Contents · • Supplies of Ativan solution for injection will be extremely limited until early...

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Supply Issues Update for Primary and Secondary Care: October 2020 This report has been produced by the Department of Health and Social Care (DHSC) Medicine Supply Team. We aim to update this report monthly to provide an update on current primary and secondary care medicine supply issues that we are working on. This information is confidential to the NHS; please do not upload to websites in the public domain. Please do share with relevant colleagues and networks. Where it has been stated ‘a clinical memo from UKMI will be published on the SPS website’, this will be found

here.

Contents New Issues ............................................................. 4

Injectables ......................................................... 4

Flucytosine (Ancotil) 2.5g/250ml solution for

infusion .......................................................... 4

Gonadorelin 100 micrograms powder for

solution for injection ..................................... 4

Lorazepam (Ativan) 4mg/ml solution for

injection ......................................................... 4

Remdesivir 100mg powder for concentrate

for solution for infusion and concentrate

solution for infusion ...................................... 4

Orals ................................................................... 5

Alprazolam (Xanax) 250mcg tablets .............. 5

Colestipol (Colestid) plain 5g granules .......... 5

Fluoxetine 30mg capsules ............................. 5

Lithium carbonate (Priadel) 200mg and

400mg tablets ................................................ 5

Ritonavir 100mg tablets ................................ 5

Sulfasalazine gastro-resistant (Salazopyrin

EN-tabs) 500mg tablets ................................. 5

Zonisamide 25mg, 50mg and 100mg capsules

....................................................................... 5

Others ................................................................ 6

Bisacodyl (Dulcolax) 5mg suppositories ........ 6

Desmopressin (DDAVP) 0.01% w/v intranasal

solution .......................................................... 6

Desmopressin (Desmospray)

10micrograms/actuation nasal spray ............ 6

Desmopressin (Octim) 150mcg/actuation

nasal spray .....................................................6

Ongoing Issues .......................................................6

Injectables ..........................................................6

Adrenaline Auto-Injectors (AAIs) ...................6

Bleomycin (Bleo-Kyowa) 15,000IU injection .7

Crisantaspase (Erwinase) injection ................7

Diamorphine 5mg and 10mg injection ..........7

Diazepam (Diazemuls) 10mg/2ml emulsion

for injection ....................................................7

Epirubicin 100mg solution for injection.........7

Mitomycin 2mg injection ...............................8

Norethisterone enantate (Noristerat) 200mg

solution for intramuscular injection ..............8

Ranitidine 50mg/2ml injection ......................8

Sodium Bicarbonate 1.8% and 2.74% for

Intravenous Infusion (Polyfusors) ..................8

Sodium Chloride 1.8% and 2.7% Polyfusors ..8

Somatropin 0.2mg MiniQuick (Genotropin)

devices ...........................................................8

Tetracosactide 1mg depot injection ..............8

Urokinase (Syner-KINASE) injection ...............9

Verteporfin (Visudyne) 15mg powder for

solution for infusion .......................................9

Orals ...................................................................9

Bupropion (Zyban) 150mg prolonged release

tablets ............................................................9

Chloral betaine 707mg tablets .......................9

Co-amilofruse 5/40 tablets ............................9

https://www.sps.nhs.uk/category/shortages-discontinuations-and-expiries/


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Co–careldopa 25mg/100mg tablets .............. 9

Colestipol (Colestid) orange 5g granules ....... 9

Colestyramine (Questran) Powder for Oral

Suspension ..................................................... 9

Contraceptive products (oral) ..................... 10

Enalapril 20mg tablets ................................. 11

Ferrous Fumarate 322mg/Folic Acid 0.35mg

(Pregaday) tablets ........................................ 11

Fluoxetine 10mg tablets .............................. 11

Galantamine 8mg/12mg tablets .................. 11

Histamine (H2) antagonists ......................... 11

Hormone Replacement Therapy products

(HRT) ............................................................ 12

Ketotifen (Zaditen) 1mg/5ml oral solution .. 13

Levodopa/carbidopa/entacapone tablets

(Sastravi) ...................................................... 13

Mepacrine 100mg tablets............................ 13

Mianserin 10mg/30mg tablets .................... 14

Moclobemide 150mg and 300mg tablets.... 14

Nabumetone 500mg tablets ........................ 14

Penicillamine 250mg tablets ....................... 14

Pethidine 50mg tablets................................ 14

Phenelzine sulphate (Nardil) 15mg tablets . 14

Phenindione 10mg and 25mg tablets .......... 14

Phenytoin (Epanutin) 50mg Chewable

Infatabs ........................................................ 14

Phenytoin 100mg capsules .......................... 15

Prazosin (Hypovase) 1mg tablets ................ 15

Pristinamycin 500mg tablets ....................... 15

Ranitidine oral preparations ........................ 15

Senna (Senokot) 7.5mg/5ml syrup .............. 15

Sterculia 62% granules (Normacol) and

sterculia 62% with frangula bark 8% granules

(Normacol Plus) ........................................... 15

Tuberculosis medications ............................ 15

Valsartan capsules ....................................... 15

Others .............................................................. 16

Fludroxycortide 0.0125% cream and

ointment ..................................................... 16

Fluticasone propionate (Flixotide) 0.5mg/2ml

and 2mg/2ml nebules ................................. 16

Metronidazole (Acea) 0.75% gel ................. 16

Prednisolone 5mg suppositories ................ 16

Sodium cromoglycate (Intal) 5mg inhaler .. 17

Eye drops/treatments ..................................... 17

Betamethasone (Vistamethasone) 0.1% eye

drops ........................................................... 17

Chloramphenicol (Eykappo) 5mg/ml

Preservative Free Eye Drops 10ml .............. 17

Sofradex ear/eye drops .............................. 17

Vaccines .......................................................... 17

Hepatitis B Vaccines .................................... 17

Pneumovax 23 pre-filled syringes ............... 17

Discontinuations ................................................. 17

Atenolol 50mg/20mg nifedipine (Tenif)

