Counterfeit drugs as major cause of maternal mortality

Toyin (pseudonym) an expectant mother went into in labour. Her husband was just pacing frantically outside the delivery room. Repeatedly, he mouthed just one simple prayer: “God grant my wife safe delivery.” On the other side, not so distant from him was his mother-in-law and her siblings, waiting to hear the good news of the new-born and the well-being of their daughter and sister.

However, unexpectedly, complications crept in during the delivery process and Toyin started to lose a lot of blood, just immediately after giving birth to her beautiful baby girl. Situations like hers require prompt medical intervention to stop the bleeding; it is called post-partum hemorrhage (PPH). PPH, which is caused by excessive bleeding as a result of the uterus being unable to contract efficiently from vaginal or cervical tears, is arguably the leading cause of maternal mortality in developing countries. Other causes of maternal deaths include eclampsia, prolonged labour, infections, etc.

Hence, to stop excessive bleeding, doctors would normally administer a medicine called oxytocin. It is used to begin or improve contractions during labour. It is also used to reduce bleeding after childbirth. According to the World Health Organisation (WHO), PPH accounts for one quarter of all maternal deaths worldwide. In fact, experts said providing solutions to PPH could lead to a reduction of about 30 per cent in maternal deaths, which is quite a significant figure.

Unfortunately for Toyin, the brand of the oxytocin bought by her husband, Sani (real name withheld), was a substandard one. Because it is substandard, the professionally accepted dosage administered did not have the expected effect to get the uterus hard; hence, more bleeding. After almost an hour of concerted efforts by the medical team attending to her promptly and to the best of their abilities to stop the bleeding, and efforts to purchase a more efficacious brand of oxytocin, Toyin gave up the ghost, leaving behind her new-born baby and her loving but distraught husband.

The big question now is: What caused Toyin’s death? Was it the lack of experience, expertise, willingness, empathy or equipment at the facility where she accessed care? Absolutely not! She died from the administration of a substandard maternal medicine. It is therefore instructive to note that many women in Nigeria die daily because of substandard and fake medicines. According to the WHO and the United Nations Children’s Fund (UNICEF), Nigeria has one of the highest maternal mortality ratios (914/100,000 live births), estimated to account for 19 per cent of the global maternal deaths. Also, according to the National Primary Health Care Development Agency (NPHCDA), every day in Nigeria, about 145 women between the ages of 15 and 45 years die from preventable causes linked to pregnancy and childbirth. The above are frightening realities; not mere numbers but human lives being lost to substandard and fake medicines.

Sadly, a 2016 report by the USAID-funded study, which was implemented by US Pharmacopeial Convention (USP) and National Agency for Food and Drug Administration and Control (NAFDAC), revealed that about 74 per cent of the oxytocin in Nigeria are substandard. This means that 3 out 4 oxytocin ampoules in Nigerian hospitals are of substandard quality. In other words, there is the likelihood that only about a quarter of oxytocin doses administered in Nigeria will be able to meet the required quality standards. In specific terms, the study showed that out of 159 samples of oxytocin in Nigeria, 74 per cent (118 samples) failed the laboratory assay. Furthermore, of the failed samples, 60.4 per cent were manufactured in China,12.6 per cent in India, 15.1 per cent in Germany, and none in Nigeria.

Health experts and other stakeholders express worries

Health experts and critical stakeholders in the health and wellness space have posited that for Nigeria to drastically reduce the preponderance of substandard and fake medicines, a holistic approach is required. Chief among these approaches would be an effective public private partnership (PPP), which has the humongous potential to birth easy, affordable and accessible healthcare services for all, towards the achievement of the universal health coverage (UHC) goal.

According to the Managing Director of Nigeria Health Watch, Vivianne Ihekweazu, Nigeria is the second highest contributor of maternal mortality after India. Also, a lot of deaths of mothers are preventable but a lot of these are not known, she said. “One of the factors is the quality of medicines that women have access to at their bedside. Looking at the figures, compared to what Sustainable Development Goal (SDG) 3.1 said of reducing maternal mortality to less than 70 to 100,000 live births, Nigeria is about 512, according to the Nigeria Demography and Health Survey (NDHS) of 2018. So we are far from achieving that. This is a national figure, and you can imagine that there will be states and regional disparities in that number.”

Ihekweazu noted that in terms of women accessing healthcare, one of the things that is very important is quality. While speaking during a stakeholders’ parley on improving access to quality maternal medicines, she added that asides accessing healthcare, the quality of that healthcare has a huge impact on outcomes. “Healthcare has to be patient-centred, especially for women. It has also got to be safe and not cause further harm to those receiving it. It must be effective and efficient. Looking at quality in the context of UHC and maternal health care, we can’t achieve UHC without access to quality medicines. 1.5 million people are dying from poor quality care rather than actual access to care.”

A public health physician, Dr Chioma Ejekam, stated that the WHO estimated in 2017 that 1 in 10 medical products in low and middle income countries (LMICs) is substandard. “These estimates were later confirmed by other researchers. Although substandard and falsified medical products have been traded for many centuries, in the last few decades, the problem has grown with the increased complexity of the global pharmaceutical economy and internet sales.

“Poor quality medicines have the greatest potential to harm the health of consumers, with far-reaching consequences, including avoidable morbidity and mortality, treatment failure, and antimicrobial resistance. Other health problems include loss of faith in healthcare providers and the health system, as well as negative economic impact for households and health systems.”

