DOCSLIB.ORG

Drug-N-Therapeutics-Committee.Pdf

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

Irrational use of medicines is a widespread problem at all levels of health care, but especially GUIDE DRUG AND THERAPEUTICS COMMITTEES: A PRATICAL in hospitals. This is particularly worrying as resources are generally scarce and prescribers in communities often copy hospital prescribing practices. Use of medicines can be greatly improved and wastage reduced if some simple principles of drug management are followed. But it is difficult to implement these principles because staff from many different disciplines are involved, often with no forum for bringing them together to develop and implement appropriate medicines policies. A drug and therapeutics committee (DTC) provides such a forum, allowing all the relevant people to work together to improve health care delivery, whether in hospitals or other health facilities. In many developed countries a well functioning DTC has been shown to be very effective in addressing drug use problems. However, in many developing countries DTCs do not exist and in others they do not function optimally, often due to lack of local expertise or a lack of incentives. Drug and Therapeutics Committees: A Practical Guide provides guidance to doctors, pharmacists, hospital managers and other professionals who may be serving on DTCs and/or who are concerned with how to improve the quality and cost efficiency of therapeutic care. It is relevant for all kinds of DTCs - whether in public or private hospitals and whether at district or tertiary referral level. This comprehensive manual covers a committee’s functions and structure, the medicines formulary process, and how to assess new medicines. The chapters on tools to investigate drug use and strategies to promote rational use are followed by a discussion of antimicrobial resistance and infection control. The publication concludes by explaining in detail how to start a committee or improve the effectiveness of an existing one. The manual has been developed by the WHO Department of Essential Drugs and Medicines Policy, in collaboration with the Rational Pharmaceutical Management Plus Program of Management Sciences for Health. WHO/EDM/PAR/2004.1 Drug and therapeutics committees A practical guide World Health Organization Department of Essential Drugs and Medicines Policy Geneva, Switzerland In collaboration with Management Sciences for Health Center for Pharmaceutical Management Rational Pharmaceutical Management Program Arlington, Virginia, USA Authors Kathleen Holloway1 (Editor) Terry Green2 with contributions from: Edelisa Carandang,1 Hans Hogerzeil,1 Richard Laing,3 David Lee,2 The text was reviewed by: John Chalker,2 Mary Couper,1 Andrew Creese,1 Marthe Everard,1 Anna Paula di Felici,4 Chris Forshaw,5 David Henry,6 Yvan Hutin,7 Sabine Kopp,1 Souly Phanouvong,8 Clive Ondari,1 Lembit Rago,1 Marcus Reidenberg,9 Budiono Santoso,10 Anthony Savelli2 and Rosamund Williams.4 1 Department of Essential Drugs and Medicines Policy (EDM), World Health Organization, Geneva, Switzerland 2 Management Sciences for Health (MSH), Washington DC, USA* 3 Department of International Health, Boston University, Boston, Massachusetts, USA 4 Department of Communicable Disease Surveillance and Response, World Health Organization, Geneva, Switzerland 5 Uganda Health Sector Programme Support, Danida, Kampala, Uganda 6 Department of Clinical Pharmacology, University of Newcastle, New South Wales, Australia 7 Safe Injection Global Network, Department of Blood Safety and Clinical Technology, World Health Organization, Geneva, Switzerland 8 Global Assistance Initiatives, United States Pharmacopeia, Maryland, USA 9 Division of Clinical Pharmacology, Weill Medical College of Cornell University, New York, USA 10Regional Office for the Western Pacific, World Health Organization, Manila, the Philippines *The MSH Rational Pharmaceutical Management Plus Program is supported by the U.S. Agency for International Development, under the terms of cooperative agreement number HRN-A-00-00-00016-00. © World Health Organization 2003 All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use. Designed by minimum graphics Printed in France 9. GETTING STARTED Contents Acronyms and abbreviations v Preface vii 1 Introduction 1 1.1 Why are drug and therapeutics committees (DTCs) needed? 