capsules (AstraZeneca) ............................... 17

Carbamazepine (Carbagen) all products

(Mylan) ........................................................ 18

Ciprofloxacin (Ciproxin) 500mg tablets

(Bayer) ......................................................... 18

Co-fluampicil 250mg/250mg capsules

(Crescent) .................................................... 18

Diamorphine (Ayendi) nasal sprays

(Wockhardt) ................................................ 18

Dihydrocodeine 30mg tablets (Wockhardt) 18

Exenatide (Bydureon) Dual Chamber Pen

(AstraZeneca) .............................................. 18

Hepatitis B (Engerix B) vials (GSK) ............... 18

Nifedipine (Adalat LA) 20mg & 60mg (Bayer)

.................................................................... 18

Testosterone (Restandol) 40mg capsules

(MSD) .......................................................... 19

Resolved (date resolved) .................................... 19

Esomeprazole 40mg injection (30/09/20) .. 19

Fentanyl (Instanyl) 50mcg nasal spray

(2/10/20) ..................................................... 19


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Fluoxetine 40mg capsules (1/10/20) ........... 19

Lansoprazole 15mg orodispersible tablets

(5/10/20) ..................................................... 19

Lodoxamide (Alomide) 0.1% eye drops

(15/09/20) ................................................... 19

Manevac granules 250g (30/09/20) ............ 19

Methylprednisolone (Medrone) 16mg tablets

(28/09/20) ................................................... 19

Oxaliplatin 50mg/10ml, 100mg/20ml,

200mg/40ml solution for infusion vials

(1/10/20) ..................................................... 19

Phosphate Polyfusors 50mmol/500ml

(18/09/20) ................................................... 19

Sildenafil (Revatio) 0.8mg/ml solution for

injection (30/09/20) .................................... 19

Sodium Bicarbonate 1.26% and 8.4% for

Intravenous Infusion (Polyfusors) (2/10/20)

.................................................................... 19

Sulfasalazine 250mg/5ml oral suspension

(18/09/20) ................................................... 19

Appendix ............................................................. 20

Table 2: HRT availability and anticipated

resolution dates .......................................... 20


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Information provided: w/c 12 October 2020

New Issues

Injectables Flucytosine (Ancotil) 2.5g/250ml solution for infusion

• Mylan, sole supplier is out of stock due to a GMP issue at the manufacturing site. The resupply date is to be confirmed.

• Unlicensed imports are not recommended as the GMP issue has affected the global supply chain.

• Specialist importers can source unlicensed supplies of flucytosine 500mg tablets. Lead times may vary.

• Patients should be reviewed on a case by case basis to decide on alternative treatments.

• Liaise with Regional Pharmacy Procurement Specialist who may be able to facilitate stock sharing between Trusts to ensure continuity of care until patients can be reviewed and switched to alternative treatments.

Gonadorelin 100 micrograms powder for solution for injection

• Intrapharm are out of stock with resupply date to be confirmed.

• Limited supplies of unlicensed imports are available. Lead times may vary.

Lorazepam (Ativan) 4mg/ml solution for injection

• Supplies of Ativan solution for injection will be extremely limited until early December 2020 and reserved for primary care only.

• A US product, lorazepam injection 2mg/ml, supplied in Carpuject single dose cartridges and considered unlicensed in the UK, is available from Pfizer during this out of stock period.

• Carpuject lorazepam 2mg/ml single dose cartridges can be considered bioequivalent to the UK brand lorazepam (Ativan) 4mg/ml solution for injection, however there is a difference in concentration of lorazepam between the two presentations so care must be taken when calculating doses.

• Carpuject lorazepam 2mg/ml single dose cartridges must be used in combination with the Carpuject holder provided. Injection in cartridge is diluted with an equal volume of compatible solution for IV administration (IM injection is administered undiluted).

• An MSN was issued 6 October 2020 (attached).

Remdesivir 100mg powder for concentrate for solution for infusion and concentrate solution for

infusion

• An interim clinical commissioning policy has been in place since 3 July 2020, defining routine access to remdesivir in the treatment of COVID-19 across the UK, following confirmation of a Conditional Marketing Authorisation (CMA) by the European Medicines Agency (EMA).

• Due to increased demand against available supply, clinicians are now asked to apply the full eligibility criteria as set out within the associated CAS alert CEM/CMO/2020/028(U), last published on 3 September 2020.

• Clinicians are also asked to adhere to a standard treatment course of 5 days.

• An SDA was issued 29 September 2020.

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103091https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103100


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Orals Alprazolam (Xanax) 250mcg tablets

• Pfizer, sole supplier will be out of stock from early November until the end of December 2020.

• Xanax 500mcg tablets will remain available.

• Xanax 500mcg tablets are scored and can be broken in half, however the score line only facilitates breaking for ease of swallowing and may not to divide into equal doses.

Colestipol (Colestid) plain 5g granules

• Limited supplies of Colestid plain sachets are available until w/c 2 November 2020.

• See information below on Colestid Orange sachets.

• UKMi have prepared a clinical memo containing further information on alternative bile-acid sequestrants.

Fluoxetine 30mg capsules

• Advanz, sole supplier is out of stock until mid-December 2020.

• Fluoxetine 10mg and 20mg capsules remain available.

• An MSN will be issued shortly.

Lithium carbonate (Priadel) 200mg and 400mg tablets

• Essential Pharma have withdrawn the discontinuation notice for Priadel with immediate effect therefore supplies will continue to remain available.

• DHSC are in discussion with the company about long-term future supplies of Priadel.

