DECEMBER
December 18, 2020 - Food and Drug Administration - The FDA has issued an EUA for a second COVID-19 vaccine for use in people 18 years of age and older…Read Here. See the FDA fact sheet for healthcare providers.
December 11, 2020 - Food and Drug Administration - The FDA has issued an emergency use authorization for the first COVID-19 vaccine to be used in the U.S. for people age 16 years and older…Read Here. See the FDA Fact Sheet for Healthcare Providers.
December 10, 2020 - CT Pharmacists Association - U.S. Supreme court rules in favor of Arkansas (See Oct 6, 2020 post on Rutledge v. PCMA), potentially opening the door for states to regulate Pharmacy Benefit Managers (PBMs)...Read Here
December 9, 2020 - Food and Drug Administration - Recall issued for one batch of sildenafil and one batch of trazodone due to possible error resulting in both medications in the same bottle…Read Here
December 7, 2020 - CT.gov - Connecticut governor issues executive order allowing licensed pharmacists to administer COVID-19 vaccines to people 11 years of age and older…Read Here
NOVEMBER
November 23, 2020 - Food and Drug Administration - The FDA has issued an ‘emergency use authorization’ for a trial combination monoclonal antibody regimen to be used in people with mild to moderate COVID-19. Casirivimab+imdevimab is given via IV infusion to non-hospitalized patients, at least 12 years of age and weighing 40kg (~88 lbs) or more, who are at high risk of worsening illness…Read Here (See the FDA Fact sheet for providers)
November 19, 2020 - Food and Drug Administration - The FDA has issued an ‘emergency use authorization’ for a trial combination therapy, which includes baricitinib - a kinase inhibitor available as an oral tablet and approved for severe rheumatoid arthritis, and the IV antiviral remdesivir - recently approved as a standalone COVID-19 treatment. The baricitinib+remdesivir regimen will be used in hospitalized patients 2 years of age and older, needing oxygen or breathing support…Read Here (See the FDA’s Baricitnib Fact Sheet for Providers)
November 9, 2020 - Food and Drug Administration - The FDA has issued an ‘emergency use authorization’ allowing the use of bamlanivimab, a monoclonal antibody given by IV infusion, to treat COVID-19 in patients age 12 years and older and weighing at least 40kg (~ 88 lbs). Unlike the other drugs that have received EUA’s so far, this one is for people with mild-moderate cases. Bamlanivimab appears not to be useful for hospitalized patients but is being tried for people at high risk of progressing to severe illness…Read Here (See the manufacturer’s Fact sheet for Providers)
November 9, 2020 - National Institutes of Health - HPTN 084 clinical trial results show cabotegravir - an integrase inhibitor injected once every eight weeks, may be more effective at preventing HIV in African women compared to the current pre-exposure prophylaxis (PrEP) daily tablet, emtricitabine+tenofovir disoproxil fumarate (Truvada). These results may not apply to pregnant & breast feeding women, or to women with significant heart or liver disease, as they were excluded from the trial. At this time the FDA has not approved cabotegravir as it is still being studied…Read Here
November 5, 2020 - New England Journal of Medicine - Results from the LoDoCo2 clinical trial show colchicine, a drug commonly used for gout, can significantly reduce the risk of another cardiovascular event in people with stable coronary artery disease. These results may not apply to people with severe liver disease, moderate to severe kidney impairment (eGFR less than 50ml/min) and patients already on long-term colchicine for other reasons, as they were excluded from this study…Read Here
November 3, 2020 - Food and Drug Administration - Another manufacturer recalls two batches of Metformin ER because of higher than acceptable levels of N-Nitrosodimethylamine (NDMA)…Read Here
November 3, 2020 - Food and Drug Administration - The FDA has issued an alert on the potential for false positive (and negative) results from COVID-19 antigen tests, especially when manufacturer instructions are not properly followed…Read Here
November 2, 2020 - National Institutes of Health - In this month’s issue, NIH News in Health focuses on Chronic Obstructive Pulmonary Disease (COPD)…Read H
October
October 22, 2020 - Food and Drug Administration - The FDA has approved Veklury (remdesivir) for treating COVID-19 in hospitalized patients 12 years & older, weighing at least 40kg (~88 lbs). Based on results from the ACTT-1 trial, the drug may reduce recovery time by as much as 5 days but it does not significantly reduce the risk of death...Read Here *Note: the WHO recently released results from their Solidarity trial, which showed no survival benefit with remdesivir.
