Home Branded Medicine Shortages
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Supply Chain Actions from the Ministerial Summit
Medicines that Pharmacies have Reported Problems Obtaining
Contingency Arrangements Contact Information
Managing Supply Problems Guidance
MHRA Enforcement & Intelligence Group Contact Details
Background
Over the past year, there has been a substantial increase in the number of problems that contractors are experiencing in obtaining certain branded medicines. At the heart of the problem are changes in the European import and export market. A weak pound and strong Euro have reduced the benefits from using parallel imported products; increasing the demand for UK medicines both from UK pharmacies and internationally.
This is a complex issue - there is no easy solution. It is not possible to prevent the export of UK medicines as this would be contrary to European trade laws. Increasing manufacturing output could be one solution but there are generally long lag times for changing manufacturing production plans to increase output and an argument used by some manufacturers is that this won't the resolve the problem, simply lead to an increase in the volume of stock exported.
Some manufacturers have introduced quotas to better manage the supply of UK medicines to ensure patient access, however where stock hasn't been allocated correctly by the manufacturer or managed appropriately by the wholesaler, problems arise. The allocation of quotas must be sophisticated enough to cope with reasonable fluctuations in demand such as changes in prescribing practice, changes in the number of pharmacy customers that wholesalers have and changes in access to the product from other sources including the availability of parallel imports.
Quotas also need to be effectively managed by wholesalers. The reports PSNC has received indicate that different wholesalers manage the stock they have been allocated in different ways and with markedly different levels of success.
An alternative option is, as Pfizer have done, monitor and restrict purchases at an individual pharmacy level rather than through wholesaler quotas. However, contractors have also reported problems with this arrangement.
Typically, when a wholesaler's quota has been exceeded, pharmacies need to obtain the product directly from the manufacturer or through alternative contingency arrangements. This increases workload in pharmacies and has an adverse financial impact on both pharmacies and the NHS.
PSNC has been working constructively with manufacturers, wholesalers, the Department of Health and the MHRA to find solutions to the current problems that could be introduced to help meet the needs of UK patients more efficiently. In 2008, PSNC proposed that the Department of Health should institute a review in conjunction with manufacturers, distributors and community pharmacy to consider what measures can be put in place to address supply issues. A supply chain forum has since been set up by the Department of Health and is supporting this collaborative solution-focussed working.
Factsheet: Branded Medicine Supply Shortages
Supply Chain Obligations to Ensure Supply
There is an existing framework in legislation to control the appropriate and continued supply of medicines to patients in the UK. Both manufacturers and wholesalers licenced to trade in the UK have a legal duty to ensure that UK patient needs are met and pharmacists and dispensing doctors have ethical obligations to ensure the needs of patients are always put first.
Agreement has been reached by the representative bodies of all parties in the supply chain to endorse and support the promotion of the existing legal and ethical obligations in relation to the trading of medicines in short supply. The obligations are outlined in the guidance note, “Trading Medicines for Human Use: Shortages and Supply Chain Obligations” which can be downloaded by clicking on the link below:
