Coherence is the essence of everything successful. Then we add integrity.

July 2015

IARMM 4th World Congress of Clinical Safety

29. july 2015 at 13:28 | Veronika Valdova |  Risk Management
Arete-Zoe announces participation at IARMM 4th World Congress of Clinical Safety in Viena, Austria, with contribution on Philosophy and strategy of clinical risk management and governance.

Date: 28-30th September, 2015

Title: Are regulations becoming a negative factor in pharmaceutical safety? Lessons from Three Mile Island

Abstract: Pharmaceutical and clinical research industries are global in nature. Most clinical trials are conducted in multiple jurisdictions and often on several continents. Pharmaceuticals are manufactured in large centers in Asia and transported over vast distances to target markets. At the same time, regulations are enforced predominantly at national level with little emphasis on soft law in the form of international guidelines unless implemented directly in national legislation. Once regulations become as voluminous and complex as those now in place in the pharmaceutical sector, they can serve as a negative factor in patient safety. Conclusions from the Three Mile Island accident report are used to demonstrate the same type of risk factor in a different industry. Because of the sheer volume and complexity of pharmaceutical regulations, the industry invests tremendous efforts into compliance with these regulations, equating due diligence and compliance with 'safety' as a result. It is, of course, the responsibility of the respective lawmaking bodies and regulatory agencies to write laws and issue regulations to ensure only drugs and biologics with favorable risk:benefit profile are made available to the public. Governments and regulatory bodies rarely take synchronized action to design an inherently safe system with adequate coordinated controls. Regulatory agencies use different algorithms for assessment of risk, depending on local circumstances, culture, and information and resources available, as well as political risks stemming from widely publicized failures. This paper argues that due diligence and compliance with national regulations alone is not enough to manage risks and ensure patient safety.

Využítí STAMP ve vývoji léčiv

27. july 2015 at 8:00 | Veronika Valdova (@AreteZoe) |  Risk Management
STAMP ve vývoji léčiv

STAMP is based on systems theory and accounts for:
•Complex human decision making
•Organizational and managerial aspects of systems (safety culture, management decisions)
•Adaptation of systems over time (migration toward hazardous states)

Most hazard analysis techniques focus on failure events.
Principle: identifying the failure events that can lead to a hazard.
•Most popular: Fault Tree Analysis (FTA) & Failure Modes and Effects Criticality Analysis (FMECA)
•Clinical research and post-market drug safety: record of past incidents (ADR reporting systems, i.e. FAERS, EudraVigilance, WHO Vigibase)

In system accidents the losses stem from dysfunctional interactions among operating components rather than failure of individual components.
•In STAMP, the cause of an accident is viewed as the result of a lack of constraints imposed on system design and operations rather than an event.
•The objective is to identify the design constraints necessary to maintain safety and to ensure that the system design and operation enforces these constraints.

Utilizing STAMP to create control structure of selected critical points in drug development, approval and commercialization on the example of TeGenero case study to explore the usability of STAMP in the Pharmaceutical Industry.Can drug development timelines be compressed while increasing regulatory confidence that public health interests and protections also advance? For the answer to be affirmative, biotech and pharmaceutical companies need to focus their attention to hazard identification and implementation risk management techniques. This proposal builds on presentation Global Pharma, risk analysis primer: An intentional interaction with uncertainty.

System Theoretic Accident Model and Processes (STAMP) will be used to construct control structure of individual critical incidents in two case studies: TeGenero, as an example of a First-In-Man Trial, and Avandia,a post-market surveillance study.

The potential benifits of utilization of STAMP to enhance quality and consistency of regulatory review will be explored as well.

TeGenero studie

New Zealand: The 1080 crisis

20. july 2015 at 8:00 | Veronika Valdova (@AreteZoe)
New Zealand: The 1080 crisis

Book: Women's Medicines

18. july 2015 at 12:27 | Veronika Valdova |  Medicine & Pharmacy
Medicines for Women

Edwards B, and Valdova V: "Political and religious perspectives on managing the risks and benefits of women's medicines," in Medicines for Women, ed. Mira Harrison-Woolrych (Springer, 2015).

Pharmacovigilance systems for regulating and controlling safety of medicines do not differentiate between those exclusively for women and those for men. And yet, the societal circumstances for certain women's medicines - especially where such medicines affect reproduction - are so obviously different from other medicines, we wished to examine what evidence exists to define how religion, cultural traditions, politics, economics, history and a society's view of science impacts the safe use of medicines by women. This is a large and complex subject which cannot be covered completely in this one chapter, but we aim to give an overview and to draw on specific examples from around the world to illustrate some of the many interesting issues.

Review of the chapter by Frank L Wallace, MD, MMS

The fundamental issue is one of gender inequality and on a global level, no less. For most of recorded history, human societies were largely paternalistically driven with women relegated to a secondary, even distant second-class status. The male of any hierarchal structure determined what was best for, and what, the woman would be allowed to have. A coequal relationship was extremely rare, if at all, to occur historically. We see that most glaringly today in what is called the emerging, undeveloped world. This ages-long accepted gender inequality itself can be reduced to an anthropological issue with how it manifests secondarily in all the social, political, religious, cultural, and finally biological spheres, impacting collectively women's health. The resultant barriers for women to obtain essentially coequal health determinism have been well discussed in the entirety of this book. To be sure, there has been slow progress in granting women equality in the last 100 years, but it has been uneven throughout the world and inconsistently practiced. Despite the 1994 ICPD historic milestone resulting in the 4 tenets under its Program of Action being a platform for 179 signatory governments, the UN and WHO follow on actions furthering these tenets, and ACOG's championing women's unrestricted EC access, we are still left with dealing with very little real movement in this kind of gender health equality. Otherwise this book would not have had to be written. Until the fundamental anthropological mind-sets at the heart of all these secondary barrier issues are changed, there can be little expected in the way of immediate resolution to women's health. But, it can be done with patience slowly over time through the continued actions advocated in this chapter and book.



Frank L Wallace, MD, MMS (AVATAR Worldlink)