Tag: cold chain

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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medication delivery

Hi, parcel service here! Your medication.

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As an Amazon Prime customer, I can now receive my painkillers just as electronics, clothing or books within an hour after ordering at my front door. At least if I live in Munich, since here Prime Now for medicinesAmazon´s new medication delivery service was launched last week.

Amazon´s tentative steps into the pharma market

This new Prime Now service is made possible by Michael Grintz, owner of the „Bienen-Apotheken“ – a pharmacy chain in Munich. Prime customers can order medication of his pharmacies via the site primenow. In doing so, the customer enters symptoms and disease history into a form. This data is checked by a pharmacist prior to releasing a delivery. The customers receive the medicines of either within one hour (extra charge 6.99 EUR) or in a two-hour time window from Monday to Saturday of the customer´s choice. Prime Now for drugs is not just launched in Germany. In Japan, too, this service is being tested.

Prescription and cold chain requiring drugs are not (yet) available via Prime Now. Cold chain logistics are currently still too complex for Amazon. As for now the drug´s integrity could not be adequately ensured during transportation, and patient health would be compromised. In addition, the visit to the doctor is unavoidable for issuing a prescription and the latter cannot be forwarded without effort to a medication mail-order. However, with the introduction of the e-prescription envisaged for 2019 in Germany, the last-named hurdle could fall. Moreover, the complexity of the cold chain certainly does not stand forever in Amazon´s way. Just as little as does the German pharmacy law. It prohibits Amazon to appear as a drug provider – which Amazon does not do. It is enough, when mail-order pharmacies integrate their online shops into Amazon. Likewise, the online retailer cleverly worked its way around legal shoals through its cooperation with the “Bienen-Apotheken”. Again, the company does not make an appearance as a provider but as deliverer and as a shop.

The future of Prime Now for medication

Even if the shipping of prescription drugs is publicly heatedly discussed, it is possible. So it could only be a matter of time until I can order insulin, multiple sclerosis drugs etc. via Prime Now. Then a completely different, much more urgent question arises: is it ethically justifiable that the limited number of Prime Now customers are better provided with medication than patients who are in the same need but have not subscribed to membership? For years, Amazon has been thinking about entering the pharma market. Now the company seems to take the gloves off. More than 20 years ago, Amazon started out as a small online bookstore and is now the world’s most famous online retailer with a worldwide sales of roughly 44 USD in the fourth quarter of 2016. Amazon has big plans.

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ePaper Hintergrund Website

Internet of Things in the pharmaceutical cold chain

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IoT – the buzzword

Buzzwords share a common fate. They are used ubiquitously, but their meaning gets blurred underway and at some point no one knows where they came from. To start off, I did some digging: The term “Internet of Things” was coined by Kevin Ashton, an internet pioneer, in 1999. He stated that computers would still be heavily dependent on humans for informational input. The next step of technical evolution would be to enable computers to think and act for themselves:

We need to empower computers with their own means of gathering information, so they can see, hear and smell the world for themselves (…). RFID (radio-frequency identification) and sensor technology enable computers to observe, identify and understand the world—without the limitations of human-entered data. (Ashton, 2009, par. 4)

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real-time data logger cold chain

Real time tracking devices in cold chain logistics

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We are craving for real time data. This morning I was sitting squeezed like a sardine in the train to work and eavesdropped on a man commenting via mobile phone live on the train´s journey: “I´m leaving Bensheim (…) just passing Eberstadt (…) now arriving at Darmstadt main station.” ‘Live tracking’ can be more or less adequate. In some cases it is indispensable.

Tracking and tracing the cold chain

Live data monitoring does make sense in temperature controlled logistics. Especially when it comes down to shipping high value medication like IMPs, vaccines, APIs, biological samples or batch samples. For many years, common data loggers with USB connection have been the tool of choice in cold chain logistics. They save data locally during transit, which is then retrieved at the destination. Pitfall of those data loggers: e. g. temperature excursions are only discovered after the damage is done.

Improvements and cost-reduction in GPS (Global Positioning System) technologies in the past years gave rise to real time tracking devices. Combined with sensors to monitor temperature, humidity, light (opening) etc., they enable monitoring location, movement, temperature, humidity and light detection (which discloses whether the shipment was opened). Thus documenting regulatory compliance, preventing loss and reducing risks.

