Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

Miranda Hester

They’re the bane of every pharmacy’s existence and in January 2024, big changes are coming to direct and indirect remuneration (DIR) fees. In a session at the National Community Pharmacists Association 2022 Annual Convention,

 Tripp Logan, PharmD, co-owner of L&S Pharmacy and Medical Arts Pharmacy and Scott Pace, PharmD, JD, co-owner of Kavanaugh Pharmacy, explained what’s going to change and what these changes could mean for pharmacies in the near future.

Although there have been many complaints about DIR fees, ranging from who got preferred status to pharmacy benefit managers seizing the opportunity to make money, one of the biggest issues was the lack of transparency. A pharmacist could go weeks or months not knowing what the pharmacy would be paid for a dispensed drug. Beginning in January 2024, pharmacists will be able to see at point-of-sale what the lowest potential net price is for a drug.

For Logan, the DIR landscape in pharmacy reminds him of the hard times his farming family felt during the first half of the twentieth century. “What we’re going through right now is the Great Depression of community pharmacy,” he said. Good are expensive and the cost to dispense has risen, leading to sluggish cash flow. This has led to increased scrutiny in Logan’s pharmacies of every contract, the cost to dispense, and the benefits of centralizing business costs for all 3 locations. Expandingrevenue outside of dispensed prescriptions—such as immunizations, point-of-care testing, and medication management for patients with chronic conditions— s of utmost importance. For Pace, it’s the point-of-care testing that acts as a bellwether for his pharmacy.

Although the future may look grim, Logan is still glad that pharmacies have 18 months to prepare for the change, allowing for new relationships, new services, and new contracts to make up for continuing downturns in prescription dispensing revenue. “We're not surviving 18 months in our drugstore, dispensing prescriptions,” he said.

The next 18 months are the time to develop strategies, according to Pace. A pharmacy could keep $5 gross profit from COVID-19 boosters to develop a cushion for rainy days. Pace also recommended that pharmacies use the Open Enrollment period in October 2023 to look at the Medicare Plan Finder; this tool will provide the clearest indication of what might happen in 2024.

Taking the time to examine where the costs are in pharmacy can be beneficial too, even if it might mean having to shift wholesalers for better prices. Even looking at specific drugs dispensed could benefit the pharmacist: take the time to see if there’s an available therapy that doesn’t cost the patient more, has the same safety and efficacy profile, and nets a higher profit for the pharmacy.

Even with prescription profit decreasing and the looming DIR fee changes, Pace is optimistic. “If you bring a prescription into my pharmacy, in some form or fashion, I'm going to find a way to make that prescription profitable,” he said. “It may take a little extra work, but I'm going to find a way to do it.”

Drug Topics’ coverage of the 2022 NCPA Annual Convention and Expo is sponsored Prescryptive Health.

Logan T, Pace S. Coming changes to DIR: Avoiding cash flow crunch. Presented at: National Community Pharmacists Association 2022 Annual Convention; October 1-4, 2022; Kansas City, MO.

Articles

Changes to DIR fees are coming. Taking proactive steps can help pharmacies avoid feeling the pinch.

Be Proactive Ahead of Upcoming DIR Fee Changes

On August 16, 2022, the FDA finalized a rule that allowed for OTC hearing aids, an important move to increase access to these devices. In just a couple of weeks, OTC hearing aids will be available in many stores, including pharmacies. Now that an appointment with an audiologist may no longer be required, the pharmacist will now be the health care provider individuals are likely to turn to with questions. This final rule offers a potential new avenue to help patients, but can also lead a number of questions for pharmacists.

Elaine Mormer, PhD, CCC-A, professor and vice chair for Clinical Education, as well as the director of Audiology Clinical Education in the Department of Communication Science and Disorders, at the University of Pittsburgh School of Health and Rehabilitation Sciences spoke with 

via email about why the rule was so important, what to know to help counsel, and “red flags” to watch out for that indicate an audiologist could be needed.

 Hearing loss is the third most common chronic condition in older adults. Hearing aids, the most common treatment for hearing loss, had been unaffordable and inaccessible to millions of Americans prior to these regulations going into effect on October 17, 2022. The sense of hearing provides a critical pathway to understanding and maintaining one’s health and quality of life. With this new FDA- regulated category of OTC hearing aids we should see a significant impact on the public health of Americans. 

What are the expected costs for the OTC hearing aids? Could this change as more options come to market?

 For consumers, price predictions for these devices seem to range from $300 to $1000 per pair. This is about 10% of the price that patients currently pay for hearing aid devices and services provided by a licensed audiologist.

What should pharmacists know, to help counsel patients?

 As frontline health providers, especially in rural and underserved areas, pharmacists are well-positioned to support patients’ safe and effective self-care solutions to hearing loss. Below are some key points to keep in mind:

OTC hearing aids are intended for adults, age 18 and above, who self-perceive mild to moderate hearing loss. There is no requirement for pharmacists to verify age and no requirement for medical clearance or hearing test, prior to purchase.

