Anger over fake Hepatitis B vaccine

Hepatitis B Vaccine: Experts say it is tip of huge trade in fake drugs in Uganda

Kampala, Uganda | FLAVIA NASSAKA | More Ugandans are infected with Hepatitis B than HIV, the virus which causes the dreaded AIDS. And both infections are spread the same way – through blood and other body fluids. Unlike HIV which destroys the immune system and opens up the sufferer to myriad infections, Hepatitis destroys the liver. And it generally kills faster than AIDS.

Until now, the good news has been that Hepatitis B can be vaccinated against. As a result many people have been flocking clinics to be vaccinated. Due the perennial vaccine stock-outs in most government health facilities, the vaccination has been done mostly in private clinics – for a fee which has been rising as demand increases. Initially, the full vaccination course, which comprises three injections spread over six months cost between Shs60, 000 and Shs90, 000 last year. Since early this year, when the media campaigns highlighting the Hepatitis B danger and the necessity to vaccinate intensified, the price jumped to between Shs90, 000 and Shs300, 000 and urban dwellers paid more than in rural villages. And counterfeits sprang up.

The National Drug Authority on March 13 announced that it had found counterfeit hepatitis B vaccines in various private clinics in Kampala, Mbarara, Mbale, and Ntungamo.

“There is high demand for vaccination now,” says Amos Atumanya, the Head of Inspection at the National Drug Authority (NDA) – the official regulator of the drugs sector, “the challenge the authorities are facing is that fakes are brought it in by hawkers who can’t be easily identified because they don’t have established addresses.”

Despite the lack of evidence, Atumanya said, his department has had to act quickly to impound some suspected fake vaccines on the market and arrest some people. He told The Independent that they are awaiting laboratory results to confirm what exactly is contained in the bottles they impounded.

“We had to do this investigation quickly,” he said.

Norvik monopoly punctured

Speaking to The Independent, Hellen Byomire Ndagije; the Director Product Safety at NDA, said the only registered importer of the Hepatitis B vaccine in Uganda is Norvik Enterprises.

She said, however, NDA has registered a number of Hepatitis B vaccine brands for supply to Uganda from various manufacturers, including a brand manufactured by Serum Institute of India. She said this is the one being counterfeited.

She said the brand is available in two registered pack sizes – 1ml ampoules (small sealed glass vials) and 10ml multi-dose vials. The 1ml ampoule pack is supplied to the private market and is identified by a white label with two green bands at the top and bottom part of the label.

The 10ml multi-dose vial is supplied to the public sector and is identified by a white label with two purple bands at the top and bottom part of the label.

“People should be keen on these when they go for vaccination,” she said.

Ndagije added that the genuine vaccine has both the manufacture and expiry date that indicate a shelf life of three years.

She said the impounded unspecified amounts of fake hepatitis B vaccines were not properly labeled and not approved for distribution in Uganda.

She said some of the bottles do not have date of manufacture but have expiry date of October 2019. Others have expiry date of April 2019 and on others, the words on the vial can be easily rubbed off.

Atumanya said NDA initiated investigations when they came across an empty counterfeit bottle. He added that NDA is awaiting laboratory results to confirm what exactly is contained in the impounded bottles.

“We will advise the public who might have gotten wrong vaccinations on what to do,” he said.

Atumanya said gaps in the import and distribution of drugs in Uganda make it possible for anybody to trade in medicine. Experts say, as a result, Uganda is increasingly becoming a haven for fakes.

Last year, several hawkers were arrested at the Uganda Cancer Institute selling fake cancer drugs that were suspected to have been smuggled into the country from China. They were peddling Avastin, a known drug for treating certain types of cancer but when tests were done, it was found that the fake medicine lacked necessary ingredients. Suspicion was raised because the genuine drug is an injection for intravenous use, but the fake drug being peddled was being sold in plastic jars.

Another fake drug NDA found in circulation last year was Sutent tablets, another cancer drug which was being sold at Shs3million per packet. The labels showed the drug is manufactured by a Swedish pharmaceutical Astrazeneca yet genuine ones are manufactured by American pharmaceutical Pfizer.

Uganda Pharmaceutical Society’s Samuel Opio says the country gets a lot of fakes; especially anti-malarial and antibiotics.

“What is usually impounded is just a small bit of the counterfeit drugs on the market,” he says.

He blames the proliferation of fakes on Uganda’s importation of over 90% of its medicines (mainly from Asia and Europe) and yet it has limited ability to control what comes into the country.

Global issue

Opio says that with global statistics indicating that counterfeiting is more profitable than dealing in genuine products, dealers also make detectability difficult.

The World Health Organisation in December 2017 showed in a report that estimated that one out of ten medicines used globally are fake.

The WHO noted that in some countries in Africa, the figure was in the highs of seven out of ten partly because those countries are in need of medicines but cannot afford to pay for genuine ones. As a result, the organisation put the figure of deaths arising from consuming counterfeit drugs at around 100,000 annually in Africa.

While we don’t know exactly what Uganda contributes to that statistic, Opio says the country might continue seeing such figures or even higher if they do not embrace a robust supply chain which can lock out fakes.

“The country’s capacity to counter fakes is what is insufficient,” Opio says, “Our developed counterparts go to the extent of monitoring drug distribution by satellite by placing tags on them.”

“That could be expensive for us but even simple measures like putting in place indicators to show the extent of the problem are not there,” he says.

“The moment you say anyone can retail. We need to specify who deals in wholesale and who deals in retail. Even the regulators don’t know who exactly they are regulating,” he said pointing out that the recent NDA raid shows a problem – all those places were selling the vaccines illegally because for a medical facility to sell those medicines they are required by law to have a registered pharmacy.

Kenneth Mwehonge, a Programs Officer at a local NGO – Coalition for Health Promotion and Social Development (HEPS) Uganda agrees with Opio. He says NDA officials at border posts lack capacity to differentiate genuine drugs from fake ones because it requires sophisticated knowledge with laid down indicators.

He adds that when unscrupulous dealers are arrested, they sometimes negotiate with officials and are freed because there are no stringent laws that can punish them.

“Post- market surveillance, which involves products being tested, should be routine to get every batch of medicine tested if the population is to be protected from fakes.”

The NDA also admits that the tools available for quality screening are insufficient and require costly machines operated by skilled technicians.

For now, NDA advises whenever you go for a vaccine, insist on reading the labels before using the medicine. That of course is not easy when you are either sick or cannot understand the technical medical jargon.