New Drug Update

New Drug Update – Tryvio

By Stefan Tolea, 2025 Pharm.D. candidate, Ferris State University

Hypertension is a common disease that is defined as having persistently elevated arterial blood pressure (BP). It is commonly referred to as the silent killer because most patients are asymptomatic, with the only clinical finding being increased BP.¹ Almost half of American adults 20 years and older have hypertension based on the 2017 updated definition from the American College of Cardiology (ACC) and American Heart Association (AHA) treatment guidelines.^1,2 Progression of uncontrolled hypertension leads to several complications, including cerebrovascular accidents, retinopathy, chronic kidney disease (CKD) and peripheral artery disease (PAD). The primary causes of cardiovascular morbidity and mortality in patients with hypertension are myocardial infarction (MI), stroke and kidney failure.¹

The ACC/AHA guidelines categorize hypertension in two stages. Stage 1 hypertension is defined as an average blood pressure of either 130-139 millimeters of mercury (mmHg) SBP or 80-89 mmHg DBP, while stage 2 hypertension is defined as a SBP of at least 140 mmHg or a DBP of 90 mmHg or higher. There are several treatment for stage 1 hypertension in patients with a history of cardiovascular disease (CVD) events and in patients with an atherosclerotic cardiovascular disease (ASCVD) score of more than 10%. These include lifestyle modifications – such as a Dietary Approaches to Stop Hypertension (DASH) diet, weight loss and exercise – along with one BP-lowering medication if they have a previous CVD event or if their ASCVD score is greater than 10%. For stage 2 hypertension, two BP-lowering medications from different classes are recommended to achieve a BP of less than 130/80 mmHg.²

Endothelin-1 (ET-1) is a peptide mainly produced by endothelial cells which acts on receptors ETA and ETB. ET-1 is a potent vasoconstrictor. Arterial vasoconstriction is mediated by ETA and venous vasoconstriction is mediated by ETB.³ Antagonism of this receptor provides a novel pathway to use in treatment-resistant hypertension, which occurs in roughly 15% of patients with hypertension.⁴

In March 2024, the U.S. Food and Drug Administration approved Idorsia’s Tryvio (aprocitentan) for treatment of hypertension in combination with other antihypertensive drugs in adult patients who are not adequately controlled on other drugs. Aprocitentan is a dual endothelin receptor antagonist, working on both ETA and ETB, to reduce vasoconstriction and thus lowering blood pressure. It is the first antihypertensive agent approved in the last 30 years which uses a new therapeutic pathway. In clinical trials, aprocitentan demonstrated a statistically significant reduction in BP at week 4 compared to placebo. Most commonly reported side effects were edema and anemia.⁵ Hepatotoxicity was a rare side effect noted during the clinical trials.^5,6

Aprocitentan is a once-daily oral medication that delivers 12.5mg of the active ingredient. The prescribing information contains a boxed warning for embryo-fetal toxicity. Due to this, aprocitentan can only be prescribed if the pharmacy is participating in its Risk Evaluation and Mitigation Strategy (REMS) program. A monthly negative pregnancy test is required for dispensing, and contraception methods must be used for the duration of treatment.^5,6

References

1. MacLaughlin EJ, Saseen JJ. Hypertension. DiPiro JT, Yee GC, Haines ST, Nolin TD, Ellingrod VL, Posey L. eds. DiPiro’s Pharmacotherapy: A Pathophysiologic Approach, 12th Edition. McGraw Hill; 2023. https://accesspharmacy-mhmedical-com.ferris.idm.oclc.org/content.aspx?bookid=3097&sectionid=267225439
2. Whelton, Paul K., et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension, 2018;71(6). doi:10.1161/HYP.0000000000000065.
3. Titus A, Marappa-Ganeshan R. Physiology, Endothelin. In: StatPearls. StatPearls Publishing; 2024. http://www.ncbi.nlm.nih.gov/books/NBK551627/
4. Carey RM, Calhoun DA, Bakris GL, et al. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From The American Heart Association. Hypertension. 2018;72(5). doi:10.1161/HYP.0000000000000084
5. IPD Analytics. New Drug Review: Aprocitentan.
6. Tryvio™ [package insert]. Idorsia Pharmaceuticals Ltd. https://www.idorsia.com/dam/jcr:d834ee09-2e6c-443d-b3ac-c111e38f0990/tryvio_pi.pdf

Legislative and Regulatory

DSCSA Compliance: Are you ready?

By Arthur Dakessian, Pharm.D.,

director of specialty pharmacy integration, Shields Health Solutions; MSCP director

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to enhance the integrity of the pharmaceutical supply chain by creating a framework for a standardized electronic tracking and tracing system for prescription drugs in the United States. The goal of the DSCSA is to protect consumers from counterfeit, contaminated and stolen medications.

