The Limited Times

Now you can see non-English news...

South Africa's challenge to protect its covid-19 vaccines from crime

2021-03-09T23:34:23.654Z


The first doses against covid-19 received in the country did not carry the barcode indicated by the Ministry of Health, so they are easier to steal


Note to readers: EL PAÍS offers openly all the content of the Future Planet section for its daily and global contribution to the 2030 Agenda. If you want to support our journalism,

subscribe here.

The first covid-19 vaccines for South Africa, which landed at OR Tambo airport on February 1, lacked security measures to protect them from criminals.

It consisted of one million doses of AstraZeneca, produced and supplied by the Serum Institute of India, which were intended for front-line toilets, and were transported to public health facilities where drug theft is widespread.

Both the Serum Institute and the National Department of Health confirmed that the vaccines did not carry barcodes.

More information

  • South Africa suspends application of AstraZeneca vaccine due to low efficacy against local variant of coronavirus

  • The new variants of the virus face the more than 100 million people who have already passed the covid

  • The new South African strain, explained by its discoverers

A source from Serum, the world's largest vaccine producer, stated: “The Government of India requires us, as manufacturers, to use barcodes for serialization and traceability, but exceptions are being made at the moment;

it is necessary to speed up shipments ”.

In early January 2021, the deputy director general of Health Anban Pillay stated that all vaccines entering the country would carry codes to prevent counterfeiting and theft.

The Health Department announced that week that it would track immunizations through an Electronic Vaccination Data System (EVDS) in which anyone who receives them would have to register.

On its website, GAVI, the Global Alliance for Vaccines, which heads COVAX, the international procurement mechanism through which South Africa will obtain most of its doses, explained the EVDS system that South Africa will use: “The EVDS will provide information on the vaccine and its follow-up (type administered and batch number);

information about the patient, including demographics and dose numbers;

information on safety (possible secondary effects after vaccination), and details on the administration sites ”.

In a press conference given on January 3 by the Department of Health, Pillay noted the following: “From distribution in other countries we have learned that security and theft of doses are a problem, so we will certainly follow up of the roads and the vehicles that transport them ”.

Likewise, he affirmed that there would be "a control and monitoring by means of barcode scanning, as well as the mandatory verification of packages, vials and data related to the volumes delivered."

Invisible in the supply chain

Rob Botha, an expert in sanitary logistics and a technician at the Department of Health who is in charge of coordinating the supply chain of covid-19 vaccines in South Africa, confirmed days before the first ones arrived that these would not have a barcode.

"Even if they do not have it, we will continue to monitor them by means of the batch number and the expiration date of the product.

We will be able to relate the product directly to the patient ”, he assured.

For seven years, Botha has managed two of the projects financed by USAID (the US international development agency) to strengthen the supply chain of medicines for the public sector in the country.

The technician affirms that "complete monitoring and traceability" of vials against covid-19 would not occur at the beginning of vaccination in South Africa, since the Department of Health had not yet adopted the "general" system that would allow such monitoring .

The system Botha refers to has been developed by GS1, an international non-profit organization specializing in supply chain security.

It has been approved by the World Health Organization (WHO) and the World Customs Organization to mark vaccines with the World Trade Item Number (GTIN) of 2D matrix Data Matrix code.

This technology enables the visibility of medicines throughout the supply chain, from the point of manufacture to their administration to the patient.

Nuran Idris, Director of GS1 Africa Healthcare, points out that the system allows scanning the barcodes of medicines at “any point” in the chain.

If at any point the scan does not occur, the system "tags" it and investigations begin immediately.

That is why he assures that, in many cases, counterfeit and inferior quality drugs do not reach their destination, because investigations and subsequent action by the authorities "remove them from the equation";

and if a theft occurs, it is detected "very soon after."

Nairobi-based Idris says that the Data Matrix barcode scan linked to the GS1 system also provides access to an international database of medicines and drug supply chains, allowing product information to be verified and contrasted.

"Authorities can identify shipments wherever they are in the supply chain, and make sure the correct products reach their recipients, because there is end-to-end visibility."

However, he explains that other security systems register drugs at point A, and then again at point F, but by not registering them at other points, "sometimes they disappear from the radar."

"We are much more vulnerable than we imagine"

Botha expects that most future vaccine shipments will contain Data Matrix barcodes and says that while the Department of Health is not trained to realize their full potential, it will use them “appropriately”, even if only for verification purposes. .

“In public health centers, for example, they are using the so-called stock visibility system, SVS.

It has a barcode scanning function that allows the product to be identified, if the user wishes to use it ”.

But Andy Gray, a professor of pharmacology at the Faculty of Health Sciences at the University of KwaZulu-Natal, says that the use of barcodes at any stage of the vaccination program would be an exception to the norm, as it is generally medicines in South Africa do not carry such codes.

