Risks minimisation

Abstract Quality of care is complicated, especially in the elderly. For a start we need drugs with evidence for the benefits and risks in the elderly, this is currently not always the case. Thereafter we need to use the drugs in an evidence based way, which may be difficult in the complex health care system. To achieve maximum benefit for the patient (outcome) and society (health-economy) a well planned process is needed. This includes identification, prevention and resolving of the patients drug-related problems decisions and selection of treatment, communication and decisions together with the patient, risk minimisation, and communication within health care. Several of these aspects are presented in this chapter. 

If risk management activities are used to permit the marketing of drugs that otherwise would be kept off because of serious safety concerns, and the activities are effective, the public will be better off. On the other hand, if risk minimisation tools are routinely applied to drugs that could be marketed without them, they could serve to deny access of physicians and patients to valuable and acceptably safe medicines. How the FDA will strike this balance remains to be seen. 

Kamal, S.Z. (2005) Process analytical technology - prodnctivity gains and risk minimisation via process intimacy. Gases and Technology, Jnly/Angnst, 4 (4). 

Banerjee AK, Zomerdijk IM, Wooder S, Ingate S, Mayall SJ. 2014. Post-approval evaluation of effectiveness of risk minimisation Methods, challenges and interpretation. Drug Safety 37 33-42. 

The purpose of the safety specification is to explicitly consider the level of safety that has been demonstrated so far. It should identify what is and is not yet known about safety and the latter (i.e. what is not known) should be a major driver of the pharmacovigilance plan. The purpose of that plan is essentially to attempt to find out what is not yet known, largely because of the limitations of clinical trials. Risk minimisation plans are not invariably required - essentially they are needed when there are known or potential risks which cannot simply be managed through routine measures contained in the product information. 

As discussed in Chapter 4, the final step in the whole process of pharmacovigilance is to assess the extent to which risk minimisation... 

An important achievement has been the demonstration of the licensability potential through an independent review of the essential elements of die safety case by a group of prominent safety experts from France, Germany and the UK. This review allowed in-depth discussions on the general approach, the main safety functions and the proposed risk minimisation measures. The outcome was as follows ... 

Each person in an organisation should be made aware of the organisation structure that governs pharmaceutical operations. In addition, individual awareness or anticipation on quality related topics is essential during day to day operations, in industry, hospital and community pharmacy. Each professional should have a leaning towards risk analysis and risk minimisation in order not be annoyed when problems pop-up. This section identifies some well-known issues from daily practice. The QP above all has to have full awareness of hazards, risks and harm. 

The Committee concluded that a number of risk-minimisation measures are necessary to ensure that only children for whom the benefits are greater than the risks are given codeine for pain relief. 

ESA s safety policy is one of protective protection of life, investment, property, and the environment. The policy is implemented through the minimisation and formal acceptance of the risks associated with the system and its operation. Risk minimisation is achieved by optimising of the system design and operational characteristics for safety, within the constraints imposed by the project objectives. 

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