Branded supply problems
Branded supply problems
See here for information on manufacturing problems impacting the supply of products to community pharmacy and also for links to useful stock information pages.
Antepsin – Supply Difficulties (Chugai) – For more information click here
GSK – (Dermatology) – For more information click here
Pfizer Access – For more information click here
Supply Difficulties (Novartis) – For more information click here
Branded Shortages List
As of 28th April 2014 PSNC no longer maintains the branded shortages list.
The PSNC first began maintaining the Branded Medicines Shortages list in 2008. This had two main aims: to create a record of problems experienced by pharmacies in obtaining branded medicines needed to dispense prescriptions for patients, and to flag to holders of wholesale dealers licences products where export may breach the requirement to prioritise the needs of patients in the UK.
In recent years there have been some improvements in the arrangements operated by some of the manufacturers for ‘quota’ products, and this has led to some alleviation of the problem. But the problems experienced by pharmacies in sourcing branded medicines have now, sadly become a routine part of their work and pharmacies are making very few reports to PSNC. As a consequence our list no longer reflects those lines in which there are regular problems for pharmacies and therefore as of 28th April 2014 we discontinued the list.
If you are a community pharmacy contractor and are experiencing problems with obtaining a specific branded medicine we can assist you click here to tell us about it.
Q. Can a pharmacy legally trade medicines to a wholesaler for export?
The holder of a wholesale dealer’s licence may only legally obtain medicinal products for human use from licensed manufacturers or licensed wholesale dealers in the UK or other eeA Member states. It is not permitted for a wholesaler to obtain medicines for human use from a pharmacy that is not also a licensed wholesale dealer.
There is no obstacle to the holder of a wholesale dealer’s licence trading medicines in a way that does not impact on availability of the product to UK patients. However, if a wholesaler chose to trade medicines for export and as a consequence the needs of patients in the UK were not met, the holder of the wholesale dealer’s licence could be in breach of the Regulations, and could face regulatory action against his licence, and/or criminal prosecution. This applies both where trading medicines compounds an existing supply problem and where the action of trading medicines creates a supply problem. A list of medicines that pharmacies are regularly reporting problems obtaining can be found on the PSNC website (www.psnc.org.uk/brandedshortages). The list is updated monthly.
The enforcement authority for the Medicines Act is the MHRA. The MHRA have committed to investigating any suspected breaches of the regulations and have begun a proactive, targeted programme of inspection. To report a suspected breach, contact the MHRA case referral centre (020 7084 2330, firstname.lastname@example.org).
More detailed information on legislation to control the appropriate and continued supply of medicines to patients in the UK can be found in the guidance note, “Trading Medicines for Human Use: shortages and supply Chain Obligations” which can be downloaded here.
Q. A manufacturer has asked me to fax a prescription before they will authorise supply. Is this not a breach of information governance?
In February 2011, supply chain best practice guidance was published by the representative bodies of all parties in the supply chain along with the Government and regulators. The guidance can be found on the Department of Health website, just click here.
This guidance makes it very clear that requesting faxed prescriptions prior to supply is not acceptable as routine practice. There are a range of reasons why this is not acceptable practice, for example for information governance reasons and because of the workload burden it imposes on pharmacies.
The guidance also states that if a pharmacy is asked to fax a prescription to a manufacturer, pharmacy staff should completely obscure all patient data and prescriber details. This should include any barcodes, which could be used to obtain confidential information.