Health Needs Solutions: The Case of Nigeria

This paper is the response by the Lutheran World Relief (LWR) Chief Administrative Officer (CAO) regarding the recent concerns raised by the board of directors requiring my office to prepare a summary of Nigeria’s health issues and needs including the proposed solutions. I understand that LWR has limited funding and is forced to receive subsidized medication from leading pharmaceutical firms. The NGO also can receive non-generic, unapproved USDA, and unapproved stem cell medication from unknown sources. Therefore, this paper's primary purpose is to provide solutions that address the proposed funding limitation while remaining sensitive to Nigerians' health needs.

FDA-Unapproved and Alternative Stem Cell Treatment 

As it is known, LWR has been allowed to obtain non-generic and not approved stem cell medication from unknown countries or sources. It would first be in my interest to elaborate on whether this is a genuine opportunity or heading in the wrong direction. As the Chief Administrative Officer, I believe there are better ways to provide a solution to the funding challenges without harming the needs of the Nigerians at large. Alternative stem cells and non-USDA approved medication is not the best options for us to obtain funding and medicines for the Nigerians.

I must first explain the importance of drug approval and the dangers of unapproved medication by a known regulator or authority. Before the drug firms bring a new medicine to the market for sale and prescription, they conduct a series of tests to ensure the medication is effective and safe to use. The US FDA (Food and Drug Administration) only approves a specific drug for use in a particular purpose-made way and within a specific group of patients. The FDA can approve medicines for a specified age group, a particular disease, a specific problem like pain relief, and a specific health problem like pregnancy or weight problem ( Nasr et al., 2011 ). Once the FDA approves the medication for a specific use, the doctors can decide whether it can be used by another patient in a way described as prescription medication 'off-label' which are regarded a safe by doctors. However, not all of the cases are approved by the FDA. Once the medication is approved for a specific purpose, the manufacturers never care to take additional approvals. Drug companies usually are the first to conduct studies, scientists, and doctors to determine how the drug works. After the studies are complete, the results are published in medical journals that are peer-reviewed. This approval process allows other scientists to look at the work and decide whether it is high-quality medication and fits the purpose of use as the manufacturer claim. It is important to note that there are several medicines in the market without FDA approval and as such, the drugs should never be prescribed ( Grossman, 2007 ). Drugs that have never been approved by the FDA are not safe for medical use because no one knows whether it is safe or not. However, there are other medications such as the ones used in homeopathic and supplemental remedies, that do not necessarily require FDA approval because they are not drugs. It is unethical and irresponsible and dangerous to the health of local patients for an organization to procure cheap FDA unapproved medication for the Nigerians.

It is a fact that stem cell therapies may provide the potential to treat conditions or diseases for which there are only a few treatments or none at all. Usually referred to as the body's 'master cells,' are the body cells that develop into bones, kidneys, and all kinds of body organs. The stem cells can restore, repair, replace, and regenerate cells and be critical in treating several diseases and medical conditions. Lutheran World Relief (LWR) can also receive funding through alternative stem cells derived from foreign countries' medications. In my humble submission, like we cannot go for non-FDA approved drugs, as well as alternative stem cells. Even if we need to obtain funding, our responsibility as a global healthcare non-profit organization is to give more attention to the outcome, rather than easy but expensive routes. Scholars believe that stem cells are the most promising and most effective treatment options for many diseases and medical conditions. However, when stem cell treatment is not approved, it can be unsafe.

Before we resort to getting stem cell treatment for Nigerians, we have to get the facts rights. Stem cells have been baptized with all kinds of names, appraising it as a 'miracle' treatment or even 'cure it all' treatment. This, I must point out, is not backed by any empirical data. There are several scrupulous providers in the market offering stem cell medications that are both unproven and unapproved. We must be very cautious and aware of potentially dangerous procedures. We must confirm the products that are being offered as stem cells before considering them for any treatment. The US FDA has raised the concern that some patients looking for remedies and cure are vulnerable to stem cell treatment that is potentially harmful and illegal. The FDA is playing its role in protecting the citizens from unscrupulous and dishonest stem cell medication, while at the same time encouraging innovations to enable the medical sector to harness the stem cell potential properly ( Nasr et al., 2011 ). As a result, the FDA demands that we ensure that the FDA approves any stem cell treatments. The FDA also directs that users to consider that the stem cell treatments are being studied under IND (Investigational New Drug Application), a clinical investigation plan allowed and to proceed by the FDA.

Impact of Medication Diversion from US to Africa 

It is essential to consider the consequences of the diversion of medication from the US to the African countries. The Americans are likely to be economically, politically, and morally impacted; they are also likely to have healthcare impacts. Drug diversion is the illicit diversion of drugs for illicit use. Diversion involves rerouting medication from legal and medically appropriate uses towards illegal uses and not medically authorized use. 

