Independent community pharmacy represented 35% of all retail pharmacies in the United States in 2019, according to the National Community Pharmacists Association’s 2020 

Particularly in rural and underserved areas, independent pharmacies have become the health care hubs for their communities, making them ideally positioned to bridge gaps in health care access. While the coronavirus disease 2019 (COVID-19) underscored disparities regarding access to care, supplies, and mortality in minority communities, pharmacy has only scratched the surface in addressing the factors that lead to these disparities.

 delves into how pharmacy professionals are serving minority populations to address these health care disparities and improve outcomes. In a series of interviews, we learn from pharmacy owners about what it means to provide culturally competent care and build trust with members of minority communities.

® Editorial Advisory Board member Lakesha Butler, PharmD, BCPS, says in this month’s issue: “Patient-provider trust is critical when serving communities of color.”

Additionally, February is American Heart Month. Individuals with diabetes are especially at greater risk of developing heart disease. On page 20, Jennifer Gershman, PharmD, discusses 

 and how pharmacists, as part an interdisciplinary team, can play an important role in helping patients with prediabetes or diabetes reduce their risk. You can also read more on this topic in our dedicated 

Immunizations are at the forefront of everyone’s mind. The COVID-19 pandemic has ushered in a renewed interest in vaccinations. This issue also discusses how pharmacies can 

effectively promote their immunization programs

 for important non-COVID vaccinations, as well as 

For health-system pharmacists, we dive into some of the top COVID-19–related medication safety errors occurring in hospitals amid the pandemic. The Institute of Safe Medication Practices (ISMP) offers 

 around potential risks associated with infusion pumps, drug shortages and importation, and drug labeling changes. 

Continue to visit drugtopics.com for up-to-date information and timely pharmacy news.

Chairman and Founder of MJH Life Sciences™

NCPA Releases 2020 Digest Report. News release. National Community Pharmacists Association; October 19, 2020. Accessed January 20, 2020. 

https://ncpa.org/newsroom/news-releases/2020/10/19/ncpa-releases-2020-digest-report

Articles

From the chairman

Particularly in underserved areas, independent pharmacies have become the health care hubs for their communities, making them ideally positioned to bridge gaps in health care access. 

Community Pharmacies Can Make a Difference As Health Hubs

Ronald Reagan was the most quotable president of my lifetime. The above quote truly resonates with me, especially when dealing with patients. I never use the term “customer” when they are at the prescription counter. They are here for health care, not just for making purchases.

Readers have heard me sing the praises of pharmacy technicians I’ve worked with. These technicians have allowed me to provide optimal patient care and ensure that the pharmacy is run efficiently. 

For example, Darlene worked as my technician for 24 years. She is highly organized, efficient, and a pharmacist’s best friend. Brad was my technician for the past 12 years. He started while in high school and learned the ever-cumbersome pharmacy software we used. He was a rock star at processing prescriptions and allowing me time to handle patient consultations, comprehensive medication reviews, and interventions that proved financially beneficial for my employer. The efficiency of the store didn’t depend on the pharmacist, but on whether Brad was there.

I currently have 2 excellent technicians, Hunter and George. I’ve been on the new job for only 4 months so I can’t take credit for their hiring or training. Both are whizzes with the operations of the system. Doing the paperwork and processing orders are their greatest strengths. Both are very capable data entry technicians as well. They are guiding me, the 62-year-old “new kid” on the block, through the challenges of working for a new employer.

What frustrates me is when I go to several general merchandise stores and I see signs saying, “The CUSTOMER is always right.” If the customer is always right, then who is always wrong? Talk about throwing your employees under the bus. If they are always right, my staff and I are always wrong. If I were an employee for that organization, I’d feel insulted every time I walked past such a sign. If patients tell me their physicians said there are refills on an oxycodone prescription, are they always right?

Of all the giants in the grocery store business, none shines as brightly as Wegmans. Their employees are always happy and helpful. They greet you with a genuine smile and a most caring attitude. Their attitude is their highly trained employees are always right. “Our employees are our No. 1 asset, period,” Kevin Stickles, the company’s senior vice president for human resources, told 

 in 2012. “The first question you ask is: ‘Is this the best thing for the employee?’ That’s a totally different model.”

I can assure Hunter and George that I will use my 40 years’ experience on the bench to guide them so they can have fulfilling careers like Darlene and Brad. As the sun begins to set on my career, I can assure my staff I will never “feed them to the crocodile.” We owe it to our pharmacy technicians to be their strongest advocates.

