Why do we need a risk management strategy for all new medicines? The objective of a risk management strategy is to ensure that the balance of benefits and risks of a medicines remains positive over the time when it is used in real world settings. Randomised controlled trials rarely represent real-life experience accurately. Health authorities have increasingly adopted new regulations mandating companies to proactively manage the risk for all their medicines.
There is some basis for suspicion of an association between the medicine and the risk occurrence, but it is not confirmed. There is insufficient or no data. Usually additional data or evidence must be collected, using a risk management plan. The association may either be adverse or beneficial, and is judged to be likely enough to justify verification. Risk management is the process of measuring or assessing risk and developing strategies to manage it.
Risk management is based on three pillars:.
Principles of risk management - EUPATI
However, the ultimate goal of any risk management plan is the same: to ensure patient safety. Risk management plans can also be requested by the EMA at other times, or whenever there is concern that a risk may be affecting the balance of benefits and risks for a particular medicine. This black inverted triangle is always applied to a medicine to indicate that it is under additional monitoring, usually for a five year period. The aim of the symbol is to notify and encourage patients and doctors to report any suspected side effects through their respective national reporting systems, so that any new emerging information can be analysed efficiently.
This reporting is essential and complementary to all other pharmacovigilance activities to better understand the risks and safety profile of a new medicine in a real-life setting. Data from this reporting will be analysed as part of the continuous assessment of the benefit-risk balance of each medicine during its life-cycle.
Lesen Sie unsere Cookie-Richtlinie Akzeptieren. Index 1 Introduction 2 Risk management strategies 3 Types of risk 3. Introduction No medicine is without risk , and the benefits of a medicine must always be weighed up against its risks. Risk management strategies Why do we need a risk management strategy for all new medicines?
Types of risk Identified risk There is adequate evidence of an association between the medicine and the risk occurrence. Potential risk There is some basis for suspicion of an association between the medicine and the risk occurrence, but it is not confirmed. Thus safety culture is one aspect of the organizational culture and can be defined as pattern of common attitudes regarding safety.
It must be considered on three levels:. The most obvious level, i. Their actions protect or jeopardize patient safety. The second level includes the conscious and thus also communicable attitudes of the colleagues regarding the value of safety in their organization. They may be congruent or discordant with the official statements of the hospital or the practice.
If those aims are focused on economic aspects, also the basic attitudes have an impact on patient safety. Generally the people are not conscious of those attitudes that are thus not communicable, but they influence the other two levels in a significant way. In this sense the conception of safety culture includes observable indicators as well as psychological aspects [ 2 ]. In this daily process of achieving safety, the staff members play a very important role.
In this context the IAEA defined safety culture globally as properties and attitudes of an organization determining that safety as highest priority is paid special attention to. Both conceptions belong together, but they have different meanings [ 5 ]. Safety climate describes a changeable, because individual, perception of the organizational staff. If staff members are asked, their reply will always be a snap-shot of the current attitudes, convictions, and perceptions on safety and risk shared at a certain time.
The safety climate of a practice or department can thus be measured and is generally inquired by means of questionnaires. Safety culture is more complex and describes properties that are present for a longer time and that cannot be changed easily. Assessing the actual safety culture of the individual ENT department or practice directly is nearly impossible and requires a deep analysis of the organization including also how staff members and management interact in order to find common perceptions of safety.
Although safety culture cannot be directly measured, there are often properties of this culture that can be associated. Those are among others [ 1 ]:.
Patient Safety & Quality
The way of interprofessional and interdisciplinary behavior staff members, nurses, physicians in hospitals, surgical team. The way of learning within the organization in particular learning from mistakes and incidents. This means that safety culture implies that all structures and processes within an organization, all workplaces and devices, the qualification of the staff and their relationships are designed in that way that safe action and interaction is possible at any time and at any workplace [ 6 ].
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- Clinical risk management.
So it becomes obvious that an efficient safety culture is not delegated to single responsible staff members e. The better the safety culture is in a practice or a hospital, the less undesired events occur [ 7 ], [ 8 ], [ 9 ] and the more staff members contribute actively to the assessment of errors or undesired events [ 10 ], [ 11 ]. Changes of values need time and motivation, therefore safety culture develops based on an adaptation to economic e.
