Analyzing and Reporting Safety Data

Generally speaking, the safety evaluat ion of new drugs is intended to detect quantifiable effects in as many organs and bodily systems as possible, hence the expression casting a wide net. However, in the domain of cardiovascular safety, hypothesis-testing approaches are employed to investigate cardiovascular adverse events of special interest. 

The previous chapter provided examples of statistical analyses that are used to assess efficacy in clinical trials. In this and the following chapter, the focus moves to assessments of safety. As will be seen in the first part of this chapter, general safety assessments are conducted quite differently from those for efficacy, in that descriptive statistics are used as opposed to hypothesis testing. However, in the domain of cardiovascular safety, hypothesis-testing approaches are employed to investigate the potential occurrence of specific cardiac and cardiovascular adverse events. In the language introduced in this chapter, these can be regarded as adverse events of special interest. 

---

As time progresses and process safety system performance improves, some data may no longer be useful. Periodically evaluate the data that is captured, analyzed, and reported, and determine if the data is still valuable to the improvement effort or to maintaining performance. Remove data that has proved to be unimportant or has outlived its usefulness. Add new data that can improve the ongoing evaluation of... 

Affect the manner in which safety performance data are collected, analyzed, and reported ... 

Analyzes pipeline safety and reported accident data... 

EPA ARIP Responses to questionnaires sent by EPA from facilities that have had significant releases purpose is to learn about causes and consequences of hazardous material incidents 1986-Present Supplements NRC reports for more significant events Additional information on causal factors, consequences, and company safety programs Data are easily analyzed for common causes Includes all states and localities Survey relies on voluntary compliance Not comprehensive limited to select cases Checklist approach limits value of information to understand root cause Not designed to be a lessons-leamed database... 

Table 2 lists some of the physical, toxicity, flammability, and reactivity properties of common chemicals (10,13,42,45—51). Also given are some of the quantities specified for reporting spills and for compliance with legislated requirements. The OSHA regulations require that material safety data sheets (MSDS) be developed for all process materials, so that the hazard data can be communicated to employees (52). Characteristics of toxicity, flammability, chemical instability, reactivity and reaction energy, operating conditions, and corrosive properties of construction materials must all be considered in analyzing hazard potentials of chemicals and chemical operations. 

It has also been reported that patients with allergic-like events after penicillin treatment have had a markedly risk of events after subsequent cephalosporin antibiotics. Cross-reactivity is not an adequate explanation for this increased risk and the data obtained indicate that cephalosporins can be considered for patients with penicillin allergy <2006MI354.ell>. Comparisons of parenteral broad-spectrum cephalosporins have been tested against bacteria isolated from pediatric patients. The results have indicated that cefepime has been the most broad-spectrum cephalosporin analyzed and it is a very potent alternative for the treatment of contemporary pediatric infections in North America <2007MI109>. The historical safety of the most commonly used oral cephalosporins has been reviewed <2007MIS67>. The antimicrobial spectrum and in vitro potency of the most frequently prescribed orally administered cephalosporins (cefaclor, cefdinir, cefpodoxime, cefprozil, cefuroxime axetil and cephalexin has also been reviewed <2007MIS5>. 

The adverse experiences reported in the new investigations should be analyzed and displayed as outlined in the integrated summary of safety. If the extent of exposure has increased substantially, the analyses should be performed including both the new data and the data submitted in the NDA. 

The data sheet is called the package insert in Japan, as it can be found in the drug packaging. The data sheet is drafted by the company and checked and completed by the authorities after the NDA review and the recommendation for approval. The content has been defined by the MHLW notification, and was revised in May 1997. Besides general information on the product, the most important entries are warnings, precautions and contraindications, and a list of adverse events quantitatively reported. These entries will be revised if necessary, with the safety data regularly analyzed for the periodic safety update report however, an ad hoc revision is made at any time in case of serious events. 

The Bureau of Labor Statistics (BLS) is the principal fact-finding agency for the federal government in the broad field of labor economics and statistics (see website http //stats.bls.gov). It collects, processes, analyzes, and disseminates essential statistical data. Among the data are occupational safety and health data, including annual reports, by industry, of rates of injuries, illnesses, and fatalities (http // stats.bls.gov/oshhome.htm). 

IMCA collects, analyzes, and shares data on industry incidents from work in offshore construction. One key system for distributing the data is an alert called a safety flash. Safety flashes are developed from reports submitted to IMCA and contain descriptions of incidents, near misses, and potential hazards. The reports also give the apparent cause (or causes) of the incident and any actions taken to prevent a recurrence. Before it is distributed publicly, a safety flash is stripped of identifying information and is sent to the contributing company for its approval. ... 

Criticality safety data have been accumulated from around the world, with the help of such unclassified reports as the three-volume publication by Koponen et al., which contains indexes, concordances, and abstracts of reports published up to 1978. We have analyzed the publication and found, as shown in Fig. 1, that the amount of experimental data for criticality safety is less than 50% of the whole criticality data base and that 13, 16, and 28% of the data are on mixtures of plutonium and uranium, solutions of plutoiuum, and solutions of uranium, respectively. In those data for mixtmes and solutions, we could not find data suffldent-for reak>nable and effective design and operation of out-of-reactor nuclear fadlities for light water reactor (LWR) and fast brewer reactor (FBR) fuel cydes. ... 

The other function of the office is to track, trend, and analyze all industry safety and risk data and maintain current risk profiles of industry organizations. The office is responsible for conducting industry-level risk assessments and determining the efficacy of current safety regulations and the accreditation process. Advanced research and new approaches to safety oversight or SMS implementation are also developed in this office. In other words, this office can be viewed as a continuous safety improvement office. Information from this office should feed back into the other safety offices reporting to the executive director. 

Patient Safety Organizations (PSOs) were created by the Patient Safety and Quality Improvement Act to improve the quality and safety of healthcare by encouraging clinicians and healthcare organizations to voluntarily report patient safety events without fear of legal discovery. PSQs offer a secure environment to identify and reduce the risks associated with patient care. As independent, external experts, PSOs collect, analyze, and aggregate patient safety data locally,... 

---