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All content is available under the Open Government Licence v3.0, except where otherwise stated, Medicines and Healthcare products Regulatory Agency, Alerts and recalls for drugs and medical devices, Drug Safety Update: monthly PDF newsletter, Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk, Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban, Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis, Letters and drug alerts sent to healthcare professionals in November 2020, Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy, Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing, Ferric carboxymaltose (Ferinject▼): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures, Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs, Isotretinoin (Roaccutane▼): contribute to expert review, Letters and drug alerts sent to healthcare professionals in October 2020, 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity, Flucytosine (Ancotil): new contraindication in patients with DPD deficiency, Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment, Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects, Warfarin and other anticoagulants: monitoring of patients during the COVID-19 pandemic, Every report counts: report suspected adverse drug reactions and take part in #MedSafetyWeek (2–8 November 2020), Letters and drug alerts sent to healthcare professionals in September 2020, Opioids: risk of dependence and addiction, Transdermal fentanyl patches for non-cancer pain: do not use in opioid-naive patients, Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing, Insulins (all types): risk of cutaneous amyloidosis at injection site, Letters and drug alerts sent to healthcare professionals in August 2020, Clozapine and other antipsychotics: monitoring blood concentrations for toxicity, Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment, Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors, Isotretinoin (Roaccutane▼): reminder of important risks and precautions, Emollients and risk of severe and fatal burns: new resources available, Letters and drug alerts sent to healthcare professionals in July 2020, Medical Device Alerts issued in July 2020, Stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) available over-the-counter: new measures to support safe use, Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection, Liposomal and lipid-complex formulations: name change to reduce medication errors, Letters and drug alerts sent to healthcare professionals in June 2020, Medical Device Alerts issued in June 2020, Cyproterone acetate: new advice to minimise risk of meningioma, Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents, Letters and drug alerts sent to healthcare professionals in May 2020, Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices, Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19), Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19), Letters and drug alerts sent to healthcare professionals in April 2020, Coronavirus (COVID-19): latest guidance for medicines safety, Letters and drug alerts sent to healthcare professionals in March 2020, Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injury, Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections, Baricitinib (Olumiant▼): risk of venous thromboembolism, SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness, Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression, Letters and drug alerts sent to healthcare professionals in February 2020, Medical Device Alerts issued in February 2020, Coronavirus (COVID-19): guidance and support, Transparency and freedom of information releases, Therapeutic area: Haematology and 1 others, Therapeutic area: Infectious disease and 1 others, Therapeutic area: Anaesthesia and intensive care and 6 others, Therapeutic area: Respiratory disease and allergy, Therapeutic area: Pain management and palliation, Therapeutic area: Endocrinology, diabetology and metabolism, Therapeutic area: Cardiovascular disease and lipidology and 4 others, Therapeutic area: Endocrinology, diabetology and metabolism and 1 others, Therapeutic area: Dermatology and 1 others, Therapeutic area: GI, hepatology and pancreatic disorders and 1 others, Therapeutic area: Anaesthesia and intensive care and 3 others, Therapeutic area: Anaesthesia and intensive care and 2 others, Therapeutic area: Cardiovascular disease and lipidology and 1 others, Therapeutic area: Anaesthesia and intensive care and 8 others, Therapeutic area: Anaesthesia and intensive care and 17 others, Therapeutic area: Anaesthesia and intensive care and 7 others, Therapeutic area: Obstetrics, gynaecology and fertility, Therapeutic area: Haematology and 2 others, Therapeutic area: Anaesthesia and intensive care and 1 others, Therapeutic area: Pain management and palliation and 1 others, Therapeutic area: Anaesthesia and intensive care and 4 others. We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. You can change your cookie settings at any time. Please use the netFormulary FEEDBACK tab to ALERT the Medicines Optimisation Team to any potential CRITICAL DRUG ... On the 18th May 2020, the MHRA issued a class 2 recall to patient level for all unexpired batches of Emerade 500mcg auto-injectors. Drug shortages are recognised as being an important global issue[1][1] that cause significant problems by delaying, and in some cases even preventing access to essential medicines. The table Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis. Remain vigilant for suspected adverse drug reactions and report them to the Yellow Card scheme. However, medicine shortages are already widespread in the UK and the EU due to long-standing structural problems in the medicines supply chain. In February 2019, the Human Medicines Regulations 2012 were changed to introduce SSPs. Find drug safety updates issued by MHRA. Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. �H�i�8g��փ3Ү��ܒ�|�s���u8%-8�425�60dt0x0J0���(g ��" �110ld6aL`Hd���h�J��뼎��h��`z��=��Y�C�f��������H;0�����n�C���5�8�fg`Pe ���j/�~e�jƵ �K� Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. In summary, views on how to tackle drug shortages vary a lot, but there is a broad consensus that pharmacists must have flexibility to mitigate shortages, with relevant controls in place. The HPRA is responsible for co-ordinating the management of shortages of human medicines on the Irish market. 0 U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA We use this information to make the website work as well as possible and improve government services. Alerts were issued about CME T34 and T34L (T60) ambulatory syringe pumps, Cardinal Health tympanic thermometers, t:slim X2 insulin pump, and Mavidon skin preparation electrode gels. Here as promised is part 2. %PDF-1.7 %���� Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. Regulatory Agency (MHRA), the wider NHS, pharmaceutical companies, wholesalers and others in the supply chain to ensure consistency of supply of medicines. Declaration of interests. Capacity issues 3. h�b```�-��@��(����1p�Z����`C��=��,��lV�}`�� u',Wi�f��g�H Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic. Dwindling raw materials among other problems are causing several narcotics to not be produced in sufficient amounts. Following a review of the risks associated with use of opioid medicines for non-cancer pain, the Commission on Human Medicines (CHM) has recommended that fentanyl transdermal patches are contraindicated in opioid-naive patie…. The market is considered covered when supply is available from at least one manufacturer to cover total market demand. Various drugs are in critically short supply. In response to this the Medicines and Healthcare products Regulatory Agency (MHRA) has decided to ban unlicensed stock trading by pharmacists. Listed in the drug tariff as Omeprazole 10mg/5ml oral suspension sugar free and Omeprazole 20mg/5ml oral suspension sugar free Licensed in Children over 1 month of age 2mg/ml x 75ml = £92.17 4mg/ml x 75ml = £178.35 3rd choice Lansoprazole Fastabs 15mg … Drug shortage is experience not only in the European region but also worldwide. Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care.. The Clinigen Direct UK drug shortages platform is for the support of UK healthcare professionals only. Notifying MHRA. Moreover, the solution requires collaboration and joint action. Commercial withdrawal 4. SSPs are the vehicle that has been created for this, but the consensus is that they need more scope to deliver better. Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. Accordingly, the ISPE Drug Shortages Task Team was formed to use the results of its 2013 Drug Shortages Survey [1] as a starting point to develop a framework that could be used by industry to develop strategies and practices for each of the six dimensions of the Plan. We … The supply chain for Active Pharmaceutical Ingredients (APIs) has been increasing in complexity for a number of years with the potential for a number of players to be involved, with multiple possible routes around the world available (significantly more than 80! 15 APR 2020 16:59 By Andrew Hill. The Royal College of Ophthalmologists works with the UK Ophthalmic Pharmacy Group to update our members on drug shortages. 829 0 obj <>/Filter/FlateDecode/ID[<459941233DF2394EA8E97B0524C1F5AC><6F720B8E6D2F33468127BF9333C01106>]/Index[814 45]/Info 813 0 R/Length 80/Prev 365114/Root 815 0 R/Size 859/Type/XRef/W[1 2 1]>>stream We’ll send you a link to a feedback form. Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. Earlier this year I posted the first part of 'Around the world in 80 ways' focussing on API supply chains. Medicines and Healthcare products Regulatory Agency (MHRA) have worked with companies to help resolve shortages by: • Expediting regulatory procedures for products deemed critical • Working with companies to manage supply of existing stocks • Identifying and liaising with other manufacturers to increase production of the A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible associat…. Availability of raw ingredients including active pharmaceutical ingredient (API) shortages 7. Ranitidine injection Drug shortages are a complex issue, which cannot be attributed to a single factor or manufacturer. Updated safety recommendations have been issued as part of the European review evaluating cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir. Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for heart valve regurgitation (incompetence). Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. products Regulatory Agency (MHRA), alongside European Health Authorities, has been investigating ranitidine products manufactured for the UK market. advancing the interests of the drug … SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. 814 0 obj <> endobj 858 0 obj <>stream Guidance has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic. The Heads of Medicines Agencies have the task of informing the patients in cases of public concern or which affect the health care system. This is not intended as a guide to patients, who should always speak to their consultant, pharmacist or other medical professional about finding alternative medication. None to declare. Update: EMA and its partners in the European Medicines Regulatory Network are putting measures in place to help prevent and mitigate possible disruptions to the supply of medicines in the European Union (EU) during the COVID-19 pandemic. ). Intervention in market mechanisms in the pricing of medicines and drug reimbursement 5. It provides a regularly updated, fully comprehensive UK drug shortage list and highlights the existing alternative available. Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme. A drug receives Resolved status when the Drug Shortages Staff (DSS) determines that the market is covered, based on information from all manufacturers. Drug shortages can have a significant impact on patient care and public health. Distribution and logistical problems 9. To keep pace with the health agency guidance related to the outbreak, it will be important to periodically check in with the applicable regulatory authorities for emerging guidance and any new announcements. In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia.