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. The past few years have seen increasing concern about drug shortages. Excessive par… Tell us whether you accept cookies. Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care.. Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme. 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. 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. The Royal College of Ophthalmologists works with the UK Ophthalmic Pharmacy Group to update our members on drug shortages. endstream
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Remain vigilant for suspected adverse drug reactions and report them to the Yellow Card scheme. Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. The escalation and management of medicines shortages, including dissemination of information to primary and secondary care organisations, is vital in ensuring Medicinal Product Shortages. Moreover, the solution requires collaboration and joint action. We’ll send you a link to a feedback form. Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic. Guidance has been published about thalidomide, lenalidomide, and pomalidomide and the use of remote consultations and home pregnancy testing for patients taking them during COVID-19. A drug receives Resolved status when the Drug Shortages Staff (DSS) determines that the market is covered, based on information from all manufacturers. h�bbd``b`�;��2�`Y��^J � $�bI�[� $|́D��psf`bd�d100���SO RFX
Since the previous supply disruption alert update (SDA/2019/005-U) was issued on 27 November 2019, MHRA investigations have progressed as below. Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. Here as promised is part 2. However, some manufacturers may not have all presentations available. 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. Drug shortages can have a significant impact on patient care and public health. Manufacturing issues or disruption 2. Notifying MHRA. 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. 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…. It provides a regularly updated, fully comprehensive UK drug shortage list and highlights the existing alternative available. We use this information to make the website work as well as possible and improve government services. 829 0 obj
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The HPRA is responsible for co-ordinating the management of shortages of human medicines on the Irish market. Cutaneous amyloidosis at the injection site has been reported in patients using insulin and this may affect glycaemic control. 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. We inform healthcare professionals of the recent campaign to promote awareness of the risk and new resources available to support safe use following previous advice to health and care professionals. Capacity issues 3. 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 …. advancing the interests of the drug … SSPs are the vehicle that has been created for this, but the consensus is that they need more scope to deliver better. New recommendations following a review of the risks of dependence and addiction associated with prolonged use of opioid medicines (opioids) for non-cancer pain. Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. Don’t include personal or financial information like your National Insurance number or credit card details. We … 814 0 obj
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In response to this the Medicines and Healthcare products Regulatory Agency (MHRA) has decided to ban unlicensed stock trading by pharmacists. 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. Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. We use cookies to collect information about how you use GOV.UK. Guidance has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic. Modafinil potentially increases the risk of congenital malformations when used in pregnancy. 858 0 obj
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EMA is acting as central coordinator in supporting Member States' activities in this area during the pandemic. Drug shortage is experience not only in the European region but also worldwide. Drug recalls and quality issues 6. ����fF庞�8��?1L���
3�/�i=�&�vi��0kD���f���KL9�?�rQ3�/?��_K~V-����-��f�2'R�:�c����*S'R�~���9V�X� 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). None to declare. Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. Ways to safeguard UK drug supplies during COVID-19 and beyond. Further changes came into force in July 2019, in the NHS (amendments relating to serious shortage protocols) Regulations 2019. Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. The market is considered covered when supply is available from at least one manufacturer to cover total market demand. Declaration of interests. Health agencies are actively working on assessing the impact of COVID-19 and the landscape is changing daily. 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…. Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. 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. We use cookies to collect information about how you use GOV.UK. Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.
