Coventry LPC

SUPPLY SHORTAGES

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Supply Shortages

Supply Chain & Shortages

Dispensing and Supply Briefings

PSNC Drug Shortages Briefing

Patient Leaflet

Shortages Reporting Form

Serious Shortages Protocol

Draft legislation on SSP

PSNC’s response to consultation

Consultation Outcome

PSNC Briefing on SSP

Media Reports

BBC News

The impact of stock shortages can have a substantial effect on a patients, community pharmacies and the NHS as a whole.

Although the impact of stock shortages on patient care is widely acknowledged, when a medicine goes into short supply, it can also have a major impact on community pharmacists. Shortages inevitably lead to increased time spent in sourcing products, discussing alternatives with prescribers and counselling patients.  Shortages can also have an impact on key pharmacy relationships as they can increase conflict between the patient and the pharmacist and the pharmacist and the prescriber.

source: PSNC

Please see our Brexit page for information about shortages relating to the UK’s exit from the EU.


Frequently Asked Questions and Additional Support


  • What causes supply shortages?
  • Is there a resource that could help me explain about drugs shortages to my customers?
  • How do I report supply issues to PSNC?
  • What’s PSNC’s position on the proposed Serious Shortages Protocol?
  • Current Shortages: Epanutin 50mg Infatabs
What causes supply shortages?

Medicines shortages can be caused by a whole range of factors, including manufacturing and distribution problems within the supply chain.  Currently, the uncertainty around Brexit and contingency planning is exacerbating the already existing supply issues.

Is there a resource that could help me explain about drugs shortages to my customers?

PSNC has produced a Patient Leaflet that community pharmacy contractors may find useful to give to patients in the event of medicines supply problems.

There are also some FAQs on the NHSE site:
https://www.england.nhs.uk/eu-exit/medicines/medicines-faq/

How do I report supply issues to PSNC?

You can report any supply issues to PSNC using their online reporting tools. There’s a different form to report generic and branded medicines.

Report shortages of a generic medicine: 
https://psnc.org.uk/dispensing-supply/supply-chain/supply-issues-feedback/problems-with-obtaining-a-generic-medicine/

Report shortages of a branded medicine: 
https://psnc.org.uk/dispensing-supply/supply-chain/supply-issues-feedback/problems-obtaining-a-branded-medicine/

What’s PSNC’s position on the proposed Serious Shortages Protocol?

PSNC is supportive of the proposed legislative changes, which will seek to safeguard the supply of essential medicines to patients in the event of serious shortages of medicines, including any serious shortages following a no-deal Brexit.

https://psnc.org.uk/wp-content/uploads/2018/12/PSNC-response-to-the-consultation-on-urgent-changes-to-the-HMRs-2012.pdf

Current Shortages: Epanutin 50mg Infatabs

There’s an imminent supply issue with Epanutin 50mg Infatabs. Pfizer, the sole supplier of Epanutin (phenytoin base 50mg) Infatabs have experienced global delays in the manufacturing of this product.  As a result, they are anticipating an imminent gap in supply until early November 2019 when their next batch arrives.

The MHRA has classified phenytoin as a Category 1 antiepileptic drug. In the event that you need to prescribe a product from a different manufacturer then this must be carefully managed and increased monitoring of the patient may be required as clinically relevant differences between different manufacturers’ products might occur. Pfizer have been able to secure supplies of a Canadian phenytoin base Infatabs (brand name Dilantin 50mg Infatabs), which will be available when current supplies of Epanutin Infatabs are depleted. Further information on this is attached and below:

  • Pfizer are confident they have sufficient supplies of Dilantin 50mg Infatabs to meet demand for Epanutin 50mg Infatabs to cover the full out of stock period. However, Dilantin will be considered an unlicensed medicine in the UK
  • The active ingredient in Epanutin 50 mg Infatabs and Dilantin 50 mg Infatabs is the same, however in the absence of bioequivalence data from Pfizer, there may be clinically relevant differences between the two products. Further information on this can be found in the DHCP letter and documents attached
  • Switching to alternative presentations should be managed under medical supervision and monitoring of phenytoin serum levels are advised to ensure the correct dosage is being given.
  • Epanutin 30 mg/5 ml Oral Suspension remains available, however, supplies are only available to meet normal market demandas such patients should not be switched to Epanutin Oral Suspension as this may precipitate a shortage of this presentation
  • General Practitioners should identify all patients currently prescribed Epanutin 50mg Infatabs. Early contact should be made with the patient or the patient’s parent/carer to determine if and when switches are likely to be required during this stock out period.
  • Alternative formulations of phenytoin continue to remain available including tablets, capsules and injections

Details on prescribing and ordering

  • If a clinician chooses to prescribe Dilantin 50mg Infatabs, they should be aware this is an unlicensed medicine in the UK.
  • Any decision to prescribe an unlicensed medicine must take into account the relevant GMC guidance and NHS Trust governance procedures. Please see link to GMC guidance:

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/prescribing-and-managing-medicines-and-devices/prescribing-unlicensed-medicines

  • Prescribers should ensure that they issue a prescription for the unlicensed product and clearly mark on the prescription that this is a special/unlicensed product. This is to ensure the pharmacy/contractor is reimbursed appropriately.
  • Pharmacies/ contractors may be unable to dispense Dilantin 50mg Infatabs and/or be reimbursed if the prescription states Epanutin.
  • Pharmacies/contractors wishing to order Dilantin should contact Pfizer Customer Contact Centre on 0845 608 8866 directly who will manage the order.

Please find some supporting documents below:

Dilantin Infatab DHCP letter -CCC (Final version)
Dilantin PIL
Epanutin Infatabs PIL


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