Source of Prescribing information

{{Infobox concept | name = Prescribing information | subtitle = Drug regulation | Also called = Label; summary of product characteristics | Approved by = The medicines regulator | Jurisdictional = Differs between countries for the same product }} '''Prescribing information''' is the regulator-approved labelling accompanying a medicine, stating its indications, dosing, contraindications, warnings, adverse effects, pharmacology and the studies supporting them. In Europe the equivalent document is the summary of product characteristics.{{r|fda_labeling}} It is a regulated document rather than a manufacturer's description. Its content is negotiated with the regulator and changes require approval, which is why it is a more reliable source than promotional material and why it lags the literature.{{r|fda_labeling}} It is jurisdiction-specific. The same product may carry different indications, different populations and different warnings in different countries, so the label of one jurisdiction does not describe the product in another.{{r|ema_smpc}} == Structure == Labelling follows a prescribed structure so that the same information is in the same place across products: indications, dosage and administration, dosage forms, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations, description, clinical pharmacology, non-clinical toxicology, clinical studies, and storage.{{r|fda_labeling}} The clinical studies section reports the trials supporting the indication, with the effect sizes as the regulator accepted them. It is a useful primary-adjacent source: the numbers are those the regulator reviewed rather than those a press release selected.{{r|ema_smpc}} Warnings and precautions differ from contraindications: a contraindication says the product is not to be used, a warning that a risk exists and is to be managed. Conflating them overstates the restriction. See [[Contraindications of incretin therapy]].{{r|fda_labeling}} == Uses and limits == | Question | Does labelling answer it? | |---|---| | What is this approved for, here? | Yes | | What dose, and how escalated? | Yes | | What did the pivotal trials show? | Yes, as accepted by the regulator | | Is this suitable for a given person? | No; that is a clinical question | | What about an unapproved use? | No; off-label use is outside the label | | What about a research chemical? | No; there is no label | The last row is the one relevant to much of this wiki. Material sold for research has no approved labelling, so there is no prescribing information for it, and clinical information about an approved product is not about it.{{r|usp1503}} 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}} == Relationship to telehealth and access == 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}} 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}} This wiki reproduces no labelling, gives no dosing advice, and is not a substitute for the product information of any medicine.{{r|ada2024}} == References == {{reflist}} <ref name="fda_labeling">United States Food and Drug Administration, ''Labeling for Human Prescription Drug and Biological Products'' (physician labeling rule requirements).</ref> <ref name="ema_smpc">European Commission, ''A Guideline on Summary of Product Characteristics'' (Notice to Applicants, Volume 2C).</ref> <ref name="ada2024">American Diabetes Association. "Standards of Care in Diabetes." ''Diabetes Care'' 47(Suppl 1) (2024).</ref> <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> == See also == * [[Contraindications of incretin therapy]] * [[Telehealth prescribing]] * [[Prior authorisation]] * [[Off-label use]] * [[Regulatory status by jurisdiction]] {{DEFAULTSORT:Prescribing information}} [[Category:Prescribing and telehealth]] [[Category:Drug regulation]] [[Category:Regulation and law]]