Communication in Drug Safety Crisis management | Communication in Pharmacovigilance | Pharmacovigilance Unit 3 Notes

Definition of Crisis: Any event that comes to public notice and threatens the health or safety of individuals or groups, or the reputation or stability of an organization. Crises usually erupt suddenly and dramatically; they require rapid and effective response and communications.

Management of a crisis requires not only resolution of the crisis event, but also very skilled management of the often intense emotions and outrage that the public may feel.

Unexpected or not?

Crises are generally regarded as sudden and unexpected, but many arise from conditions where there has been a history of neglect, carelessness or poor safety management; where warning signs and vulnerabilities have been ignored. Many crises were long in the making and were waiting to happen; many of these could have been prevented or the damage they caused reduced through early awareness, planning and action.

Prevention of Crisis Management

Every system and organization has actual or potential weaknesses and vulnerabilities arising from internal and external sources. Every aspect of management and safety systems, communications, data collection; staff motivation, knowledge and commitment; quality control, supplier management, and so on, needs to be examined for any potential failures, weaknesses or problems: what could possibly go wrong and how can it be anticipated and prevented?

The second aspect of prevention is being in a high state of alert for early, maybe weak signals of problems: a handful of ADR reports; a newspaper report of patient injury; new safety concerns emerging in another country; unexplained failure of treatment; anything that could escalate over time into a major crisis. Bureaucracies tend to stifle dissent and minor signs of possible trouble, sometimes leading to explosive problems later on: when, as so often, there were early signs of problems, how can an organization hold up its head and convincingly explain its neglect of them?

The third element of crisis prevention is reputation. An organization that has open communications with its audiences, conscientiously explains what it is doing at all times, is known and trusted, will suffer far less in crisis than one that is regarded as remote and secretive. A regulator that has thoroughly and openly communicated about the risks of medicines and its activities will be subject to much less criticism than one that has been defensive and distant; indeed some crises arise simply because patients, or the media, or healthcare professionals have been kept in the dark about what is going on and are angry and hostile when the facts eventually emerge. All organizations need to be actively communicating with their audiences at all times; when crises emerge, a familiar voice is more likely to be trusted, even forgiven.

A sudden batch of unexpected and serious ADRs

This is one of the commonest causes of crisis in pharmacovigilance for which every PV centre should plan. The issues and relationships and communications are more complex than in the case of fires, but the basic crisis management process is exactly the same:

• Identify the risk: unexpected injury to patients and public outrage
• Assess the risk: probable and serious
• Initiate preventive measures: a constant state of high alert and attention for any evidence or allegation, however seemingly weak, from any source, of unexpected injury or death or other problems
• Establish procedures for rapid investigation, review, analysis and decision-making about problems, and for communication with all stakeholders (this may require, for example, immediate access to pre-designated technical experts to be sent out into the field)
• Review and rehearse procedures prior to crisis erupting.

Steps of Crisis Management in Drug Safety

1. Step one: Context analysis of the project of drug safety crisis management:
It is a subsystem of the international drug monitoring program. All processes influencing in the main process of drug safety should be reviewed. These processes include:
manufacturing, prescribing, order communication, packaging, labeling, nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use. Sometimes it is necessary to make some changes in each of mentioned processes to conduct drug safety crisis management.

All threats, weaknesses, strengths and opportunities should be monitored in this step. Table 2 shown in lecture(see above for link of lecture) a sample PESTEL approach for drug safety crises management.

2. Stakeholders analysis
Table 1 (see above for link of lecture) shows common stakeholders involved in drug safety crises.

3. Problem analysis
Root- cause analysis should be conducted in this section, e.g., in case of mioflex, there were errors in different levels of drug handling. Problem tree can be helpful in this section.

4. Objective analysis
Objectives should be discussed in different levels.

a. Overall objectives: e.g., Improving drug safety

b. Purpose: e.g., preventing adverse events induced by suspected medicine in drug safety crisis

c. Results: e.g., abrupt discontinuation of observed adverse event in drug safety crisis

5. Activities Scheduling
It is recommended to prepare a list of necessary activities to manage drug safety crises. These activities can be divided to two types. The first group includes activities required for controlling of the crisis. The second group includes required activities for preventing similar crises in the future.

6. Resource scheduling
It is recommended to preparing trained team for evaluating drug safety crises, predict budget recourses, issue necessary regulations and guidelines and prepare
required equipment.

7. Indicators recognition
Success indicators should be determined and the tools for its assessment should be predicted, e.g., in Mioflex example, immediate recall of the product from community
pharmacies and no other occurrence of the reaction can be considered as indicators which can be assessed by inspection and scanning IPC database.

8. Risk analysis:
Factors with possibility of negative impact on the project of drug safety crisis management should be recognized and alternative strategies should be taken, e.g., in case of
counterfeit lidocaine, multiple resources for producing counterfeit product should be regarded

MCQ given in Video Lecture –  watch it & Solve them