1 1.2 Goals and objectives of the DTC 2 1.3 Functions of the DTC 2 1.4 Role of the DTC in the drug management cycle 5 2 Structure and organization of a DTC 6 2.1 Principles in setting up a DTC 6 2.2 Steps in setting up and managing the DTC 7 Annex 2.1 Example of a declaration of interest form 12 Annex 2.2 Model terms of reference for a DTC in Zimbabwe 13 Annex 2.3 Example of a mandate for a DTC: excerpts from the Zimbabwe National Drug Policy 1998 14 3 Managing the formulary process 15 3.1 The formulary process 15 3.2 The formulary list (essential medicines list) 16 3.3 The formulary manual 22 3.4 Standard treatment guidelines (STGs) 23 Annex 3.1 Application forms to be filled in by applicants when applying for a new drug to be added to the hospital formulary list 28 Annex 3.2 Drug information included in a comprehensive formulary 34 4Assessing new medicines 35 4.1 The need for critical assessment of new medicines 35 4.2 Sources of information to assess new medicines 36 4.3 Assessing the efficacy and safety of new medicines from the literature 36 4.4 Measuring and comparing clinical treatment outcomes 38 4.5 Measuring and comparing drug costs 39 Annex 4.1 Sources of information 46 Annex 4.2 Checklist to detect common problems encountered in articles 48 iii DRUG AND THERAPEUTICS COMMITTEES – A PRACTICAL GUIDE 5 Ensuring medicine safety and quality 51 5.1 The need for ensuring medicine safety and quality 51 5.2 Monitoring and addressing medication errors 51 5.3 Monitoring and ensuring medicine quality 54 5.4 Safety of medicines 58 Annex 5.1 Basic analytical medicine tests 65 Annex 5.2 Examples of adverse drug reaction reporting (ADR) reporting forms 66 Annex 5.3 Naranjo algorithm for assessing the causality of an ADR 70 6Tools to investigate the use of medicines 71 6.1 Stepwise approach to investigating the use of medicines 71 6.2 Analysis of aggregate medicine use data 72 6.3 WHO/INRUD drug use indicators for health facilities 81 6.4 Qualitative methods to investigate causes of problems of medicine use 81 6.5 Drug use evaluation (DUE) (drug utilization review) 85 Annex 6.1 Defined daily doses (DDD) of some common medicines 91 Annex 6.2 DUE criteria on data collection form for amikacin 94 7Promoting the rational use of medicines 95 7.1 Changing a medicine use problem 95 7.2 Educational strategies 96 7.3 Managerial strategies 99 7.4 Regulatory strategies 102 7.5 Choosing an intervention 103 7.6 Evaluating interventions 103 Annex 7.1 Examples of structured order forms from a hospital in Nepal 106 8 Antimicrobials and injections 108 8.1 Antimicrobials, resistance and infection control 108 8.2 Safe and appropriate use of injections 115 9 Getting started 122 9.1 Addressing the problem 122 9.2 Stepwise approach to starting a DTC where none exists 123 9.3 Revitalizing non-functioning DTCs 126 9.4 Using this manual to solve problems 126 Glossary 130 References 136 Further reading 139 Useful addresses and websites 140 iv 9. GETTING STARTED Acronyms and abbreviations ABC ABC analysis ADR adverse drug reaction AGREE Appraisal of Guidelines for Research and Evaluation in Europe AHFS American Hospital Formulary Service AMR antimicrobial resistance ARR absolute risk reduction ASHP American Society of Health-System Pharmacists DALYs disability-adjusted life years DDD defined daily dose DTCdrug and therapeutics committee DUE drug use evaluation DUR drug utilization review EDL essential drugs list EML essential medicines list EDLIZ Essential Drug List of Zimbabwe GMP good manufacturing practices IM intramuscular INN International Nonproprietary Name INRUD International Network for Rational Use of Drugs IV intravenous MCAZ Medicines Control Authority of Zimbabwe MI myocardial infarction MoH Ministry of Health MSHManagement Sciences for Health MUE medication use evaluation NDTPAC National Drug and Therapeutics Policy Advisory Committee NNT numbers needed to treat QALYsquality-adjusted life years RCT randomized controlled trial RPM Rational Pharmaceutical Management Project RR relative risk v DRUG AND THERAPEUTICS COMMITTEES – A PRACTICAL GUIDE RRR relative risk reduction SC subcutaneous SIGN Scottish Intercollegiate Guidelines Network SK streptokinase STG standard treatment guideline TB tuberculosis TPA tissue plasminogen activator UNFPA United Nations Population Fund UNICEF United Nations Children’s Fund VEN analysis vital, essential and non-essential analysis WHO World Health Organization vi 9. GETTING STARTED Preface Inefficient and irrational use of medicines is a widespread problem at all levels of health care (Hogerzeil 1995). Per capita wastage from inefficiencies and irrational use tends to be greatest in hospitals; this is particularly worrisome since resources are scarce and prescribers in communities often copy hospital prescribers. Many of these sources of wastage could be reduced if some simple principles of drug management and use were followed.
Recommended publications
  • The Role of Nanobiosensors in Therapeutic Drug Monitoring

