The cost of packing, labeling, storing, and distributing a drug product is an important aspect to calculate the overall expenses of a clinical trial and to ensure that the sponsor counts on enough funds to conduct a clinical study.
This article will summarize the main costs involved in packaging, labeling, storing, and distributing drugs to be used in clinical trials.
We will also provide a summarized real-world quote example for the services required to handle a drug in a typical phase 2 clinical trial in oncology.
What is the cost of packaging, labeling, storing, and distributing a drug in a clinical trial?
The answer to this question depends on several elements, but usually the cost of packaging, labeling, storing, and distributing a drug in a clinical trial may be in the average range of US$40,000 to 100,000 per study.
Why are drug packaging, labeling, storage, and distribution services needed in clinical trials?
The handling of drugs —and related logistics— is essential to conduct clinical trials.
Once the drug products have been manufactured for a clinical study, they have to be packed, labeled, stored, and sent to the pharmacies of clinical sites where the patients will be recruited and treated.
Biotech and pharmaceutical companies may subcontract the services of a depot specialized in receiving the drug product batches, and preparing them to be stored and then shipped to hospitals as required.
Biotechnology and pharmaceutical companies normally do not have the internal teams, infrastructure, or capabilities to perform drug logistics tasks, so hiring the services of a specialized drug distributor makes sense.
From a regulatory perspective, counting on the support of a drug depot becomes fundamental as clinical trial drugs must be handled by authorized distributors only, with qualified staff and standard operating procedures that guarantee the integrity and quality of the products.
In fact, the trajectory of the drug from the manufacturing site (origin) to the hospital’s pharmacy (final destination) must always be through the hands of officially qualified companies.
Regarding labeling, clinical trial drugs must be labelled according to regulatory authority requirements.
For instance, European regulation 536/2014 on clinical trials on medicinal products for human use, states:
“Investigational and auxiliary medicinal products should be appropriately labelled in order to ensure subject safety and the reliability and robustness of data generated in clinical trials, and in order to allow for the distribution of those products to clinical trial sites throughout the Union.”
Therefore, appropriate labeling of the drugs is a basic element in clinical studies.
As far as packaging is concerned, it is important to differentiate between primary and secondary packaging.
The primary packaging consists of those packaging components that have a direct contact with the product (i.e. bottle, blister).
The primary package protects from environmental hazards that may cause product deterioration.
The packaging external to the primary package is the secondary packaging.
The secondary packaging provides an additional layer of physical protection.
Drug depot companies usually offer secondary packaging services in the context of clinical trials.
Finally, drug depots are in charge of storing the drugs at their facilities —under the required temperature conditions—, until they are finally shipped for use to clinical sites.
In most cases, drugs are sent from depot to the sites in a gradual manner.
Site pharmacies have limited space, so all the drug amount needed for the study cannot be shipped at once.
According to a predefined plan, the distributor will progressively ship the medicines to the hospital’s pharmacy, depending on how many patients are recruited in that site.
What are the factors influencing the cost of drug packaging, labeling, storage, and distribution in a clinical trial?
The main factors influencing the cost of drug packaging, labeling, storage, and distribution in clinical trials are: (1) amount of drug needed, (2) number of clinical sites, (3) temperature conditions, (4) number of shipments from source to depot, and (5) number of shipments from depot to sites.
Firstly, of course, the larger the amount of drug needed (e.g. more vials or bottles), the higher the logistics costs.
The cost of packaging and labeling is typically based on units, so when the number of vials, bottles, or boxes increases, the total cost of the services increases as well.
Secondly, the number of hospitals recruiting patients in a clinical study has a direct impact on distribution costs.
More participating sites implies more shipments of drugs and additional shipping costs.
Third, the temperature conditions required to handle the drug product is a very important factor.
For instance, storing and shipping vials at -80 or -20ºC of temperature will be a lot more expensive than handling the products at room temperature.
The management of frozen medicines becomes costly since drug depots have to deploy freezers, temperature monitoring systems, particular shipment conditions (use of ice), and temperature monitoring devices in each shipment.
Finally, two more aspects need to be considered: the number of drug shipments from the manufacturing site to the depot facilities, and the number of shipments from the depot to the hospital’s pharmacies.
In order to keep costs low, the minimum number of shipments should be performed.
However, this is not always possible due to space constraints at the hospitals (local pharmacies are not able to store large amounts of products, as they may have limited space due to other trials).
A drug packaging, labeling, storage, and distribution quote example
Let’s describe the costs involved in managing an antiangiogenic agent in the form of tablets at ambient temperature, in a phase 2 clinical trial in oncology.
A total of 2,500 bottles of drug will be managed.
Let’s assume a study duration of 36 months, and the need for customized labeling, storage, and regular shipments to six hospitals:
1.- Initial planning
The drug depot staff will conduct initial meetings to plan the project and generate the required set-up documentation.
Initial planning total: $2,000
2.- Monthly management
This section includes a monthly fee corresponding to administrative work, reporting, and technical support, during 36 months.
Monthly management total: $25,000
3.- Drug arrivals in depot
The drug is manufactured and sent in separate batches to the depot in charge of distribution, during the duration of the trial. We can assume a total of five resupplies from source to depot. For each arrival of drugs, the depot personnel will have to receive, review, and store the material.
Drug arrivals in depot total: $2,500
4.- Drug storage
The drug must be stored at ambient temperature (15-25 ºC) at the depot’s facilities during 36 months.
Drug storage total: $3,600
Customized labels will be designed, printed, and placed on the medicinal products, for a total of 2,500 bottles of drug.
Labeling total: $10,000
6.- Distribution to sites
Assuming six hospitals and ten shipments per site, the quotation will include a total of 60 drug shipments. For each shipment we include shipment preparation, packaging materials, temperature monitoring devices, and courier costs.
Distribution to sites total: $21,000
TOTAL COSTS = $64,100
The cost of packaging, labeling, storing, and distributing a drug in a clinical trial may be in the range of US$40,000 to 100,000 per study.
The cost of managing drugs in a clinical trial depends on the quantity of drug required, the number of hospitals, the temperature conditions, the number of shipments from source to depot, and the number of shipments from depot to sites.
Selecting a qualified depot with high quality service is a key operational aspect when planning a clinical trial.
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