2- Tuesday Pharmacy Practice News – 20th July

 1 – Challenges Faced by Providers During the Shift to Online Care

• In this interview Mary Reed, DrPH, research scientist at Kaiser Permanente described multiple challenges encountered by providers during the shift to online health care.
• Her list includes the need to develop, improve, and be trained on the technology required to make telemedicine possible, as well as a number of fundamental organizational changes.

Source: Pharmacy Times

2 – FDA Approves Daratumumab, Hyalyronidase-fihj in Combination With Pomalidomide, Dexamethasone for Multiple Myeloma

• Multiple myeloma is an incurable blood cancer that impacts plasma cells.
• When damaged, these cells spread rapidly and replace normal cells with tumors in the blood marrow.
• Officials with the FDA have approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma following their first or subsequent relapse.
• This marks the sixth indication for daratumumab and hyaluronidase-fihj and follows Janssen’s FDA submission in November 2020.

Source: Pharmacy Times

3 – FDA To Attach Warning for Guillain-Barre Syndrome to Johnson & Johnson COVID-19 Vaccine

• Officials with the FDA are planning to attach a warning for Guillain-Barre syndrome to the Johnson & Johnson COVID-19 vaccine
• The syndrome occurs when the body’s immune system attacks the nerves, according to the Mayo Clinic.
• The first symptoms are usually weakness and tingling in the extremities, although this can quickly spread and paralyze the entire body.
• Severe forms of the syndrome can be a medical emergency and most people require hospitalization.
• Although researchers have found that the risk of developing the rare neurological condition after vaccination are low, the risk seems to be 3 to 5 times higher among recipients of the vaccine compared to the general population.
• The new warning follows a temporary safety pause on the vaccine earlier in the year for concerns about rare blood clotting issues.

Source: Pharmacy Times

4- Pharmacist Medication Insights: Margetuximab for Metastatic HER2-Positive Breast Cancer

• In December 2020, the FDA approved margetuximab-cmkb (Margenza) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which for metastatic disease.
• The regulatory decision was based on findings from the phase 3 SOPHIA trial, in which the Fc-engineered monoclonal antibody plus chemotherapy demonstrated a statistically significant reduction in the risk of disease progression or death of 24% vs trastuzumab (Herceptin) in combination with chemotherapy.
• The median PFS with the margetuximab-cmkb regimen was 5.8 months vs 4.9 months with the trastuzumab regimen.

Source: Pharmacy Times

5 – Research Shows Regular Rapid Testing Detects COVID-19 To Stop Transmission in Schools

• Researchers have found that proactive, frequent rapid testing of all students for COVID-19 is more effective at preventing large transmission clusters in schools than measures that are started when someone develops symptoms and then tests positive.
• The analysis, published in PLOS Computational Biology, showed that in a classroom with 25 students, anywhere from 0 to 20 students might be infected after exposure based on the small adjustments to transmission rates for infected individuals or environments.
• The researchers also tested the effectiveness of 2 different transmission control strategies.
• The team found that in settings with high transmission rates, the interventions used in the first control strategy in which preventive actions took effect after a positive test result were slower at preventing large outbreaks.

Source: Pharmacy Times

6 – Phase 2 Study Indicates Mirikizumab Induces Mucosal Healing in Patients With Ulcerative Colitis

• New phase 2 data demonstrated that gene expression changes induced by mirikizumab in patients with ulcerative colitis (UC) were maintained for up to 1 year, according to a press release from Lilly.
• These changes, which were induced over a 12-week treatment period and were unique among individuals who responded to mirikizumab compared to placebo, were associated with mucosal healing.
• According to the investigators, this indicates that mirikizumab affects a distinct molecular healing pathway when compared to the spontaneous healing that occurred among the cohort administered the placebo.

Source: Pharmacy Times

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