Quality, speed, and price has been referred to as the "Unattainable Triangle". Fast, good, cheap-pick 2. Every business faces this question every time the doors are open for business. You can’t possibly have all 3. When you try to improve 1 side of the triangle, the other 2 sides will be impacted.

 Price seems to get the most attention. The monetary aspects of our profession seem to govern most of its workings. The insurance companies and government have put the squeeze on the community pharmacies for the last 4 decades-they want lower and lower prices; our patients want lower and lower prices. It comes at a price. Most pharmacies are always cutting staffing to satisfy the demand for the price side.

Many patients are forced to go to one of the preferred chains in their insurance company’s “preferred network”. They get a 90-day supply for the same price as they would pay for a 60-day supply at my pharmacy, if I’m not in their network. A family member recently went to one of the preferred pharmacies in his insurance plan’s network to get the new nasal glucagon. The cashier asked the obligatory question “do you have any questions for the pharmacist?” He replied “Yes, I do; how do you work this thing?” The pharmacist hurriedly came out read him the directions on the box and said, “use it like any other nasal spray.” That is not how you use the nasal glucagon. My relative got a good price from the preferred pharmacy, but the quality sure wasn’t there. Thank heavens he has a relative in the profession!

 In the store I have staffed for the past 11 years, we have a huge Medicaid population. It never ceases to amaze me that the first question a patient asks is “how long is it going to be?”

I smile and tell them “10 minutes, it is always 10 minutes” I tell my student pharmacists that you only have to know 3 answers to staff the pharmacy: 10 minutes (how long); we won’t know until we run it through your insurance (how much); no we don’t (have a public bathroom!). Price doesn’t matter to our Medicaid population, speed does.

This is the aspect of the Unattainable Triangle that appeals to me the most as a pharmacist. I frequently hear pharmacists describe how they can “bust out” 400 prescriptions in an 8-hour shift. It scares me. Today at the pharmacy I had a bag flagged for consultation. It was a 15-year-old who was put on Flovent 110, who was new to my store. Her mom was in to pick up the prescription. She informed me that her daughter was on this medication and this was a dosage increase. In my usual fashion, I continued with my speech about mechanism, adherence, and of course rinsing and spitting after each dose.

The mom said, “We’ve never been told that before, I’ll have her come in.” I described how inhaled corticosteroid therapy worked and the importance of adherence, as well as rinsing and spitting. The daughter agreed to use her Flovent in the morning before school and at bedtime before brushing her teeth. I went further and gave her a free peak flow meter from my stash. I set her peak flow meter and instructed her on its appropriate use and handed her an asthma action plan. They were both delighted with the quality care I provided. We both sacrificed speed for a quality engagement.

Our owners struggle with the triangle, but think about our individual struggle with the triangle. How many of us are in low quality, high stressed jobs because of our “price” (salary)? In a fulfilling pharmacist career, the focus is always on quality.

Articles

Quality, speed, and price has been referred to as the "Unattainable Triangle".

The 'Unattainable Triangle' of Community Pharmacy

Community acquired bacterial pneumonia (CABP) can result in hospitalizations, morbidity, and mortality.

 is one of the most common bacterial pathogens and has shown increased resistance to typical antibacterial therapies.

 Lefamulin, a novel pleuromutilin antibiotic that inhibits the 50S ribosomal subunit at the peptidyl transferase center, with known activity against typical CABP organisms, was approved by the FDA in August 2019 for the treatment of CABP.

In the LEAP 1 trial, lefamulin was shown to be noninferior to moxifloxacin ± linezolid (if MRSA coverage necessary) in the treatment of CABP in hospitalized adults. In a randomized controlled trial, IV to PO lefamulin was as successful as IV to PO moxifloxacin ± linezolid at improving at least 2 CABP symptoms without worsening of CABP or the need to receive a non-study antibiotic for treatment.

In the LEAP 2 trial, oral lefamulin demonstrated noninferiority to oral moxifloxacin for CABP. PO lefamulin was as successful as PO moxifloxacin at achieving resolution of CABP symptoms without worsening of CABP or the need to receive a non-study antibiotic for treatment.

Although in the LEAP 1 trial lefamulin was used to treat CABP caused by MRSA, the product package insert does not endorse that use due to only treating a small number of patients in the study and the need for additional antibiotics for treatment.

Commonly reported adverse events related to lefamulin in LEAP 1 and LEAP 2 include administration site reactions, elevation of hepatic enzymes, nausea/vomiting/diarrhea, headache, insomnia, and hypokalemia. Serious adverse events include QTc prolongation and the risk of Clostridium difficile-associated diarrhea. No 

 infections were observed in either treatment arm of LEAP 1 and 1 incidence of 

 was associated with lefamulin treatment in LEAP.

Lefamulin IV is dosed at 150 mg every 12 hours over 60 minutes for 5-7 days. It can be switched to oral therapy once the patient is clinically stable. Lefamulin IV is available as a 15 mL vial that will be further diluted by addition into a supplied diluent bag that contains 250 mL of 10 mM citrate buffered 0.9% sodium chloride. Lefamulin PO is dosed at 600 mg every 12 hours for 5 days. Take the tablets at least 1 hour before or 2 hours after a meal. The tablets cannot be crushed or split.

