Category: general

home storage temperature-sensitive medication

Storing temperature-sensitive medication at home

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Infographic Storing Temperature-Sensitive Medication at Home

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gene and cell therapy: challenges in clinical trial logistics, Gen- und Zelltherapie

Gene and Cell Therapy: The top 5 challenges for cold chain logistics

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Gene and cell therapy are the essence of the popular buzzwords personalized medication, patient-specific therapies or targeted medicine. Gene and cell therapy both aim at the direct cause of a disease by replacing or repairing defective genes or cells. These therapies are around for some time, but only in the past two decades have they been applied in a wider range and haven been taken on to an advanced therapy stage. When gene and cell therapies undergo clinical trials, they provide unprecedented challenges for the supply chain – especially for cold chain logistics.

Gene and cell therapy defined

Both cell and gene therapy are fields of biomedical research. Yet, their procedures slightly differ from one another:

  • Cell therapy: This approach implies the injection of whole live cells into a patient. This has been applied broadly in bone marrow transplantation and in oncology. A patient´s defective bone marrow cells are being destroyed by radiation or chemotherapy. Then donor cells, usually of a closed relative, are infused so that they can populate in the bone marrow and replicate. The repertoire of cell types apt for cell therapy is growing.
  • Gene therapy: This approach is designed to insert gene material into cells to compensate for defective genes or to produce an advantageous protein. Since directly inserting a gene does not work, the gene is delivered by a carrier into the cell. Modified viruses are usually used as carriers since they “infect” the cell and thus insert the engineered gene. The modified virus is either injected or administered intravenously as an infusion. That depends on where the defective gene that is to be replaced is located. As an alternative form of delivery, a sample of a patient´s cells can be extracted and then be treated with the carrier virus in a laboratory setting. Then it is returned to the patient.

Why the bar for cold chain logistics is rising

Even though gene and cell therapy have been around for a bit, only lately are they applied more often to rare diseases, neurological, cardiovascular, metabolic or infectious diseases. Research is advancing rapidly as gene and cell therapy is a promising field – aiming at the cause of an illness not merely at its symptoms. This comes to no wonder that more and more clinical trials focus on cell and gene therapies. The number of gen-based clinical trials alone has increased about 500 % in the past 20 years.

Clinical trial logistics procedures in gene and cell therapies are complex and demand a lot of all stakeholder involved in the supply chain. These therapies entail taking up starting cell material from the patients (e.g. stem cells, whole blood etc.) and delivering living cells or viral vectors which have a limited lifespan. This needs strict temperature-management and fast delivery. Even more so since medication is targeted at a single, specific patient which fragments the supply chain.

  1. Keeping up a seamless cold chain:  All the way from and to the patient
  2. Keeping a strict temperature range: According to World Courier most common is 2-8°C, but there are also frozen or cryogenic transports
  3. Sticking to tight delivery times: Living cells must be administered swiftly
  4. Managing cross-border shipments: There are trials that are carried out in 39 sites all over the world
  5. Handling various regulations:  Cross-border shipments need to take into account the different regulations for the handling of living cells in the different countries

Gene and cell therapy clinical trials require safe and 100 % reliable cold chain packaging and logistics providers that are flexible and dependable. The bar for cold chain delivery is raising.

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Direct-to-Patient practices in clinical trials, Direct-to-Patient Ansatz

Direct-to-Patient Practices in Clinical Trials – why they are worth the effort

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Direct-to-Patient (DtP) practices in clinical trials is a market few players are willing to take on for now. Too high are the requirements that patient-centred trials impose. They make clinical trial design even more complex and increase the strain on all stakeholders to cooperate even closer. Besides, they demand an even greater flexibility and reliability of logistics procedures. So why should anyone turn to Direct-to-Patient practices in clinical trials? The answer is simple: It is worth it.

