The Selection and Use of Essential Medicines [OP]: Report of the WHO Expert Committee, 2015 (including the 19th WHO Model List of Essential Medicines and the 5th WHO Model List for Children)

The Selection and Use of Essential Medicines [OP]: Report of the WHO Expert Committee, 2015 (including the 19th WHO Model List of Essential Medicines and the 5th WHO Model List for Children)

by World Health Organization

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Overview

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model Lists of Essential Medicines.. The goal of the meeting was to review and update the 18th WHO Model List of Essential Medicines (EML) and the 4th WHO Model List of Essential Medicines for Children (EMLc).

In accordance with approved procedures, the Expert Committee evaluated the scientific evidence on the basis of the comparative effectiveness, safety and cost effectiveness of the medicines. Both lists went through major revisions this year, as the Committee considered 77 applications, including 29 treatment regimens for cancer, and innovative hepatitis C and tuberculosis (TB) medicines. The Expert Committee recommended the addition of 36 new medicines to the EML (15 to the core list and 21 to the complementary list); and recommended the addition of 16 new medicines to the EMLc (five to the core list and 11 to the complementary list).

Annexes to the main report include the revised version of the WHO Model List of Essential Medicines (19th edition) and the WHO Model List of Essential Medicines for Children (5th edition). In addition there is a list of all the items on the Model List sorted according to their Anatomical Therapeutic Chemical (ATC) classification codes.

Product Details

ISBN-13: 9789241209946
Publisher: World Health Organization
Publication date: 02/15/2016
Series: WHO Technical Report Series
Pages: 461
Product dimensions: 6.25(w) x (h) x (d)

About the Author

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.

Table of Contents

Executive summary vii

List of participants x

Declaration of interests xiii

1 Introduction 1

2 Open session 2

3 General items 4

3.1 High-priced medicines 4

3.2 Note on evaluation of "off-label" medicines 7

3.3 Structure and function of the EML Committee and application process 7

3.4 Essential Medicines List for children 8

4 Summary of recommendations 9

Additions to Model Lists 9

Deletions from Model Lists 11

Changes to sections 11

Amended dosage strength and form 11

Reinstatement 12

Rejected applications 12

5 Applications for the 19th Model List of Essential Medicines and the 5th Model List of Essential Medicines for Children 18

Section 2 Medicines for pain and palliative care 18

2.2 Opioid analgesics 18

Morphine - (hydromorphone and oxycodone) (Review) - EML and EMLc 18

Section 5 Anticonvulsants/antiepileptics 19

Magnesium sulfate (review) - EML 19

Midazolam (new indication) - EML and EMLc 20

Valproic acid (sodium valproate) (new formulation) - EML and EMLc 22

Section 6 Anti-infective medicines 26

6.2 Antibacterials 26

6.2.4 Antituberculosis medicines 26

Bedaquiline (addition) - EML 26

Delamanid (addition) - EML 26

Linezolid (addition) - EML and EMLc 26

Terizidone (addition) - EML and EMLc 26

Rifapentine (addition) - EML and EMLc 35

6.3 Antifungal medicines 38

Itraconazole (addition) - EML and EMLc 38

6.4 Antiviral medicines 42

6.4.2 Antiretrovirais 42

Various anti retroviral medicines and/or formulations (deletion) - EML and EMLc 42

6.4.2 Antiretrovirals - fixed-dose combinations 45

Abavacir + lamivudine (addition) - EML and EMLc 45

Cobicistat + elvitegravir + emtricitabine + tenofovir disoproxil fumarate (addition) - EML 47

Emtricitabine + rilpivirine + tenofovir disoproxil fumarate (addition) - EML 47

6.4.2.2 Non-nucleoside reverse transcriptase inhibitors 50

Efavirenz (EFV or EFZ) (new formulation) - EML and EMLc 50

Nevirapine (NVP) (new formulation) - EML and EMLc 50

6.4.2.3 Protease inhibitors 52

Darunavir (addition) - EML and EMLc 52

6.4.3 Other antivirals 54

Valganciclovir (addition) - EML 54

6.4.4 Anti-hepatitis medicines 56

6.4.4.1 Medicines for hepatitis B 56

Entecavir (addition) - EML and EMLc 56

Tenofovir disoproxil fumarate (new indication) - EML 56

6.4.4.2 Medicines for hepatitis C 60

Sofosbuvir (addition) - EML 60

Daclatasvir (addition) - EML 60

Simeprevir (addition) - EML 60

Ledipasvir + sofosbuvir (addition) - EML 60

Ombitasvir + paritaprevir + ritonavir with or without dasabuvir (addition) - EML 60

