Branded medicine shortages

Branded medicine shortages

Over recent years, contractors have continued to experience difficulties in obtaining certain branded medicines.

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Background

At the heart of the problem are changes in the European import and export market. A weak Pound and strong Euro had 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 (this document is currently being updated)

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

Branded Medicine Manufacturers’ Wholesaler Distribution Arrangements – 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.

Department of Health Supply Chain Group

Following the Ministerial Summit in March 2010, a set of actions where agreed for the Department of Health Supply Chain Group.  The group is attended by DH, PSNC, RPS, NPA, BAPW, BAEPD, ABPI, MHRA, Patients Association, DDA, BMA & the devolved nations.

Since 2013 one of the key objectives of PSNC has been to work with the Supply Chain to reduce the burden on community pharmacies when purchasing branded medicines.  One of the measures we have been promoting is a standard order form for contingency stock which can be adopted by manufacturers. ABPI have so far opposed this standardised form, PSNC will however continue to press the matter.  The other has been working with the BAPW and ABPI to seek to reform the codes used by wholesalers when products are unavailable to pharmacies to purchase.  This work involves expanding the current codes used by wholesalers to help provide more useful and consistent information to community pharmacies.

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 at the link below:

Trading Medicines for Human Use: Shortages and Supply Chain Obligations (PDF File/Updated January 2013)

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, and select the relevant document, to download a copy of the guidance in full.

Best Practice for Ensuring the Efficient Supply and Distribution of Medicines to Patients (PDF File updated January 2013)

APPG Inquiry into Medicine Shortages

The All Party Pharmacy Group published the report of their inquiry into medicines shortages on 15th May 2012.  The enquiry was launched in November 2011.  The inquiry called for all stakeholders in the medicines supply chain including pharmacy bodies, manufacturers, wholesalers and government departments provide both written and verbal evidence.

The PSNC, Pharmacy Voice and the Royal Pharmaceutical Society responded to the APPG’s report into medicines shortages.

All three bodies were pleased to see Parliamentarians undertaking an independent investigation into an issue that requires urgent resolution. The organisations gave evidence to the inquiry with the intention of putting all the facts on the table to help resolve the current medicine shortages suffered by patients. MPs heard from organisations representing every step in the medicines supply chain and the particular strains upon each part of the chain in attempting to deliver medicines to patients on time.

The three bodies considered the following issues to be key to finding a resolution to medicines shortages:

Pharmacies should have to wait no more than 24 hours for supplies of medicines – patients have a right to expect that this commitment, which is supported by the Department of Health, is met consistently

To help meet this commitment, emergency supply arrangements must be more responsive, using the warehousing and distribution infrastructure of wholesalers. Additionally, medicines quotas must be flexible enough to meet patient needs at local level

Every organisation and individual involved in the medicine supply chain must operate with the overriding aim of meeting the needs of patients. To do this effectively, those delivering medicines via the medicines supply chain must act within the parameters of law and relevant professional ethics

The evidence compiled by the APPG reinforces the views of all pharmacy bodies, delays to the supply of medicines to patients cause distress, risk patient harm and are unacceptable. Pharmacists across the UK will continue to work hard to get medicines to patients promptly.

The bodies express their thanks to Kevin Barron MP and all members of the All-Party Pharmacy Group for undertaking this difficult task and we look forward to working with all stakeholders to deliver the recommendations contained in the report.

On the publication of today’s report on medicines shortages from the All-Party Pharmacy Group, Sue Sharpe, Chief Executive of PSNC said:

“Too often pharmacists have to really struggle to source medicines for their patients which should be readily available. We wholeheartedly welcome the report, as it shines a much-needed spotlight on an issue we have been pushing for action on for a number of years.

“It’s our view that the Department of Health has been too focussed on the supposed constraints EU legislation has on the Government, rather than looking to how we can solve the problem together through measures such as greater flexibility on quota arrangements, standardisation of emergency supply arrangements and locally managed buffer stocks, which will help to better translate the principles outlined in the joint best practice guidance.

“We thank the All-Party Group for their powerful call to action. The Department of Health must respond before anyone else gets seriously hurt.”

APPG Report into Medicines Shortage May 2012

Pricing of branded NHS medicines

In June 2013, the Department of Health proposed revisions to the statutory scheme to control prices of branded NHS medicines to make it work more effectively, and to align it more closely to core parts of the voluntary Pharmaceutical Price Regulation Scheme (PPRS).

In response, PSNC stated its view to the Department of Health that there is need to incorporate obligations on manufacturers to ensure prompt supply to patients through their chosen dispenser.

See: PSNC response to Department of Health consultation on statutory PPRS (July 2013)

Reporting Problems

Contractors who experience problems in obtaining medicines because of quota arrangements can feed this to the PSNC Dispensing and Supply Team to support PSNC’s ongoing representation of issues in the supply chain. PSNC passes 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 Dispensing and Supply Team.

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: 0203 080 6330
Email: casereferrals@mhra.gsi.gov.uk


FAQs

Q. 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:

  • a) a manufacturer’s licence holder or a wholesale dealer’s licence holder; or
  • 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.

Q. 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.

Q. 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 unlicensed specials and imports and products listed in Category A or M of Part VIIIA 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.

Q. A manufacturer has asked me to fax a copy of a prescription before they will release stock. What information should be obscured?

All patient and prescriber information should be obscured.

Note, 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.

Whilst there may be a need in exceptional circumstances for a manufacturer to verify a request, routine checking of proof of prescription is rarely acceptable because of the need to safeguard patient confidentiality and the associated administrative burden.


Related Resources

NPA toolkit on medicines supply chain



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