Stricter monitoring for UK supply chain
pharmafile | March 5, 2010 | News story | | parallel trade, supply chain
New measures to ensure that the UK doesn’t suffer from shortages of prescription medicines have been announced by the government.
Changes in the UK supply chain in recent years have resulted in some medicines being in short supply, including particularly vital drugs such as cancer treatments.
New supply chain controls by pharmaceutical companies and the emergence of parallel exports from the UK to the rest of Europe have been identified as the leading causes, but profiteering by pharmacists and even hospitals has also been suspected.
The government has now promised ‘tougher action’ to guarantee medicines supplies, including enforcing existing regulations more closely, and reminding pharma companies and wholesalers of their responsibilities.
The new measures were agreed in an emergency summit chaired by health secretary Andy Burnham and health minister Mike O’Brien that brought together industry, wholesalers, community pharmacist and NHS representatives.
Preventing UK medicine shortages
The actions agreed by all sides at the summit were:
• A more explicit duty for manufacturers and wholesalers to ensure sufficient stocks of medicines are available to NHS patients
• A series of targeted inspections by regulator the MHRA
• Tougher standards for the issue of licences for medical wholesalers
• Development of best practice guidance on how supply difficulties should be dealt with by doctors, pharmacists, manufacturers and wholesalers
Targeted inspections will mean manufacturers and wholesalers risk losing their licences and face prosecution if they breach legal duties on supply of medicines.
At the same time, pharmacists and doctors risk being called to account by their professional bodies for breaching their ethical obligation to put patients first.
Health minister Mike O’Brien said: “We have reached agreement on a way to help NHS patients get the medicines they need. Manufacturers, wholesalers, pharmacy bodies, regulators and Government all agreed to work together to resolve the issue.
“The lower value of sterling has resulted in some medicines destined for NHS patients being sold abroad for extra profit by a small number of unscrupulous speculators. Some pharmacists have had trouble getting hold of certain drugs because of this.”
He continued: “For months, I have been seriously concerned about the potential impact of this on patients. It is unacceptable that some people have already had to wait longer than they should have to get their medication. Patients must come before profits. This new package of measures will help to ensure that NHS patients do not suffer and get the care they need when they need it.”
ABPI director general Richard Barker said: “Getting vital medicines to NHS patients is the job of all of us in the medicines supply chain and so we welcome the collaborative approach being taken by the Forum.
“We also strongly support the proposal to raise the standards to be applied to the licensing of wholesalers, to reinforce their mission to deliver medicines to meet the needs of UK patients, who should be at the centre of all of our activities.”
Sue Sharpe, chief executive of pharmacist representative body the Pharmaceutical Services Negotiating Committee, said: “Nothing is more important to community pharmacists than obtaining and dispensing the medicines patients need. A collaborative approach is crucial to addressing this issue, and we are pleased that all parts of the supply chain are committed to working collectively and constructively.
“The robust package of measures that has now been agreed, including supporting all parts of the supply-chain with best practice guidance, will be instrumental in addressing this continuing problem.”
Overall, the government approach is to enforce existing laws and regulations, rather than introduce new legislation or systems. Wholesalers and manufacturers already have a legal duty to ensure an ‘appropriate and continued’ supply of medicines, and pharmacists are bound by a code of ethics to put patients ahead of profit.
The Government issued new guidance in November 2009 to clarify legal and ethical duties, as well as the consequences of breaching them. NHS chief executive David Nicholson and chief pharmaceutical officer Keith Ridge also wrote to NHS hospitals in February 2010 reminding them that they should be not be trading in medicines as it could jeopardise patient care.
After the summit date was arranged, it came to light that one hospital in particular – the Royal Surrey in Guildford – had been re-selling medicines for profit. The hospital defended its actions, saying it had been given the all-clear by foundation trust regulator Monitor, and said it had ensured no medicines in short supply had been sold on.
The Agreement
Listed below in full are the provisions of the new agreement. The government says there was ‘broad agreement’ from the organisations represented at the summit, but some are yet to formally ratify the agreement.
• 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.
The Medicines Supply Summit was held at the Department of Health on 2 March.
It was attended by the following organisations: Dispensing Doctors’ Association, Pharmaceutical Services Negotiating Committee, National Pharmacy Association, Royal Pharmaceutical Society of Great Britain, BMA’s GP Clinical and Prescribing Committee, Community Pharmacy Scotland, Pharmaceutical Contractors’ Committee – Northern Ireland, Pharmaceutical Society of Northern Ireland, Pharmaceutical Adviser, Welsh Assembly Government, Chief Pharmacists, The ABPI (England and Wales offices) Community Pharmacy, Wales, Ethical Medicines Industry Group, British Association of Pharmaceutical Wholesalers.
Related Content
Medicines recalled after FMD alert
The MHRA has warned patients that batches of drugs for Parkinson’s, epilepsy and blood clots …
No-deal Brexit could cause shortages and higher prices, healthcare distributors warn
The Healthcare Distribution Association (HDA) has warned MPs that Britain could face shortages of medicines …
The missing link: Blockchain in clinical data management
Louis Goss explores the potential uses for the much-hyped technology blockchain as a tool to …