Section 8 Antineoplastics and immunosuppressives 75

8.1 Immunosuppressive medicines 75

Azathioprine (new indication) - EML 75

8.2 Cytotoxic and adjuvant medicines & 8.3 Hormones and antihormones 77

Acute myelogenous leukaemia (AML) including Acute promyelocytic leukaemia (APML)-EML 82

Chronic lymphocytic leukaemia (CLL) - EML 94

Chronic myelogenous leukaemia (CML) - EML 102

Diffuse large B-cell lymphoma - EML 109

Early-stage breast cancer - EML 115

Early-stage cervical cancer - EML 125

Early-stage colon cancer - EML 133

Early-stage rectal cancer - EML 141

Early- and advanced-stage head and neck cancers - EML 148

Epithelial ovarian cancer - EML 153

Ewing sarcoma - EMLc 160

Follicular lymphoma - EML 166

Gastrointestinal stromal tumour (GIST) - EML 175

Gestational trophoblastic neoplasia (GTN) - EML 180

Granulocyte colony stimulating factor (G-CSF) (addition) - EML and EMLc 187

Hodgkin lymphoma (adult) - EML 190

Hodgkin lymphoma (paediatric) - EMLc 197

Kaposi sarcoma - EML 204

Metastatic breast cancer - EML 210

Metastatic colorectal cancer - EML 220

Metastatic prostate cancer- EML 227

Nasopharyngeal carcinoma - EML 234

Non-small cell lung cancer - EML 240

Osteosarcoma - EMLc 249

Ovarian germ cell tumours - EML and EMLc 255

Paediatric cancers: Burkitt lymphoma, acute lymphocytic leukaemia (ALL), Wilms tumour-EMLc 261

Retinoblastoma - EMLc 264

Rhabdomyosarcoma - EMLc 272

Testicular germ cell tumours - EML and EMLc 278

Section 9 Antiparkinsonism medicines 285

Dopamine agonists (review) - EML 285

Section 10 Medicines affecting the blood 289

10.1 Antianaemia medicines 289

Folic acid (new formulation) - EML 289

Ferrous salt + folic acid (new formulation) - EML 291

10.2 Medicines affecting coagulation 293

Desmopressin (addition) - EML 293

Low-molecular-weight heparin (addition) - EML 295

Novel oral anticoagulants (NOACs - dabigatran, rivaroxaban, apixaban) (addition) - EML 300

Section 11 Blood products of human origin and plasma substitutes 309

11.2.3 Plasma proteins (new section) 309

Plasma-derived C1 esterase inhibitor (addition) - EML and EMLc 309

Section 12 Cardiovascular medicines 311

12.3 Antihypertensive medicines 311

12.4 Medicines used in heart failure 311

Atenolol (review) - EML 311

12.5 Antithrombotic medicines 314

Clopidogrel (addition) - EML 314

12.7 Fixed-dose combinations of cardiovascular medicines 317

Aspirin + statin + antihypertensive "polypiil" (addition) - EML 317

Section 14 Diagnostic agents 321

14.2 Radiocontrast media 321

Gadopentate dimeglumine (addition) - EML 321

Gadoterate meglumine (addition) - EML and EMLc 321

Section 15 Disinfectants and antiseptics 323

15.2 Disinfectants 323

Alcohol-based hand rub (addition) - EML and EMLc 323

Section 17 Gastrointestinal medicines 325

17.1 Antiulcer medicines 325

Omeprazole (new formulation) - EML 325

Section 18 Hormones, other endocrine medicines and contraceptives 330

18.3.3 Intrauterine devices 330

Levonorgestrel-releasing intrauterine system (new formulation) - EML 330

18.3.5 Implantable contraceptives 332

Etonogestrel-releasing implant (addition) - EML 332

18.3.6 Intravaginal contraceptives (new section) 334

Progesterone contraceptive vaginal ring (addition) - EML 334

Section 19 Immunologicals 337

19.3 Vaccines (review) - EML and EMLc 337

Section 21 Ophthalmological preparations 339

21.6 Anti-vascular endothelial growth factor (VEGF) preparations 339

Ranibizumab (addition) - EML 339

Section 22 Oxytocics and antioxytocics 345

22.1 Oxytocics 345

Misoprostol (deletion) for PPH prevention - EML 345

Misoprostol (new indication - treatment of postpartum haemorrhage) - EML 347

References 351

Annex 1 19th WHO Model List of Essential Medicines (April 2015) 417

Annex 2 5th WHO Model List of Essential Medicines for Children (April 2015) 471

Annex 3 The Anatomical Therapeutic Chemical (ATC) Classification System 507

Annex 4 Alphabetical list of essential medicines (with ATC classification code numbers) 535

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