• Therefore, patients should continue to remain on Priadel and earlier advice to switch patients to alternate brands has been rescinded.

• New patients should be started on lithium in line with usual clinical practice underpinned by the relevant NICE guidance.

• An updated SDA was shared on 8 October 2020.

Ritonavir 100mg tablets

• Accord and Mylan are currently out of stock until late December 2020.

• Supplies remain available from Abbvie who can support additional demand during this time.

• A maximum of two months’ supply should be dispensed for all patients until January 2021 (Homecare and Outpatient pharmacies).

• Homecare providers will amend patient delivery schedules to ensure maximum quantities are not exceeded.

• An MSN was issued 2 October 2020 (attached)

Sulfasalazine gastro-resistant (Salazopyrin EN-tabs) 500mg tablets

• Pfizer are out of stock until early December 2020.

• Sulfasalazine gastro-resistant 500mg tablets remain available from Genesis Pharma and can support the full market demand.

• An MSN will be issued shortly.

Zonisamide 25mg, 50mg and 100mg capsules

• Teva are out of stock of zonisamide 25mg and 50mg capsules until February 2021.

https://www.sps.nhs.uk/articles/shortage-of-bile-acid-sequestrants/https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103103


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• Teva are out of stock of zonisamide 100mg capsules until December 2020.

• Glenmark are out of stock of zonisamide 50mg and 100mg until w/c 19 October and w/c 16 November 2020, respectively.

• All strengths of zonisamide capsules remain available from Eisai Ltd.

• An MSN was issued 25 September 2020 (attached); however, the information has now changed. An update will be issued shortly.

Others

Bisacodyl (Dulcolax) 5mg suppositories

• Sanofi, sole supplier is out of stock until early December 2020.

• Dulcolax 10mg suppositories and other laxatives remain available.

• An MSN was issued 15 October 2020 (attached)

Desmopressin (DDAVP) 0.01% w/v intranasal solution

• DDAVP (desmopressin) 0.01% w/v (100micrograms/ml) intranasal solution will be out of stock from the end of October until mid-2021.

• Supplies of desmopressin 100micrograms/ml nasal spray (10 micrograms per actuation) remain available from Aspire Pharma Ltd and can fully support demand during this time for patients on doses ≥10 microgram.

• Unlicensed imports of desmopressin 100micrograms/ml intranasal solution can be sourced.


Desmopressin (Desmospray) 10micrograms/actuation nasal spray

• Ferring Pharmaceuticals have recalled Desmospray with resupplies expected in mid-2021.

• Desmopressin 10micrograms/actuation nasal spray remains available from Aspire Pharma Ltd.

Desmopressin (Octim) 150mcg/actuation nasal spray

• Desmopressin (Octim) 150 micrograms/actuation nasal spray is out of stock until mid-2021.

• Ferring Pharmaceuticals have recalled Octim nasal sprays as a precautionary measure due to a lower volume of solution being observed and out of specification results of desmopressin acetate and benzalkonium chloride.

• Desmopressin (Octim) 15 micrograms per ml injection remains available and can be prescribed as an alternative.


Ongoing Issues Injectables Adrenaline Auto-Injectors (AAIs)

• There are currently sufficient supplies of EpiPen and Jext to meet normal UK demand.

• Specific batches of EpiPen 300mcg have received MHRA approval for extended use by four months beyond the labelled expiry date.

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-ferring-pharmaceuticals-limited-desmopressin-nasal-spray-all-strengths-pl-03194-0024-pl-03194-0090-pl-03194-0056-el-20-a-29https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-ferring-pharmaceuticals-limited-desmopressin-nasal-spray-all-strengths-pl-03194-0024-pl-03194-0090-pl-03194-0056-el-20-a-29http://www.epipen.co.uk/


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• Clinicians should check with patients requesting these devices to establish if they currently hold one of the batches that can be used beyond the listed expiry. If one of the listed batches is held, further supplies should be delayed until the extended expiry date, counselling the patient on the extended expiry.

Emerade (Bausch & Lomb UK Ltd)

• On 4 March, 7 April and 18 May 2020, the MHRA issued a patient level recall for Emerade 150mcg, 300mcg and 500mcg devices, respectively.

• Patients and/or carers should return Emerade 150, 300 and 500mcg auto-injectors to their local pharmacy once they have obtained a prescription for, and been supplied with, an alternative brand.

Bleomycin (Bleo-Kyowa) 15,000IU injection

• Bleomycin 15,000IU injection is out of stock until mid-2021.

• Specialist importers can source unlicensed products. Lead times may vary.

• An updated MSN was issued 15 May 2020 (shared previously).

Crisantaspase (Erwinase) injection

• Porton Biopharma, the manufacturer of Erwinase, have had ongoing manufacturing issues affecting this product for the past 1-2 years with intermittent supply issues expected throughout 2020.

• Jazz Pharmaceuticals distributes Erwinase and supplies of UK licensed stock are currently available.

Diamorphine 5mg and 10mg injection

• There are two suppliers of diamorphine hydrochloride 5mg and 10mg in the UK, Wockhardt and Accord.

• Accord are experiencing a long term out of stock of both strengths with no confirmed resupply date.

• Organisations in primary and secondary care should have now made the permanent switch to morphine or other opioid alternatives as advised in the SDA below.

• Wockhardt are currently in stock of both strengths and can cover the reduced demand.

• The indication from both suppliers of diamorphine 5mg and 10mg strengths is that the supply will remain unpredictable for the foreseeable future.

• Diamorphine hydrochloride 30mg, 100mg, 500mg are available but manufacturers are unable to support an increase in demand on these strengths.

• Sufficient supplies of morphine sulphate 10mg/ml injection are available from Ethypharm and Hameln to ensure continuity of supply. The Hameln presentation is preservative free.

• An updated SDA was issued 25 March 2020.