In patients with severe hepatic impairment (Child-Pugh Class C), lefamulin IV should be hepatically dose-adjusted to 150 mg IV every 24 hours over 60 minutes. Lefamulin PO has not been studied in patients with hepatic impairment. Both lefamulin formulations do not need to be renally dose adjusted.

1. FDA.gov [Internet]. 2019 Aug 19. FDA approves new antibiotic to treat community-acquired bacterial pneumonia. Available from: https://www. fda.gov/news-events/press-announcements/ fda-approves-new-antibiotic-treat-community-acquired-bacterial-pneumonia.

2. File Jr. TM, Goldberg L, Das A, et al. Efficacy and safety of intravenous-to-oral leafmulin, a pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia: the phase III lefamulin evaluation against pneumonia (LEAP 1) trial. 

3. Alexander E, Goldbery L, Das A, et al. Oral lefamulin is safe and effective in the treatment of adults with community-acquired bacterial pneumonia (CABP): results of lefamulin evaluation against pneumonia (LEAP 2) study. Open Forum Infectious Diseases. 2018 Nov 26; 5(S1): S761. Available at: https://idsa.confex.com/ idsa/2018/webprogram/Paper74297.html

4. Lefamulin (Xenleta®) package insert. Nabriva Therapeutics US, Inc., of Nabriva Therapeutics Ireland DAC. 2019.

Lefamulin was approved by the FDA in August 2019 for the treatment of CABP.

Lefamulin (Xenleta) for Community Acquired Bacterial Pneumonia

 is exploring some of the latest pharmacy trends and how they will shape the industry in the next decade. 

An article from Jennifer Gershman, PharmD, explored upcoming drug pipeline approvals and provides a look at some of the most valuable and exciting drugs expected to be approved by the FDA in the months ahead. She also explores some of these medications’ potential financial impacts.			

As Gershman notes, “Vizient, a health care performance improvement company, released its 2019 Drug Price Forecast for health systems, with an expected 4.57% increase for pharmaceutical purchases made from January 1, 2020 to December 31, 2020.” The pipeline looks strong for migraine and oncology medications, as well as some exciting new vaccines, including Merck’s Ebola vaccine.

This issue also features an article focused on upcoming 2020 trends for the industry. How will the role of technology change? What policy changes are slated to impact pharmacy? As the pharmacy profession moves into 2020, pharmacists will need to find new ways to diversify their practice to match the ever-changing landscape.

To help keep you up to date with vaccination policy changes, this issue also offers an article providing an update on state vaccination laws for pharmacists. In this article, pharmacy associations discuss the current status of vaccination regulations and how pharmacists’ can help expand their authority and immunization offerings.

With the new year comes new resolutions, and in this issue you will find recommendations for how to enhance your pharmacy services and get creative with your business offerings. A column in this issue offers advice on how to build on your pharmacy career in the new year with 4 potential new year’s resolutions.

Last but certainly not least, contained within this issue, and of course on

, readers will find our conference coverage from the American Society of Health System Midyear Clinical Meeting & Exposition held in Las Vegas last month.

As we head into a new year, Drug Topics® is exploring some of the latest pharmacy trends and how they will shape the industry in the next decade. 

Pharmacy Trends in 2020 and Beyond: Preparing for a New Decade

Narcolepsy and obstructive sleep apnea (OSA) are associated with excessive sleepiness. Several monoamines such as norepinephrine and dopamine impact wake-promotion and have been popular drug targets.

Solriamfetol (Sunosi, Jazz Pharmaceuticals) to treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea was approved on March 20, 2019.

 Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI) and is categorized as a schedule IV controlled substance (low potential for abuse and low risk of dependence).

For each indication (Narcolepsy and OSA), separate 12-week, multi-center, randomized, double-blind, placebo-controlled studies were conducted. Primary Endpoints were the change from baseline in the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS). The MWT measures an individual’s ability to remain awake during the daytime in a darkened, quiet environment. The ESS is an 8-item questionnaire by which patients rate their perceived likelihood of falling asleep during usual daily life activities.

In the narcolepsy study, NCT02348593, patients randomized toreceive 150 mg of solriamfetol (received 75 mg for the first 3 days) showed statistically significant improvement in both MWT (+7.7 mins) and ESS (-3.8 points) compared to placebo. The study arm randomized to receive 75 mg did not achieve statistical significance.

The OSA study, NCT02348606, compared placebo to solriamfetol doses of 37.5, 75, and 150 mg (75 mg for the first 3 days) for 12 weeks. Patients in all three treatment arms showed statistically significant improvements on the MWT (+4.5, 8.9, and 10.7 mins, respectively) and ESS (-1.9, 1.7, and 4.5 points respectively) compared to the placebo group.

Solriamfetol comes to market with warnings and precautions for its use. This drug can increase systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion. Patients with risk factors for major adverse cardiovascular events are at increased risk and should be monitored. In clinical trials, patients have also experienced psychiatric adverse effects like anxiety, irritability, and insomnia.

