Quality Processes Ensure Drug Safety

Mar 21, 2014
Express Scripts is committed to protecting its supply of drugs from substandard manufacturing practices and counterfeit products to ensure patient safety.

Patient safety is our top priority at Express Scripts. We are committed to protecting our supply of drugs from substandard manufacturing practices and counterfeit products. To that end, we only dispense medications – brand and generics alike – that are manufactured according to the strict current Good Manufacturing Practices (cGMP) standards of the U.S. Food and Drug Administration (FDA). cGMP provides guidance for manufacturing, testing and quality assurance in order to ensure that a drug product is safe for human consumption. Express Scripts only purchases medications from drug manufacturers who follow these practices and allow regular FDA inspections.

The FDA Addresses Patient Safety

The FDA requires all drugs approved in the United States, regardless of where they are made, be in compliance with the Federal Food, Drug and Cosmetic Act. This act requires that drugs meet manufacturing standards, including quality and product label requirements.

Domestic and foreign drug manufacturing plants are routinely inspected for compliance with applicable regulations, including the cGMP. Under the FDA’s Globalization Initiative, the agency addresses the challenge of making sure imported drugs are as safe and effective as products made in the United States. Given that raw materials and finished goods for both brand and generic drugs are produced around the world, this initiative is critically important to the safety of drugs produced for the U.S. market.

The FDA has increased inspections of manufacturing plants outside of the United States and has been working with industry and international partners to develop new methods to address quality concerns globally.

The FDA must approve each location used to manufacture every drug produced for the U.S. market. If a manufacturer wants to move production of an approved product to another plant, whether located in the U.S. or in a foreign country, that facility must be approved for production of that drug.

Quality Processes at Express Scripts

Express Scripts purchases drugs only from FDA-approved manufacturers and facilities. Our pharmacy technicians, support staff and pharmacists review medications for quality control on an ongoing basis.

Any batch that fails the quality check will be reported to the manufacturer and removed from stock. Consistent or unresolved quality problems can lead to suspension or cancellation of our agreement to purchase the product. We work closely with manufacturers and the FDA regarding any potential quality or safety concerns and have processes in place to ensure prompt compliance with recommended actions such as quarantining, destroying or recalling products from patients. Express Scripts also tracks every FDA or manufacturer notice regarding safety and each individual pharmacy maintains its own recall records in accordance with state pharmacy laws.

In addition, we visit manufacturers’ facilities in the U.S. and overseas, and collaborate with other stakeholders in the industry on issues impacting safety and quality. Most recently, we have been working with the government to encourage the establishment of an Office of Drug Safety at the FDA.

Protection Against Counterfeits

The greatest opportunity for the introduction of stolen or counterfeit medications into a supply chain is when there are many “hand-offs” in the chain – when medication passes through many intermediaries. At Express Scripts, we take several precautions to ensure our medication pipeline is direct, controlled and verified.

Express Scripts purchases the majority of generic drugs directly from FDA approved manufacturers and the remainder from licensed wholesalers who are authorized distributors for those manufacturers. The majority of brand medication is purchased from wholesalers authorized to distribute those products and employ sound buying practices.

The wholesalers we work with are licensed and regulated under the authority of the federal Prescription Drug Marketing Act (PDMA) and by each state where they do business. PDMA sets storage and handling requirements, specific procedures for inspecting and accepting product into inventory and detailed record keeping for the receipt and disposition of prescription drugs. The wholesalers also are regulated by the Drug Enforcement Administration (DEA), which conducts regular inspections of their facilities.

When purchasing from an authorized distributor of the manufacturer, the wholesalers receive a detailed pedigree, which traces the origin and transaction history for that particular product back to the manufacturer or the authorized distributor.

Express Scripts’ purchasing policies are designed to eliminate counterfeit and diverted drugs from entering its pharmacy stock.

Confidence in the Safety of Medications

At Express Scripts, we have a responsibility to vigilantly protect our supply chain. Increasing globalization of the pharmaceutical industry and evolving market dynamics require our diligent attention. We are committed to continually evaluating and improving our processes to provide products that keep patients safe and support healthy outcomes.

Author Bio

Lab Staff
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