Patient safety research

Like all other research, patient safety research involves some methodological issues. There are important factors that may cause both under- and overestimation of the number of medical accidents in the U.S. health care system. Some methodological concerns focus on the reliability of clinicians judgments about the events themselves (Brennan, 2000) and their failure to account for the morbidity of hospitalized patients before calculating adverse event rates (Leape, 2000). When studies have not been able to address these issues, they may have overestimated the extent of medical accidents. 

In addition, the U.S. Department of Health and Human Services (HHS) and other federal agencies formed the Quality Interagency Coordination Task Force in 2000 and issued an action plan for reducing medical errors. In 2001, former HHS Secretary Tommy G. Thompson announced a Patient Safety Task Force to coordinate a joint effort to improve data collection on patient safety. The lead agencies are the FDA, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality. 

SIG (prescription instructions), and RxNorm (standard name, dose, and form availability) were not considered ready for implementation because of numerous approaches used in these three areas across health information technology. Electronic prescribing is not required under MMA, but plans are to have it available should providers choose to use it. As standards are developed, the adoption of e-prescribing is expected to improve patient safety by reducing prescribing and dispensing errors (Agency for Healthcare Research Quality, 2007). 

Lead CRA—The lead contract research associate is usually responsible for interfacing with field monitors and addressing investigator non-compliance. They review field reports provided by field staff- and determine adequate follow-up to problems that have been identified by the field staff"as well as investigators. Clinical QA must ensure that the lead CRA is adequately trained to respond comprehensively and in a timely manner. It must also be formally trained on the notification process required when patient safety or data integrity is in question. 

Any research conducted in the United States must comply with the federal regulations regarding informed consent, despite the type of form or procedure used. It is important for those involved in patient safety and welfare issues to know that there are some state or local laws that may have additional requirements regarding informed consent procedures. The California Research Subjects Bill of Rights is an example of a state law in California that requires all research subjects to be provided with a document entitled Experimental Subjects Bill of Rights before they participate in a research trial. 

To Err Is Human contains a four-part plan for decreasing the number of medical errors, and each part has implications for the pharmacy profession. To provide leadership and a research focus for patient safety. Part one recommends the creation of a center for patient safety within the Agency for Healthcare Research and Quality (AHRQ). Pharmacy organizations and pharmacists have the opportunity to contribute by including the study of medical errors in their applied research agendas. Using their expertise, pharmacists can provide input to the national goals, their content, and professional responsibilities for medicahon safety. ... 

Misconduct or fraud is a rare occurrence in clinical research, but when misconduct or fraud is confirmed the consequences can be disastrous (Lock et al., 2001 Eichenwald and Kolata, 2004). Fraudulent practices in clinical trials can lead to trial subjects being exposed to safety risks, to submitted or published clinical data being j eopardized and, if the product has been licensed based on false data, this may result in compromised patient safety. Therefore, any suspected case of misconduct or fraud should be taken seriously and be assessed -this is when QA auditors should be involved. 

Quality me a.t are merit and improvement requires developing and testing quality measures and investigating the best ways to collect, compare, and communicate these data so they are useful to decision makers. AHRQ s research emphasizes studies of the most effective ways to implement these measures and strategies in order to improve patient safety and healthcare quality. 

ASHP s Center on Patient Safety helps pharmacists lead implementation of proven medication-use safety practices, fosters best practices, identifies training opportunities, promotes pharmacy s role, facilitates alliances, and collaborates with the ASHP Research and Education Foundation to achieve its goals. 

Since its establishment in 1989, AHRQ has sponsored and conducted research to improve the quality of health care, reduce its cost, and increase access. It also supports research to address patient safety issues and medication errors. AHRQ s goal is to provide information that allows people to make better decisions about healthcare. 

To enhance the quality, appropriateness, and effectiveness of health care services, and access to these services the federal government in the Omnibus Budget Reconciliation Act of 1989 (Public Law 101-239) established the AHCPR. The act, sometimes referred to as the Patient Outcome Research Act, called for the establishment of a broad-based, patient-centered outcomes research program. In addition to the traditional measures of survival, clinical endpoints and disease- and treatment-specific symptoms and problems, the law mandated measures of functional status and well-being and patient satisfaction. In 1999, then President Clinton signed the Healthcare Research and Quality Act, reauthorizing AHCPR as the AHRQ until the end of fiscal year 2005. Presently, its mission is to improve the outcomes and quality of health care, reduce its costs, address patient safety and medical errors, broaden access to effective services, and improve the quality of health care services. 

The process chemist must develop a commercial route for a drug candidate that addresses cost issues, environmental concerns, atom economy, and ease of synthesis, and with the specified quality attributes that will ensure patient safety during development and post-launch, underscoring the importance of process research and development disciplines in the industry. 

Every person involved in clinical research, be he/ she a monitor, an auditor, a statistician, a medical adviser, a medical director, a head of department, a co-investigator, a company or health service chief executive, or a university vice-chancellor, should be committed to such a policy and to its publicity, not least to act as a deterrent, in a determination to stamp out fraud in clinical research if it is humanly possible. Every international company, every regulatory authority, and every individual pharmaceutical physician should strive to ensure that there is an effective mechanism in place, in every country, by which anyone who commits fraud can be summarily dealt with. Only the utmost vigor in applying this policy will be successful, but it is in the ultimate interests of patient safety that this happens. 

After To Err Is Human there was a significant rise in patient safety research [9] and general attention. A number of countries outside the US invested in research and found similar results to those highlighted in the lOM report. The percentage of hospital inpatient episodes leading to an adverse event was found to be 16.7 % in Australia [10] and 10 % in the UK [11],... 

HIT is finding an increasing role in healthcare dehvery and no longer is its apph-cation limited to simple order entry. Outside of medication management the evidence for HIT playing an active role in the reduction of risk is lacking and much more research is required [39]. This is hampered by no obvious or consistent benchmark by which to measure these benefits. Nevertheless, the prospect of HIT better informing care delivery makes it likely that in the near future improvements in patient safety will be achieved. The US Office of the National Coordinator for... 

Agency for Healthcare Research and QuaMty. Patient safety organisation programme. Common formats. [OnMne]. Available from HYPERLINK http //www.pso.ahrq.gov/common http //... 

Agency for Healthcare Research and Policy. Patient safety network. [Online]. 2015 [cited July 2015. Available from http //www.psnet.ahrq.gov/primer.aspx piimerID=10. 

Reproduced from Quality Safety in Health Care. C Brown, T Hofer, A Johal et al. "An epistemology of patient safety research a framework for study design and interpretation. Part 3. End points and measurement". 17, no. 3, [ 158-162], 2008, with permission from BMJ Publishing Group Ltd. 

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