| Titre : |
A practical handbook of the pharmacovigilance of medicines used in the treatment of tuberculosis : enhancing the safety of the TB patient |
| Type de document : |
texte imprimé |
| Auteurs : |
World Health Organization (Genève, Suisse), Auteur |
| Editeur : |
Genève [Suisse] : World Health Organisation |
| Année de publication : |
2012 |
| Langues : |
Français (fre) |
| Catégories : |
Médicaments antituberculeux -- Effets adverses ; Pharmacovigilance
|
| Résumé : |
Most of the medicines used to treat tuberculosis (TB) today have been on the market for several decades. Clinicians treating TB patients around the world know these medicines well, and are usually well aware of their associated adverse drug reactions (ADRs). The occurrence of these reactions is known to be frequent. The TB patient on treatment is taking more than one anti-TB medicine simultaneously and regimens last from many months to 2 years or more. This increases the likelihood of ADRs, some of which are severe. Most patients on treatment for drug-resistant TB experience at least one side-effect, and a recent study has shown that two thirds of such patients have had at least one medicine stopped temporarily or permanently as a result of ADRs. These events may damage public confidence in any national treatment programme and affect patient adherence. Patients who stop taking anti-TB medicines pose a risk to themselves and to others. The generation of drug resistance is a very real risk. So why should TB practitioners today reflect on a more systematic approach to surveillance of drug-related problems, which is at the heart of pharmacovigilance? Firstly, while national TB programmes are generally well structured to monitor patients and have a long tradition of following up care using standardized indicators, they do not collect information on ADRs directly. It is therefore difficult to assess precisely the net benefit of a treatment programme if adversities related to the medicines used are not factored in. The contribution of ADRs to death, treatment default and failure can therefore only be conjectured. Secondly, the widespread recognition by health workers that anti-TB medicines often cause ADRs is poorly reflected in the published information on the subject. There is a dearth of published literature about anti-TB drug-induced mortality, morbidity and reduced quality of life, particularly in low-resource settings. The overall burden of adversity directly attributable to anti-TB medicines is poorly quantified and it is not usually well profiled in individual TB control programmes. Thirdly, with the increasing use worldwide of more extensive regimens for drug-resistant TB, the added use of antiretrovirals (ARVs) in patients with HIV-associated TB, and the imminent advent of new classes of medicines to treat TB, the case for improved pharmacovigilance becomes even stronger. Pharmacovigilance needs to be an integral accompaniment to treatment programmes as they expand their geographical coverage, given that the frequency and expression of ADRs may be influenced by factors linked to the demographic, genetic and nutritional patterns, and to the background co-morbidity (e.g. TB/HIV) in a population. The cornerstones of pharmacovigilance apply equally to TB as to any other disease amenable to medication. Events linked to medications, particularly novel medicines or new combinations thereof, need to be recognized in a timely fashion if the events are to provide benefit to the individual patient and enrich public knowledge. Appropriate measures need to be put in place to ensure that harm is reduced and symptoms relieved. Health-care workers need to be informed and trained about the methodology and routes for reporting ADRs. This handbook aims to satisfy the need for pharmacovigilance, which has been neglected in the domain of TB for too long. |
| Note de contenu : |
Abbreviations and acronyms --
Acknowledgements --
Preface: Why pharmacovigilance for anti-TB medicines? --
Key messages --
A. Introduction --
B. Which approach to pharmacovigilance? --
C. Spontaneous reporting --
D. Targeted spontaneous reporting (TSR) --
E. Cohort event monitoring (CEM) --
F. Data processing --
G. Relationship and causality assessment --
H. Special types of event --
I. Signal identification --
J. Evaluating a signal --
K. Identifying risk factors --
L. Data description and analysis --
M. Organization --
Annex 1. Useful websites and other resources --
Annex 2. Form for spontaneous reports of suspected adverse --
drug reactions (ADRs) (Ghana) --
Annex 3. Relationship between sample size and probability of --
observing an adverse event (AE) --
Annex 4. Abbreviations for tuberculosis (TB) medicines and regimens --
Annex 5. List of adverse drug reactions (ADRs) commonly associated --
with anti-tuberculosis (TB) medication --
Annex 6. Treatment initiation form --
Annex 7. Treatment review form --
Annex 8. Tuberculosis identity card --
Annex 9. Manual coding sheet --
Annex 10. Major clinical categories in events dictionary --
Annex 11.Decision tree for cohort event monitoring --