GPS real-time tracker – how do they work?

Live tracking devices are equipped with a GPS receiver. The tracking device is thus able to receive signals of various GPS satellites circling the earth. There are more than 24 working GPS satellites in total, which follow different orbits. Due to their number and arrangement, GPS devices receive signals from minimum 4 GPS satellites at a time.

Based on the period of time the GPS signal needs to travel to the GPS receiver, the latter can measure its location, movement and speed. So far, so good. But how does the data get to the recipient? Two different technologies are used to transmit data. Both drag along pros and cons.

  • GPS GSM tracker:

The live tracking device using GSM (Global System for Mobile Communications) or UMTS[1] (Universal Mobile Telecommunications System) in other words is using the mobile telephone network with a SIM card. The live tracking device sends the data to the nearest mobile mast. The mobile mast is an intermediate station that transforms the incoming radio signal into data packets that are sent via the Internet to a server (e. g. the server of the tracking device provider). From there, the logistics data is sent to the end-user who can see the temperature, humidity profile etc.

GSM GPS real time trackingPro: In using common mobile technology, the data transmission of a GPS GSM tracker is cheap, given country borders are not crossed. In this case roaming fees are high.

Con: The technology falls short in areas that are not covered by GSM such as in remote areas, on the sea etc.

  • GPS satellite tracker:

A monitoring device using satellite networks functions slightly different. The device sends the data via satellite to a satellite relay which hence sends the data in packages via Internet to a server.

GPS real-time trackingPro: GPS satellite tracking devices make sense in remote locations and when tracking shipments across country borders.

Con: Satellite-based tracking is in general more costly than devices working on GSM basis.

­Often the pros of both technologies are combined in using satellite driven tracking functions in shippings across borders and GSM based systems where GSM coverage is good.

Real time data tracking in cold chain logistics is more than a short-lived trend. It is the future. We are getting ever more used to receiving information, no matter where we are, in real time.

Thinking about it: You are familiar with Glympse? It´s an app to automatically share one´s location to others. Next time I meet the man, I´ll drop him the hint.

[1] Which achieves a higher data transmission rate than GSM.

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temperature sensitive medication

Future market: Temperature sensitive medication

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Cold chain requiring medications and samples are pretty sensitive. They feel comfortable between 2-8°C and do not like it at all when the temperature deviates upward or downward. If this happens the delicate protein structure they consist of is being destroyed and the medicine gets ineffective or even dangerous: As proteins decompose toxins and antigens may develop that lead to a counter-reaction of the immune system. In the worst case, the immune system turns against the body’s own substances.

There are many such sensitives. In Germany alone there are 2.000 cold chain requiring medications . These include, for instance, vaccines against rubella, measles, tetanus, mumps, special eye drops, asthma medicine and so called biologicals. Biologicals are produced by genetically engineering protein molecules . They come to use in rheumatism and cancer therapy and help to regulate the patient´s immune system.

The proportion of temperature-sensitive medicines is increasing steadily: Every tenth medication that is introduced to the German market is requiring a cold-chain. In the USA already every third newly approved drug is subject to cold chain transportation and storage. One reason for this trend is the increase in biologicals , which are seen by many in the industry as a new wonder weapon. They are complex and expensive in the manufacturing process and therefore generate high prices. The rheumatic drug of the pharmaceutical company AbbVie – Humira – costs, for example, 5.200 € per syringe .

It is no surprise that cold-chain medications generate astronomical revenue: Humira (11.25 billion USD ), Solvadi against hepatitis C ( 9,25 billion USD ), Remicade for rheumatoid diseases ( 8.31 billion USD ), MapThera against lymphomas (7.79 billion USD ) and Enbrel for rheumatism ( 7.68 billion USD ) . According to a prognosis of BT9 – Tech 8 of the 10 best selling drugs worldwide in 2018 will require a cold chain.

Such valuable goods need to be securely packed, since the economic damage would be enormous otherwise. For this reason, spending on worldwide transportation of cold chain requiring drugs increases correspondingly with the rise of the latter. By 2018, the costs will increase to 10.3 billion US $ from currently 9.3 billion US $ . For 2020 an expenditure of 16.7 billion US $ is being predicted.

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