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Researchers highlight more than 30% decrease in HIV diagnosis rates

BY David Salazar

CHICAGO — The annual rate of HIV diagnoses dropped by 33% between 2002 and 2011, according to a research letter in this week’s issue of the Journal of the American Medical Association.

The researchers drew on data from legally mandated HIV screenings on individuals older than 13 from 2002 to 2011 in all 50 states and the District of Columbia.

Over the years that the researchers looked at, the number of people diagnosed with HIV per 100,000 went from 35.8 to 26.1 in men and from 13 to 6.9 in women—decreases of 27% and 49%, respectively.  The diagnosis also decreased overall for most races and ethnicities—the largest decrease was among Hispanics of any race, with a 41% decrease overall.

There was a 34% decline among cases of HIV contracted from heterosexual contact. However, among cases of HIV attributed to male-to-male sexual contact, there were increased diagnoses within several demographics. The largest increase (132.5%) was among 13- to 24-year-old men who have sex with men.

There were also increased diagnoses among men in that group over 45 years of age, though not one as marked as among the youngest demographic. The increase, though, might be due to the number of 13- to 24-year-olds (typically at high risk) getting tested during this time.

“Although increases in diagnoses were found in young men who have sex with men, reports show that many at high risk do not test annually and the overall percentage of youth who had ever tested for HIV during the period of analysis was low compared with other age groups,” the letter said.

Additionally, HIV contraction through injection drug use was down 70% during the period researchers looked at. 

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Office of Generic Drugs updates key leadership positions

BY Raven Romero

WASHINGTON — The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced. OGD has made assignments, most of which are in an acting capacity, to key OGD subordinate office leadership positions in preparation for Oct. 1 — the beginning of Year 3 of GDUFA when GDUFA goal dates go into effect.

Rob Lionberger will lead the Office of Research and Standards, or ORS, which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling. John Peters will lead the Office of Bioequivalence, or OB, which includes the three Divisions of Bioequivalence and the Division of Clinical Review. Jason Woo will lead the Office of Regulatory Operations, or ORO, which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems. Keith Flanagan will remain as transition lead for the Office of Generic Drug Policy, or OGDP, which includes the Division of Policy Development and the Division of Legal and Regulatory Support. Kathleen “Cook” Uhl, M.D. will remain in her current role as acting director of OGD.

According to the FDA, these changes will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review. It also will provide higher visibility within the Center and Agency to address generic drugs challenges, and better positions OGD to maximize its efficiency in meeting GDUFA requirements, as demonstrated by the formation of an Office of Research Standards and an Office of Generic Drug Policy.

Generic drugs make up nearly 85%  of prescriptions filled in the United States and represent affordable access to treatment for many patients and consumers. These individuals depend on the FDA to ensure that generic drugs perform clinically in the same way as their brand-name counterpart drugs. Transforming OGD into a super office was a critical and necessary step in recognizing the importance of generic drugs to public health and the national economy, the agency said.

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New prescription counter double-counts, stores data

BY David Salazar

LAKE FOREST, Ill. — A new tablet counter from Kirby Lester is looking to make dispensing the proper amount of medication faster. The new KL1Plus double counts the tablets it dispenses and can then store the count data for up to 10 years.

The tool is meant to streamline double counts for filling prescriptions like controlled medications, which pharmacies are required to count twice. If there’s a dispute about medication dispensed, pharmacists can access stored counts on the tool’s touchscreen.

"The KL1Plus's trackable double-count is a pharmacy's safety net against counting errors or customer complaints," Kirby Lester’s VP sales Dave Johnson. "Regardless of what brand of robot a pharmacy uses, the KL1Plus enhances that pharmacy's defenses. … One hundred percent of your orders are verified, counted and archived with automation."

The KL1Plus will be showcased by Kirby Lester at upcoming shows like NACDS Boston, the North Carolina Mutual Annual in Myrtle Beach and the Morris & Dickson M.A.D. Days of Summer in Austin, Texas.

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