Prescribing information: difference between revisions
Diff·revision 13 → 14·18:31, 7 May 2025
Difference between revision 13 and revision 14 of Prescribing information. 6 lines changed; the page grew by 641 bytes.
| Revision 13 — 09:38, 7 Apr 2025 LurkerLevi (talk) add the note that price is not a proxy for quality 3,683 bytes ±0 | Revision 14 — 18:31, 7 May 2025 NauseaNoor (talk) add the note that list price is rarely what is paid 4,324 bytes +641 | ||
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| 34 | Labelling also lags. A finding published after the most recent labelling revision will not appear, which is why the label is authoritative for regulatory status and not for the current state of the literature.{{r|ema_smpc}} | 34 | Labelling also lags. A finding published after the most recent labelling revision will not appear, which is why the label is authoritative for regulatory status and not for the current state of the literature.{{r|ema_smpc}} |
| 35 | 35 | ||
| + | 36 | == Relationship to telehealth and access == | |
| + | 37 | Prescription is the mechanism by which labelled products reach people, and the models by which prescriptions are obtained have changed substantially. See [[Telehealth prescribing]] and [[Prior authorisation]].{{r|ada2024}} | |
| + | 38 | ||
| + | 39 | Off-label prescribing — use outside the approved indication — is lawful in most jurisdictions and is a clinical decision. It is distinct from unapproved supply, where no authorisation exists at all. See [[Off-label use]].{{r|fda_labeling}} | |
| + | 40 | ||
| 36 | == References == | 41 | == References == |
| 37 | {{reflist}} | 42 | {{reflist}} |
| 38 | <ref name="fda_labeling">United States Food and Drug Administration, ''Labeling for Human Prescription Drug and Biological Products'' (physician labeling rule requirements).</ref> | 43 | <ref name="fda_labeling">United States Food and Drug Administration, ''Labeling for Human Prescription Drug and Biological Products'' (physician labeling rule requirements).</ref> |
| 39 | <ref name="ema_smpc">European Commission, ''A Guideline on Summary of Product Characteristics'' (Notice to Applicants, Volume 2C).</ref> | 44 | <ref name="ema_smpc">European Commission, ''A Guideline on Summary of Product Characteristics'' (Notice to Applicants, Volume 2C).</ref> |
| + | 45 | <ref name="ada2024">American Diabetes Association. "Standards of Care in Diabetes." ''Diabetes Care'' 47(Suppl 1) (2024).</ref> | |
| 40 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 46 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 41 | 47 |