Pan Mersey CCG Tablets - Prescribing Newsletter June 2019

Products in short supply and product discontinuations

The following links provide prescribers with up to date information on commonly prescribed products which are currently in short supply from the manufacturers.

The information held on these lists is not exhaustive. Availability can vary geographically and also between wholesalers. Up-to-date information should be sought from manufacturers, local community pharmacies and suppliers.

DHSC report May 2019

This report has been produced by the Department of Health and Social Care (DHSC) Medicine Supply team. This report is updated monthly to provide information on the current primary and secondary care medicine supply issues being worked on. This information is confidential to the NHS as it may be commercially sensitive.

New Issues

Injectables

Diamorphine 5mg injection

Accord and Wockhardt have advised that they are experiencing issues with the manufacture and availability of diamorphine 5mg injection. They are likely to go out of stock of diamorphine 5mg injection by 27 May 2019 with a resupply date of w/c 5th August 2019. All other strengths of diamorphine injection are available. Following consultation, a management plan has been developed.

Primary care, private hospitals, hospices and substance misuse treatment centres

There is sufficient diamorphine 10mg injection to support forecasted use of diamorphine 5mg injection. Diamorphine will be available to order from usual wholesalers.

Recommended Local Action for Primary Care:

Please share this information with relevant networks locally including GP practices, community pharmacies and substance misuse networks.
Prescribers should be made aware that only diamorphine 10mg ampoules will be available during this period and ensure that prescriptions specify this preparation. Prescribers should take extra care when calculating the dose to be administered.
Locally, health care professionals should follow local controlled drug policies for the safe management and disposal of excess waste of diamorphine during this time and should ensure that:
- Any wastage should be rendered irretrievable and must be disposed of.
- Clear records should be kept of what was administered, and what was discarded and should be witnessed wherever possible.
- Please work with your Controlled Drug Accountable Officer where necessary.

Orals

Actiq (fentanyl) lozenges
Teva are experiencing supply issues with several strengths of Actiq lozenges with no supplies of the 200mcg or 400mcg strength available until mid-July. All other strengths remain available. Immediate release fentanyl products are not interchangeable and when considering switching patients from one product to another, patients should not be converted on a microgram per microgram basis from one to another; it is necessary to titrate the new formulation with advice from a specialist.

See the link below for advice from UKMI:
https://www.sps.nhs.uk/articles/shortage-of-actiq-lozenges-and-instanyl-nasal-spray-immediate- release-fentanyl-citrate/

Ammonaps (sodium phenylbutyrate) 940mg/g granules
SOBI, the sole supplier of Ammonaps (sodium phenylbutyrate) 940mg/g granules, has had an interruption in supply due to a change in the marketing authorisation holder. Currently, they are unable to advise on a resupply date. Ammonaps (sodium phenylbutyrate) 500mg tablets continue to remain available.

As per UKMI advice, for those patients that are unable to take tablets, Ravicti 1.1g/ml (glycerol phenylbutyrate) liquid is available, please note a dose conversion is required and specialist input should be sought prior to switching a patient. If switching a patient to Ravicti 1.1g/ml liquid is deemed appropriate; prescribers should consult the dose conversion guidance closely as outlined in the Ravicti SPC and patients should be counselled about the administration of the new formulation.

Please see the link below for the Ravicti 1.1g/ml (glycerol phenylbutyrate) liquid SPC: https://www.medicines.org.uk/emc/product/2494/smpc

Bezalip (bezafibrate) 200mg tablets
Teva, sole suppliers, are currently out of stock of bezafibrate 200mg tablets until mid/end July 2019. A clinical memo from UKMI will be published on the SPS website shortly.

Cardura (doxazosin) XL tablets
Pfizer have a supply issue with of Cardura XL 4mg and 8mg tablets and further stock is expected at the end of August 2019. Pfizer are the sole UK supplier of Cardura XL 8mg tablets but supplies of doxazosin XL 4mg tablets are available from alternative suppliers.

Disopyramide
Disopyramide is licensed for the treatment of cardiac arrhythmias and is often employed as a last line antiarrhythmic agent. Dosage is adjusted according to the response of the patient. There is a short-term supply issue affecting disopyramide capsules due to a manufacturing delay of UK licensed stock. Sanofi and Mylan are the only licensed UK suppliers of disopyramide 100mg capsules; Mylan are the sole UK supplier of disopyramide 150mg capsules. It is anticipated that current stock of 100mg will be depleted by mid-June and 150mg by mid-August. Further supplies are currently anticipated to be available to the market late July (100mg) and mid-September (150mg). Supplies are available from specialist importers on an ‘unlicensed’ basis.

