Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Strategies for Promoting the Safe Use of Prescription Opioids and the Potential Impact of Overregulation ***

Dr. Katja Bendrin (Abschlußjahr: 2020)

Summary
Language: English
Opioids constitute the to date most potent known class of pain relievers. However, great differences concerning the access of the general population to opioid drugs exist between countries. Although access to adequate pain management is a fundamental human right, these discrepancies often result in inappropriate treatment of cancer pain as well as non-cancer pain. On the other hand, an inadequacy of barriers to the general availability of opioids bears the risk of an epidemic opioid dependency, as currently evident in several countries worldwide.
This thesis provides a global overview on the availability and the regulation of controlled drugs, focusing on nine countries that were selected to illustrate the factors and barriers influencing opioid accessibility. The comparison of the national legislations in these countries is based on the respective legislation(s) for narcotic drugs. Aside from the main national laws and regulations on narcotic drugs, further specialized acts, e.g. for physicians, might exist in the respective countries, which include additional information in a particular context. These are, however, beyond the scope of this work.
All countries considered in this thesis ratified the UN Single convention on narcotic drugs that dates from 1965. Still, the availability of narcotic drugs is highly imbalanced between the countries, as it is shown in a comparison of the average consumption overall and of certain opioids mainly used for pain management such as codeine, fentanyl, morphine and oxycodone between 2006-2008 and 2016-2018. While the national legislations implement the evaluated aspects of the UN Single Convention in general, they are highly divers in their level of detail. The outcome of this thesis considers a higher level of detail in the main legislations for narcotic drugs as beneficial, that in turn provides a greater transparency about all circumstances and requirements under which activities with controlled substances are prohibited and permitted and thus, about the legal framework within medical practitioners need to work. Furthermore, a higher level of alignment on the narcotic drugs legislations between the respective constituent states of the Commonwealth nations Australia and Canada is recommended, especially considering the currently ongoing opioid epidemics in these two countries.
To evaluate the acceptance of opioids for the pharmacotherapy of pain in general among health care professionals, exemplary national guidelines available in English or German language were selected that encompass the therapy of cancer, chronic and/or acute pain. All selected guidelines considered opioids as an element of the pharmacotherapy. However, the level of detail and the data basis of the recommendations is very divers. Furthermore, guidelines for all three types of pain, cancer, chronic or acute pain, are available in only a few of the selected countries, and special patient populations, such as children, were often not considered separately. Surprisingly, Rwanda, as a less developed country with a low opioid consumption, provides a comparatively more advanced approach by using a four-step analgesic ladder in their guidelines, while most of the guidelines from the other selected countries are generally based on the three step WHO analgesic ladder and its recommendations, at least for the treatment of cancer pain. As such, a worldwide effort for conducting well-designed, controlled trials seems to be a desirable essential effort to improve the clinical guidelines for pharmacotherapy with opioids, and thus for improving the management of pain in general.
Existing regulatory actions against an opioid epidemic or against an undersupply with opioids were highlighted as well. Regulatory measures provide an important tool to react on certain developments regarding the use of opioids. However, reasons and mechanisms for overuse and underuse of opioids for pain management are divers and often specific for the respective country. Thus, measures to reduce misuse or to increase the opioid availability cannot be addressed equally to all countries.
In conclusion, robust scientific data availability is crucial for legislative and regulatory frameworks, as well as for clinical guidelines. Only based on this principle, a safe and appropriate use of opioids and a balance between restrictions against abuse and permissions for pharmaceutical treatment can be achieved.
Pages: 76
Annexes: 03, Pages: 06