Respiratory Medication Use in Australia 2003–2013
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Nature, Frequency and Determinants of Prescription Modifications in Dutch
Nature, frequency and determinants of prescription modi®cations in Dutch community pharmacies Henk Buurma,1,3 Peter A. G. M. de Smet,2,5 Olga P. van den Hoff2 & Antoine C. G. Egberts3,4 1SIR Institute for Pharmacy Practice Research, Leiden, 2WINAp (Scienti®c Institute Dutch Pharmacists), The Hague, 3Department of Pharmacoepidemiology and Pharmacotherapy, Faculty of Pharmacy, University of Utrecht, 4Hospital pharmacy `Midden-Brabant', TweeSteden Hospital and St Elisabeth Hospital, Tilburg and 5Department of Clinical Pharmacy, University Hospital Nijmegen, The Netherlands Aims To examine the nature, frequency and determinants of prescription modi®cations in Dutch community pharmacies. Methods A prospective case-control study comparing modi®ed prescriptions with nonmodi®ed prescriptions was carried out in 141 Dutch community pharmacies. 2014 modi®ed prescriptions (cases), collected in the selected pharmacies on a predetermined day in a speci®c period (25th February until 12th March 1999) and 2581 nonmodi®ed prescriptions (controls) randomly selected on the same day were studied. The nature and frequency of prescription modi®cations and patient, drug and prescriber related determinants for a modi®ed prescription were assessed. Results The overall incidence of prescription modi®cations was 4.3%, with a mean of 14.3 modi®cations per pharmacy per day. For prescription only medicines (POM) the incidence was 4.9%. The majority of POM modi®cations concerned a clari®cation (71.8%). In 22.2% a prescription could potentially have had clinical consequences when not altered; in more than half of the latter it concerned a dose error (13.7% of all cases). POM prescriptions of patients of 40±65 years had a signi®cantly lower chance of modi®cation compared with those of younger people (OR=0.74 [0.64±0.86]). -
Glypressin Ferring Pharmaceuticals Pty Ltd PM-2010-03182-3-3 Final 26 November 2012
Attachment 1: Product information for AusPAR Glypressin Ferring Pharmaceuticals Pty Ltd PM-2010-03182-3-3 Final 26 November 2012. This Product Information was approved at the time this AusPAR was published. Product Information ® GLYPRESSIN Solution for Injection NAME OF THE MEDICINE Terlipressin (as terlipressin acetate). The chemical name is N-[N-(N-Glycylglycyl)glycyl]-8-L- lysinevasopressin. Terlipressin has an empirical formula of C52H74N16O15S2 and a molecular weight of 1227.4. CAS No: 14636-12-5. The pKa is approximately 10. Terlipressin is freely soluble in water. Although the active ingredient is terlipressin, the drug substance included in this product contains non-stoichiometric amounts of acetic acid and water, and this material is freely soluble in water. The structural formula of terlipressin is DESCRIPTION GLYPRESSIN is for intravenous injection. It consists of a clear, colourless liquid containing 0.85 mg terlipressin (equivalent to 1 mg terlipressin acetate) in 8.5 mL solution in an ampoule. The concentration of terlipressin is 0.1 mg/mL (equivalent to terlipressin acetate 0.12 mg/mL). List of excipients GLYPRESSIN contains the following excipients: Sodium chloride, acetic acid, sodium acetate trihydrate, Water for Injections PHARMACOLOGY Pharmacodynamics Terlipressin belongs to the pharmacotherapeutic group: Posterior pituitary lobe hormones (vasopressin and analogues), ATC code: H 01 BA 04. Terlipressin is a dodecapeptide that has three glycyl residues attached to the N-terminal of lysine vasopressin (LVP). Terlipressin acts as a pro-drug and is converted via enzymatic cleavage of its three glycyl residues to the biologically active lysine vasopressin. A large body of evidence has consistently shown that terlipressin given at doses of 0.85 mg and 1.7 mg respectively (equivalent to terlipressin acetate 1 mg and 2 mg respectively) can effectively reduce the portal venous pressure and produces marked vasoconstriction. -
ZOMACTON Powder and Solvent for Solution for Injection 4Mg Package
