The document analyzes the availability of essential medicines in the Czech Republic as compared to the WHO Model List of Essential Medicines. It finds that while many essential medicines are available locally, some important ones are still unavailable. It provides breakdowns by organ class of medicines available and unavailable. Key medicines reported as unavailable include hyoscine hydrobromide, oral rehydration salts, and magnesium sulfate.
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Essential medicines availability in Czech Republic
1. AVAILABILITY OF ESSENTIAL MEDICINES
Country study: Czech Republic
Comparison of locally available products with WHO list of essential medicines
Data source: Czech State Institute for Drug Control
Data download date: December 30, 2016
Publication date: January 27, 2017
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2. Essential medicines by organ class
A β Alimentary tract and metabolism
B β Blood and blood forming organs
C - Cardiovascular system
D β Dermatologicals
G β Genito-urinary system and sex hormones
H β Systemic hormonal preparations, excl. sex hormones and insulins
J β Antiinfectives for systemic use
L β Antineoplastic and immunomodulating agents
M β Musculo-skeletal system
N β Nervous system
P β Antiparasitic products, insecticides and repellents
R β Respiratory system
S β Sensory organs
V β Various
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3. Availability of essential medicines
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34 30
25 21 19
11
119
45
6
37 36
10 13
2125 23 22
9 12 10
80
39
5
33
6 9 9 10
0
20
40
60
80
100
120
140
WHO Essential Medicines
Availability (number of registrations)
Availability (number of registrations)
4. BREAKDOWN BY ORGAN CLASS
Essential medicines marketed and available by organ class
List of medicines unavailable locally
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5. ALIMENTARYAND METABOLISM
Essential medicines marketed and available
List of medicines unavailable locally
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6. Availability of essential medicines: A
0
100
200
300
400
500
600
700
Approvals (number of registrations)
Availability (number of registrations)
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7. Availability of essential medicines: A
8
430
2 5 7
79
05
52
2 2 3 13 0
0
50
100
150
200
250
300
350
400
450
500
ranitidine
omeprazole
atropin
hyoscinebutylbromide
metoclopramide
ondansetron
hyoscinehydrobr
A02BA02 A02BC01 A03BA01 A03BB01 A03FA01 A04AA01 A04AD01
Approvals (number of registrations)
Availability (number of registrations)
A02 - Acid related disorders | A03 - functional GI disorders
A04 β Antiemetics, antinauseants
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10. Unavailable essential medicines: A
ATC Code Active ingredient
A04AD01 hyoscine hydrobromide
A06AA02 docusate sodium
A07AA6 paromomycin
A07CA oral rehydration salt formulations
A07EA02 hydrocortisone
A11HA01 nicotinamide
A11HA04 riboflavin
A12CB01 zinc sulfate
A12CD01 sodium fluoride
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11. BLOOD AND BLOOD FORMING ORGANS
Essential medicines marketed and available
List of medicines unavailable locally
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12. Availability of essential medicines: B
0
50
100
150
200
250
300
350
400
450
Approvals (number of registrations)
Available (number of registrations)
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13. Availability of essential medicines: B
4
1
0
12
17
13
15
0
4
1
0
12
17
13
15
0
0
2
4
6
8
10
12
14
16
18
warfarin
heparin
dalteparin
enoxaparin
nadroparin
clopidogrel
acetylsalicylicacid
streptokinase
B01AA03 B01AB01 B01AB04 B01AB05 B01AB06 B01AC04 B01AC06 B01AD01
Approvals (number of
registrations)
Available (number of
registrations)
2 2 6
95
2 2 3
17
0
10
20
30
40
50
60
70
80
90
100
trenexamicacid
phytomenadione
coag.factorsIX,II,VIIand
X
coagulationfactorVIII
B02AA02 B02BA01 B02BD01 B02BD02
Approvals (number of
registrations)
Available (number of
registrations)
B01 β Antithrombotics | B02 β Antihemorrhagics
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14. Availability of essential medicines: B
B03 β Antianemics
4 4
5
0
11
3 3