In the healthcare environs, the prescription drugs can be diverted at any point along the supply chain as they move from the manufacturers to the distributors and through to the pharmacies, to the hospital and other healthcare organizations before it finally reaches the patient. The hospitals are mostly at a very high risk of diversion of the drugs because they have drugs readily available. These diversions mostly happen in outpatient settings where most of the prescription drugs are used. Opioids are the most popularly diverted drugs from healthcare facilities. Today's pharmaceutical supply chain is complex. The ingredients used in the manufacture of medications are sourced from different countries worldwide. The majority of the final product is exported from the manufacturing countries such as India or the United States. These products can still be packaged and repacked in other countries before they find their way into Africa. The drugs also change hands several times between the manufactures before they get to patients. Every single transaction is falsified or substandard products introduced. 

It also has to be noted that drug misuse and drug diversion worldwide are an escalating public health challenge. The impact of drug diversion is related to high chances of poor health care outcomes, increased mortality rates, and increased incarceration cases and theft of prescription medicines. The drug classes that are usually misused, diverted, and abused worldwide include analgesics, sedatives, and stimulants ("GAO-02-634, Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion", 2002) . The UN Office on Crime and Drugs estimates that about 35.7 million people in 2014 around the world used stimulants like prescription stimulants and amphetamine. The report further evaluated that 33.12 million people used analgesics, and 207,400 persons died worldwide from causes related to drug use. Irrespective of the fact that pharmaceuticals play a critical role in healthcare, a significant number of the recreational drugs used by medical professionals are later prohibited or banned as a result of serious medical consequences that cannot be ignored anymore ("World Drug Report", 2014) . Some of these drugs end up in Africa. The drugs diversion is a growing health concern and is negatively impacting the American health systems, individuals, increasing mortality rate and morbidity. 

There is a considerable societal impact of controlled prescription drug (CPD) diversion and misuse, and are many international headlines talking of UK companies divert Aids drugs meant for Africa. Prescription drugs are sold illegally in Uganda, and many more African countries. The diverted drugs end up in the wrong hands, and sometimes, find their way back to America through the black market. These drugs especially opioids and other stimulants, have varied social impacts. The property and violent crime related to CPD diversion and misuse have escalated in all parts of the United States in the last decade, as presented by National Drug Threat Survey (NDTS) and the National Drug Intelligence Center (NDIC) ( Sweet et al., 2011 ). However, the relations between CPD diversion and crime are not reported very frequently ( McCabe et al., 2006 ) compared to the relationship between illicit drug use and crime. An increase in crime rates typically contributes to increased budget expenditures for law enforcement to source more resources.

Additionally, the drug diversion's estimated cost to the private and public medical insurers is $72.5 billion every year. Most of this cost is usually passed to the American consumer through increased insurance premiums ( Fischer et al., 2010 ). Furthermore, when there is an increase in drug abuse because of the diversions and many illicit drugs finding their way into the market, the American budgets allotted for substance abuse treatment are burdened.

Insurance is a primary enabler and financier of drug diversion. Not many health insurers understand the critical role insurance plays in a drug diversion problem that costs the insurers more than $72.5 billion annually. To be more specific, the drug abusers and swindlers get the bulk of their illicit prescription narcotics through fraudulent claims for fake prescriptions, treating illegal deceptions. The private insurers are reported to lose up to $24.9 billion every year. These losses include the insurance schemes and the hidden costs for treating the patients who develop severe problems from abusing the addictive narcotics obtained illegally ( Charnovitz, 2006 ). Insurance is significantly vulnerable to huge lawsuit liabilities for failure to reasonably prevent these fraud schemes that injure and kill people involved in the scheme. Pharmacists are already facing such lawsuits because they are diverting the drugs on a bigger scale to the African countries.

Core Objectives 

As has been seen in our discussion above, prescription medicine diversion is a severe problem for Nigeria, African nations, America, and the world. There is a need to implement effective financial, legal, and better healthcare alternatives to protect Nigeria's interest. 

Lutheran World Relief (LWR) 's core objective is to strictly deal with safe medications that guarantee better Nigerian recipients' outcomes. Therefore, my recommendation is that we intentionally ignore the opportunity to get non-generic, non-USDA approved, alternative stem cell derived medication from foreign sources and chose the safer alternatives. First, the alternative we choose must be USDA Approved medication, and we must also go for the safe and approved stem cell products.

Lutheran World Relief must adopt a donation model and funding that does not restrict it to take unsafe and unapproved medication from any source. The principle of only use USDA approved medication must be anchored in the LWR principles and policies. LWR must also adhere to the International Disaster Response Law (IDRL) and other similar laws that promote solving problems through safe methods, observing legal regulations, and promoting better living legally ( Dupuy et al., 2016 ). Lutheran must also adhere to the National-Drug Control Law International Drug Conventions to fight against the diversion of the prescription drugs from their intended uses to prevent loss of life and to put unsuspecting people's lives at risk.