Trading Medicines for Human Use: Shortages and Supply Chain Obligations (PDF File)
MHRA Clarification Statement on Guidance
Supply Chain Actions from the Ministerial Summit
On the 2nd March 2010, the Department of Health hosted a Ministerial Summit on the Supply problems. Participants included PSNC, the RPSGB, the NPA, the BAPW, the ABPI, the MHRA and DH. The new Government have endorsed the approach and actions agreed at the Summit. The actions agreed by participants were:
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• As organisations representing the supply chain, regulators and Government, we will continue to work collaboratively to ensure that patients get the medicines they need. • The MHRA will undertake a proactive, targeted programme of inspection. • Those who are breaching existing duties to supply medicines, will face the consequences. Manufacturers and wholesalers risk losing their licences and prosecution, pharmacists and doctors risk being called to account by their respective professional bodies. The MHRA commits to investigating any suspected breaches of the regulations and the RPSGB or PSNI to any suspected breaches of the Code of Ethics referred to them. Evidence of suspected breaches should be referred to the MHRA or RPSGB or PSNI as appropriate. • The Government will raise the standards required for wholesaler dealers’ licences. This will be taken forward through the current MHRA consultation on strengthening the supply chain that ends later this month. • Through the Supply Chain Group, we will together develop and maintain a list of products in short supply, so that no-one has the excuse that they were not aware of supply difficulties. • Through the Supply Chain Group, we will jointly prioritise the products on that list for further examination, with a view to finding possible means of mitigation and resolution. • We will jointly develop best practice guidance for dispensing doctors, pharmacy, wholesalers and manufacturers to help them better manage the difficulties they face. This will include quota arrangements, ensuring awareness of contingency arrangements and communication with patients. • We will explore with manufacturers and wholesalers how we might place them under a more explicit duty to ensure that sufficient stocks are available to meet the needs of patients. • We agree to explore establishment of buffer stocks to be held by certain wholesalers to give greater flexibility to the supply chain. • We agree to regularly assess and monitor the situation through exchange of information. |
Reporting Problems
Contractors who have experienced problems in obtaining medicines because of quota arrangements are encouraged to feed this to the PSNC Information Team to support PSNC's ongoing monitoring of the situation. PSNC passed a monthly summary of the feedback received to the Department of Health to support their monitoring of the situation. This information is also used as an evidence base in discussions with manufacturers on manufacturer-specific problems, for example highlighting problems with contingency arrangements and promoting solutions. Please use the online feedback form for this purpose. For support on this issue, please contact the PSNC Information Team (01296 432823).
Link: Online Feedback Form
Medicines that Pharmacies have reported having problems obtaining (Last Updated: 11.8.10)
Pharmacies have reported problems obtaining the following medicines through wholesalers. If a product cannot be obtained through the normal channels, emergency stock can be obtained direct from the manufacturer.
Actonel 35mg tablets (Procter & Gamble Pharmaceuticals UK Ltd)
Aprovel 300mg tablets (sanofi-aventis)
Arava 20mg tablets (sanofi-aventis)
Arimidex 1mg tablets (AstraZeneca UK Ltd)
Asasantin Retard capsules (Boehringer Ingelheim Ltd)
Azilect 1mg tablets (Lundbeck Ltd)
Azopt 10mg/ml eye drops (Alcon Laboratories (UK) Ltd)
Bonviva 150mg tablets (Roche Products Ltd)