NAME OF THE MEDICINAL PRODUCT Intra‑cranial lesions or other active neoplasms ZOMACTON® 4 mg, powder and solvent for solution for injection In patients with growth hormone deficiency secondary to an intra‑cranial lesion, frequent QUALITATIVE AND QUANTITATIVE COMPOSITION monitoring for progression or recurrence of the underlying disease process is advised. In One vial of powder contains: Somatropin* 4 mg childhood cancer survivors, an increased risk of a second neoplasm has been reported in (corresponding to a concentration of 1.3 mg/ml or 3.3 mg/ml after reconstitution) patients treated with somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the * Produced in Escherichia coli cells using recombinant DNA technology most common of these second neoplasms. List of excipients: Discontinue ZOMACTON® therapy if progression or recurrence of the lesion occurs. Powder: Mannitol Solvent: Sodium chloride, benzyl alcohol, water for injections In patients with previous malignant diseases special attention should be given to signs and symptoms of relapse. PHARMACEUTICAL FORM Powder and solvent for solution for injection, 4 mg Scoliosis ZOMACTON® is a white to off‑white lyophilised powder. Scoliosis may progress in any child during rapid growth. Signs of scoliosis should be monitored The solvent in ampoule is clear and colourless. during somatropin treatment. THERAPEUTIC INDICATIONS Slipped capital femoral epiphysis ® Slipped capital femoral epiphysis may occur more frequently in patients with endocrine ZOMACTON is indicated for: ® - the long‑term treatment of children who have growth failure due to inadequate secretion disorders. A patient treated with ZOMACTON who develops a limp or complains of hip or of growth hormone knee pain should be evaluated by a physician. -
Rapport 2008
rapport 2008 Reseptregisteret 2004-2007 The Norwegian Prescription Database 2004-2007 Marit Rønning Christian Lie Berg Kari Furu Irene Litleskare Solveig Sakshaug Hanne Strøm Rapport 2008 Nasjonalt folkehelseinstitutt/ The Norwegian Institute of Public Health Tittel/Title: Reseptregisteret 2004-2007 The Norwegian Prescription Database 2004-2007 Redaktør/Editor: Marit Rønning Forfattere/Authors: Christian Lie Berg Kari Furu Irene Litleskare Marit Rønning Solveig Sakshaug Hanne Strøm Publisert av/Published by: Nasjonalt folkehelseinstitutt Postboks 4404 Nydalen NO-0403 Norway Tel: + 47 21 07 70 00 E-mail: [email protected] www.fhi.no Design: Per Kristian Svendsen Layout: Grete Søimer Acknowledgement: Julie D.W. Johansen (English version) Forsideillustrasjon/Front page illustration: Colourbox.com Trykk/Print: Nordberg Trykk AS Opplag/ Number printed: 1200 Bestilling/Order: [email protected] Fax: +47-21 07 81 05 Tel: +47-21 07 82 00 ISSN: 0332-6535 ISBN: 978-82-8082-252-9 trykt utgave/printed version ISBN: 978-82-8082-253-6 elektronisk utgave/electronic version 2 Rapport 2008 • Folkehelseinstituttet Forord Bruken av legemidler i befolkningen er økende. En viktig målsetting for norsk legemiddelpolitikk er rasjonell legemiddelbruk. En forutsetning for arbeidet med å optimalisere legemiddelbruken i befolkningen er kunnskap om hvilke legemidler som brukes, hvem som bruker legemidlene og hvordan de brukes. For å få bedre kunnskap på dette området, vedtok Stortinget i desember 2002 å etablere et nasjonalt reseptbasert legemiddelregister (Reseptregisteret). Oppgaven med å etablere registeret ble gitt til Folkehelseinstituttet som fra 1. januar 2004 har mottatt månedlige opplysninger fra alle apotek om utlevering av legemidler til pasienter, leger og institusjoner. Denne rapporten er første utgave i en planlagt årlig statistikk fra Reseptregisteret. -
ATC) Classification and the Defined Daily Dose (DDD
Anatomical Therapeutic Chemical (ATC) classification T and the Defined Daily Dose AF DR (DDD): principles for classifying and quantifying drug use Yong Chen Merck, Whitehouse Station, NJ USA Disclosure • Author is an employee of Merck • A lot of slides are adopted from a prior ICPE English short course on drug utilization by Hege Salvesen Blix 2 Outline • The ATC/DDD methodology – definitions, purpose, structure and principles • Real world applications of ATC/DDD 3 What is ATC/DDD? • ATC (Anatomical Therapeutic Chemical) classification –Don’t confuse it with Anatomical Therapeutic (AT) classification developed by European Pharmaceutical Market Research Association (EPhMRA) • DDD (Defined Daily Dose) The assumed average maintenance dose per day for a drug used for its main indication in adults Introduction