Pharmacy Update

Page 1: Introduction and Learning Objectives

• Event Information

  • Title: Pediatric Pharmacology Update

  • Dates: Chicago March 10-13 Virtual May 15-July 31

  • Host: National Association of Pediatric Nurse Practitioners

• Speaker: Teri Woo PhD, ARNP, CPNP-PC, FAANP

  • Affiliation: ARNP in Pediatric Urgent Care Mary Bridge Children’s Tacoma, WA; Professor, Saint Martin’s University

• Disclosure: No conflicts reported

• Learning Objectives:

  • Discuss newly approved or relabeled pediatric medications

  • Discuss pediatric pharmacology studies in process

  • Examine issues related to pediatric prescribing

Page 2: Newly Approved Pediatric Medications - 2024

• Berdazimer (Zelsuvmi)

  • Indication: Treatment of molluscum contagiosum

  • Age Approval: 1 year and older

  • Formulation: Topical gel (10.3% berdazimer) in two tubes (A & B)

  • Dosing: Mix equal amounts from both tubes and apply once daily for 12 weeks

  • ADRs:

    • Burning/stinging at application site (18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), allergic contact dermatitis

  • Cost: Not specified

• Concizumab-mtci (Alhemo)

  • Approved for ages 12 years and older

  • Indications: Hemophilia A (with inhibitors) and Hemophilia B (with inhibitors)

  • Dosing: Daily SC injections based on plasma concentrations

  • ADRs: Injection site reactions, urticaria

• Marstacimab-hn (Hympavzi)

  • Approved for ages 12 years and older for hemophilia A and B (without inhibitors)

  • Dosing: Weekly SC injections

  • ADRs: Injection site reactions, urticaria, thrombotic events

  • Drug Interactions: None, does not alter PT/aPTT

Page 3: Additional Medication Approvals

• Cystic Fibrosis – Alyftrek

  • Composition: Combination of CFTR potentiators

  • Age Approval: 6 years and older

  • Dosing: Daily oral tablets

  • ADRs: Drug-induced liver injury, hypersensitivity, cataracts

• Crinecerfont (Crenessity)

  • Indication: Congenital adrenal hyperplasia

  • Age Approval: 4 years and older

  • Formulation: Oral solution or capsules

  • ADRs: Fatigue (25%), risk of acute adrenal insufficiency

Page 4: New Medications for 2025

• Mirdametinib (Gomekli)

  • Indication: Neurofibromatosis type 1

  • Age Approval: 2 years and older

  • ADRs: Rash (72%), ocular toxicity, embryo-fetal toxicity

• Pediatric Drug Trials:

  • Focus on off-patent drugs lacking pediatric data

  • Help revise drug labels for safer pediatric usage

  • Relabeled Drugs: Acyclovir, caffeine, diazepam, fluconazole, etc.

  • Results Source: pediatrictrials.org

Page 5: Ongoing Pediatric Trials

• Anesthesia and Analgesics in Children (ANA):

  • Enrolling trials on Ketamine, hydromorphone, ketorolac

• Pharmacokinetics and Safety of Antiretroviral Drugs:

  • Focus on breastfed infants

• Guafacine for Hyperactivity in Down Syndrome:

  • Enrolling for safety and efficacy studies

Page 6: Emerging Hazards in Pediatric Health

• E-cigarettes and Nicotine:

  • Symptoms of Poisoning: Diaphoresis, tremor, bradycardia, can lead to coma

  • Prevention: Education to parents about hazards

• Edible Cannabis:

  • Symptoms of Poisoning: Vomiting, confusion, seizures

  • Response: Immediate contacting of Poison Control Center

Page 7: Vaccination Updates

• Measles Treatment:

  • Vitamin A supplementation for confirmed cases

  • Guidelines for exposed children regarding vaccination

• Pertussis Updates:

  • Treatment recommendations during different illness phases

  • Use of Azithromycin for antibiotic treatment

Page 8: Drug Shortages

• List of Medications in Short Supply (Feb 2025):

