|Titre :||Clinical provision of improvised nasal naloxone without experimental testing and without regulatory approval: imaginative shortcut or dangerous bypass of essential safety procedures? [For debate] (2016)|
|Auteurs :||J. STRANG ; R. McDONALD ; B. TAS ; E. DAY|
|Type de document :||Article : Périodique|
|Dans :||Addiction (Vol.111, n°4, April 2016)|
|Article en page(s) :||574-582|
|Note générale :||
- Tangled-up and blue: releasing the regulatory chokehold on take-home naloxone. Winstanley E.L., p. 583-584.
- Intranasal naloxone soon to become part of evolving clinical practice around opioid overdose prevention. Dietze P., Cantwell K., p. 584-586.
- Radical red tape reduction by government supported nasal naloxone: the Norwegian pilot project is innovative, safe and an important contribution to further development and dissemination of take-home naloxone. Lobmaier P.P., Clausen T., p. 586-587.
- Ethical issues and stakeholders matter. Dale O., p. 587-589.
- Ensure global access to naloxone for opioid overdose management. Balster R.L., Walsh S.L., p. 589-590.
- New approved nasal naloxone welcome, but unlicensed improvised naloxone spray kits remain a concern: proper scientific study must accompany innovation. Strang J., McDonald R., p. 590-592.
Letters to the Editor:
- Doe-Simkins M., Banta-Green C., Davis C.S., Green T.C., Walley A.Y., Addiction, 2016, 111(1), p. 1879-1880.
- While we dither, people continue to die from overdose. Coffin P., Rich J., Dailey M., Stancliff S., Beletsky L., Addiction, 2016, 111(1), p. 1880-1881.
- Authors' response: Strang J., McDonald R., Addiction, 2016, 111(1), p. 1881-1883.
|Discipline :||TRA (Traitement et prise en charge / Treatment and care)|
Thésaurus TOXIBASENALOXONE ; MORTALITE ; URGENCE ; HEROINE ; SURDOSE ; VOIE NASALE ; PHARMACOCINETIQUE ; EFFICACITE ; AMM ; REGLEMENTATION ; PRATIQUE PROFESSIONNELLE ; ETHIQUE ; PRISE EN CHARGE
Context: Take-home naloxone is increasingly provided to prevent heroin overdose deaths. Naloxone 0.4-2.0 mg is licensed for use by injection. Some clinicians supply improvised nasal naloxone kits (outside lisenced approval). Is this acceptable?
Aims: (1) To consider provision of improvised nasal naloxone in clinical practice and (2) to search for evidence for pharmacokinetics and effectiveness (versus injection).
Methods: (1) To document existing nasal naloxone schemes and published evidence of pharmacokinetics (systematic search of the CINAHL, Cochrane, EMBASE and MEDLINE databases and 18 records included in narrative synthesis). (2) To analyse ongoing studies investigating nasal naloxone (WHO International Clinical Trials Registry Platform and US NIH RePORT databases).
Findings: (1) Multiple studies report overdose reversals following administration of improvised intranasal naloxone. (2) Overdose reversal after nasal naloxone is frequent but may not always occur. (3) Until late 2015, the only commercially available naloxone concentrations were 0.4 mg/ml and 2 mg/2 ml. Nasal medications are typically 0.05-0.25 ml of fluid per nostril. The only published study of pharmacokinetics and bioavailability finds that nasal naloxone has poor bioavailability.
Questions for debate: (1) Why are pharmacokinetics and bioavailability data for nasal naloxone not available before incorporation into standard clinical practice? (2) Does nasal naloxone have the potential to become a reliable clinical formulation? (3) What pre-clinical and clinical studies should precede utilization of novel naloxone formulations as standard emergency medications?
Conclusions: The addictions treatment field has rushed prematurely into the use of improvised nasal naloxone kits. Evidence of adequate bioavailability and acceptable pharmacokinetic curves are vital preliminary steps, especially when effective approved formulations exist.
|Domaine :||Drogues illicites / Illicit drugs|
|Refs biblio. :||40|
|Affiliation :||National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK|