Patient Safety

The global pharmaceutical market is massive, with over US $700 billion in sales during 2007 according to IMS Health, with the United States representing approx. 40% of the total. In a market where an individual or organization may make more money with less risk selling counterfeited or diverted pharmaceuticals than they can selling illegal drugs, patient safety is increasingly under attack. At the end of the day, a key goal of participants throughout the global supply chain is to ensure the safety and efficacy of drug products dispensed to the patient.

Growing Global Issues

Taking a closer look at some of the recent statistics reveals just how daunting of a problem protecting patient safety can be:

• World Health Organization estimates that between 5% and 10% of pharmaceuticals worldwide are counterfeit.
• U.S. Customs and Border Protection has more than quadrupled its interceptions of illegal prescription drug parcels to nearly 10,000 per year.
• One counterfeiting organization gained $1 million in just a week, according to testimony to a 2004 Health and Human Services task force.

The US-based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010.

• More than 600,000 Americans may have received a 30-day supply of counterfeit Lipitor® in 2003 before the $55 million recall occurred. The product helps reduce cholesterol.
• Criminals pocketed $28 million in a single transaction for diluted Epogen® which is used by kidney dialysis patients for anemia.
• As many as 25,000 cancer patients may have received sub-potent medicine that was one-twentieth the strength prescribed by their physicians when Procrit® was relabeled by US counterfeiters. Only 8,000 of 110,000 vials were recovered; the counterfeiters gained approximately $46 million.

Product Security Threats Come in Many Shades

Virtually all kinds of pharmaceutical and medical device products may be at risk of product security and integrity threats. While most of the headlines focus on completely fake products, the reality is that security threats take on many forms:

"Some of the experts are telling us it's more lucrative to sell a counterfeit drug than it is a narcotic such as heroin."William Hubbard, FDA associate commissioner for policy and planning
Source: WebMD

• Counterfeit
  Drug counterfeiting comes in many forms. Completely fake product may be produced and sold as legitimate, with the ingredients ranging from water to baking soda. Legitimate product may be tampered with. Contents may be partially substituted so the effective dosage is decreased. Labels may be altered to increase perceived content dosage or lengthen purported shelf life. Finally, Not Fit-for-Use product, including completely expired product or recalled drugs may be passed off as legitimate. Counterfeiting doesn't just threaten finished drug products. A growing health threat has recently risen due to fake or diluted active ingredients or excipients (substances that bind active ingredients) used to create finished products.
  
  
• Theft
  Drug products may be intercepted in transit. A single pallet of pharmaceutical products may have a street value of hundreds of thousands of dollars, proving a tempting target for organized crime. Theft may occur within an organization as well, as employees seek to profit from rising drug prices or easy street resale of "lifestyle" drugs.
  
  
• Improper Handling
  Drug efficacy can be affected even when traveling through legitimate drug channels when appropriate care is not taken to handle drugs correctly. Biopharmaceuticals often are particularly sensitive to the temperature range they experience from manufacture to dispensation, mandating a closely watched cold-chain distribution process.
  
  
• Diversion
  Diversion is the means by which counterfeiters, thieves, and other entities outside the legitimate supply chain distribution network generate profit. Counterfeit and stolen product must be introduced into the legitimate supply chain in a systematic way for steady profits to be made. FDA's Office of Criminal Investigation (OCI) has stated that every case of counterfeiting is accompanied by a matching drug diversion incident. In addition, diverters may seek to profit within the legitimate supply chain by diverting drugs from low cost distribution channels or geographies to high cost ones, pocketing through arbitrage the cost difference.

Unfortunately, virtually any kind of drug product is at risk from these threats, from expensive lifestyle and anti-cancer medicines to steroids, pain killers, cholesterol lowering drugs, and antibiotics.

"The company [Eli Lilly] said it spends more than $1 million a day to fight drug counterfeiting around the world"Source: Indianapolis Star (01/22/08)

Financial Impacts of Patient Safety Threats

The financial impact experienced by a company due to counterfeiting and diversion may far exceed the actual loss from the specific incident. A company may face several indirect costs with add to the financial impact. A counterfeiting incident where the exact scope of the problem is hard to pin down may result in a product recall of an entire lot of manufactured product. Public disclosure of product integrity issues may erode the public confidence in a brand, creating incentive to switch brands. The documented reaction to an adverse event affecting public health can play a key role in determining the level of corporate liability if lawsuits loom.