Figura 1 - Modelo CIOMS de comunicação da ... - Estudo Geral
Figura 1 - Modelo CIOMS de comunicação da ... - Estudo Geral
Figura 1 - Modelo CIOMS de comunicação da ... - Estudo Geral
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ANEXO II<br />
RELATÓRIO DE REACÇÃO ADVERSA<br />
I. INFORMAÇÃO DA REACÇÃO<br />
1. IDENT. DOENTE 1a. PAÍS 2. DATA DE NASCIMENTO 2a. IDADE 3. SEXO 3a. PESO 4-6 INICIO DA REACÇÃO<br />
Dia Mês Ano<br />
Dia Mês Ano<br />
7 + 13 DESCRIÇÃO DA(S) REACÇÃO(ÕES) (incluindo testes relevantes/<strong>da</strong>dos laboratoriais)<br />
8-12 ASSINALE OS CAMPOS<br />
APLICÁVEIS À REACÇÃO<br />
ADVERSA<br />
MORTE<br />
MOTIVOU OU<br />
PROLONGOU A<br />
HOSPITALIZAÇÃO<br />
PROVOCOU<br />
INCAPACIDADE OU<br />
DEFICIÊNCIA<br />
SIGNIFICATIVA OU<br />
TEMPORÁRIA<br />
PÔS EM PERIGO A<br />
VIDA<br />
OUTRA<br />
II. INFORMAÇÃO DE MEDICAÇÃO SUSPEITA<br />
14. MEDICAMENTO(S)/ FARMACO(S) SUSPEITO(S) 20. REACÇÃO<br />
DESAPARECEU APÓS<br />
SUSPENSÃO DA<br />
MEDICAÇÃO?<br />
15. DOSE DIÁRIA 16. VIA DE ADMINISTRAÇÃO<br />
SIM NÃO NA<br />
17. INDICAÇÃO TERAPÊUTICA<br />
21. REACÇÃO APARECEU<br />
APÓS REINTRODUÇÃO?<br />
18. DATAS DE TRATAMENTO 19. DURAÇÃO DO TRATAMENTO SIM NÃO NA<br />
III. MEDICAÇÃO CONCOMITANTE E DADOS ADICIONAIS<br />
22. MEDICAÇÃO CONCOMITANTE E DATAS DE ADMINISTRAÇÃO (EXCLUÍDOS AQUELES USADOS COMO TRATAMENTO)<br />
23. OUTROS DADOS RELEVANTES<br />
24a. NOME E MORADA DA AUTORIDADE<br />
IV. INFORMAÇÕES DA AUTORIDADE REGULADORA<br />
26a. Observações<br />
24b. N.º INFARMED<br />
24c. DATA DE RECEPÇÃO 24d. ORIGEM DA NOTIFICAÇÃO<br />
<strong>Figura</strong> 1 - <strong>Mo<strong>de</strong>lo</strong> <strong>CIOMS</strong> <strong>de</strong> <strong>comunicação</strong> <strong>da</strong> suspeita <strong>de</strong> reacção adversa ao titular <strong>de</strong> A.I.M.<br />
e à O.M.S.<br />
235
SYSTEM-ORGAN CLASSES<br />
CODES<br />
Skin and appen<strong>da</strong>ges disor<strong>de</strong>rs 0100<br />
Musculo-skeletal system disor<strong>de</strong>rs 0200<br />
Collagen disor<strong>de</strong>rs 0300<br />
Central & peripheral nervous system disor<strong>de</strong>rs 0410<br />
Autonomic nervous system disor<strong>de</strong>rs 0420<br />
Vision disor<strong>de</strong>rs 0431<br />
Hearing and vestibular disor<strong>de</strong>rs 0432<br />
Special senses other, disor<strong>de</strong>rs 0433<br />
Psychiatric disor<strong>de</strong>rs 0500<br />
Gastro-intestinal system disor<strong>de</strong>rs 0600<br />
Liver and biliary system disor<strong>de</strong>rs 0700<br />
Metabolic and nutritional disor<strong>de</strong>rs 0800<br />
Endocrine disor<strong>de</strong>rs 0900<br />
Cardiovascular disor<strong>de</strong>rs, general 1010<br />
Myo-, endo-, pericardial & valve disor<strong>de</strong>rs 1020<br />
Heart rate and rhythm disor<strong>de</strong>rs 1030<br />
Vascular (extracardiac) disor<strong>de</strong>rs 1040<br />
Respiratory system disor<strong>de</strong>rs 1100<br />
Red blood cell disor<strong>de</strong>rs 1210<br />
White cell and RES disor<strong>de</strong>rs 1220<br />
Platelet, bleeding & clotting disor<strong>de</strong>rs 1230<br />
Urinary system disor<strong>de</strong>rs 1300<br />
Reproductive disor<strong>de</strong>rs, male 1410<br />
Reproductive disor<strong>de</strong>rs, female 1420<br />
Foetal disor<strong>de</strong>rs 1500<br />
