All News

Despite the barriers to provision of MTM that exist for pharmacists, figuring out a way to do it is our professional obligation.

A pharmacy that engages in veterinary compounding has been embroiled in a struggle with FDA since it compounded a vitamin supplement for administration to 21 polo ponies during the U.S. Open Polo Championships in April 2009. When they were injected with the compounded vitamin supplement, all 21 ponies collapsed and died. FDA's subsequent court challenge raises the question of when compounding becomes manufacture.

In his 200th column for Drug Topics' "JP at Large," Jim Plagakis reflects on some moments that stand out.

Counterfeit medications and substandard medications are on the rise, according to Interchange 2010, a conference sponsored by the Partnership for Safe Medicines.

PainSAFE, an initiative of the American Pain Foundation, has launched a website to educate patients and practitioners about pain-management therapies and their risks.

At the Third Annual Risk Management and Drug Safety Summit, attendees and presenters discussed the latest issues related to risk and safety, and examined how REMS and drug safety have fared since 2007.

A survey of new Rx, new generic, and new OTC products

Pharmacists speak out about the pros and cons of the placebo effect.

The first interstate electronic exchanges of real patient information should begin shortly in Ohio, at what is expected to become a national hub that will enable information related to prescription drug monitoring to flow across state lines.

After fighting about it for years, Congress included legislation in the mammoth healthcare reform bill that would allow an easier approval path for ?biosimilars,? sometimes referred to as generic versions of biologic products.

The National Association of Chain Drug Stores Foundation received $1.76 million from 120 benefactors at its 12th annual dinner, held in New York City in November.

In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter.

Johnson & Johnson announced another product recall, this one involving Children's Benadryl Allergy Fastmelt Tablets, Junior Strength Motrin Caplets, and Extra Strength Rolaids softchews, the Associated Press reported.

The majority of Americans and Canadians are getting enough vitamin D and calcium to meet their needs, according to a new report from the Institute of Medicine.

An FDA panel has recommended that the agency approve Orexigen Therapeutics? and Takeda?s obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.

FDA voted today against approving 2 drugs for the prevention of prostate cancer: finasteride (Proscar, Merck) and dutasteride (Avodart, GlaxoSmithKline).

In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recall of Tylenol Cold Multi-Symptom liquid products; Children?s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors; Junior Strength Motrin Caplets, 24 count; and Rolaids Extra Strength Softchews, Cherry Flavor 36-count package.

Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing their propoxyphene-containing products from the market as well.

FDA has approved denosumab (Xgeva, Amgen), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6-month priority review by FDA. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.

FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.

The National Community Pharmacists Association installed Robert Greenwood of Iowa as its new president during the organization?s 112th Annual Convention and Trade Exposition, held in October in Philadelphia.

A team of pharmacy students from Washington State University?s College of Pharmacy won the 2010 Good Neighbor Pharmacy National Community Pharmacists Association Pruitt-Schutte Student Business Plan Competition. The announcement was made during NCPA?s 112th Annual Convention and Trade Exposition in October in Philadelphia.

The National Association of State Controlled Substances Authorities (NASCSA) has received a $200,000 grant from Purdue Pharma LP, which it will distribute to state government agencies that are able to accept private funding specifically for their state prescription-monitoring programs. NASCSA will manage the solicitation, review, and funding of the grant proposals. Selection of recipients will be based on an independent review conducted by its Special Projects Committee, which consists of association members with expertise in the fields of prescription drug abuse and diversion, and prescription drug-monitoring programs. NASCSA expects to distribute the grants by the end of 2011. The grant is part of Purdue Pharma?s efforts to support the operation, expansion, and awareness of appropriately designed state prescription drug-monitoring programs.

McNeil Consumer Healthcare, a unit of Johnson & Johnson, is voluntarily recalling nearly 128,000 bottles of Tylenol 8-hour caplets after some consumers complained of a musty or moldy odor in the products, the company announced.

In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter.

With single-pill, fixed-dose combinations of antihypertensive agents, as well as triple-therapy, single-pill agents emerging, updated guidance on specific types of combination therapy for hypertension has emerged.

FDA is asking the manufacturers of gonadotropin-releasing hormone agonists to add new safety information to the Warnings and Precautions section of the drugs? labels about an increased risk of diabetes and certain cardiovascular diseases.

New safety information has been added to the label for the HIV antiviral drug saquinavir (Invirase, Genentech), describing potentially life-threatening side effects on heart function when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, FDA announced.