PHARMACY

NCPA announces endorsement of bill aimed at curbing Rx drug abuse

BY Antoinette Alexander

ALEXANDRIA, Va. — Legislation recently introduced by U.S. Rep. Tom Marino, R-Pa., which is intended to reduce the abuse of prescription drugs by fostering greater collaboration among stakeholders and implementing new safeguards, has received the endorsement of the National Community Pharmacists Association.

“America is in the throes of a prescription drug abuse crisis,” said NCPA CEO B. Douglas Hoey. “No one wants to address it more than community pharmacists, who are the experts in the proper use of prescription medication and who understand the consequences of drug diversion and abuse. We commend Representative Marino for his leadership in this area. Our support for this legislation reflects the constructive approach that NCPA has taken to working with federal and state policymakers, law enforcement and all stakeholders in support of effective, practical solutions to the prescription drug abuse epidemic, while preserving access to medication for those with legitimate health needs.”

The Ensuring Patient Access and Effective Drug Enforcement Act (H.R. 4069) would amend the Controlled Substances Act and implement the following reforms:

  • Require manufacturers and distributors registered with the Drug Enforcement Administration to ensure that their employees with access to controlled substances satisfy criminal background checks and drug tests; and
  • Establish a Combating Prescription Drug Abuse Working Group of federal and state officials as well as private sector stakeholders dedicated to examining ways to reduce abuse and diversion. Members of the panel would include a representative of community pharmacy. It would also be a forum by which concerns of independent community pharmacies may be addressed.

In presentations to Congress, the FDA and DEA, NCPA has recommended steps to combat prescription drug abuse while protecting patients. They include utilization of electronic prescription drug monitoring programs and tracking systems, more effective education of prescribers, shutting down rogue pain clinics, offering more disposal options for excess medications and more scrutiny of controlled substances delivered by mail order pharmacies.

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Brand medicines at retail pharmacy to no longer be covered by Tricare for Life

BY Michael Johnsen

FALLS CHURCH, Va. — Tricare for Life beneficiaries soon will receive letters guiding them to Tricare Pharmacy Home Delivery or a military pharmacy for some prescriptions as part of a congressionally mandated pilot program, officials of the military healthcare plan reported Tuesday.

Tricare for Life is secondary coverage for Tricare beneficiaries who have both Medicare Parts A and B in the United States and U.S. territories.

Beginning the week of Feb. 17, officials will send letters to affected Tricare for Life beneficiaries notifying them of the pilot program. The pilot program starts March 15, and it requires beneficiaries who use Tricare for Life to get certain medications through home delivery or at a military pharmacy. The program applies to refills of maintenance medications taken regularly for chronic conditions, officials said.

As part of the pilot program, officials added, Tricare will stop paying for these medications from a retail pharmacy. But they noted that the program does not apply to medications for acute conditions taken for a limited time, such as antibiotics or pain medications or any generic medications. 

At this time, they said, it also does not apply to generic drugs.

Congress mandated the pilot program in the 2013 National Defense Authorization Act. It will last for five years, but beneficiaries may choose to opt out after filling an affected prescription under the pilot program through home delivery for one year.

Beneficiaries will be notified if they are taking a medication covered under the program. They will have two “courtesy fills” available through a retail pharmacy before they are responsible for the entire cost of their medication.

Some people are exempt, including people with another prescription drug plan or people living overseas. People living in a nursing home may contact Express Scripts to request a waiver from the pilot program.

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FDA initiates Secure Supply Chain Pilot Program with 13 prequalified pharmaceutical distributors

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. 

In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.

“By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs,” stated Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”  

During these next two years, the FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.

The prequalified companies accepted into the program that will receive expedited entry, are the following:

  • AbbVie;
  • Allergan;
  • Astellas U.S. Technologies;
  • Bristol-Myers Squibb Company;
  • Celgene Corporation;
  • GE Healthcare;
  • GlaxoSmithKline;
  • Merck Sharp & Dohme Corporation;
  • Mylan Pharmaceuticals;
  • Novartis Pharmaceuticals;
  • Pfizer;
  • Teva Pharmaceutcials USA; and
  • Watson Laboratories.

Each of the 13 companies met multiple participation conditions, including:

  • Committing to comply with requirements of the Food, Drug, and Cosmetics Act;
  • Having a validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism program;
  • Having a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products;
  • Having effective recall and corrective action plans in place; and
  • Maintaining control over their drugs from the time of manufacture abroad through entry into the United States.

 

 

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