Branded Medicine Shortages

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The Branded Medicine Shortages List

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Background

Over recent years, contractors have continued to experience difficulties 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 resolve the problem, and 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.

Further information:

Branded Medicine Supply Shortages Factsheet

Reference list including key affected products and manufacturers' phone numbers:

Branded Medicine Manufacturers' Quick Reference Guide

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:

• 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.

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/Updated December 2010)

Best Practice Guidance for Ensuring the Efficient Supply of Medicines

Best practice guidance for ensuring the efficient supply and distribution of medicines to patients has been jointly published by the representative bodies of all parties in the supply chain along with the Government and regulators.

The key points in the guidance are:

An expectation that, under normal circumstances, pharmacies should receive medicines within 24 hours;
Requesting faxed prescriptions prior to supply is not acceptable routine practice and where verification is necessary, dispensers should not disclose patient or prescriber identifiable details;
The importance of regular communication between manufacturers and wholesalers so that all parties have a good understanding of the supply and demand for particular products;
The need for all in the supply chain to have contingency arrangements in place to source supply where there are supply difficulties;
Prescribers should, where appropriate, consider a change in medication for patients and advise patients to request prescriptions in good time where there are supply difficulties.

Responding to the publication of the guidance, PSNC Chief Executive Sue Sharpe said:

“We welcome this Guidance as a step in the right direction. Given that a collaborative approach will be crucial in addressing this issue, it is positive that has been agreed by all parts of the supply chain, including manufacturers. We are also pleased that the guidance explicitly recognises that requesting faxed prescriptions prior to supply is not acceptable routine practice.

“However, there is much still to be done if pharmacies are to be able to give confidence to patients who have experienced delays in sourcing the medicines they need. We will continue to do all we can to improve the situation, and will look to explore with the Department how they might take enforcement action to ensure appropriate practice going forward.”

Click on the link below to download a copy of the guidance in full

Best Practice for Ensuring the Efficient Supply and Distribution of Medicines to Patients (PDF File)

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 (0844 381 4180).

Link: Online Feedback Form

MHRA Enforcement & Intelligence Group Contact Details

If a wholesaler chose to trade medicines for export that were in short supply in the UK and as a consequence the needs of patients in the UK were not met, the holder of a wholesale dealer's licence could be in breach of the Regulations, and could face regulatory action against his licence, and/or criminal prosecution. The requirements apply to all holders of a wholesale dealer's licence including pharmacists and pharmacy owners who hold a wholesale dealer's licence.

To report a suspected breach of the Regulations, please contact:

MHRA Case Referral Centre
Telephone: 020 3080 6330 / 6168
Email: casereferrals@mhra.gsi.gov.uk

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