"It is certainly strange that all items in a supermarket carry a barcode and yet we do not have them for our medicines," criticizes Gray, who is also a member of the WHO Expert Group on Drug Policy and Management, and Member of various commissions in the country's drug regulatory body, the South African Health Products Regulatory Authority (Sahpra).

Gray explains that, for decades, South Africa has relied only on the batch numbers stamped on the packaging of pharmaceutical products to maintain their safety.

“Those lot numbers are printed or engraved in some way on the cardboard.

Both technologies are very easy to counterfeit.

Those who manufacture counterfeit products put a batch number on them, and they can even look for a legitimate number, to be included in that series ”.

And although the Department of Health uses the Data Matrix codes of vaccines for any purpose, Gray says that some public hospitals and clinics are not "sufficiently computerized", so it will not always be possible to scan and enter the information in the systems.

It does think, however, that the SVS, in those cases where it is functional, could serve to protect vaccine stocks… If there is “excellent” coordination and communication between the different actors.

It is certainly strange that all the articles in a supermarket carry a barcode and, however, the medicines do not carry them

“Nurses are submitting stock reports with the SVS through their mobiles.

So there are ways to take advantage of the capacity that we have.

In our private sector, we have systems for sending data in real time.

You go to a pharmacy, and before giving you the medicine, they have already consulted with your insurance if it is going to pay you or not ”, affirms the expert.

"We have to make sure that all the elements of that system are applied at the same time to solve the same problem."

But Gray is concerned that the risk of vaccine theft remains.

“I think we are even more vulnerable than we think.

Certainly, thefts of medicines have been detected in provincial warehouses, and in hospitals there are many robberies.

In fact, we have had problems with robberies on demand, where people call a staff member who prepares a box for them. "

South Africa has never implemented a plan to improve the security system: "We don't know how many counterfeit drugs there are," he says.

Idris, for his part, explains that South Africa could have had “complete monitoring and control” and “complete end-to-end visibility” of vaccines in most of its public health sector, but has never established a plan to implement the GS1 system.

In a notice published in the State Bulletin on September 15, 2017, the Department of Health indicated its intention to "include the Data Matrix GTIN-14 code in the special requirements and conditions established in contracts for pharmaceutical products."

The notice continued: “The Global Trade Item Number ™ (GTIN ™) Data Matrix code is used for unique identification of trade items worldwide, and matches existing global criteria.

This requirement is intended to establish harmonization with the global healthcare market to allow end-to-end data visibility;

identify and apply efficiencies in the supply chain;

guarantee the security of said chain;

and increase patient safety ”.

However, Botha says that in most countries where this system has been implemented, the main reason has been to "prevent counterfeit drugs and pharmaceuticals from entering their supply chains."

Gray believes that the government has not applied the GS1 system "because it did not believe it would have a big problem" with counterfeit or poor quality drugs, and, like the rest of the world, did not foresee that it would have to regulate the rapid entry and distribution of millions of vaccines in such a short time.

End of the form

However, the largest private hospital group in South Africa, Netcare, is using barcodes to track and verify medicines in its 54 hospitals, after partnering with GS1 in 2016 and subsequently investing in the technology. and the necessary networks.

Gray says South Africa has a reputation for having a secure drug supply chain, but it is not known how many counterfeit drugs are in the country at any one time.

"There is a lot we don't know about the South African market," he says.

“We do not carry out proactive sampling.

We react to reports of quality problems, and then those reports are generally investigated by the manufacturer, no one else. "

South Africa is reputed to have a secure drug supply chain, but it is not known how many counterfeit drugs there are in the country.

Mlungisi Wondo, deputy director of the regulatory compliance section at Sahpra, confirms: “The responsibility (to investigate suspected drugs) rests with the manufacturer.

There are countries that have control and monitoring systems to eliminate counterfeits and unwanted products.

Our system is still purely manual, and therefore we oblige companies to take responsibility for their products through good manufacturing practices, or GMP, or good surveillance practices, commonly known as GMP ”.

In Gray's view, South Africa's reliance on “good manufacturing practices” to keep counterfeit drugs out of the country could cause “us to overlook the problems that are occurring.

For example, if our drugs are exported to neighboring countries, is someone introducing counterfeit versions in those countries?

We do not know.

Are imported drugs arriving at our pharmacies that are not what we expect to find?

We have not detected any, but it is not impossible that it is happening ”.

This is the first in a series of four articles on covid-19 and organized crime.

This research has been made possible thanks to funding from the

Global Initiative Against Transnational Organized Crime (GI-TOC)

.

Article

originally

published in English

in Bhekisisa

, a

South African publication specializing in health

.

You can consult the newsletter

Bhekisisa Center for Health Journalism

here

.

FUTURE PLANET can follow on

Twitter

,

Facebook

and

Instagram

, and subscribe

here

to our 'newsletter'

.

Source: elparis

All news articles on 2021-03-09

You may like

Trends 24h

News/Politics 2024-03-28T06:04:53.137Z

Latest

© Communities 2019 - Privacy

The information on this site is from external sources that are not under our control.
The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.