to Drug Utilization Research, WHO 2003 4 Main Purpose • “International language for drug utilization research” –to serve as a tool for presenting drug utilization research in order to improve quality of drug use –to compare data within a country and between countries 5 The WHO Collaborating Centre for Drug Statistics Methodology • Established in 1982 as a European WHO Centre • Since 1996 a global WHO Centre • Located in the Department of Pharmacoepidemiology at the Norwegian Institute of Public Health • The staff of the Centre is responsible for drug consumption statistics in Norway 6 The WHO Centre • To classify drugs according to the ATC system and assign DDDs • To review and revise as necessary the ATC classification system and DDDs • To stimulate and influence the practical use of the ATC system • To organize training courses in the ATC/DDD methodology 7 ATC Main Group • A Alimentary tract and metabolism • B Blood and blood forming organs • C Cardiovascular system • D Dermatologicals • G Genito urinary system and sex hormones • H Systemic hormonal preparations, excl. -
Modul 2(Pdf 551,29
Dokumentvorlage, Version vom 20.01.2011 Dossier zur Nutzenbewertung gemäß § 35a SGB V Pixantron (Pixuvri®) CTI Life Sciences Ltd. Modul 2 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete Stand: 20.11.2012 Dossier zur Nutzenbewertung – Modul 2 Stand: 20.11.2012 Allgemeine Angaben zum Arzneimittel, zugelassene Anwendungsgebiete Inhaltsverzeichnis Seite Tabellenverzeichnis .................................................................................................................. 2 Abbildungsverzeichnis ............................................................................................................. 3 Abkürzungsverzeichnis ............................................................................................................ 4 2 Modul 2 – allgemeine Informationen ............................................................................ 7 2.1 Allgemeine Angaben zum Arzneimittel ....................................................................... 7 2.1.1 Administrative Angaben zum Arzneimittel ............................................................ 7 2.1.2 Angaben zum Wirkmechanismus des Arzneimittels ............................................... 8 2.2 Zugelassene Anwendungsgebiete ............................................................................... 34 2.2.1 Anwendungsgebiete, auf die sich das Dossier bezieht .......................................... 34 2.2.2 Weitere in Deutschland zugelassene Anwendungsgebiete ................................... 34 2.2.3 Zulassungsstatus international -
International Price Comparison of Pharmaceuticals 2017
International price comparison of pharmaceuticals 2017 – a volume based analysis of Swedish pharmaceutical prices and volumes relative to 19 other European coun- tries. 2 (101) You are welcome to quote Dental and Pharmaceutical Benefits Agency reports, but please remember to cite the source: the report’s name, year and Dental and Phar- maceutical Benefits Agency. Dental and Pharmaceutical Benefits Agency, February 2018 Authors: Emil Aho, Pontus Johansson and Gunilla Rönnholm. Reference number: 3611/2017 Postal address: Box 22520, 104 22 Stockholm Visiting address: Fleminggatan 18, Stockholm Telephone: +46 8 568 420 50 www.tlv.se 3 (101) Preface The Dental and Pharmaceutical Benefits Agency’s (TLV’s) mandate includes moni- toring and analysing the price development of pharmaceuticals from an interna- tional perspective. In this report, TLV presents the results of the analysis of price and volume data for the first quarter of 2014, 2015, 2016 and 2017 in Sweden in comparison with 19 other European countries. The segments analysed are pharmaceuticals not exposed to competition and pharmaceuticals exposed to competition, with the latter includ- ing all pharmaceuticals available as substitutable medicines in the product-of-the- month system as per March 2017. The report should be viewed as a basis for further analysis of the dynamics of Swe- dish prices and price changes compared to that seen internationally. Sofia Wallström Director-General 4 (101) 5 (101) Table of contents Preface .................................................................................................................. -
