Medicine transport: from pharmacy to ward, branch or institution. Conditions, documentation and responsibilities

In the Dutch medicines chain there are roughly three flows for which a carrier is engaged. The first runs from the wholesaler to pharmacies, hospitals and other institutions allowed to receive medicines; under the Dutch Medicines Act a wholesaler may only supply other wholesalers and those authorised to dispense medicines. The second flow runs inside a care organisation: from the hospital pharmacy to wards, outpatient clinics and satellite locations, or from a compounding pharmacy to branches. The third is delivery to the patient at home, which falls under the pharmacy's responsibility and is left aside here.

Who the client is determines which regulatory framework travels along. The Medicines Act describes wholesale distribution as buying, holding in stock, supplying or exporting medicines; transporting as such is not on that list. A wholesaler is the holder of a wholesale distribution authorisation and has to work in line with the GDP guidelines. A pharmacy is not a wholesaler: according to the IGJ it falls under the professional standards of pharmacists, not under GDP. Medical devices again fall under different rules, the European regulations on devices and in-vitro diagnostics.

For the carrier that matters. With a wholesaler as client, the requirements of chapters 7 and 9 of the GDP guidelines land on its desk through the contract; with a pharmacy as client, the requirements come from the agreement and from what the product itself needs. In both cases the answer to the question of how a shipment must be transported is the same: as the client and the pack prescribe.

The GDP guidelines are addressed to wholesalers, but the introduction asks other parties involved in distribution to comply with the parts relevant to them. Chapter 9 places the responsibility for transport with the supplying wholesaler: it protects the medicines against breakage, falsification and theft, keeps the temperature within acceptable limits and bases its approach on a risk assessment. If it outsources the transport, chapter 7 applies: a written contract with a clear division of tasks, the right to audit, and no further subcontracting without its approval.

In concrete terms chapter 9 requires that storage conditions during transport stay within the limits of the manufacturer or the outer packaging, that deviations are reported to the distributor and the recipient and investigated, and that medicines are delivered to the address on the delivery note, to the addressee. The wholesaler informs the carrier of the transport conditions. Its own staff must be trained, with specific attention to temperature-sensitive products; through the contract and the audits it makes sure that its carrier can handle the work as well.

The IGJ has clarified the carrier's position: a company that only transports medicines and holds them at a location for less than 72 hours needs no wholesale distribution authorisation; one that structurally stores them for 72 hours or longer does. In both cases the GDP rules must be observed, under the client's supervision. The wholesaler cannot transfer the responsibility for transport to the carrier by contract; who then remains responsible for what is explained in GDP responsibilities in outsourced transport. A carrier without an authorisation does not obtain a GDP certificate; what that means for so-called GDP-certified couriers is explained in GDP training or GDP certificate. The whole framework is in GDP and transport.

That depends on the product, and the answer is printed on the pack. European medicines carry standardised storage statements: 'Do not store above 25 °C', 'Store in a refrigerator (2 °C - 8 °C)', 'Store in a freezer', 'Do not refrigerate or freeze' or 'This medicinal product does not require any special storage conditions'. The statement 'Store and transport refrigerated' is meant for exceptional cases. Which statement a product gets follows from the manufacturer's stability data; terms such as room temperature or ambient are not allowed on a label, because they state no limit.

The GDP guidelines themselves give no figures anywhere. They require transport to stay within the limit on the pack. For products without a storage condition, or with 'do not store above 25 °C' or '30 °C', the IGJ assumes an environment representative of room temperature, 15 to 25 °C; for short transports of at most a few hours the inspectorate applies a lower limit of 2 °C, and of 9 °C for products that do not belong in a refrigerator. That is supervisory policy, not statute, but it is the framework against which compliance is assessed. Refrigerator products and products that must stay frozen form the cold chain; according to the IGJ that means 2 to 8 °C or below -20 °C.

Refrigerated transport is therefore not needed for every medicine, but 'at room temperature' is no free pass either: a car in summer gets well above 25 °C. How the conditions are met in practice is explained in temperature-controlled transport; how the temperature is measured and recorded in temperature logging in medical transport; what should happen in the event of an excursion in temperature excursion during transport.

Chapter 9 asks for packaging and containers suited to the product, the volume, the expected outside temperature and the duration of the ride. For temperature-sensitive products it asks for qualified equipment, such as thermal packaging or conditioned containers; cooling elements may not come into direct contact with the product, and whoever assembles insulated boxes must know how to do that per season. On request, the customer receives temperature information.

In practice that means for a courier: an insulated box for 15-25 °C, a cool box with pre-conditioned elements for 2-8 °C, a separation between product and cooling element, and a thermometer to measure at pickup and delivery. Whether a box is qualified for a given duration and outside temperature follows from the supplier's test data or from the carrier's own measurements; without that data it is an insulated box, not qualified equipment.

A ride goes right or wrong at the order. In practice a carrier needs beforehand: what is being shipped and in what quantity, the condition and where it comes from (label, manufacturer or the client's instruction), the delivery address and the addressee, the time window, and the contact persons on both sides. Patient data do not belong there; a ride number or the client's reference is enough to track the shipment.

Afterwards the client wants to see what happened: the actual pickup and delivery times, the name and role of the person who took receipt, and the measured temperature where that was agreed. That is not bureaucracy: it is what the wholesaler needs to meet its own responsibility under chapter 9 and to investigate a deviation. According to the EMA, GDP exists precisely to safeguard the correct storage conditions up to and including transport; the proof of that lies at delivery.

A deviation, a delay, a shipment that cannot be handed over to the right person: chapter 9 requires that deviations from storage conditions are reported to the distributor and the recipient and investigated. The decision whether a product is still usable after a deviation lies with the owner of the product or the client's quality officer, not with the carrier, who supplies the facts. A carrier that quietly delivers a shipment with a deviation takes that choice away from the client.

• Report immediately to the agreed contact, with what was measured and when.
• Do not deliver without the client's decision; keep the shipment apart under the best possible condition.
• Record what happened, who was called and what was decided, so that the file is complete.
• Enter the deviation in the client's own deviation register, so that it counts in its quality system.

Medicine transport is rarely one kind of ride. A preparation that has to be administered today is an urgent ride; the daily supply of branches is a fixed route; supplying a satellite location on fixed days is an agreement. For the condition and the proof that makes no difference; for the planning it does: with urgency the time between preparation and administration counts, with a fixed route the reliability of the window per stop.

How UrgentX carries out an urgent ride is described under the urgent medical ride; how a fixed round is agreed under fixed routes.

UrgentX Transport is a carrier without a wholesale distribution authorisation and therefore has no GDP certificate; we do not claim one either. What is true: the driver completed GDP training for transport, and our way of working is built around the transport-related parts of chapter 9: the condition you or the manufacturer prescribe, measurement of the temperature at pickup and at delivery, immediate reporting of a deviation, and delivery to the addressee with name, role and time. Your quality department can audit us. What you get from us and what we need from you is described under transporting medicines in line with GDP and under refrigerated medical transport.