The DSCSA set out a 10-year implementation timeline to build an interoperable, electronic system for exchanging transaction documentation to facilitate tracing of prescription drugs at the package level.^1,2 These requirements apply to prescription drugs in finished dosage forms intended for human consumption. Over-the-counter drugs, drugs solely intended for veterinary use and radioactive drugs are notable exemptions from the requirement (a comprehensive list of exempted products is available on fda.gov).¹ The final implementation phase, which includes additional dispenser requirements, went into effect Nov. 27, 2023. However, the FDA delayed the enforcement of these requirements to Nov. 27, 2024, to provide a one-year stabilization period and allow supply chain partners additional time to comply with the requirements.^1,2

In June 2024, the FDA issued exemptions from certain requirements of section 582 of the Food Drug and Cosmetic Act to small dispensers (pharmacies) and their trading partners where applicable, until Nov. 27, 2026.³ This provides small dispensers additional time to bring their operations to full compliance with the DSCSA. An entity is considered a small dispenser if “the company that owns the dispenser has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians” as of Nov. 27, 2024.³

In addition to transaction data exchange requirements, the DSCSA seeks to establish uniform national licensure standards for wholesale drug distributors and third-party logistics providers (TPL) to replace the current patchwork of varying state-specific standards.⁴ The proposed rule, announced in February 2022, holds all U.S. wholesalers and TPLs to the same standards and allows only entities licensed according to these standards to perform transactions with other members of the pharmaceutical supply chain.

Requirements for Pharmacies and Pharmacists

There are many DSCSA requirements which impact all participants in the pharmaceutical supply chain. However, there are three main requirements that pharmacies and pharmacists are expected to comply with:

• Conduct business with authorized trading partners only
• Confirm licenses of your wholesale distributors, repackagers and TPLs.⁵ Your state’s license verification tools and fda.gov are good resources. Wholesalers and TPLs are now required to report their state licensure information to the FDA on an annual basis.¹
• Receive, store, and provide product tracing documentation⁵
• Only accept prescription drugs that are accompanied by product tracing documentation (transaction information, transaction history, and transaction statement). 
• Store the tracing documentation for six years.
• Provide all product tracing documentation with the transaction if you sell a prescription drug to a trading partner. There is no need to provide this information when you dispense a prescription drug to a patient or if you sell to a pharmacy for dispensing to a specific patient.
• Investigate and properly handle suspect and illegitimate drugs⁵
• Quarantine and investigate suspect prescription drugs to determine if they are illegitimate.
• When illegitimate drugs are identified, pharmacies should work with the manufacturer to ensure patients do not receive these drugs. In addition, pharmacies must notify the FDA and impacted trading partners within 24 hours using the 3911 form. This can be done either online on FDA’s CDER NextGen platform or by emailing the completed form to drugnotifications@fda.hhs.gov.⁶

Preparing for November 2024

Below are a few recommendations to help prepare your team for full compliance with DSCSA requirements in November:

• Educate yourself and your team. Document staff training and maintain records. The following websites are excellent educational resources on the topic and are updated regularly. Sign up for email updates to stay up to date on the latest and greatest.
• FDA.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
• DSCSA.pharmacy
• NABP.pharmacy/pulse
• Establish policies and procedures to comply with DSCSA requirements including handling of suspect products. 
• Reach out to your wholesaler(s) to understand how product tracing documents are provided and stored. 
• Reach out to your dispensing software vendor to understand if any system enhancements are available or pending to promote compliance with DSCSA requirements.
• Evaluate the need for third party DSCSA compliance solutions/ software. These solutions can consolidate storage and sharing of tracing documents from multiple sources and may be especially valuable for pharmacies using multiple wholesalers. 

References

1. FDA. “Drug Supply Chain Security Act Law and Policies.” U.S. Food And Drug Administration, www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies. Accessed 18 June 2024
2. DispenserEDU. “Drug Supply Chain Security Act (DSCSA) Resources for Dispensers.” https://Dscsa.Pharmacy/, 2024, dscsa.pharmacy.
3. FDA. “Waivers and Exemptions Beyond the Stabilization Period.” U.S. Food And Drug Administration, https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period?utm_medium=email&utm_source=govdelivery. Accessed 12 June 2024.
4. FDA. “FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers.” U.S. Food And Drug Administration, www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period?utm_medium=email&utm_source=govdelivery. Accessed 18 June 2024.
5. FDA. “Pharmacists: Utilize DSCSA Requirements to Protect Your Patients.” U.S. Food And Drug Administration, www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/pharmacists-utilize-dscsa-requirements-protect-your-patients. Accessed 12 June 2024.
6. FDA. “Notify FDA of Illegitimate Products.” U.S. Food And Drug Administration, www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products. Accessed 12 June 2024.