October 20, 2020 - Department of Health and Human Services - The HHS has issued a guidance on the Public Readiness and Emergency Preparedness (PREP) Act, concerning vaccines given by pharmacy personnel. The provision allows qualified, state licensed pharmacy interns & technicians to administer COVID-19 vaccines and other FDA approved vaccines to patients 3 years & older, under the supervision of a qualified pharmacist…Read Here
October 16, 2020 - Food and Drug Administration - The FDA cautions against the use of nonsteroidal anti-inflammatory drugs (NSAIDs) e.g., ibuprofen & naproxen, in women 20 or more weeks pregnant. Manufacturers are required to update prescribing information to “describe the risk of kidney problems in unborn babies that result in low amniotic fluid”…Read Here
October 15, 2020 - World Health Organization - The global Solidarity Therapeutics Trial coordinated by the WHO has concluded with initial results showing remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens did not improve 28-day survival rates in patients hospitalized with COVID-19…Read Here *Note: the NIH released a statement in May based on data from the ACTT trial that showed an improved ‘time-to-recovery’ and possible 14-day survival benefit with remdesivir in severely ill patients needing oxygen.
October 13, 2020 - Food and Drug Administration - The FDA clarifies recommendations to dispense insulin pens in “original sealed cartons” to reduce the risk of medication error and tampering…Read Here
October 7, 2020 - Food and Drug Administration - The FDA recommends healthcare providers give visual instructions to patients who self-collect samples for COVID-19 tests. This guidance is to ensure sufficient specimen quantities are obtained for accurate testing...Read Here
October 6, 2020 - SCOTUS Blog - The supreme court will hear Rutledge v. PCMA, a case that will set the tone for how states may regulate Pharmacy Benefit Managers (PBM’s)…Read Here (For an explanation of the case Watch Here)
October 5, 2020 - Center for Disease Control and Prevention - The CDC website has been updated (again) to acknowledge airborne COVID-19 spread, with particular risk in poorly ventilated spaces…Read Here-
SEPTEMBER
September 24, 2020 - Food and Drug Administration - The FDA communicates risks of high dose diphenhydramine in response to reports of teenagers being hospitalized and even dying after participating in the “Benadryl Challenge”…Read Here
September 23, 2020 - Food and Drug Administration - The FDA requires benzodiazepine (e.g. clonazepam, lorazepam, alprazolam) black box warning update to include risk of abuse, addiction, withdrawal reactions and other serious side effects…Read Here
September 8, 2020 - Food and Drug Administration - IMpassion131 clinical trial finds paclitaxel+atezolizumab is not effective for treating advanced triple negative breast cancer, however, paclitaxel protein-bound (Abraxane)+atezolizumab (Tecentriq) remains an approved treatment…Read Here
September 2, 2020 - Reuters - International studies show corticosteroids, dexamethasone and hydrocortisone, improve survival in critically ill COVID-19 patients…Read Here
AUGUST
August 2020 - American Cancer Society - The American Cancer Society mourns the passing of Chadwick Boseman: Learn about colorectal cancer
August 26, 2020 - Food and Drug Administration - The FDA removes the Black Box Warning about an increased risk of leg/foot amputation from diabetes drug canaglifozin (Invokana, Invokamet) but notes some risk is still present…Read Here
August 25, 2020 - Mayo Clinic - TAILOR-PCI trial shows benefit from using genetic testing (CYP2C19 gene variant) to guide anti-platelet therapy selection (clopidogrel vs. ticagrelor) in patients who have undergone PCI or stent placement…Read Here
August 23, 2020 - The Food and Drug Administration - The FDA issues Emergency Use Authorization for COVID-19 convalescent plasma (CCP) to treat hospitalized patients, building on the Mayo Clinic Expanded Access Program launched in April…Read Here
August 20, 2020 - Food and Drug Administration - The FDA issues an update on breast implant associated adverse events including lymphoma…Read Here
August 5, 2020 - Food and Drug Administration - Ferring Pharmaceuticals US is recalling all lots of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL due to higher potency than indicated on labels…Read Here
JULY
July 31, 2020 - Connecticut Department of Consumer Protection - Public Act 20-4, which goes into effect January 1, 2021, requires prescriptions for insulin, glucagon and diabetes management devices be shared with CPMRS. This act also allows Connecticut licensed pharmacists to prescribe 30-day supplies of insulin, glucagon and diabetes devices under certain conditions…Read Here
