Patient Safety Is a Collective Responsibility

THE WORLD HEALTH ORGANIZATION has deemed patient safety an endemic concern — one that our organization shares and addresses by putting patients first to ensure the safety and availability of critical-care medications we supply. But, we are just one of the key stakeholders, which include government agencies, manufacturers, healthcare providers and others, all working collectively to safely care for patients.

One sterling example of this joint effort is the vigilant management of the U.S. blood supply, which is considered the safest in the world. As noted in our article “Blood Protein Therapeutics: It All Starts with the Plasma,” the number of liters of human plasma from U.S. donors has increased more than 40 percent over the last five years to meet the demand for protein therapeutics, including immune globulin, hyperimmune globulins, albumin, alpha-1 proteinase inhibitor and activated prothrombin complex concentrate. Due to overlapping safeguards implemented by plasma collection facilities, manufacturers and others, the quality and safety of these lifesaving products are ensured and patient health is protected.

Admittedly, prior to safeguards now in place to screen blood donors, the hepatitis C virus (HCV) was transmitted through blood donations. Today, highly accurate tests detecting HCV prevent carriers from donating. Still, the disease continues to plague thousands, who, for decades, have been treated with limited effectiveness. Indeed, for those who could tolerate treatment, it resulted in just higher than a 50-percent cure rate. Until, as our article “Hope for Hepatitis C” describes, collaboration among researchers resulted in a “miraculous” breakthrough with the development of direct-acting antiviral drugs, the first of which have already been replaced by even more effective treatments to provide cure rates as high as 99 percent. And, scientists aren’t stopping there. For those few who experience treatment failure, “rescue regimens” are being developed.

Coagulation factor replacement products to treat the thousands challenged by bleeding disorders are also among the many new therapies being developed through industry collaboration. As outlined in our article “The New Therapeutic Renaissance for Patients with Rare Bleeding Disorders,” where manufacturers previously focused mostly on two predominant bleeding disorders, they have now turned their attention to the more rare hereditary and acquired coagulation disorders with the development of five new factor replacement therapies. And, as innovation continues, more are on the horizon.

But the mission to improve patient safety could potentially be in jeopardy from the newly recognized threat posed by what is now known as the “reproducibility crisis.” The development of medicines and therapies rests on scientific research, which relies on evidence. But recently, much research has been found to be “useless” because, when replicated, the results can’t be duplicated. In our article “Irreproducible Research: The Need for Study Validation,” we discuss the scientific and cultural challenges that are believed to be the culprits. Thankfully, identification of these challenges has led to changes already underway, with organizations like the National Institutes of Health and medical and academic journals, the study gatekeepers, reforming their systems.

As always, we hope you enjoy this issue of BioSupply Trends Quarterly and find it both relevant and helpful to your practice.

Patrick M. Schmidt

Publisher