Problems conventional clinical trials are facing

Recruiting participants for conventional clinical trials is a difficult undertaking. It is time- and cost-consuming to convince participants to enroll in a clinical study and remain until it is completed. Patient-recruitment makes up 32 % of the total trial budget. Thus it is the most relevant factor responsible for increasing clinical trial costs. 50 % of clinical studies are delayed due to patient-recruitment issues – a costly delay affecting not only study costs, but also subsequent sales with losses between 600.000 $ and 8 million $ per day. That is why it is all the more painful to lose already recruited patients during a clinical trial. 30 % of patients drop out at an early stage. One of the reasons they do so is that the site visits are too stressful for them and that they cannot match the trial with their daily schedule. It is clear that participating in clinical trials that involve regular visits to the clinical site obviously provides a severe inconvenience for the patients.

Why Direct-to-Patient practices are the solution

Means to render clinical studies more comfortable for participants is therefore an important goal in conducting clinical trials. And here is where Direct-to-Patient practices come in. DtP implies that the investigational medicinal products (IMPs) are being delivered from the production site (via hubs/pharmacy) directly to the patient´s home. Biological samples are collected at the patient´s site and are then being forwarded to the central laboratory for testing. The patient´s home gets a central locality in this clinical approach and the focus of the latter is set on the patient.

The logistics service provider Marken states that the Direct-to-Patient approach has a positive impact on patient retention and that the compliance is just as high as studies conducted at an investigator site. According to the Medical Research Network (MRN) the Direct-to-Patient model has increased patient recruitment by up to 60 % and has helped maintain patient retention at over 95 %. As a further positive effect, Direct-to-Patient services facilitate access to new participant groups: People that live at a great distance from a trial site and people whose physical state does not allow for regular visits to a trial clinic. Moreover, with fewer participants dropping out, studies can be completed faster and with more reliable results.

3 big hurdles for Direct-to-Patient services

This is all promising, but why then is not every one switching to Direct-to-Patient services? There are three major hurdles to overcome and to consider:

  • Hurdle 1: Since Direct-to-Patient practices are a new approach, most governments do not specify regulations on how a clinical trial with this approach should be conducted. So DtP services operate in a blurry area – regulatory speaking.
  • Hurdle 2: Direct-to-Patient services, at least for now, cannot be applied to each and every trial. They are most suitable for the health care of elderly people, of children and adolescents as well as for patients who need orphan drugs. Overall, the approach makes sense when no intervention is needed as is the case in a biopsy for instance.
  • Hurdle 3: The DtP model requires a close collaboration between stakeholders. Logistics providers, nursing organizations and hub or pharmacy staff have to work together seamlessly to ensure each patient gets the intact medication in the predetermined time window. This is a complex and demanding undertaking.

It is but a matter of time when Direct-to-Patient practices will see a break-through in clinical trials. The players already on the market take on an important role in paving the way. The future has always belonged to the bold.

 

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Biologika, Biosmiliars, Biologicals

Biologicals and biosimilars – similar, yet not the same

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Approved biosimilars have an “identical pharmacological effect” on the human body. This is stated in the currently published guide to biosimilars by the Drug Commission of the German Medical Association (AkdÄ). Biosimilars correspond to their reference medicinal product in terms of “quality, biological activity, safety and efficacy”. An accolade for biosimilars.

Biological medicines – complex and sensitive

Biologicals and biosimilars are protein-based drugs. They are produced in lengthy and cost-intensive biotechnological processes in living, genetically modified organisms or cells. The amino acid sequence, stays the same, however, as a result of the production in living organisms, the proteins obtained differ in their three-dimensional structure and could thereby trigger different immune responses in the human body. However, clinical data suggests that this is highly unlikely. The batch of a biological is never identical to the previous batch due to the said manufacturing process.

Biosimilars are medicinal products containing a version of the active substance of an already approved biological. The difference between biosimilar and reference medicinal product is no greater than that between the different batches of a biological. This variation is called microvariability or microheterogeneity.

The bioengineered drugs have a delicate structure which makes them different from the unevenly more robust chemically produced medicinal products. Temperature fluctuations and even vibrations can break up the tertiary structure of the drug and make it ineffective.

The fight for biosimilars

Why are biosimilars so heatedly debated? Indeed, you could even call it a battle that has broken out between the market newcomers and the patent-protected biologicals. It is about money and a lot of it. Biologicals generated gross sales of 7.8 billion EUR in 2016 according to the AOK Scientific Institute (WIdO). This comes as no surprise for a syringe of the rheumatoid Humira is sold for over 1000 EUR.