 Use caution in patients with history of psychosis or bipolar disorders. Other less serious, but common (>5% incidence) side effects include nausea, vomiting, headache and decrease in appetite.

Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days is contraindicated with solriamfetol.

Solriamfetol is available in 75 and 150 mg tablets. The 75 mg tablet is scored and may be split for 37.5 mg doses.

 Initial dosing for narcolepsy is 75 mg by mouth upon awakening; dose may be doubled 3 days later based on efficacy and tolerability to a max of 150 mg/day. Initial dosing for OSA is 37.5 mg by mouth upon awakening; dose may be doubled at intervals of at least 3 days based on efficacy and tolerability to a max of 150 mg/day. Avoid use within 9 hours of planned bedtime. Solriamfetol may be taken with or without food.

Ninety-five percent of solriamfetol is renally excreted unchanged, which necessitates dose adjustments in renal impairment.

1. Solriamfetol (Sunosi) package insert. Palo Alto, CA. Jazz Pharmaceuticals, Inc.; 2019.

2. Schweitzer PK, et al. Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial. 

. 2019 Jun 1;199(11):1421-1431. doi: 10.1164/rccm.201806-1100OC.

3. Solriamfetol. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: micromedexsolutions. com/. Accessed June 19, 2019.

Sunosi for Excessive Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea

Social media posts show that pharmacists are more overworked and stressed out than ever.

Salaries and Stress Stagnate: 2019 Pharmacy Salary Survey Results

Let’s take a look at some of the most common issues pharmacists are facing, as seen recently on Facebook.

Pharmacists are reporting enormous stress due to a hectic daily workload combined with demanding flu shot quotas. On top of filling hundreds of prescriptions daily, pharmacists are constantly being pulled from behind the counter to administer flu shots or other immunizations.

“The stress is unbelievable. I’m actually going to go in today and speak with my PIC. Turns out my suspicions have been correct. Although my cough is instigated by an illness, it is magnified by stress. The biggest culprit is work. There’s just an unbelievable workload. MTM, vaccines, constant training of new staff. High turnover. Good techs don’t stick around because of the low pay and high stress.”

“We get weekly threats on...vaccinations (we have a contract quota to uphold or ‘we’ll lose a million dollars’ lol)”.

“I wish everyone was competent, but that’s not the case anymore. Those of us that are, we’re burning out. The lack of help. The tight job market that makes it hard to get out. All of it. It’s hard to have high expectations when others just don’t get it, so workflow is always different depending on who’s working.”

“I personally don’t understand how some are doing 400 prescriptions plus 40+ vaccines in 1 day. I struggle with breaking 200 with what I have and I’m working every queue. A lot of people turn queues off, but I never feel like I can do that because my techs are usually stuck up front and that’s the only way I can get things moving forward.”

It’s not all bad news though: Some pharmacists seem relatively satisfied with their job.

Stress isn’t the only thing pharmacists are worried about. Pharmacists are worried about job security. The prevailing worry is, “Will I be forced out and replaced with someone younger that will work for less money?” Many pharmacists are seeing this happen in the workplace, and fear for their jobs.

“It seems like a cycle. Increased pay rate with sign on bonuses, pharmacy schools turn out students, the market saturates, they lower the pay rate, less people enter the profession due to pay, time goes by, people retire, competitors open, there’s a demand for pharmacists, they increase the rate, market saturates, then repeat.”

“I got pushed out after 20 years at (my chain) and replaced by a new grad making $18 less an hour.”

“We need provider status, a desk, 1:4 pharmacist to tech ratio, mandatory lunch breaks, and absolutely no more opening of pharmacy schools!"

Given decreased technician hours at a time when they are needed the most, pharmacists are torn between going home at closing time or staying and working off the clock. It’s a catch- 22: those who work off the clock may be helping their team open up to a smooth morning the next day; however, many argue that working off the clock for free shows the companies that they can keep decreasing support staff hours because they see that everything is getting done. 

What Pharmacists Are Saying About Stress

Pharmacists can play an integral role in managing patients with psoriasis through medication therapies and lifestyle modifications. 

Psoriasis is a common chronic autoimmune disease that affects the skin, causing raised, red, scaly patches. Complications may include psoriatic arthritis, metabolic disorders, and cardiovascular disease. 

Psoriasis Treatment Options and Counseling Pearls

Treatment for psoriasis can be broken down into 3 categories: topical, phototherapy, and systemic medications. Phototherapy is a prescription treatment usually performed by a dermatologist that involves exposing the skin to controlled amounts of ultraviolet light. Most patients with mild-to-moderate psoriasis can have their symptoms controlled with topical medications or phototherapy, while biologics should be reserved for individuals with moderate-to-severe psoriasis.

 Topical products may be available OTC or by prescription. Salicylic acid products are available OTC and work as a scale lifter to help soften and remove scales and plaques. Coal tar is found in OTC shampoos, creams, and oils, but it can irritate the skin and should be avoided in women who are pregnant or breast-feeding. Moisturizers with an ointment base can be more effective than creams or lotions and should be applied right after a bath or shower to lock in the moisture. Prescription topical non-steroid options include vitamin D analogues such as calcipotriene (Dovonex) and calcitriol (Vectical), and these products may cause skin irritation.