“If some among you fear taking a stand because you are afraid of reprisals from customers, clients, or even government, recognize that you are just feeding the crocodile hoping he’ll eat you last.” – Ronald Reagan

Advocate for Your Pharmacy Staff

The coronavirus disease 2019 (COVID-19) pandemic triggered medication safety concerns related to drug and medical supply availability across the health care system.

A session during the American Society of Health-System Pharmacists 2020 Midyear Clinical Meeting and Exhibition, held virtually December 6-10, 2020, addressed the effects of COVID-19 in the annual medication safety update from the Institute for Safe Medication Practices (ISMP).

During the presentation, Christina Michalek, BS, RPh, FASHP, medication safety specialist and administrative coordinator for the Medication Safety Officers Society at ISMP, discussed top COVID-19–related medication safety issues that occurred in 2020 and recommendations for mitigating harm connected to some of them.

At the start of the pandemic, health care providers were faced with dwindling supplies of personal protective equipment (PPE), and many hospitals employed strategies to preserve PPE and limit staff exposure to COVID-19. “Some of the choices that were made really affected safe medication practices,” Michalek said.

One of these choices involved moving infusion pumps outside the critical care rooms of patients with COVID-19, according to Michalek. However, she noted several challenges and risks associated with this strategy:

Mechanical issues, such as delayed occlusions alarms at low flow rates, more frequent alarms at high flow rates, and affected flow rate accuracy

Need for increased priming volume because of length of tubing

Effects on barcode scanning and double-checks

“This definitely presented some challenges,” Michalek said. “Throughout, ISMP tried to represent the risks so that everybody could make the best and most informed decisions.” 

Although a long-standing issue, drug shortages have presented even more intense challenges during the pandemic. “We had many more critically ill patients, which really led to shortages of every drug that we use in mechanically ventilated patients,” Michalek said.

To combat some of these challenges, the FDA allowed importation of some medications. One of them was propofol. “Typically, in the United States, we use propofol as a 1% solution, and the FDA allowed us to import a 2% solution,” Michalek said. Because of shortages of propofol 1%, Fresenius Kabi received an emergency use authorization to bring in propofol 20 mg/mL (Fresenius Propoven 2%

“If the double concentration of this imported product is overlooked, we could have an overdose in patients,” Michalek said.

According to Michalek, ISMP recommends that hospitals:

Alert providers to the double concentration

Post wall charts and distribute fact sheets

Apply warning stickers to individual vials and cartons

Update drug databases and smart pump libraries

Affix a barcode if the international barcode does not scan

The FDA offers a wall chart on its website that can be posted in care areas, along with fact sheets designed for health care providers as well as patients and caregivers.

Absence of Cap Warnings on Vials of Neuromuscular Blocking Agents

Because of a shortage, Gland Pharma Ltd was allowed to manufacture and market vecuronium and rocuronium vials without the usual required labeling on the vial cap: “Warning: Paralyzing Agent.” The rest of the labels remained unchanged, but the caps were allowed to be marketed without the warning.

With the unlabeled caps, “it can be very easy for practitioners to mistake them for a normal medication,” Michalek said.

“We know with neuromuscular blockers, these are one of those high-alert medications that are so likely to be linked to harm in situations where they’re used as mistaken for another product.”

Alerting staff about the absence of the usual warning statement

Affixing auxiliary labels noting “Warning: Paralyzing Agent” to vial caps

Storing the vials lying down (not cap up) so labels are visible

Using barcode scanning during preparation and administration

Pharmacists can also visit ISMP.org for additional strategies on medication safety best practices.

Michalek C, Grissinger M. ISMP Medication Safety Update for 2021. Presented at: American Society of Health-System Pharmacists 2020 Midyear Clinical Meeting and Exhibition; December 6-10, 2020; virtual.

The presentation discussed the pandemic’s effect on medication safety and provided recommendations to hospitals.

ISMP’s Top COVID-19–Related Medication Safety Errors 

On August 5, 2020, the FDA granted accelerated approval to belantamab mafodotin-blmf (Blenrep; GlaxoSmithKline).

Belantamab mafodotin-blmf is now indicated for adult patients with relapsed or refractory myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immune modulating agent. Belantamab mafodotin-blmf is a first-in-class, anti–B-cell maturation antigen (BCMA) immunoconjugate with afucosylated, humanized immunoglobulin G1 anti-BCMA monoclonal antibody conjugated by a protease-resistant maleimidocaproyl linker to a microtubule-disrupting agent, monomethyl auristatin F (MMAF).

