Thursday, July 1, 2010

Are you getting erythropoietin or plain water?

Most people on dialysis are anemic. They have lower than normal blood counts. The main reason for this is that their kidneys are not performing their duties as well as they should. Apart from cleaning the blood of toxins and excess fluid, kidneys perform a number of other important functions, one of which is producing a hormone called erythropoietin, which stimulates the production of red blood cells. So, when the kidney does not function, the body needs supplements of erythropoietin to maintain healthy levels of RBC.

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.

Tomorrow: What is a possible solution to this?

5 comments:

B said...

I think medicine is ripe for 'process improvement' as opposed to just quality control and regulatory compliance.

If you have not read this...please read this amazing article:

http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawande

Shan Chelliah said...

Hi Kamal,

This is also what I thought. I am using Eprex currently, the 'instruction manual' that comes in the box states that it must be allowed to come up to room temperature (which in my center would be around ~ 25degC) before administration.

Take a look at http://www.racgp.org.au/cmi/jcceprex.pdf.

Puzzling .....

Kamal D Shah said...

Yes, it must be brought to room temperature just before taking it. But right up to that time, it must be maintained around 4 degrees centigrade. Otherwise it is useless.

Kamal D Shah said...

Bhanu, I will go through the article soon. You are absolutely right about process improvement.

Kamal D Shah said...

Excellent article Bhanu. Thanks so much for posting the link.