{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,7]],"date-time":"2025-07-07T02:10:09Z","timestamp":1751854209571,"version":"3.41.0"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2019,7,1]],"date-time":"2019-07-01T00:00:00Z","timestamp":1561939200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2019,7]]},"DOI":"10.1177\/2168479018795857","type":"journal-article","created":{"date-parts":[[2018,9,11]],"date-time":"2018-09-11T03:00:37Z","timestamp":1536634837000},"page":"549-553","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Off-Label Use of Antipsychotic Agents in Dementia: Evidence for the Revision of the Reimbursement Policy"],"prefix":"10.1007","volume":"53","author":[{"given":"Donatas","family":"Staki\u0161aitis","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristina","family":"Zamaryt\u0117-Sakavi\u010dien\u0117","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vita","family":"Lesauskait\u0117","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rimas Jonas","family":"Jank\u016bnas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,12,23]]},"reference":[{"key":"5304549_CR1","unstructured":"Directive 2001\/83\/EC of the European Parliament and of the Council of 6 Nov 2001 on the Community code relating to medicinal products for human use. Official Journal L 311. https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-1\/dir_2001_83_consol_2012\/dir_2001_83_cons_2012_en.pdf. Published November 28, 2001. Accessed July 25, 2018."},{"key":"5304549_CR2","unstructured":"Order on the change of the lists of diseases, reimbursed medicinal products for their treatment, reimbursed medicines and medicinal devices approved by the Decree of the Minister of Health of Lithuania No 159, 5 April 2002 including amendments. Valstyb\u0117s \u017einios 2002, Nr. 39-1450; https:\/\/www.e-tar.lt\/portal\/lt\/legalAct\/TAR.E83CFAB10E7B\/mowqwUsGUT."},{"key":"5304549_CR3","unstructured":"State Medicines Control Agency are under the Ministry of Health of the Republic of Lithuania. https:\/\/vapris.vvkt.lt\/vvkt-web\/public\/medications?. Accessed February 24, 2018."},{"key":"5304549_CR4","unstructured":"List of diseases and reimbursed medicines for their treatment approved by the Order of the Minister of Health of Lithuania No 49, 28 Jan 2000 as amended. Valstyb\u0117s \u017einios 2000, Nr. 10-253. https:\/\/www.e-tar.lt\/portal\/lt\/legalAct\/TAR.FA9CC3E1430C\/PAnzulvnKH."},{"key":"5304549_CR5","unstructured":"List of reimbursable diagnoses, common names of medicines and medical devices (January 1, 2017). http:\/\/www.vmnvd.gov.lv\/lv\/kompensejamie-medikamenti\/kompensejamo-zalu-saraksts. Accessed February 24, 2018."},{"key":"5304549_CR6","unstructured":"Guideline on the diagnostics and treatment of the Alzheimer dementia. http:\/\/www.vlk.lt\/veikla\/veiklos-sritys\/kompensuojamieji-vaistai\/Documents\/alzheimerio_diagnozavimo_gydymo_metodika.pdf approved by the Order of the Minister of Health of Lithuania No 382, 4 Jul 2000. Accessed June 25, 2018."},{"key":"5304549_CR7","first-page":"CD009268","volume":"7","author":"M Tardy","year":"2014","unstructured":"Tardy M, Huhn M, Kissling W, Engel RR, Leucht S. Haloperidol versus first-generation low-potency antipsychotic drugs for schizophrenia. Cochrane Database Syst Rev. 2014;7:CD009268.","journal-title":"Cochrane Database Syst Rev"},{"key":"5304549_CR8","doi-asserted-by":"publisher","first-page":"2335","DOI":"10.1056\/NEJMoa052827","volume":"353","author":"PS Wang","year":"2005","unstructured":"Wang PS, Schneeweiss S, Avorn J, et al. Risk of death in elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med. 2005;353:2335\u20132341.","journal-title":"N Engl J Med"},{"key":"5304549_CR9","doi-asserted-by":"publisher","first-page":"1934","DOI":"10.1001\/jama.294.15.1934","volume":"294","author":"LS Schneider","year":"2005","unstructured":"Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA. 2005;294:1934\u20131943.","journal-title":"JAMA"},{"key":"5304549_CR10","first-page":"87","volume-title":"Clinical Geriatric Psychopharmacology","author":"LL Moltke von","year":"2005","unstructured":"von Moltke LL, Abernethy DR, Greenblatt DJ. Kinetics and dynamics of psychotropic drugs in the elderly. In: Salzman C, ed. Clinical Geriatric Psychopharmacology. Vol. 4. Philadelphia, PA: Lippincott, Williams and Wilkins; 2005:87\u2013114."},{"key":"5304549_CR11","unstructured":"FDA Public Health Advisory. Deaths with antipsychotics in elderly patients with behavioral disturbances. https:\/\/wayback.archive-it.org\/7993\/20170723113222\/https:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm053171.htm. Published April 11, 2005. Accessed June 25, 2018."