    The Role of Nanobiosensors in Therapeutic Drug Monitoring

    Journal of Personalized Medicine Review Personalized Medicine for Antibiotics: The Role of Nanobiosensors in Therapeutic Drug Monitoring Vivian Garzón 1, Rosa-Helena Bustos 2 and Daniel G. Pinacho 2,* 1 PhD Biosciences Program, Universidad de La Sabana, Chía 140013, Colombia; [email protected] 2 Therapeutical Evidence Group, Clinical Pharmacology, Universidad de La Sabana, Chía 140013, Colombia; [email protected] * Correspondence: [email protected]; Tel.: +57-1-8615555 (ext. 23309) Received: 21 August 2020; Accepted: 7 September 2020; Published: 25 September 2020 Abstract: Due to the high bacterial resistance to antibiotics (AB), it has become necessary to adjust the dose aimed at personalized medicine by means of therapeutic drug monitoring (TDM). TDM is a fundamental tool for measuring the concentration of drugs that have a limited or highly toxic dose in different body fluids, such as blood, plasma, serum, and urine, among others. Using different techniques that allow for the pharmacokinetic (PK) and pharmacodynamic (PD) analysis of the drug, TDM can reduce the risks inherent in treatment. Among these techniques, nanotechnology focused on biosensors, which are relevant due to their versatility, sensitivity, specificity, and low cost. They provide results in real time, using an element for biological recognition coupled to a signal transducer. This review describes recent advances in the quantification of AB using biosensors with a focus on TDM as a fundamental aspect of personalized medicine. Keywords: biosensors; therapeutic drug monitoring (TDM), antibiotic; personalized medicine 1. Introduction The discovery of antibiotics (AB) ushered in a new era of progress in controlling bacterial infections in human health, agriculture, and livestock [1] However, the use of AB has been challenged due to the appearance of multi-resistant bacteria (MDR), which have increased significantly in recent years due to AB mismanagement and have become a global public health problem [2].
  • Biopharmaceutical Optimization in Neglected Diseases for Paediatric Patients by Applying the Provisional Paediatric Biopharmaceu

    Biopharmaceutical Optimization in Neglected Diseases for Paediatric Patients by Applying the Provisional Paediatric Biopharmaceu

    Gonzalez-Alvarez Isabel (Orcid ID: 0000-0002-1685-142X) i. Title (including PI’s name) “Biopharmaceutical Optimization in neglected diseases for paediatric patients by applying the provisional paediatric Biopharmaceutical Classification System” Principal investigator: Gordon L. Amidon Author for correspondence: [email protected] ii. Short running title of less than 40 characters Paediatric Biopharmaceutical Optimization in Neglected Diseases iii. The full names of all authors Jose Manuel del Moral Sanchez (delMoral-Sanchez JM) Isabel Gonzalez Alvarez (Gonzalez-Alvarez I) Aaron Cerda Revert (Cerda-Revert A) Marta Gonzalez Alvarez (Gonzalez-Alvarez M) Andres Navarro Ruiz (Navarro A) Gordon L. Amidon (Amidon GL) Marival Bermejo Sanz (Bermejo M) This is the author manuscript accepted for publication and has undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/bcp.13650 This article is protected by copyright. All rights reserved. iv. The authors’ institutional affiliations (ie where the work was carried out, with a footnote for an author’s present address if different from where the work was carried out) Jose Manuel del Moral Sanchez (delMoral-Sanchez JM) 1Institute of Molecular and Cellular Biology of Miguel Hernandez University. Avda de la Universidad s/n, 03202 Elche (Alicante) Spain 2Department of Pharmacokinetics and Pharmaceutical Technology,
  • Tetracycline and Sulfonamide Antibiotics in Soils: Presence, Fate and Environmental Risks