Legislative Update: Quarter 2, 2024

By Eric Roath, Pharm.D., MPA director of government affairs

Department of Justice Proposes Rule to Move Marijuana to Schedule III

On May 21, the Department of Justice (DOJ) published a notice of proposed rulemaking in the Federal Register to reclassify marijuana as a Schedule III controlled substance. According to the posting’s summary:

(“DOJ”) proposes to transfer marijuana from Schedule I of the Controlled Substances Act (“CSA”) to schedule III of the CSA, consistent with the view of the Department of Health and Human Services (“HHS”) that marijuana has a currently accepted medical use as well as HHS's views about marijuana's abuse potential and level of physical or psychological dependence. The CSA requires that such actions be made through formal rulemaking on the record after opportunity for a hearing. If the transfer to Schedule III is finalized, the regulatory controls applicable to Schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations. If marijuana is transferred into Schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA's definition of “marijuana” would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act (“FDCA”). DOJ is soliciting comments on this proposal.

Comments will be taken on the proposed rule until July 22, 2024.

Hormonal Contraception Bill Package Voted Out of Committee

On April 18, House Bills 5013, 5435 and 5436 were voted out of the House Health Policy Committee. The votes in the committee were as follows:

Yeas:

• Rep. Julie Rogers, D-District 41
• Rep. Karen Whitsett, D-District 4
• Rep. Brenda Carter, D-District 53
• Rep. Jim Haadsma, D-District 44
• Rep. Cynthia Neeley, D-District 70
• Rep. Carol Glanville, D-District 84
• Rep. Betsy Coffia, D-District 103
• Rep. Jennifer Conlin, D-District 48
• Rep. Alabas Farhat, D-District 3
• Rep. John Fitzgerald, D-District 83
• Rep. Reggie Miller, D-District 31
• Rep. Carrie Rheingans, D-District 47

Nays:

• Rep. Curtis VanderWall, R-District 102
• Rep. Jamie Thompson, R-District 28

Abstaining:

• Rep. Graham Filler, R-District 93
• Rep. Mike Mueller R-District 72
• Rep. Greg VanWoerkom, R-District 88
• Rep. John R. Roth, R-District 104
• Rep. Kathy Schmaltz, R-District 46

HB 5013 requires insurance coverage of a 12-month supply of hormonal contraception furnished in a single dispensing. HBs 5435 and 5436 allow pharmacists to prescribe hormonal contraception and requires reimbursement for the prescription and associated screening services rendered under a pharmacist NPI.

The bills now move on for a vote in the full House of Representatives. It’s vitally important that pharmacy professionals take the time to reach out to their representatives and encourage them to support this bill package. Click here to go to the MPA Advocacy Action Center and send an email to your state representative telling them to support this initiative.

Naloxone Bill Package Clears House, Referred to the Senate

House Bills 5077 (Rep. Curtis VanderWall) and 5078 (Rep. Carrie Rheingans) passed out of the House of Representatives April 24 by a vote of 96-11. The bill package amends the Administration of Opioid Antagonists Act and the Public Health Code to allow an agency (or a trained employee of that agency) that purchases an opioid antagonist to directly or indirectly distribute that opioid antagonist to any individual. A distribution described in the bills would be added to provisions that now provide immunity from civil liability for injury, death, or damages arising from the administration or failure to administer an opioid antagonist, as long as the person’s conduct does not amount to willful or wanton misconduct. Similarly, the agency, employee, or agent would be exempt from criminal prosecution for the distribution. The bills would also allow an agency to obtain an opioid antagonist by means other than purchasing it.

Pharmacy General Rule Revisions Now in Effect

The revised Pharmacy – General Ruleset was filed with the Secretary of State and became effective Feb. 29, 2024. As previously reported by MPA and the Bureau of Licensing and Regulatory Affairs (LARA), the revised rules contained several notable changes, including:

• MPJE requirement eliminated
• New USP 795 and 797 chapters adopted (2023 revisions)
• PIC must be changed if unable to fulfill duties for 120 consecutive days
• Implementation of the emergency supply of insulin provision:
• Only one emergency dispensing per qualified prescription
• Limit of three emergency dispensings per year
• Smallest package size available to provide up to a 30-day supply

Within the ruleset now being official, the path for the Board of Pharmacy to reopen the rules to incorporate legislative changes required by Senate Bill 219 is now open. This would include, at a minimum, the establishment of approved training programs for immunization and point-of-care testing services.

Make Your Voices Heard: Call Out PBM Abuses

The rollout of enforcement for the PBM Licensure and Regulation Act has been slow. This means that it is more important than ever to make your concerns to the Department of Insurance and Financial Services (DIFS).

