Table of Contents

• DSCSA Implementation Delayed
• U.S. Could See Early Flu Season
• Part D Open Enrollment Begins Oct. 15
• October is American Pharmacists Month
• On The Shelf: Calmposure

DSCSA Implementation Delayed

Pharmacies and other entities in the pharmaceutical distribution chain will have another year to prepare for upcoming federal regulations on drug supply chain security.

The Food and Drug Administration announced a one-year delay in enforcement of interoperability provisions of the Drug Supply Chain Security Act, also known as DASCA. Enforcement is now scheduled to begin on November 27, 2024.

Originally passed in 2013, DSCSA is intended to create a tighter, closed prescription drug distribution system to curb harmful drugs from entering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found.

Enforcement was originally scheduled to go into effect in November 2023, with the entirety of the drug supply chain expected to be interoperable using secure electronic systems to manage product tracing at the package level. However, several questions remained about the readiness of all links of the supply chain, as evidenced in a letter this summer to the FDA from the American Pharmacists Association, National Community Pharmacists Association, and the National Association of Chain Drug Stores.

“There was a lot of advocacy by national pharmacy groups to give pharmacies another year to figure out how to comply with the law,” said Greg Reybold, APCI General Counsel and Director of Healthcare Policy. “Pharmacies had a lot of concerns about the package-level interoperability, and it’s a good thing that we’ll have more time to get everything figured out.”

APCI has worked with PRS on two webinars regarding DSCSA. Recordings of the webinars are available on the APCI website here and here (site login required).

U.S. Could See Early Flu Season

Experts expect the 2023-2024 flu season to start early in the United States, much as it did last year, as the country continues to experience changes in seasonal illness resulting from the COVID-19 pandemic.

“We probably are a bit more likely to have an early flu season this year—again, just because the last flu season was pushed early, too,” said infectious disease epidemiologist David Dowdy in an interview with the Johns Hopkins Bloomberg School of Public Health. “And it might take another year or two for us to get back to the usual way of things.”

“We don’t know for sure what’s going to happen,” he continued. “But we don’t have any evidence to strongly suggest that things are going to be much, much worse this coming year than they were pre-pandemic.”

The CDC estimates that there were approximately 290,000 hospitalizations, and 19,000 deaths due to flu during the 2022-2023 season, including 154 pediatric deaths attributed to flu.

The U.S. is also likely to experience another “tripledemic” this year, with flu, COVID, and RSV viruses circulating.

“Just because we’re coming out of the pandemic doesn’t mean that we’re suddenly immune to these other viruses, and we need to continue to do what we can to prevent those viruses from taking hold,” Dowdy said. “That means getting your flu shot when it’s available, getting your monovalent COVID vaccine when it becomes available, getting your infant children these new antibodies for RSV, and if you’re indicated to, getting an RSV vaccine yourself. The way that we prevent the brunt of deaths from all of these viruses is to take each of these different steps in tandem.”

Although this year’s flu season may peak in November as opposed to January or February as it usually does, recommendations call for patients to get their flu vaccines in September or October.

APCI member pharmacies who want to promote their immunization services can order flu-related marketing materials from the APCI Marketing Department. Available items include a full “flu kit” that includes a 3-foot by 8-foot banner, four yard signs with stakes, and 1,000 bag attachers/stuffers. Other items available include feather flags, stickers, and A-frame signs. Items feature either flu-shot-only messaging or a combination of a flu-and-COVID message.

For information on flu and other immunization programs, contact the APCI Clinical Affairs Department.

Part D Open Enrollment Begins Oct. 15

Millions of Medicare enrollees will have an opportunity to change their prescription drug plans during Medicare’s Open Enrollment period from October 15 through December 7. Open Enrollment is an excellent opportunity for APCI member pharmacies to offer their Medicare-eligible patients a vital service in helping to choose the most appropriate plan for their needs.

Most Medicare Part D enrollees are not in the lowest-cost plan available to them and comparing the options can be overwhelming. By setting up a system to offer Medicare plan reviews during Open Enrollment and promoting the services provided, APCI members can demonstrate the value and service they provide patients all year long.

