There are numerous medicines that need to be kept cool. In 2014, 26 million refrigerated drugs were sold only to stately insured persons by Germany pharmacies. The total amount is therefore far higher. The number of temperature-sensitive drugs has steadily increased in recent years and will probably continue to do so in the future.
Cold chain, refrigerated, cold chain requiring, ambient?
The conceptions sometimes differ in literature and are not used uniformly. In general, a distinction is made between different temperature ranges. Refrigerated drugs must be transported and stored between 2 °C to 8 °C. This also holds true for medication the patient keeps at home. They must be placed in the fridge and here in the vegetable compartment at best. This is because the temperature fluctuations are lower here than in a door compartment or even worse near the refrigerator´s back wall. Then there are drugs which can be stored at ambient temperature, between 15 °C and 25 °C – so called ambient zone – at home. In some cases, short-term temperature excursions of up to 30 ° C are acceptable. It is essential to read the package leaflet carefully, as not every doctor or pharmacist will tell the patient how to store the medicine at home. At worst, the drug is no longer effective when the patient uses it.
In the last blog post we talked about the fact that the domestic refrigerator is not necessarily the right place to store temperature-sensitive medication. Temperature fluctuations and lack of hygiene make it rather a temporary solution. But due to a lack of alternatives some medication need to be put in the refrigerator, because otherwise they get ineffective. Which medication to treat which diseases are so temperature-sensitive?i
- Biologicals / biosimilars against rheumatism: Rheumatism is a disease with many faces. Over 100 rheumatic diseases are recorded. Affected persons have pain in connective tissue, tendons, joints or muscles. In Germany alone, there are about 10 million people suffering from a form of rheumatism. Not all of those affected are treated with biologicals or biosimilars. This form of therapy is only used if two therapies with basic drugs have not been effective. Biologicals used for rheumatism are, for example, Orencia®, Humira®, Kineret® or Enbrel®. Biosimilars, non-identical but equally effective and cheaper imitation products of biologics, are, for example, Inflectra © and Remsima ©. The costs for these drugs are high for the health insurance companies. A dose of powder of Inflectra © costs over 700 €, 4 ready-made pens from Enbrel approx. 1.800 €.
- Crohn’s disease: Crohn’s disease is a chronic inflammatory disease, which occurs in batches. Persons affected suffer from ulcerative inflammations, which can affect the entire digestive system. Usually, however, the transition from the thin to the intestine is affected. In Germany, 400.000 people are suffering from Crohn’s disease. Patients are treated with biologicals or biosimilars only if they are suffering from moderate or severe Crohn’s disease or if they do not tolerate common drugs for this disease. Biopharmaceuticals used against Crohn’s disease are Humira®, Simponi®, Remicade®, Entyvio® or Stelara®. An injection solution Stelara © in a pre-filled syringe costs about 5.000 €.
- Multiple sclerosis: Multiple sclerosis (MS) is a disease of the central nervous system. The progression of the disease and complaints are very different. In general, patients suffer from motor disorders, numbness of the skin or stiffness. In Germany, 200.000 people suffer from MS. Biologicals or biosimilar are only used when a series of therapies have already been carried out ineffectively. However, this step-up pyramid is critically discussed in specialist circles. Biopharmaceuticals used in MS are, for example, Entyvio ©, Lemtrada ©, or Tysabri ©. An infusion concentrate of Tysabri © costs the health insurance over 2.000 €.
- Diabetes type 1: Type 1 diabetes is a chronic metabolic disease, in which the body’s insulin is no longer produced. As a result, the blood glucose level increases. Those who are not in therapy have great thirst, suffer from constant fatigue, severe urge to urinate, dry skin and infections. 300.000 people in Germany have type 1 diabetes. The therapy of this disease consists in the injection of insulin depending on the blood glucose level. The common insulins are, for example, Humalog®, Insuman Basal Aventis® or Lantus®. Three ampoules Lantus © cost about 80 €.
- Growth disturbances: Growth disorders can occur, among other factors, if there is a genetic disposition, if the hormonal balance is disturbed, or if metabolic disorders do exist. In Germany, one in 5.000 children suffers a growth disorder. These are a total of approximately 21.000 children. A therapy is carried out from early childhood on to the end of the growth phase. The therapy costs for a hormone treatment are very high, per patient up to 14.000 € per year. Hormone preparations which are used are, for example, Omnitrope®, Genotropin® or Humatrope®. A Pen Humatrope costs approximately 1.500 €.
The number of temperature-sensitive drugs will continue to rise in the future. By 2020, 8 out of 10 drugs that enter the market will be temperature sensitive and must be transported and stored in compliance with the cold chain – even at home.
i The list is not complete and includes the drugs whose loss due to incorrect temperature / storage is particularly painful as they are highly valuable. In addition, vaccines that need refrigeration are not considered, since the patient is usually not storing them at home, but visits the doctor who administers them.