0
1
0
1
2
3
4
5
6
iron bivalent, oral iron trivalent, oral iron in combination
with folic acid
hydroxycobalamin folic acid
B03AA B03AB B03AD B03BA03 B03BB01
Approvals (number of
registrations)
Available (number of
registrations)
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16. Unavailable essential medicines: B
ATC Code Active ingredient
B01AB04 dalteparin
B01AD01 streptokinase
B03BA03 hydroxycobalamin
B05AA05 dextran
B05AX01 red blood cells
B05AX03 fresh frozen plasma
B05XA05 magnesium sulfate
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17. CARDIOVASCULAR SYSTEM
Essential medicines marketed and available
List of medicines unavailable locally
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18. Availability of essential medicines: C
0
50
100
150
200
250
300
350
400
450
500
Approvals (number of registrations)
Available (number of registrations)
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19. Availability of essential medicines: C
2 2
28
3
15
1
13
36
2 1
8
1
8
1
7 6
0
5
10
15
20
25
30
35
40
digoxin lidocaine amiodaron dopamine epinephrine
(adrenaline)
ephedrine glyceryl trinitrate isosorbide
dinitrate
C01AA05 C01BB01 C01BD01 C01CA04 C01CA24 C01CA26 C01DA02 C01DA08
Approvals (number of
registrations)
Available (number of
registrations)
C01 β Cardiac therapy
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21. Unavailable essential medicines: C
ATC Code Active ingredient
C02DB02 hydrazaline
C02DD01 nitroprusside
C03DB01 amiloride
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22. DERMATOLOGICALS
Essential medicines marketed and available
List of medicines unavailable locally
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23. Availability of essential medicines: D
40
26
24 24
4
2 2 1 1 1
23
9
4
6
3
1 2
0 1 1
0
5
10
15
20
25
30
35
40
45
povidone-iodine
antipsoriaticsfortopical
use
terbinafine
betamethasone
benzoylperoxide
podophyllotoxin
carbamide
mupirocin
nystatin
hydrocortisone
D08AG02 D05A D01BA02 D07AC01 D10AE01 D06BB04 D02AE01 D06AX09 D01AA01 D07AA02
Approvals (number of registrations)
Available (number of registrations)
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24. Unavailable essential medicines: D
ATC Code Active ingredient
D01AC02 miconazole
D01AE12 salicylic acid
D01AE13 selenium sulfide
D01BA01 griseofulvin
D02AB zinc products
D06BA01 silver sulfadiazine
D06AX09 muciprocin*
D08AC02 chlorhexidine
D08AE05 chloroxylenol
D08AX05 isopropanol
D08AX06 potassium permanganate
D08AX08 ethanol
* Registered, not available in Q4/2016
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25. GENITO-URINARY SYSTEM
SEX HORMONES
Essential medicines marketed and available
List of medicines unavailable locally
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27. Unavailable essential medicines: G
ATC Code Active ingredient
G02AB03 ergometrine
G02BA02 plastic IUD with copper
G03AA05 norethisterone and ethinylestradiol
G03AA08 medroxyprogesterone and estrogen
G03AC01 norethisterone
G03AC03 levonorgestrel
G03AC08 etonorgestrel
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28. SYSTEMIC HORMONES
EXCL. SEX HORMONES AND INSULINS
Essential medicines marketed and available
List of medicines unavailable locally
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30. Unavailable essential medicines: H
ATC Code Active ingredient
H02AB06 prednisolone
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31. ANTIINFECTIVES
Essential medicines marketed and available
List of medicines unavailable locally
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32. Availability of essential medicines: J
0
50
100
150
200
250
300
350
400
Approvals (number of registrations)
Available (number of registrations)
J01 - Antibacterials for systemic use
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33. Availability of essential medicines: J
J01 - Antibacterials for systemic use
12 2 12 14 12 24
1 6
372
10 9
31 25
5 97 1 4 10 3 12 1 2
24
3 5 5 5 1 2
0
50
100
150
200
250
300
350
400
doxycycline
chloramphenicol
ampicillin
amoxicillin
benzylpenicillin
phenoxymethylpenicillin
benzathinbenzylpenicilin
procainbenzylpenicilin
amoxicillinandenzyme
inh.
cefazolin
cefotaxime
ceftazidime
ceftriaxone
cefixime
imipenemandenzymeinh.
