Current Issues
Temperature Controls
HDA members have concerns around what they observe as inconsistencies and inequalities in the regulatory environments governing the end-to-end supply of medicines, specifically in relation to the transportation of ambient medicines and expected temperature controls.
The journey of this type of ambient medicine from manufacturer to patient involves the product being moved through a supply chain with differing standards. Medicines originate with manufacturers (regulated by the MHRA under GMP) and transferred to wholesalers (regulated by the MHRA under GDP). They are stocked at retail, distance, and other types of pharmacies (regulated by the GPhC) and then dispensed to patients potentially via homecare/prescription delivery or collection services/Royal Mail to patients (regulated by GPhC).
The current variable situation could mean that a medicine might be:
- Delivered to a wholesaler from a manufacturer in a curtain-sided trailer (not in a temperature-controlled vehicle) into a wholesaler’s warehouse (in compliance with GDP);
- Delivered to a retail pharmacy in a temperature-controlled vehicle to then be held in a non-temperature controlled pharmacy and delivered to a patient in a car; or
- Posted via Royal Mail which is not temperature-controlled.
As this scenario highlights, a typical medicine is under the control of a wholesaler, on average, for only approximately 40% of the time during its journey through the supply chain, and whilst in the control of the wholesaler the product spends at least 95% of that time in a temperature-controlled warehouse. It therefore cannot be right that there are different and conflicting regulatory requirements and enforcement regimes.
We believe that HDA members operate to some of the highest standards in the medicines supply chain, and our members are committed to complying with all applicable legislation. Alongside this, HDA members are subject to a rigorous regime of internal and external audits which further validate the integrity of medicines whilst under their control. We therefore question the current MHRA expectation of wholesalers regarding temperature-controlled environments for vehicles, where there is no parity with GPhC requirements. At a time when wholesalers are already contending with COVID-19 cost implications, Brexit planning, and warehouse air cooling, this expectation – and the MHRA’s current enforcement of it – is placing a large financial burden on the sector. Expectations also appear contradictory to the positions taken by several competent authorities in other EU Member States, who have differing interpretations of the GDP requirement. For example, the ANSM in France clarified their position on the safety of ambient drugs when temperatures reach upwards of 40°C in heatwaves:
“Temporarily going beyond these temperatures (a few days to a few weeks) does not have any impact on the stability of the drugs…….it has been shown that after several weeks exposure to a controlled constant temperature of 40°C drugs are not deteriorated. Thus a few days of exposure of a drug to temperatures higher than 30°C will be without effect on its quality.”
In addition, the HDA has been given a copy of a data study which was undertaken in Germany by an independent testing company on behalf of a pan-European medicines wholesale company. This study supported using non-controlled ‘last-mile’ delivery vehicles because it demonstrated that any exposure to temperatures outside labelled conditions was of short duration and of limited severity. This study has been used by medicines wholesalers in discussions and decision-making with German regulators in support of not having to use temperature-controlled vehicles in localities which have more varied continental climates than the UK’s maritime conditions.
The HDA and our members appreciate that the MHRA does not currently have any jurisdiction over the supply chain in pharmacy and beyond, but we do believe there needs to be one consistent approach across the whole of the medicines supply chain, from end-to-end, in relation to the requirements for the temperature control of medicines during distribution.
At present, with no uniform position across the supply chain, there is an inequitable and discriminatory position for our members. The HDA and our members are keen to work with the MHRA, GPhC and DHSC in a collaborative manner in order that a comprehensive, objective consultation can be carried out to find an aligned solution, without anomalies, to ensure equality of enforcement of regulation and penalties across all the regulators, which will respect the end-to-end integrity of a medicine and guarantee patient safety. It is critical for our members that we can achieve agreed clarity and resolution regarding anomalies on this issue across the medicines supply chain, and that a fair, equitable and proportionate regime is in place.
The HDA is therefore looking to arrange a joint stakeholder and regulators meeting with the MHRA, representative of the whole medicines supply chain – including the DHSC and GPhC. The HDA has also shared its own document for MHRA consideration, proposing what its member companies believe is a sustainable and pragmatic way forward for one specific part of the wholesale distribution process.