Diazepam (Diazemuls) 10mg/2ml emulsion for injection

• Accord are out of stock until February 2021.

• NOTE: There are insufficient supplies of Ativan injection to support, please do not use in place of Diazemuls.

• An MSN was issued 27 March 2020 (shared previously).

• UKMi have prepared a clinical memo to support management of this issue.

Epirubicin 100mg solution for injection • All suppliers are out of stock until at least November 2020.

• Epirubicin 10mg and 50mg strengths are currently available from Teva UK.

• An MSN was issued 14 January 2020 (shared previously).

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-emerade-150-micrograms-solution-for-injection-in-pre-filled-syringe-pl-33616-0013-el-20-a-14https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-emerade-300-micrograms-solution-for-injection-in-pre-filled-syringe-pl-33616-0014-el-20-a-20https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103036https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103005https://www.sps.nhs.uk/articles/shortage-of-diazemuls-diazepam-5mgml-emulsion-for-injection/


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Mitomycin 2mg injection

• Accord, the sole supplier of mitomycin 2mg vials has experienced a delay in getting this product to market related to a packaging deviation. There is currently no licenced stock of this vial size available and no confirmed date for replenishment.

• Other vial sizes of mitomycin for injection and/or infusion remain available including 10mg and 40mg from Accord and 20mg from Vygoris.


• An MSN was issued 1 July 2020 (shared previously).

Norethisterone enantate (Noristerat) 200mg solution for intramuscular injection

• Bayer are out of stock until w/c 16 November 2020.

• Depo-Provera injection remains available.

Ranitidine 50mg/2ml injection

• Ranitidine 50mg/2ml injection is out of stock.

• An updated MSN with clinical revisions was issued 16 June 2020 (shared previously).

Sodium Bicarbonate 1.8% and 2.74% for Intravenous Infusion (Polyfusors)

• Sodium bicarbonate Polyfusors 1.8% and 2.74% are out of stock with resupply anticipated mid-November 2020.

• Sodium bicarbonate 1.26%, 1.4%, 4.2% and 8.4% Polyfusors are available but cannot support an uplift in demand.

• Sodium bicarbonate 8.4% 20ml vials (Fresenius Kabi) are in stock and can support increased demand.

• Sodium bicarbonate 8.4% 100ml bottles (B Braun) and 10ml ampoules (Ethypharm) are also available.


Sodium Chloride 1.8% and 2.7% Polyfusors

• Fresenius Kabi are out of stock with resupply anticipated mid-November 2020.

• Other strengths of sodium chloride Polyfusors remain available but cannot support an uplift in demand.

• Analysis of available data indicates that there is significant stock holding across Trusts in England.

• Commercially compounded bags of the affected strengths are available for order from commercial compounders.

• Sodium chloride 30% concentrate 10ml ampoules are available.

• An MSN was issued on 30 July 2020 (shared previously).

Somatropin 0.2mg MiniQuick (Genotropin) devices

• Genotropin 0.2mg MiniQuick devices are out of stock until January 2021.

• All other Genotropin lines remain available.

Tetracosactide 1mg depot injection • Mallinckrodt, sole suppliers will be out of stock until early December 2020.



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Urokinase (Syner-KINASE) injection

• Syner-Med are currently in stock of all strengths of Syner-KINASE injection.

• Supply restrictions for the 10,000IU and 25,000IU will likely remain in place until the end of 2020.

• Details of suggested alternative products, if required, can be found in the UKMi memo.

• Additional information for the product Taurolock has been shared previously. To place orders for this product, contact [email protected] and copy [email protected]

Verteporfin (Visudyne) 15mg powder for solution for infusion

• Supplies of short dated UK licensed stock remains available (expiry 30/11/2020).

• Resupply of UK licensed stock is expected during Q1 2021.

• Cheplapharm will supply US Visudyne (considered unlicensed in the UK) during this time in sufficient quantities to meet full UK demand.

Orals

Bupropion (Zyban) 150mg prolonged release tablets

• GlaxoSmithKine will be out of stock until early December 2020.


• Champix (varenicline tartrate) and various nicotine replacement therapies remain available.

• An SDA was issued on 29 May 2020.

Chloral betaine 707mg tablets

• Atnah’s, sole supplier, are out of stock with resupply expected November 2020.

• Unlicensed specials are available through Alliance Healthcare using PIP code: 802-0745.

Co-amilofruse 5/40 tablets

• Milpharm and Sanofi (Frumil) are out of stock until w/c 19 October and late December 2020, respectively.

• Supplies remain available from Wockhardt.

Co–careldopa 25mg/100mg tablets

• Teva, a generic supplier is out of stock and is currently unable to provide a resupply date.

• MSD, the supplier of the brand Sinemet Plus can cover supply for the whole market during this time.

Colestipol (Colestid) orange 5g granules

• Colestid orange sachets are out of stock until April 2021.

• See above for information on Colestid plain sachets.


Colestyramine (Questran) Powder for Oral Suspension

• Cheplapharm are out of stock of Questran Powder 4g sachets until Q3 2021.


https://www.sps.nhs.uk/articles/shortage-of-urokinase-injection-syner-kinase-10000-iu-25000-iu-and-100000-iu-powder-for-solution-for-injection-or-infusion/mailto:[email protected]:[email protected]://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103049https://www.sps.nhs.uk/articles/shortage-of-bile-acid-sequestrants/


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• Supplies of Questran Light are currently available through Alliance Healthcare and Phoenix.

• Mylan are also in stock of generic colestyramine 4g light sachets.


Contraceptive products (oral)

• See the table below for a summary of the supply position of oral contraceptive products.

• An updated MSN was issued 24 August 2020 (shared previously).