Safety culture is a task to be fulfilled by the management. Efforts undertaken for changes that are only supported by particularly motivated staff members and that have to be enforced against the existing culture are generally not successful. Looking for positive characteristics that promote a safety culture, especially the following factors are important [ 6 ]:.
If an incident or accident with patient damage occurs, important safety-related information comes up unsolicited. Traditional attitudes and procedures of a department or practice are probably questioned. Based on a series of key aspects regarding the handling of safety-related information, different degrees of maturity of the safety-culture can be described. They will be further explained in the following.
Instead, attention is paid to the interaction of different factors concerning the people, the general conditions under which the incident has happened, and other influencing factors that might have been introduced probably several years before and that suddenly become relevant for the development of the incident. Seen from the systemic perspective, it is rarely a false action that leads to the undesired event.
A culture where everything is allowed and everything is forgiven would be beyond belief and risky in the eyes of the staff and so a just safety culture does not accept a general amnesty for failures. Because the personal responsibility of the individual is not denied, all staff members know that certain patterns of behavior endanger the safety and are thus inacceptable.
The human factor as risk and resource: Human factors render the action of the staff in the health sector unsafe and contribute mainly to the jeopardisation of patients. At the same time, however, the human factor is the decisive resource helping to realize patient hazard and to successfully avert the risk. Every time when an attentive person recognizes a critical situation or an error, finds a correct diagnosis and introduces corrections, human factors play a role. Orienting based on the theory of high reliability organizations HRO [ 17 ] : Big organizations of other economic sectors with comparably complex structures as hospitals can work without incidents and thus reliably and safe [ 3 ].
Supposing that an attentive organizational design and management can generally achieve safety and reliability of the processes, HRO exist according to certain principles:. Assessment of failures: Generally there is skepticism towards persisting and quiet phases of success because success bears the risk of an attitude of self-satisfaction and carelessness. That is why the staff focuses very much on failures and incidents.
Since little deviations may indicate problems in the system, they are considered as cost-free opportunities to learn. Caution against simplifying suppositions: Skepticism is shown towards simplifying suppositions and interpretations of events. In order to understand the complexity of the system environment differentiated and complex models and conceptions about internal and external events are preferred. Sensitivity for operational processes: Operational processes and normal routine are analyzed carefully with regard to their weaknesses and their potential for errors.
Respect of expertise: Decisions are made case-by-case at the point where the highest professional expertise for the problem is located. This high respect of professional expertise generally allows separating functional decisions from the formal hierarchy. Aspiration for flexibility and resilience: Staff members of reliable organizations know that undesired surprises may always occur. That is why the strive for flexibility on one hand in order to discover errors early and on the other hand in order to make the system more resistant by flexible adaptation in case of the occurrence of failures.
Intensive communication about deviations: In reliability organizations the staff members are explicitly invited to discuss actual states, deviations, individual intended actions, minimal events, and failures. The properties described here for high reliability organizations can be understood as encouragement for the development in otorhinolaryngology. Culture develops and changes, and so at a certain time within an organization there may be attitudes regarding safety of different intensity and changes may occur during time. This circumstance is taken in account by Diane Parker who described the model of maturity degrees of safety culture Figure 1 Fig.
This model shows the dynamism and multidimensionality of safety culture and its possibilities of development over five levels [ 19 ]. The increasing maturity of the safety culture leads to the fact that self-protecting and suppressing views become less important and that attitudes and actions focus on safety:. Based on the phases and corresponding aspects described in Table 1 Tab. The objectives of risk management in medical services with regard to the patients should aim at.
An effective risk management should not start only after the evaluation of an incident but it should start at a time when failure can still be avoided and damage can be prevented. In the context of risk management, an iterative process e. Since in many manuals all aspects of risk management in medical services are described exhaustively, the following paragraphs will only describe some important measures as examples that are relevant for a future improvement of the safety culture in otorhinolaryngology.
As the organizational safety correlates with its management of information, in particular. A second and very important pillar of a strong safety culture that will have to be implemented in otorhinolaryngology is the significance of good teamwork for a higher patient safety. ENT departments often focus on. First published results in this context seem to be promising. This information based on observed or experienced incidents, failures, or process deviations can be collected by staff members and transferred to the organization. Synonymous terms to describe this kind of reporting system are error reporting system, critical incident reporting system, or reporting and learning system.
