Patients and healthcare professionals should be able to trust any medicine sold or supplied as fit for purpose.
To ensure this assumption can be maintained, medicines must be manufactured in licensed facilities and distributed through licensed wholesalers. At every stage, Good Manufacturing Practice (GMP) must be followed.
Assuming manufacturing has been conducted appropriately, the next step is preparing the medicines for distribution.
Often, products will need to be stored and transported at low temperatures; these are known as “cold chain products”. They must be stored and distributed with strict obedience to labelling requirements, particularly when dealing with ‘high risk’ medications such as vaccines or insulin, as these can freeze if too cold or spoil if too warm.
It’s not unusual for medical products to be transported through a range of storage locations along their journey. The arrangements from one location to another are treated as an “extension of storage”, so distributors should consider each journey as unique and take the same precautions for each step as for the journey as a whole.
Cold chain items must be packed to ensure correct temperatures are maintained. For small amounts of lower-risk products being transported over a short distance (i.e. a journey time of under three hours), distributors can usually package these in insulated containers. If the journey will be longer, icepacks can be added, although they must be careful not to allow icepacks to touch the medicine.
For larger volumes refrigerated transport may be required. This is particularly important if the journey may be delayed. Ensuring the correct medical refrigeration is used throughout the journey is vital to safe delivery.
For pharmacies receiving cold chain items, these must be immediately stored in a refrigerator before checks are made to ensure transportation was completed with appropriate care.
If the pharmacy cannot confirm products have been transported appropriately, the delivery must be quarantined whilst the supplier is questioned. Until the pharmacy is convinced products are safe, they should not be used or sold.
Pharmacists must ensure medical refrigeration can store products between 2 and 6 degrees C, contains an accurate thermometer, is checked daily and minimum and maximum temperatures are recorded.
It’s recommended for pharmacies to use purpose-built refrigeration units for medication, especially if handling high-risk products.