PHARMACY

NACDS responds to report on integrity of pharmaceutical supply chain

BY Antoinette Alexander

ALEXANDRIA, Va. — Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report’s proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.

NACDS’ comments on the report come on the heels of a "60 Minutes" segment that aired Sunday evening that revealed the harsh reality of drug counterfeiting.

The report was prepared by the Office of Intellectual Property Enforcement Coordinator, the Food and Drug Administration, U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement, the Departments of Justice, State, Commerce and the Agency for International Development on counterfeit pharmaceuticals. The report discusses a number of issues and efforts to combat counterfeit drugs, including importation, ports of entry, international law enforcement efforts and partnerships, international public awareness campaigns, and others.

"The report recognizes that there are thousands of illegal websites that sell unapproved or counterfeit drugs without a valid prescription, which pose a threat to patient health. We also welcome the report’s support for the private sector initiative that would share information on the illicit websites, fund educational campaigns, establish a list of legitimate online pharmacies and share information with law enforcement," stated NACDS president and CEO Steve Anderson.

"NACDS has been engaged in federal and state policy initiatives to further safeguard the supply chain," Anderson continued. "The association advocated for legislation enacted in 2008 that cracks down on rogue online pharmacies, and distinguishes between such sites and legitimate sites operated by licensed pharmacies. NACDS also helped to enact state legislation that strengthened wholesale distributor licensure requirements and increased penalties for intentional distribution of counterfeit drugs."

"NACDS does not support the report’s proposal to mandate a ‘track and trace’ system in the [United States]," Anderson noted. "The operational processes surrounding a mandated ‘track and trace’ system are still under development and cannot achieve their desired purpose at this time, which will prove extraordinarily costly for pharmacies and other supply chain operators."

The comments come on the heels of a "60 Minutes" segment during which Kumar Kibble, deputy director of Immigration and Customs Enforcement, said, "Fake drugs are a big threat and an exploding threat."

Kibble, who tracks counterfeit drugs from their source in clandestine labs around the world to the United States, where they’re typically sold online through rogue pharmacy sites, told "60 Minutes" that increasingly, traditional criminal groups, including many once involved in illegal drug trafficking, are shifting operations to take advantage of the low-risk/high-reward economics of the counterfeit drug trade — a $75 billion-a-year industry, according to estimates.

The "60 Minutes" segment came as no surprise to Drug Store News, which has argued for many years that drug counterfeiting is the key reason lawmakers need to forget the recurring pipe dream they share that rogue Internet sites and drug reimportation is a legitimate solution to rising healthcare costs.

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IAF: 10 U.S. states will see highest diabetes prevalence, cost

BY Allison Cerra

WASHINGTON — A new study conducted by the Institute for Alternative Futures and funded by Novo Nordisk highlighted the top 10 U.S. states that are labeled as "diabetes hot spots" and are projected to carry the brunt of the epidemic over the next 15 years.

The IAF diabetes model projected that the overall number of people in the United States living with diabetes will increase 64% by 2025 to 53.1 million, or 1-in-7 Americans. In turn, the medical and societal cost of diabetes will be almost $514 billion, a 72% increase from 2010, IAF said. Breaking down the statistics, IAF projected the following states will carry the biggest diabetes burden:

  1. California: Projected cost of $63.63 billion, 6.6 million people with diabetes;

  2. Texas: Projected cost of $52.17 billion; 5.5 million people with diabetes;

  3. Florida: Projected cost of $40.43 billion; 4.2 million people with diabetes;

  4. New York: Projected cost of $28.38 billion; 2.9 million people with diabetes;

  5. Ohio: Projected cost of $19.76 billion; 2.1 million people with diabetes;

  6. Illinois: Projected cost of $19.67 billion; 2 million people with diabetes;

  7. Georgia: Projected cost of $19.54 billion; 2 million people with diabetes;

  8. Pennsylvania: Projected cost of $18.37 billion; 1.9 million people with diabetes;

  9. North Carolina: Projected cost of $17.91 billion; 1.9 million people with diabetes; and

  10. Michigan: Projected cost of $15.85 billion; 1.6 million people with diabetes.

Currently the 10 states carry nearly 60% of diabetes-related costs.

The IAF study was based on available national diabetes data, including the recent CDC projections to 2050, as well as population projections.

"This research maps the alarming demographic realities of diabetes through 2025 if we don’t make fundamental changes, particularly in our lifestyles and health system," said William Robert Rowley, senior fellow at the Institute for Alternative Futures and lead author of the study. "The burden of diabetes will not fall equally. To change this tragic trajectory, it is imperative that public and private agencies work together on national, as well as state and local levels."

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Late-stage trial to commence for AstraZeneca’s opioid-induced constipation treatment

BY Alaric DeArment

WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

The phase-3 trial will investigate the safety and efficacy of NKTR-118 as a treatment for opioid-induced constipation. It will consist of two 12-week placebo-controlled studies with about 630 patients each, and a long-term safety study that will include patients from the efficacy studies, as well as new patients. AstraZeneca is developing the drug under a license agreement with Nektar Therapeutics.

“This is a key milestone for NKTR-118,” AstraZeneca EVP global medicines development Anders Ekblom said. “We will put our knowledge and our effort into studying NKTR-118 as a potential new treatment option for opioid-induced constipation, which continues to be an area of unmet need in patients needing effective pain treatment.”

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