Every incident should be reported that leads to a risk for patients, independently from the aspect if the incident could have been avoided or not and if it was based on misbehavior of the medical staff or not. Because of this functional description the term of error reporting system — not all safety-related incidents are caused by human errors — and the term of critical incident reporting system CIRS — not all reported incidents are potentially critical for the patients — are not really appropriate.
Based on a historical background, however, the term of CIRS has been coined so that it will further be used. An analysis of the information contained in the reports can be used to detect potential sources of errors and up to that time unidentified systemic weaknesses. Those error-enhancing conditions formerly also called latent errors can then be defused so that they do not become relevant at another time in combination with other factors. A second significant function of information can be an organization learning process [ 20 ].
If the report is made available beyond the individual practice or department to the public e. Moreover, IRS can only be introduced successfully when the basic presuppositions are present:. IRS are exclusively meant to avoid future incidents, their purpose it not to clarify questions of guilt or liability.
The property of IRS is to be proactive and solution-oriented. In order to assess all aspects of the incident other instruments e. IRS are participation programs that can only exist due to the readiness of the staff members to contribute with their knowledge about sources of errors and improvement possibilities in the processes of the hospital. IRS for itself is useless. In order to be effective, they have to be part of an probably only department-related system of risk and quality management.
Authors of the international literature mostly agree on the organization of incident reporting systems [ 22 ], [ 23 ], [ 24 ], [ 25 ]. The most important properties of an IRS are:. Anonymous and confidential reporting: The staff members must be able to rely on absolute confidentiality and anonymity of their reports. Anonymisation or disidentification of the reports must be performed before the public is informed so that only directly concerned people can suppose that the report describes the original incidence.
Freedom from sanction: A report must not lead to legal consequences for the staff members. The explicit written confirmation of the medical and nursing direction can be helpful in this context. The possibly applicable criminal responsibility or civil liability, however, is not abrogated by this confirmation. No legally relevant cases: Even if an anonymisation and disidentification of the reports before publication does not allow subsequent reconstruction of the incidents, a reporting of legally relevant cases is not recommended.
Since severe incidents are analyzed by other means the information that results from those investigations is at the disposition of the organization. Independent from, but supported by the management: IRS must be introduced and supported by the management. At the same time, the structure of the CIRS team should be independent from the hospital management. System oriented analysis by experts: If the systemic analysis of reports is meant to be systematic and successful, high expertise is required. This expertise can be present on site or imported in form of external analysis. Rapid response about the consequences: The reporting staff members must be able to see the benefit of their reports.
If a short-term change is not possible because of the complexity of the problem, a regular report about the current state of realization is helpful. Teaching of the staff members regarding the use of IRS: The staff members must be informed about the philosophy and the operation of an IRS and undergo continuous updating.
Some hospitals have made good experience with a kick-off event for introduction of the system. With respect of the pragmatic organization of an IRS, the following aspects are applied:. The questionnaire must contain free-text fields. Since the relevant information is based on a possibly detailed description of the incident and the accompanying circumstances, the focus of the questionnaire should be the possibility of inserting free texts.
Since a successful management of the incidents leads to safety-relevant information, also successful strategies for problem solution should be assessed [ 26 ]. The reporting threshold must be low because not only dramatic incidents are opportunities for improvement but also unimportant deviations from standards and routine procedures. The workload to submit a report must be low so that it can be integrated in the clinical routine that is characterized by time pressure. The most appropriate systems are user-friendly. Which system finally is introduced in a practice or hospitals is not relevant as long as the assessment and analysis of the reports corresponds to the mentioned criteria.
Often this decision is anticipated by the hospital owner or the hospital group. Since many systems do not allow an insight for external people, the organizational learning potential is not used by others. Some medical associations e. Reports that are introduced in an incident reporting system initiate a cyclical process consisting of report, analysis, measures, response. Beside changes, the report also launches learning processes within an organization organizational learning. The knowledge about the origin and the remedial action are supposed to remain and be effective in the organization even if the staff members involved in the incident are no longer present Figure 2 Fig.
Those steps are:. With the submission of a report by a staff member, the real work starts and so the decisive factor for acceptance and long-term implementation of IRS is based on the action resulting from reports. If IRS reports do not lead to visible changes the system will soon peter out. Since some reports touch very basic problems, their analysis and correction requires probably a long time and therefore regular communication about the current status of the management of those problems is important.
