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Physiotherapists who work alone ensure their safety and the safety of the service user. Such processes are crucial to assess and validate the standard of entry level education provision to ensure graduates full statutory and professional recognition to practice 1. In Europe, there is often an authority with legislative responsibility involved in these processes and procedures vary from country to country 4. Crucial for establishing a knowledge-based society is the need to coordinate policies across different areas, linking higher education with research and innovation 5.

The ESG was further developed and the revised version was adopted in May The revision reflects a consensus among all the organisations and ministries involved on how to progress Quality Assurance in the European Higher Education Area and, as such, provides a firm basis for successful implementation. Quality Assurance QA covers both internal and external procedures, systems and structures and the Quality Assurance procedures were initiated in order to move towards greater internationalisation.

The physiotherapy education QA procedures should aim to achieve a balance between accountability and improvement. The MOs of the European Region have an important role to support, and contribute to, the quality enhancement of physiotherapy education in the HEIs 8. In total, 37 out of 39 MOs have replied to the survey over the years.

Several reminders were sent to the MOs where no information had been provided, and some MOs provided information at the time of the GM or even later. An overview of the responses is presented in Table 1. Thirty-two MOs stated that there is a National Agency responsible for QA work, which also covers physiotherapy education. The repeated surveys demonstrate a clear development over the years with an increasing number of countries employing QA procedures.

Most of the evaluations by the national agencies were repeated every three to six years, depending on the country. One MO Spain reported that the frequency of the evaluation varies depending on which level is being targeted Bachelor, Master or Doctoral. Sanctions imposed due to poor levels of Quality Assurance were similar across countries and commonly included loss of approval, suspension of the programme, re-organisation and re-evaluation.

Nineteen MOs reported that there is a National Regulatory Body within their country, with seven taking a role in Quality Assurance of education. Sanctions were the same as those used by National Agencies.

DEFINING SYSTEMS OF CARE

Fourteen MOs reported that they undertook QA procedures in assessing physiotherapy education and five stated that they were working towards developing such processes. The frequency of such activity ranged from continuous to a flexible approach allowing up to seven years between reviews.

Data is available from a total of 37 MOs. The responses show that, independent of the Member Organisations, the majority of countries either already have some form of Quality Assurance processes or are currently developing them. It is evident that many Member Organisations also promote a range of QA procedures within the educational institutions. The recommendation is to continue to follow the development and implementation of Quality Assurance in higher education in the member countries of the European Region. It would also be of value to share experiences and procedures amongst MOs as this would contribute to raising standards of education across Europe.

In addition, in some institutions, specific programmes, departments, and schools are sometimes ranked. Often however, there is a lack of common transparent criteria for the ranking, which in addition to competitive interests make objective comparisons difficult. The Quality Assurance process is generally developed by the national agencies in each country. Regardless of it being a national process or within an MO or other, it should be transparent. The process is often conducted at the level of university administration and policy-makers.


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It aims to comprehensively cover the different dimensions of higher education such as education quality, research quality, mission of the institution, etc. The ranking process focuses on the provision of general information about the universities to the students and to society as a whole.

What stakeholders do I need buy-in from? Anita began to do researching on the Internet but also began to recall key concepts from her Quality Improvement and Medication Error Reduction class in pharmacy school. Armed with this information, she began the planning that would make her pharmacy truly exceptional. How is quality defined within the context of pharmacy practice? Define health care quality in layperson's terms. How can Forgot Password? What is MyAccess?

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Why Innovation in Health Care Is So Hard

Davis PT Collection. Murtagh Collection. About Search. Enable Autosuggest. Previous Chapter. In , Massengill, a Tennessee drug company, began to market a liquid sulfa drug called Elixir Sulfanilamide. Unfortunately, the solvent in this drug was a highly toxic variant of antifreeze; as a result, over people died from taking this drug. Public outcry over this tragedy was critical in breaking the Congressional deadlock over tighter regulation Young ; Jackson ; Carpenter and Sin Under the law, the FDA was given considerably greater authority over the food and drug industry.

The FDA was granted the power to regulate the therapeutic claims drug manufacturers printed on their product labels; authority over drug advertising, however, rested with the Federal Trade Commission FTC under the Wheeler-Lea Act of Additionally, the new law required that drugs be marketed with adequate directions for safe use, and FDA authority was extended to include medical devices and cosmetics.


