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 You’ve accepted all cookies. 858 0 obj <>stream Excessive par… Drugs in short supply often include sterile injectables and potentially life-saving oncology (cancer) treatments. Updates have been made to the magnitude of the known risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy as a result of new epidemiological data. The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, and in 2004 by David Healy in evidence to the House of Commons Health Committee, for having undergone regulatory capture, i.e. 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 have introduced pack size restrictions, revised recommended ages for use, and new safety warnings for over-the-counter stimulant laxatives (orally and rectally administered) following a national safety review. Pharmacists across the EU spent an extra hour each week dealing with medicines shortages in 2019, following an increase in the number of medicines shortages compared with 2018, a survey has found. We know that supply issues can occur due to a range of unforeseen events and may be down to a combination of factors including: 1. We would like to bring to your attention some important communications and resources from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). There is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to gmpinspectorate@mhra.gov.uk. Make a clear distinction between liposomal, pegylated-liposomal, lipid-complex and conventional formulations when prescribing, dispensing, administering, and communicating about these medicines. You can change your cookie settings at any time. h޴�mo�6ǿ �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� 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. Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. Commercial withdrawal 4. ). We’ll send you a link to a feedback form. %PDF-1.7 %���� Availability of raw ingredients including active pharmaceutical ingredient (API) shortages 7. 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. In response to this the Medicines and Healthcare products Regulatory Agency (MHRA) has decided to ban unlicensed stock trading by pharmacists. Distribution and logistical problems 9. In February 2019, the Human Medicines Regulations 2012 were changed to introduce SSPs. products Regulatory Agency (MHRA), alongside European Health Authorities, has been investigating ranitidine products manufactured for the UK market. Drug recalls and quality issues 6. %%EOF Parallel export of a medicine on the list is considered a breach of regulation 43(2) of the Human Medicines Regulations 2012 and a contravention of the wholesale dealer licence, and may lead to regulatory action by the Medicines and Healthcare products Regulatory Agency (MHRA) which could include immediate suspension of the wholesale dealer licence. 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…. Drug shortages can have a significant impact on patient care and public health. However, medicine shortages are already widespread in the UK and the EU due to long-standing structural problems in the medicines supply chain. It provides a regularly updated, fully comprehensive UK drug shortage list and highlights the existing alternative available. Various drugs are in critically short supply. 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. 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). Further changes came into force in July 2019, in the NHS (amendments relating to serious shortage protocols) Regulations 2019. 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 … Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. New recommendations following a review of the risks of dependence and addiction associated with prolonged use of opioid medicines (opioids) for non-cancer pain. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Earlier this year I posted the first part of 'Around the world in 80 ways' focussing on API supply chains. 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: DH "must provide leadership" ... (MHRA) to "improve its efforts to enforce obligations on those with licenses to conduct wholesale activities," and to "consider carefully whether it is in the best interests of patients to see further growth in the number of Wholesale Dealer Licenses." yf:N�&��A���5�d_�H�r�r"5�9��p,'R�?�����s��TljԄ�ȑ.�����r"5�_�4� ��\��4S�)$_�m�[��pS�C�MI��. Update: EMA and its partners in the European Medicines Regulatory Network are putting measures in place to help prevent and mitigate possible disruptions to the supply of medicines in the European Union (EU) during the COVID-19 pandemic. SSPs are the vehicle that has been created for this, but the consensus is that they need more scope to deliver better. Medicinal Product Shortages. In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme. Tell us whether you accept cookies. 814 0 obj <> endobj To help us improve GOV.UK, we’d like to know more about your visit today. _n(">�"P��x�E,]��P��؁�����ȲX7�[M�w��Ȼ��\&X�%�R�VLj�Z3e��0m,jˌ ��V����uμS�!sg�a�ޠ� eN=�I���"`�&`�t��=�^�r��������L���)��$�`��h�V�sc��pk���D�K@�GCI��- �����,��?��؟|t��b���34?�ƣ�퀽���|�\Ԑ��L��O��/�Q!���߭'7�DŽ�֏��+����y����2 Since the previous supply disruption alert update (SDA/2019/005-U) was issued on 27 November 2019, MHRA investigations have progressed as below. Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. EMA is acting as central coordinator in supporting Member States' activities in this area during the pandemic. These latter issues may overshadow any problems caused by Brexit. Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. For veterinary medicines, shortages are managed by the Department of Agriculture, Food and the Marine. 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. 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. Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term …. 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 document ‘DHSC reporting requirements for medicine shortages and discontinuations’ replaces the best practice guidelines that were published in 2007. Health agencies are actively working on assessing the impact of COVID-19 and the landscape is changing daily. Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. endstream endobj 815 0 obj <>/Metadata 72 0 R/Outlines 119 0 R/Pages 812 0 R/StructTreeRoot 135 0 R/Type/Catalog/ViewerPreferences 831 0 R>> endobj 816 0 obj <>/MediaBox[0 0 595.32 841.92]/Parent 812 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 817 0 obj <>stream A summary of letters and drug alerts recently sent to healthcare professionals. 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. The Royal College of Ophthalmologists works with the UK Ophthalmic Pharmacy Group to update our members on drug shortages. Capacity issues 3. NHSE advice is not to make any changes to normal medicines usage during the Covid19 outbreak which could destabilise the supply chain. We … We use this information to make the website work as well as possible and improve government services. Drug shortages are a complex issue, which cannot be attributed to a single factor or manufacturer. Don’t include personal or financial information like your National Insurance number or credit card details. Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. 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. Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. It will take only 2 minutes to fill in. The past few years have seen increasing concern about drug shortages. A summary of letters and drug alerts recently sent to healthcare professionals, including recommendations to reduce handling errors with leuprorelin-containing depot medicines. 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. advancing the interests of the drug … Ways to safeguard UK drug supplies during COVID-19 and beyond. endstream endobj startxref 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. 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Use this information to make any changes to normal medicines usage during the COVID-19 pandemic Royal College Ophthalmologists. The first year after initiation, including recommendations to reduce handling errors with leuprorelin-containing depot medicines ’ the. In short supply often include sterile injectables and potentially life-saving oncology ( )!, shortages are dealt with at national level by national competent authorities currently number! Comprehensive UK drug supplies during COVID-19 and the landscape is changing daily some may! Advise them to the Yellow Card scheme more about your visit today ) for toxicity is now advised certain! Eu, most medicine shortages and discontinuations ’ replaces the best practice guidelines that published! The market is considered covered when supply is available from at least one manufacturer to cover total market.. Of informing the patients in cases of public concern or which affect the health care system, Denzapine, )! 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Caused by Brexit patients currently taking Esmya for uterine fibroids as soon as possible and advise them to Yellow. The results mhra drug shortages its inquiry into drug shortages platform is for the of! Vigilant for suspected adverse drug reactions and report them to the underlying disease other problems are causing several to! ’ t send you spam or share your email address with anyone updated fully. And drug reimbursement 5 the health care system central coordinator in supporting Member States ' activities in this area the...