CellCept 250mg capsules (Roche Products Ltd)
CellCept 500mg tablets (Roche Products Ltd)
Cialis 20mg tablets (Eli Lilly and Company Ltd) (addition)
Cipralex 10mg tablets (Lundbeck Ltd)
Cipralex 20mg tablets(Lundbeck Ltd)
CoAprovel 150mg/12.5mg tablets (sanofi-aventis)
CoAprovel 300mg/12.5mg tablets (sanofi-aventis)
CoAprovel 300mg/25mg tablets (sanofi-aventis)
Crestor 40mg tablets (AstraZeneca UK Ltd)
Cymbalta 30mg gastro-resistant capsules (Eli Lilly and Company Ltd)
Cymbalta 60mg gastro-resistant capsules (Eli Lilly and Company Ltd)
DesmoMelt 120microgram oral lyophilisates (Ferring Pharmaceuticals Ltd)
DesmoMelt 240microgram oral lyophilisates (Ferring Pharmaceuticals Ltd)
Elidel cream (Novartis Pharmaceuticals UK Ltd)
Emselex 7.5mg modified-release tablets (Novartis Pharmaceuticals UK Ltd)
Emselex 15mg modified-release tablets (Novartis Pharmaceuticals UK Ltd)
Estradot 50micrograms/24hours patches (Novartis Pharmaceuticals UK Ltd)
Estradot 75micrograms/24hours patches (Novartis Pharmaceuticals UK Ltd)
Eucreas 50mg/1000mg tablets (Novartis Pharmaceuticals UK Ltd)
Exforge 10mg/160mg tablets (Novartis Pharmaceuticals UK Ltd)
Exforge 5mg/160mg tablets (Novartis Pharmaceuticals UK Ltd)
Exforge 5mg/80mg tablets (Novartis Pharmaceuticals UK Ltd)
Ezetrol 10mg tablets (MSD-SP Ltd)
Femara 2.5mg tablets (Novartis Pharmaceuticals UK Ltd)
Fosrenol 1000mg chewable tablets (Shire Pharmaceuticals Ltd)
Fosrenol 500mg chewable tablets (Shire Pharmaceuticals Ltd)
Fosrenol 750mg chewable tablets (Shire Pharmaceuticals Ltd)
Glivec 100mg tablets (Novartis Pharmaceuticals UK Ltd)
Glivec 400mg tablets (Novartis Pharmaceuticals UK Ltd)
Inegy 10mg/20mg tablets (MSD-SP Ltd)
Inegy 10mg/40mg tablets (MSD-SP Ltd)
Inegy 10mg/80mg tablets (MSD-SP Ltd)
Januvia 100mg tablets (Merck Sharp & Dohme Ltd)
Levemir FlexPen pre-filled pen (Novo Nordisk Ltd)
Madopar 50mg/12.5mg dispersible tablets (Roche Products Ltd)
Micardis 40mg tablets (Boehringer Ingelheim Ltd)
Micardis 80mg tablets (Boehringer Ingelheim Ltd)
MicardisPlus 40mg/12.5mg tablets (Boehringer Ingelheim Ltd)
MicardisPlus 80mg/12.5mg tablets (Boehringer Ingelheim Ltd)
Myfortic 360mg gastro-resistant tablets (Novartis Pharmaceuticals UK Ltd)
Neoral 25mg capsules (Novartis Pharmaceuticals UK Ltd)
Neoral 50mg capsules (Novartis Pharmaceuticals UK Ltd)
Persantin Retard 200mg capsules (Boehringer Ingelheim Ltd)
Pentasa 500mg modified-release tablets (Ferring Pharmaceuticals Ltd)
Pulmozyme 2.5mg nebuliser liquid 2.5ml ampoules (Roche Products Ltd)
Rilutek 50mg tablets (sanofi-aventis)
Sandostatin LAR powder and solvent for susp for injection vials 10, 20 and 30mg (Novartis Pharmaceuticals UK Ltd)
Singulair 10mg tablets (Merck Sharp & Dohme Ltd)
Spiriva 18microgram inhalation powder capsules (Combopack and Refill Pack) (Boehringer Ingelheim Ltd)
Spiriva Respimat 2.5micrograms/dose solution for inhalation cartridge with device (Boehringer Ingelheim Ltd)
Symbicort Turbohaler (AstraZeneca UK Ltd)
Travatan 40micrograms/ml eye drops (Alcon Laboratories (UK) Ltd) (addition)
Zyprexa 2.5mg, 5mg, 10mg, 15mg, 20mg tablets (Eli Lilly and Company Ltd)
Zyprexa 5mg, 10mg, 15mg, 20mg velotabs (Eli Lilly and Company Ltd)
PSNC has been alerted to manufacturing issues impacting on the supply of the following products. More information is available by clicking on the relevant link:
Cardura XL 8mg tablets (Pfizer Ltd)
Sinemet and Sinemet CR (Merck Sharpe & Dohme Ltd)
Please note: If a wholesaler chose to trade medicines for export and as a consequence the needs of patients in the UK were not met, the holder of the wholesale dealer’s licence could be in breach of the Regulations, and could face regulatory action against his licence, and/or criminal prosecution. This also applies to products that have not been reported as having supply problems and are therefore not listed above. There is no obstacle to exporting medicines in a way that does not impact on availability of the product to UK patients.