 This conjugated drug allows delivery of cytotoxic MMAF to BCMA-expressing multiple myeloma cells causing apoptosis and tumor lysis through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Accelerated approval of belantamab mafodotin-blmf stemmed from the results of the multicenter open-label, phase 2 DREAMM-2 (NCT03525678) study.

 The study enrolled patients with relapsed or refractory multiple myeloma with disease progression after 3 or more lines of therapy and who were refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant to an anti-CD38 monoclonal antibody. The primary end point of patients achieving a partial response or better occurred in 31% (97.5% CI, 20.8-42.6) of patients in the 2.5 mg/kg cohort. Another key secondary end point was probability of having a duration of response 4 months or longer, which was estimated by the Kaplan Meier curve to be 78% (95% CI, 57-89) in the 2.5 mg/kg cohort.

The most common adverse effects (AEs) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common grade 3 or 4 laboratory abnormalities are decreased platelet count (21%), decreased lymphocytes (22%), decreased hemoglobin level (18%), decreased neutrophils (9%), increased creatine level (5%), and increased γ-glutamyl transferase (5%).3 Because of the risks of ocular toxicity, the medication is restricted under the Risk Evaluation and Mitigation Strategy (REMS) program. Prescribers must be certified with the Blenrep REMS program. Patients must be enrolled in the program and adhere to monitoring.

This medication also carries a black box warning: corneal epithelium changes can occur, resulting in alteration in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes. Ophthalmic examinations should occur at baseline (3 weeks prior to the first dose), prior to each dose (at least 1 week after previous dose and within 2 weeks prior to next dose), and promptly for worsening symptoms. 

Patients should be advised to use preservative-free lubricant eye drops at least 4 times per day starting with the first infusion and continuing until end of treatment, to avoid contact lens use, and to use caution when driving. Complete blood counts should occur at baseline and as clinically indicated thereafter. If applicable, patients should use contraception while on this medication because of the potential of embryo-fetal toxicity. Female patients of reproductive potential should continue to use contraception 4 months after the last dose and male patients with female partners of reproductive potential should use contraception for 6 months after the last dose.

The recommended belantamab mafodotin-blmf dose is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every 3 weeks. For AEs requiring dose reductions, decrease to 1.9 mg/kg intravenously once every 3 weeks.

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma. FDA. August 5, 2020. Accessed November 18, 2020. 

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma#:~:text=On%20August%205%2C%202020%2C%20the,antibody%2C%20a%20proteasome%20inhibitor%2C%20and

Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. 

 2020;21(2):207-221. doi:10.1016/S1470-2045(19)30788-0

Blenrep. Prescribing information. GlaxoSmithKline; 2020. Accessed November 18, 2020. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf

Belantamab mafodotin-blmf is now indicated for adult patients with relapsed or refractory myeloma who have received at least 4 prior therapies. 

Belantamab mafodotin-blmf for Relapsed or Refractory Multiple Myeloma

Atopic dermatitis (AD) is a chronic, inflammatory skin condition with symptoms ranging from dry, itchy skin to painful rashes that interfere with sleep and daily activities.

 AD usually starts in early childhood; however, cases also are diagnosed in some adults.

 It is estimated that 25% of children in the United States have AD compared with 10% of adults.

 Study results have shown that African American and Asian populations are more likely to develop the disease.

 Patients with AD can develop other autoimmune conditions; for example, asthma and hay fever are reported in more than half of children with eczema.

Pharmacists can play a major role in educating patients on how to manage flare-ups and take preventive measures. The goal of the treatment is to enhance patients’ quality of life by reducing outbreaks, controlling symptoms, and lowering the risk of infection.

Patients should stay hydrated and apply moisturizer at least twice daily.

 Pharmacists should help patients learn to identify triggers that can cause skin irritations. Keeping a list of such triggers can help patients reduce skin flare-ups and better manage symptoms. Some triggers include stress, dry skin, detergent, fragrance, dye, and other chemicals.

The first-line treatment for mild AD is a topical steroid (eg, hydrocortisone) that can be applied twice daily during flare-ups.

 Hydrocortisone is safe to use for patients 2 years and older. However, if symptoms have not been controlled within 7 days of treatment, seeing a dermatologist is recommended.

