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Availability of essential medicines in the Czech Republic

Availability of essential medicines in the Czech Republic

Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.

Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).

Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.

The report provides overview of the situation in the Czech Republic. 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 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.

Of the 427 essential medicines, 311 are registered. Of these, 292 essential medicines showed active marketing in Q3 2016 and 19 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. However, 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 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 opportunity for the introduction of counterfeit, falsified and substandard drugs into clinical practice.


This report analyzes 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 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 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 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.

Research Coverage:
Availability of essential medicines in the Czech Republic, presented in graphs and tables by number of registered products by organ class. 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.

Reasons to buy this report:
Detailed insight into the situation of a small EU country in Central Europe offers understanding of the challenges and opportunities in this part of the world. Essential medicines are an indispensable part of managed care and access to these products is typically one of the priorities for national health systems.

The report provides insights into the following topics:
Appendix 1 - Availability of essential medicines in the Czech Republic shows summary table and summary graph of total number of essential medicines by their generic names and their availability in the Czech Republic by organ class. The series of graphs shows detailed breakdown of all system organ classes by availability of essential drugs.
Appendix 2 - Essential medicines unavailable in the Czech Republic lists all essential medicines not available in the Czech Republic, organized by organ class. The table includes information about number of registrations and number of marketed products.
Appendix 3 - Essential medicines unavailable in the Czech Republic: Global context lists all essential drugs unavailable in the Czech Republic in a summary table by organ class, adds information on patent status of the drug and main indication, and makes mention of major shortages of the products worldwide.
Appendix 4 - Essential medicines available in the Czech Republic: Registration and marketing compares the share of actively marketed products and products that are registered but not marketed."