DIFS has updated their website to include the mechanism for filing a report against pharmacy benefit managers (PBMs) who are suspected of having violated the PBM Licensure and Regulation Act. Complaints can be submitted:

• Online: https://www.michigan.gov/DIFSComplaints
• Email: DIFS-PBMComplaints@michigan.gov
• Fax: 517-284-8837
• Mailed to: Department of Insurance and Financial Services, Office of Consumer Services, PO Box 30220, Lansing, MI 48909

If you are unable to file a complaint online, you may obtain a copy of the complaint form and mail, email, or fax it to DIFS. MPA encourages you to retain a copy of any complaint you submit and share the outcome with Eric Roath at eroath@michiganpharmacists.org.

Event Recaps

2024 MSCP Annual Meeting & Luncheon Recap

By Brooke Roe, Pharm.D., BCPS; MSCP board chair

Michigan Society of Community Pharmacists (MSCP) members were invited back together at the MSCP Annual Meeting during MPA’s Annual Conference & Exposition in February. Our Annual Meeting is a time many members look forward to as we get to reconnect with pharmacists and technicians throughout the state over a delicious meal. The MSCP Board of Directors also provides an update to membership on the past year, which includes introduction of board members, recognition of outgoing board members and the presentation of our Pharmacist of the Year award.

At the end of 2023, Rony Foumia completed his term with the MSCP Board of Directors. He was thanked for his service and we wished him well on his future endeavors! Additionally, we celebrated and thanked our outgoing chair, Lisa Bade, for her leadership and dedication to the organization.

2024 Pharmacist of the Year

Amy Ellis was recognized as the 2024 MSCP Pharmacist of the Year. Ellis is currently the director of pharmacy at SpartanNash. Her responsibilities include oversight of all retail pharmacy operations, any patient care services offered by the SpartanNash clinical pharmacists, the pharmacy warehouse, central fill and the SpartanNash Affiliate Buying Group. She also serves as the site coordinator for the Ferris State University-SpartanNash PGY-1 Community Pharmacy Residency program. She graduated from Ferris State University in 1999.

She has worked in various roles within community pharmacy including Director of Pharmacy Operations and Clinical Care, Manager of Pharmacy Services, Clinical Care Coordinator and Pharmacy Manager. Ellis has been actively involved with the Michigan Pharmacists Association, the OutcomesMTM National Advisory Board along with membership of American Pharmacist Association and National Council of Prescription Drug Programs. Her work has been recognized by Progressive Grocer’s Top Women in Grocery, Drug Store News’ Top Women in Health, Wellness and Beauty, SpartanNash University and as a fellow with the Michigan Pharmacists Association. Congratulations, Amy, on the recognition of the important contributions you have made and continue to make to the pharmacy profession!

The 2024 Annual Meeting and Luncheon was wonderful! We’re already preparing for next year’s MSCP luncheon and looking for ways to get even more of the membership involved!

Upcoming CE Programs

Point of Care Test and Treat, Q3

Live Webinar: Aug. 14, 9 a.m.-1 p.m.

Mixed Format – Self Study Must Be Completed Before Live Date

4th Annual Outpatient Antimicrobial Stewardship Innovations

Symposium (OASIS)

Aug. 15, 11 a.m.-4 p.m.

Pharmacy-based Immunization Training

Live Webinar: Sept. 11, 9 a.m.-noon

Mixed Format – Self Study Must Be Completed Before Live Date

MPA 2024 Law and Policy Symposium

Sept. 25, 9 a.m.-4 p.m.

In-Person and Virtual Options Available



Events and Announcements

Penicillin Allergy De-Labeling Survey

The Penicillin Allergy De-Labeling Survey aims to explore the practices and knowledge of Michigan outpatient pharmacists regarding the de-labeling of penicillin allergies. The information being sought includes area of practice; year of graduation; zip code of practice site; familiarity with relevant terms/tools; procedures at participant's current practice sites; barriers to current practice; social determinants of health of patients that may act as determinants of pharmacist intervention; a short case study; and continuing education preferences of participants.

Register for the UP Fall Conference

MPA and its Upper Peninsula Division return to beautiful Marquette Oct. 5-6 for the UP Division Fall Conference. Registration is open now and available by clicking the button below. A detailed agenda will be coming, but topics will include ethics and jurisprudence, cardiovascular health, addiction and the brain, and natural approaches to inflammation.

Room booking is available now! The Staybridge Suites has reserved at block of 10 king suite rooms for the Fall Conference. The Superior Stay is not blocking off rooms, but is offering the discount code CNMU for patrons to submit on a first-come, first-served basis. Click the buttons below to start reserving your room.