 Topical hydrocortisone is available over the counter at 1% strength. It can be used on almost all body areas for a short time. Oral first-generation antihistamine (eg, diphenhydramine) can help reduce itching.

Some remedies for adults and children include the following

Take a warm bath for no more than 10 minutes

Pat skin gently to dry and apply petroleum jelly-based moisturizer after bathing

Trim fingernails to avoid scratching and skin infection

Keep room temperature at a comfortable level

Pharmacists should recommend a physician visit for moderate to severe cases of AD that involve intense itching, children younger than 1 year, infected skin, and facial flare-ups.

If a patient’s condition is not controlled with OTC medications, a dermatologist or primary care physician can prescribe other medications to help lessen symptoms. The physician may prescribe more potent topical corticosteroids, topical calcineurin inhibitors, or crisaborole.

 Topical calcineurin inhibitors can be used on the eyelids, neck, and skin folds, whereas high-potency corticosteroids can cause skin atrophy when applied to these areas.

 Studies show that oral immunosuppressant cyclosporine may help in reducing AD symptoms, but recurrence is common after discontinuation.

For severe cases, a dermatologist may recommend phototherapy, which includes using UV light 2 to 3 times per week for a few weeks or months.

 Another option that a physician may recommend for moderate-to-severe eczema is the wet wrap therapy. Medication is applied, then a wet dressing is worn over the area and covered with a dry dressing.

 Wet wrap therapy can help calm the skin and reduce itching and scratching.

Patients who fail other treatments and are not qualified to receive phototherapy may be prescribed dupilumab injection.

 Dupilumab is a human monoclonal antibody inhibiting IL-4 and IL-13 that is approved to treat AD in patients aged 6 years and older.

 Some patients may consider a bleach bath to prevent flare-ups by decreasing bacteria on the skin. Patients will be instructed to add half a cup of household bleach to 40 gal of warm water.

 Then the patients will soak from the neck down or just the affected areas of the skin for about 10 minutes.

 Bleach baths should not be taken more than twice a week.

Eczema types: atopic dermatitis diagnosis and treatment. American Academy of Dermatology Association. Accessed December 19, 2020. 

https://www.aad.org/public/diseases/eczema/types/atopic-dermatitis/atopic-dermatitis-treatment

Eczema types: atopic dermatitis causes. American Academy of Dermatology Association. Accessed December 19, 2020. https://www.aad.org/public/diseases/eczema/types/atopic-dermatitis/causes. 

Atopic dermatitis (eczema). Mayo Clinic. Accessed December 19, 2020. 

https://www.mayoclinic.org/diseasesconditions/atopic-dermatitis-eczema/symptoms-causes/syc-20353273

https://www.pharmacytoday.org/action/showPdf?pii=S1042-0991%2819%2931140-5

Weston WL, Howe W. Treatment of atopic dermatitis (eczema). UpToDate. Updated September 24, 2020. Accessed December 20, 2020.
https://www.uptodate.com/contents/treatment-of-atopic-dermatitis-eczema 

Eczema types: atopic dermatitis: tips for coping. American Academy of Dermatology Association. Accessed December 19, 2020. https://www.aad.org/public/diseases/eczema/atopic-dermatitis-coping

Pharmacists can advise patients on how to control symptoms and reduce exacerbations. 

A Primer on Atopic Dermatitis

Pharmacists across the country are seeing a milder flu season this year, thanks in part to the precautions put in place to prevent coronavirus disease 2019 (COVID-19), but many are also seeing increases in the number of flu vaccinations administered at their stores.

The COVID-19 pandemic has ushered in a greater focus on health and prevention efforts, which has led to fewer cases of the flu this season than in past years. “This flu season, we have seen lower incidences of flu compared to an average season, which may be due to our shift in behavior to reduce the spread of COVID-19,” said Tasha Polster, BSPharm, vice president of pharmacy quality, compliance and patient safety for Walgreens. “For example, more people are social distancing, wearing face masks, hand washing, and forgoing travel.”

According to the CDC, laboratory-confirmed cases of the flu remain “low at this time.”1 Additionally, reported deaths due to COVID-19 remain higher than for influenza, according to recent National Center for Health Statistics (NCHS) mortality surveillance data. For the data available on January 7, 2021, the NCHS reported that 14.5% of deaths occurring during the week ending January 2, 2021, were from pneumonia, influenza, and COVID-19 (PIC). However, of the 2150 PIC deaths reported in that week, 1496 had COVID-19 listed as an underlying or contributing cause of death, whereas only 2 listed influenza.