Contingency Arrangements
The table below summarises the contingency arrangements for the manufacturers and products that PSNC is currently most frequently receiving calls about:
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Manufacturer |
Affected Products include |
Summary of Contingency Ordering Procedure |
| ALK-Abello |
EpiPen |
If a pharmacy has difficulties in obtaining stocks of these medicines from the wholesaler they should contact the ALK Customer Services Team on 01488 686 016, emergency supplies can then be located and dispatched. The Customer Services Team are available 9am to 5.00pm Mon-Thur and 9am to 4.30pm Friday. |
| Astrazeneca | Any | If any pharmacy has problems with obtaining stock of any AZ medicine from AAH or Unichem - they should contact the Supply Chain Team on 0800 032 0501. Quick Link: SimplyAZ website |
| Boehringer Ingelheim |
Micardis Micardis Plus |
If any pharmacy has problems with obtaining stock of Boehringer Ingelheim medicines - they should contact Boehringer Inhelheim customer services on 01344 741101. Alternatively complete the emergency supply form and fax it to: 01344 741177 To download the form click here. |
| Dr Falk | Budenofalk |
If any pharmacy experiences difficulties obtaining stock of Budenofalk 3mg capsules, please contact UDG Customer Services on 01773 510123 or alternatively UDG have a web based ordering system which can be accessed online at http://62.189.215.135/wholesaler/startup.php |
| Genzyme | Renagel |
If any pharmacy has problems obtaining Renagel from their wholesaler they should complete the exceptional supply form, and fax it to Genzyme customer service fax number: 01865 774254 To download the form click here |
| Janssen-Cilag |
Topamax |
If any pharmacy has problems obtaining Janssen-Cilag products from their wholesaler they should complete the emergency supply form, and fax it to the emergency supply fax number: 01494 567401 To download the form click here. |
|
Lilly UK |
Cialis |
If wholesaler can't supply the product, contact Lilly's emergency ‘Direct 2 Pharmacy' customer service desk which is open Monday - Friday, 8.30am - 5pm (0800 0121178) |
| Lundbeck | Azilect Cipralex |
If wholesaler can't supply the product, contact Lundbeck customer service department on 01908 638935 who will be able to assist you in obtaining emergency supplies, or fax a request to 01908 638959 with the following details:
Name and Address of Pharmacy |
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MSD |
Januvia |
If wholesaler can't supply this product,then please contact MSD customer services on 01992 452094 or FAX MSD customer services on 01992 467270 with the following details: Delivery will normally be made within 48 hours. |
|
Novartis |
Femara |
Products only available via Unichem and AAH. Novartis is also able to deliver directly to pharmacies with a direct account if there are any supply difficulties with the wholesalers. To order directly call Novartis Customer Care on 08457 419 442, or fax the Novartis Pharmaceuticals Emergency Order Form to 0845 741 9443 (or email it to novartis.customercare@novartis.com) Deliveries will normally be made within 48 hours of order, depending on location. |
| Novo Nordisk | Any |
If sufficient supplies of product are not available from a pharmacy's wholesaler for any reason, Novo Nordisk can ship direct to a pharmacy if they have a patient prescription to fulfill. Urgent orders can be placed by phoning Novo Nordisk Customer Care on 0845 600 5055. |
|
Roche |
Bonviva |
If wholesaler can't supply the product, you can contact Roche Customer Care on 0800 731 5711. Delivery will normally be made next working day for orders received up until 16.00, dependent upon location. |
|
Sanofi-aventis |
Aprovel |
These products are available via three national wholesalers; AAH, Phoenix and Unichem. However if problems are experienced in obtaining these products then the pharmacy should contact Sanofi-aventis customer services directly on 0800 854 430 who will in turn facilitate an emergency direct to pharmacy order. |
| Schering - Plough Ltd | Cerazette | If wholesaler can't supply the product contact Schering Plough's customer service team on 01707 363785 |
| Shire | Fosrenol |
If any pharmacy has problems obtaining Fosrenol - they should contact Movianto on 01234 248653. Movianto can arrange a next day direct delivery. A copy of the fax order form can be accessed by clicking on the following link: Movianto Order Form |
|
UCB |
Keppra Vimpat |
