Drug Safety, Post-FDA Approval: What to Look For
What characteristics of new drugs might help predict safety issues years later? Find answers and tips on what classes to watch.
At least 1 new safety issue was detected in the years after FDA approval in 1 of every 3 novel therapeutics that received approval during a recent decade. Four therapeutic areas were affected by classwide safety communications between 2006 and 2015: triptans, phosphodiesterase-5 inhibitors, bisphosphonates, and dipeptidyl 4 peptidase inhibitors.Researchers conducted a cohort study of novel therapeutics approved between 2001 and 2010 to determine the frequency of postmarket safety events: withdrawals because of safety concerns, issuance of boxed warnings, and issuance of safety communications.They also wanted to find out whether any novel therapeutic characteristics known at the time of approval-drug class, therapeutic area, priority review, accelerated approval, orphan status, nearâregulatory deadline approval, and regulatory review time-were associated with increased risk.Click on the slides above for highlights of their findings and conclusions.  Reference:Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017;317(18):1854-1863.Â
3 Reasons Urology Practices Should Add Onsite UTI PCR Labs Under New LCD Rules
March 11th 20251. ONSITE PCR TESTING BRINGS SIGNIFICANT CLINICAL BENEFITS TO A PRACTICE. - ACCURACY Traditional urine cultures can give false-negative results. - SPECIFICITY Accurate microbial identification leads to targeted treatment. - SPEED Same day results vs. 3-5 days for traditional urine cultures - - - ANTIBIOTIC RESISTANCE MARKERS Improves antimicrobial stewardship 2. MAINTAIN INDEPENDENCE BY INCREASING REVENUE SIGNIFICANTLY THROUGH REVENUE SHIFTING FROM THE REFERENCE LAB TO THE PRACTICE. - Turnkey: Consultation on COLA and CLIA certification, all necessary equipment, standard operating procedures, personnel sourcing and interview, billing and coding training, 3-4 days of onsite training. - Stark Law Compliant: Complies with anti-kickback statutes. - Medicare part B pays at 100%, Med Advantage Plans at 80% - No lab build-out, only 8 linear feet of counter space needed - Z-code procurement for required states 3. BETTER PATIENT CARE LEADS TO BETTER OUTCOMES. - CONVENIENCE Point of care, no third-party referral lab. - TIMELY Results early in the care process. - CORRECT MEDICATION Avoids two trips to the pharmacy. - BETTER OUTCOMES Reduction of recurrent UTI and hospitalizations
