The regulations for the transportation of drugs were approved by the Ministry of Health through the Ministerial Decree of July 6, 1999. With the issuance of this ministerial decree, distribution companies must adhere to the Good Distribution Standards to ensure that the drug transport courier retains the product without altering its characteristics.
The Good Distribution Standards must first provide general guidance about personnel, required documentation, premises and tools, supplies, returned products, and self-inspections.
Currently, storage temperatures are placed on drug labels. In particular, medicines cannot be kept at a temperature exceeding 30° and 25°. The ideal climate that refrigerated drug transport containers should maintain is between 2° and 8°. When the medicine does not have specific storage temperature indications, it means that it keeps its properties intact even at unaltered temperatures. A report with good distribution practices for pharmaceutical products has been issued at the European level. The risk of product expiration where control systems are lacking is emphasized in this document, and guidance on:
What does the European regulation on drug transportation provide for?
The Italian Official Pharmacopoeia, like the other reference pharmacopoeias (European and U.S.), use generic expressions to indicate the need to store a medicine at a controlled temperature.
These indications, which appear on the packaging or in the product monograph, are for the pharmacist only as precautionary information, and as a rule the indicated temperatures can be applied for active ingredients in their pure state or for galenic preparations.
On the other hand, when a medicine requires specific temperature conditions for its storage, these must be indicated by the AIC holder and displayed on the packaging as a numerical range in degrees centigrade. The pharmacist and drug distributor, in this case, are obliged to comply with the indicated storage temperature values.
In 2005, the Parenteral Drug Association, in collaboration with the European “Cold Chain” committee, compiled a specific technical report that provides a GDP guideline. The report describes many steps in the cold chain and mainly the transport methods of heat-sensitive substances, materials for primary and secondary packaging of medicines, and principles of validation of transport methods.
How to protect the drug
Protecting a drug from environmental influences requires knowledge of specific stability data including microbiological stability. Studies regarding stability at different temperatures provide us with important information about what can happen in the presence of external factors: weather conditions, delivery delays, equipment malfunction, abnormal handling/transport, primary container such as transport packaging. Weather conditions, as anticipated, can severely reduce the functioning of the active ingredient. Especially in the drug cruise phase, drug transport cooler bags must maintain a temperature suitable for transporting the product.
There are numerous tools on the market today for monitoring sensitive drugs used in the supply chain. These control devices allow monitoring of temperature and humidity conditions of the medicine. The most common systems are pouches and liquid/gel bars that maintain temperature for a long time. They are durable and inexpensive and come in different shapes. In contrast, drug transport coolers are powered by electricity and usually equipped with an alarm that can detect system malfunction. Refrigerated drug transport containers are the ideal solution for keeping the product intact without altering its function.
Useful tips for the proper transportation of drugs
Knowing the regulations for transporting drugs is very important in order to follow the directions of qualified bodies and not take risks. In addition, defining the characteristics of medicines and collecting data on shipping and delivery time is a good way to best calculate the route and then choose the best type of storage. Finally, taking note of the current weather conditions is a good way to regulate the temperature and avoid wasting energy.