Product

affected Ingredients

Resupply

Date Management Advice

Brevinor

Ethinylestradiol/norethisterone

35microgram/500 microgram

tablets

Jan 2021

There are no exact equivalent preparations

available in the UK market. Other

ethinylestradiol and norethisterone OCP

products remain available.

Clinicians are advised to refer to CKS

guidance and BNF for advice.

Eloine Ethinylestradiol/Drospirenone

20mcg/3mg tablet

Late Oct

2020

Unlicensed imports of Eloine tablets have

been sourced; lead times vary.



ethinylestradiol and drospirenone OCP


Clinicians are advised to refer to the BNF for

advice.

Norimin Ethinylestradiol/norethisterone

35microgram/1mg tablets

Jan 2021



ethinylestradiol and norethisterone OCP



guidance and BNF for advice.

Synphase

Ethinylestradiol/norethisterone

/ 35microgram/500microgram

and

35microgram/1mg tablets

Jan 2021

Unlicensed imports of Synphase tablets have

been sourced; lead times vary.

Other brands of phasic oral contraceptive

tablets of differing composition remain

available.

Yiznell Ethinylestradiol/drospirenone

30microgram/3mg tablets Nov 2020

Equivalent alternatives with same

composition remain available from suppliers

of following brands: Dretine, Yacella, Yasmin,

Ellaite and Lucette.

https://www.sps.nhs.uk/articles/shortage-of-bile-acid-sequestrants/https://cks.nice.org.uk/contraception-combined-hormonal-methodshttps://cks.nice.org.uk/contraception-combined-hormonal-methodshttps://cks.nice.org.uk/contraception-combined-hormonal-methodshttps://cks.nice.org.uk/contraception-combined-hormonal-methods


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Zoely Estradiol/nomegestrol

1.5mg/2.5mg tablets

Late Oct

2020


available in the UK market.


guidance for advice.

Enalapril 20mg tablets

• Supplies are currently available from Aurobindo.

• Dexcel and Noumed are currently out of stock with resupply expected by w/c 9 November 2020 and early 2021, respectively.

• There will be ongoing constraints with supplies of enalapril 20mg tablets until November 2020 when more manufacturers are back in stock.



Ferrous Fumarate 322mg/Folic Acid 0.35mg (Pregaday) tablets

• Recipharm are out of stock until the end of October 2020.

• An MSN was issued on 8 July (shared previously).

Fluoxetine 10mg tablets

• Endo Ventures are out of stock of fluoxetine 10mg tablets until March 2021.

• Fluoxetine 10mg capsules and fluoxetine 20mg/5ml oral solution remain available.


• A serious shortage protocol (SSP) was issued on 12 March 2020.

Galantamine 8mg/12mg tablets

• Teva will be out of stock of their immediate release galantamine preparations (8mg and 12mg) until late 2020.

• Galantamine modified release capsules (8mg, 16mg, 24mg) and galantamine 4mg/ml oral solution are available.

• UKMi guidance for switching preparations below: o It is recommended that the same total daily dose of galantamine is administered to patients.

Patients switching to the once-daily regimen should take their last dose of galantamine

tablets or oral solution in the evening and start prolonged- release capsules once daily the

following morning.

Histamine (H2) antagonists

• See the table below for a summary of the supply position with oral H2 antagonists.

• An updated MSN was issued on 17 July 2020 (shared previously).

https://cks.nice.org.uk/contraception-combined-hormonal-methodshttps://cks.nice.org.uk/contraception-combined-hormonal-methodshttps://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/serious-shortage-protocols-ssps


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Product Supplier Current Stock

Position Anticipated resupply

date Suggested management

plan

Famotidine 20mg tablets Tillomed Out of stock End October 2020

Unlicensed supplies have been sourced

Teva Out of stock TBC

Famotidine 40mg tablets Tillomed In stock n/a

Teva Out of stock End October 2020

Cimetidine 200mg tablets Ennogen Out of stock June 2021

Medreich Out of stock to be confirmed





Cimetidine 200mg/5ml oral solution

Rosemont In stock n/a n/a

Nizatidine 150mg capsules

Mylan Out of stock January 2021 Unlicensed supplies have

been sourced Medreich Out of stock to be confirmed

Relonchem Out of stock End November 2020

Nizatidine 300mg capsules

Mylan Out of stock January 2021

Refer to MSN/2019/020 -U Medreich Out of stock to be confirmed

Relonchem Out of stock End October 2020

Hormone Replacement Therapy products (HRT) There are still some ongoing supply issues, please see Table 2 in the Appendix for a full update on the

availability of all HRT products.

Elleste oral HRT Range

• Mylan, sole supplier of the Elleste range, are out of stock due to manufacturing issues at their contract manufacturing site. Resupply is expected in late 2020.

• See Table 1 below for equivalent alternatives to the Elleste range.

Table 1. Equivalent HRT alternatives for the Elleste HRT range

Brand Ingredient(s) Current Availability

Equivalent Ingredient(s) Current Availability

Elleste Solo 1mg

estradiol hemihydrate

Out of stock Progynova 1mg estradiol valerate In stock

Zumenon 1mg estradiol hemihydrate

In stock

Elleste Solo 2mg

estradiol hemihydrate

Out of stock

Progynova 2mg estradiol valerate In stock

Zumenon 2mg estradiol hemihydrate In stock

Elleste Duet Conti

estradiol 2mg/ norethisterone

1mg

Out of stock Kliofem estradiol 2mg/ norethisterone 1mg

In stock


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Elleste Duet 1mg

estradiol 1mg/ norethisterone

1mg

Out of stock NovoFem estradiol 1mg/ norethisterone 1mg

In stock

Ethinylestradiol 10microgram/50microgram tablets

• UCB, sole supplier is out of stock due to manufacturing issues and currently unable to advise a resupply date.


FemSeven Transdermal patch range

• Teva divested the FemSeven product range to Theramex UK Ltd mid-2018.