Fostering enabling environment for effective PPP

It is a known fact that the private sector provides nearly 70 per cent of the healthcare service in Nigeria. It would therefore be wise for the government and other relevant stakeholders to form a viable partnership with the sector. There is an urgent need to leverage PPP in order to expand treatment access, improve quality, build capacities of workers, and foster a strong accountability and governance mechanism.

According to Dr Kayode Afolabi, the Director of Reproductive Health at the Federal Ministry of Health, ensuring effective PPP is critically important to engendering equitable access to quality maternal healthcare services. Interestingly, there have been some engagements on the part of the government with the private sector on reproductive and maternal health in this country, he added.

“There are quite a number of challenges that PPP may face, and some of them on the surface might appear very mild, but are very daunting on the system and the collaboration that the PPP could bring to us. For instance, the way of conducting business with the government is totally different from private business owners who want to optimize profits, while the government is essentially for social services.

“There is also the issue of accountability, transparency and communication. These are really fundamental to the success of PPP. Currently, this remains a very serious challenge. Where accountability is lacking, there won’t be trust for the partnership. The same goes with transparency. The other critical challenge is poor data availability. Anything that we must do that will be successful must be based on evidence, and we generate this evidence from the data at our disposal. Data is very poor currently, when we look at its availability. For instance, do we actually know the gap in the quantity and quality of maternal health medicine that is needed on an annual basis in this country? We don’t have such data.”

Pharm Frank Muonemeh, Executive Secretary/Chief Executive Officer (CEO) of the Pharmaceutical Manufacturing Group of Manufacturers Association of Nigeria (PMG-MAN), said the local manufacturers are evidence-based and are exonerated from one of those manufacturing drugs that are substandard and falsified. “In a study carried out by USP in 2017, if you look at post-marketing surveillance, it showed that for those that are manufactured in Nigeria, failure rate is insignificant compared to those imported to the country. Regarding medicine security, except the people are on the driver’s seat about how the medicines they consume are produced – at the end-to-end distribution to the last mile – access to safe, quality, affordable and health inequities cannot be balanced and continue to be a mirage. Also substandard medicines will continue to be in circulation.

“There are three components that need to be focused on and have to do with policy. We need very strong and efficient policies – regulation policies and agencies. We also need innovative partnerships. If these are in place, trust me, we will reduce the circulation of falsified and substandard medicines.”

Solving the medicine

storage puzzle

Oxytocin, like many medicines, requires adequate cold chain storage for it to maintain its effectiveness. However, most primary healthcare centres lack refrigerators or reliable electricity supply, which are some of the factors outside the ability of the health workers to improve. According to Ihekweazu, the whole supply chain (not just from the procurement of medicines) from when the medicines reach the health facility is very critical in ensuring that the quality of medicines are maintained. “We also have humidity degradation, which impacts the quality of medicines. There is also manufacturing oversight, and this is where we talk about regulation and accountability, in ensuring that health facilities, state governments actually have policies in place to ensure that they are procuring quality medicines.

“For policy makers and stakeholders, political will is critical in combating the use and sale of substandard medicines in states. Financing is also important to fund health facilities to buy the medicines that they need, not just for maternal health, but the gamut of health issues people face. Finally, public awareness is very critical. Most Nigerians do not know how to check for quality medicines or the right questions to ask, checking expiry dates etc.

“Digital technology is also important. It ensures that there is innovation to ensure that the supply chain procurement is as efficient as possible. It can also ensure that there are quality assurance mechanisms through open source, artificial intelligence etc. A lot of pharmaceutical companies are introducing innovations that you can actually just scan medicines now with your phones or using barcodes to check the expiry dates etc., of medicines.”

Advocacy for more stringent punitive measures against counterfeit medicines

While it is very important and beneficial to build qualitative PPP, ensure adequate storage of maternal medicines, and properly regulate the circulation and use of medicines, experts said people must be held accountable for their crimes against humanity. Even NAFDAC, which is the regulatory agency for food and drug administration in Nigeria, continues to advocate to the judiciary and the National Assembly for more stringent punitive measures for peddlers and manufacturers of substandard and fake medicines. It urged the National Assembly to pass the counterfeit medical product bill to strengthen its war against offenders.

According to Dr Kay Adesola, President of the Association of Nigerian Private Medical Practitioners (ANPMP), “Our problem has never been that of human resources, but has rather been how we coordinate all the resources we have. We therefore need the kind of leadership that will take this country back on the path of glory because we are going backwards. In those days, you give a woman just a little dose of oxytocin; if you are operating and you give into the drip, you would observe the uterus getting strong. You touch it, and it becomes split and very hard. These days, you put ten times that, you press it and feel it so soft, and blood continues to flow. Most of us at the provider-ship aspect of medical care will be so happy to get this solved.

“If as a doctor, I give oxytocin to my patient and it does not work, when I bring it to the regulator’s attention, they should not say – it is duly noted; they need to go after those who import the drugs. If we don’t have penalties, people will continue to have freedom to do what they like. Nigeria needs to stop being a dumping ground for fake and substandard medicines, especially maternal medicines. Penalties must also come as part of measures we can use to curb the circulation of bad maternal medicines in this country. I am not talking about regulatory – cutting prevalence from 1,000 to 100. We are saying arrest and make them face prosecution; the importers of bad brands of medicines. If we do this, we will realise that more than half of these people will disappear from the country.”