Biosimilars, on the other hand, are around a quarter cheaper than biologicals. Biosimilars can thus save costs in the healthcare system for health insurance companies. The WIdO has determined that the German health insurances saved 77 million EUR last year by switching to biosimilars. And there is still room for further savings. The WIdO sees a potential of another EUR 214 million. With the money saved more patients could be treated with bioengineered drugs.

By 2020 patents of twelve of the highest-selling drugs are running out. These include Rituximab (2013), Infliximab (2014), Trastuzumab (2014), Etanercept (2015), Enbrel (2015), Remicade (2015) and Humira (2018). The manufacturers of the reference drugs had partly tried to slow down their competitors by handing in follow-up patents. Yet, they were not successful. The running out of patents will open the door for biosimilars to the markets a bit wider.

Biosimilars today and tomorrow

The first genetically engineered drug worldwide was human insulin, which was approved in 1982 in the USA and Germany. In 2006, the first biosimilar was approved in the European Union – Omnitrope ©. To date (as of June 2017), 32 biosimilars were accepted by the European Medicines Agency (EMA). Mostly for the two indicative areas of rheumatology and oncology. Although the biosimilars have a great potential to relieve the health care system financially, they are not yet sufficiently spread in the health care system. In 2015 of 656.65 million biosimilar-capable daily doses, only 9.22 million of them were replaced by biosimilars. There are still reservations about the counterfeit products, doctors are reluctant in their prescription, and discount agreements by the health insurance companies makes it difficult for biosimilars to spread. Perhaps the published guideline of the Drug Commission of the German Medical Association (AkdÄ) changes that attitude towards biosimilars. Not least in the name of the patients this switch would be good.

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Kühlpflichtige Medikamente im Urlaub richtig kühlen, cold chain requiring medication, travel

Keeping cold chain requiring medication safe during travel

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The summer holiday season finally is knocking at the door. Quickly a few T-shirts and shorts are being stuffed into the suitcase and then off to sunny beaches. The holiday planning for patients who depend on temperature-sensitive medication is far less easy and spontaneous. It is vital to plan in advance precisely where the cold chain requiring medication can be stored safely during the trip.

Storing medication safely at home

Patients who are affected by, for example, multiple sclerosis, rheumatism, Crohn’s disease, or who are taking growth hormones are often treated with temperature-sensitive biologicals or biosimilars. At home, the storage of the latter is usually not a big deal. The vegetable compartment in the refrigerator is the right place, since here the temperature fluctuations, unlike in the door compartment, are very low and a constant temperature storage can be ensured. It only gets tricky when it comes to traveling with the medication. On weekend trips, many patients who have to take their medicine once a week plan “round” the drug administration. If it cannot be avoided or if patients have to take their medication more frequently, the drug must travel them. And here is the problem: How can the drug be safely transported to the holiday destination?

Keeping medication cool during travel? A challenge

Cooling temperature-sensitive drugs underway is a challenge, because they must not be transported too warm or too cold. Patients usually use cool bags with ice packs. The latter must be frozen a few hours ahead of the journey in the fridge´s freezer compartment. This of course considerably curbs the patients´ flexibility. Cooling with ice packs is risky, because there is the danger that the drug freezes when it is in direct contact with the ice pack and thereby loses its effectiveness. In addition, such ice packs only keep cool for a certain period of time. A traffic jam in the blazing sun – not uncommon during vacations season – is therefore extremely problematic, because there is no way to “re-freeze” the ice packs. Going on holiday by plane provides just the same problem, especially on long-distance flights. What is important here is that the medication is carried in the hand baggage and is not checked in, since it might get too cold in the aircraft´s luggage compartment. Of course, it is also necessary to clarify in advance whether there is a possibility at the holiday resort to keep the medication safely at an appropriate temperature. One solution would be to put it in one of the fridges of the hotel another to put it in the mini bar (if there is one). There are, of course, great differences in hygiene standards, depending on where in the world one is traveling. Besides, hotel refrigerators are not always functioning. So the storage in the hotel refrigerator is also a risk, at least in some cases, and nothing one should rely on blindly. Planning vacation with temperature-controlled medication requires a considerable logistical effort.

Which medication coolers are there for travelling with temperature-sensitive medication?