I further recommend that LWR must adopt more transparent and legal modes of financing recognized by law. The organization must adhere to protocols that prevent global drug trafficking and money laundering. The most appropriate funding model must be through reputable funders, reputable funders, and sustainable funding.

The Financials 

C.1. Financial Summary
Period (please specify the calendar year)		Total	2021	2022	2023
Total OSF Funding for this Project, USD		$96,000,000	$22,000,000	$32,000,000	$42,000,000
Total Organizational Budget, USD		$90,000,000	$20,000,000	$30,000,000	$40,000,000
OSF OSIFE's support share		$1	$1	1.066666667	1.05
Total organizational annual expenditures for the most recent fiscal year, USD		20000000
Total expenditures start and ending date fiscal year (mm/dd/yy)		1/31/2021 to 31/12/2021
Is supporting financial documentation attached to the proposal?		Yes

C.2. Expenses:
	TOTAL PROJECT EXPENSES	OTHER FUNDING FOR THIS PROJECT	OSF FUNDING FOR THIS PROJECT
1. Personnel	$4,000,000	$2,000,000	$2,000,000
2. Consultants and External Contributors	$300,000	$150,000	$150,000
3. Equipment and Capital Purchases	$1,000,000	$500,000	$500,000
4. Administration and Overhead	$10,000,000	$5,000,000	$5,000,000
5. Research Costs	$1,600,000	$800,000	$800,000
6. Communications and Advocacy Costs	$1,400,000	$700,000	$700,000
7. Grants, Fellowships, etc.	$200,000	$150,000	$50,000
8. Events and Travel	$1,000,000	$500,000	$500,000
9. Other	$500,000	$200,000	$300,000
TOTAL USD:	$20,000,000	$10,000,000	$10,000,000

C.3. Sources of Funding for this project:
SOURCES	USD REQUEST	USD GRANTED	EXPECTED DECISION DATE	PROJECT TITLE and COMMENTS
OSI/OSF sources for this project
USA Government Grant	20000000	13000000	Granted	Education Funding and Operation
Other grants for this project
Bill Gates and Melinda Foundation	20000000	5000000	Granted	Food relief
Consulting contracts / other income-generating activities
Internal Activities in Nigeria	$1,500,000	$1,000,000	Granted	Food relief
In-kind contributions
General Population	$2,000,000	$1,000,000	Granted	Medication
TOTAL USD:	$43,500,000	$20,000,000	46%

Conclusion 

This report has successfully achieved its purpose, to provide solutions that address the proposed funding limitation while remaining sensitive to the needs of the health of Nigerians. The report recommends that non-USDA approved medication is unsafe for Nigerians, and LWR must resort to transparent, sustainable, and legal funding methods like donations from companies. The report has further recommended that unapproved and alternative stem cells are unsafe for use, and the organization must only accept credible products approved by USDA. Diversion of prescription medicine has been especially dangerous for America and other countries worldwide, and LWR must only receive medications from legal supply chains ( Cleverley et al., 2011 ). The report further recommends that LWR must respect and conform to the international conventions and regulations on diversion, the use of unsafe medication, accepting only legal funding, and refusing to accept diverted medicines from other countries. The best funding sources have to be transparent, legal methods, sustainable, corporate donations, community donations, and other funds that do not harm the community.

References 

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Journal of International Law,    100 (2), 348-372. Retrieved November 2, 2020, from http://www.jstor.org/stable/3651151 

Cleverley, W. O., Song, P. H., & Cleverley, J. O. (2011).  Essentials of health care finance  (7th 

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Dupuy, K., Ron, J., & Prakash, A. (2016). Hands off my regime! Governments' restrictions on 

foreign aid to nongovernmental organizations in poor and middle-income countries.  World Development ,  84 , 299-311. 

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prescription drugs.  Journal of American College Health ,  54 (5), 269–278. https://doi-org.proxy-library.ashford.edu/10.3200/jach.54.5.269-278 

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the Food and Drug Administration.  Advances in therapy ,  28 (10), 842. 

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reduce diversion / United States General Accounting Office . (2002). Washington, D.C.: U.S.GeneralAccountingOffice,2002 http://search.ebscohost.com.proxylibrary.ashford.edu/login.aspx?direct=true&db=edsgpr&AN=edsgpr.000572283&site=eds-live&scope=site 

Sweet BV, Schwemm, AK, & Parsons, DM. (, 2011). Review of the processes for FDA oversight 

of drugs, medical devices, and combination products.  Journal of Managed CarePharmacy ,  17 (1),4050.    http://search.ebscohost.com.proxylibrary.ashford.edu/login.aspx?direct=true&db=ccm&AN=104983360&site=eds-live&scope=site 

World Drug Report . Unodc.org. (2014). Retrieved 4 November 2020, from 

https://www.unodc.org/documents/data-and-analysis/WDR2014/World_Drug_Report_2014_web.pdf . 

("GAO-02-634, Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion", 2002) 

("GAO-02-634, Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion", 2002)