J01AA02J01BA01J01CA01J01CA04J01CE01J01CE02J01CE08J01CE09J01CR02J01DB04J01DD01J01DD02J01DD04J01DD08J01DH51
Approvals (number of registrations)
Available (number of registrations)
Tetracyclines
Amphenicoles
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Penicillins
Other beta-lactams
43. Unavailable essential medicines: J
ATC Code Active ingredient
J07AF01 diphtheria toxoid
J07AJ01 pertussis vaccine
J07AN01 tuberculosis, live attenuated
J07BD01 measles vaccine, live attenuated
J07BE01 mumps vaccine, live attenuated*
J07BJ rubella vaccines
J07 - Vaccines
* Registered, not available in Q4/2016
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44. ANTINEOPLASTIC AGENTS
IMMUNOMODULANTS
Essential medicines marketed and available
List of medicines unavailable locally
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47. Unavailable essential medicines: L
ATC Code Active ingredient
L01DA01 dactinomycin
L01DB02 daunorubicin
L01XB01 procarbazine
L01XX02 asparaginase*
L01XX09 miltefosine
L01XX14 tretinoin
* Registered, not available in Q4/2016
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48. MUSCULOSKELETAL SYSTEM
Essential medicines marketed and available
List of medicines unavailable locally
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49. Availability of essential medicines: M
557
56
4 3 2 0
58
9 1 1 2 0
0
100
200
300
400
500
600
ibuprofen allopurinol suxamethonium atracurium penicillamine vecuronium
M01AE01 M04AA01 M03AB01 M03AC04 M01CC01 M03AC03
Approvals (number of registrations)
Available (number of registrations)
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50. Unavailable essential medicines: M
ATC Code Active ingredient
M03AC03 vecuronium
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51. NERVOUS SYSTEM
Essential medicines marketed and available
List of medicines unavailable locally
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52. Availability of essential medicines: N
L01 - Anesthetics
0
10
1
49
79
21
7
20 3 1
11 9
3 3 0
0
10
20
30
40
50
60
70
80
90
halothane isoflurane ketamine propofol nitrous oxide bupivacaine lidocaine lidocaine,
combinations
N01AB01 N01AB06 N01AX03 N01AX10 N01AX13 N01BB01 N01BB02 N01BB52
Approvals (number of registrations)
Available (number of registrations)
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55. Unavailable essential medicines: N
ATC Code Active ingredient
N01AB01 halothane
N01BB52 lidocaine, combinations*
N05BA06 lorazepam
N07BC02 methadone*
* Registered, not available in Q4/2016
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56. ANTIPARASITICS, INSECTICIDES
REPELLENTS
Essential medicines marketed and available
List of medicines unavailable locally
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58. Unavailable essential medicines: P
ATC Code Active ingredient
P01CB01 meglumine antimoniate*
P01CX01 pentamidine isethionate*
P01AC01 diloxanide
P01BA01 chloroquine
P01BA06 amodiaquine
P01BB01 proguanil
P01BC02 mefloquine
P01BD01 pyrimethamine
P01BD51 pyrimethamine, comb.