The following list of medication coolers that can be used for holiday trips is not exhaustive. In addition, it is not a purchase recommendation, but merely an overview of researched products on the market:

  • Cool Safe: The cool bag works with ice packs, yet the drug is prevented from freezing via a special inlay.
  • Mini-cooling bags: Designed for small volume transport – not just for medicines. These also work with ice packs that are placed into the bag. There are many different suppliers, among others: TravelSafe, ONEGenug, Goldwheat, Yvonnelee, Be Cool, Kloud city, Ardes
  • Frio: Cooling works via water evaporation.
  • Dison: The cooling works electrically by battery. Unfortunately, there is no German-speaking website, since the provider is based in the Asian country.
  • Definitiv: The cooling works electrically by battery.

Unfortunately, there is no totally satisfactory solution on the market and the patients´ creativity is still required when it comes to safely transporting their temperature-sensitive drugs to their holiday destination.

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Cold Chain Temperature Monitoring

Cold Chain Temperature Monitoring in Pharma

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Cold chain temperature monitoring in pharma Download Infographic

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home-based clinical trials, direct-to-patient services

Direct to Patient services in clinical trials

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home-based clinical trials, direct-to-patient services

Download Infographic

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MS-Schwester, MS, Zuhause

Treating multiple sclerosis at home … with MS nurses

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In Germany, 120.000 to 140.000 people are affected by multiple sclerosis or MS. The German Multiple Sclerosis Society (DMSG) defines MS as “an inflammatory disease of the central nervous system that includes the brain and the spinal cord and usually begins in the early adult age“. It manifests itself differently with each patient. Accordingly, the therapy must be administered individually. MS is not curable, yet its symptoms can be alleviated and disease´s progress can be slowed down.

MS medication for home use

MS is treated according to its activity, i.e. how heavy its acute phases are, how often they occur. A therapy of these acute phases is treated with cortisone preparations. Long-term immunotherapy aims to reduce the frequency and severity of the acute phases. Medications used in this therapy at home are for instance:

  • Avonex: Injected into the muscle once a week. It must be kept in the refrigerator.
  • Betaferon: Injected every second day into the subcutaneous fat tissue. To be kept at 25 ° C.
  • Rebif: Injected into the hypodermic tissue three times a week. Store in a refrigerator.
  • Copaxone: Injected daily or several times a week into the subcutaneous fat tissue. To be stored in the refrigerator.
  • Imurek: Tablets are taken once daily.

Where MS nurses can help

Patients rarely find doctors or neurologists for practical questions concerning their drug administration: How do I set the injection correctly? How to react to side effects? In addition, doctors rarely have time to respond to a patient´s questions. Here, the MS nurses come into play. MS nurses are specially trained nurses who visit patients at the beginning of MS therapy at home, inform them, advise them, explain how to put the syringe and give them personal assistance. Thus they form an important supplement to physicians and neurologists.

How to become MS nurse?

The idea of MS nurses as a service program came from the pharma companies. In the late 1990s, nurses were specially trained to assist patients in administering MS medication at home. Due to the poor adherence to MS medication at that time, the termination rate was very high. As studies show, the termination rate for MS injection therapy even today is very high in the first three months. Every fourth patient stops the therapy. With MS nurses the rate is significantly reduced: from 26 per cent to only 6 per cent. The interests of the MS nurses who are paid in full or in part by the pharmaceutical manufacturers are not always clear. The opinion about MS nurses expressed in MS online forums is divided. Some patients report of MS nurses who appear as mere advertisers, others that their MS nurse has taken care of them very well and professionally – regardless of which company is paying them.

Since 2007, there are also pharma-independent MS nurses, which are trained by the DMSG in cooperation with other MS centers across Europe. Nurses are trained through self-study and intensive seminars to take care of MS patients at home. 150 nurses have already completed the training, more will follow.

MS nurses will certainly remain important in the future as more and more drugs against MS conquer the market. Medicines, for which the patient needs help at home.

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Welche Medikamente müssen gekühlt werden

Which drugs must be stored refrigerated

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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.

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.

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Medikamentenkühlschrank zuhause, medicine fridge

Home medicine fridge for temperature-sensitive medication

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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.

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