MPA News

Sign Up Now for MPA SIGs!

Earlier this year, MPA asked its members for input on forming special interest groups, or SIGs for short. You responded and we listened! Below are the 10 special interest groups that MPA will forming:

• Compounding
• Educators
• Health system/clinical care
• Independents
• Legal/regulatory
• Outpatient
• Preceptors
• Specialty
• Third-party payer
• 340B

SIGs will not be formal committees, work groups or task forces; rather, they will be more informal groups for networking and discussing topics unique to their practice settings. They are intended to engage members on a more personal level when they want and how they want. 

These new SIGs won’t be just another listserv or discussion forum. They’re intended to engage members on a more personal level when they want and how they want. SIGs have the power to transcend section boundaries and be transformational for MPA and you!

Each SIG will meet quarterly via a virtual meeting, with an option to have an in-person meeting at MPA's Annual Convention & Exhibition. The deadline to sign up is Nov. 30. You can select however many SIGs you wish to be a part of.

Regulatory News

Saying Goodbye to Oral Phenylephrine after 50 Years

Phenylephrine Efficacy and Role in Therapy

Hanadi Thomas-Salamey, BSPharm; Sarah Channey Pharm.D. candidate;

Taif Afat Pharm.D. candidate 

Recently the U.S. Food and Drug Administration (FDA) convened a meeting of the Non-Prescription Drug Advisory Committee to evaluate the efficacy of oral phenylephrine in over-the-counter (OTC) cough and cold products designed for temporary congestion relief.¹ They found that scientific evidence did not substantiate the suggested oral phenylephrine dosage as an effective treatment for nasal congestion.¹

Phenylephrine was approved by the FDA for OTC use in 1970 and is commonly used as a decongestant to relieve nasal congestion; it is found in over-the-counter cold and allergy medications in various forms, such as nasal sprays, nasal drops, and oral tablets or capsules.² When taken in oral form, phenylephrine is significantly absorbed through first pass metabolism resulting in a minimal amount reaching the bloodstream, which is essential for its effectiveness in reaching the nasal area.³

Furthermore, a randomized, open label, placebo control study found that oral phenylephrine at doses up to 40 milligrams is not significantly better than placebo at relieving nasal congestion.⁴ Additional research is being performed pertaining to the drug's efficacy when administered at doses higher than the typical 10 to 40 milligrams. Nevertheless, it appears from the FDA briefing documents that doses ranging from 80 to 90 milligrams may lead to an increase in blood pressure.¹

In 2020, oral phenylephrine accounted for an estimated 66,296 prescription orders spanning more than 15,000 patients.⁵ The call to question the efficacy of phenylephrine can significantly impact the basis of OTC cold and allergy medications; prompting the question of what alternative medications or nonpharmacologic therapies can be recommended to patients.

Recently, some of the big chain pharmacies like CVS have already removed oral decongestants that include phenylephrine due to it being ineffective and due to the availability of alternative options that are effective decongestants.⁶ Pharmacists can help in counseling their patients on why oral phenylephrine is not effective. They can also suggest some of the alternative options that are effective that do not contain oral phenylephrine; it should be noted that nasal phenylephrine can still be recommended. These products are listed below:

• Sudafed (pseudoephedrine - located behind the pharmacy counter)
• Afrin (oxymetazoline HCl nasal solution-nasal decongestant)
• Flonase (fluticasone propionate 50 mcg nasal spray)
• Simple Saline Spray (purified water, sodium chloride, sodium bicarbonate)
• Robitussin DM (dextromethorphan and guaifenesin oral solution)*
• Coricidin HBP (dextromethorphan and guaifenesin capsules)*
• Mucinex max strength (1,200-milligram guaifenesin extended-release bi-layer tablets)*

*Medications that help with chest congestion and cough.

References

1. United States Food & Drug Administration. FDA clarifies results of recent advisory committee meeting on oral phenylephrine. U.S. Food & Drug Administration. September 14, 2023. Accessed October 22, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine 
2. AHFS Patient Medication Information. Phenylephrine. American Society of Health-System Pharmacists. January 15, 2022. Accessed October 22, 2023. https://medlineplus.gov/druginfo/meds/a606008.html 
3. Gelotte CK, Zimmerman BA. Pharmacokinetics, safety, and cardiovascular tolerability of phenylephrine HCl 10, 20, and 30 mg after a single oral administration in healthy volunteers. Clin Drug Investig. 2015;35(9):547-558. doi:10.1007/s40261-015-0311-9
4. Meltzer EO, Ratner PH, McGraw T. Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):702-8. doi: 10.1016/j.jaip.2015.05.007. Epub 2015 Jul 2. PMID: 26143019.
5. Kane SP. Phenylephrine, ClinCalc DrugStats Database, Version 2022.08. ClinCalc. August 24, 2022. Accessed October 22, 2023. https://clincalc.com/DrugStats/Drugs/Phenylephrine
6. Murphy T. CVS health pulls some cough-and-cold treatments with ingredient deemed ineffective by doctors. AP News. October 20, 2023. Accessed October 26, 2023. https://apnews.com/article/cvs-health-cold-medications-phenylephrine-c8953a17b8e404cfe9e4a37d76993dc4.

