New guidance from the government establishes for the first time the principle that,“under normal circumstances,” UK pharmacies should receive medicines from suppliers within 24 hours.
Moreover, all parts of the pharmaceutical supply chain should have contingency arrangements in place to source medicines where there are supply difficulties, says the joint guidance, which has been produced by organisations representing the supply chain, regulators and government.
The guidance acknowledges that medicine supply problems can occur for “various reasons, such as manufacturing problems, difficulties in obtaining raw materials, regulatory issues, changes to manufacturers’ distribution systems and fluctuations in parallel trade,” and it emphasises 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.”
In another key point, the guidance says 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.” Also, as part of these arrangements, dispensers should not disclose details which could identify the patient or the prescriber.
Prescribers should where appropriate consider a change in medication for patients and advise them to request prescriptions in good time where there are supply difficulties, particularly for patients for whom there would be a significant clinical consequence to missing any doses of their medicine. such as those taking antipsychotics, anti-epileptics and anti-cancer drugs, it adds.
As part of the exercise, the Medicines and Healthcare products Regulatory Agency (MHRA) is undertaking a series of targeted inspections “so that those who are breaching existing duties to supply medicines will face the consequences,” and a list of products in short supply has been published on the website of the Pharmaceutical Services Negotiating Committee (PSNC) “so that no-one has the excuse that they are not aware of supply difficulties,” the document notes.
PSNC chief executive Sue Sharpe describes the guidance as “a step in the right direction,” and welcomes the fact that it has been agreed by all parts of the supply chain, including manufacturers. However, she adds, 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.”
Ms Sharpe noted that the PSNC is particularly pleased that the guidance explicitly recognises that requesting faxed prescriptions prior to supply “is not acceptable routine practice,” and this was also welcomed by Ian Facer, chairman of pharmacy representative groups Pharmacy Voice and the National Pharmacy Association (NPA).
“Where quotas are used by manufacturers to control the supply of medicines, the guidance states that they must be flexible and equitable. Currently, quotas are being applied bluntly, causing inconvenience and distress for pharmacists and patients. This means that many patients, sometimes with serious conditions, have had to wait for medicines while the pharmacist faxes an anonymised copy of their prescription to prove to the manufacturer that the need is genuine,” said Mr Facer.
He also welcomed the guidance’s establishment of the principle that pharmacies should receive medicines within 24 hours of ordering them, but added: “we would have preferred a strong obligation on suppliers.”
Martin Astbury, president of the Royal Pharmaceutical Society (RPS), warned that the real test will be how effectively the guidance is implemented by all parties, “particularly the focus of the Scottish Government, the Welsh Assembly and the Department of Health on making the supply chain work for patients.”
The snowstorms of last December had caused a crisis in the supply of medicines to Scottish pharmacies, with 92% of pharmacists in Scotland surveyed by the RPS saying they had been prevented from dispensing a prescription because they were not able to obtain the medicine.
“When pharmacists have to rely on a single supplier, patients feel the consequences when something goes wrong,” said Alex McKinnon, director for RPS Scotland.