On September 7 2013 things got serious for pharma wholesalers, logistics providers, couriers and pharmacies. This day the GDP guideline (Good Distribution Practice) for the transport of human medicine came into effect. This guideline sets special requirements on the distribution practices of temperature-sensitive drugs. It states that manufacturers´ storage requirements must also apply to all downstream participants in the supply chain. This means that the cold chain must be maintained from A to Z. The directive, however, grasps into the void at one point because what happens after the temperature-sensitive medication has crossed the pharmacy’s counter remains a blank spot.
And from the pharmacy? Back home!
In 2014 26 million cold chain requiring medication were handed out only to statutory insureds by German pharmacies. The total amount is consequently much higher. Cold chain requiring drugs include, for example, medicines for the treatment of growth disorders, medicines against rheumatism and arthritis, against asthma, multiple sclerosis and for fertility enhancement. These drugs must be transported and stored at a given temperature. Otherwise they lose their effectiveness; can even endanger the patient´s health.
Anyone who believes that only the way home represents a hurdle for the drug´s integrity could not be farther from the truth. Many patients store their temperature-sensitive medications wrongly at home without their knowledge. An observation study commissioned by the British Society for Rheumatology in 2016 revealed that of the 255 study participants only 17 stored their medication at the recommended temperature range at home.
Storing temperature-sensitive medicine at home
Temperature-sensitive medications are stored at different locations by the patients in their home. Popular places are refrigerator and the bathroom cabinet. Even though the fridge is the most appropriate place for temperature-sensitive medication, it still carries risks. It depends on where the medicine is stored in the fridge. It should not be placed near the back wall, as there the medicine is at stake of freezing and thus of becoming ineffective. A compartment in the refrigerator´s door is also the wrong place. Here the temperature fluctuations are too great. The vegetable compartment is most appropriate to be used – the temperature varies the least. Regardless of this, the domestic refrigerator is not the best place to store medicine in terms of hygiene.
Some brief words on the bathroom cabinet. For temperature-sensitive drugs, this is the completely wrong place due to its high humidity and high average temperature. But even for more insensitive medications the storage there is problematic.
Medicine fridge for home use
Proper medical refrigerators for home use are not available as of yet. Medicine refrigerators are at the moment being used to store temperature-sensitive for professional use in laboratories, clinics, pharmacies etc. at a large scale. There are smaller versions for sure like the Dometic miniCool, Kirsch Med-100 or Liebherr MEB-140-0. However, their internal volumes range between 30 and 140 liters. For private users this is simply too big and with up to 1.000 EUR too expensive to purchase. Especially when the patient is undergoing only a temporary treatment with temperature-sensitive medication.
Storing medication safely at home
Against the background of a growing number of temperature-sensitive, high-priced medicine, medicine refrigerators for private use will get into the focus of health care systems[i]. In particular for health insurance companies as cost carriers of the drugs, safe medication cooling at the patients´ home could save them money. At present, 50.000 daily doses are spoiled every single day because their cooling has not be ensured. If the home medicine refrigerator enters the patient´s home, finally the GDP guideline truly would be implemented: The seamless cold chain from A to Z.
[i] The author in particular refers to the German health care system.