OTC hearing aids provide a self-care treatment option for hearing loss. This includes self-managed customization for both physical and acoustic fit, which may involve the patient’s use of software, smart phone, internet, or other accessory.

Hearing loss can result from a very wide array of etiologies, many of which are medically treatable.In many cases, patients will not be aware of a possible underlying medical cause for their hearing loss. OTC hearing aids will be labelled with “Red Flag” conditions that should be considered exclusions to self-care.

It can be confusing to differentiate actual OTC Hearing Aids from unregulated Personal Sound Amplification Products (PSAPS). PSAPs are sound amplifiers which are intended to enhance specific listening situations (eg, birdwatching, hunting) for listeners with normal hearing. FDA labeling will require outside packaging to clearly contain “OTC” and “hearing aid” to avoid potential product confusion.

FDA regulations do not require a manufacturer return policy, so policies of individual suppliers should be considered.

Hearing aids are not an instant solution to hearing loss. Unlike eyeglasses, there is a slow period of adjustment as the brain adapts to new input from the ears. Adjustment to amplified hearing can require patience and persistence.

Continuing Education resources are available for pharmacists to learn more about OTC hearing aids. The University of Pittsburgh created an online continuing pharmacy education course on OTC hearing aids which can be accessed at 

https://pittprofessional.catalog.instructure.com/courses/champ

What are the “red flags” in a patient that pharmacists should look out for to suggest going to an audiologist?

OTC hearing aid legislation does not pertain to patients under age 18 or to adults who have more than a moderate degree of hearing loss. These patients should be referred to an audiologist. In addition to these exclusions for hearing self-care, the FDA has recognized a list of “red flag” conditions that require referral to hearing health care providers, including otolaryngologists, in certain circumstances. These conditions are listed below:

6. Sudden onset, change, or fluctuation in hearing loss, in past 6 months

Could a collaborative relationship between an audiologist and a pharmacist help prevent any serious issue?

Audiologists are licensed hearing health care providers specializing in the non-medical assessment and treatment of hearing loss. Additionally, they are trained to recognize ear-related symptoms or conditions requiring medical assessment or intervention. Given these new FDA regulations, collaborations between local audiologists and pharmacists will enhance patient safety in the pursuit of self-care.For example, referral to an audiologist may uncover a potentially serious underlying medical issue, a medically treatable hearing issue, or a risk of hearing damage due to over-amplification.

OTC Hearing Aids will soon be available, but this access also comes with questions about counseling and ensuring safety.

Preparing to Counsel Patients on OTC Hearing Aids

Scope of practice for pharmacists in Michigan has expanded again. Governor Gretchen Whitmer announced recently that pharmacists can now prescribe birth control, in partnership with physicians, saying, “Access to birth control is critical to a woman’s ability to plan her family and chart her own destiny. We are taking action to guarantee that Michigan women have the right to easily make reproductive health care decisions that are best for them.”

The decision from the Michigan Department of Licensing and Regulatory Affairs is meant to help women have better and easier access to contraceptives. This move was part of Governor Whitmer’s executive directive in May 2022 to increase protections for reproductive health care in the event that Roe v. Wade was overturned—which came to pass in June 2022.

Under this order, physicians may delegate to pharmacists the ability to prescribe self-administered hormonal contraceptives, such as oral contraceptives, the ring, and the patch. This expansion is based on the education and training pharmacists have received, including knowledge of the contents, impacts, and adverse effects. Pharmacists can now opt into the program, but the news release did emphasize that pharmacists are not required to prescribe hormonal contraceptives if they choose not to. Prescription and dispensing practices will be reviewed during routine pharmacy inspections and any violations of the state’s Public Health Code will be investigated.

Natasha Bagdasarian, MD, MPH, chief medical executive of the State of Michigan highlighted why this expansion was so important.

“This expansion allows for broader access to certain forms of birth control. Nearly 30% of U.S. women of childbearing age have reported difficulty obtaining or refilling birth control prescriptions. Expanded access to hormonal contraceptives provides flexibility for women to manage their reproductive health outside their regularly scheduled health care appointments.”

This move is just 1 of many made by Governor Whitmer to ensure reproductive health care in Michigan. Other actions include education on the difference between emergency contraception and abortion, working through the court to reverse the 1931 state ban that remains on the books, and calling on tech firms to protect the privacy of users’ health information.

1. Whitmer announces expansion of access to birth control. News Release. State of Michigan. September 19, 2022. Accessed September 20, 2022. 

https://www.michigan.gov/whitmer/news/press-releases/2022/09/19/whitmer-announces-expansion-of-access-to-birth-control

The move is meant to expand access to reproductive health care for women in the state.