If wholesaler can't supply the product, then fax UCB's national distributor UDG, on 01773 810 644 with the following details:
Link: Template Fax Back Form (PDF File) Alternatively, UDG have set up an electronic ordering system as an alternative to fax orders. This can be accessed online at: http://62.189.215.135/wholesaler/startup.php UDG Customer Services can be contacted on 01773 510123 or 01773 515170. |
| Warner Chilcott Ltd (previously Procter & Gamble Pharmaceuticals) | Actonel Once Weekly |
Warner Chilcott Ltd have provided the following statement regarding emergency supplies of Actonel: “Warner Chilcott (formerly Procter & Gamble Pharmaceuticals) does not have a direct ordering system. We make Actonel available through three wholesalers in the UK - AAH, Alliance & Phoenix and in N. Ireland - AAH, Sangers & Alliance. If you experience problems sourcing Actonel from any of these wholesalers you can contact us at 0800 0328701 (UK) and 1800 882937 (ROI). You will be asked to try with the wholesalers for three (3) working days from the first call. If you are still unable to get the product from either of the wholesalers we will be able to source an emergency supply.” |
Click on the link for a downloadable quick reference list of phone numbers: Factsheet and Contact Numbers
Managing Supply Problems in Pharmacies
Suggestions that PSNC and the NPA have received from pharmacists on steps that could be taken to help manage the problems at pharmacy level include:
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Discussing the issue with neighbouring pharmacies and consider putting in place more robust arrangements for ‘borrowing stock’ to meet urgent patient needs where required.
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Advising patients to request their prescription in good time. This is particularly important for patients taking medicines where there may be a significant clinical consequence to missing any doses (e.g. anti-psychotics, anti-epileptics, anti-cancer, etc.).
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Discuss the problems of stock availability with local prescribers. It is helpful for them to understand the sort of products involved and the fact that all pharmacies can be affected.
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It is important for prescribers not to increase prescribing lengths in response to problems. Increased demand will exacerbate the problem and sudden increases in an individual contractor’s usage may delay stock.
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Likewise, to prevent putting additional pressure on the system keep additional ‘next patient’ stock to a reasonable level.
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Most major branded medicine manufacturers have contingency order arrangements for when stock is exhausted at wholesalers. The details can be found above including a downloadable contact list for manufacturers that could be placed beside the pharmacy phone for easy access.
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Ensure staff, including locums, are aware of the pharmacy ordering procedures to ensure prompt ordering from manufacturers when stock isn’t available through the usual routes. It may be helpful to designate a member of the pharmacy team as lead on procurement.
If you have any tips for managing the problems locally, let us know and we can add them to this list.
MHRA Enforcement & Intelligence Group Contact Details
If a wholesaler chose to trade medicines for export and as a consequence the needs of patients in the UK were not met, the holder of the wholesale dealer’s licence could be in breach of the Regulations, and could face regulatory action against his licence, and/or criminal prosecution. There is no obstacle to exporting medicines in a way that does not impact on availability of the product to UK patients.
To report a suspected breach of the Regulations, please contact:
MHRA Case Referral Centre
Telephone: 020 7084 2330
Email: casereferrals@mhra.gsi.gov.uk
Links/Resources
Template letter from pharmacies to GPs (new)
NPA patient leaflet on supply problems
Frequently Asked Questions
1. I have been contacted by a wholesale dealer's licence holder who is trying to obtain stocks of medicines by way of wholesale. I don't have a wholesaler dealer's license; can I supply the requested products?
No. The RPSGB issued guidance on this in a Law and Ethics Bulletin on the 23rd August 2008. Registered pharmacies may not wholesale medicines to holders of a wholesale dealer's licence.