Neonatal and infancy disor<strong>de</strong>rs 1600<br />
Neoplasms 1700<br />
Body as a whole – general disor<strong>de</strong>rs 1810<br />
Application site disor<strong>de</strong>rs 1820<br />
Resistance mechanism disor<strong>de</strong>rs 1830<br />
Secon<strong>da</strong>ry terms - events 2000<br />
Poison specific terms 2100<br />
Tabela 1- World Health<br />
Organization Adverse Reaction<br />
Terminology - classes <strong>de</strong> órgãos e<br />
sistemas.<br />
236
CATEGORIAS DE CODIFICAÇÃO<br />
1 Infectious and Parasitic Diseases<br />
2 Neoplasms<br />
3 Endocrine, Nutritional and Metabolic Diseases, and Immunity Disor<strong>de</strong>rs<br />
4 Diseases of the Blood and Blood-forming Organs<br />
5 Mental Disor<strong>de</strong>rs<br />
6 Diseases of the Nervous System and Sense Organs<br />
7 Diseases of the Circulatory System<br />
8 Diseases of the Respiratory System<br />
9 Diseases of the Digestive System<br />
10 Diseases of the Genitourinary System<br />
11 Complications of Pregnancy, Childbirth, and the Puerperium<br />
12 Diseases of the Skin and Subcutaneous Tissue<br />
13 Diseases of the Musculoskeletal System and Connective Tissue<br />
14 Congenital Anomalies<br />
15 Certain Conditions Originating in the Perinatal Period<br />
16 Symptoms, Signs, and Ill-<strong>de</strong>fined Conditions<br />
17 Injury and Poisoning<br />
V<br />
E<br />
Supplementary classification of factors influencing health status and contact<br />
with health services<br />
Supplementary classification of external causes of injury and poisoning<br />
Tabela 2 - The International<br />
Classification of Diseases. Ninth<br />
Revision. Clinical Modification. -<br />
ICD.9.CM<br />
237
1º Nível<br />
2º Nível<br />
A<br />
A01<br />
A02<br />
A03<br />
A04<br />
A05<br />
A06<br />
A07<br />
A08<br />
A09<br />
A10<br />
A11<br />
A12<br />
A13<br />
A14<br />
A15<br />
A16<br />
CLASSIFICAÇÃO ATC<br />
ALIMENTARY TRACT AND METABOLISM<br />
Stomatological preparations<br />
Antacids, drugs for treatment of peptic ulcer and flatulence<br />
Antispasmodic and anticholinergic agents and propulsives<br />
Antiemetics and antinauseants<br />
Bile and liver therapy<br />
Laxatives<br />
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents<br />
Antiobesity preparations, excl. diet products<br />
Digestives, incl. enzymes<br />
Drugs used in diabetes<br />
Vitamins<br />
Mineral supplements<br />
Tonics<br />
Anabolic agents for systemic use<br />
Appetite stimulants<br />
Other alimentary tract and metabolism products<br />
B<br />
B01<br />
B02<br />
B03<br />
B05<br />
B06<br />
C<br />
C01<br />
C02<br />
C03<br />
C04<br />
C05<br />
C07<br />
C08<br />
C09<br />
C10<br />
BLOOD AND BLOOD FORMING ORGANS<br />
Antithrombotic agents<br />
Antithemorrhagics<br />
Antianemic preparations<br />
Plasma substitutes and perfusion solutions<br />
Other haematological agents<br />
CARDIOVASCULAR SYSTEM<br />
Cardiac therapy<br />
Antihypertensives<br />
Diuretics<br />
Peripheral vasodilators<br />
Vasoprotectives<br />
Beta blocking agents<br />
Calcium channel blockers<br />
Agents acting on the renin-angiotensin system<br />
Serum lipid reducing agents<br />
238
D<br />
D01<br />
D02<br />
D03<br />
D04<br />
D05<br />
D06<br />
D07<br />
D08<br />
D09<br />
D10<br />
D11<br />
G<br />
G01<br />
