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Hazard and risk management in Pharmaceutical industry Dr Jurgen Porst Senior Advisor GTZ-ASEM HAWA Project, Bangalore Introduction • Over the past few decades, there has been an increasing concern that human actions and natural catastrophes have been adversely impacting the environment, and posing serious ecological and health hazards . Environmental risk management aims at studying the nature of hazards (emission of a pollutant, natural hazard events, use of a hazardous technology, or any possible combination of these), estimating the associated probability of occurrence of such events and characterizing the adverse effects of environmental hazards resulting from human and ecological exposures. Introduction • There is no such thing as zero risk because no matter what precautionary steps are taken, there is always some chance of an accidental release of a hazardous substance and a chance that someone will be adversely affected. The objective of risk and environmental management is to prevent or reduce the illness, injury or loss of life due to the operation of facilities which handle hazardous materials UNDERSTANDING THE HAZARD • The first step in managing chemical reactivity hazards is identifying those facility operations and chemicals that represent a potential chemical hazard. Facilities that handle chemicals are actively engaged in managing risks to ensure the safety of their workers and the community. Before risk can be managed, it must be understood. Risk analysis helps to understand the risk of a hazardous facility and the reductions in risk achievable by certain risk control measures. Whether we judge a risk to be small or large, acceptable or unacceptable depends on many factors. UNDERSTANDING THE HAZARD • Risk can be reduced by decreasing the likelihood and/or consequences of hazardous events. • Risk control measures can be broadly classified into: safety management of the hazardous facility, incident management, and land-use restrictions. Hazard identification is the first of several elements in the process of risk analysis In order to identify hazardous events it is necessary to: • establish the undesirable consequences of interest • identify the material, system, process and facility characteristics that can produce these undesirable consequences. UNDERSTANDING THE HAZARD • Managing risk The point of managing risk is not necessarily to eliminate risk, but to have an overview of the most critical risks and manage them professionally. In Europe there are companies that have technology understanding blended with competency within risk management that has been used to assess, evaluate and manage the risks involved in numerous high-profile projects around the world. UNDERSTANDING THE HAZARD • Working with healthcare organisations on risk management, companies have gained knowledge of the range of different risks which such organisations, including pharmaceutical companies, have to manage and the systems they use to achieve this. • Areas: Process Safety Management and Bio-risk Management. Managing Major Hazard Risks Process Safety Management • Major hazards are an issue for pharmaceutical facilities, as well as for others (eg chemical process and energy companies). Risk management companies support in this area for pharmaceutical organisations draws on their experience working across the full range of these industries. Managing Major Hazard Risks Process Safety Management • Risk assessment; • Formal safety management systems; • Behaviour-based safety programmes Laboratory Task Risk Assessment • Biological containment laboratories are necessary for diagnostic and detection work, and are also critical for research and development. There are many different types of micro-organisms that are handled in these laboratories, and each activity that is performed on the micro-organism has the potential to pose a risk. • Therefore, the risks should be evaluated, so that measures can be put in place to protect both the workers and the environment from infection. According to the WHO’s laboratory Biosafety Manual, risk assessments provide the backbone to any laboratory safety programme. Laboratory Task Risk Assessment • Some countries also have a legal requirement that the activities carried out in containment laboratories should be covered by a risk assessment. • However, risk assessments can prove difficult to complete without the correct knowledge and tools. Risk management companies are developing tools which will help workers carry out their risk assessments more easily and constructively. Biosafety-Europe • Biosafety-Europe is a co-ordination action funded through the European Commission’s sixth framework and which started April 1 2006. The project has 20 partners from 11 European countries and has an overall aim of promoting European harmonisation and the exchange of practices relating to biosafety and biosecurity management of biological containment. Biosafety-Europe • Laboratories must take into account regional and national regulatory requirements, as well as international biosafety guidelines, when developing biosecurity and biosafety management systems. The different requirements may treat some issues differently, and some issues can even be conflicting. • The differences in legislative frameworks and differing ways they are interpreted is one of the major reasons that various approaches, different controls and alternate best practices have developed within the fields of biosecurity and biosafety. The German Experience • Germany has had a "drug budget silo mentality" throughout this period. But the focus of the mentality moved rapidly from the central budget to regional budgets and to drug budgets per physician based on historical data. • These amounts do not correspond to either medical necessity or economic considerations. • An analysis of the health-care system as a whole shows that the efforts to constrain spending with budget in one area can lead to higher total costs. Pharmaceuticals in the environment • When pharmaceuticals are administered to patients, some of the active pharmaceutical ingredient (API) may not be completely metabolised (biochemically altered and inactivated). • These unmetabolised portions are generally excreted and find their way into sewage systems where they are transported to wastewater treatment systems that remove most of the pharmaceutical residues. Pharmaceuticals in the environment • However, extremely low concentrations may pass through the wastewater treatment plant and be discharged to the environment. Historically, the presence and amount of pharmaceuticals in different parts of the environment have been estimated. • Recently, as a result of advances in analytical techniques, extremely low concentrations of pharmaceuticals are being measured in wastewater, surface water (rivers and streams) and drinking water. In addition, low level effects on aquatic organisms have been observed for specific APIs such as synthetic hormones Pharmaceuticals in the environment • In Europe, draft guidelines for Environmental Risk Assessments (ERAs) that accompany Marketing Authorisation Approval Applications have been available for a number of years. • The most recent guidelines were issued in January 2005 and are expected to be approved and implemented in 2006. A key change in these guidelines is the requirement for chronic rather than acute ecotoxicity testing, recognising that most pharmaceutical active ingredients are not acutely toxic but may have longer term chronic effects on aquatic organisms at low levels. • In Sweden, a classification scheme based on environmental characteristics of APIs is being implemented. Case Study No. 1: • Risk Assessment for Sourcing Inactive Ingredients: Glycerin and Propylene Glycol Over the years there have been repeated episodes of Diethylene Glycol contamination of either glycerin or propylene glycol, resulting in multiple fatalities often of children. This case study will use Failure Mode and Effects Analysis (FMEA) to: • Identify the hazards associated with sourcing ingredients • Consider the potential severity of any incident of contamination • Consider the likelihood of occurrence • Consider the likelihood of detection Case Study No. 1: • • Perform an assessment of current controls that companies have in place and if necessary consider additional controls • Perform a second risk assessment after implementation of additional controls to see if the residual risk is now acceptable • • Consider how residual risk is communicated to concerned persons to increase awareness and compliance: risk communication • Consider effectiveness of controls: risk monitoring and feedback mechanisms Case Study 2: • Risk Assessment in Pharmaceutical Development Websites • www.greenconversionsystems.com/germa n.htm • www.reputationsymposium.com/_files/presentations/Pres entation_by_Prof_Ehlers_on_the_Pharma ceutical_Industry.