PHARMACY

Doctations partners with SureScripts Doctations partners with SureScripts to provide Rx record access

BY Drew Buono

GARDEN CITY, N.Y. Doctations, the creator of the medical system DocPatient.com, announced today that it has partnered with electronic prescription information provider SureScripts. The partnership will allow DocPatient.com to further empower its physician-patient relationship utilities by offering secure access to patient prescription records. Doctations has completed certification as a SureScripts Certified Solution. Through the Pharmacy Health Information Exchange, operated by SureScripts, DocPatient.com users will now be able to electronically and securely exchange prescription information with community pharmacies.

Doctations provides a secure platform for communication and information retrieval between patients, doctors and healthcare providers. With the addition of SureScripts, physicians visiting DocPatient.com will be able to find important prescription information they wouldn’t be able to get ahead of time without the service.

“Integrating SureScript’s Pharmacy Health Information Exchange into DocPatient.com’s existing clinical community allows the doctor-patient relationship more efficiency,” said Dr. Louis Cornacchia III, president and chief executive officer of Doctations. “Having an online prescription service tied-in with our existing services brings us one step closer to integrating that relationship.”

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Scientific Labs shut down by the FDA

BY Drew Buono

WASHINGTON The Food and Drug Administration announced that Scientific Laboratories and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction that bars the company from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Labs is a contract manufacturer and distributor of various prescription cough and cold products. The government’s complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug and Cosmetic Act. The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements.

The unapproved new drugs manufactured and marketed as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Labs against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

“The FDA will not allow a company to put the public’s health at risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations.

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Amgen cancer drug trials show significantly reduced fracture risk

BY Alaric DeArment

THOUSAND OAKS, Calif. Amgen’s cancer drug denosumab cuts fracture risk in cancer patients and women with postmenopausal osteoporosis, tests have shown.

According to early results released by the American Society of Clinical Oncology, the experimental cancer drug reduced fracture risk in 64 percent of the 111 patients tested, most of whom had breast and prostate tumors. Breast and prostate cancer are two types of cancer likely to spread to bones.

Results of Phase III testing of the drug released last month showed increases in bone mineral density among women with postmenopausal osteoporosis. Those tests examined 332 patients over a two-year period in which subjects received injections of denosumab twice a year.

Denosumab is a genetically engineered antibody that inhibits RANK Ligand, a protein that contributes to bone loss.

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