G02<br />
G03<br />
G04<br />
H<br />
H01<br />
H02<br />
H03<br />
H04<br />
H05<br />
J<br />
J01<br />
J02<br />
J04<br />
J05<br />
J06<br />
J07<br />
L<br />
L01<br />
L02<br />
L03<br />
L04<br />
M<br />
M01<br />
M02<br />
M03<br />
DERMATOLOGICALS<br />
Antifungals for <strong>de</strong>rmatological use<br />
Emollients and protectives<br />
Preparations for treatment of wounds and ulcers<br />
Antipruritics, incl. antihistamines, anesthetics, etc.<br />
Antipsoriatics<br />
Antibiotics and chemotherapeutics for <strong>de</strong>rmatological use<br />
Corticosteroids, <strong>de</strong>rmatological preparations<br />
Antiseptics and disinfectants<br />
Medicated dressings<br />
Anti-acne preparations<br />
Other <strong>de</strong>rmatological preparations<br />
GENITO URINARY SYSTEM AND SEX HORMONES<br />
Gynecological anti-infectives and antiseptics<br />
Other gynecologicals<br />
Sex hormones and modulators of the genital system<br />
Urologicals<br />
SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES<br />
Pituitary, hypothalamic hormones and analogues<br />
Corticosteroids for systemic use<br />
Thyroid therapy<br />
Pancreatic hormones<br />
Calcium homeostasis<br />
GENERAL ANTI-INFECTIVES FOR SYSTEMIC USE<br />
Antibacterials for systemic use<br />
Antimycotics for systemic use<br />
Antimycobacterials<br />
Antivirals for systemic use<br />
Immune sera and immunoglobulins<br />
Vaccines<br />
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS<br />
Antineoplastic agents<br />
Endocrine therapy<br />
Immunomodulating agents<br />
Immunosuppressive agents<br />
MUSCULO-SKELETAL SYSTEM<br />
Anti-inflammatory and anti-rheumatic<br />
Topical products for joint and muscular pain<br />
Muscle relaxants<br />
239
M03<br />
M04<br />
M05<br />
M09<br />
N<br />
N01<br />
N02<br />
N03<br />
N04<br />
N05<br />
N06<br />
N07<br />
P<br />
P01<br />
P02<br />
P03<br />
R<br />
R01<br />
R02<br />
R03<br />
R05<br />
R06<br />
R07<br />
S<br />
S01<br />
S02<br />
S03<br />
V<br />
V01<br />
V03<br />
V04<br />
V06<br />
V07<br />
V08<br />
V09<br />
V10<br />
V20<br />
Muscle relaxants<br />
Antigout preparations<br />
Drugs for treatment of bone diseases<br />
Other drugs for disor<strong>de</strong>rs of the musculo-skeletal system<br />
NERVOUS SYSTEM<br />
Anesthetics<br />
Analgesics<br />
Antiepileptics<br />
Anti-Parkinson drugs<br />
Psycholeptics<br />
Psychoanaleptics<br />
Other nervous system drugs<br />
ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS<br />
Antiprotozoals<br />
Anthelmintics<br />
Ectoparasitici<strong>de</strong>s, incl. scabici<strong>de</strong>s, insectici<strong>de</strong>s and repellents<br />
RESPIRATORY SYSTEM<br />
Nasal preparations<br />
Throat preparations<br />
Anti-asthmatics<br />
Cough and cold preparations<br />
Antihistamines for systemic use<br />
Other respiratory system products<br />
SENSORY ORGANS<br />
Ophthalmologicals<br />
Otologicals<br />
Ophthalmological and otological preparations<br />
VARIOUS<br />
Allergens<br />
All other therapeutic products<br />
Diagnostic agents<br />
General nutrients<br />
All other non-therapeutic products<br />
Contrast media<br />
Diagnostic radiopharmaceuticals<br />
Therapeutic radiopharmaceuticals<br />
Surgical dressings<br />
240
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