@Risk

Prescription drug shortages are increasing healthcare costs and putting patients at risk, according to a new study released last week by Premier healthcare.

The majority of drugs that are in short supply are needed for sedation, emergency care and chemotherapy, and the Premier healthcare alliance analysis concluded that the shortage cost US hospitals at least $200 million annually through the purchase of more expensive generic or therapeutic substitutes. The total economic impact is likely much higher, since the research excluded drugs purchased on the “gray market” or those with therapeutic alternatives. It also did not include indirect costs, such as added labor needed to manage shortages and secure alternative supplies.

Premier surveyed experts from 228 hospitals and found that over a six-month period in 2010 (July-December): (more…)

Pharmaceutical companies are facing increasing pressure to update their supply chains.

For some, it’s going to be an uphill battle.

A new report from PwC US concludes that many pharmaceutical supply chains have suffered from what amounts to benign neglect. Now, they are inefficient, under-utilized and ill-equipped to cope with new medicines, cost pressures and health reform expectations.

Essentially, the pharma supply chain needs to adopt a new consumer-oriented focus. As a result, PwC says we can expect the pharma supplier network to become: (more…)

The European Parliament has approved a new law to help prevent fake drugs from entering the supply chain. The legislation introduces new safety regulations, traceability measures and sanctions against counterfeiters.

The problem of counterfeit drugs is a growing concern throughout the world. Researchers estimate that 1 percent of medicinal products sold to the European public through the legal supply chain are now fake. In other parts of the world, more than 30 percent of the medicines on sale can be fake, and counterfeiters appear to be increasingly targeting innovative and life-saving drugs.

An article at PharmaTimes outlines provisions of the new EU legislation. For instance, the new regulations require that: (more…)

Supply chain security is now a top concern for companies throughout the pharmaceutical industry. Several recent high profile cases have underscored vulnerabilities, and most pharma organizations now recognize that a holistic approach is required to detect and prevent adulteration, counterfeiting, illegal diversion, and theft.

Last month, ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, released a white paper to help firms address these critical supply chain issues. “Supply Chain Security: A Comprehensive and Practical Approach” encourages pharmaceutical companies to strengthen their overall supply chain security by adopting a layered approach that includes:

• Signal detection and response

• Supplier quality management

• Management of logistics and transportation services providers

• Additional specific programs

I found the discussion of signal detection and response particularly interesting, as it illustrates how adulteration of one particular excipient can have broad effects on the quality of finished products across several countries and can impact several organizations. Here’s an example from the report: (more…)

The counterfeiting of pharmaceuticals is growing in both scope and impact, and now manufacturers and regulators alike are searching for more sophisticated traceability systems.

One “breakthrough approach” currently in development will allow manufacturers to label their products with a two-dimensional dot-matrix that is linked to an online database. GB Innomech, the company developing the new coding system, says this new approach is low-cost and effective: (more…)