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Perhaps the most striking and novel feature of the law was that it introduced mandatory pre-market approval for new drugs. Under this new law, drug manufacturers were required to demonstrate to the FDA that a new drug was safe before it could be released to the market. This feature of the legislation was clearly a reaction to the Elixir Sulfanilamide incident; food and drug bills introduced in Congress prior to did not include provisions requiring mandatory pre-market approval of new drugs. Within a short period of time, the FDA began to deem some drugs to be so dangerous that no adequate directions could be written for direct use by patients.

Like the law, the Drug Amendments were passed in response to a therapeutic crisis — in this instance, the discovery that the use of thalidomide a sedative that was marketed to combat the symptoms associated with morning sickness by pregnant women caused birth deformities in thousands of babies in Europe. Under the Drug Amendments , responsibility for regulating prescription drug advertising was transferred from the FTC to the FDA; furthermore, the FDA was given the authority to establish good manufacturing practices in the drug industry and the power to access company records to monitor these practices.

As a result of these amendments, the United States today has among the toughest drug approval regimes in the developed world. A large and growing body of scholarship has been devoted to analyzing the economics and politics of the drug approval process. These views have been challenged by Temin who maintains that much of the decline in new drug introductions occurred prior to the Drug Amendments. In international comparisons, scholars have also found that new medicines generally become available more quickly in Europe than in America, suggesting that tighter regulation in the U.

Some critics believe that the costs of this drug lag are large relative to the benefits because delay in the introduction of new drugs prevents patients from accessing new and more effective medicines. Gieringer , for instance, estimates that the number of deaths that can be attributed to the drug lag far exceeds the number of lives saved by extra caution on the part of the FDA. Hence, according to these authors, the Drug Amendments may have had adverse consequences for overall welfare.

Other scholarship has examined the pattern of drug approval times in the post period. It is commonly observed that larger pharmaceutical firms receive faster drug approvals than smaller firms. Empirical work by Olson and Carpenter , however, casts some doubt on this Stiglerian interpretation. Indeed, in other work, Carpenter a demonstrates that a regulator that seeks to maximize its reputation for protecting consumer safety may approve new drugs in ways that appear to benefit large firms.

Since the passage of the Drug Amendments, federal food and drug regulation in the United States has evolved along several lines. For instance, the Medical Device Amendments required medical device manufacturers to register with the FDA and to follow quality control guideline. These amendments also established pre-market approval guidelines for medical devices. Along similar lines, the Nutrition Labeling and Education Act required all packaged foods to contain standardized nutritional information and standardized information on serving sizes. In other cases, regulations have been enacted to streamline the pre-market approval process for new drugs.

Substandard drugs: a potential crisis for public health

Concerns that mandatory pre-market approval of new drugs may have reduced the rate at which new pharmaceuticals become available to consumers prompted the FDA to issue new rules in to accelerate the review of drugs for life-threatening diseases. Similar concerns also motivated Congress to enact the Prescription Drug User Fee Act of which required drug manufacturers to pay fees to the FDA to review drug approval applications and required the FDA to use these fees to pay for more reviewers to assess these new drug applications.

Evidence presented by Olson suggests that faster drug approval times have also contributed to a higher incidence of adverse drug reactions from new pharmaceuticals. For example, the Vitamins and Minerals Amendments precluded the FDA from establishing standards that limited the potency of vitamins and minerals added to foods. Akerlof, George A. Anderson, Oscar E. The Health of a Nation: Harvey W. Wiley and the Fight for Pure Food. Chicago: University of Chicago Press, Carpenter, Daniel P. Princeton: Princeton University Press, Comanor, William S.

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Coppin, Clayton and Jack High. Ann Arbor: University of Michigan Press, Darby, Michael R. French, Michael and Jim Phillips. Cheated Not Poisoned? Food Regulation in the United Kingdom, Manchester: Manchester University Press, Gieringer, Dale H. Goodwin, Lorine S. Grabowski, Henry G. Harris, Steven B. Ippolito, Pauline M. Bureau of Economics Staff Report.

Falsified Medicines

Jackson, Charles O. Food and Drug Legislation in the New Deal. Kaitin, Kenneth I. Klein, Benjamin and Keith B. Kolko, Gabriel. New York: MacMillan, Law, Marc T. Enforcement of the Pure Food and Drugs Act, Chicago: University of Chicago Press, forthcoming. Lee, R.