Coherence is the essence of everything successful. Then we add integrity.

March 2017

Availability of Essential Medicines in the Czech Republic

26. march 2017 at 23:33 | Veronika Valdova, ARETE-ZOE |  Medicine & Pharmacy
This report analyzes the availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015) in the Czech Republic. The report offers comprehensive information on active pharmaceutical ingredients offered locally as well as the number of registrations for each API by system organ class.
The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents a serious public health concern. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016.
Research Coverage:
Availability of essential medicines in the Czech Republic, presented in graphs and tables by a number of registered products by organ class. The full list of 427 active ingredients covered as defined in The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015.
Examples of the most significant global shortages of essential medicines are presented in the context of local availability gap. Complex causes of global drug shortages such as manufacturing issues, availability of raw materials, consolidation and monopolization of the industry, regulatory concerns, unpredictable demand, as well as sudden price hikes following acquisition and rebranding.
Causes of limited local availability such as small profit margin, small market, and complex regulatory environment, and inconsistently applied and enforced rules that change in response to political demand.
Essential medicines availability gap represents both public health degradation and risk of harm to individual patients. Drug unavailability makes it impossible to follow evidence-based practice guidelines, and force prioritization of patients. Public health concerns arise due to inability to prevent and treat contagious diseases such as tuberculosis.
Alternative sources of essential medicines and opportunity for to the introduction of counterfeit, falsified and substandard drugs into clinical practice due to efforts to secure supplies despite limited availability
Natural market dynamics will not make essential medicines available without specific regulatory intervention or concerted advocacy by caregivers and patients.

Perception is reality

21. march 2017 at 16:24 | Veronika Valdova, ARETE-ZOE
It has long been recognized that perception of events shapes popular beliefs, and influences attitudes and behaviors. Some cultures are more malleable to misrepresentation of reality than others; partly due to sudden exposure to outside influences not previously encountered as a result of a regime change, as well as cultural factors such as traditional concepts of truth and its objective existence. This disregard for objective truth is not limited to Russia, but spreads to the Balkans and Eastern Europe also.

Why merging medical records, hospital reports, and clinical trial data is a very bad idea.

21. march 2017 at 16:22 | Veronika Valdova, ARETE-ZOE

Data breaches endanger your clinical trial success

Medical privacy and breaches of personal health information (PHI) has been a hot topic for several years. For the clinical trial industry, the main concerns are decline in recruitment resulting from lack of confidence in data handling and instances of breaches that affect data integrity that adversely affect NDA and MA applications in major markets, which precipitates administrative action taken by national regulators in response to local incidents.

Read more at ClearClinica