NACDS’ Nicholson testifies to House on drug supply chain safety
ALEXANDRIA, Va. The National Association of Chain Drug Stores today testified before the House Energy and Commerce Subcommittee on Health regarding the safety of the prescription drug supply chain. The hearing was titled, “Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Drug Safety Provisions.”
Kevin Nicholson, vice president of pharmacy regulatory affairs for NACDS, testified before the committee about chain’s pharmacy commitment to patient safety and ensuring the security of the prescription drug supply chain.
“Chain pharmacy supports requirements that will ensure the safety of the drugs dispensed to patients,” Nicholson stated. “We recognize the diligent efforts of the committee, and we appreciate the opportunity to work with the committee in this process. However, we want to urge the committee to resist any attempt to add a track-and-trace mandate. Such a mandate would be fraught with technical difficulties and formidable costs, and would not live up to safety expectations at this time.”
He also testified that though the NACDS strongly believes the domestic supply chain is safe, a set of principles called the Safe Drug Distribution Program will lead to a stronger and more secure system:
- Create federal requirements for strong, uniform state wholesale drug distributor licensure standards.
- Create a Food and Drug Administration-administered certification program for manufacturers, distributors and pharmacies assuring adherence to secure drug distribution supply chain practices.
- Require chain of custody pedigrees for distributions by uncertified supply chain entities.
- Ensure a uniform and strong national drug distribution safety regimen through federal preemption of state laws.
“These steps would build on effective systems currently in place,” Nicholson added. “This approach focuses on strengthening areas where safety problems may occur, and is more feasible than the disruptive and costly changes contemplated under track-and-trace proposals.”
FDA approves first U.S. drug for IBS-C
WASHINGTON Takeda and Sucampo Pharmaceuticals’ Amitiza, indicated for treatment of irritable bowel syndrome with constipation, was approved by the Food and Drug Administration for women over the age of 18, according to published reports.
IBS, an ailment characterized by cramping, abdominal pain, bloating, constipation and diarrhea, affects twice as many women as men, the FDA said. The reason for Amitiza’s approval for women only, however, was based on a lack of proof that the drug was effective for men.
“For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities,” said Julie Beitz of the FDA’s Center for Drug Evaluation and Research. “This drug represents an important step in helping to provide medical relief from their symptoms.”
Amitiza (lubiprostone) is already approved for the treatment of chronic idiopathic constipation, though at a much higher dosage than for treatment of IBS-C.
CDC says more than 25% of children not receiving recommended vaccinations
WASHINGTON According to the Centers for Disease Control and Prevention, more than a quarter of children in the U.S. are not meeting childhood vaccinations in accordance with government recommendation, according to Reuters. The study was of children between the ages of 18 months and 3-years-old.
The report went beyond studying if children were getting the recommended number of doses of various vaccines by, examining whether the children were getting them at the right time.
CDC researchers found that 28 percent did not meet vaccination recommendations. The results were based on a 2005 government survey involving 17,563 U.S. children in that age group.
Missed doses accounted for about two-thirds of those not in compliance. The rest of the children got them at the wrong age or too soon after a previous dose to be considered completely effective. Using the usual method of examining only whether children got the right number of doses, 81 percent of the children met government recommendations, according to the CDC.
The CDC recommends a number of vaccines to protect children against diseases like measles, polio, mumps, chicken pox and several others. Some require multiple doses.