    Tetracycline and Sulfonamide Antibiotics in Soils: Presence, Fate and Environmental Risks

    processes Review Tetracycline and Sulfonamide Antibiotics in Soils: Presence, Fate and Environmental Risks Manuel Conde-Cid 1, Avelino Núñez-Delgado 2 , María José Fernández-Sanjurjo 2 , Esperanza Álvarez-Rodríguez 2, David Fernández-Calviño 1,* and Manuel Arias-Estévez 1 1 Soil Science and Agricultural Chemistry, Faculty Sciences, University Vigo, 32004 Ourense, Spain; [email protected] (M.C.-C.); [email protected] (M.A.-E.) 2 Department Soil Science and Agricultural Chemistry, Engineering Polytechnic School, University Santiago de Compostela, 27002 Lugo, Spain; [email protected] (A.N.-D.); [email protected] (M.J.F.-S.); [email protected] (E.Á.-R.) * Correspondence: [email protected] Received: 30 October 2020; Accepted: 13 November 2020; Published: 17 November 2020 Abstract: Veterinary antibiotics are widely used worldwide to treat and prevent infectious diseases, as well as (in countries where allowed) to promote growth and improve feeding efficiency of food-producing animals in livestock activities. Among the different antibiotic classes, tetracyclines and sulfonamides are two of the most used for veterinary proposals. Due to the fact that these compounds are poorly absorbed in the gut of animals, a significant proportion (up to ~90%) of them are excreted unchanged, thus reaching the environment mainly through the application of manures and slurries as fertilizers in agricultural fields. Once in the soil, antibiotics are subjected to a series of physicochemical and biological processes, which depend both on the antibiotic nature and soil characteristics. Adsorption/desorption to soil particles and degradation are the main processes that will affect the persistence, bioavailability, and environmental fate of these pollutants, thus determining their potential impacts and risks on human and ecological health.
  • OVESTIN PESSARY (0.5Mg)

    OVESTIN PESSARY (0.5Mg)

    NEW ZEALAND DATA SHEET 1. OVESTIN PESSARY (0.5mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 0.5 mg Estriol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pessary 0.5 mg - white, torpedo formed pessary. One pessary (2.5 g weight) contains 0.5 mg oestriol. Length 26.5 mm; largest diameter 14 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Atrophy of the lower urogenital tract related to oestrogen deficiency, notably • for the treatment of vaginal complaints such as dyspareunia, dryness and itching. • for the prevention of recurrent infections of the vagina and lower urinary tract. • in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence. Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery. A diagnostic aid in case of a doubtful atrophic cervical smear. 4.2 Dose and method of administration Dosage OVESTIN is an oestrogen-only product that may be given to women with or without a uterus. Atrophy of the lower urogenital tract 1 pessary per day for the first weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1 pessary twice a week) is reached. Pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery 1 pessary per day in the 2 weeks before surgery; 1 pessary twice a week in the 2 weeks after surgery. A diagnostic aid in case of a doubtful atrophic cervical smear 1 pessary on alternate days in the week before taking the next smear. Administration OVESTIN pessaries should be inserted intravaginally before retiring at night.
  • UK Clinical Guideline for Best Practice in the Use of Vaginal Pessaries for Pelvic Organ Prolapse