Pharmacists Can Prescribe Birth Control in Michigan, in Partnership with Physicians

Following the introduction of Overdose Prevention Framework, the FDA has issued final guidance

 geared toward making naloxone available to prevent overdose and death from opioids.

Harm reduction programs have been important to reducing overdoses in underserved communities, but many of these communities have faced difficulties in getting naloxone. This guidance is meant to support those programs by clarifying public health emergency exclusion and exemption from certain requirements under the Drug Supply Chain Security Act (DSCSA).

Enacted in 2013, the DSCSA is intended to secure the drug supply in the United States through a closed prescription drug distribution system. However, declared public health emergencies are exempt from requirements of this act. The opioid epidemic was declared a public health emergency on October 26, 2017—and has been renewed every 90 days since the initial declaration.

The new guidance indicates that the FDA will generally not take enforcement against trading partners during the public health emergency when engaging in either of these activities:

Distributing FDA-approved naloxone directly to harm reduction programs that are not authorized trading partners, which includes product donations

Distributing FDA-approved naloxone to harm reductions that would be considered to otherwise meet the DSCSA’s definition of a wholesale supplier, except they are not considered such because “They are currently engaged in distributing FDA-approved naloxone products for emergency medical reasons resulting from the opioid public health emergency.”

This guidance is in effect only for as long as the opioid public health emergency remains in effect.The emergency ends when either the Secretary of the Department of Health and Human Services declares it over or the 90-day period lapses without renewal, whichever comes first.

Exemption and exclusion from certain requirements of the drug supply chain security act for the distribution of FDA-approved naloxone products during the opioid public health emergency guidance for industry. FDA. Guidance. Published September 22, 2022. Accessed September 26, 2022. 

https://www.fda.gov/media/161750/download

Sokolowska M. FDA issues new guidance to help facilitate availability of naloxone to prevent opioid overdoses and reduce death. FDA. Published September 23, 2022. Accessed September 30, 2022. 

https://www.fda.gov/news-events/fda-voices/fda-issues-new-guidance-help-facilitate-availability-naloxone-prevent-opioid-overdoses-and-reduce

The new guidance aims to improve supply for harm reduction programs.

FDA Clarifies Naloxone Supply Chain Rules

Supporting the Next Era of Independent Pharmacies in the US & Abroad

The future of independent pharmacy requires the combination of what makes independent pharmacy special and the digital landscape found elsewhere in retail.

Update on Using Dextromethorphan-Bupropion in Depression

A new—cough, cough—combination treatment for depression. Researchers performed an RCT of dextromethorphan-bupropion in major depressive disorder.

Is There a Link Between COVID-19 and Increased Type 1 Diabetes Diagnoses?

A pair of studies released within days of one another have produced conflicting reports related to the apparent increase in type 1 diabetes diagnoses following a COVID-19 infection in younger patients.

Program for Safer Opioid Supply Shows Positive Results

Positive effects emerge when patients get medical care, avoid deadly fentanyl-laced street drugs.

Adjustments in Drug Coverage Criteria in Health Plans Based on New Evidence

However, researchers found that only a small percentage of plans use available real-world evidence studies and economic evaluations in their coverage policies.

Your weekly roundup of the latest news from Drug Topics®.

News Roundup: September 26 to September 30

Did you miss the top stories on Drug Topics® this month? Catch up on these noteworthy stories today.

Women and CBD: Increased Interest, but Caution Is Warranted

CBD can be used to treat a myriad of women’s health conditions, but research is still limited.

The Evolution of the CBD Regulatory Landscape

No federal agency has taken charge of regulating cannabidiol products, leaving decisions up to the individual states.

Considering comorbidities is just as important as lowering patient HbA1c.

How Pharmacists Can Address Vaccine Hesitancy for the Flu and Beyond

Address vaccine hesitancy at your pharmacy to encourage patients and their families to get vaccinated against COVID-19, flu, and more.

FDA Approves Voquezna for Helicobacter pylori Infection in Adults

This new treatment option copackages 3 drugs for optimal treatment.

Mitigating Costs of Cancer Treatment: The Role of Pharmacists

Cancer care is expensive, but pharmacists can help.

FDA, Medtronic Alert Users to Cybersecurity Risk with MiniMed 600 Systems

The risk could allow unauthorized users to change insulin levels.

Impact of Laws on Pediatric Opioid Prescriptions

Are prescription cap laws for opioids effective for children and teenagers?

Maternal Vaccination Cut the Risk of COVID-19 Hospitalization for Infants

Infants of fully vaccinated mothers had fewer cases of hospitalization from COVID-19 than those unvaccinated.

Waste Problem Shows COVID-19 Vaccines Aren’t Just a Dime a Dozen

When it comes to the COVID-19 vaccine, independent pharmacies are being set up to fail by federal health partners.

Take a look back at our most popular news from September 2022.