The Selection and Use of Essential Medicines

WHO Technical Report Series

The Selection and Use of Essential Medicines

Report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2017 (including the 20th WHO Model List of Essential Medicines and the 6th WHO Model List of Essential Medicines for Children)

The Selection and Use of Essential Medicines Report of the 21st WHO Expert Committee

Contents

Contents ................................................................................................................................................ 2 Executive summary ............................................................................................................................. 7 List of participants ............................................................................................................................ 18 Declaration of Interests for Expert Committee Members, Temporary Advisers and WHO Secretariat ........................................................................................................................................... 21 1. Introduction ............................................................................................................................... 24 2. Open session .............................................................................................................................. 25 3. General items ............................................................................................................................. 27 4. Summary of recommendations .............................................................................................. 30 5. Applications for the 20th Model List of Essential Medicines and the 6th Model List of Essential Medicines for Children .................................................................................................. 35 Section 1: ANAESTHETICS, PREOPERATIVE MEDICINES AND MEDICAL GASES .. 35 1.4 Medical gases (new sub-section)............................................................................................. 35

Oxygen......................................................................................................................................... 35 Section 2: MEDICINES FOR PAIN AND PALLIATIVE CARE............................................... 39 2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) ..................... 39

Paracetamol ? addition of new strength ? EML and EMLc.................................................. 39 2.2 Opioid analgesics....................................................................................................................... 40

Fentanyl (addition) ? EML ........................................................................................................ 40 Methadone (new indication) EML and (addition) EMLc ..................................................... 44 Tramadol (addition) ? EML and EMLc ................................................................................... 50 2.3 Medicines for other common symptoms in palliative care................................................. 54 Gabapentin ? addition ? EML .................................................................................................. 54 Section 5: ANTICONVULSANTS/ANTIEPILEPTICS ............................................................. 60 Lamotrigine (addition) ? EML and EMLc............................................................................... 60 Section 6: ANTI-INFECTIVE MEDICINES ................................................................................ 68 6.1 Anthelminthics ............................................................................................................................ 68 Ivermectin ? new indication ? EML and EMLc...................................................................... 68 6.2 Antibacterials.............................................................................................................................. 73

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The Selection and Use of Essential Medicines Report of the 21st WHO Expert Committee

Comprehensive review of antibiotics ? EML and EMLc ...................................................... 73 Community acquired pneumonia (CAP)................................................................................ 79 Pharyngitis .................................................................................................................................. 84 Sinusitis........................................................................................................................................ 87 Otitis media ................................................................................................................................. 89 Hospital acquired pneumonia (HAP) & ventilator associated pneumonia (VAP) ........... 91 Sepsis in children........................................................................................................................ 94 Urinary tract infections (UTI) ................................................................................................... 96 Meningitis.................................................................................................................................... 99 Complicated intra-abdominal infections .............................................................................. 101 Skin & soft tissue infections (including cellulitis and surgical site infections)................ 106 Acute infectious diarrhoea ...................................................................................................... 111 Sexually transmitted infections .............................................................................................. 115 Exacerbations of chronic obstructive pulmonary disease (COPD) ................................... 121 Bone and joint infections ......................................................................................................... 124 Febrile neutropenia .................................................................................................................. 127 Severe acute malnutrition ....................................................................................................... 131 Preserved antibiotic list ? EML and EMLc ........................................................................... 133 Azithromycin ? new indication ? EML and EMLc .............................................................. 135 Clofazimine ? new indication ? EML and EMLc ................................................................. 138 Delamanid ? new indication - EMLc ..................................................................................... 142 Gatifloxacin ? addition ? EML and EMLc............................................................................. 145 Isoniazid + pyrazinamide + rifampicin ? new formulation? EMLc .................................. 148 Isoniazid + rifampicin ? new formulation ? EMLc .............................................................. 148 Ofloxacin ? deletion ? EML and EMLc ................................................................................. 150 Streptomycin ? deletion ? EML and EMLc........................................................................... 152 6.3 Antifungal medicines.............................................................................................................. 153 Itraconazole ? addition ? EML and EMLc ............................................................................ 153 Voriconazole ? addition ? EML and EMLc........................................................................... 158 6.4 Antiviral medicines ................................................................................................................. 162 ARV formulations for deletion from EML and EMLc ........................................................ 162

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The Selection and Use of Essential Medicines Report of the 21st WHO Expert Committee