    UK Clinical Guideline for Best Practice in the Use of Vaginal Pessaries for Pelvic Organ Prolapse

    UK Clinical Guideline for best practice in the use of vaginal pessaries for pelvic organ prolapse March 2021 Developed by members of the UK Clinical Guideline Group for the use of pessaries in vaginal prolapse representing: the United Kingdom Continence Society (UKCS); the Pelvic Obstetric and Gynaecological Physiotherapy (POGP); the British Society of Urogynaecology (BSUG); the Association for Continence Advice (ACA); the Scottish Pelvic Floor Network (SPFN); The Pelvic Floor Society (TPFS); the Royal College of Obstetricians and Gynaecologists (RCOG); the Royal College of Nursing (RCN); and pessary users. Funded by grants awarded by UKCS and the Chartered Society of Physiotherapy (CSP). This guideline was completed in December 2020, and following stakeholder review, has been given official endorsement and approval by: • British Association of Urological Nurses (BAUN) • International Urogynecological Association (IUGA) • Pelvic Obstetric and Gynaecological Physiotherapy (POGP) • Scottish Pelvic Floor Network (SPFN) • The Association of Continence Advice (ACA) • The British Society of Urogynaecology (BSUG) • The Pelvic Floor Society (TPFS) • The Royal College of Nursing (RCN) • The Royal College of Obstetricians and Gynaecologists (RCOG) • The United Kingdom Continence Society (UKCS) Review This guideline will be due for full review in 2024. All comments received on the POGP and UKCS websites or submitted here: [email protected] will be included in the review process. 2 Table of Contents Table of Contents ................................................................................................................................
  • Pessary for Management of Pelvic Organ Prolapse

    Pessary for Management of Pelvic Organ Prolapse

    Pessary for management of Pelvic Organ Prolapse Cathy Davis Clinical Nurse Specialist Department of Urogynaecology King’s College Hospital, London Definition of Prolapse The descent of one or more of the anterior vaginal wall, posterior vaginal wall, uterus (cervix) or vaginal vault (cuff scar after hysterectomy). The presence of any such sign should be correlated with relevant POP symptoms. (Haylen et al 2016) Risk Factors • Increased intra-abdominal pressure • Chronic cough • Chronic constipation • Weight lifting • Presence of abdominal tumours - fibroids & ovarian cysts • High impact exercise • Age/ Menopause • Obesity Risk Factors contd.... • Smoking • Multiparity • Congenital weakness – rare; due to deficiency in collagen metabolism • Injury to pelvic floor muscles • Iatrogenic/ pelvic surgery - hysterectomy Symptoms of POP • May be asymptomatic – a small amount of prolapse can often be normal • Sensation of a lump or bulge " coming down" - most common • Backache • Heaviness • Dragging or discomfort inside the vagina – often worse on standing /sitting for prolonged periods • Seeing a lump or bulge Symptoms of POP contd.... • Bladder / Urinary symptoms -Frequency -Difficulty initiating voids, low-flow, incomplete bladder emptying -Leakage on certain movements or when lifting heavy objects -Recurrent urinary tract infections • Bowel symptoms -Constipation - Incomplete bowel emptying - May have to digitate to defecate/use aides • Symptoms related to Sex – uncomfortable, lack of sensation Diagnosis of Prolapse • Vaginal examination •
  • Combi Soft Gel Pessary & External Cream

