• norsk
    • English
  • English 
    • norsk
    • English
  • Login
View Item 
  •   Home
  • Universitetet i Stavanger
  • Faculty of Social Sciences
  • Department of Media and Social Sciences (SV-IMS)
  • Studentoppgaver (SV-IMS)
  • View Item
  •   Home
  • Universitetet i Stavanger
  • Faculty of Social Sciences
  • Department of Media and Social Sciences (SV-IMS)
  • Studentoppgaver (SV-IMS)
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Disharmonized regulation of complementary and alternative medicine (CAM) in Europe - implications for patient safety

Wiesener, Solveig
Master thesis
Thumbnail
View/Open
Wiesener.Solveig.pdf (4.191Mb)
URI
http://hdl.handle.net/11250/184764
Date
2013
Metadata
Show full item record
Collections
  • Studentoppgaver (SV-IMS) [1545]
Abstract
3 Summary

3.1 Research question and Objectives

Patient safety is a highly prioritized area within the provision of public and private health

care services in both the European Union (EU) as a whole, member states, as well as in

associated states. Risk governance giving preference to patient safety, includes regulation

as an important management tool. Complementary and Alternative Medicine (CAM) is, in

Europe, regulated either as conventional, complementary or alternative medicine, or not

regulated at all. CAM regulation is, however, different in each of the 39 European

countries included in the CAMbrella WP2 survey. Consequently an essential question is;

What are the patient safety implications of the European disharmonious landscape of

health regulation?

The master thesis consists of the following documents; this summing up document, the

attached FoKoM article, and the attached conference discussion paper. Analyses and

facts are based on the three CAMbrella EU FP7 project reports describing the status of

CAM regulation in 39 European countries and in the EU/EFTA/EEC.

The objectives for the research are: to describe the status of CAM regulation in Europe

with a patient safety focus, to highlight international theory dealing with patient safety,

especially the role of regulation, and to analyse whether CAM regulation in Europe is in

accordance with current theory dealing with risk governance and patient safety.

3.2 Materials and Methods

CAM can be regulated both within and outside the national public health care systems. It

was therefore necessary to perform a combined search for both conventional and CAM

health care regulation in each country. Materials and methods used for data collection

are: documents and web sites, meetings and personal communication, and

questionnaires. A literature search to identify official law documents and regulations was

performed in national web sites/databases, as well as scientific and non-scientific journals

and web sites. Searches were performed in the web sites/databases EUROPA and EUR-lex

to identify European Union (EU) official legal documents. Personal visits, including

meetings with the Ministries of Health (MoH), CAM practitioners and CAM associations

were made to selected countries, CAM conferences and EU associations.

It has been difficult to find appropriate methods to describe European CAM regulation in

a uniform, European terminology where national legal traditions are understood and

referred correctly.

3.3 Results and Discussion

Current risk governance and patient safety theory emphasize regulation as an important

risk management instrument. We found no harmonization of, or comparable, CAM

regulation between states, regions or in the EU, except for adapting legislation to EU

directives on medicinal products.

The Directive 2011/24/EU on patients' rights in cross-border healthcare states that

patients should be able to make informed treatment choices, and healthcare

professionals are supposed to provide safe and effective treatments for European

citizens. According to the FoKoM article and Birmingham conference paper, European

patients may encounter substantial differences in regulation of and the professional

background of apparently identical CAM providers and treatments both nationally and

between countries.

The regulation of CAM is so unclear that information given to patients on treatment

efficacy and, -risk factors and their resulting risk perception are sub-optimal. National

health authorities seem to regulate CAM based on insufficient basic information about

risk factors, and regulation is consequently not balanced between risk reduction and risk

tolerance. By analysing each step of the regulation process, we should find indications of

how and if harmonized national and EU regulation of CAM may ensure increased patient

safety and CAM treatment quality in Europe.

Seen from a patient safety perspective, it is difficult to see a “CAM treatment security

system” where both patients and authorities know the skills of the providers, and where

the providers’ performance of the modalities is standardized. However, we do not have

research evidence to claim that CAM patients are more exposed to unsafe treatment

offered by non-medical providers than treatment offered by regulated health personnel.

3.4 Conclusion and Recommendations

CAM in Europe is not regulated in accordance with current theory dealing with risk

governance, risk regulation and patient safety.

European patients make their CAM treatment and provider choices based on insufficient

and not trustworthy information. The diversity of European CAM providers’ skills and

regulation may challenge patient safety.

The above situation hampers CAM research, establishment of an efficient supervision

system for health care providers, and reduces expected impacts of a governmental risk

governance system on patient safety.

Health authorities in Europe should raise attention to how CAM risk governance and CAM

regulation could be embodied within the regulation of national health care services.

The physiotherapy model of educational harmonization, research and modality

standardization could be used as a template for the regulation of CAM treatments.

Treatment standardization, CAM terminology clarifications and provider harmonization

together with CAM research, will probably strengthen the safety of CAM patients in

Europe. A Directive on CAM could be developed more or less in parallel with the

Directives 2011/24/EC and 2005/36/EC.
Description
Master's thesis in Risk management and societal safety
Series
Masteroppgave/UIS-SV-IMKS/2013;

Contact Us | Send Feedback

Privacy policy
DSpace software copyright © 2002-2019  DuraSpace

Service from  Unit
 

 

Browse

ArchiveCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsDocument TypesJournalsThis CollectionBy Issue DateAuthorsTitlesSubjectsDocument TypesJournals

My Account

Login

Statistics

View Usage Statistics

Contact Us | Send Feedback

Privacy policy
DSpace software copyright © 2002-2019  DuraSpace

Service from  Unit