Topical corticosteroids are the most common treatment option for mild-to-moderate psoriasis and may be combined with phototherapy for more severe cases. It is important for patients to apply a small amount on the affected areas. Pharmacists should recommend short-term use of corticosteroids since they can cause thinning of the skin and may stop working overtime. Systemic medications are used to treat moderate-to-severe psoriasis and are an option for patients that do not respond to topical drugs or phototherapy. Acitretin (Soriatane) is an oral retinoid taken once per day with food. Acitretin can cause severe birth defects so it’s important to counsel that women of childbearing potential must have 2 negative pregnancy tests before starting the medication, and use 2 effective forms of birth control at least 1 month before beginning therapy, while on the drug, and for 3 years after stopping. Cyclosporine is taken orally daily for up to 2 years and may increase the risk of developing infections, kidney problems, hypertension, and skin cancer. Methotrexate is available orally and as a subcutaneous injection and may cause stomach pain, appetite loss, and fatigue as well as serious adverse effects including liver damage and low blood counts. Apremilast (Otezla) is taken orally twice per day, and adverse effects include diarrhea, nausea, and vomiting. Tofacitinib (Xeljanz) is taken orally once or twice daily, and adverse effects include upper respiratory infections, headache, diarrhea, and an increased risk of serious infections.

Biologics target specific parts of the immune system and are taken by injection or intravenous infusion. Medications include certolizumab pegol (Cimzia), secukinumab (Cosentyx), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), and brodalumab (Siliq), among others. Biologics can increase the risk of infection and tuberculosis screening is required prior to starting therapy. All inactivated vaccines can be given with biologics; however, biologics may need to be stopped prior to and after administering live vaccines.

National Psoriasis Foundation. About Psoriasis. 

https://www.psoriasis.org/about-psoriasis

Menter A, Strober BE, Kaplan DH. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. 

Journal of the American Academy of Dermatology.

https://doi.org/10.1016/j.jaad.2018.11.057

National Psoriasis Foundation. Treatment Comparison [chart]. June 2019. 

FDA. Biosimilar Product Information. FDA’s website. November 11, 2019. 

https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

Statement from Sarah Yim, MD, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25

 biosimilar [FDA statement]. FDA’s website. November 15, 2019. 

https://www.fda.gov/news-events/press-announcements/statement-sarah-yim-md-acting-director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug

Bimekizumab Phase 3 Psoriasis Study Meets All Endpoints, Achieving Significantly Greater Efficacy Versus Placebo and Ustekinumab [news release]. UCB’s website. October 17, 2019. 

https://www.ucb.com/stories-media/Press-Releases/article/Bimekizumab-Phase-3-Psoriasis-Study-Meets-All-Endpoints-Achieving-Significantly-Greater-Efficacy-Versus-Placebo-and-Ustekinumab

What Pharmacists Need to Know About Psoriasis Medications

For some motivation in 2020, I turned to Jerrica Dodd, PharmD, MS, Founder and CEO of Your Pharmacy Advocate, for advice on how to build on your pharmacy career in the new year.

Below are 4 pharmacy-related New Year’s resolutions that can help enhance your pharmacy services, according to Dodd.

According to the American College of Clinical Pharmacy (ACCP), a board certification indicates an extra level of skill and expertise and can lead to personal satisfaction, financial reward, and career advancement.

 Not to mention, in this competitive job market, a certification will surely make one stand out from the crowd.			

Patty Taddei-Allen, PharmD, MBA, BCACP, BCGP, Senior Director of Clinical Analytics at WellDyneRx, advises pharmacists to perform self-reflection to “assess where you are in your career and what you hope to achieve in the short term (within 1 year) and long term (in the next 3 to 5 years).”						

Once you identify your goals, Taddei-Allen recommended assessing what skills are necessary to achieve these goals. For example, when she knew she wanted to design and deliver clinical programs, she realized that a Board Certification in Ambulatory Care Pharmacy would be a great certification to achieve, giving her a broad focus on chronic disease management. From there, she went on to obtain her BCGP, knowing that the elderly population was rapidly growing and would need clinical services.							

Taddei-Allen credits her certifications with helping her to develop clinical programs and analytics as well as formulary management. A bonus: “The ongoing board certification education requirements, which are intense and require focus and true understanding of clinical principles, also keep me on my toes and up to date with relevant clinical care.					

According to an article in PBA health, customers prefer shopping from companies committed to the environment.

“We believe it is our responsibility to maintain this planet for future generations,” Courtney McQuade, PharmD, owner of McQuade’s Marketplace pharmacies, said. “We are always looking to improve our environmental impact. As grocery store pharmacies, we always strive to ]provide the best service while helping to maintain the environment for future generations.” 														

McQuade’s deliveries, both prescriptions and groceries, go out in diesel vans that have been retrofitted to use vegetable oil that is a waste product of their kitchens and cafe. They boast a large solar array, converting natural sunlight into energy and have also eliminated plastic bags at the checkouts, using recycled paper bags instead.								

