- Orders placed but registration causes complications
Bureaucratic red tape continues to contribute to delays in importing a vital radioactive substance which is essential for the use of PET scan medical equipment at Apeksha Hospital in Maharagama, The Sunday Morning learns.
This, as hundreds of patients await PET scan analysis of their medical complications in order to receive treatment.
The PET scan units at the hospital have not been used for more than a month due to the unavailability of fluorodeoxyglucose (FDG), caused by a delay in registering the newly-appointed local agent by the respective manufacturer of the radioactive substance, it is reliably learnt.
Around 10 PET scans are performed per week at the Maharagama hospital and the delay in receiving the required FDG substances have put the scheduled PET scans on hold.
Speaking to The Sunday Morning, Apeksha Hospital Director Dr. Aruna Jayasekara said the hospital had placed the orders one-and-a-half months ago, but had not received them yet.
“This is a very expensive substance. Ten vials cost nearly Rs. 1.2 million. We need nearly 10 per week as consultants only suggest around 10 PET scans per week, therefore there is no major waiting list as of now. There is a delay from the National Medicines Regulatory Authority (NMRA) over registration. We were told that we would be given the chemical by last Friday, but this did not happen as planned,” Dr. Jayasekara explained.
PET stands for ‘Positron Emission Tomography’ and is a nuclear medicine imaging test in which a small amount of liquid radioactive material is injected into the body and is used to diagnose a variety of diseases, including many types of cancers and brain and heart diseases.
The radioactive substance commonly referred to as FDG is injected into the bloodstream and accumulates in the body where it gives off energy in the form of gamma rays. These are detected by the PET scanner and a computer converts the signals into detailed pictures or images showing how tissue and organs are working.
The PET scan is commonly used for cancer imaging, as the cancer cells need sugar to grow. FDG is also useful for imaging inflammatory or infectious processes and for imaging brain metabolism.
However, when contacted for clarification on the allegations levelled against it as the reason for the delay, NMRA Chief Executive Officer (CEO) Dr. Vijith Gunasekera said the manufacturers had changed the local agent of the respective drug and the new agent was not registered with the NMRA. Therefore, he said the registration process would take some time as the local agent had not presented the proper documents required to proceed with the matter.
“The particular manufacturer has given authorisation for a different local agent. That agent is not registered with the NMRA. So again the NMRA will have to give a Waiver of Registration (WoR), which is not a good thing. It takes a long time because the particular agent has not given the proper documentation. They have submitted their documents, but there were some delays,” he said.
Dr. Gunasekera however said that the NMRA officers were communicating with the agent and sorting it out, and assured that the matter would be resolved by Monday (26).
The NMRA CEO said that the FDG was not an injection but a radioactive source which decayed within a short period. “Once you manufacture the substance, it decays fast. It has to be brought to Colombo within a couple of hours of manufacture and transferred to Maharagama. It decays by evening,” he stressed.
– By Maheesha Mudugamuwa