EVALUATION OF THE THERAPEUTIC VALUE OF DRUGS REGISTERED IN PERU IN 1996

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EVALUATION OF THE THERAPEUTIC VALUE OF DRUGS
REGISTERED IN PERU IN 1996

• Mg. Raúl Cruzado Ubillús

Study Funding United States Pharmacopeia
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BACKGROUND

• Over the past few years, the Peruvian government
  has promulgated laws that allow the registration
  of almost any pharmaceutical product, thereby
  increasing the irrationality of the offer and use
  of drugs in the country.
• (D.L. N 25596 1992 to 1997 and D.L. N 26842
  1997 until now).

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OBJECTIVES

• Classify and evaluate the drugs registered in
  Peru in 1996 based on their intrinsic therapeutic
  value.
• Identify the percentage of essential drugs,
  generic drugs, combinations of fixed doses,
  therapeutic groups of major register.

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METHODS DESING

• A list of drugs registered in Peru in 1996
  (excluding diagnostic agents, contrast media,
  biologicals, blood coagulation factors, perfusion
  solutions, and galenical drugs) was provided by
  the General Directorate of Drugs and Medical
  Supplies (DIGEMID). Of the 1,613 drugs registered
  in 1996, only 1,484 (92) were evaluated.
• Drugs were evaluated and classified based on
  categories established by the non-governmental
  organization Provida (A, B and C Categories).

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METHODS CLASSIFICATION OF THE INTRINSIC
THERAPEUTIC VALUE (NGO PROVIDA - PERU)

• Essential drugs

• A Category

• Safe and efficacious drugs but which are not
  essentials it could be alternative drugs.

B Category

• Questionable drugs combinations of fixed doses
  that are not justified or products which are not
  safe or efficacious.

C Category
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METHODS INFORMATION BASIC RESOURCES FOR
EVALUATION OF THE INTRINSIC THERAPEUTIC VALUE

• USP DI, British National Formulary, Martindale,
  AMA Drug Evaluation, Pharmacological Bases of
  Therapeutic (Goodman and Gilman), Applied
  Therapeutics (Young - Koda - Kimble)

Basic Consulted Bibliography
Sistematic Revision in Data Bases

• MEDLINE
• IDIS
• LILACS.

Evaluation of original researches

• Double-blind controlled trials that have been
  published in full peer-reviewed journals.

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Total 1484
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Total 1484
9
21.3
15.5
11.6
9.0
8.5
7.1
7.1
3.8
3.7
2.8
2.6
2.6
2.2
2.1
0.1
Total 1484
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81.7
86.7
57.0
94.3
94.3
66.9
63.5
97.6
73.2
74.5
94.7
81.6
96.8
36.4
Total 1484
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Total 1484
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(No Transcript)
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(1141)
Total 1484
14
(412)
(1072)
Total 1484
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CONCLUSIONS

• In Peru in 1996 were registered about 25 of
  drugs without therapeutic value.
• Only 24.1 of the registered drugs were
  essentials.
• Combinations of fixed doses represented 23.2
• Only 27,2 of the registered drugs were generics
• About 75 of combinations of fixed doses didnt
  have therapeutic value.
• The pharmacotherapeutic groups more frequently
  registered were antiinfectives for systemic use
  (21,3 ), drugs for alimentary tract and
  metabolism (15,5 ), and drgus for nervous system
  (11,6 )

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RECOMMENDATIONS
Questionable drugs represent an important group
of drugs registered in Peru in 1996, which shows
the evidence of the countrys flexible drug
registration system. It is crucial that the drug
registration process be improved by the
government to ensure that pharmaceuticals in the
market are effective and safe.