Risk management planning

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. 

In the next three sections I shall consider the key principles underpinning each part of the plan. 

This should include the descriptive epidemiology of the disease indication(s), i.e. incidence, prevalence and demographic considerations, prognosis, likely co-morbidity and co-prescribing, plus medical events associated with the indication which could be mistaken for ADRs. Such information will be helpful for setting spontaneous ADR reports in context. 

This can be summarised in the form of graphs or tabulations with calculations of the resultant statistical power to detect adverse reactions according to duration of treatment and potential latency (i.e. time to onset), based on the following information  

The main focus here should be on ADRs identified in clinical trials described and quantified by system organ class based on statistically 

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API Publ 761, Model Risk Management Plan Guidance for Exploration and Production Facilities—Guidance for Complying with EPA s RMP Rule (40 Code of Federal Regulations 68), 2nd ed., August 1997... 

Was the facility required to submit a risk management plan to the EPA ... 

Risk Management Program (RMP) EPA s rule requiring some facilities to prepare, submit, and implement a risk management plan. 

The OSHA standard is required by the Clean Air Aet Amendments, as is the Environmental Proteetion Ageney s Risk Management Plan, whieh was proposed in 1992. Employers who merge the two sets of requirements into their proeess safety management program will better assure full eomplianee with eaeh as well as enhanee their relationship with the loeal eommunity. 

These facilities, belonging to one of eight industrial classes, will be required to iinpleinent and document tlie full RMP rule. Tliis will include liazard assessment, preventive steps, emergency preparation and response (see next cliapter) and a risk management plan. ... 

On June 20,1996, the EPA published the Risk Management Plan (RMP) as a final rule.1 This regulation is also a response to the Bhopal accident. It is recognized by industry and the government as an excellent regulation that will reduce the number and magnitude of accidents — if it is understood and practiced as intended. 

DanieI A. Crowl, Consequence Modeling for the EPA Risk Management Plan (RMP), Process Safety Progress (Spring 1997), pp. 1-5. 

The selection of the release case depends on the requirements of the consequence study. If an internal company study is being completed to determine the actual consequences of plant releases, then the realistic cases would be selected. However, if a study is being completed to meet the requirements of the EPA Risk Management Plan, then the worst-case releases must be used. 

The EPA Risk Management Plan (RMP) defines a worst-case scenario as the catastrophic release of the entire process inventory in a 10-min period (assumed to be a continuous release). The dispersion calculations must be completed assuming F stability and 1.5 m/s wind speed. As part of the RMP rule, each facility must determine the downwind distance to a toxic endpoint. These results must be reported to the EPA and to the surrounding community. 

Laws and Regulations 64 Creating a Law 64 Creating a Regulation 64 OSHA Process Safety Management 68 EPA Risk Management Plan 71... 

EPA promulgated the Accidental Release Prevention Requirements (40 CFR 68), which contain the list of regulated chemicals and requirements for facilities possessing more than a threshold quantity of a listed chemical in an individual process. Covered facilities are required to implement a risk management program and submit a risk management plan to EPA. 

Spellman, F. R. 1997. A guide to compliance for process safety management/risk management planning (PSM/RMP). Lancaster, PA Technomic Publishing Company. 

The off-site consequence analysis must be reviewed and updated every five years. However, if process changes might reasonably be expected to cause the worst-case scenario footprint or signature to increase or decrease by a factor of two or more, then the OCA must be revised and the risk management plan must be resubmitted to USEPA or designated authority within six months. 

Risk management plan contents executive summary registration worst-case data ... 

Risk management plan contents executive summary registration worst-case data alternative release data five-year accident history prevention program data emergency response data certification. 

However, this is not the case with RMP. In addition to requiring full compliance by those facilities covered under the regulation, it also requires each source to submit a risk management plan. 

Prepare and submit a single risk management plan (RMP) that covers all affected processes and chemicals. 

A short synopsis of the overall emergency management structure, how other industrial emergency response, contingency, and risk management plans fit into the ERP for chemical emergencies, and applicable policies, procedures, actions plans, and reference documents should be cited. Policies should include interconnect agreements with adjacent communities and just how the ERP may affect them. 

MerlT states that a proactive risk management plan reduces product liability lawsuits, but it can also reduce drug sales "for reasons that turn out to be ephemeral." He warns pharmaceutical companies, however, that being defensive — such as described by Fitzgerald — is extremely risky. "Ongoing product liability litigation can damage a company s bottom... 

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