    Combi Soft Gel Pessary & External Cream

    Combi Soft Gel Pessary Canesten & External Cream 500mg vaginal capsule & 2% w/w cream Clotrimazole Read all of this leaflet carefully because it contains important To treat internal thrush, your doctor may recommend that you use the information for you. pessary without the help of an applicator. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. HOW TO USE CANESTEN® COMBI • This medicine has been prescribed for you. Do not give it to anyone else 3. under any circumstances. The Soft Gel Pessary: • If you have any unusual effects after using this product, tell your doctor. Unless directed otherwise by your doctor, the Soft Gel Pessary should be inserted as high as possible into the vagina, preferably before going to sleep IN THIS LEAFLET at night for convenient and comfortable treatment. Wash your hands before removing the foil from the blister pack and again 1. What is Canesten Combi and what is it used for? afterwards when you have used the applicator. 2. Before you use Canesten Combi 3. How to use Canesten Combi 1. Remove the applicator from the packaging. Pull out the plunger A until it 4. Possible side effects stops. Remove the pessary from the foil blister pack and place firmly into the 5. How to store Canesten Combi applicator B. 6. Further information 1. WHAT IS CANESTEN® COMBI AND WHAT IS IT USED FOR? Canesten Combi Soft Gel Pessary & External Cream is a full course of treatment for vaginal thrush (candidiasis) because it treats both the internal cause and external symptoms.
  • Human African Trypanosomiasis in Non-Endemic Countries (2000-2010)

    Human African Trypanosomiasis in Non-Endemic Countries (2000-2010)

    1 REVIEW Human African Trypanosomiasis in Non-Endemic Countries (2000–2010) Pere P. Simarro, PhD,∗ Jose´ R. Franco, MD,∗ Giuliano Cecchi, MD,† Massimo Paone, MD,† Abdoulaye Diarra, PhD,‡ Jose´ A. Ruiz Postigo, PhD,§ and Jean G. Jannin, PhD∗ ∗World Health Organization, Control of Neglected Tropical Diseases, Innovativ and Intensified Disease Management, Geneva, Switzerland; †Food and Agriculture Organization of the United Nations (FAO), Animal Production and Health Division, Rome, Italy; ‡World Health Organization, Regional Office for Africa, Brazzaville, Congo; §World Health Organization, Regional Office for the Eastern Mediterranean, Cairo, Egypt DOI: 10.1111/j.1708-8305.2011.00576.x Background. Human African trypanosomiasis (HAT) can affect travelers to sub-Saharan Africa, as well as migrants from disease endemic countries (DECs), posing diagnosis challenges to travel health services in non-disease endemic countries (non-DECs). Methods. Cases reported in journals have been collected through a bibliographic research and complemented by cases reported to the World Health Organization (WHO) during the process to obtain anti-trypanosome drugs. These drugs are distributed to DECs solely by WHO. Drugs are also provided to non-DECs when an HAT case is diagnosed. However, in non-DEC pentamidine can also be purchased in the market due to its indication to treat Pneumocystis and Leishmania infections. Any request for drugs from non-DECs should be accompanied by epidemiological and clinical data on the patient. Results. During the period 2000 to 2010, 94 cases of HAT were reported in 19 non-DECs. Seventy-two percent of them corresponded to the Rhodesiense form, whereas 28% corresponded to the Gambiense. Cases of Rhodesiense HAT were mainly diagnosed in tourists after short visits to DECs, usually within a few days of return.
  • Pharmacometabolomics of Meglumine Antimoniate in Patients with Cutaneous Leishmaniasis

    Pharmacometabolomics of Meglumine Antimoniate in Patients with Cutaneous Leishmaniasis

    Edinburgh Research Explorer Pharmacometabolomics of meglumine antimoniate in patients with cutaneous leishmaniasis Citation for published version: Vargas, DA, Prieto, MD, Martínez-Valencia, AJ, Cossio, A, Burgess, KEV, Burchmore, RJS & Adelaida Gómez, M 2019, 'Pharmacometabolomics of meglumine antimoniate in patients with cutaneous leishmaniasis', Frontiers in pharmacology, vol. 10, 657. https://doi.org/10.3389/fphar.2019.00657 Digital Object Identifier (DOI): 10.3389/fphar.2019.00657 Link: Link to publication record in Edinburgh Research Explorer Document Version: Publisher's PDF, also known as Version of record Published In: Frontiers in pharmacology General rights Copyright for the publications made accessible via the Edinburgh Research Explorer is retained by the author(s) and / or other copyright owners and it is a condition of accessing these publications that users recognise and abide by the legal requirements associated with these rights. Take down policy The University of Edinburgh has made every reasonable effort to ensure that Edinburgh Research Explorer content complies with UK legislation. If you believe that the public display of this file breaches copyright please contact [email protected] providing details, and we will remove access to the work immediately and investigate your claim. Download date: 07. Oct. 2021 ORIGINAL RESEARCH published: 20 June 2019 doi: 10.3389/fphar.2019.00657 Pharmacometabolomics of Meglumine Antimoniate in Patients With Cutaneous Leishmaniasis Deninson Alejandro Vargas 1,2, Miguel Dario Prieto
  • Multi-Residue Determination of Sulfonamide and Quinolone Residues in Fish Tissues by High Performance Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

