Assurances that there are no issues would also be welcomed via the same email address. 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. 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. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Flucytosine is a prodrug of 5-fluorouracil used to treat systemic yeast and fungal infections and can cause life-threatening and severe toxicity in patients with complete and partial dihydropyrimidine dehydrogenase (DPD) def…, Increase the frequency of blood pressure monitoring to at least weekly for the first 2 months, and then monitor monthly for the first year and periodically thereafter during treatment, following recent reports of onset of se…. 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 …. Make a clear distinction between liposomal, pegylated-liposomal, lipid-complex and conventional formulations when prescribing, dispensing, administering, and communicating about these medicines. 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! The Royal College of Ophthalmologists works with the UK Ophthalmic Pharmacy Group to update our members on drug shortages. 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. Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Don’t include personal or financial information like your National Insurance number or credit card details. 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. Distribution and logistical problems 9. Find drug safety updates issued by MHRA. Drug shortages are a complex issue, which cannot be attributed to a single factor or manufacturer. 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). 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 On 14 May 2012, the All-Party Pharmacy Group (APPG) published the results of its inquiry into drug shortages in the UK. ����fF庞�8��?1L��� 3�/�i=�&�vi��0kD���f���KL9�?�rQ3�/?��_K~V-����-��f�2'R�:�c����*S'R�~���9V�X� Here as promised is part 2. 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. Regulatory Agency (MHRA), the wider NHS, pharmaceutical companies, wholesalers and others in the supply chain to ensure consistency of supply of medicines. The HPRA is responsible for co-ordinating the management of shortages of human medicines on the Irish market. h�b```�-��@��(����1p�Z����`C��=��,��lV�}`�� u',Wi�f��g�H advancing the interests of the drug … Letters were sent on Typhim Vi vaccines, Mepact (mifamurtide), and Xeljanz (tofacitinib) and an alert issued to recall Emerade 150 microgram adrenaline pens. Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. 858 0 obj <>stream However, some manufacturers may not have all presentations available. Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care.. Further changes came into force in July 2019, in the NHS (amendments relating to serious shortage protocols) Regulations 2019. Drugs Shortages. EMA is acting as central coordinator in supporting Member States' activities in this area during the pandemic. %PDF-1.7 %���� Ways to safeguard UK drug supplies during COVID-19 and beyond. None to declare. Notifying MHRA. Below is a table of those drugs which are likely to have highest impact. By reviewing the content below you are confirming you are a UK healthcare professional. 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). Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. 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. Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Medicinal Product Shortages. Earlier this year I posted the first part of 'Around the world in 80 ways' focussing on API supply chains. In response to this the Medicines and Healthcare products Regulatory Agency (MHRA) has decided to ban unlicensed stock trading by pharmacists. Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme. 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. We … Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect. Dwindling raw materials among other problems are causing several narcotics to not be produced in sufficient amounts. The Clinigen Direct UK drug shortages platform is for the support of UK healthcare professionals only. Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic. 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. The table �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� Excessive par… Don’t worry we won’t send you spam or share your email address with anyone. 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…. 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. 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. The Heads of Medicines Agencies have the task of informing the patients in cases of public concern or which affect the health care system. endstream endobj startxref Drug shortage is experience not only in the European region but also worldwide. 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