Rite Aid and CVS officials also reported decreased numbers in flu incidence this year among patients. “As a general trend, people are more aware of health and immunity than perhaps ever before, which fits into our purpose to become a neighborhood destination for whole being health, including traditional medicine like vaccinations and alternative remedies and supplements that may help boost immunity or reduce stress,” said Jocelyn Konrad, BSPharm, executive vice president and chief pharmacy officer for Rite Aid.

Moreover, the number of Americans receiving the flu vaccine is on the rise this season. The CDC led a push to encourage more individuals to get their vaccinations in order to avoid illness or hospitalizations that could tax an already overworked health care system.

“During the COVID-19 pandemic, reducing the overall burden of respiratory illnesses is important to protect vulnerable populations at risk for severe illness, the health care system, and other critical infrastructure,” the CDC said in its pandemic guidance released to the public.

The push—and greater concerns about health among Americans—resulted in a significant increase in the number of individuals who have received vaccinations to date. According to the CDC, by December 19, 2020, an estimated 46.9 million adult flu vaccinations had been administered in pharmacies, compared with 32.9 million at the same time in 2019, representing a 43% increase. An additional 28.9 million adult flu vaccinations were administered in physician medical offices.

Although last year 32.1 million turned to physicians’ offices to receive vaccinations—about the same number as those who went to a pharmacy setting in 2019—this year to date there has been a significant increase in those seeking immunizations at pharmacies rather than at their physicians’ offices (46.9 million vs 28.9 million, respectively).

These trends seem to match what pharmacists are seeing in stores. “This flu season we anticipate administering nearly 20 million vaccines, which is more than double last year, so the demand to be vaccinated has certainly increased,” said Ryan Rumbarger, BSPharm, senior vice president of retail 

Polster said Walgreens has seen “double-digit growth” in the number of flu vaccinations administered this year at its stores compared to this time last year

. The company has also seen seniors 65 or older—who are particularly at risk for COVID-19—getting flu vaccinations in higher numbers and earlier in the flu season than in past years.

“Our marketing mix is consistent with previous flu seasons; however, understanding the importance of flu shots amidst the COVID-19 pandemic, we wanted to ensure we reached our customers to raise broad awareness far earlier this flu season, and ramped up our flu messaging beginning in August,” Polster said. The organization continued its Flu Fighter campaign this year, emphasizing that getting a flu vaccination “not only helps protect you, but those you love—your crew,” she said.

Konrad said Rite Aid’s messaging focused on communicating the importance of getting a vaccination “as a way to prevent a possible ‘twindemic’ that some health care experts feared could result from the collision of flu season and the COVID-19 pandemic.”

To date, it appears that concern has failed to come to fruition, but flu season is not over, and experts and the CDC said the community needs to remain vigilant in the months ahead. “We’ve continued to remind people it’s never too late to get your flu shot,” Rumbarger said. “We’ve also increased access to flu shots for communities in need.”

Brian Caswell, RPh, National Community Pharmacists Association president and owner of Wolkar Drug in Baxter Springs, Kansas, said that although he hasn’t necessarily seen an increase in the number of flu vaccinations administered at his pharmacy this season, he has seen more interest from patients who may have declined vaccinations in past years.

“I have not talked to anyone who said that they are going to forgo their flu shot because of what’s going on, but I have talked to a few people who’ve said, ‘You know, I haven’t had a flu shot ever’ or ‘I haven’t had a flu shot in the last 2 years and with everything going on, I thought I better go ahead and get it this year,’ ” he said.

Although the COVID-19 pandemic appears to have motivated many Americans to seek out flu vaccinations, it has also presented challenges to pharmacies in terms of marketing and logistics. Caswell said his pharmacy was forced to close its lobby twice during the pandemic, and had to rely more heavily on communicating with patients through word of mouth and social media outlets like Facebook. It also switched to an appointment-based approach to vaccinations to minimize the number of individuals in the store at any given time.

“Moving over to an appointment model, I thought was going to be a problem. It hasn’t been a problem,” he said. “People were willing to do it, and I think they didn’t want to be hanging around a lobby with sick people, either.”

Caswell said he had expected the pharmacy’s home delivery services to rise during the pandemic, but was surprised to find the biggest growth was in drive-through use. “I think people still wanted to get out,” he said.

Rumbarger said CVS also amplified its digital experience within its mobile app and expanded home delivery options, like DoorDash and Instacart, to reach patients during the pandemic. “Before and during the pandemic we’ve deployed a diverse marketing strategy to meet people where they are—in our pharmacies, in the community, in the home or in the palm of their hand,” he said, adding that officials will continue to revise strategies based on patient feedback.

Konrad said Rite Aid’s marketing messages have focused on how the pharmacy chain is still able to serve patients amid the pandemic and the increased safety precautions in place. “We’ve worked hard to provide essential pharmacy services—including vaccinations—despite the need to socially distance and protect customers and associates from COVID-19 transmission,” she said. “From enhanced cleaning and sanitation protocols to [personal protective equipment] and social distancing, we’ve made sure our customers can safely visit their neighborhood Rite Aid, whether to get a flu shot, get tested for COVID-19, or pick up medications and immunity-boosting supplements.”

Polster said pharmacies are expecting the COVID-19 vaccine to be more broadly available toward the end of the flu season. There will likely be high demand for COVID-19 vaccinations, but even with help on the horizon, pharmacies will need to encourage patients to remain as healthy as possible.

“It’s going to take time for a COVID-19 vaccine to be available to the general population, so we encourage everyone to get vaccinated against the flu to avoid 2 respiratory illnesses circulating at the same time and reduce the burden on our strained health care system,” Polster said.

Flu season. CDC. Updated January 11, 2021. Accessed January 11, 2021. 

https://www.cdc.gov/flu/season/index.html

Interim guidance for routine and influenza immunization services during the COVID-19 pandemic. CDC. Reviewed October 20, 2020. Accessed January 11, 2021. 

https://www.cdc.gov/vaccines/pandemic-guidance/index.html

Weekly national flu vaccination dashboard. CDC. Reviewed January 6, 2021. Accessed January 11, 2021. https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-dashboard.html. 



Preventive efforts, renewed interest in vaccinations drive milder flu season. 

Pandemic Precautions Lead to Low Incidence of Flu

Last year, California Gov Gavin Newsom announced the state would transition the pharmacy benefit for Medi-Cal beneficiaries from managed care plans to a fee-for-service (FFS) program, bringing approximately 13 million Medi-Cal beneficiaries to a new pharmacy program by January 2021.

Because of the ongoing challenges and evolving health care landscape associated with the coronavirus disease 2019 (COVID-19) pandemic, the Department of Health Care Services (DHCS) has delayed implementation until April 1, 2021.

This change was implemented pursuant to an executive order, as opposed to legislative efforts. It reflects patient dissatisfaction with the performance of the Medi-Cal managed care organizations when it comes to pharmacy services and medication access, as well as state concerns about a system that was failing to control prices.

Ken Thai, PharmD, CEO of 986 Degrees Corporation, said the extension to April was welcomed because some details of the rollout needed to be finalized. He noted that during the last few months of 2020, more pharmacists voiced concerns that reimbursements were going from bad to worse—and independent pharmacies were hit especially hard.

“I think there’s optimism that this Medi-Cal FFS program changing back to the state will be very positive for the most part; however, there are concerns about the transition,” Thai said. “With 13 million lives being taken back on, there are some hiccups expected.”

Other concerns he’s heard involve how this structure will apply to higher-cost drugs such as HIV or mental health medications. “I do expect this to be easier for patients who didn’t really understand how the Medi-Cal system worked previously,” Thai said.

Lucas W. Morgan, an attorney in Frier Levitt’s life sciences department

, explained that DHCS will reimburse pharmacies based on a combination of their actual drug acquisition cost and preestablished fees (eg, dispensing fees).

Magellan Medicaid Administration, Inc will be the sole pharmacy benefit manager (PBM) responsible for administering the program and was awarded a 5-year contract on December 12

, 2019 with 5 optional 1-year extension periods.

The executive order states that California’s “spending on prescription drugs has increased at an unsustainable rate, including hikes of approximately 20% per year since 2012, constituting a substantial fiscal drain.”

“The stated goal of the executive order is to achieve cost savings for California’s spending on prescription drugs,” Morgan said. “A relatively small subset of high-cost drugs accounts for a disproportionate amount of spending, with the 25 most expensive drugs accounting for approximately half of the state prescription drug expenditures.”