120 Mg Film-Coated Tablet 2. QUALITATIVE and QUANTITATIVE
1. NAME OF THE MEDICINAL PRODUCT [Product name] 120 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 120 mg of fexofenadine hydrochloride equivalent to 112 mg of fexofenadine For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Peach coloured oblong, bi-convex film-coated tablet; plain on both sides. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Symptomatic relief of seasonal allergic rhinitis. 4.2. Posology and method of administration Adults and children 12 years and older: The recommended dose of fexofenadine hydrochloride to adults and children 12 years and older is 120 mg once daily. The tablet should be swallowed with a sufficient amount of water. Children under 12 years: Fexofenadine hydrochloride is not recommended for use in children below age 12 due to a lack of data on safety and efficacy. Special populations at risk: Only limited data is available regarding the administration in elderly and in patients with renal or hepatic impairment. It is not necessary to adjust the dose of fexofenadine hydrochloride in these patient groups, however, it should be used with caution in these patient groups. 4.3. Contraindications Hypersensitivity to the active substance or to any of the excipients. 4.4. Special warnings and precautions for use Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class have been associated with the adverse events tachycardia and palpitations (see section 4.8). As with most new drugs there is only limited data in the elderly and renally or hepatically impaired patients. -
Dispensing of Orphan Drugs
23-3-2016 Hospital Pharmacists taking the lead in Orphan Drugs Marc Dooms (presenter) Helena Jenzer, Thomas De Rijdt (facilitator) EAHP Congress on partnerships and technologies Vienna March 2016 Nothing to disclose 1 23-3-2016 YES or NO Questions 1. Orphan drugs are a new class of pharmacological agents 2. Cost effectiveness and budget impact is always a problem 3. Orphan drugs are innovative medicinal products 2 23-3-2016 Observationum Exempla Rara Definition Orphan Drugs “Medicinal products intended for the diagnosis, prevention or treatment of a life-threatening condition affecting no more than 5 in 10 000 persons in the EU” EMA 2000 3 23-3-2016 Anatomical Therapeutic Chemical Classification System (WHO) letter code Omschrijving hoofdgroep (eerste letter) A ATC code A Spijsverteringsstelsel en metabolisme B ATC code B Bloed en bloedvormende organen C ATC code C Cardiovasculair systeem D ATC code D Dermatologica G ATC code G Genito-urinaire systeem en geslachtshormonen H ATC code H Systemische hormonale preparaten, met uitzondering van insuline en geslachtshormonen J ATC code J Anti-infectie middelen voor systemisch gebruik L ATC code L antineoplasie en immunomodulerende stoffen M ATC code M Spier- en skeletsysteem N ATC code N Zenuwstelsel P ATC code P Antiparasitische middelen, insecticiden en repellents Q ATC code Q Veterinare geneesmiddelen R ATC code R Ademhalingssysteem S ATC code S Sensorische organen V Varia Incentives • Protocol assistance • Market exclusivity (10 years) • Financial incentives (fee reduction) • Centralized EU-procedure • National incentives (reimbursement) • Research support • etc… 4 23-3-2016 Community Register • 119 authorised orphan drugs (1621 designated) • 106 rare diseases • 33 withdrawn or suspended • 80 non-orphan status 5 23-3-2016 Route of administration Cost and Prevalence Orphan Medicines Bron : prof. -
Summary of Product Characteristics
Health Products Regulatory Authority Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT ZOMACTON 4 mg powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains: Somatropin* …..……………………………………………………………..4 mg (corresponding to a concentration of 1.3 mg/ml or 3.3 mg/ml after reconstitution) * produced in Escherichia coli cells by recombinant DNA technology Excipient with a known effect (in the solvent): Benzyl alcohol: 9 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. ZOMACTON is a white to off-white powder. The solvent in ampoule is clear and colorless. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications ZOMACTON is indicated for the long‑term treatment of children who have growth failure due to inadequate secretion of growth hormone and for the long-term treatment of growth retardation due to Turner’s Syndrome confirmed by chromosome analysis. 