  • ADHD medications such as Mixed amphetamine salts, Amoxicillin suspension, Albuterol solutions

• Next Issues in Peds Pharmacology:

  • New guidelines for strep throat and pneumonia treatments

Page 9: Conclusion and Resources

• Questions:

  • Contact: teriwoo@woofamily5.net

• References:

  • Includes sources from American Academy of Pediatrics and the FDA on recent drug approvals and shortages

Voice lecture notes

New Pediatric Drugs and Their Impacts

Overview of Recent Developments

• Discussion on emerging pediatric medications affecting current practices.

• Importance of having drugs available for younger patients, including those not yet on the market.

Nitric Oxide Releasing Agent

• Description: A complex medication that consists of two components mixed before application.

• Mechanism: Functions similarly to hydrogen peroxide; has antiviral activities likely due to nitric oxide.

• Dosage: Applied to treat molluscum contagiosum, once a day for 12 weeks.

• Adverse Effects:

  • Possible stinging, burning, redness, itching.

  • Skin peeling and allergic contact dermatitis observed.

  • Effects generally resolve within 24 hours.

Hemophilia Treatments

• Hemophilia A: Affects factor VIII, while Hemophilia B affects factor IX.

• New treatments: Hemoctin (daily injections) and Hemyciz (weekly injections).

• Adverse Effects: Injection site reactions, urticaria, potential thromboembolic events due to effectiveness.

Cystic Fibrosis Treatment

• Cystic Fibrosis Gene Therapy: Medication targeting F508del mutation; available for ages 6 and older as an oral tablet.

• Monitoring: Liver enzymes need careful monitoring due to risks of drug-induced liver injury.

• Eye Health Monitoring: Possible development of non-congenital lens opacities in under 18s; follow-up with an ophthalmologist recommended.

Congenital Adrenal Hyperplasia Treatment

• Cranesi: For children aged 4 and over. Works by inhibiting ACTH secretion from the pituitary gland.

• Dosage: Available as oral solution or capsules.

• Adverse Effects: Fatigue, adrenal insufficiency, adrenal crisis, numerous drug interactions.

Anticholinergic for Excessive Sweating

• New anticholinergic medication approved for ages 8 and older.

• Administration: Applied topically to underarms to decrease sweat production.

• Adverse Effects: Possible dry mouth, blurred vision, absorption can occur if misused.

Motor Function Improvement Drugs

• New medication approved for ambulatory patients aged 6 and older to improve motor function.

• Adverse Effects: Stomach upset, thrombocytopenia, triglyceride increase, and potential QT prolongation.

New Epinephrine Nasal Spray

• Approved for managing type 1 allergic reactions and anaphylaxis in children over 30 kg.

• Administration: One spray per nostril, comparable efficacy to auto-injectors.

• Patient Education: Proper usage instructions needed, such as avoiding nasal medication interaction.

Cautions on Pediatric Drugs

• Ongoing issues with medication approvals and drug interactions.

• Caution advised on the use of pediatric formulations ensuring accessibility for children.

Pediatric Pharmacology Developments

• The Pediatric Trials Network aims to enhance collaboration in pediatric research, accelerating the study and relabeling of medications.

• Importance of updated pediatric drug books due to evolving drug information.

Emerging Hazards in Pediatrics

• Increased exposure in pediatric populations to nicotine vapes and edible cannabis.

• Impact: Serious health risks from ingestion; preventive measures should be advised.

• Education: Communicate potential dangers and trends with parents to keep harmful substances out of reach.

Current Trends in Infectious Diseases

• Recent rise in measles cases observed, emphasizing the need for vaccinations.

• Recommendations updated for Vitamin A use in children with measles.

• Exposure Protocol: MMR vaccination suggested for children exposed within three days.

Conclusion

• The landscape of pediatric pharmacology is rapidly evolving with new treatments, but vigilance remains crucial in monitoring effects and ensuring safety.