Once again this year, many APCI Choice members are utilizing the Your Medicare Assistant program to identify, contact, and assist patients in finding appropriate plans both during Open Enrollment and throughout the year when patients become Medicare eligible. Your Medicare Assistant directs patients to an advocate to discuss plan options under the participating pharmacy brand. These YMA advocates represent all products and plans available and are not limited by a specific plan or license. Additionally, advocates are local to the community and are already often known to the patient.

For those members working with patients directly on the Part D benefit, here are some helpful tips to make Open Enrollment flow more smoothly.

Find your expert

Designate someone within your pharmacy to be your Medicare expert, or consider hiring someone part-time during Open Enrollment. Whomever you choose, make sure that person has plenty of time for training about Medicare, along with how to use your systems and how to talk with customers about their options. While they can provide information, legally they are not allowed to steer a person to a plan.

Choose your tools 

Although CMS has redesigned its free plan finder tool on the Medicare website, other tools such as PrescribeMedicare and Amplicare Match will estimate a patient’s drug costs based on his or her medications, and are likely to be much easier to use than the Medicare finder. You will want a system that will integrate easily with your pharmacy software, to save time entering information about a patient’s medications.

Establish a workflow

Each appointment with a Medicare beneficiary can take as little as 15 minutes if your staff has prepared for the review in advance. Developing a workflow allows you to use time and staff efficiently. For example, a technician may be able to prepare information for a pharmacist to review.

Plan your marketing and outreach

Order marketing fliers, signs and other advertising to promote the plan review service you will offer during Medicare Open Enrollment (see the Marketing Materials and Resources section on the APCI website for materials and ideas). Also determine how to let customers know in which plans your pharmacy participates, following any restrictions on advertising. Develop a schedule for personal outreach to customers, too, such as asking them when they pick up medications whether they would like to schedule an appointment during Open Enrollment. Another option is to target groups of patients over a period of weeks to ensure their medication information is up to date in your pharmacy system and invite them to schedule a plan review in early October. Early scheduling will ease any last-minute rush from seniors who haven’t made a choice before Thanksgiving.

Promote the savings

While pharmacies can’t legally steer a Medicare beneficiary to one plan or another, you can tout the value of the education you provide during Open Enrollment. Plan how you will record and promote that value. For example, you might post a note on social media immediately after an appointment saying, “XYZ Pharmacy just showed a Medicare customer which plan will save him $642 next year. Call now to schedule an appointment for your review.” Keep a running tally, too. “So far, XYZ Pharmacy’s Medicare reviews have helped 27 customers identify ways to save $18,559 on their medications next year. Let us help you, too. Call now for your appointment.”

Make Medicare appointments flow

With a well-planned system, a pharmacy can save time and use its staff efficiently in conducting Medicare plan reviews with patients. Follow these steps:

Before the appointment

• Schedule appointments. Set times for talking with patients about their options, so the pharmacy can be prepared and patients won’t have to wait. Designate days and times when you will have staff available, and then ask customers to schedule their time. While most reviews may take only 15 minutes, you may want to allot longer time slots, particularly for the first few while you fine-tune your system.
• Check medication data. Have a staff member verify the customer’s current medications with that person. Customers may be taking medications that they don’t buy from your pharmacy, so don’t rely only on the data already in your pharmacy software (having patients on a med sync program will speed up this part of the process).
• Ask about preferences. When scheduling the appointment and checking that the medication list is up to date, ask about the customer’s priorities in choosing a plan. For example, a couple may want to be on the same plan, even if they would save some money by each being under a different plan. They also may want to know about which plans require prior authorization or step-up therapy for certain drugs. Many beneficiaries say access to their preferred pharmacist is important to them.
• Process the information. Researching the options and comparing plans can take as little as 10 minutes per patient. With that done, your staff can focus on talking with patients when they come in.

During the appointment

Ensure you provide all the information that may influence a plan choice. Your Medicare expert should be able to discuss:

• The cost of staying with their current plan, based on the changes made to it for the coming year. Customers may be unaware, for example, about how a plan’s formulary changes will affect their costs.
• The estimated annual cost of various plan options, including the separate costs for premiums, deductibles, co-pays, and costs during the coverage gap known as the “donut hole.”

Be ready to show patients which pharmacies are available and which cost more under each plan, too. Even if they make a decision and choose to enroll in a plan right then, the entire appointment can take less than half an hour.

