Rational Approaches to the Regulation of Nonprescription Medicines
Notice bibliographique
Résumé
In recent years, self-medication products have undergone a dramatic change due to the advent of herbal medicines, dietary supplements, nutraceuticals and health foods in addition to traditional nonprescription medicines and the increasing societal preferences towards greater individual control over the use of medicines. Globally, the role and importance of nonprescription medicines in healthcare delivery is also rapidly increasing due to the potential cost-savings. Hence, this area is beginning to receive much attention from regulatory authorities, academia and professional/industry/trade organizations. This dissertation presents a comprehensive analysis of the classification of nonprescription medicines and Rx-to-OTC switch criteria/policy in the United States, United Kingdom, Canada, Japan and Australia. A new approach to investigating US FDA's overall switch regulatory policies through the combined application of casehistory evaluations, electronic survey questionnaire and telephone interviews has been utilized. This investigation was conducted in three phases. Phase-1 involved information retrieval and a critical review of existing literature, phase-2 applied switch case history analyses pertinent to US FDA and phase-3 measured the attitudes/opinions of the academic/professional community and key opinion leaders in nonprescription medicines across the US, Canada, UK and Australia on important questions. The subject matter of this dissertation is of enormous current interest in the global nonprescription medicines arena. The significance of the results presented in this dissertation is amplified as this area has received little academic attention and this is perhaps the first comprehensive treatment of this subject. Overall, inferences based on the information elicited have been summarized to provide data-based responses to questions of global interest in the self-medication arena. This information is especially valuable to the US FDA as they are currently seeking public comment. Data shows that the OTC regulatory model in the United States may be improved. Evidence indicates that principles upon which approaches for improvement of the US regulatory system must be based should include: an objective evaluation of pharmacist class of OTC medicines, development of effective consumer education tools, increase in regulation of non-traditional OTC medicines, acknowledge that not all disease conditions and drug classes are suitable for self-treatment, a collaborative approach by FDA towards switching that includes all stakeholders is more favored, decisions on switch petitions must be case-specific without a presumptive bias and public health benefit must be the paramount evaluation criterion.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».