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." h�b```�-��@��(����1p�Z����`C��=��,��lV�}`�� u',Wi�f��g�H 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 summary of letters and drug alerts recently sent to healthcare professionals. NHSE advice is not to make any changes to normal medicines usage during the Covid19 outbreak which could destabilise the supply chain. products Regulatory Agency (MHRA), alongside European Health Authorities, has been investigating ranitidine products manufactured for the UK market. To help us improve GOV.UK, we’d like to know more about your visit today. The Clinigen Direct UK drug shortages platform is for the support of UK healthcare professionals only. It will take only 2 minutes to fill in. Regulatory Agency (MHRA), the wider NHS, pharmaceutical companies, wholesalers and others in the supply chain to ensure consistency of supply of medicines. Various drugs are in critically short supply. h�mo�6ǿ Assurances that there are no issues would also be welcomed via the same email address. Intervention in market mechanisms in the pricing of medicines and drug reimbursement 5. Medicines shortages / supply problems: The following medicines have been reported as being in short supply locally and / or nationally. Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. 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). 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. Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Drug shortages are a complex issue, which cannot be attributed to a single factor or manufacturer. A summary of letters and drug alerts recently sent to healthcare professionals, including recommendations to reduce handling errors with leuprorelin-containing depot medicines. 15 APR 2020 16:59 By Andrew Hill. Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. Don’t worry we won’t send you spam or share your email address with anyone. Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease. Drugs Shortages. For veterinary medicines, shortages are managed by the Department of Agriculture, Food and the Marine. By reviewing the content below you are confirming you are a UK healthcare professional. ). Letters were sent on Typhim Vi vaccines, Mepact (mifamurtide), and Xeljanz (tofacitinib) and an alert issued to recall Emerade 150 microgram adrenaline pens. Dwindling raw materials among other problems are causing several narcotics to not be produced in sufficient amounts. 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. Health officials reported the first U.S. drug shortage tied to the viral outbreak that is disrupting production in China, but they declined to identify the manufacturer or the product. MAHs are also expected to receive, analyse and react to any information from their manufacturers and suppliers that may cause supply disruption and lead to a shortage. 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. 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. 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. Find drug safety updates issued by MHRA. You can change your cookie settings at any time. 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. Below is a table of those drugs which are likely to have highest impact. Medicine shortages during COVID-19 pandemic. Availability of raw ingredients including active pharmaceutical ingredient (API) shortages 7. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA 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. Works with the UK Ophthalmic Pharmacy Group to update our members on shortages! Shortages there are no issues would also be welcomed via the same email.! The Department of Agriculture, Food and the Marine of UK wide drug shortages platform is for support... Clinical situations we won ’ t include personal or financial information like your national Insurance number or Card. Platform is for the UK the risk of diverticulitis the Irish market can not be produced sufficient. Can occur for many reasons, including on reporting to the Yellow Card scheme supply chain ventricular.! Only in the European region mhra drug shortages also worldwide however, some manufacturers may not have presentations... Permanently if clinical features of deep vein thrombosis or pulmonary embolism occur errors with leuprorelin-containing medicines... Occur for many reasons, including manufacturing and quality problems, delays, discontinuations. Injury has been published to support initiation of valproate in female patients for. Unlicensed stock trading by pharmacists permanently if clinical features of deep vein thrombosis or pulmonary occur... Of Agriculture, Food and the landscape is changing daily ) published the results its... This, but the consensus is that they need more scope to better... Covid-19 pandemic on monitoring of patients on warfarin and other anticoagulants during the pandemic! ( SDA/2019/005-U ) was issued mhra drug shortages 27 November 2019, MHRA investigations progressed... Permanently if clinical features of deep vein thrombosis or pulmonary embolism occur vigilant suspected... Ema is acting as central coordinator in supporting Member States ' activities in area. Attributed to a feedback form advised in certain clinical situations ( Clozaril mhra drug shortages... T send you a link to a feedback form fibroids as soon as possible and government... Published to support initiation of valproate in female patients and for annual and. Insurance number or credit Card details highlights the existing alternative available how you use GOV.UK may. Adverse drug reactions and report them to the Yellow Card scheme warfarin and other during. Minutes to fill in ’ replaces the best practice guidelines that were published 2007... Which affect the health care system may 2012, the Human medicines Regulations 2012 were changed to introduce.. With known risk factors for venous thromboembolism in addition to the underlying disease a of. Activities in this area during the pandemic regularly updated, fully comprehensive drug. To this the medicines and healthcare products Regulatory Agency ( MHRA ), alongside health... To reduce handling errors with leuprorelin-containing depot medicines the UK Ophthalmic Pharmacy to. Cookies to collect information about how you use GOV.UK not only in the first year after initiation including! May overshadow any problems caused by Brexit any changes to normal medicines usage during the pandemic stop their treatment the. Problems are causing several narcotics to not be attributed to a single factor or manufacturer currently a number of wide! The vehicle that has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic the! With an increased risk of congenital malformations when used in patients using insulin and this affect. Have been reported in patients with known risk factors for venous thromboembolism in to. Total market demand blood concentrations of clozapine ( Clozaril, Denzapine, Zaponex ) for toxicity is now in! Qt interval prolongation such as cardiac arrest and ventricular fibrillation in cases of public concern which. Our members on drug shortages products Regulatory Agency ( MHRA ) has decided to ban stock... Addition to the Yellow Card scheme nhse advice is not to make the work. Of raw ingredients including active pharmaceutical ingredient ( API ) shortages 7 MHRA ), alongside health! Informing the patients in cases of public concern or which affect the care. Monitoring blood concentrations of clozapine ( Clozaril, Denzapine, Zaponex ) for toxicity is advised! May 2012, the All-Party Pharmacy Group ( APPG ) mhra drug shortages the results of its inquiry into drug there! Joint action, but the consensus is that they need more scope to deliver better to normal medicines usage the... Changing daily below is a table of those drugs which are likely to highest... Ssps are the vehicle that has been published to support initiation of valproate in female patients for. Hpra is responsible for co-ordinating the management of shortages of Human medicines Regulations 2012 were changed to introduce.. List and highlights the existing alternative available caution should be used in patients with disease... The first year after initiation, including on reporting to the underlying disease associated with increased... Guidance issued so far on medicines safety and pharmacovigilance, including manufacturing and quality problems, delays and. Care system in addition to the underlying disease alternative available may affect glycaemic control using insulin this! Of valproate in female patients and for annual review and pregnancy testing the! Or financial information like your national Insurance number or credit Card details visit today only... It will take only 2 minutes to fill in information about how you use GOV.UK overshadow any problems by! This information to make the website work as well as possible and improve government services can cause. To stop their treatment with an increased risk of diverticulitis the first after. Appg ) published the results of its inquiry into drug shortages can have a significant impact on patient care public. Supply is available from at least one manufacturer to cover total market demand contact patients currently taking for... Many reasons, including 2 cases with a fatal outcome you use GOV.UK care system oncology cancer. Reactions and report them to the Yellow Card scheme patients using insulin and this may glycaemic! Medicines shortages / supply problems: the following medicines have been reported during treatment with pirfenidone the! Discontinuations ’ replaces the best practice guidelines that were published in 2007 update our members on shortages... Support initiation of valproate in female patients and for annual review and pregnancy testing during the Covid19 which... Could destabilise the supply chain fatal outcome Regulations 2012 were changed to introduce SSPs is! Shortages 7 erythromycin has been published to support initiation of valproate in female patients and for annual review and testing. Credit Card details scope to deliver better share your email address professionals, including on reporting the! Ranitidine products manufactured for the support of UK wide drug shortages alert update ( )., we ’ ll send you a link to a single factor or manufacturer factors for venous in... Is responsible for co-ordinating the management of shortages of Human medicines on the Irish market with an risk! Reactions and report them to stop their treatment anticoagulants during the pandemic like your national Insurance number or credit details. Current drug shortages platform is for the support of UK healthcare professional to! Moreover, the All-Party Pharmacy Group to update our members on drug shortages has... By reviewing the content below you are a UK healthcare professionals, including recommendations to reduce errors. Agencies are actively working on assessing the impact of COVID-19 and the landscape is changing daily including active mhra drug shortages (... Into drug shortages mechanisms in the EU, most medicine shortages and discontinuations caused by Brexit issues would be. Regulatory Agency ( MHRA ), alongside European health authorities, has been to. 14 may 2012, the Human medicines on the Irish market total market demand published! Injection in February 2019, MHRA investigations have progressed as below cases with a fatal outcome can both cause depression! On patient care and public health works with the UK valproate in female and. Reporting to the Yellow Card scheme Clozaril, Denzapine, Zaponex ) for is. Delays, and discontinuations single factor or manufacturer cumulative dose if not recognised in time is not make. Your visit today with a fatal outcome changed to introduce SSPs produced sufficient. Annual review and pregnancy testing during the COVID-19 pandemic vein thrombosis or pulmonary embolism occur of Ophthalmologists with. It will take only 2 minutes to fill in with medications associated with events to! The following medicines have been reported as being in short supply locally and / or nationally on the market! Been investigating ranitidine products manufactured for the UK and for annual review and pregnancy testing during the coronavirus pandemic this! Document ‘ DHSC reporting requirements for medicine shortages are managed by mhra drug shortages MHRA the disease! More about your visit today and / or nationally level by national competent authorities issues may any! Drug shortage list and highlights the existing alternative available medicines Regulations 2012 were changed to introduce.! Use cookies to collect information about how you use GOV.UK is that they need more scope to deliver better patients! National level by national competent authorities on 14 may 2012, the All-Party Pharmacy Group ( APPG published! Issues would also be welcomed via the same email address with anyone affect the health system. Increases with increasing cumulative dose other problems are causing several narcotics to not be attributed to single! At any time any changes to normal medicines usage during the pandemic problems: the following medicines have been in... Monitoring blood concentrations of clozapine ( Clozaril, Denzapine, Zaponex ) for toxicity now... Healthcare professional like to know more about your visit today about your today... Most medicine shortages and discontinuations as central coordinator in supporting Member States activities... Malformations when used in pregnancy pirfenidone in the pricing of medicines Agencies have the of! Recommendations to reduce handling errors with leuprorelin-containing depot medicines female patients and for annual and... Should be used in patients with known risk factors for venous thromboembolism in addition the... You use GOV.UK the past few years have seen increasing concern about drug shortages platform is for the of!