The FDA has issued a final guidance outlining the steps the agency will take to address medicines that are marketed without FDA approval. The activity will begin with prescription products containing the antihistamine carbinoxamine because of safety concerns regarding their use in children less than two years of age.
Despite findings from a new study of ACE-inhibitor use during the first trimester of pregnancy, the FDA will not change the drugs' warning labels right now, the agency said in a recent conference call. The study, "Major Congenital Malformations after First-Trimester Exposure to ACE Inhibitors," published recently in the New England Journal of Medicine, found a 2.7 times higher risk for birth defects when the mother was taking an ACE inhibitor during the first trimester of pregnancy.
The Governor of Massachusetts is planning to veto a bill the state senate just passed that does away with the requirement of a prescription before syringes can be sold in pharmacies. The house had already passed the measure in November 2005.
The Generic Pharmaceutical Association (GPhA) called the approvalof Sandoz Pharmaceutical's Omnitrope human growth hormone (HGH) asignificant first step in bringing more affordablebiopharmaceuticals to the U.S. marketplace. GPhA president/CEOKathleen Jaeger said that FDA's Omnitrope decision demonstratesthat sound science exists to support the approval of genericbiopharmaceuticals.
Let's say several prescription drug plans (PDPs) are asking you toprovide medication therapy management (MTM) services, but each planhas its own requirements. How can you best meet their welter ofneeds?
A former drug distributor admitted that he sold $7.3 million worthof prescription drugs that he knew were stolen from warehouses andtrucks. Gregory Broccoli pleaded guilty to five conspiracy charges,acknowledging wrongdoing from 2002 through 2004 at a company heoperated in Jersey City and Elizabeth, N.J.
Proposed legislation would require that New Jersey pharmaciesreport retail Rx price data weekly to the state so that citizenscould comparison shop by visiting a public Web site. Consumerswould log onto the site to search drug prices by zip code.
The police departments in Phoenix, Tempe, Chandler, Scottsdale, andother Arizona municipalities are investigating more than 49pharmacy robberies that have occurred at various pharmacies in thegreater Phoenix area over the past 11 months. Police investigatorsbelieve it is likely that these robberies are being committed bythe same individual or individuals.
According to a recent study published in Proceedings of theNational Academy of Sciences, scientists reported that increasingcarbon dioxide levels in the atmosphere are expected to foster anenvironment conducive to widespread poison ivy growth by the year2050. A leading scientific expert predicts that under atmosphericcarbon dioxide concentrations the planet will likely reach by themiddle of this century, poison ivy will grow faster, bigger, andmore poisonous.
The Generic Pharmaceutical Association (GPhA) called the approvalof Sandoz Pharmaceutical's Omnitrope human growth hormone (HGH) asignificant first step in bringing more affordablebiopharmaceuticals to the U.S. marketplace. GPhA president/CEOKathleen Jaeger said that FDA's Omnitrope decision demonstratesthat sound science exists to support the approval of genericbiopharmaceuticals.
CDC has released new vaccine information materials related tohepatitis A. The agency said that as of July 1, whenever a healthprofessional administers a hepatitis A vaccine to a patient, a copyof these materials must be dispensed.
The in vitro diagnostics group, bioMerieux, has launched aneight-month, multi-city Innovation in Motion tour, which consistsof a bus traveling to small and mid-sized hospitals to demonstratethe company's latest diagnostic technologies. Lab professionals,pharmacists, physicians, and others are the targets of this bustour.
Close to half of all respondents who voted in a poll posted on DrugTopics Web site in May feel that when the cervical cancer vaccineis approved by the FDA, it should be administered on a voluntarybasis, with a warning given to patients that the shot could beassociated with risky sexual behavior. Only 16% feel that thevaccine should be mandatory for girls at puberty to protect thembefore they become sexually active. Another 16% believe the vaccineshould not be mandatory since there are not enough data on thelong-term safety of the product.
Results of a new survey sponsored by Ferring Pharmaceuticals showthat only 30% of women undergoing fertility treatments are able toadminister the medications once a day, a frequency that is thoughtto reduce patient anxiety and administration errors. The survey wasconducted on-line by the National Infertility Association among 238respondents between the ages of 27 and 40.
CMS has admitted that it has no hard evidence to back up deputyadministrator Leslie Norwalk's Congressional testimony thatpharmacies are being paid for Part D scripts on a 15-day billingcycle. Instead, Norwalk's assertion was based on informalinformation provided by Part D drug plans.
