To ask the Scottish Executive what its position is on reports that pharmacies are experiencing a shortage of drugs in (a) Dumfries and Galloway for cancer treatment and (b) for the treatment of other conditions nationally.
Medicines shortages can occur for a number of reasons, including manufacturing problems or difficulties in obtaining raw materials. Supply issues can also occur as a result of distribution problems or as a result of fluctuations in parallel trade.
The Scottish Government is monitoring closely information about supply problems experienced by community pharmacists and is in contact with organisations representing the various parts of the supply chain, including the Association of the British Pharmaceutical Industry and Community Pharmacy Scotland. Medicines shortages is a UK-wide problem therefore Scottish Government officials are also in touch with officials in England, Wales and Northern Ireland to review the situation at a UK level.
Article 81 of EC Directive 2001/83/EC requires that marketing authorisation holders and distributors of medicines ensure, within the limits of their responsibilities, appropriate and continuous supplies of the medicines so that the needs of patients are met. This requirement was transposed into UK medicines legislation in 2005. In November 2009, guidance was issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and other key organisations to help manufacturers, wholesalers and others in the supply chain on their existing legal and ethical responsibilities relating to the supply of medicines. This guidance, which was updated and republished in December 2010, was drawn to the attention of NHSScotland. The guidance and other relevant information on medicines shortages and supply chain obligations can be found on the MHRA’s website at www.mhra.gov.uk.
In Scotland, the NHS (Pharmaceutical Services) (Scotland) Amendment Regulations 2010 (SSI 2010/128), introduced on 1 May 2010, place an obligation upon pharmacists who dispense NHS prescriptions to use all reasonable endeavours to provide prescribed drugs and appliances with reasonable promptness and not to engage in activity which might delay or prevent the dispensing of prescribed drugs and appliances to NHS patients. The amendment regulations also place on pharmacists an obligation to contact the prescriber to discuss alternative arrangements where there is likely to be, in that pharmacist’s opinion, a clinically significant delay to the dispensing of prescribed drugs or appliances. A copy of the amendment regulations can be found at:
http://www.opsi.gov.uk/legislation/scotland/ssi2010/pdf/ssi_20100128_en.pdf.