One of the challenging situations that Pharmacovigilance functions will have to manage one day or another is a pharmacovigilance crisis. The management of the crisis itself requires a broad cross-functional reaction from the company which will not be discussed here, but there are a lot of practical aspects to consider regarding what can lead to a safety crisis and how to minimize the risk for a safety crisis to rock our world.
Though most pharmaceutical companies have set up a crisis management plan to handle financial, manufacturing or media crises, there is no common standard in the pharmaceutical world for what is a safety crisis, or what type of safety issues can escalate into full crisis mode. However, there is common agreement that it all starts with issues which can represent risks being identified (or sometimes not recognized), then those issues escalates into actual risks, which can turn into a full crisis mode if certain conditions are met (dependent on the nature of the risk, the population impacted, the media coverage, and often how long the stakeholders will remain in the state of denial that something is brewing...). A crisis “occurs when new information, which could have a serious impact on public health, is received (…), and which requires immediate action”[1], or a crisis “underlines the inability of an organization to have a major influence on its course and the speed with which the flow of events escalates during a crisis. A crisis is a major, abrupt and often unexpected event that has a potentially negative outcome for an organization and its employees, products, services, financial situation and reputation”[2].
Most crises result from severe non-compliance to regulations, to established standards or to fundamental ethical principles. When such situations unfold, they lead quickly to growing and uncoordinated communications (from media, regulators, or any type of stakeholders), each triggering additional reactions and emotions. This escalation becomes quickly out of control and it becomes difficult to maintain the narrative and to ensure a reasonable debate around the facts and the actual risks. Any crisis will always bring significant damage to the company’s activities, reputation and assets. This will also impact all parties identified as co-responsible in the crisis outbreak, such as regulatory agencies or the scientific community. Many times, a crisis will bring unacceptable behaviors to daylight and will bring better practices and standards.
Sometimes however, a crisis will appear like an exaggerated reaction from the media, the public (or the regulators…), due to a difference in the perception of risks and interpretation of facts. We will focus on the latter, concentrating on what we can do to prevent known and accepted safety risks from evolving into unmerited crisis situations.
There are no regulations or guidelines mandating how companies should be organized for safety crisis prevention, detection, and management. Regulations or structures in place at the EMA[3] or FDA [4] describe mostly what the Regulatory Agencies should do in case of safety crisis, disasters or pandemic situations, but do not give information applicable to companies on how to prevent such situations. However, if you look at the spirit of all the safety regulations and guidelines, it is quite clear that their intent is indeed focused on detecting and recognizing issues and risks, and reducing these, with the indirect consequence of preventing the occurrence of a safety crisis. So, would it be enough to say that, if you are compliant with applicable safety regulations, you are out of trouble? That would certainly a great start, but there might be other aspects that you need to look at.
Some Crisis Prevention Principles
There are several fundamental rules that any enterprise should implement and enforce in order to minimize the risk of a crisis to occur. These rules apply broadly to all functions contributing directly or indirectly to safety data collection and management.
Expected behaviors and processes should be clearly defined through a Code of Conduct, Business Ethics and Compliance, Fraud and Misconduct identification and reporting: many companies have gaps in their Corporate Policies, and that translates into lack of adequate values and model to follow down the food chain.
The Quality System in place should be consistent throughout the organization, starting from the enforceable Policies (general principles governing the companies and third-parties’ activities), down to SOPs and detailed Work Instructions: all operational activities should cascade down directly from a consistent, robust and comprehensive Quality System. Too many companies have loose Policies, which oblige functions on the ground to figure out what best practices to follow. This is an opportunity for a loose cannon to go off on a tangent and creates a fertile ground for a crisis to happen.
A truly independent and experienced Quality Assurance group has to measure, through dashboards and audits, the compliance to established standards regarding behaviors and activities; there should be no compromise in the execution of its mandate and this group must be able to resist peer pressure when necessary in a for-profit environment.
A well-established and clearly understood Safety Governance Model, handling the adequate management of safety information from all sources through a tiered model, will ensure the consistency of decisions and actions throughout the company. This will ensure that all safety decisions are made with all relevant stakeholders involved, and that they are transparent, documented, and aligned with the company mission and ethical values.
Other Key success factors for Crisis Prevention
There are many other variables that can have a significant influence on the probability for a crisis to happen. These include but are not limited to:
implementing a culture of positive and open communication, enabling individuals to recognize and escalate issues without fear of retribution or negative impact;
the ability to recognize potential outcomes from any risk identified; always giving serious consideration to the worst possible case scenario, beyond the usual reasonable and expected. Denial of issues is a major contributor to crises…
ensuring the independence of individuals and groups working on establishing and measuring quality standards, including the ones embedded into the functional groups (such as Quality, Standards and Training roles);
a clear accountability of actions and decisions at all levels;
fostering a culture and a way of working which breaks siloes and helps cross-functional collaboration across entities and geographical regions.
Companies will be better prepared to detect safety issues and prevent crisis if they:
conduct a strategic and critical review of the established processes and structures;
honestly assess how much the company culture and leadership style are likely to increase or decrease the risk of a crisis to occur;
aggressively implement corrective actions to address the identified weaknesses or threats;
measure the impact of these correction with a continuous improvement mindset.
Instead of using its precious resources to manage a crisis that should have never happened, this will allow the pharmaceutical company to focus on its corporate mission of improving patients’ lives.
[1] EMA Volume 9A 2.B.2 [2] Koster & Politis-Norton, Drug Safety 2004:27 (8): 603-608 [3] EMA Incident Management Plan [4] FDA Crisis Management
JP Clement, MD
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