They have state-of-the-art distribution centers serving wide geographic areas. They are involved in testing cutting-edge technology. While this may describe the top three national pharmaceutical wholesalers-AmerisourceBergen, Cardinal, and McKesson-which command over 90% of the market, it also covers some regional wholesalers.
Pharmacists in California have finally agreed to technicians checking technicians in hospital settings. Buoyed by studies showing that putting hospital pharmacists on the floor can reduce medication errors and patient deaths, the state board of pharmacy has voted to let techs check medication cassette fills by other technicians.
Mark McClellan, M.D., Ph.D., administrator of CMS, has pledged that the government will be on guard for fraud or practices that mislead seniors covered under prescription drug plans (PDPs). To that end, Medicare has about 500 staff members nationwide to investigate fraud allegations and $80 million available to track and enforce adherence to Medicare policies.
A new set of standardized electronic messages, endorsed after anintense six-week effort, may alleviate some of the problems withthe Part D Medicare benefit, according to pharmacy organizations.
Statistics show that at least one-half of all people with diabeteshave diabetic peripheral neuropathy (DPN). And while many of thesepatients may develop a lack of sensation, approximately 11% havechronic and painful symptoms that seriously affect their quality oflife. For this reason, and the current lack of consensus about thecondition's pathophysiology and most effective treatment, a groupof 11 pain specialists convened in a two-day conference in 2005 tocreate the first diabetic peripheral neuropathic pain (DPNP)guidelines.
For a condition where compliance can be a big issue, a newonce-monthly injection will soon be available to help alcoholicskick the habit. In April, the Food & Drug Administrationapproved Vivitrol (naltrexone for extended-release injectablesuspension), a new treatment option from Alkermes and Cephalon.Vivitrol is indicated for alcohol-dependent patients who are ableto abstain from drinking in an outpatient setting and are notactively drinking at the beginning of treatment.
Let's say several prescription drug plans (PDPs) are asking you toprovide medication therapy management (MTM) services, but each planhas its own requirements. How can you best meet their welter ofneeds?
The pharmacy associations and pharmacy schools in seven ruralstates have signed up for a two-phase demonstration project toshowcase the ability of pharmacists to deliver medication therapymanagement (MTM) services to Medicare patients.
Teva has received permission from the FDA to market rasagiline(Azilect) for the treatment of Parkinson's disease (PD). The newmolecular entity is a monoamine oxidase type B inhibitor that worksby blocking the breakdown of dopamine. Rasagiline was approved asan initial single-drug treatment in early PD and in addition tolevodopa in more advanced patients. Like other MAOIs, rasagilinehas the potential to cause a hypertensive crisis if a patientconsumes tyramine-containing foods while on therapy. The efficacyof the new drug was tested in 404 patients with early disease and1,100 patients with more advanced PD.
Bulk Rx ingredient supplier Spectrum Laboratory has recalled alllots of tacrolimus powder due to sub-potency in some lots. Allpharmacies that have received Spectrum's tacrolimus powder shouldstop using it immediately and contact the company to makearrangements to return it.
The Medicines and Healthcare Products Regulatory Agency, London,has announced that the migraine medication sumatriptan (Imigran) isto be reclassified from Prescription Only Medicine (POM) toPharmacy Medicine (P) status, making it available from pharmacieswithout the need for a prescription. With England setting aprecedent, will the United States be next?
Bausch & Lomb has decided to permanently remove from marketsworldwide its ReNu with MoistureLoc contact lens cleaning solution,based on data suggesting that the product may increasesusceptibility to Fusarium. The company has proposed theformulation as the potential root cause of the increased relativerisk of Fusarium keratitis.
An independent panel convened by the NIH Office of MedicalApplications of Research and the Office of Dietary Supplements hasassessed the available evidence of multivitamin/minerals (MVMs) andmade recommendations regarding certain supplements. The panel'srecommendations include the following: the combined use of calciumand vitamin D protects the bone health of postmenopausal women;antioxidants and zinc help nonsmoking adults with early-stage,age-related macular degeneration; and women of childbearing ageshould take folate daily.
The Consumer Healthcare Products Association has joined forces withthe Partnership for a Drug-Free America to launch an advertisingcampaign designed to curb the abuse of prescription and OTCmedicines and to draw public attention to the substance abuse trendamong teenagers. At dual press conferences held recently inWashington, D.C., and New York, TV, print, and radio public serviceads were unveiled.