The holder of a wholesale dealer's licence may only obtain supplies of medicines from either:
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a) a manufacturer's licence holder or a wholesale dealer's licence holder; or
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b) a person authorised by another EEA State to manufacture or distribute medicines by way of wholesale dealing. (Ref: Regulation 9 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005)
This prevents a wholesaler dealer buying medicines, by way of wholesale, from a registered pharmacy.
Section 1.2.5 ("Wholesale Dealing") of the Medicines, Ethics and Practice guide, 32nd edition, outlines the person(s) and organisation(s) a registered pharmacy may wholesale medicines to under the Medicines Act 1968. Point "d" allows a registered pharmacy to wholesale to "holders of a wholesale dealer's licence". This does not take into account the above regulations and therefore a pharmacy should not wholesale medicines to a holder of a wholesale dealer's licence.
2. I am unable to obtain the prescribed strength of a tablet. If I supply a lower strength and endorse the prescription accordingly, will I be reimbursed correctly?
The Code of Ethics states that 'Except in an emergency, pharmacists must not substitute any other product for a specifically named product without the approval of the patient or carer and the prescriber' and under the NHS Terms of Service, a chemist is required to supply the drugs ordered with reasonable promptness. Although prescriptions should therefore normally be dispensed as prescribed, the Code of Ethics also states 'Make the care of patients your first concern', so if patient care is compromised through the non availability of a particular product, there may be a need to source alternatives and / or discuss the matter with the prescriber.
If a product cannot be obtained with reasonable promptness and the patient is in urgent need of the medicine, one option that is sometimes available is to provide ‘double the quantity' of a lower strength product to meet the prescribed dose. The patient must be counselled about such a change, because the labelling and appearance of the product will be different.
Reimbursement is always based on the prescribed strength and quantity so if contractors do ‘double up' to support patient care, they are advised to return the prescription to the prescriber for amendment to ensure correct payment. In some circumstances, for example if there is likely to be a long term supply problem, referring the prescription back to the prescriber so that an alternative product can be prescribed may be appropriate.
3. My wholesaler has been unable to supply me with a medicine because they have exceeded the quota set by the manufacturer. If I order the product through an alternative route, I will be charged a handling fee. Can I claim this back as an out of pocket expense?
Yes. Out of Pocket Expenses can be claimed in exceptional circumstances on all medicines except products in Category A or M of Part VIII of the Drug Tariff. Out of Pocket Expenses can also be claimed on appliances in Part IXB and IXC of the Drug Tariff but cannot be claimed on items in Part IXA or IXR.
Expenses linked to obtaining that individual product can be claimed, for example postage and packaging, telephone calls made in procuring the product and wholesaler handling charges. Pharmacy contractors cannot make an out of pocket expense claim for minimum order charges or telephone calls with the prescriber.
Prescriptions should be clearly marked with the out of pocket expense endorsement (XP), information on the amount being claimed and the reason for the claim (e.g. "postage & packing"). Pharmacy contractors are also required to declare the total number and value of out of pocket expense claims each month on the FP34C submission document.
Some wholesalers have recently introduced monthly fuel surcharges. They can not be claimed back as an out of pocket expense as they do not relate to a specific product. PSNC has had discussions with the Department of Health on this issue. We are working to ensure that fuel surcharges are considered as part of the annual funding discussions.
4. A manufacturer has asked me to fax a copy of a prescription before they will release stock. What information should be obscured?
As a short term measure to ensure products reach those patients with urgent need, some manufacturers are requesting copies of prescriptions before stock is released. This is not viable as a long term routine method for the management of supply and is only appropriate where stock of a product is at risk of being completely exhausted.
Patient identifiable information should not be shared without patient consent therefore any information that could be used to identify the patient needs to be obscured. As well as the patient name and address, it is necessary to obscure the barcode and EPS prescription identifier number. Although the identifier does not provide any patient sensitive information, this could allow someone access (via the Electronic Prescription Service) to the patient-sensitive information included in the electronic prescription message.
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