July 31, 2020 - Connecticut Department of Consumer Protection - Public Act 20-2, which goes into effect January 1, 2021, allows licensed pharmacists to transfer electronic prescriptions for controlled substances, provided the prescription was never filled…Read Here
July 30, 2020 - Center for Disease Control and Prevention - Physicians, healthcare providers can be reimbursed for counseling patients to self-isolate after COVID test…Read Here
July 27, 2020 - Food and Drug Administration - The FDA warns against hand sanitizers containing methanol…Read Here
July 23, 2020 - Food and Drug Administration - The FDA requires drug label changes recommending healthcare providers discuss naloxone with their patients on opioids…Read Here
July 4, 2020 - Reuters - The WHO halts trial of hydroxychloroquine and ARV’s, finding no evidence of reduced mortality in hospitalized patients…Read Here
JUNE
June 2020 - Center for Disease Control and Prevention - Clinical Questions about COVID-19… Read Here
June 29, 2020 - NPR - Remdesivir priced at over $3,000 per 5-day treatment course for commercially insured patients…Listen Here
June 20, 2020 - National Institutes of Health - The NIH halts trial of hydroxychloroquine due to lack of benefit in hospitalized adults…Read Here
June 19, 2020 - Food and Drug Administration - The FDA issues list of COVID tests that should not be used…Read Here
June 18, 2020 - Food and Drug Administration - GlaxoSmithKline announces nationwide recall of some children cough syrups due to incorrect dosing cups…Read Here
June 15, 2020 - Food and Drug Administration - The FDA warns of a potential drug interaction that may reduce effectiveness of remdesivir…Read Here
June 5, 2020 - American Pharmacists Association - National pharmacy associations issue joint statement on racial injustice… Read Here
June 5, 2020 - Food and Drug Administration - Several manufacturers issue recalls for metformin ER due to N-nitrosodimethylamine (NDMA) impurity…Read Here
June 5, 2020 - Associated Press - UK study finds no survival benefit with hydroxychloroquine use in COVID-19 patients… Read Here
June 4, 2020 - World Health Organization - The WHO resumes hydroxychloroquine testing with Solidarity clinical trials…Read Here
MAY
May 29, 2020 - American Public Health Association - Racism is an ongoing public health crisis that needs our attention now…Read Here
May 15, 2020 - National Institutes of Health - Initial results from the NIH’s randomized, controlled, Adaptive COVID-19 Treatment Trial (ACTT) appear to show some benefit with remdesivir in patients hospitalized with severe COVID-19 and needing oxygen therapy. Per the NIH, remdesivir shortened the time to recovery, compared to placebo, and possibly improved 14-day survival rate (though not statistically significant)…Read Here
May 7, 2020 - CT.gov - Connecticut removes referral requirement, allows pharmacists order and administer COVD-19 tests…Read Here
May 1, 2020 - Food and Drug Administration - Emergency Use Authorization issued for remdesivir COVID-19 treatment in certain hospitalized patients with severe laboratory confirmed disease…Read Here
APRIL
April 29, 2020 - National Institutes of Health - Very low dose avastin is effective for preventing retinopathy related blindness in pre-term infants… Read Here
April 15, 2010 - CT.gov - Connecticut approves ‘no-cost’ life insurance for front line health workers during COVID-19… Read Here
April 9, 2020 - Reuters - The National Institutes of Health begins trial to test hydroxychloroquine for COVID-19…Read Here
April 1, 2020 - Food and Drug Administration - Emergency Use Authorization issued for COVID-19 serological antibody test… Read Here
MARCH
March 28, 2020 - Food and Drug Administration - Emergency Use Authorization issued for hydroxychloroquine in certain hospitalized patients…Read Here
March 9, 2020 - Ct.gov - CT State Insurance Department bulletin to insurance companies and health centers…Read Here
March 4, 2020 - Food and Drug Administration - The FDA requires stronger warning for risk of neuropsychiatric events associated with montelukast (Singulair)…Read Here
March 3, 2020 - Medicare.gov - Medicare coverage for coronavirus test…Read Here
March 2020 - Medicare.gov - COVID-19: Medicare covers tele-health visits with conditions…Read Here
March 2020 - Center for Disease Control and Prevention - Video communication resources on the coronavirus disease… Watch Here
FEBRUARY
February 27, 2020 - Food and Drug Administration - COVID-19 Supply Chain Update…Read Here
February 21, 2020 - Medicare.gov - Medicare Part B enrollment…Read Here
February 11, 2020 - Reuters - WHO: Vaccine for new coronavirus 'COVID-19' could be ready in 18 months…Read Here
February 5, 2020 - Journal of the American Medical Association - Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder…Read Here