},{"key":"5304549_CR12","unstructured":"Busko M. FDA requires conventional and atypical antipsychotics to warn of increased death risk in elderly dementia. https:\/\/www.medscape.com\/viewarticle\/576382. Published June 20, 2008. Accessed June 25, 2018."},{"key":"5304549_CR13","unstructured":"CHMP Assessment report on conventional antipsychotics, London, 20 November 2008 EMEA\/CHMP\/590557\/2008. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Report\/2010\/01\/WC500054057.pdf. Accessed June 25, 2018."},{"key":"5304549_CR14","doi-asserted-by":"publisher","first-page":"1113","DOI":"10.1001\/archpsyc.1983.01790090075012","volume":"40","author":"GA Keepers","year":"1983","unstructured":"Keepers GA, Clappison VJ, Casey DE. Initial anticholinergic prophylaxis for neuroleptic-induced extrapyramidal syndromes. Arch Gen Psychiatry. 1983;40:1113\u20131117.","journal-title":"Arch Gen Psychiatry"},{"key":"5304549_CR15","doi-asserted-by":"publisher","first-page":"1916","DOI":"10.1111\/jgs.13054","volume":"62","author":"LM Kalisch Ellett","year":"2014","unstructured":"Kalisch Ellett LM, Pratt NL, Ramsay EN, Barratt JD, Roughead EE. Multiple anticholinergic medication use and risk of hospital admission for confusion or dementia. J Am Geriatr Soc. 2014;62:1916\u20131922.","journal-title":"J Am Geriatr Soc"},{"key":"5304549_CR16","doi-asserted-by":"publisher","first-page":"103","DOI":"10.1007\/s40266-012-0044-x","volume":"30","author":"L Pasina","year":"2013","unstructured":"Pasina L, Djade CD, Lucca U, et al. Association of anticholinergic burden with cognitive and functional status in a cohort of hospitalized elderly: comparison of the anticholinergic cognitive burden scale and anticholinergic risk scale: results from the REPOSI study. Drugs Aging. 2013;30:103\u2013112.","journal-title":"Drugs Aging"},{"key":"5304549_CR17","unstructured":"Medicinal Product Register of Latvia. https:\/\/www.zva.gov.lv\/zalu-registrs\/?lang=en. Accessed February 24, 2018."},{"key":"5304549_CR18","unstructured":"The electronic Medicines Compendium (eMC) on medicines licensed for use in the UK. https:\/\/www.medicines.org.uk\/emc\/. Accessed February 24, 2018."},{"key":"5304549_CR19","unstructured":"Deutsches Institut f\u00fcr Medizinische Dokumentation und Information. http:\/\/www.dimdi.de\/static\/de\/amg\/index.htm. Accessed February 24, 2018."},{"key":"5304549_CR20","unstructured":"Arzneispezialit\u00e4tenregister. Bundesamt f\u00fcr Sicherheit im Gesundheitswesen Medizinmarktaufsicht; https:\/\/aspregister.basg.gv.at\/aspregister\/faces\/aspregister.jspx?_afrLoop=47858239438131233&_afrWindowMode=0&_adf.ctrl-state=vtl1sdv8q_4. Accessed February 24, 2018."},{"key":"5304549_CR21","unstructured":"Vademecum.es. http:\/\/www.vademecum.es. Accessed February 24, 2018."},{"key":"5304549_CR22","unstructured":"Geneesmiddeleninformatiebank. http:\/\/www.geneesmiddeleninformatiebank.nl\/ords\/f?p=111:1:0::NO:SESSION:P0_DOMAIN,P0_LANG:H,NL. Accessed February 24, 2018."},{"key":"5304549_CR23","unstructured":"Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9. R\u00e9pertoire des Sp\u00e9cialit\u00e9s Pharmaceutiques. http:\/\/agence-prd.ansm.sante.fr\/php\/ecodex\/index.php. Accessed February 24, 2018."},{"key":"5304549_CR24","unstructured":"Commission Directive 2003\/63\/EC of 25 June 2003 amending Directive 2001\/83\/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official Journal L 159, 2003.06.27, pp. 46\u201394. https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-1\/dir_2003_63\/dir_2003_63_en.pdf."},{"key":"5304549_CR25","doi-asserted-by":"crossref","unstructured":"le Polain M, Franken M, Koopmanschap M, Cleemput I. Drug reimbursement systems: international comparison and policy recommendations. The Belgian Health Care Knowledge Centre report 147. https:\/\/kce.fgov.be\/publication\/report\/drug-reimbursement-systems-international-comparison-and-policy-recommendations-0#.WL6HA_nyjDc. Published 2010.","DOI":"10.57598\/R147C"},{"key":"5304549_CR26","doi-asserted-by":"publisher","first-page":"303","DOI":"10.1111\/j.1088-4963.1997.tb00082.x","volume":"26","author":"N Daniels","year":"1997","unstructured":"Daniels N, Sabin J. Limits to health care: fair procedures, democratic deliberation, and the legitimacy problem for insurers. Philos Public Aff. 1997;26:303\u2013350.","journal-title":"Philos Public Aff"},{"key":"5304549_CR27","first-page":"CD003476","volume":"1","author":"C Ballard","year":"2006","unstructured":"Ballard C, Waite J. The effectiveness of atypical antipsychotics for the treatment of aggression and psychosis in Alzheimer\u2019s disease. Cochrane Database Syst Rev 2006;1:CD003476.","journal-title":"Cochrane Database Syst Rev"},{"key":"5304549_CR28","doi-asserted-by":"publisher","first-page":"1525","DOI":"10.1056\/NEJMoa061240","volume":"355","author":"LS Schneider","year":"2006","unstructured":"Schneider LS, Tariot PN, Dagerman KS, et al. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer\u2019s disease. N Engl J Med. 2006;355:1525\u20131538.","journal-title":"N Engl J Med"},{"key":"5304549_CR29","doi-asserted-by":"publisher","first-page":"1577","DOI":"10.1177\/0269881110379307","volume":"24","author":"SJ Wilson","year":"2010","unstructured":"Wilson SJ, Nutt DJ, Alford C, et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010;24:1577\u20131600.","journal-title":"J Psychopharmacol"},{"key":"5304549_CR30","first-page":"CD003476","volume":"1","author":"C Ballard","year":"2006","unstructured":"Ballard C, Waite J. The effectiveness of atypical antipsychotics for the treatment of aggression and psychosis in Alzheimer\u2019s disease. Cochrane Database Syst Rev. 2006;1:CD003476.","journal-title":"Cochrane Database Syst Rev"},{"key":"5304549_CR31","doi-asserted-by":"publisher","first-page":"a1227","DOI":"10.1136\/bmj.a1227","volume":"337","author":"IJ Douglas","year":"2008","unstructured":"Douglas IJ, Smeeth L. Exposure to antipsychotics and risk of stroke: self controlled case series study. BMJ 2008;337:a1227.","journal-title":"BMJ"},{"issue":"9","key":"5304549_CR32","doi-asserted-by":"publisher","first-page":"e001666","DOI":"10.1161\/JAHA.114.001666","volume":"4","author":"M Sahlberg","year":"2015","unstructured":"Sahlberg M, Holm E, Gislason GH, K\u00f8ber L, Torp-Pedersen C, Andersson C. Association of selected antipsychotic agents with major adverse cardiovascular events and noncardiovascular mortality in elderly persons. J Am Heart Assoc. 2015;4(9):e001666.","journal-title":"J Am Heart Assoc"},{"key":"5304549_CR33","doi-asserted-by":"publisher","first-page":"1390","DOI":"10.1016\/j.euroneuro.2016.07.006","volume":"26","author":"N Schmedt","year":"2016","unstructured":"Schmedt N, Kollhorst B, Enders D, et al. Comparative risk of death in older adults treated with antipsychotics: a population-based cohort study. Eur Neuropsychopharmacol. 2016;26:1390\u20131400.","journal-title":"Eur Neuropsychopharmacol"},{"key":"5304549_CR34","unstructured":"ATC DDD Index. WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health. https:\/\/www.whocc.no\/."},{"key":"5304549_CR35","doi-asserted-by":"publisher","first-page":"103","DOI":"10.1007\/s40266-012-0044-x","volume":"30","author":"L Pasina","year":"2013","unstructured":"Pasina L, Djade CD, Lucca U, et al. Association of anticholinergic burden with cognitive and functional status in a cohort of hospitalized elderly: comparison of the anticholinergic cognitive burden scale and anticholinergic risk scale: results from the REPOSI study. Drugs Aging. 2013;30:103\u2013112.","journal-title":"Drugs Aging"},{"key":"5304549_CR36","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1016\/j.neurobiolaging.2017.01.012","volume":"53","author":"N Richter","year":"2017","unstructured":"Richter N, Michel A, Onur OA, et al. White matter lesions and the cholinergic deficit in aging and mild cognitive impairment. Neurobiol Aging. 2017;53:27\u201335.","journal-title":"Neurobiol Aging"},{"key":"5304549_CR37","first-page":"47","volume":"9","author":"Q Liu","year":"2017","unstructured":"Liu Q, Zhu Z, Teipel SJ, et al. White matter damage in the cholinergic system contributes to cognitive impairment in subcortical vascular cognitive impairment, no dementia. Front Aging Neurosci. 2017;9:47.","journal-title":"Front Aging Neurosci"}],"container-title":["Therapeutic Innovation &amp; Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1177\/2168479018795857.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2168479018795857","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1177\/2168479018795857\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2168479018795857","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1177\/2168479018795857.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,7]],"date-time":"2025-07-07T01:53:11Z","timestamp":1751853191000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1177\/2168479018795857"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7]]},"references-count":37,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2019,7]]}},"alternative-id":["5304549"],"URL":"https:\/\/doi.org\/10.1177\/2168479018795857","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"type":"print","value":"2168-4790"},{"type":"electronic","value":"2168-4804"}],"subject":[],"published":{"date-parts":[[2019,7]]},"assertion":[{"value":"3 April 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 July 2018","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 December 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}}]}}