• Theramex have confirmed that whilst new manufacturing arrangements are being established, the FemSeven range will be out of stock until early of 2021 except for FemSeven Conti which is expected end of 2020.


Ketotifen (Zaditen) 1mg/5ml oral solution

• Zaditen oral solution is out of stock with resupply date to be confirmed.

• Zaditen 1mg tablets are currently available.

• Specialist importers can source unlicensed ketotifen oral solution. Lead times may vary.


Levodopa/carbidopa/entacapone tablets (Sastravi)

• In February 2020, Teva went out of stock of some strengths and pack sizes of Stanek tablets.

• This was due to manufacturing delays and impacted some supplies of other strengths of Stanek, Sastravi and Stalevo tablets.

• Accord remain out of stock of two presentations of Sastravi. Refer to the updated table below for further information.

• All Stanek and Stalevo presentations, which are considered equivalent, are currently available.

• An MSN was issued 16 June 2020 (shared previously).

Sastravi tablets

Strength Pack size Anticipated resupply dates

175mg/43.75mg/200mg 30 Early November 2020

150mg/37.5mg/200mg 100 Early November 2020

200mg/50mg/200mg 100 By late October 2020

Mepacrine 100mg tablets

• Mepacrine tablets marketed by BCM Specials have been recalled. Further information on recall can be found here.

• Supplies from alternative manufacturers, including Ascot Labs, remain available.

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-mepacrine-hydrochloride-100-mg-tablets-batch-85641-el-20-a-27?utm_source=6887b8ad-c526-4b49-bc6b-534d31560316&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate


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Mianserin 10mg/30mg tablets

• Mylan, sole supplier is out of stock of both strengths until Q1 2021.


• For patients where imports are not appropriate, see previous updates for clinical advice.

Moclobemide 150mg and 300mg tablets

• Mylan (Manerix) now have both strengths back in stock

• Sandoz currently expect resupply for the 150mg in July 2021 and the 300mg in March 2021.

Nabumetone 500mg tablets

• Nabumetone 500mg tablets are out of stock until early November 2020.


• An MSN was issued on 3 August 2020 (shared previously).

Penicillamine 250mg tablets

• Kent Pharmaceuticals are out of stock until December 2020.

• Mylan have supplies of penicillamine 125mg and 250mg tablets available.

Pethidine 50mg tablets

• Martindale and Teva are out of stock with resupply date to be confirmed.

• Specialist importers can source unlicensed products. Lead times may vary or be extended as this product is a controlled drug.

• An MSN was issued on 7 August 2020 (shared previously).

Phenelzine sulphate (Nardil) 15mg tablets

• Kyowa Kirin, the previous sole supplier, has been out of stock due to manufacturing delays since August 2019 and was unable to provide a resupply date.

• In September 2020, Kyowa Kirin advised Nardil has been divested to Neon Healthcare. Resupply date is to be confirmed.

• Specialist importers are sourcing unlicensed imports of the tablets.

• Supplies of phenelzine 15mg capsule specials are also available. Further information can be found in the SDA.

• An SDA was issued on 25 June 2020 and a subsequent update was issued on the 3 July 2020.

Phenindione 10mg and 25mg tablets

• Advanz, sole supplier of phenindione tablets, only have supplies of short dated stock available (expiry 30/11/2020).

• Further resupply is expected during November 2020.

Phenytoin (Epanutin) 50mg Chewable Infatabs

• Pfizer are out of stock with resupply date to be confirmed.

• Pfizer are supplying Canadian Dilantin (phenytoin) Infatabs (considered unlicensed in the UK) during this time in sufficient quantities to meet full UK demand.

• A copy of the DHCP letter has been shared previously.

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103059


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Phenytoin 100mg capsules

• Accord are out of stock of phenytoin sodium NRIM 100mg capsules resupply was expected in early May 2020, however, this has been delayed – resupply date to be confirmed.

• Flynn Pharma can support the full market during this time.

• As phenytoin is classed as a Category 1 anti-epileptic drug by the MHRA, switching to an alternative formulation requires monitoring and may also require specialist support, advice or referral.

• An SDA was issued on 10 January 2020.

Prazosin (Hypovase) 1mg tablets • Hypovase 1mg tablets are out of stock with resupply date to be confirmed.

• Hypovase 500mcg tablets are currently available and able to support the full market demand for both strengths.

Pristinamycin 500mg tablets

• Pristinomycin is only available in the UK as an unlicensed medicine via specialist importers.

• Specialist importer companies currently only have access to a very limited supply.

• Please contact your Trust Microbiology clinical leads for further guidance on alternatives if required.

Ranitidine oral preparations

• Ranitidine tablets, effervescent tablets and oral solution are expected to be out of stock until further notice due to global regulatory investigations.

• An updated MSN with clinical revisions was issued 12 June (shared previously).

Senna (Senokot) 7.5mg/5ml syrup

• Reckitt Benckiser Healthcare are sole suppliers of senna 7.5mg/5ml syrup.

• The 150ml bottles are currently available to secondary care only. In November 2020 stock is expected to be available to both primary and secondary care.

• The 500ml bottles are currently available to both primary and secondary care.

Sterculia 62% granules (Normacol) and sterculia 62% with frangula bark 8% granules (Normacol Plus)

• Normacol granules are out of stock until early November 2020.

• Normacol Plus granules are out of stock until December 2020.


• An MSN was issued 27 August 2020 (shared previously).

Tuberculosis medications

• The final MSN for TB oral agents was issued 28 September 2020 (attached).

• See table in the MSN for a summary of the supply position with tuberculosis medications.

Valsartan capsules • There are ongoing intermittent supplies of valsartan. See the table below for an overview of current

availability.

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102954


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Product Supplier Current Stock

Position Anticipated resupply

date

Valsartan 40mg capsules

Mylan In stock n/a

Teva Out of stock End of October 2020

Milpharm Out of stock TBC

Crescent Out of stock Nov 2020 at the earliest


Mylan In stock n/a

Teva In stock n/a




Mylan In stock n/a

Teva In stock n/a



Valsartan 320mg capsules Mylan In stock n/a

Others

Fludroxycortide 0.0125% cream and ointment

• Typharm Limited cannot release further stock of fludroxycortide cream and ointment due to updates to their licences and changes to regulatory standards.

• There is no confirmed resupply date.

• Fludroxycortide 4micrograms/cm2 tape remains available.

Fluticasone propionate (Flixotide) 0.5mg/2ml and 2mg/2ml nebules

• Both strengths of Flixotide nebules are out of stock until mid-February 2021.

• An MSN was issued on 26 June (shared previously).

Metronidazole (Acea) 0.75% gel

• Ferndale Pharmaceuticals are out of stock of Acea 0.75% gel until at least January 2021.

• Metrogel 0.75% and Rozex gel 0.75% gel remain available.


Prednisolone 5mg suppositories

• RPH Pharmaceuticals are out of stock until early November 2020.


• An MSN was issued on 10 June (shared previously).


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Sodium cromoglycate (Intal) 5mg inhaler • Sanofi are out of stock until March 2021.

• Parallel imports are available through Alliance or directly from DrugsRUs.

Eye drops/treatments Betamethasone (Vistamethasone) 0.1% eye drops

• Martindale are out of stock until w/c 19 October 2020.

• RPH Pharma have sufficient supply of Betnesol eye/ear 0.1% drops to support the market.

Chloramphenicol (Eykappo) 5mg/ml Preservative Free Eye Drops 10ml • Aspire Pharma, sole supplier of a multidose preservative free chloramphenicol eye drop, have

supplies of short dated stock available (expiry 31/12/2020).

• Further resupply is expected during Q1 2021.

• Minims Chloramphenicol 0.5% single-use eye drops remain available for patients who require a preservative free formulation once supplies of Eykappo are unavailable.

Sofradex ear/eye drops

• Out of stock until December 2020.

• Alternative preparations for use in the ear/eye remain available.

Vaccines For updates on other vaccine supply positions, please refer to PHE’s Vaccine Update Bulletin.

Hepatitis B Vaccines Renal dose

• MSD’s renal vaccine HBVAXPRO 40micrograms are unavailable until end of 2020

• GSK’s Hepatitis B renal vaccine, Fendrix, is currently available. Adult dose

• MSD are out of stock HBVAXPRO 10mcg vaccine unavailable until end of 2020

• GSK are confident they can support the increased demand during this time.

Pneumovax 23 pre-filled syringes

• Supplies of Pneumovax pre-filled syringes are available. However, to ensure equitable distribution and ensure stock management, monthly quotas have been applied at wholesaler level. If you are unable to access supplies, please do contact AAH customer services.

• Public Health England (PHE) have issued guidance on how available supplies should be managed at this time. This guidance advises the need for the prioritisation of patients considered to be in the high priority clinical risk group. Find full guidance on PHE’s Vaccine Update Issue 300 (page 12).

Discontinuations

Atenolol 50mg/20mg nifedipine (Tenif) capsules (AstraZeneca)

• AZ are planning to discontinue Tenif capsules from the UK market in December 2020.

• The separate components – atenolol and nifedipine – remain available from several alternate manufacturers.

https://www.gov.uk/government/collections/vaccine-update#2019https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/844742/PHE_11388_vaccine_update_300_bug_special_october2019ppv.pdf


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• See Dear Healthcare Professional Letter for further information (attached).

Carbamazepine (Carbagen) all products (Mylan)

• Mylan have discontinued all Carbagen lines following a long out of stock period.

• Due to the long term out of stock all patients should have already been switched over to the only alternative, Tegretol, which remains available.

Ciprofloxacin (Ciproxin) 500mg tablets (Bayer)

• Bayer is discontinuing Ciproxin 500mg tablets from the UK market with immediate effect.

• Generic ciprofloxacin 500mg tablets remain available from several alternate manufacturers.

Co-fluampicil 250mg/250mg capsules (Crescent)

• Crescent, sole supplier are discontinuing co-fluampicil 250mg/250mg capsules from the UK market in December 2020 due to a manufacturing issue.

• The separate components – amoxicillin and flucloxacillin – remain available from several manufacturers.

Diamorphine (Ayendi) nasal sprays (Wockhardt)

• Wockhardt have discontinued all Ayendi lines with immediate effects following a long out of stock period.

• Wockhardt have been in contact with customers who use the products.

Dihydrocodeine 30mg tablets (Wockhardt)

• Wockhardt are planning to discontinue dihydrocodeine 30mg tablets from the UK market in December 2020.

• Accord appear to be the sole UK supplier for dihydrocodeine 30mg tablets and have been alerted.

Exenatide (Bydureon) Dual Chamber Pen (AstraZeneca)

• This device is being replaced by the Bydureon BCise 2 mg prolonged-release suspension for injection.

• See Dear Healthcare Professional Letter for further information (attached).

Hepatitis B (Engerix B) vials (GSK)

• GSK have confirmed that stocks of Engerix B vials have now been exhausted.

• Engerix B vials have been replaced by Engerix B pre-filled syringes.

Nifedipine (Adalat LA) 20mg & 60mg (Bayer)

• Following long-term supply issue since 2018 Bayer has now decided to discontinue these lines (originally planned to bring back in 2021).

• Due to the long term out of stock all patients should have already been switched over to alternate brands.


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Testosterone (Restandol) 40mg capsules (MSD)

• MSD have discontinued Restandol 40mg capsules from the UK market and stocks are now exhausted. MSD have already sent out comms to HCPs.