Prescribers and pharmacists should identify all patients currently prescribed disopyramide 100mg/150mg capsules. Early contact should be made with the patient or patient’s carer to determine if they have enough disopyramide capsules to last for the duration of the shortage. If the patient has sufficient supplies to last through the affected period, then no further action is required. If a patient does not have sufficient supplies, the following advice should be followed:

Switch patients to an unlicensed import.
If unlicensed imports are not considered suitable then patients should be referred to secondary care specialists for further management.
Patients should be prescribed a licensed product if available, therefore if patients are switched to an unlicensed preparation they should be switched back to a licensed product when supplies are back in stock, which is likely to be late July for the 100mg capsules and mid-September for the 150mg capsules.

If prescribers have any concerns about switching a patients’ medication, they should consult the patient’s secondary care specialist prescriber to seek support

Unlicensed product:
Unlicensed specialist importers are able to source disopyramide from abroad. Pharmacists will know how to source these unlicensed and specials products and should be able to advise you further. Before prescribing, you should liaise with your pharmacist to clarify local availability of products.
When prescribing and dispensing unlicensed preparations, prescribers and pharmacists should always ensure the following:
 Clear patient consent has been sought for use of an unlicensed preparation.
 If a switch is made to a different product, prescribers, carers and patients must be made aware of the change and it should be confirmed that patients are taking the correct dose.
 Patients are supplied sufficient quantity of a specific unlicensed preparation to cover until licensed disopyramide returns to stock.
 Any decision to prescribe an unlicensed medicine must take into account the relevant GMC guidance and NHS Trust / Local governance procedures. Please see link to GMC guidance:
https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managingmedicines-and-devices/prescribing-unlicensed-medicines

Epanutin (phenytoin) 30mg/5ml oral suspension
DHSC are aware of a supply issue with Epanutin oral suspension byPfizer. Please see below for a link to the CASalert:
https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102868

Heminevrin (clomethiazole) 192mg capsules
Cheplapharm, the sole supplier of Clomethiazole 192mg Capsules have a short-term supply issue due to packaging issues. It is anticipated that the resupply date will be mid-September. They also manufacture Heminevrin (Clomethiazole) 31.5mg/ml syrup, however, there is insufficient supplies to meet any additional demand. A clinical memo from UKMI will be published on the SPS website shortly.

Megace (megestrol) 160mg tablets
SOBI, sole distributors of megestrol tablets in the UK are out of stock until 31st July. National clinical experts have confirmed there are several other products available to treat the licensed indication but, if appropriate, unlicensed supplies of megestrol can be used. Unlicensed megestrol 160mg tablets are available from some specialist importers although lead times vary. Unlicensed megestrol 40mg tablets are also obtainable as an unlicensed import with several importers currently holding stock. A very limited supply of megestrol 160mg tablets is available for those patients for whom an alternative option is unsuitable.

Pharmacies should contact Alloga directly on 01773510123.

Ovranette (ethinylestradiol 30 mcg/levonorgestrel 150mcg) tablets
Due to capacity constraints, Pfizer will be out of stock of Ovranette tablets from early June until end of August2019. Patients who do not have sufficient supply of Ovranette tablets to last throughout the affected period should be prescribed Rigevidon, Levest, Elevin or Microgynon 30 tablets, if clinically appropriate. Prescribers are advised not to switch to Microgynon 30 ED, Leandra or Maexeni during the affected period as they are unable tosupport.

Others

Dalacin (clindamycin) 2% vaginal cream
Pfizer, sole supplier of clindamycin 2% vaginal cream, are out of stock until mid-July due to delays in packaging.

Instanyl (fentanyl) nasal spray
Takeda are currently out of stock of all strengths of Instanyl nasal spray with resupply date as follows: 50mcg end June; 100mcg mid-July; 200mcgmid-September. Immediate release fentanyl products are not interchangeable and when considering switching patients from one product to another, patients should not be converted on a microgram per microgram basis from one to another; it is necessary to titrate the new formulation with advice from aspecialist.

See the link below for advice fromUKMI:
https://www.sps.nhs.uk/articles/shortage-of-actiq-lozenges-and-instanyl-nasal-spray-immediate- release-fentanyl-citrate/

Ongoing Issues:

For advice on ongoing issues please click here

Contents

Formulary Update

Safety Updates

Prescribing News

Drug Availability

Drug Tariff Changes

Antimicrobial Updates