Additionally, McQuade is replacing a large percentage of health and beauty care products with sustainable lines that use minimal packaging. The stores carry many other items that are reef safe and packaged in metal tins. Dr Bronner’s soaps and washes are a hot seller due to the company’s commitment to the environment.

According to ASHP Guidelines on Pharmacist-Conducted Patient Education and Counseling, “pharmacists can contribute to positive outcomes by educating and counseling patients to prepare and motivate them to follow their pharmacotherapeutic regimens and monitoring plans.”																			

A major cause of nonadherence is that patients do not understand their conditions and medications and the importance of adherence to therapy. However, in the daily chaos of being overworked and understaffed while trying to add in dozens of immunizations, how do we find time to fulfill our duty to help patients?																					

Trisha Winroth, PharmD, is the pharmacy manager at Walgreens in Lowell, MA. She acknowledged, “Counseling patients in a busy retail setting is an ongoing challenge as the demands grow to do more with less.” Winroth prioritizes patient-centered tasks and delegates other tasks to her qualified technicians. “Training and engaging technician staff to work at their top capacity frees up valuable minutes for pharmacists to engage with patients.” For example, with vaccinations, her technicians perform data entry, go over paperwork with the patient, and ring up the sale, so that the pharmacist can spend time speaking to the patient while administering the vaccine.																																																																

“A successful pharmacy team will quickly develop methods to ensure the patients who need the pharmacist’s time get it.”																																																																							

Bhavana Mutha, RPh, BCMAS, reminded us that “counseling patients is one of the most important aspects of pharmacy.” Mutha recalled a time when, on just another routine, hectic day at the pharmacy, she noticed a patient who seemed out of sorts. “I immediately stepped out of the pharmacy. This woman was 7 months pregnant, dizzy, and about to fall. I had her sit down and checked her blood pressure. The number was very low. I directed the technician to maintain the pharmacy workflow and had another member of the team grab Gatorade while keeping her in sight.”												

Mutha and her pharmacy team helped the patient, staying with her until she felt better, reached out to her family, and made sure she made it home safe. Feeling gratification from helping this patient out of a risky situation, Mutha proudly said, “We are the face of health care, with so much knowledge, and should abide by counseling in our role.”											

We hear a lot about provider status and pharmacists being reimbursed for clinical services.																											

Ambulatory care pharmacists are already being reimbursed for services such as anticoagulation, behavioral health, and oncology. Some pharmacists are billing for office visits. Often, getting reimbursed involves getting creative, forming collaborative practice agreements with physician offices, offering enhanced services such as medication consultations or managing prior authorizations.														

After completing his community pharmacy rotation, Michael Higbee, PharmD, pharmacy manager and clinical specialist at Buhl Drug in Buhl, Idaho, saw the potential in providing reimbursable clinical services to the community.														

Soon after he graduated pharmacy school, Higbee opened Buhl Drug. “From the start, I focused on MTM services, employer health programs, and physician outreach.” Over the last 9 years, Higbee has built a fee-for-service patient care pharmacy.														

Through marketing his MTM services, he receives patient referrals from local providers who pay cash for clinical services. Higbee goes out into the community to provide on-site flu shot clinics for various clubs, businesses, schools, and municipalities, billing directly for those services.																													

Building on those relationships, he offers smoking cessation treatment and weight loss clinics, charging the employer $40 per employee who enrolls.															

Several years ago, Higbee wrote a collaborative practice agreement with a local physician so he could prescribe smoking cessation therapies. Since then, laws have changed in Idaho and pharmacists are allowed to prescribe for a host of conditions. Because they cannot currently bill insurance for these services, they charge a competitive cash price in line with insurance copays.																																																																		

“Patients are usually happy to pay the small service fee because they can get quick service instead of waiting days to get into an available doctor,” Higbee said.																		

Higbee, who has been recognized for outstanding outcomes and was a regional McKesson Healthmart Pharmacy of the Year winner, also regularly prescribes naloxone (Narcan) to patients on opioids, without charging for that service.																																																																																																				

“I personally feel so much more fulfilled with my career when I am an active participant in my patient’s health care team. Pharmacists learn and train to provide these services, but all too often are stuck just trying to keep their head above water in understaffed pharmacies. There is nothing better than making a real difference for my patients.”

American College of Clinical Pharmacy. Board Certification. ACCP’s website.https://www.accp.com/stunet/compass/certification.aspx.				

How to Make Your Pharmacy Go Green and Wow Patients. PBA Health. Published August 24, 2017. https://www.pbahealth.com/ make-pharmacy-go-green-wow-patients/

ASHP. ASHP guidelines on pharmacist-conducted patient education and counseling. 

Here are 4 pharmacy-related New Year’s resolutions that can help enhance your pharmacy services.

4 Pharmacy New Year’s Resolutions For 2020

The opioid crisis continues to be one of the worst public health crises that the United States has ever seen. Opioids- mainly synthetic opioids (other than methadone)-are currently the main driver of drug overdose deaths. According to the CDC, opioids were involved in 47,600 overdose deaths in 2017 or 67.8% of all drug overdose deaths. Approximately 2.1 million Americans live with opioid use disorder.