The executive order states that a major cause of skyrocketing prescription drug prices is unequal bargaining power, by which the pharmaceutical industry—often wielding monopoly power—is left unchecked in the absence of a strong counterparty at the bargaining table.

“The language of the executive order and other related commentary suggests that this unequal bargaining power is related to drug manufacturers,” Morgan said. “While manufacturers certainly play a role in this, it is important to note the critical role PBMs have played in the rising costs of prescription drug prices.”

Sidebar. Medi-Cal Rx Transition to Fee-For-Service Objectives

California Governor Newsom’s executive order to transition all Medi-Cal pharmacy services from managed care to fee-for-service (FFS) seeks to

Marshal public and private entities to counterbalance corporate bargaining power to address rising prescription drug prices and promote broader access to affordable health care for Californians

Establish a single-purchaser for the highest-cost prescription drugs

Standardize the California Medicaid pharmacy benefit

The Department of Health Care Services (DHCS) noted that transitioning pharmacy services from managed care to FFS will better standardize the Medi-Cal pharmacy benefit statewide and will improve access to pharmacy services with a pharmacy network that includes approximately 94% of the state’s pharmacies, while strengthening California’s ability to negotiate state supplemental drug rebates with drug manufacturers.

Furthermore, DHCS explains that expenditures for medical care and services administered to Medi-Cal certified eligibles can take many forms, including capitation payments to managed care health plans, Medicare premiums for low-income dual eligibles, and federal disproportionate share hospital payments to safety-net public hospitals.

Harry Nelson, JD, managing partner of Nelson Hardiman, a health care law firm in Los Angeles, said this change will expand dramatically the number of pharmacies able to participate in dispensing outpatient prescription medications to the 14 million Medi-Cal members in California without the challenge of being part of the Medi-Cal managed care networks, which had been a barrier to patient access and a regulatory burden for pharmacies.

“Instead, pharmacies can directly enroll in Medi-Cal with DHCS and bill claims, which will be managed by a single, centralized pharmacy benefit manager,” he said. “My sense is that the majority of pharmacies see this as a positive change, particularly given that Medi-Cal has become the single biggest payer in the state, with almost 36% of state residents and growing.”

Because there will be a single payer for California’s pharmacy benefit, Morgan said this is in stark contrast to previous arrangements in which multiple PBMs managed the pharmacy benefit with varying reimbursement benchmarks.

“The FFS model will likely eliminate PBM spread pricing in California Medicaid, which is a widespread PBM practice where the PBM charges a plan sponsor a higher price for a medication but then reimburses the pharmacy a lower amount and retains the difference,” he said.

Many states have investigated the practice of PBM spread pricing within in-state Medicaid programs and found prominent use of such practices in Medicaid.

“Pharmacy reimbursement being based on pharmacies’ actual drug acquisition cost combined with predetermined fees should result in more reasonable [and] sustainable reimbursement for pharmacies, at least in Medicaid, especially independent pharmacies,” Morgan said. “This could be especially pronounced in reimbursement for generic drugs, which comprise that vast majority of the prescription drugs prescribed and dispensed throughout the country annually.”

Morgan further explained that with in-state Medicaid programs relying on multiple PBMs to manage the pharmacy benefit on behalf of various plans, generic drug reimbursement is often made under a Maximum Allowable Cost (MAC) framework 

created solely by that particular PBM. However, PBM MAC reimbursement is often inconsistent among the various PBMs and often occurs at levels that are so low, pharmacies are losing substantial amounts of money.

“MAC reimbursement is also one of the primary ways in which PBM spread pricing is implemented by PBMs at their sole discretion,” he said. “In addition, because PBM MAC lists are deemed by the PBM to be confidential and proprietary, they are not subject to public scrutiny, which enables the PBM to set arbitrary and unreasonable MAC reimbursement that is not subject to any meaningful challenges.” Therefore, more pharmacies will likely be able to participate in California Medicaid.

One of the primary benefits of the new program will be increased access and freedom for patients to choose pharmacy providers because there likely will be more pharmacies able to participate in California Medicaid.

According to DHCS, “the vast majority of the state’s pharmacies” will be included in California Medicaid’s pharmacy network—citing 94% at last report.

“Patients were restricted to a relatively smaller number of pharmacies that contracted with the 2 dozen or so Medi-Cal managed care organizations,” Nelson said. “After the carve-out, patients will be able to obtain their medications through most pharmacies that will participate in ‘straight’ Medi-Cal [without the managed care organizations]. This is likely to benefit pharmacies focused on Medi-Cal populations, including pharmacies contracted to support federally qualified health centers through the 340B program.”