New Drug Update

New Drug Update – Exxua

By Katie Wenstrom, PharmD, CSP

Major depressive disorder (MDD) is a serious mood disorder characterized by loss of interest in activities that previously provided enjoyment and persistently low or depressed mood.^1-3 Sleep, appetite and ability to think clearly may also be affected.³ It is one of the most common mental disorders in the United States, affecting about 21 million adults in the United States in 2021.⁴ The World Health Organization ranked MDD as the third highest cause of disease burden in 2008 and predicts a move to the first highest cause of disease burden by 2030.²  

Treatment of depression includes pharmacotherapy and psychotherapy, either alone or in combination.⁴ There is a large variety of medications, with many different mechanisms, approved for the treatment of depression.

On Sept. 22, 2023 gepirone (Exxua) was approved for the treatment of major depressive disorder in adults.⁶ It is the first selective serotonin 1A (5-HT1A) receptor agonist approved for this indication. Unlike other drugs that work on serotonin for the treatment of depression, it is not a reuptake inhibitor, but instead elicits its therapeutic effect by activating 5-HT1A receptors.⁴ Due to this difference in mechanism, it has less incidence of sexual dysfunction and weight gain compared to other antidepressant medications, especially SSRIs and SNRIs.

In clinical trials, patients treated with gepirone experienced significantly greater reductions in the 17-item Hamilton Rating Scale for Depression (HAMD-17) compared to placebo after eight weeks of treatment.

Gepirone is available in 18.2, 36.3, 54.5 and 72.6-milligram extended-release tablets. Due to the risk of QT interval prolongation, patients should have electrolyte abnormalities corrected and an ECG performed prior to treatment, and the dose should be titrated. Treatment should begin with the 18.2-milligram dose given orally once daily with food at approximately the same time each day.⁶ Depending on clinical response and tolerability, the dose may be increased to 36.3 milligrams on day 4, 54.5 milligrams after day 7 and 72.6 milligrams after an additional week. 

Gepirone carries a black box warning for the risk of suicidal thoughts and behaviors, especially in pediatric and young adult patients (though it should be noted that gepirone is not indicated for use in pediatric patients). Use of gepirone is contraindicated in patients with prolonged QTc intervals, congenital long QT syndrome, concomitant use of strong CYP3A4 inhibitors, severe hepatic impairment, or within 14 days of discontinuing an MAOI. The most common side effects were dizziness, nausea, insomnia, abdominal pain and dyspepsia.⁶

References

1. VandenBerg AM. Depressive Disorders. In: DiPiro JT, Yee GC, Haines ST, Nolin TD, Ellingrod VL, Posey L. eds. DiPiro’s Pharmacotherapy: A Pathophysiologic Approach, 12th Edition. McGraw Hill; 2023. Accessed October 31, 2023. https://accesspharmacy-mhmedical-com.ferris.idm.oclc.org/content.aspx?bookid=3097§ionid=268013768
2. Bains N, Abdijadid S. Major Depressive Disorder. StatPearls; 10 April 2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK559078/ 
3. Cleveland Clinic. Clinical Depression (Major Depressive Disorder). 30 Nov 2022. Available from: https://my.clevelandclinic.org/health/diseases/24481-clinical-depression-major-depressive-disorder 
4. IPD Analytics. New Drug Review: Exxua (gepirone). October 2023.
5. MDCalc. DSM-5 Criteria for Major Depressive Disorder. Available from: https://www.mdcalc.com/calc/10195/dsm-5-criteria-major-depressive-disorder 
6. Exxua [package insert]. Houston, TX: Fabre-Kramer Pharmaceuticals; 2023.

Events and Announcements

ACE 2024 Registration Is Open!

It's time to start planning for the Annual Convention & Exposition (ACE)! Registration opened Oct. 10, so reserve your spot now.

The signature event of Michigan Pharmacists Association (MPA), ACE will take place Feb. 23-25, 2024, at the Renaissance Center in downtown Detroit. This will be MPA's last ACE in the Motor City for a while as we hit the road for Traverse City in 2025 and Lansing in 2026, 2027 and 2028, so don't miss out!

ACE is the premier continuing education event for pharmacists, pharmacy students and pharmacy technicians in Michigan. There will be something for everyone at ACE.

Looking forward to seeing you all there!

Michigan Pharmacist Journal Published

The October/November/December edition of the Michigan Pharmacist Journal is now available online! Click the cover image to read about the following topics:

• MPA's 140th President: Get to know incoming MPA President Sarah Hill and her goals for the Association.
• Happy Birthday MPA: MPA turns 140 years old in November and plans to celebrate throughout the year.
• PDAC 2023: A recap of a successful day of advocacy at the Capitol.
• ACE 2024: A sneak peak at upcoming activities planned at the Annual Convention & Exposition.
• President-Elect Candidates: Ryan Greenley and Jamie Tharp outline their vision for MPA.
• MSPT Priorities: MSPT President Erith Welch shares what the practice section has in the works.

NOTE: The Michigan Pharmacist is available in digital format only. Printed copies may be requested, though MPA prints a limited number of these and will issue them on a first-come, first-serve basis. Contact MPA@MichiganPharmacists.org for more information.

Upcoming CE Programs

Pharmacy Technician Immunization Administration

Live Session and Self Study

(Next Live Webinar:

Dec. 2, 10-11:30 a.m.)

APhA Pharmacy-Based

Immunization Training

Dec. 6, 9-11 a.m.

Michigan Pharmacy Law and Ethics Update, Quarter 4

Dec. 4, Noon-1 p.m.

Implicit Bias 2.0:

Education, Practice and Teams

Dec. 11, 4-6 p.m.