Updated best practice for ensuring the efficient supply and distribution of medicines has been developed by 11 groups representing the industry, healthcare professionals and the government, and has now been published by the Department of Health.
Medicines supply problems can occur for various reasons, says the document. These can include manufacturing problems, difficulties in obtaining raw materials, regulatory issues, changes to manufacturers’ distribution systems and fluctuations in parallel trade.
Key points in the new document, which updates the guidance first published in February 2011, are:
– an expectation that, under normal circumstances, pharmacies should receive medicines within 24 hours:
– 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;
– where manufacturers put arrangements in place to verify that a medicine is required for a genuine UK patient, they should be sensitive to the workload implications for dispensers and, as part of these arrangements, dispensers should not disclose patient- or prescriber-identifiable details; and
– the need for all in the supply chain to have contingency arrangements in place to source supply where there are supply difficulties.
Manufacturers should, where appropriate, make available and advertise a dedicated supply shortages phone helpline which has sufficient capacity and is adequately resourced with appropriately-trained personnel, says the document.
“It is essential that these arrangements are communicated to pharmacies and doctors’ dispensaries – some manufacturers have successfully used their sales force to support raising awareness of contingency arrangements,” it goes on, adding: “best practice is for details of individual supply problems and related contingency arrangements to be flagged to dispensing staff at the point of order, for example through electronic ordering systems.”
In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) – one of the organisations involved in developing the new guidance – is undertaking a series of targeted inspections so that those who are breaching existing duties to supply medicines “will face the consequences,” the Department states.
It also points out that the Supply Chain Group has developed a list of products which are in short supply, and this is listed on the Pharmaceutical Services Negotiating Committee (PSNC) website, “so that no-one has the excuse that they are not aware of supply difficulties.”
The guidance has been developed by: – Association of the British Pharmaceutical Industry (ABPI); – British Association of Pharmaceutical Wholesalers (BAPW); – British Medical Association (BMA); – Department of Health; – Dispensing Doctors’ Association (DDA); – Ethical Medicines Industry Group (EMIG); – General Pharmaceutical Council (GPC); – Medicines and Healthcare products Regulatory Agency (MHRA); – National Pharmacy Association (NPA); – Pharmaceutical Services Negotiating Committee (PSNC); and – Royal Pharmaceutical Society.
These groups have also endorsed separate new updated guidance on the trading of medicines for human use, which sets out the key legal and ethical obligations that manufacturers, wholesalers, NHS Trusts, registered pharmacies and dispensing doctors have in the supply and trading of medicines. The new document, which replaces the guidance first published in November 2009, emphasises that “patient care must never come second to business considerations.”