Executive Summary
Synopsis
About ARETE-ZOE
Table of Contents
I. Analysis and Interpretation
Relevance of unavailability of essential medicines for health care systems:
II. Situation in the Czech Republic
Alimentary tract and metabolism
Blood and blood forming organs
Cardiovascular system
Dermatologicals
Genito-urinary products and sex hormones
Hormones for systemic use, excluding sex hormones and insulins
Antiinfectives for systemic use
Antineoplastic products
Musculoskeletal system
Nervous system
Antiparasitics
Respiratory system
Sensory organs
Various
III. Significant global drug shortages
Parenteral nutrition components
Sterile injectable drugs
Adulterated heparin
Sudden price spikes in off-patent prescription drugs
Antibacterials
Front-line tuberculosis therapy
Drugs for the treatment of HIV/AIDS and other antivirals
Immune sera and immunoglobulins
Vaccines
Miltefosin
Oncology drugs
Central Nervous System
Antimalarial drugs
Pharma Bro: Daraprim (pyrimethamine) and the like
IV. Conclusion
APPENDIX 1 Availability of essential medicines in the Czech Republic
TABLE 1 - Summary (table): Availability of essential medicines by organ class
GRAPH 1 – Summary (graph): Availability of essential medicines by organ class
Alimentary Tract and Metabolism (A)
GRAPH 2 – Summary (graph): Availability of registered and marketed products (A)
GRAPH 3 - Acid related disorders (A02), functional GIT disorders (A03), and antiemetics and antinauseants (A04)
GRAPH 4 - Constipation (A06), antidiarrheals (A07) and digestives incl. enzymes (A09)
GRAPH 5 - Drugs used in diabetes (A10)
GRAPH 6 - Vitamins (A11) and mineral supplements (A12)
Blood and Blood-forming organs (B)
GRAPH 7 - Summary: Availability of registered and marketed products (B)
GRAPH 8 - Anti-thrombotic agents (B01)
GRAPH 9 – Anti-hemorrhagic agents (B02)
GRAPH 10 – Anti-anemic agents (B03)
GRAPH 11 - Blood substitutes and perfusion solutions (B05)
Cardiovascular system (C)
GRAPH 12 – Summary (graph): Availability of registered and marketed products (C)
GRAPH 13 - Cardiac therapy (C01)
GRAPH 14 - Diuretics (C02) and peripheral dilatators (C03)
GRAPH 15 - Beta-blockers (C07), Calcium-channel blockers (C08), renin-angiotensin system (C09) and lipid modifiers (C10)
Dermatologicals (D)
GRAPH 16 – Summary (graph): Availability of registered and marketed products (D)
GRAPH 17 - Antifungals (D01), emollients and protectives (D02)
GRAPH 18 - Antipsoriatics (D05), antibiotics (D06) and corticosteroids (D07)
GRAPH 19 - Antiseptics and disinfectants (D08), anti-acne preparations (D10)
Genito-urinary system and sex hormones (G)
GRAPH 20 – Summary (graph): Availability of registered and marketed products (G)
GRAPH 21 - Antiinfectives and antiseptics (G01), other gynecologicals (G02)
GRAPH 22 - Sex hormones and modulators of the genital system (G03)
Hormones for systemic use, excl. sex hormones and insulins (H)
GRAPH 23 - Summary: Availability of registered and marketed products (H)
Antiinfectives for systemic use (J)
GRAPH 24 - Antibacterials (J01): Summary: Availability of registered and marketed products (J01)
GRAPH 25 – Antibacterials (J01) - Tetracyclines (J01A), Amphenicols (J01B), Penicillins (J01C)
GRAPH 26 – Antibacterials (J01) - Non-penicillin beta-lactams (J01D)
GRAPH 27 – Antibacterials (J01) - Sulfonamides and Trimethoprim (J01E) and Macrolides, Lincosamides and Streptogramins (J01F)
GRAPH 28 – Antibacterials (J01) - Aminoglycosides (J01G) and Quinolones (J01M)
GRAPH 29 – Antibacterials (J01) - Other antibacterials (J01X)
GRAPH 30 - Antifungals (J02)
GRAPH 31 - Antimycobacterials (J04) – Summary (graph): Availability of registered and marketed products (J04)
GRAPH 32 - Antimycobacterials (J04) – Tuberculosis: Aminosalicylic acid and derivatives (J04AA), Antibiotics (J04AB), Hydrazides (J04AC) and thiocarbamides (J04AD)
GRAPH 33 - Antimycobacterials (J04) – Other antituberculars (J04AK) and combinations (J04AM), drugs for the treatment of leprosy (J04B)
GRAPH 34 - Antivirals (J05) – Summary (graph): Availability of registered and marketed products (J05)
GRAPH 35 - Antivirals (J05) – Nucleosides and nucleotides excl. reverse transcriptase inhibitors (J05AB) and Protease inhibitors (J05AE)
GRAPH 36 - Antivirals (J05) – Nucleoside and nucleotide reverse transcriptase inhibitors (J05AF), Non-nucleoside reverse transcriptase inhibitors (J05AG) and Neuraminidase inhibitors (J05AH)
GRAPH 37 - Antivirals (J05) – Antivirals for treatment of HIV infections, combinations (J05AR) and other antivirals (J05AX)
GRAPH 38 - Immune sera and immunoglobulins (J06)
GRAPH 39 - Vaccines (J07) – Summary (graph): Availability of registered and marketed products (J07)
GRAPH 40 - Vaccines (J07) – Bacterial vaccines (J07A)
GRAPH 41 - Vaccines (J07) – Viral vaccines (J07B) and combined viral and bacterial vaccines (J07C)
Antineoplastic and immunomodulating agents (L)
GRAPH 42 – Summary (graph): Availability of registered and marketed products (L)
GRAPH 43 - Antineoplastic agents (L01) - Alkylating agents (L01A)
GRAPH 44 - Antineoplastic agents (L01) Antimetabolites (L01B)
GRAPH 45 - Antineoplastic agents (L01) Plant alkaloids and other natural products (L01C)
GRAPH 46 - Antineoplastic agents (L01) - Cytotoxic antibiotics (L01D)
GRAPH 47 - Antineoplastic agents (L01) Other antineoplastic agents (L01X)
GRAPH 48 - Endocrine therapy (L02)
GRAPH 49 - Immunostimulants (L03) and Immunosuppressants (L04)
Musculo-skeletal system (M)
GRAPH 50 – Musculoskeletal system
Nervous system (N)
GRAPH 51 – Summary (graph): Availability of registered and marketed products (L)
GRAPH 52 - General anesthetics (N01A), Local anesthetics (N01B)
GRAPH 53 - Analgesics (N02A) and Antiepileptics (N03)
GRAPH 54 - Anti-Parkinson drugs (N04) and Psycholeptics (N05)
GRAPH 55 - Psychoanaleptics (N06) and Other nervous system drugs (N07)
Antiparasitic products, insecticides and repellents (P)
GRAPH 56 – Summary (graph): Availability of registered and marketed products (P)
Respiratory system (R)
GRAPH 57 – Summary (graph): Availability of registered and marketed products (R)
Sensory organs (S)
GRAPH 58 – Summary (graph): Availability of registered and marketed products (S)
Various (V)
GRAPH 59 – Summary (graph): Availability of registered and marketed products (V)
APPENDIX 2 Essential medicines unavailable in the Czech Republic
TABLE 2 - Alimentary tract and metabolism (A)
TABLE 3 - Blood and blood forming organs (B)
TABLE 4 - Cardiovascular system (C)
TABLE 5 - Dermatologicals (D)
TABLE 6 - Genito-urinary system and sex hormones (G)
TABLE 7 - Systemic hormonal preparations, excl. sex hormones and insulins (H)
TABLE 8 - Antiinfectives for systemic use (J)
TABLE 9 - Antineoplastic and immunomodulating agents (L)
TABLE 10 - Musculo-skeletal system (M)
TABLE 11 - Nervous system (N)
TABLE 12 - Antiparasitic products, insecticides and repellents (P)
TABLE 13 - Respiratory system (R)
TABLE 14 - Sensory organs (S)
TABLE 15 - Various (V)
APPENDIX 3 Essential medicines unavailable in the Czech Republic: Global context
TABLE 16 - Alimentary tract and metabolism (A)
TABLE 17 - Blood and blood forming organs (B)
TABLE 18 - Cardiovascular system (C)
TABLE 19 - Dermatologicals (D)
TABLE 20 - Genito-urinary system and sex hormones (G)
TABLE 21 - Systemic hormonal preparations, excl. sex hormones and insulins (H)
TABLE 22 - Antiinfectives for systemic use (J)
Antibacterials
Antifungals
Antimycobacterials
Antivirals
Immune sera and immunoglobulins
Vaccines
TABLE 23 - Antineoplastic and immunomodulating agents (L)
TABLE 24 - Musculo-skeletal system (L)
TABLE 25 - Nervous system (N)
TABLE 26 - Antiparasitic products, insecticides and repellents (P)
TABLE 27 - Respiratory system (R)
TABLE 28 - Sensory organs (S)
TABLE 29 - Various (V)
TABLE 30 – Essential medicines unavailable in the Czech Republic: alternative sources
APPENDIX 4 - Essential medicines available in the Czech Republic: Registration and marketing
GRAPH – 60 – Essential medicines available in the Czech Republic: Share of products marketed in Q3 2016
GRAPH – 61 – Essential medicines available in the Czech Republic: Share of products marketed in Q3 2016 by organ class
GRAPH – 62 – Essential medicines available in the Czech Republic: Availability gap
GRAPH – 63 – Essential medicines available in the Czech Republic: Availability gap by organ class
References

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