P01BE02 artemether
* Registered, not available in Q4/2016
P01 β Antiprotozoals
ATC Code Active ingredient
P01BE03 artesunate
P01BF01 artemether and lumefantrine
P01BF02 artesunate and mefloquine
P01BF03 artesunate and amodiaquine
P01CA02 benznidazole
P01CB02 sodium stibogluconate
P01CC01 nifurtimox
P01CD01 melarsoprol
P01CX02 suramin sodium
P01CX03 eflornithine
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59. Unavailable essential medicines: P
ATC Code Active ingredient
P02BA01 praziquantel*
P02BA02 oxamniquine
P02BX04 triclabendazole
P02CA03 albendazole
P02CB02 diethylcarbamazine
P02CC01 pyrantel
P02CE01 levamisole
P02CF01 ivermectin
P02DA01 niclosamide
P03AX01 benzyl benzoate
* Registered, not available in Q4/2016
P02 β Anthelmintics | P03 - Ectoparasiticides
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60. RESPIRATORY SYSTEM
Essential medicines marketed and available
List of medicines unavailable locally
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62. Unavailable essential medicines: R
ATC Code Active ingredient
R06AE03 cyclizine
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63. SENSORY ORGANS
Essential medicines marketed and available
List of medicines unavailable locally
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64. Availability of essential medicines: S
1 1 1 1
19
45
1 3 11 1 1 1
11
16
1 1 1
0
5
10
15
20
25
30
35
40
45
50
gentamicin aciclovir prednisolone acetazolamide timolol latanoprost atropine tropicamide fluorescein
S01AA11 S01AD03 S01BA04 S01EC01 S01ED01 S01EE01 S01FA01 S01FA06 S01JA01
Approvals (number of registrations)
Available (number of registrations)
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65. Unavailable essential medicines: S
ATC Code Active ingredient
S01AA09 tetracycline
S01EA01 epinephrine
S01EB01 pilocarpine
S01HA03 tetracaine
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66. VARIOUS
Essential medicines marketed and available
List of medicines unavailable locally
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68. Unavailable essential medicines: V
ATC Code Active ingredient
V03AB03 edetates
V03AB06 thiosulfate*
V03AB08 sodium nitrite
V03AB09 dimercaprol
V03AB17 methylthioninium chloride (methylene blue)*
V03AB23 acetylcysteine
V03AB34 fomepizole
* Registered, not available in Q4/2016
V03 β All other therapeutic products
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69. Unavailable essential medicines: V
ATC Code Active ingredient
V04CF01 tuberculin, purified protein derivative (PPD) - BCG
V07AV technical disinfectants
V08AA01 diatrizoic acid
V08AC02 iotroxic acid
V04 β Diagnostic agents | V07 β Other non-therapeutic products | V08 β Contrast media
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70. ARETE-ZOE, as a consultancy, provides solutions to complex problems in the
high stakes and high consequence environment of Global Pharmaceuticals,
including clinical research, healthcare informatics, and public
health. We blend established, Pharma sector methodologies, innovation, and
adaptations/transfers from other sectors to identify and resolve consequential
practices that pose risk and often result in avoidable patient casualty. However,
we are specifically, not a patient advocacy group but believe in optimizing
organizational effectiveness and that smart business is agile, competitive and
profitable, while intrinsically safe, secure, and resilient. We work within a global
context because transnational interests influence national circumstances and
choices at point of prescription.
ARETE-ZOE, provides full spectrum organizational and operational risk
management consultancy. Our published materials provide a glimpse of some
aspects of our services to demonstrate both knowledge and ongoing participation
within the Pharmaceutical Industry. Our analysis and consultancy includes all
channels of misuse, diversion, counterfeiting and illicit exploitation of
pharmaceuticals, medical devices, and precursor chemicals. Our advisement is to
manufactures, jurisdictional entities, insurers, legislators, litigators, patients, and
health care providers.
β
This scope also frequently segues into the nexus of crime and terrorism as
significant influencers that undermine sector integrity differentiated from other
criminal activity. Obviously, vulnerability assessment, information collection
management and intelligence production supporting decision-making for risk
reduction and interventions are routinely within the scope of our services as well
as design and implementation of operational control measures.
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