QUALITY ASSURANCE

https://www.pakistantoday.com.pk/2020/04/11/quality-assurance/

With cases of the novel coronavirus increasing in the country as well as around the world the government of Pakistan is now encouraging the local production of ventilators, sanitisers and a larger quantity of chloroquine. It has also given the go-ahead for clinical trials for plasma therapy if required following infection with the covid-19 corona virus. This is good; it is in fact something that should have been done long ago. Sanitisers and chloroquine are already being made in Pakistan, but it is necessary to keep an eye on their quality if they are in much greater demand.

Making ventilators too is well within the capability of local manufacturers. The cost of a single ventilator is prohibitive, and it makes sense for the government to try and produce them right here in Pakistan, but stringent quality standards must be adhered to and no one, but no one, must be allowed to get away with carelessness.

Locally manufactured products tends not to be made with a care to safety. Ventilators require meticulous manufacturing as well as maintenance, or they can lead to a patient’s death from the treatment rather than the disease.

As for clinical trials, they pose a similar question mark.

Plasma therapy requires a plasma donor and a recipient. The plasma donor must be recently recovered from covid-19, which means he should at the time of donation be confirmed as negative following a positive diagnosis for infection with covid-19. And so that the plasma does not pass on any diseases, the donor must be tested negative for diseases such as HIV, AIDS, Hep-C, syphilis or others. If he or she is free from all of the above, he can then donate blood from which the plasma– the liquid part of the blood- is separated and transfused into a recipient who is currently critically sick with covid-19. The idea is that the antibodies in the plasma of the donor will generate similar antibodies in the recipient.

Clinical trials are a meticulous exercise conducted in several stages, all of which will not apply in this case because plasma therapy is not a new treatment, Still, the effect on recipients of the plasma donation must be painstakingly recorded and studied, also because covid-19 is a new disease, and so therefore is whatever is being used to treat it.

The donor’s blood must be properly screened to prevent diseases being passed on to the recipient. A single mistake can lead to terrible results.

Phase II of a clinical trial involves testing of the drug, transfusion or procedure on patients to assess and record the effectiveness. The process is monitored by the researcher. Any side effects must be noted and recorded.

During transfusion attention must be paid to sanitization, which is not one of our strong points.

Phase III involves much the same with a larger number of patients, and this time also a clinician to oversee the process.

Phase III is a follow-up phase after treatment. Personal physicians are involved in this phase where long-term effects of the treatment, positive and negative are noted and recorded.

Pakistan is not best known for meticulous work. Gross carelessness and even fudging of records and results by medical assistants and even doctors has been experienced even in some of the best hospitals of Lahore. It must be the same in other cities. Even students have been known to be censured when their figures did not meet the data conclusions anticipated by their University. You wonder how much of this is likely to occur during the course of these trials, which stand in danger of not being taken seriously by the international community just because of where they took place.

In Pakistan the Drug Regulatory Authority is in charge of clinical trials. No trial can be carried out without a certificate from this authority which is issued after the scrutiny of an application and the payment of a fee. The proposal must also pass through an ethics committee, and the researchers must possess the specified qualifications and experience.

Unfortunately in Pakistan money changes hands all too frequently to get the desired results. It takes place in every sector, every aspect of national life. In the case of clinical trials and the manufacture of life saving equipment more than any in other, such deplorable practices must not be allowed to happen, or the death or disability of hapless individuals will be on the heads of the authorities, if they care.