4.2 Posology and method of administration Posology ZOMACTON therapy should be used only under the supervision of a qualified physician experienced in the management of patients with growth hormone deficiency. The dosage and schedule of administration of ZOMACTON should be individualised for each patient. The duration of treatment, usually a period of several years, will depend on maximum achievable therapeutic benefit. The subcutaneous administration of growth hormone may lead to loss or increase of adipose tissue at the injection site. Therefore, injection sites should be alternated. Growth Hormone Deficiency Generally a dose of 0.17 - 0.23 mg/kg bodyweight (approximating to 4.9 mg/m2 – 6.9 mg/m2 body surface area) per week divided into 6 - 7 s.c. -
Treatment of COPD Groups GOLD a and B with Inhaled Corticosteroids in the COSYCONET Cohort – Determinants and Consequences
International Journal of Chronic Obstructive Pulmonary Disease Dovepress open access to scientific and medical research Open Access Full Text Article ORIGINAL RESEARCH Treatment of COPD Groups GOLD A and B with Inhaled Corticosteroids in the COSYCONET Cohort – Determinants and Consequences This article was published in the following Dove Press journal: International Journal of Chronic Obstructive Pulmonary Disease Johanna I Lutter, 1 Rudolf A Jörres, 2 Background: In COPD patients of GOLD groups A and B, a high degree of treatment with 3 4 Franziska C Trudzinski, Peter Alter, inhaled corticosteroids (ICS) has been reported, which is regarded as overtreatment accord Christina Kellerer,2,5 Henrik Watz,6 ing to GOLD recommendations. We investigated which factors predict ICS use and which Tobias Welte, 7 Robert Bals,8 Diego Kauffmann-Guerrero, 9 relationship it has to clinical and functional outcomes, or healthcare costs. Jürgen Behr,9 Rolf Holle, 10 Methods: We used pooled data from visits 1 and 3 of the COSYCONET cohort (n=2741, Claus F Vogelmeier,4 Kathrin Kahnert9 n=2053, interval 1.5 years) including patients categorized as GOLD grades 1–4 and GOLD On behalf of the COSYCONET study group group A or B at both visits (n=1080). Comparisons were performed using ANOVA, and regression analyses using propensity matching and inverse probability weighting to adjust for 1Institute of Health Economics and Health Care Management, Helmholtz Zentrum München differences between ICS groups. These were defined as having ICS at both visits (always) vs GmbH – German Research Center for For personal use only. no ICS at both visits (never). -
Identifying Paediatric Needs in Cardiology and the Prediction of Sildenafil Exposure in Children with Pulmonary Arterial Hypertension
Identifying paediatric needs in cardiology and the prediction of sildenafil exposure in children with pulmonary arterial hypertension Inauguraldissertation zur Erlangung des Doktorgrades der Mathematisch-Naturwissenschaftlichen Fakultät der Heinrich-Heine-Universität Düsseldorf vorgelegt von Linda Hsien aus Latakia Juli 2010 Aus dem Institut für Klinische Pharmazie und Pharmakotherapie der Heinrich-Heine-Universität Düsseldorf Gedruckt mit der Genehmigung der Mathematisch-Naturwissenschaftlichen Fakultät der Heinrich-Heine-Universität Düsseldorf Referent: Prof. Dr. med. S. Läer Koreferent: Prof. Dr. J. Breitkreutz Tag der mündlichen Prüfung: 12.07.2010 Table of contents 1 Introduction ...............................................................................................................1 1.1 Clinical studies in the paediatric population.........................................................1 1.2 Off-label drug use in paediatrics..........................................................................2 1.3 Off-label use of cardiovascular drugs in children .................................................3 1.4 Pulmonary arterial hypertension in children.........................................................4 1.5 Sildenafil for the treatment of paediatric pulmonary arterial hypertension............5 1.6 Pharmacokinetics of sildenafil .............................................................................6 1.7 Pharmacokinetic studies in paediatric patients ....................................................7 1.8 Whole