researchers continue to work toward discovering advances such as expanded uses of medicines, new dosage forms, or alternative delivery systems, she says.

Brand-name drug companies are finding creative ways to extend patent protection, causing patient access problems.

Drug Makers Find New Ways to Thwart Generic Competition

	The Ohio Department of Insurance has told PBMs and health insurers that they have to disclose the lowest price for a prescription drug to patients and prohibits them from charging more for prescription drugs that cost less than the copay. The department has also banned the gagging of pharmacists by contractually preventing them from telling patients they could pay less out of pocket for a drug than the insurance copay.

	There had been many examples of egregious clawbacks in Ohio, says Antonio Ciaccia, using the term to describe the overcharging of the patient and the later collection of some of that overcharge by the PBM. Ciaccia is director of government and public affairs for the 

	In testimony to a committee of the Ohio House of Representatives, Chiaccia gave an example:

	“For a medication used to treat severe vitamin deficiency, the pharmacy’s cash price was $92. The pharmacy processed the claim and was told to charge the patient $115.19. The PBM later performed a $55.47 clawback. So in the end, the patient was overcharged $23.19, the pharmacy lost $32.28, and the PBM pocketed it all. And again, while this was occurring, the pharmacist was prohibited in their contract from blowing the whistle on the charade, and helping the patient find a cheaper alternative method of payment.”

	Preventing pharmacists from informing their patients about drug prices is a serious matter, Ciaccia told the committee. “Pharmacists should not be silent pawns in drug pricing shell games, and should be free to discuss all options for the patient at the pharmacy counter-including whether or not there are ways to save money on their needed medications.”

Pharmacists Are the Vitamins of Healthcare

	The results of the ruling from the insurance department is an immediate lowering of drug copays, Ciaccia tells 

. “Ultimately, the Ohio Department of Insurance acted once they learned how pervasive the problem of clawbacks was,” he says. The Ohio legislature had been making an effort to prohibit the practice of charging a higher copay than the actual price of a drug, which gave the insurance department the impetus to act, he adds.

	Other states have enacted similar rules or are considering legislation to increase drug price transparency. “There seems to be a universal gag reflex by lawmakers who learn about co-pay clawbacks and mandated silence of pharmacists,” says Ciaccia. “The practices are so distasteful that even the PBMs’ own association won’t stand up for them.”

	Two large PBMs-Express Scripts and CVS Caremark-told Reuters that their contracts include clauses that ensure that members receive the lowest drug price automatically.

	On the federal level, two bills have been introduced that are aimed at making drug pricing transparent to consumers and preventing gag clauses.

	The legality of such gag clauses has always been questionable, Ciaccia adds, since they are the subject of several lawsuits across the country. “Theoretically, plans and PBMs could still penalize pharmacists for pushing back and blowing the whistle on non-compliance with the new rules, but ultimately, if PBMs ignore these new policies, they stand to be fined or having their licenses suspended by the Ohio Department of Insurance. Personally, I think the ODI edict ... will end these shenanigans for good.”

A new rule in Ohio is designed to bring transparency to drug prices in the pharmacy.

Ohio Cracks Down on PBMs

 state to adopt telepharmacy legislation. The legislation is expected to be signed into law this year with the first outlets scheduled to open in early 2019.

	Six other states have authorized pilot programs that could apply to telepharmacy and five states permit waivers of legislative or administrative requirements that could allow for telepharmacy, according to the Rural Policy Research Institute at the 

University of Iowa College of Public Health

Telepharmacy: New Jobs, Expanded Opportunities

	As more states adopt telepharmacy legislation, some pharmacists are raising concerns over what it could mean for patients and the pharmacist job outlook. To help address those concerns and others, the 

, which supports the legislation, negotiated a series of protections for pharmacists and patients.

	“The big issue that came up from some of our members and other stakeholders is to ensure that this is a safe practice,” says association CEO Kelly Fine, RPh. “We are equipping and training both technicians and pharmacists, making sure that security and surveillance are sufficient, and requiring HIPAA-compliant high-definition video conferencing for face-to-face interaction with the remote pharmacist.”

	Most telepharmacy locations will likely be in rural areas, at least to start, she says. But community health centers and hospitals have also expressed interest. "So have independent pharmacists who want to expand into pharmacy deserts, areas with few or no pharmacies and severely limited local access to pharmacy care."

	The potential for urban expansion has raised objections among some pharmacists. “This bill can and will likely be used to lay off hundreds of pharmacists and convert hundreds of ‘underperforming’ pharmacies in urban areas, effectively reducing pharmacist jobs by over 75%,” says P. Charles Zaffrey, RPh, pharmacist at 

, a supermarket chain pharmacy in Tempe, AZ, who opposed the legislation.

Arizona joins a growing list of states to adopt telepharmacy legislation. Here’s how it could affect pharmacists. 

Vol. 164 No. 5