Can Pharmacovigilance Learn From the Oil and Gas Industry, Which Has Been Outsourcing for Over a Century?

Therapeutic Innovation
& Regulatory Science 1-5

Bert P. van Leeuwen, MD1, Christine Prendergast, MSc2, Brian Edwards, MD, MRCP3, and Barbara Dawson, BSc(Hons)4

Submitted 10-Jun-2016; accepted 20-Jun-2016

Abstract

Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for initiating as well as maintaining an outsource relationship. In this paper, the authors propose that the sector can learn from other industries that have been outsourcing activities for a much longer time, such as the oil and gas industry. The Safety Case is put forward as a body of evidence that facilitates the continuous exchange of data, especially focused on risk management of the relationship between outsourcer and vendor. Finally, the authors will make an attempt to come to a global consensus in this area through the Allliance for Clinical Research Excellence and Safety (ACRES) network.

Introduction

While companies in the oil and gas industry started out in the 19th century as ‘‘complete’’ companies, performing everything themselves from drilling to refining to retail, nowadays out- sourcing is a well-established part of the industry so much that the drilling contractors are a subset of the industry branch on their own. Outsourcing in the pharmaceutical industry started only a few decades ago, first in research and development, then in pharmacovigilance (PV), and has really started to soar throughout the industry since 2005. However, there are no (global) standards and guidelines for pharmaceutical outsour- cing in general and PV in particular. Would it not be wise for the pharmaceutical industry to examine the outsourcing experi- ences of other safety-critical sectors to see what we can learn from their experience—similar to the concept of risk manage- ment—rather than reinvent the wheel ourselves? After all, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q10 Quality Management, as we know it now in the pharmaceutical sector, largely originates from the vast experi- ence (both positive and negative) of sectors such as the oil and gas industry and their experience with standards such as those created by International Organization for Standardization (ISO; http://www.iso.org/iso/iso_9000).

Regulations: Prescriptive or Goal Oriented?

As described by Leveson,1 the mostly prescriptive regulations set standards for the production and the product (requiring specific design features for products or details in processes) that often have to only be passed once. The other type, ‘‘performance-based regulations’’ that focus continuously on output (the products or the results) without specifying the details about how to get to that, have been implemented in a low number of cases since the 1980s. A systems view is more subtle, requiring control of the production/product or activity (by means of in-process quality control) and checks on main- taining of standards, in short, a continuous feedback loop. In order to better guarantee proper safety and risk management, a more flexible and adaptive approach to reaching these goals should be required. This approach should be continuously oriented toward safe performance, based on goals for all sta- keholders in safety and not just the regulatory agencies.

Outsourcing Practices in the Oil and Gas Industry

An example of such an approach has been the Safety Case,2,3 established over the past 40 years in industries such as the railways and oil and gas. Although discussed as part of nuclear industry regulation, the Safety Case arose from the high-profile analysis of the independent public enquiry into the Piper Alpha disaster chaired by Lord Cullen.4 This system of goal-oriented risk management focuses more on the continuous evaluation and assessment of hazards and safety than a prescriptive approach to processes and product standards. The prescriptive nature of many regulations is mostly based on anticipated risks, whereas a more goal-oriented requirement would lead to com- panies being or becoming more resilient and having to reach the same goals under different circumstances.5 With the chang- ing environment of the Internet, social media, and Big Data, assuring patient safety in PV by collecting individual case safety reports (ICSRs) based on rigid, prescriptive regulations, would look very different under goal-based regulations.

The widely accepted Health, Safety and Environment (HSE) Case Guidelines6 for land drilling contractors were actually proposed by the drilling contractors themselves (International Association of Drilling Contractors [IADC]). These guidelines are mainly focused on internal quality and risk management for health, safety, and the environment; they can also be—and are being—used for external contracts (ie, for the companies con- tracting the drilling out to them).

The chapters in the HSE Case Guidelines are based on well- established topics:

Chapter 1: Health and safety introduction
Chapter 2: Management system of drilling contractors Chapter 3: Rig description and supporting information Chapter 4: Risk management
Chapter 5: Emergency response
Chapter 6: Performance

Apart from a description of the organization and hardware, they prescribe the risk management system, the handling of emergencies as well as the performance of all these routine activities. Furthermore, these are presented voluntarily to the companies wanting to outsource the drilling activities. This is in line with the well-established standards ISO 45000 (draft on occupational health and safety management, currently OHSAS 18001), ISO 14001 (environmental management), as well as ISO 9001 (quality management). The latter, for instance, requires a producer to inform the customer about his lack of knowledge at the time when the customer defines the require- ments of the delivery of services.

While several elements described in the guidance above may look familiar to ‘‘pharma PV people,’’ others such as the Risk Assessment Matrix (Figure 1) will not. Nevertheless, this matrix shows how risk assessment can be visualized. Tools such as these improve the communication between drilling companies and outsourcing companies. An equivalent level of communica- tion of information is not standard in PV specifically with regard to sharing information regarding lack of knowledge both from ‘‘vendor to company’’ and ‘‘company to vendor.’’

It should be noted that the IADC guidance focuses only on risk management concerning health, safety, and the environ- ment. It does not encompass broader business risk management in the wider system. The HSE Case Guidelines in this guidance provides assurance that risk management (‘‘risk reducing con- trols’’) is performed (on a continuous/regular basis) that will reduce risks to a level ‘‘tolerable’’ for the outsourcing com- pany’s standards. Interestingly, such an approach is consistent with the concept of risk tolerance principles mentioned in the ICH E6 Addendum7 out for consultation.

More recently, the oil and gas industry suffered a serious setback in public confidence because of the Macondo disaster in the Gulf of Mexico in 2010. It became apparent that the Safety Case had not always been properly established and maintained. Although standards in the oil and gas industry are high, there is significant variation between companies and some do not always abide by the Safety Case principles. Fol- lowing an independent inquiry by the US government of the Macondo disaster, the Ocean Energy Safety Institute was estab- lished to act as a forum for dialogue, shared learning, and cooperative research among academia, government, industry, and other nongovernmental organizations to drive development of a safety culture in the sector. This includes an in-depth review of outsourcing practices in the context of Safety and Environmental Management Systems (SEMS). No equivalent organization exists for the pharmaceutical sector.

Discussion Comparing the Oil and Gas Industry With the Pharmaceutical Industry

This discussion around the trials and tribulations of outsourcing

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