Page 189 - CW E-Magazine (16-1-2024)

Special Report Special Report

shortages has been highlighted as a critical medicine shortage. The solida- mmendations on tackling shortages Methylergometrine Erythromycin Meningococcal group C vaccine
key priority in the EU Pharmaceutical rity mechanism, which is based on an of medicinal products. The toolkit in- Other gynaecologicals Clarithromycin Meningococcal group B vaccine
Strategy for Europe, conclusions of the informal setup during COVID-19, will cludes recommendations for monitor- Salbutamol Azithromycin Diphtheria, tetanus, pertussis vaccine
European Council, resolutions of the enable any EU member state facing a ing supply and demand, an approach Other sex hormones and modulators of the Clindamycin (inactivated, whole cell)
European Parliament, and the proposed critical shortage that has been escalated that was used to tackle the widespread genital system Aminoglycoside anti-bacterials Diphtheria, tetanus, pertussis vaccine
revision of EU pharmaceutical legisla- to the MSSG for coordination at the critical shortages of antibiotics in Mifepristone Tobramycin (purifi ed antigen)
tion. Once adopted, the legislation will European level to request assistance the autumn and winter seasons of H - Systemic hormonal preparations, excl Gentamicin Diphtheria, tetanus vaccine
provide further clarity on obligations from other EU member states in obtaining 2022/2023. The toolkit also provides sex hormones and insulins Amikacin Typhoid vaccine (polysaccharide)
and implications. medicine stocks. This mechanism can guidance on interactions with market- Posterior pituitary lobe hormones Quinolone anti-bacterials Viral vaccines
only be used under very limited condi- ing authorization holders and manu- Desmopressin Ciprofl oxacin Encephalitis (Japanese, whole virus,
Other measures to address drug tions and was developed as a last resort facturers to increase and redistribute Oxytocin Levofl oxacin inactivated)
shortages for EU member states after they have existing stocks and the implementa- Carbetocin Other anti-bacterials Infl uenza vaccine (various forms, strains)
In October 2023, the EMA pub- exhausted all other possibilities. tion of regulatory fl exibilities, such as Corticosteroids for systemic use, plain Vancomycin Infl uenza vaccine (various forms, strains)
lished details of the newly created the exceptional supply of certain medi- Fludrocortisone Teicoplanin Hepatitis B vaccine
solidarity mechanism developed by The solidarity mechanism comple- cines that may not be authorised in a Methylprednisolone Colistimethate Hepatitis A vaccine
the EMA Medicines Shortages Steer- ments a number of actions that the particular EU member state, or full or Prednisolone Metronidazole Measles, mumps, rubella vaccine
ing Group (MSSG). This voluntary MSSG can carry out to address critical partial exemptions to certain labelling Hydrocortisone Fosfomycin Measles, mumps, rubella, varicella vaccine
mechanism allows EU member states shortages in the EU. These are those and packaging requirements for medi- Anti-thyroid preparations Anti-mycotics for systemic use Poliomyelitis vaccine (trivalent)
to support each other in the face of a as part of the MSSG Toolkit on reco- cines. Propylthiouracil Amphotericin B Rabies vaccine
EU list of critical medicines – Version 1 Carbimazole Posaconazole Varicella vaccine (live)
A – Alimentary tract and metabolism Tenecteplase Cardiac stimulants excl. cardiac glycosides Thiamazole Drugs for treatment of tuberculosis Yellow fever vaccine
Drugs for peptic ulcer and gastro- Dabigatran Isoprenaline Glycogenolytic hormones Rifampicin Human papillomavirus vaccine (9-valent)
oesophageal refl ux disease (gord) Anti-fi brinolytics Norepinephrine Glucagon Rifabutin Bacterial and viral vaccines, combined
Esomeprazole Tranexamic acid Dopamine J – Anti-infectives for systemic use Isoniazid Diphtheria, tetanus, poliomyelitis vaccine
Belladonna and derivatives, plain Vitamin k and other haemostatics Dobutamine Tetracyclines Ethambutol Diphtheria, tetanus, pertussis, poliomyelitis
Atropine Phytomenadione Epinephrine Doxycycline Bedaquiline vaccine
Propulsives Human fi brinogen Ephedrine Beta-lactam anti-bacterials, penicillins Isoniazid, rifampicin Diphtheria, tetanus, pertussis vaccine
Metoclopramide Human coagulation factor VIII Milrinone Ampicillin Drugs for treatment of leprosy Diphtheria, tetanus, pertussis, poliomyelitis,
Intestinal anti-infectives Human coagulation factor IX Vasodilators used in cardiac diseases Amoxicillin Dapsone hepatitis b vaccine
Vancomycin Vitamin B12 and folic acid Glyceryl trinitrate Benzylpenicillin Direct acting anti-virals L - anti-neoplastic and immunomodulating
Fidaxomicin Hydroxocobalamin Other cardiac preparations Phenoxymethylpenicillin agents
Intestinal adsorbents Blood and related products Adenosine Benzathine benzylpenicillin Acyclovir Anti-neoplastic agents
Medicinal charcoal Albumin Anti-adrenergic agents, centrally acting Cloxacillin Ganciclovir Cyclophosphamide
Insulins and analogues Plasma protein fraction Methyldopa (levorotatory) Flucloxacillin Valganciclovir Chlorambucil
Insulin human (fast-acting) IV solutions Methyldopa (racemic) Amoxicillin, clavulanic acid Foscarnet Melphalan
Insulin human (intermediate-acting) Potassium chloride Clonidine Piperacillin, tazobactam Zidovudine Ifosfamide
Insulin human (intermediate - or long- Mannitol Arteriolar smooth muscle, agents acting on Lamivudine Busulfan
acting combined with fast-acting) IV solution additives Sodium nitroprusside Other beta-lactam anti-bacterials Abacavir Treosulfan
Other mineral supplements Potassium chloride High-ceiling diuretics Cefuroxime Emtricitabine Dacarbazine
Magnesium sulfate Magnesium sulfate Furosemide Cefotaxime Nevirapine Anti-metabolites
Other alimentary tract and metabolism Other haematological agents Beta blocking agents Ceftazidime Abacavir, lamivudine
products Human hemin Propranolol Ceftriaxone Immunoglobulins Methotrexate
Imiglucerase Complement C1 esterase inhibitor Labetalol Cefi xime Human normal immunoglobulin Mercaptopurine
B. Blood and blood forming organs C – Cardiovascular system Selective calcium channel blockers with Ceftazidime, avibactam (extravascular use) Tioguanine
Anti-thrombotic agents Cardiac glycosides mainly vascular effects Aztreonam Human normal immunoglobulin Fludarabine
Warfarin Digoxin Nimodipine Cilastatin sodium, imipenem, relebactam (intravascular use) Cytarabine
Heparin Anti-arrhythmics, class I and III Selective calcium channel blockers with di- Tazobactam, ceftolozane Human anti-d immunoglobulin Gemcitabine
Antithrombin III Lidocaine rect cardiac effects Sulfonamides and trimethoprim Human tetanus immunoglobulin Plant alkaloids and other natural products
Clopidogrel Mexiletine Verapamil Trimethoprim Human rabies immunoglobulin Vinblastine
Eptifi batide Flecainide G - Genito urinary system and sex hormones Sulfamethoxazole and trimethoprim Bacterial vaccines Vincristine
Alteplase Amiodarone Uterotonics Macrolides, lincosamides and streptogramins Cholera vaccine, oral, inactivated Etoposide

188 Chemical Weekly January 16, 2024 Chemical Weekly January 16, 2024 189

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