Yesterday, we saw how important it was to maintain the temperature at which erythropoietin was stored. If the proper temperature was not maintained, it was equivalent to injecting plain water.
Who is best placed to ensure this? 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. I used Johnson and Johnson's Eprex until a few years back. They had an excellent "No question asked" policy or replacements. If I, the patient, felt that any lapse in the cold chain had occured, I could get a replacement for the injections. I switched to Wockhardt's Wepox a few years back. Recently, I had a power failure at home for many hours during which the temperature was not maintained. I called the vendor and asked him to replace the injections. He was hesitant at first but then agreed if I gave him a letter stating the case. I did get the replacements.
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.