Some small signs of improvement have come to light. Opioid prescribing has declined since 2012, and July 2019 data from the CDC demonstrated a 5.1% decline in overdose deaths for the first time since 1990.

 “These numbers are provisional and positive, but improvement is minimal and slow,” Jim Lichauer, PharmD, BCPS, FASHP, program director for Pharmacy Performance Improvement Collaboratives at Vizient, a health care performance improvement company, said. “Increased awareness, appropriate education regarding opioid risks and benefits, and education on non-pharmacologic and non-opioid alternatives have improved prescribing practices.”

The federal government continues to address the crisis with new regulations, said Katharine Van Tassel, JD, MPH, visiting professor of law, Case Western Reserve University School of Law. In the summer of 2019, the FDA issued new draft guid- ance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” which describes the application of the benefit-risk assessment framework that the agency uses in evaluating applications for opioid analgesic drugs.

“Normally, when deciding whether to approve a new drug, the FDA only looks at the risks and benefits to patients who take it as directed, not risks to everyone else,” Van Tassel explained. “Under its new proposal, the FDA will consider whether a new opioid works better than other painkillers-opioid and non-opioid-that are already on the market. Officials will also analyze a new drug’s potential impact on public health.” For example, does it have characteristics that might tempt people to misuse it, such as it being very potent, or easy to crush, dissolve, and inject.

On another front, the Drug Enforcement Administration (DEA), which is responsible for keeping controlled substances from being diverted for abuse and sets a quota for how many opioid pills drug makers are allowed to produce in the United States along with input from the FDA and drug manufacturers, is proposing that appropriate quota reductions be made only after estimating the potential for pills to be sold illegally. Under the proposal, the diversion potential would be based on rates of overdose deaths and abuse, as well as the overall public health impact related to specific controlled substances.

Furthermore, the FDA is using its authority under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act of 2018 to mandate short-duration packag- ing for outpatient dispensing of certain solid, oral dosage forms of immediate-release opioid analgesics to treat acute pain and require manufacturers to develop technologies such as mailback pouches to dispose of unused opioid medications, Van Tassel reported

The FDA also plans to announce changes to strengthen the Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl medicines, and issue updated guidance to promote the development of non-opioid drugs to treat pain, Van Tassel added.

Finally, the FDA is focused on securing the legitimate supply chain and doing more to hold distributors responsible. Under the Drug Supply Chain Security Act (DSCSA), manufacturers, re-packagers, wholesale distributors, and dispensers-which are all mainly pharmacies-are all required to have systems and processes in place to quarantine and investigate suspect and illegitimate medications, Van Tassel said.

“The FDA plans to ensure that entities responsible for maintaining the supply chain take measurable steps under the law to appropriately track and trace opioid medications as these products move through the supply chain, and to respond to incidents involving illegitimate products to protect the public health,” Van Tassel said.

States also issue their own laws regarding drugs, which generally address limiting initial prescription quantities, requiring prescribers to query the state’s prescription drug monitoring program prior to prescribing, requiring provider education or training as well as patient education, and requiring co-prescribing of naloxone, the opioid reversal agent, Lichauer said.

Regarding states’ rules, Lichauer said that limiting initial prescription quantities will reduce the potential for leftover pills, which can fall into the wrong hands and be misused, and can lower the risk of long-term opioid dependency. A CDC study correlated higher initial prescription quantities with a greater risk of continued use at 1 and 3 years.

 The same study also demonstrated an increase in continued use at 1 and 3 years for patients who received a third prescription refill of their initial opioid pain medication.

Upon dispensing in most states, pharmacists are required to query a patient’s history in the prescription drug monitoring program (PDMP) database. “Pharmacists need to know their state regulations on prescription quantities and refills as well as requirements for patient education,” Lichauer said

Pharmacists should be sure that their entire staff is registered for their state’s PDMP and that they check it every time a controlled substance medication is dispensed, said Andrew Smith, PharmD, BCPS, BCCCP, assistant professor and PGY-2 emergency medicine residency program director, Touro College of Pharmacy. Furthermore, since pharmacies are required to send data to the state for this reporting program, finding ways to streamline the reporting process will help decrease their perceived workload burden.

Pharmacists need to review their state laws and figure out what their roles can be to help their communities. “If naloxone is available as a standing order under state law, pharmacies should be sure to have an adequate supply and they should train their pharmacists and interns to counsel patients and be candid about the risks of even a short course of opioids for patients,” Smith said. Furthermore, pharmacies should become more familiar with medication-assisted treatment (MAT) as more emergency physicians begin initiating treatment in the emergency department as a bridge to long-term treatment with an addiction medicine specialist. MAT will grow over time as more patients get the help they need.

Van Tassel said that pharmacists are stepping up to address the opioid crisis by playing an active role in stewardship programs to prevent opioid misuse. These programs are designed to promote appropriate use of opioids, improve patient outcomes, and reduce the misuse of opioids.