Abacavir ? addition of new formulation and strength - EMLc ......................................... 165 Zidovudine (ZDV or AZT) ? addition of new formulation and strength? EMLc........... 167 Atazanavir + ritonavir ? addition ? EML ............................................................................. 169 Lopinavir + ritonavir ? new formulation and strength ? EMLc ....................................... 171 Dolutegravir ? addition ? EML .............................................................................................. 174 Raltegravir ? addition ? EML and EMLc .............................................................................. 177 Abacavir + lamivudine ? addition of a new strength ? EMLc ........................................... 180 Cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide ? addition ? EML ..... 182 Efavirenz + lamivudine + tenofovir disoproxil fumarate ? addition ? EML.................... 186 Emtricitabine + tenofovir alafenamide ? addition ? EML .................................................. 188 Emtricitabine + rilpivirine + tenofovir alafenamide ? addition ? EML............................. 191 Tenofovir disoproxil fumarate ? new indication (pre-exposure prophylaxis) ? EML ... 194 Emtricitabine + tenofovir disoproxil fumarate? new indication ? EML........................... 194 Lamivudine + tenofovir disoproxil fumarate? new indication ? EML ............................. 194 Isoniazid+pyridoxine+sulfamethoxazole+trimethoprim ? addition ? EML and EMLc . 198 Oseltamivir ? deletion ? EML and EMLc.............................................................................. 202 Tenofovir alafenamide ? addition ? EML ............................................................................. 208 Elbasvir + grazoprevir ? addition ? EML.............................................................................. 211 Sofosbuvir + velpatasvir ? addition ? EML .......................................................................... 215 6.5 Antiprotozoal medicines ........................................................................................................ 220 Artesunate + pyronaridine ? addition ? EML and EMLc ................................................... 220 Artesunate ? addition of new strength - EMLc.................................................................... 224 Dihydroartemisinin + piperaquine ? addition ? EML and EMLc ..................................... 226 Section 8: ANTINEOPLASTICS AND IMMUNOSUPPRESSIVES .................................... 230 8.2 Cytotoxic and adjuvant medicines ....................................................................................... 230 Erlotinib, gefitinib, afatinib, crizotinib ? EML - NSCLC..................................................... 230 Nilotinib, dasatinib ? addition ? EML - CML....................................................................... 235 Trastuzumab emtansine ? addition ? EML ? breast cancer ............................................... 239 Zoledronic acid ? addition ? EML ? cancer bone metastases ............................................ 245 8.3 Hormones and antihormones ................................................................................................ 250 Enzalutamide (addition) ? EML ? prostate cancer .............................................................. 250

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The Selection and Use of Essential Medicines Report of the 21st WHO Expert Committee

Section 10: MEDICINES AFFECTING THE BLOOD ............................................................. 254 10.1 Antianaemia medicines ......................................................................................................... 254

Erythropoiesis-stimulating agents ? addition ? EML and EMLc ..................................... 254 Section 12: CARDIOVASCULAR MEDICINES ...................................................................... 271 12.3 Antihypertensive medicines ................................................................................................ 271

Lisinopril + hydrochlorothiazide ? addition ? EML............................................................ 271 Losartan ? addition ? EML...................................................................................................... 275 12.7 Fixed-dose combinations of cardiovascular medicines (new sub-section) ................. 280 Aspirin + atorvastatin + ramipril ? addition ? EML ............................................................ 280 Section 15: DISINFECTANTS AND ANTISEPTICS .............................................................. 288 15.1 Antiseptics............................................................................................................................... 288 Hypochlorous acid ? addition ? EML and EMLc ................................................................ 288 Section 18: HORMONES, OTHER ENDOCRINE MEDICINES AND CONTRACEPTIVES ...................................................................................................................... 291 18.3 Contraceptives ........................................................................................................................ 291 Ulipristal acetate ? addition ? EML ....................................................................................... 291 Medroxyprogesterone acetate ? new formulation and strength - EML ........................... 295 18.5 Insulins and other medicines used for diabetes .............................................................. 298 Long-acting insulin analogues (addition) ? EML and EMLc ............................................. 298 Second-line treatments for type 2 diabetes (addition) ? EML and EMLc ........................ 303 Section 21: OPHTHALMOLOGICAL PREPARATIONS....................................................... 318 21.1 Anti-infective agents ............................................................................................................. 318 Natamycin ? addition ? EML and EMLc .............................................................................. 318 21.6 Anti-vascular endothelial growth factor (VEGF) preparations ..................................... 321 Bevacizumab ? deletion - EML............................................................................................... 321 Section 22: OXYTOCICS AND ANTIOXYTOCICS ................................................................ 324 22.1 Oxytocics.................................................................................................................................. 324 Misoprostol ? delete indication (PPH prevention) - EML .................................................. 324 Section 25: MEDICINES ACTING ON THE RESPIRATORY TRACT ............................... 327 25.1 Antiasthmatic and medicines for chronic obstructive pulmonary disease................. 327 Budesonide + formoterol ? addition ? EML and EMLc ...................................................... 327

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