Today’s Top Story
FDA issues final guidance on abuse-deterrent opioid products.
The U.S. Food and Drug Administration (FDA) has issued final guidance to assist industry in the development of opioid drug products with abuse-deterrent properties. The document outlines the agency’s current views on conducting and evaluating appropriate studies, and discusses what labeling claims may be approved based on the results of those studies. FDA notes that the science of abuse-deterrent technology is still relatively new and evolving, and states that it is working with industry to support advancements in this area and help drug makers navigate the regulatory path to market as quickly as possible. Read more…
Read the guidance (PDF)…
FDA announces recall of products from Prescription Center Pharmacy in Fayetteville, N.C.
FDA and the North Carolina Board of Pharmacy have announced a recall for all lots of non-sterile and sterile products compounded, repackaged, and distributed by Prescription Center Pharmacy, 915 Hay Street, Fayetteville, N.C., between Sept. 10, 2014, and March 10, 2015. An inspection conducted in March by the Board of Pharmacy observed significant deficiencies that raised concerns about the company’s ability to assure the sterility, stability, and potency of the sterile and non-sterile human and veterinary drug products that it produced. FDA states that the agency is not currently aware of any adverse events associated with use of Prescription Center products, but advises healthcare professionals to check their medical supplies and quarantine any drug products from the company, and advises not to administer them to either human or animal patients. Drug products made by the Prescription Center have been distributed nationwide and to Canada. Read more…
Read the recall statement…
May 20 deadline for physicians to review Open Payments data before next public release.
Physicians have until May 20, 2015, to review and dispute reports regarding their financial interactions with drug and medical device manufacturers reported under the Open Payments (Sunshine Act) program. Disputes initiated by May 20 will be flagged as such when the data set is made public on June 30. The U.S. Centers for Medicare & Medicaid Services (CMS) states that data can still be disputed after public release, but corrections will be held until the next Open Payments system update. Read more…
View the Open Payments website…
Senate will need to address SGR repeal quickly upon return.
On March 26, the U.S. House of Representatives passed a bipartisan bill to permanently repeal the Medicare Sustainable Growth Rate (SGR) formula, but the Senate soon adjourned for a 2-week recess, leaving it unable to consider the measure until Congress reconvenes on April 13. Unless otherwise averted, CMS will on April 15 begin processing claims that include a 21 percent cut to physician reimbursement called for under the SGR. To avert the cut, the Senate will have 2 days to approve the House bill or address other legislation. An article in Morning Consult outlines issues that could complicate Senate approval, including concerns of some legislators who would prefer the bill to include a greater extension of the Children’s Health Insurance Program, and of others who oppose the bill’s $141 billion increase in spending without corresponding offsets. Read more…
Study: DCR may not improve outcomes for some patients who undergo rotator cuff repair.
Data from a study published in the April issue of The American Journal of Sports Medicine suggest that outcomes may be similar for patients with symptomatic acromioclavicular joint (ACJ) injury in the rotator cuff who are treated with or without distal clavicle resection (DCR). The researchers conducted a randomized, controlled trial of 21 shoulders treated with DCR and rotator cuff repair, and 26 shoulders treated with rotator cuff repair only. At approximate mean 44-month follow-up, they found similar improvement in American Shoulder and Elbow Surgeons, Constant, and Visual Analog Scores across cohorts, and no significant difference in ACJ tenderness between groups. Read the abstract…
Study: Compared to CPE bearings, HXPE bearings linked to less wear in TAA system.
According to a study of in vitro wear testing published in the April issue of the journal Foot & Ankle International, the use of highly crosslinked polyethylene (HXPE) bearings may reduce the incidence of clinical complications linked to polyethylene wear in total ankle arthroplasty (TAA). The authors manufactured HXPE and conventional polyethylene (CPE) inserts within a semiconstrained, bicondylar TAA system, and subjected those samples to 5.0 million cycles of wear using an in vitro wear simulator. They found that the use of HXPE was associated with a 74 percent reduction in wear compared to CPE. Read the abstract…
Are functional outcomes scores the next step in determining quality in hip and knee procedures?
A perspective piece published in HealthLeaders Media looks at the use of functional outcomes data as a determiner of quality for patients who undergo hip and knee procedures. The writer notes that the American Joint Replacement Registry—as well as a number of others—records Hip Disability and Osteoarthritis Outcome Score (HOOS) and Knee injury and Osteoarthritis Outcome Score (KOOS), and points out that functional outcomes surveys are designed to determine factors such as whether a surgery has restored a person’s ability to engage in certain activities, met the patient’s expectations, and reduced pain. The writer points out that functional outcomes data like HOOS and KOOS are not currently recorded on the Medicare Hospital Compare website, but argues in favor of releasing that data. Read more…
Call for volunteers: OKU Evaluation Committee.
July 31 is the last day to apply for a position on the newly formed Orthopaedic Knowledge Update (OKU) Evaluation Committee. Members of this committee develop and review the OKU self-assessment examination—a 200 question examination produced triennially. The following openings are available:
- Foot & Ankle Item Writer (two member openings)
- Hand & Wrist Item Writer (two members)
- Hip & Knee Reconstruction Item Writer (two members)
- Trauma Item Writer (two members)
- Orthopaedic Diseases Item Writer (two members)
- Musculoskeletal Tumors & Basic Science Item Writer (one member)
- Pediatric Orthopaedics Item Writer (two members)
- Orthopaedic Rehabilitation Item Writer (one member)
- Shoulder & Elbow Item Writer (two members)
- Spine Item Writer (two members)
- Sports Medicine Item Writer (two members)
Applicants for the chair position must be active fellows, candidate members, or emeritus fellows who have served at least one term on the Central Evaluation Committee or one of the Evaluation Committees. Applicants for member positions must be active fellows, candidate members, or emeritus fellows with broad orthopaedic practice experience in the relevant topic. Learn more and submit your application…(member login required)