Once enacted, this will be good for all parties going forward, he said.

“The big attraction for Medi-Cal patients is the ability to go to almost any pharmacy in the state and have instantaneous processing thanks to the technology that allows PBMs to provide convenience for patients with private insurance,” he said. “For the state, centralizing drug rebates and having a single PBM utilizing a cost-based model holds out the potential for savings that did not materialize” in the current managed care organization-negotiated model.

Medi-Cal Rx: transition. Department of Health Care Services. Updated December 21, 2020. Accessed January 12, 2020. 

https://www.dhcs.ca.gov/provgovpart/pharmacy/Pages/Medi-CalRX.aspx

Executive order N-01-19. Executive Department, State of California. January 7, 2019. Accessed January 12, 2020. 

https://www.gov.ca.gov/wp-content/uploads/2019/01/EO-N-01-19-Attested-01.07.19.pdf

Medi-Cal and fee-for-service expenditures. Department of Health Care Services. Updated October 7, 2020. Accessed January 12, 2020. https://www.dhcs.ca.gov/dataandstats/statistics/Pages/Medi-Cal_Fee-for-Service_Expenditures.aspx

What pharmacy needs to know about the transition to the new fee-for-service program in California for Medi-Cal 

Pharmacy Benefit Changes Are Coming for Medi-Cal Beneficiaries 

Immunization is one of the most familiar pharmacy clinical services; approximately 77% of community pharmacies offer flu vaccines and 73% provide other immunizations, according to the National Community Pharmacists Association (NCPA).

 All 50 states have had authorized pharmacists to immunize patients in some form since 2010, but promoting such services also is necessary to achieve results.

“People don’t often come in out of nowhere asking for flu vaccine or a shingles shot,” said Beverly Schaefer, RPh. “You need to start the conversation.”

Schaefer has been starting immunization conversations at Katterman’s Sand Point Pharmacy in Seattle, Washington, for more than a decade. She is co-owner and evangelist-in-chief for a program that delivered over 4000 influenza immunizations from September 1 to October 10, 2020, even amid store closures for Sundays and Labor Day weekend.

Promoting immunization services is more about generating questions and providing information than about selling, she said. Something as simple as a countertop card asking “Have you had your shingles vaccine yet?” can be highly effective. Patients see the sign while they’re doing something else, such as having a prescription filled, asking a question, or looking for an OTC product, Schaefer explained.

“If they know about shingles vaccine, they think, ‘Oops, I need to get that done,’ ” she said. “If they don’t know about it, they ask what it is. Either way, you started that first conversation that leads to immunization. And because they asked the question, you’re providing information they can use, not trying to sell them some product they may or may not want.”

The scenario is different for severe acute respiratory syndrome coronavirus 2 vaccines. The coronavirus disease 2019 (COVID-19) pandemic itself is starting vaccine conversations around the world.

“Vaccine demand greatly exceeds supply right now,” said John Vinson, PharmD, CEO of the Arkansas Pharmacy Association. Community pharmacies have been the primary distribution point for COVID-19 immunizations in Arkansas since the first doses were delivered in late December 2020.

“Anytime demand greatly exceeds supply, you don’t have to do a lot of marketing,” Vinson said. “But you do have to do a lot of planning to get that vaccine into as many people as possible, as fast as you can.”

Planning is part of any successful immunization program. Under normal circumstances, state laws and regulations govern pharmacy immunization programs.

“Some states have [been] pretty liberal with vaccine authority,” noted John Beckner, RPh, NCPA senior director of strategic initiatives. “Others are still pretty restrictive, whether it’s limited pharmacists to certain vaccines or certain age groups.”

Pharmacists must tailor their immunization programs to meet state requirements. That could mean not providing pediatric immunizations or only providing select vaccines such as influenza, shingles, or measles-mumps-rubella.

In Wisconsin, however, changes to the state pharmacy act that took effect in early 2020 allow pharmacists to prescribe and administer any vaccine approved by the FDA as recommended by the CDC. Pediatric vaccines must be reported within 7 days.

Wisconsin’s broad immunization authority was no accident. The Pharmacy Society of Wisconsin (PSW) actively promoted pharmacy-based immunization—first with other providers, then with state legislators and regulators—to expand vaccine access.

Pharmacists can employ several strategies to enhance these programs. 

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