The form of erythropoietin available widely needs to be maintained at a temperature of around 4 degrees centigrade. This is because erythropoietin is unstable at room temperature. So, for the etryhropoietin to act, it must be kept throughout at 4 degrees centigrade. If the temperature goes above this significantly, the liquid in the injection is not effective at all. It is equivalent to injecting plain water!
This is a very important factor which is taken lightly by many people involved in the distribution and delivery of the injection. The problem is most people do not realize the importance of maintaining the correct temperature. They do not realize that not maintaining the correct temperature renders this extremely expensive injection virtually useless.
Let us take an example in the Indian scenario. A distributor, who receives the injections from the manufacturer may have the requisite infrastrcuture to maintain the tempertaure since he is dealing with a large number or units. He delivers it to the pharmacy who delivers it to the patient through delivery boys. These delivery boys are barely educated and know little about hormones and their effectiveness. Though the pharmacy or their bosses might tell them about this, there is little hope of them giving it the seriousness it deserves.
If there is a break in the 'cold chain', as this is often called, there is little chance of anyone, least of all the patient being told about it. The fear of having to bear the cost of the wasted injection will outweigh any concerns for the well-being of the patients.
Who will know that this happened? No one. The effects of the erythropoietin are hardly immediate. Someone who is not benefitting from the treatment will know a few weeks down the line. And like most things in medicine, no one can pin point anything to one particular incident.
Who is best placed to ensure that this does not happen in the first place? I feel the onus lies on the company making the erythropoietin. No one else has both the interest and the wherewithal to ensure this. Companies have the interest because they want to make sure their brands are seen as effective in the long run. They also have the wherewithal because they control the entire supply network.
Let me explain how they can do this.
The key is the number of stopovers from the time the injection is manufactured to the time it reaches the patient's refrigerator. The lesser the number of stopovers, the lower the chance of breaks in the cold chain. Transfers from one place to another increase the chances of improper temperatures being introduced. If there is a way of minimizing the number of hands through which the injections passes, it must be implemented.
Another important thing that should be ensured is that disruptions in the cold chain are not seen as 'lapses' but rather as 'possibilities'. The manufacturer must be open to taking back a reasonable number of units of the injections if it is found that the cold chain has been broken. The manufacturer must not penalize or make the distributor, vendor or patient bear the loss for this. This will ensure that no one accepts such breaks and immediately 'quarantines' the defective units for replacements from the manufacturers.
This is definitely possible. The writer used Johnson and Johnson's Eprex until a few years back. They had an excellent "No question asked" policy or replacements. If the patient, felt that any lapse in the cold chain had occured, he/she could get a replacement for the injections. The writer switched to Wockhardt's Wepox a few years back. Recently, during a power failure, for many hours the temperature was not maintained. The vendor was called and asked to replace the injections. He was hesitant at first but then agreed if he was given a letter stating the case. The replacements were eventually obtained.
As patients, we need to be proactive about this and insist on replacements. Remember that margins in the medical pharmacy business are extremely high and that should take into account incidents such as these. Companies should absorb such costs. We must never take this lying down. We are paying huge amounts for the injections. The least we can expect is that they work.