October is American Pharmacists Month

It’s time to celebrate the profession! American Pharmacists Month begins Oct. 1 to recognize the many ways pharmacists contribute to their communities and health care overall.

National pharmacist recognition began in 1925, when radio stations across the U.S. took a week to broadcast programming highlighting pharmacists. In 2004, the American Pharmacists Association (APhA) recognized the month of October as American Pharmacists Month and has promoted the time of recognition ever since.

Much of American Pharmacists Month is devoted to promoting how pharmacies positively affect health care in communities across the country. APhA highlights many of the services pharmacists provide beyond dispensing prescriptions, including how pharmacy is a crucial aspect of overall patient care.

In addition to pharmacist recognition in October, the month is also highlighted by:

• National Pharmacy Student Day (Oct. 5)
• Women Pharmacist Day (Oct. 12)
• National Pharmacy Technician Day (Oct. 18)

For more information on American Pharmacists Month as well as social media downloads, visit pharmacistsmonth.com.

Calmposure

Medella Springs Healthcare announces Calmposure, a naturally derived supplement formulated to restore a sense of calm or control for individuals that experience situational stress or temporary anxious feelings.

Calmposure is specially formulated with the highest quality blend of vitamins, minerals, amino acids, and naturally derived ingredients to balance stress hormones and support a healthy nervous system. Calmposure works fast to reduce symptoms of stress, promote calmness, and relieve anxious feelings that arise daily or occasionally. The amino acids in Calmposure work to balance the stress hormones in your body to help keep you calmer and in control of the situation. Calmposure includes vitamins and minerals that help maintain a healthy nervous system to effectively counter the symptoms of stress, provide energy, and support your natural bodily systems that respond to stress.

Calmposure is specially formulated to reduce stress without delivering any undesirable side effects such as sluggishness, fogginess, fatigue, or euphoria. Simply said, Calmposure is formulated to keep you on your game.

Active ingredients in Calmposure include:

• Magnesium, which has been shown to boost mood and reduce muscle cramps and spasms.
• Bromelain (from pineapple stem) that exhibits anti-inflammatory effects helping to relieve minor aches and pain.
• Suntheanine® (L-Theanine), a patented form of an amino acid that helps regulate serotonin levels and produces a calming effect. L-Theanine reduces stress with a relaxing and calming mode of action (GABA, serotonin), inhibition of cortical neuron excitation, mild anxiolytic.
• L-Glycine, an inhibitory neurotransmitter shown to produce a generalized calming effect.
• Cyracos® Lemon Balm Extract (leaf and stem), an anxiety-modulating botanical, in vitro inhibitor, and neuroendocrine transducer. Cyracos® offers mild GI benefits, and data suggests worry/stress reduction.
• Valerian root powder (Valeriana officinalis) that encourages relaxation and has a calming effect.

Other ingredients include Vitamin C, Vitamin B1, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, L-Lysine (as Lysine Hydrochloride), BCM-95® (Curcugreens), Curcuma longa (rhizome), Stearic Acid, Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Magnesium Stearate, Pharmaceutical Glaze, Povidone, and Silicon Dioxide.

Calmposure should be taken by people seeking to reduce stress arising from situations or life events. Individuals that are experiencing chronic or severe anxious feelings should consult their physician. Calmposure is formulated to be taken up to 30 minutes prior to an event that’s likely to cause acute stress or anxious feelings, however, Calmposure can also be taken during or after an event to alleviate stress.

Patients can take up to six tablets of Calmposure per day. If the desired effect is not fully achieved after the initial dose of two tablets, it is safe to take up to two additional tablets 30 minutes later but not to exceed six tablets per day. In clinical trials, Calmposure was studied up to six tablets per day with participants reporting no side effects across dosing ranges.

Calmposure is designed to deliver stress relief for up to four hours after the initial dose to help you manage the stressful situation. You have the flexibility to take up to six tablets a day for longer occurring events or if additional stress relief is needed.

Calmposure is featured in the November sales circular. Calmposure can be ordered directly from Medella Springs Healthcare at (513) 204-3648 with exclusive offers for APCI members. Calmposure is also available through McKesson.