IN THIS ISSUE
AUGUST 12, 2022
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- COVID-19 Updates
- Upcoming Events
- Indiana General Assembly Special Session Wrap-Up
- APhA Delegate Selection
- IPA Federal Advocacy
- New Drug Approvals
- Federal Regulatory Update
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CDC Recommends Novavax's COVID-19 Vaccine for Adults
Novavax's COVID-19 vaccine is the first so-called protein vaccine for COVID-19 and was already in wide use in Europe. This vaccine is made of copies of the spike protein that coats the COVID-19 virus.
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Gilead Completes Remdesivir Recall
In December 2021, Gilead recalled two lots of remdesivir after an investigation compared the presence of glass particulates. The FDA has reported that the recall is now complete and has been terminated by the FDA.
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Paxlovid Drug Interactions More Likely with Older Patients
A study published in the International Journal of Infectious Diseases posited that older adults were more likely to be taking drugs that have drug interactions with Paxlovid, such as anticoagulants, statins, analgesics, calcium channel blockers, or digoxin. The authors urge clear guidance for prescribers to ensure patient safety and treatment success.
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Upcoming Events
All times ET
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Are you an independent pharmacist interested in learning about collaborative practice agreements?
Join IAIP for their Town Hall on August 28 at 6:30 p.m. where they will have a presentation and discussion on this topic.
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IPA Fall Meeting
Focus on Workforce & Workplace Issues
CPE awarded
Less than 100 spots remain!
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September 23, 2022
Embassy Theatre
Ft. Wayne, IN
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IPA Residency Showcase
Programs & Students
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October 21, 2022
Ritz Charles, Carmel, IN
1-4 p.m.
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Indiana General Assembly Special Session Wrap-Up |
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On Friday, August 5, the Indiana General Assembly's Special Session came to an end after 11 working days. Two key bills were passed - Senate Bill 1, the "abortion ban bill" and Senate Bill 2, the "tax refund bill."
An amendment was offered on the House floor to Senate Bill 1 that would have permitted pharmacists to prescribe self-administered hormonal contraceptives. This amendment failed though by one vote, 48-49. We want to thank all of our IPA members who wrote their legislators. The impact was felt in discussions with legislators. We remain optimistic that this will be introduced again in the 2023 session as this has garnered a lot of publicity in the press and has been made a priority by the House Democrats.
Here is a summary of Senate Bill 1 as it passed:
- Terminates the licensure of abortion clinics. Abortions may only be provided in hospitals or hospital-owned clinics.
- Specifies that the abortion statutes do not apply to in vitro fertilization.
- Makes changes to when an abortion may be performed, including when:
- (1) the abortion is necessary to prevent any serious health risk of the pregnant woman or to save the pregnant woman's life (22 weeks gestational age);
- (2) the fetus is diagnosed with a lethal fetal anomaly (22 weeks gestational age); or
- (3) the pregnancy is a result of rape or incest (12 weeks gestational age).
- Provides that the statute requiring consent of a parent or legal guardian for a minor's abortion does not apply to a minor who is pregnant as a result of rape or incest by a parent, legal guardian, or custodian of the unemancipated minor.
- Requires the revocation of a physician's license for specified violations. Provides a defense for a pregnant mother charged with a criminal offense for terminating or seeking the termination of her pregnancy.
- Specifies that a person who terminates the pregnancy of a pregnant woman upon her request may only be charged with certain crimes.
- Exempts from the crime of feticide:
- (1) the pregnant mother;
- (2) a person who provides medical treatment in good faith to a pregnant woman that results in the accidental or unintentional termination of the pregnancy; and
- (3) a physician who performs a medical procedure to terminate the pregnancy upon request of the pregnant woman.
- Requires the maternal mortality review committee to study how changes in the state's abortion laws affect maternal mortality in Indiana and extends the committee until June 30, 2027.
- Voids certain administrative rules concerning abortion clinics.
- Establishes the prosecutorial oversight taskforce and specifies duties of the task force.
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Congratulations to Veronica Vernon, IPA President; Stephanie Arnett, IPA President-Elect; Cory Holland; and, Laura Sosinski for their election as IPA's delegates to the APhA House of Delegates and to Jordan Smith on her election as an alternate delegate! |
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IPA joined APhA, NASPA, and state pharmacy associations across the U.S. in urging the National Governor's Association and National Association of Medicaid Directors to provide direct reimbursement for pharmacists prescribing Paxlovid. We are asking states and Medicaid programs to submit emergency plan amendments and implement payment pathways for direct reimbursement. This is absolutely critical if access to Paxlovid treatment is going to be expanded. Read full letter here.
IPA also joined over 200 organizations in urging the Senate Committee on Commerce, Science & Transportation to support S. 4293, Pharmacy Benefit Manager Transparency Act of 2022. This would provide greater transparency and grant the Federal Trade Commission greater enforcement powers. Read full letter here.
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New Drug Approvals - July 2022 |
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Bludigo (indigotindisulfonate sodium) - manufactured by Provepharm SAS - injection as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures
Bortezomib - manufactured by Intas Pharms USA - Injection for treatment of adult patients with multiple myeloma and treatment of adult patients with mantle cell lymphoma.
Bortezomib - manufactured by MAIA Pharms Inc. - Injection for the treatment of adult patients with multiple myeloma and the treatment of adult patients with mantle cell lymphoma.
Midazolam - manufactured by Exela Pharma - Midazolam in 0.8% sodium chloride injection for continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as component of anesthesia or during treatment in a critical care setting.
Paclitaxel - manufactured by HBT Labs Inc - use of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), lyophilized powder for reconstitution, 100 mg/vial for the treatment of:
• Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
• Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
• Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.
Pemetrexed - manufactured by Accord Healthcare Inc - use of Pemetrexed Injection:
• in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
• in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, NSCLC.
• as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
• as a single agent for the treatment of patients with recurrent, metastatic nonsquamous, NSCLC after prior chemotherapy.
• initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
Zoryve (roflumilast) - manufactured by Arcutis Biotherapeutics - 0.3% for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older.
Kyzatrex (testosterone undecanoate) - manufactured by Marius Pharmaceuticals - oral capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Zonisade (zonisamide) - manufactured by Azurity - adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years and older.
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Federal Regulatory Update |
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Bipartisan Group of Lawmakers Urge HHS to Crack Down on Drugmakers' 340B Drug Discount Program Restrictions
As reported by Healthcare Dive, more than 180 members of the House of Representatives urged the Biden administration to "crack down" on drugmaker 340B program restrictions, including the issuance of fines. Read more here.
FDA Proposes Revisions to National Drug Code (NDC)
The FDA has proposed a revision to the National Drug Code to use a 12-digit format in place of the current 10-digit format. FDA said it would convert existing NDCs by adding leading zeroes where appropriate. The estimated cost to convert existing NDCs is estimated to be between $6.1 and $19.4 million. Read more here.
CDC Launches Two New Heart Disease and Stroke Prevention Resources
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IPA'S CORPORATE PARTNERS |
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317.634.4968 | inpharm@indianapharmacists.org |
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