Product Recalls and the Need for Pharmaceutical Distribution Software

Mark Canes

As you can imagine, the pharmaceutical industry is characterized by many regulations and an abundance of meticulous standards that must be met by suppliers and distributors. As an increasing number of products enter the marketplace, the need for tight control measures becomes more prevalent in order to ensure public health and safety. The onus now lies with the suppliers and distributors to meet (perhaps exceed) the standards in place. However, despite these standards, certain circumstances have arisen where products have needed to be recalled in the interest of public health. Some of the most prominent drug recalls in terms of scale and magnitude include:

(1) Fenfluramine/Phentermine (Fen-Phen) – developed by Wyeth-Ayerest Labs was recalled in 1997 after 24 years on the market. Fen-Phen was a popular weight loss drug taken by approximately 6.5 million people to help combat obesity. After many users began experiencing heart disease and other related illnesses, the FDA set a recall in motion. The result was roughly $14 billion in damages paid to victims.

(2) Cerivastatin (Baycol) – developed by Bayer and was prescribed to patients as a treatment for high cholesterol and was later linked to a severe muscle disorder. It was recalled in 2001, after roughly 4 years in the market. Damages paid to victims totalled roughly $1.2 billion.

(3) Rofecoxib (Vioxx) – widely considered to be the largest drug recall in history, took place in 2004 after 5 years on the market. Vioxx was prescribed to more than 20 million people as a pain reliever for arthritis; unfortunately, it was found to be responsible for increased risk of heart attack and stroke. Evidence suggests that nearly 140,000 people could have suffered from serious heart conditions as a result.

Visit this website for more information on these recalls and others in the industry.

Despite the standards in place and the sheer amount of testing and preparation involved in bringing a product to market, situations like those above may still arise. In the first example, it wasn’t until nearly a quarter of a century later that complications were discovered. As a result, a growing number of distributors have turned to ERP vendors to provide a system that can not only be fully integrated into their everyday business operations but also provide flexibility to meet pharmaceutical industry-specific requirements and the ability to act promptly in dire circumstances. Some of these features include:

Lot Tracking

One of the major pillars of an effective pharmaceutical distribution software platform is the ability for lot (batch) tracking. This will provide a company with the ability to keep track and account for which customers received specific groups (or shipments) of items and when those specific items were received. In addition, the date that the items were purchased as well as the supplier that they were purchased from is also tracked.

DEA & State License Expiry Management

Effective ERP systems can successfully identify the type of license, state, license number, expiry date, and allowable drug schedule for each customer in the system. This information needs to be easily accessible to provide users with the ability to generate reports about licenses approaching expiry.

Pedigree Management

Adhering to FDA standards, pharmaceutical distributors need a system that includes pedigree management. A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties. The pharmaceutical distribution system selected by your company needs to provide the ability to enter information about a specific drug’s route from the manufacturer to your company.

These are just a few specific features that must be considered when deciding between pharmaceutical distribution software platforms. In addition to the pharmaceutical specific features listed above, the system should also be able to handle a company’s basic inventory, accounting, contact management, and order entry processes. This will ensure you implement an all-encompassing solution that will meet your basic business needs as well as the numerous pharmaceutical industry requirements and regulations. Should there be an extenuating circumstance where you are required to recall certain products, pharmaceutical distribution software will provide your company with the necessary tools to facilitate that response in a timely and effective manner.