Availability of Essential Medicines in the Czech Republic

The Czech Republic is a small market with a complex regulatory environment and inconsistently applied and enforced rules that often change in response to political demand. Most essential drugs that are not available in the Czech Republic were not registered, and therefore not available, rather than in shortage. Essential medicines that are not available in the Czech Republic significantly overlap with drugs that have been experiencing chronic or periodic shortages worldwide.

Availability of Essential Medicines in the Czech Republic

Of the 427 essential medicines, 311 are registered in the Czech Republic. Of these, 292 (68%) essential medicines showed active marketing in Q3 2016 and 19 (5%) were registered but not marketed. 116 (27%) were not registered, and therefore not available, rather than in shortage locally. Availability gap amounts to 135 (32%) essential medicines for both unregistered and not marketed essential medicines. Of the total number of 13,256 registrations for essential medicines, only 2,110 (14%) showed active marketing in Q3 2016.

Essential medicines that are not available locally significantly overlap with medicines that are in periodic or chronic global shortage. Examples of the most significant global shortages of essential medicines are presented in the context of local availability gap. The Czech Republic is a small market with a complex regulatory environment and inconsistently applied and enforced rules that often change in response to political demand. Alternative sources currently include parallel import from other EU countries. Attempts to obtain essential medications from alternative sources provide an opportunity for the introduction of counterfeit, falsified and substandard drugs into clinical practice.

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 Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015 (Including The 19Th WHO Model List Of Essential Medicines And The 5Th WHO Model List Of Essential Medicines For Children).

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.

Locally available products were compared to the WHO list of essential medicines. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress.

Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize a certain group of people over another. Public health concerns arise due to inability to prevent and treat contagious diseases such as tuberculosis. Significant resources have to be dedicated to overseeing and managing the situation at government and supranational level.

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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.
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