    Multi-Residue Determination of Sulfonamide and Quinolone Residues in Fish Tissues by High Performance Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

    674 Journal of Food and Drug Analysis, Vol. 20, No. 3, 2012, Pages 674-680 doi:10.6227/jfda.2012200315 Multi-Residue Determination of Sulfonamide and Quinolone Residues in Fish Tissues by High Performance Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) CHUNG-WEI TSAI1, CHAN-SHING LIN1 AND WEI-HSIEN WANG1,2* 1. Division of Marine Biotechnology, Asia-Pacific Ocean Research Center, National Sun Yat-Sen University, Kaohsiung, Taiwan, R.O.C. 2. National Museum of Marine Biology and Aquarium, Pingtung, Taiwan, R.O.C. (Received: August 30, 2010; Accepted: April 26, 2012) ABSTRACT A LC-MS/MS method was validated for the simultaneous quantification of 4 quinolones (oxolinic acid, enrofloxacine, ciprofloxacine, norfloxacine) and 4 sulfonamides (sulfamethoxypyridazine, sulfadoxine, sulfadimidine, sulfamerazine) on fish muscle following the Euro- pean Union’s (EU) criteria for the analysis of veterinary drug residues in foods. One gram of sample was extracted by acidic acetonitrile (0.5 mL of 0.1% formic acid in 7 mL of ACN), followed by LC-MS/MS analysis using an electrospray ionization interface. Typical recoveries of the 4 quinolones in the fish tissues ranged from 85 to 104%. While those of the sulfonamides ranged from 75 to 94% at the fortification level of 5.0 μg/kg. The decision limits (CCα) and detection capabilities (CCβ) of the quinolones were 1.35 to 2.10 μg/kg and 1.67 to 2.75 μg/kg, respectively. Meanwhile, the CCα and CCβ of the sulfonamides ranged from 1.62 μg/kg to 2.53μg/kg and 2.01μg/kg to 3.13 μg/kg, respectively.
  • Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1

    Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1

    TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object.
  • (OTC) Antibiotics in the European Union and Norway, 2012

    (OTC) Antibiotics in the European Union and Norway, 2012

    Perspective Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway, 2012 L Both 1 , R Botgros 2 , M Cavaleri 2 1. Public Health England (PHE), London, United Kingdom 2. Anti-infectives and Vaccines Office, European Medicines Agency (EMA), London, United Kingdom Correspondence: Marco Cavaleri ([email protected]) Citation style for this article: Both L, Botgros R, Cavaleri M. Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway, 2012. Euro Surveill. 2015;20(34):pii=30002. DOI: http://dx.doi.org/10.2807/1560-7917.ES.2015.20.34.30002 Article submitted on 16 September 2014 / accepted on 09 February 2015 / published on 27 August 2015 Antimicrobial resistance is recognised as a growing throughout the EU; however, there are still consider- problem that seriously threatens public health and able differences in Europe due to the different health- requires prompt action. Concerns have therefore been care structures and policies (including the extent of raised about the potential harmful effects of making pharmacist supervision for OTC medicines), reimburse- antibiotics available without prescription. Because of ment policies, and cultural differences of each Member the very serious concerns regarding further spread of State. Therefore, the availability of OTC medicines var- resistance, the over-the-counter (OTC) availability of ies in the EU and products sold as POM in certain coun- antibiotics was analysed here. Topical and systemic tries can be obtained as OTC medicines in others. OTC antibiotics and their indications were determined across 26 European Union (EU) countries and Norway As risk minimisation is an important criterion for some by means of a European survey.