Pharmacists are also participating in opioid stewardship programs through clinical education and guideline generation, and by using PDMP database searches to track prescribing practices and patient behavior that can drive opioid abuse, Van Tassel said. Pharmacists are monitoring prescribing practices to identify outliers among providers, to assess the appropriate use of clinical decision support, to impose restrictions on specific opioids and doses, and to provide daily feedback to prescribers.

Most hospitals assign pharmacists to play pivotal roles in drug therapy management. Pharmacists do so by assessing therapeutic drug levels, patient outcomes, laboratory results, and adverse drug events to track potential opioid abuse, Van Tassel concluded.

Ahmad FB, Escobedo LA, Rossen LM, et al. Provisional drug overdose death counts. National Center for Health Statistics. 2019. 

https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm?mod=article_inline

Shah A, Hayes CJ, Martin BC. Characteristics of initial prescription episodes and likelihood of long-term opioid use – United States, 2006-2015. 

http://dx.doi.org/10.15585/mmwr.mm6610a1external icon

The opioid crisis continues to be one of the worst public health crises that the United States has ever seen.

Addressing the Opioid Crisis in 2020

When it comes to state vaccination laws, pharmacists are gaining increasing authority to administer immunizations, but association experts say there’s still work that needs to be done.

“Pharmacy differs from other health professions like medicine in that our authority is state dependent,” Mitchel C. Rothholz, RPh, MBA, Chief Strategy Officer for the American Pharmacists Association, said. “Our vision for pharmacists’ authority is that pharmacists will be authorized to administer all (Advisory Committee on Immunization Practices) recommended vaccines as valued members of the immunization neighborhood.”

Although pharmacists in all 50 states have been given the authority to administer influenza vaccines to adult patients, pharmacists in some states are still limited by which vaccines outside of influenza they are able to administer, the age of patients they are able to administer to, and whether a patient needs a prescription before getting a vaccine at the pharmacy.

According to a January 2019 report released by the National Alliance of State Pharmacy Associations, pharmacists in 48 states-including Puerto Rico and the District of Columbia-are authorized to administer all vaccines to adult patients. However, 9 of those states require prescriptions for at least some of the vaccinations.

Four states still do not have the authority to administer all vaccines, the report found.

Many states also continue to limit pharmacists’ vaccination authority by age restrictions for the patients they are able to immunize, with just 27 states allowing pharmacists to administer to any age-for at least for some of the vaccinations, according to the report.

“With respect to pharmacists’ authority to be able to administer vaccines, there’s just a patchwork of laws across the country,” Michelle Cope, director of federal and state public policy for the National Association of Chain Drug Stores (NACDS), said.

Some states have made recent progress to expand pharmacists’ authority. In Wisconsin, a bill was recently passed that expands a pharmacists’ ability to administer vaccines for any age, as long as a prescription is obtained for certain vaccines. It also gives authority for pharmacy students to administer vaccines if they are under the direct supervision of a pharmacist.

Legislators in South Carolina are also expected to consider a bill in the upcoming legislative session that would lower the age for pharmacist-administered vaccines. What makes this bill unique, according to Allie Jo Shipman, PharmD, MBA, director of state policy for the National Alliance of State Pharmacy Associations, is that it was brought up by parents who wanted to see the changes made.

“You are seeing now that it’s not just pharmacists, but the public, I feel like the patients are really starting to see the pharmacy as the place that they go for that public health care,” Shipman said.

Although there has been advances at the state level, pharmacy association leaders say there is still progress to be made. “Our broadest policy goal is for pharmacists to have autonomous authority to provide immunizations for all FDA-approved vaccines that are available and that have been approved by the FDA in the same manner as all other vaccine providers,” Mary Ellen Kleiman, senior vice president of state government affairs/deputy general counsel for NACDS said.

Cope said NACDS is now looking to “standardize” the vaccine types that can be administered while also eliminating the administrative barriers that still exist in some states that make delivery more challenging.

John Beckner, RPh, senior director of strategic initiatives for the National Community Pharmacists Association (NCPA) echoed those sentiments, saying the NCPA believes pharmacists should be able to administer any approved vaccine to any patient.

“I think NCPA as an association really believes that immunization services really need to be a core competency of the pharmacy profession,” he said. “It’s such an important service that we offer and we began offering it in the mid-to-late ‘90s, so obviously something that we feel is very important.”

In addition to expanding authority for pharmacists, Beckner believes that it’s also important to give pharmacy students the authority to administer vaccines under the supervision of a trained pharmacist as part of their training.

“Certainly, it makes sense that these students and interns need to be trained to provide immunizations if it is going to become a core competency and service offered by all pharmacies,” he said.

One of the largest challenges remains expanding pharmacists’ authority to administer vaccines to those patients 17 years of age and younger.

Pediatricians and legislators have historically been more cautious in allowing these vaccines to take place outside the physicians’ office, but Cope said she believes pharmacists’ success in adult immunizations has helped to quell possible concerns.

“It’s just getting policy makers to get comfortable with the idea, but the evidence now has grown that pharmacists are great providers for vaccines, that they are convenient to access, that they can help improve overall vaccine rates, so I think with that growing evidence that’s really kind of put policy makers minds at ease around this,” she said.

Although the rate of adolescents who are receiving the recommended vaccines continues to rise, the population group continues to lag behind younger children, according the US Department of Health and Human Services.