Staff members want to know that their reports are being read, taken seriously, and serve as inducement for changes. An informed culture knows about the safety relevance of an information loss at the perioperative interfaces: insufficient communication and unsatisfactory team work result in the largest part of safety-relevant incidents and complications in the perioperative medical services.
This is mainly due to the loss of important information associated with the communication deficit [ 27 ]. A standardized information transmission in form of structured briefings is most common in high risk sectors and has also the potential in perioperative medical services to improve teamwork and the quality of results [ 28 ], [ 29 ]. In order to make the quality of the processes and the results independent from the individual user, the introduction of checklists turned out to be useful. With the purpose to systematically address the aspects that are prone to errors of diagnosis or treatment, serial checklists were suggested for the different areas in perioperative medical services [ 30 ].
A direct transfer and unchanged acceptance of the original checklist is neither desired nor useful. Moreover, it should be adapted to the local circumstances according to certain rules [ 32 ] in order to guarantee the patient safety at the interfaces of the perioperative phases mostly extensively. Independently from the aspect which modifications are performed, it is important to guarantee the objective of a structured communication about the most important contents within the team.
Because the description in the mentioned publication is very extensive, the authors only want to indicate this publication instead of discussing it at this point. If there is an accepted best procedure for a repeatedly occurring task, this procedure should be applied by all staff members. The desired high similarity of the processes is achieved by standardization.
Standardization e. A type of standards that is very specific for practices or departments is the local definition of standard procedures standard operating procedures, SOP. An SOP is the detailed written description of a desired procedure that is meant to standardize the accomplishment of certain tasks. The advantage of those standard procedures for the individual is that they stipulate successful treatment concepts for many situations and thus the basic process quality allows a high quality of the results.
In the context of the team of the operating room, SOPs offer the advantage that all people involved know about the necessary treatment steps and their sequence and in this way the creation of common mental models is facilitated. First results indicate that the treatment results can be improved by an introduction of standardized treatment processes. Standardization causes for example that the hospital stays could be shortened which led to a reduction of the costs [ 34 ], [ 35 ].
While the non-compliance of SOPs represents a punishable default in certain high-risk technologies e. Qualified staff members are a decisive resource for safety-conscious working and for avoiding failures. However, the focus of this qualification should not only be placed on the acquaintance of medico-technical knowledge and technical skills but also on learning non-technical skills [ 37 ], [ 38 ], [ 39 ].
Communication, teamwork, and decision-making competence should be associated with medico-technical contents as part of medical and nursing competences.
Especially in the medical field expert knowledge, clinical algorithms, and practical skills had been trained up to now without considering the fact that the treatment of patients is generally performed in the context of a team. In the clinical routine it is taken for granted that communication and cooperation within a team go smoothly without any problem [ 40 ]. Beside the mentioned educational deficit, the open dialogue within a treatment team is often difficult because of rigid hierarchical structures. Sometimes the significance of a hint or a warning does not depend on the logical nature of the argument but on the professional group, the professional status, or the position within the hospital hierarchy.
In extreme cases an atmosphere comes up where a whole professional group e. Meanwhile it can be considered as a fact that poor up to non-existent teamwork is one of the key factors for insufficient patient care and for the occurrence of incidents [ 43 ], [ 44 ]. However, upon reversion it could be shown that effective communication and good teamwork allow improvement of the quality of the patient care regarding conservative as well as operative medicine and that the frequency of failures and incidents can be reduced [ 43 ], [ 45 ], [ 46 ], [ 47 ].
The systematic teaching of non-technical skills and the team training play an important role in the context of patient safety and mature safety culture. All social and interpersonal skills that are necessary for teamwork can be systematically achieved through those training programs. Since the non-technical skills that are significant in one field cannot be transferred from one environment to another for example from civil aviation to the ENT operating room , behavioral marker systems were developed and validated for the surgical disciplines NOn Technical Skills for Surgeons; NOTSS  or for teams of an operating room Observational Teamwork Assessment for Surgical teams, OTAS [ 49 ].
Those behavioral markers describe which behavior patterns may strengthen the teamwork during surgical interventions and thus should be specifically trained. Table 2 Tab. After the majority of simulation-based team trainings had been performed for a long time in the classical acute care disciplines e.