Tackling contaminated medicines, drug insecurity

*How to boost local pill, vaccine production, by Yakasai
In recent times, Nigeria and indeed the rest of the developing world have been enmeshed with stories of contaminated and adulterated medicines, rising prices of essential and prescription brands and low local capacities to ensure self-sufficiency and drug security.

A recent document identified drug products containing human remains from fetuses, infants and flesh heavily contaminated with viruses (bio-hazards), which were smuggled into South Korea via mail by Chinese nationals for local use.

In 2009, 84 Nigerian children were reported to have died after being given My Pikin, teething syrup contaminated with diethylene glycol. In November 2012, 404 cases of fungal infection occurred with 29 deaths due to contaminated injectable medication in the New England Compounding Centre meningitis outbreak.

In July 2018, one of China’s largest vaccine manufacturers was found to have falsified records and distributed 250,000 faulty vaccines for children.

Following an investigation, Changchun Changsheng Bio-technology Limited was found to have falsified reports regarding the production and inspection of some 113,000 rabies vaccines, according to the South China Morning Post.

The incident has reignited long-held fears over fake medicine and distrust in China’s scandal-plagued health and food authorities. In 2008, six children died and 300,000 became unwell after drinking contaminated milk powder formula. In 2016, $90 million worth of improperly stored vaccines were found to have been sold around the country, while in July, a cardiac drug was recalled after a European medical regulator discovered that it contained an impurity linked to cancer.

Also, plans in Nigeria to boost local drug and vaccine production are in jeopardy. It also seems that the four companies that got their manufacturing outfits pre-qualified by the World Health Organisation (WHO) are yet to pre-qualify any of their products for possible global patronage.

The Guardian investigation revealed that some of the companies have gone under following failure to recoup the over $4 million spent in getting WHO pre-qualification.

The Guardian investigation also revealed that high interest rate, exorbitant tariff for imported active pharmaceutical ingredients, weak infrastructure and poor patronage from the Federal Government (FG) have caused some local manufacturers to fold up and some are just surviving by resorting to importation.

Also, a company, Biovaccine, set up by the Federal Government (FG) through May & Baker PLC to begin local production of vaccines are yet to commence manufacturing. The Guardian investigation revealed that the company is still shopping for international partners and building a WHO prequalified production facility.

To address this menace, pharmacists under the aegis of the Pharmaceutical Society of Nigeria (PSN) have urged the regulatory authorities to re-examine the approach to quality control.

President PSN, Ahmed Yakasai, said companies and regulatory bodies like World Health Organization (WHO) and the National Agency for Food and Drug Administration and Control (NAFDAC) have to ensure that processes for detecting and controlling contamination and cross-contamination and risk management strategies are put in place at manufacturing facilities.

Yakasai told The Guardian that processes and equipment need to be designed to avoid or minimise risks of contamination. Irrespective of contaminants like products / substances, foreign products, particulate matter, micro-organisms, endotoxins, drugs have to be purified by dilution of contaminants or flushing contaminants.

Meanwhile, the PSN had alerted the Federal Government over possible circulation of medicines from China contaminated with human remains from fetuses, infants’ flesh and viruses in the country. The PSN ahead of its 91st Annual National Conference scheduled for Ibadan, Oyo State, from October 29 to November 3, 2018, advised the Federal Ministry of Health (FMoH), the National Agency for Food Drug Administration and Control (NAFDAC), the National Drug Law Enforcement Agency (NDLEA), Customs and other security agencies to remain on high alert to safeguard the health of the public.

The theme of the PSN Conference is “Innovative Disruption in Pharmacy In Emerging Economies: A Road Map for Nigeria.”

The Society blamed the situation on dependence of imported drugs occasioned by high productivity cost, very prohibitive interest rate of 22 per cent, and poor infrastructure that discourages local production.

President PSN, Ahmed I. Yakasai, said a safety alert from the South Korean Ministry of Food and Drug has made it necessary to address significant threats posed by inadequate implementation of the National Drug Distribution Guidelines (NDDG).

The pharmacist said for medicines security, the government must as a matter of urgency take critical action to implement the National Drug Policy to promote local drug production, reduce dependence on imported medicines and implement without further delay the NDDG.

Yakasai said as part of efforts to sanitise the drug distribution system in Nigeria, the PSN on Tuesday October 23, 2018, in Lagos, launched the Pharma Information Technology for online National Drug Distribution based on NDDG, PSNPay and the PSN vision 2050 Strategy document engineered by the Lere Baale led Strategy Committee.

The PSN President said Pharma IT NDDG Platform is an online platform that provides a distribution channel, which is in consonance with the NDDG. “The platform provides check and balances of medicines from the manufacturers to the consumers thereby improving the distribution channel and enhancing the safety and efficacy of medicines,” he said.

Yakasai said it is open to all pharmacists and pharmaceutical outlets in the health-delivering value chain of the country. He said the Pharma IT NDDG Platform would contribute immensely in the fight against fake, substandard and falsified drugs in the country because every batch of medicines in the country can be traced.

On PSNPay, he explained: “The PSN would launch PSNPay to digitalise the payment and collection of PSN annual capitation and other technical and interest groups of PSN dues both in states and national. The existing collection process is manual, rigorous and prone to error, which needs to be disrupted. PSNPay is an end-to-end automated payment/collection platform that will ultimately improve operational efficiency of PSN and its technical and interest groups.”

Meanwhile, a report termed, “The Power of Advocacy” gives a systematic highlights the journey of Yakasai as PSN President. “The journey itself has been challenging and gratifying. It is challenging because it has taken toil on my health, family, businesses and lifestyle. However, it is also gratifying because together we have achieved many milestones in achieving our set objectives. Today, we have a better PSN than we met three years ago,” he said.

Yakasai said the Lere Baale led strategy committee undertook a critical review on all the aspects of pharmacy practice in Nigeria and came up with a document (PSN VISION 2050 STRATEGY) to move the profession to the next level of impact and progress in order for us to be at par with other successful pharmaceutical practices across the globe.