Glossary |
A practical handbook of the pharmacovigilance of medicines used in the treatment of tuberculosis : enhancing the safety of the TB patient [texte imprimé] / World Health Organization (Genève, Suisse), Auteur . - Genève (Suisse) : World Health Organisation, 2012. Langues : Français ( fre)
| Catégories : |
Médicaments antituberculeux -- Effets adverses ; Pharmacovigilance
|
| Résumé : |
Most of the medicines used to treat tuberculosis (TB) today have been on the market for several decades. Clinicians treating TB patients around the world know these medicines well, and are usually well aware of their associated adverse drug reactions (ADRs). The occurrence of these reactions is known to be frequent. The TB patient on treatment is taking more than one anti-TB medicine simultaneously and regimens last from many months to 2 years or more. This increases the likelihood of ADRs, some of which are severe. Most patients on treatment for drug-resistant TB experience at least one side-effect, and a recent study has shown that two thirds of such patients have had at least one medicine stopped temporarily or permanently as a result of ADRs. These events may damage public confidence in any national treatment programme and affect patient adherence. Patients who stop taking anti-TB medicines pose a risk to themselves and to others. The generation of drug resistance is a very real risk. So why should TB practitioners today reflect on a more systematic approach to surveillance of drug-related problems, which is at the heart of pharmacovigilance? Firstly, while national TB programmes are generally well structured to monitor patients and have a long tradition of following up care using standardized indicators, they do not collect information on ADRs directly. It is therefore difficult to assess precisely the net benefit of a treatment programme if adversities related to the medicines used are not factored in. The contribution of ADRs to death, treatment default and failure can therefore only be conjectured. Secondly, the widespread recognition by health workers that anti-TB medicines often cause ADRs is poorly reflected in the published information on the subject. There is a dearth of published literature about anti-TB drug-induced mortality, morbidity and reduced quality of life, particularly in low-resource settings. The overall burden of adversity directly attributable to anti-TB medicines is poorly quantified and it is not usually well profiled in individual TB control programmes. Thirdly, with the increasing use worldwide of more extensive regimens for drug-resistant TB, the added use of antiretrovirals (ARVs) in patients with HIV-associated TB, and the imminent advent of new classes of medicines to treat TB, the case for improved pharmacovigilance becomes even stronger. Pharmacovigilance needs to be an integral accompaniment to treatment programmes as they expand their geographical coverage, given that the frequency and expression of ADRs may be influenced by factors linked to the demographic, genetic and nutritional patterns, and to the background co-morbidity (e.g. TB/HIV) in a population. The cornerstones of pharmacovigilance apply equally to TB as to any other disease amenable to medication. Events linked to medications, particularly novel medicines or new combinations thereof, need to be recognized in a timely fashion if the events are to provide benefit to the individual patient and enrich public knowledge. Appropriate measures need to be put in place to ensure that harm is reduced and symptoms relieved. Health-care workers need to be informed and trained about the methodology and routes for reporting ADRs. This handbook aims to satisfy the need for pharmacovigilance, which has been neglected in the domain of TB for too long. |
| Note de contenu : |
Abbreviations and acronyms --
Acknowledgements --
Preface: Why pharmacovigilance for anti-TB medicines? --
Key messages --
A. Introduction --
B. Which approach to pharmacovigilance? --
C. Spontaneous reporting --
D. Targeted spontaneous reporting (TSR) --
E. Cohort event monitoring (CEM) --
F. Data processing --
G. Relationship and causality assessment --
H. Special types of event --
I. Signal identification --
J. Evaluating a signal --
K. Identifying risk factors --
L. Data description and analysis --
M. Organization --
Annex 1. Useful websites and other resources --
Annex 2. Form for spontaneous reports of suspected adverse --
drug reactions (ADRs) (Ghana) --
Annex 3. Relationship between sample size and probability of --
observing an adverse event (AE) --
Annex 4. Abbreviations for tuberculosis (TB) medicines and regimens --
Annex 5. List of adverse drug reactions (ADRs) commonly associated --
with anti-tuberculosis (TB) medication --
Annex 6. Treatment initiation form --
Annex 7. Treatment review form --
Annex 8. Tuberculosis identity card --
Annex 9. Manual coding sheet --
Annex 10. Major clinical categories in events dictionary --
Annex 11.Decision tree for cohort event monitoring --
Glossary |
|
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