Article: The Cost of Failure Part 2: The Patient

By Ruediger Lomb |

The pharmaceutical industry is quickly realizing that the value that a quality-first mindset creates within the supply chain far outweighs the cost savings associated with not investing in it. By focusing exclusively on cost-cutting in the supply chain — at the expense of the product and its delivery— you risk the wellbeing of the patients that you aim to treat.

Quality within the supply chain must continue after the product has left the manufacturer. However, quality can only be properly achieved when the right patient, receives the right drug, at the right time and in the right condition - demonstrating the significance of post-manufacturing delivery as a critical part of the supply chain and quality equation. But why?

The purpose of drug manufacturing and specialty logistics is to move healthcare forward, with the overarching aim of improving patient wellbeing. Yet a lapse in quality has the potential to cause excursions in delivery time and temperatures which can adversely impact the product and consequently, your patient’s health in a multitude of ways.

What does a lapse in quality really mean for the patient?

Failures in storage or transportation can cause a drug to lose its efficacy. When the complex therapies of today are exposed to excursions, they can suffer degradation of their active component that makes that drug so effective. If clinical professionals were to administer this drug to the intended patient they run the risk of providing a dose that has little to no effect on that patient’s health, which could adversely impact patient wellbeing and the clinical outcome. Additionally, to not administer the drug - the most likely scenario – forces patients to wait for new product to be manufactured and shipped to the clinical site, which can take up to 6 months [1] at which point it may be too late.

Whether an ill patient has to wait for new product to be shipped or remade, their current symptoms risk exacerbation. As well as this, rescheduled appointments and necessary travel may cause them undue stress, which compromises their condition further. In the worst-case scenario, a delayed dosing can be fatal. 

clinical trial waiting room

For patients who are part of a clinical trial study, the results can be just as damaging. Excursions may force the need to reschedule appointments which, while risking additional stress to the individuals, may also prompt them to lose confidence in the study. This increases the risk of patient dropout as well as the risk of the patient refusing to seek further treatment – which again could prove harmful. Should these dropout rates increase, sponsors also run the risk of their study being delayed or even discontinued – disrupting innovations in the industry that could be lifesaving.  

Regardless of a patient’s current state of wellbeing, any delay in treatment has the potential to negatively impact health and may lead to patient interventions to mitigate any adverse symptoms that arise. This could force your patient’s condition to worsen, and can be expensive and even critical if not acted on.

Clearly the risks that a lapse in quality can have on a patient far outweighs the costs attributed to the sponsor when not investing in the quality of your supply chain providers– as described in The Cost of Failure Part One. Moreover, while regulatory requirements have significantly increased, innovations in technology and logistics have produced breakthrough improvements in packaging and shipping, meaning the risk of an excursion in your shipment is heavily minimized should you invest in a proven quality logistics provider.

[1] https://www.worldcourier.com/insights/the-cost-of-quality
Topics:
Quality

About the Author

Portrait of Ruediger Lomb

Ruediger Lomb

Vice President, Global Quality & Compliance
AmerisourceBergen Global Commercialization Services & Animal Health
As the Vice President, Global Quality and Compliance for World Courier, as well as for Integrated Commercialization Solutions (ICS), Dr. Ruediger Lomb oversees the quality program for both entities, ensuring facility and process compliance with all current and future GxP standards such as relevant FDA guidelines, the most recent EU Good Distribution Practices Guidelines and other relevant quality standards. Dr. Lomb is a licensed pharmacist and holds a Ph.D. in pharmaceutical biochemistry.
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