• There are no other suppliers for testosterone oral formulations.

• Testosterone transdermal and long-acting injection formulations remain available.

Resolved (date resolved)

Esomeprazole 40mg injection (30/09/20)

Fentanyl (Instanyl) 50mcg nasal spray (2/10/20)

Fluoxetine 40mg capsules (1/10/20)

Lansoprazole 15mg orodispersible tablets (5/10/20)

Lodoxamide (Alomide) 0.1% eye drops (15/09/20)

Manevac granules 250g (30/09/20)

Methylprednisolone (Medrone) 16mg tablets (28/09/20)

Oxaliplatin 50mg/10ml, 100mg/20ml, 200mg/40ml solution for infusion vials (1/10/20)

Phosphate Polyfusors 50mmol/500ml (18/09/20)

Sildenafil (Revatio) 0.8mg/ml solution for injection (30/09/20)

Sodium Bicarbonate 1.26% and 8.4% for Intravenous Infusion (Polyfusors) (2/10/20)

Sulfasalazine 250mg/5ml oral suspension (18/09/20)


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Appendix Table 2: HRT availability and anticipated resolution dates

Oestrogen Only

Ingredient (s) Manufacturer Brand Strength Current Availability

Anticipated resupply date Oral preparations

Estradiol hemihydrate

Mylan Elleste Solo 1mg OOS

End of 2020 2mg OOS

Mylan Zumenon 1mg In stock

2mg In stock

Estradiol valerate Bayer Progynova 1mg In stock

2mg In stock

Conjugated oestrogen Pfizer Premarin

300mcg In stock

625mcg In stock

1.25mg In stock

Ethinylestradiol UCB pharma

Ltd. Ethinylestradiol

10mcg Long term OOS Unlicensed imports available; lead times vary 50mcg Long term OOS

1mg Long term OOS

Transdermal patches

Estradiol Theramex Evorel

25 mcg In Stock

50mcg In Stock

75mcg In Stock

100mcg In Stock


Novartis Estradot

25 mcg In stock

37.5mcg In stock

50mcg In stock

75mcg In stock

100mcg In stock

Merus Labs/Norgine

Estraderm

25 mcg In stock

50mcg In stock

75mcg In stock

100mcg In stock

Theramex FemSeven

Mono

50mcg Long term OOS

Early 2021

75mcg Long term OOS

100mcg Long term OOS Early 2021

Bayer Progynova TS 50mcg In stock

100mcg In stock

Mylan Elleste Solo MX 40mcg In stock

80mcg In stock

Topical (Transdermal gels/creams/other delivery systems)


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Estradiol Besins

Healthcare (UK) Ltd

Oestrogel 0.06% In stock


Orion Sandrena

0.5mg In stock

1mg (28) In stock

1mg (91) In stock

Pfizer E-string vaginal delivery system

7.5mcg/ 24hours

In stock

Novo Nordisk Vagifem vaginal

tablets 10mcg In stock

Estriol

Flynn Pharma Blissel 50mcg/g In stock

Marlborough Pharma

Estriol cream (generic)

0.01% In stock

Aspen Ovestin cream 1mg In stock

Progestogen only

Levonorgestrel Bayer Mirena

Intrauterine device

20mcg/24hr In stock

Progesterone Besins

Healthcare (UK) Ltd

Utrogestan 100mg In stock

Utrogestan 200mg In stock

Combined HRTs (Progestogen and oestrogen)

Continuous combined therapy

Oral preparations

Estradiol hemihydrate / norethisterone acetate

Mylan Elleste Duet

Conti 2mg / 1mg OOS End of 2020

Novo Nordisk

Kliofem 2mg/ 1mg In stock

Kliovance 1mg/

500mcg In stock

Estradiol hemihydrate / Mylan Femoston Conti

500mcg/ 2.5mg

In stock

dydrogesterone 1mg/ 5mg In stock

Estradiol valerate/medroxyprogest

erone Orion Indivina

1mg /2.5mg In stock

2mg/ 5mg In stock

1mg/5mg In stock

low dose conjugated oestrogen/medroxyprog

esterone Pfizer Premique

300mcg/1.5mg

In stock

Transdermal patch

Estradiol hemihydrate/ norethisterone acetate

Theramex Evorel Conti 3.2mg/11.2

mg In stock


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Estradiol hemihydrate/ levonorgestrel

FemSeven Conti

1.5mg/ 0.525mg

Long term OOS End of 2020

Sequential combined therapy

Oral preparations


Mylan

Elleste Duet 1mg/ 1mg OOS

End of 2020 2mg/ 1mg OOS

Estradiol hemihydrate/ dydrogesterone

Femoston 1mg/ 10mg In stock

2mg/10mg In stock


Novo Nordisk

Novofem 1mg/ 1mg In stock

Estradiol hemihydrate [X,X,X]/ norethisterone

acetate Trisequens

In stock [2mg, 2mg, 1mg]/ 1mg

Estradiol valerate/

medroxyprogesterone acetate

Orion Tridestra 2mg/20mg In stock

Transdermal patch

a) Estradiol hemihydrate and b) estradiol hemihydrate/

norethisterone acetate Theramex

Evorel Sequi

a)3.2mg b) 3.2 mg /11.2 mg

In stock

a) 1.5mg of estradiol hemihydrate b) Estradiol

hemihydrate /levonorgestrel

FemSeven Sequi a) 1.5mg b)

1.5mg /1.5mg

Long term OOS End of 2020

Gonadomimetic (s)

Tibolone 2.5mg MSD/Advanz

pharma Livial tablets

Tibolone 2.5mg

In stock

Selective oestrogen receptor modulator

Ospemifene 60mg tablets

Shionogi Senshio tablets Ospemifene 60mg tablets

In stock

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