Cope believes if pharmacists in more states are given the authority to administer vaccines to adolescents, they could help close this gap and improve adolescent vaccination rates.

“If we’re opening pharmacists’ vaccines up to that age group in particular, given that pharmacists have historically improved vaccine rates, I think that that can really help to address that,”she said.

Pharmacists can help expand pharmacists’ authority on an individual level by continuing to demonstrate their capabilities and value as an immunization provider.

“When others outside our profession advocate for our increased inclusion then we are doing things right-and there are folks doing this,” Rothholz said.

Shipman said pharmacists also need to make sure “they are doing everything in their practice to provide the vaccines that people need,” whether that’s expanding the current offerings, keeping vaccines fully stocked, or taking a proactive approach to determining which vaccines a patient may need.

Although the industry has “made incredible progress,” Shipman said there is still “a long way to go.”

Advances can still be made both within state legislatures and in individual pharmacies themselves as they continue to offer more vaccine options for patients.

“I think that’s the area where we as an association are encouraging our members to expand is their vaccine portfolio because it’s such an opportunity for them to diversify their revenue, but it’s also an opportunity for them to have an impact on the public health arena,” Beckner said.

Pharmacists can also support the efforts of their state pharmacy associations by inviting state legislators into their practices to show the value of the services they provide or take a more active role in advocacy efforts at the state level themselves.

“Certainly, pharmacists on the state and local level can become actively involved with their legislature, they can continue to forge relationships in the medical community and really market and advertise their services to let people know that they are an immunizer and what vaccines they are able to offer,” Beckner said. “The more people that know about it, the more likely that it’s going to be an accepted practice.”

APhA/NASPA. Pharmacist Administered Vaccines [report]. NASPA’s website. Published January 2019. 

https://naspa.us/wp-content/uploads/2019/04/IZ-Authority-012019.pdf

State of Wisconsin 2019-2020  Legislature. 2019 Assembly Bill 137. 

http://docs.legis.wisconsin.gov/2019/related/proposals/ab137.pdf

Department of Health and Human Services. Vaccines and Adolescent Development. HHS’ website. 

https://www.hhs.gov/ash/oah/adolescent-development/physical-health-and-nutrition/vaccines/index.html

Progress has been made, but there’s still a long road ahead.

An Update on Pharmacists’ Vaccination Authority

Optimism is strong around the pharmacy industry as we head into a new decade, and many believe that 2020 is going to be a pivotal year for the industry.

Raj Jhala, PharmD, Pharmacist in Charge of Saint Peters Community Pharmacy, located in Saint Peters, Missouri, said that in 2020, more and more pharmacies will be offering delivery.

“From my perspective, with Amazon entering the prescription market with PillPack, and Walmart, Costco, and CVS offering delivery, brick and mortar shops will have to move in this direction,” he said. “Every year from here on out will see a greater trend toward delivery.”

Brian Nightengale, RPh, president of Good Neighbor Pharmacy, a cooperative network of more than 4500 independently owned and operated pharmacies, said the reimbursement environment has continued to intensify and its impact on the pharmacy segment is going to become more visible in the year ahead.

“Across retail chains and independent community pharmacies, we’ve already seen poor reimbursement impact bottom lines and ultimately lead to store closures,” he explained. “2020 will be a defining year for pharmacies that have stayed complacent and those who have pushed to diversify their businesses. And this year, those who have worked to develop new solutions beyond dispensing will benefit from that decision and see opportunities for more growth.”

Ramzi Yacoub, PharmD, chief pharmacy officer at Boston-based RxSense, said as insurance plans and patients continue to try to find ways to help reduce their medical and pharmacy spend in 2020, he foresees increased enrollment in high-deductible health plans (HDHPs).

“As a result, patients will continue to look for lower cost options when purchasing prescription medications,” he said. “Patients are increasingly comparison shopping for their medications and taking advantage of prescription savings services like SingleCare to save money on their medications.”

In 2020, he also expects the continuation of health care services expanding in retail pharmacy settings as pharmacies try to increase offerings for more convenient services.

Optimism is strong around the pharmacy industry as we head into a new decade, and many believe that 2020 is going to be a pivotal year for the industry.

Drug Topics January 2020

The 'Unattainable Triangle' of Community Pharmacy

Lefamulin (Xenleta) for Community Acquired Bacterial Pneumonia

Pharmacy Trends in 2020 and Beyond: Preparing for a New Decade

Sunosi for Excessive Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea

What Pharmacists Are Saying About Stress

What Pharmacists Need to Know About Psoriasis Medications

4 Pharmacy New Year’s Resolutions For 2020

Addressing the Opioid Crisis in 2020

An Update on Pharmacists’ Vaccination Authority

A Look Ahead: What to Expect from the Pharmacy Landscape in 2020

Educating Patients on the Latest Diabetes Technology

Most Valuable Drugs in the 2020 Pipeline

Rapid Diagnostic Technologies Can Play a Role in Antimicrobial Stewardship Programs

Gestational Diabetes: Pharmacists Can Play a Role in Interventions, Counseling