ABSTRACT
The problems of fake drug proliferation in Nigeria have affected the credibility of the Healthcare system and can exert very harmful effects on the consumer resulting to illness; disability and even death and anyone can be a victim. Some of the incidences have resulted in death even among children because most times the consumers do not know the quality of what they are buying or taking. This makes it imperative that there is need to intensify effort in fake drug eradication. National Agency for Food and Drug Administration and Control (NAFDAC) is the government agency in Nigeria that is fully empowered to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of drugs in order to ensure that safe and quality drugs are available to the public. As NAFDAC tasks herself dutifully in fighting fake drugs, more challenges comes up from unscrupulous drug dealer who sometimes have the backings of lawmakers and politicians making the stipulated drug laws and standard unattainable.
General objective: The objective of the thesis is to review the work done at my workplace (NAFDAC) in the efforts made in controlling the circulation of fake drug products.
Methods: I reviewed the work of NAFDAC to identify their strength and weaknesses in the fight against sale of fake drugs as well as the drug regulating authorities of some other countries to identify their areas of success. The major player in fake drug business and factors that influences fake drug proliferation was also identified
Study outcome/findings: The inability to close the unmonitored, unlicensed, unregulated chaotic open drug market that forms major drug distribution centre where many drug outlets patronize, has brought a wider spread of fake drugs without control. Government on the other hand, does not help the situation, as there is political setback in giving adequate penal sanctions to offender as stipulated in the drug laws. Some country’s DRA under study monitors easily drug channels from licensed manufacturers down to the dispensary, and they license these channels before they can distribute drugs. Hence, they are able to know when fake drugs filters into the market. The reasons why people patronize drug outlets as their first line for treatment are that they are cheap, close proximity, no consultation fees, flexible payment method, perception of confidentiality; they feel that the quality of care and attention received are adequate, high stock out rate at the health facilities. Hence, closing such outlets, seizing, destroying and penalizing the violators, as often done by NAFDAC though good, but it might not give a lasting solution to fake drug proliferation, as availability, accessibility and affordability is low, consumers will always demand for such services.
Conclusion: NAFDAC has not been able to achieve good success in the fight of fake drug in Nigeria even with their intense efforts to do so. Some of the reasons are lack of adequate and continuous support of the government. Inadequate support from some stakeholders that are expected to join team with NAFDAC in the fight such as the customs, police and the judiciary.
Recommendations: The government should have a clear, firm and equitable legislation that addresses all important issues with appropriate sanctions for drug violators, provide financial support to the DRA especially in areas of staffing, GMP inspection, quality control laboratories and enforcement, should stand its ground in defense of situation concerning public health. In addition, give full support when legislated sanctions are given to drug offenders. Support NAFDAC in closing the chaotic drug market by implementing the stipulated drug laws that drugs should not be sold at open market unless they are licensed to do so by the drug regulating authority.
NAFDAC with the help of the government should adapt the strategy used in Tanzania and Ghana where the government started a program for accreditation of drug dispensing outlet (ADDO). Through this initiative, unlicensed drug vendors are licensed, regulated and trained to understand basic pharmacy ethics in order for them to provide better services to consumers that patronizes them.
Recommendations for further research:
• How to provide good quality, affordable medicines in government clinics and hospitals.
• Action research on the strategies of licensing, training and regulating illegal drug vendors in Nigeria, as done in Ghana and Tanzania.
TABLE OF CONTENTS
TABLE
OF CONTENTS.........................................................................................................................I
TABLE
OF CONTENTS.....................................................................................................................
II
DEDICATION............................................................................................................................................III
ACKNOWLEDGMENT............................................................................................................................IV
ABBREVIATIONS
......................................................................................................................................V
ABSTRACT..................................................................................................................................................
1
INTRODUCTION........................................................................................................................................
3
GENERAL INTRODUCTION...............................................................................................................
3
CHAPTER 1.
................................................................................................................................................
3
1.1 BACKGROUND INFORMATION ON NIGERIA.........................................................................
3
CHAPTER 2.
PROBLEM STATEMENT, PRELIMINARY LITERATURE REVIEW, OBJECTIVE
OF THESIS AND METHODOLOGY........................................................................................................
7
2.1 PROBLEM STATEMENT
...............................................................................................................
7
2.2 PRELIMINARY LITERATURE REVIEW....................................................................................
9
2.3 OBJECTIVE OF THESIS................................................................................................................10
2.4 METHODOLOGY...........................................................................................................................11
CHAPTER 3.
DOMAIN OF DRUG CONTROL AND THE INFLUENCING FACTORS.................13
3.1 THE PLAYERS IN THE FAKE DRUG BUSINESS:.....................................................................13
3.1.1 DRUG MANUFACTURERS
.......................................................................................................13
3.1.2 DRUG IMPORTERS/WHOLESALERS/RETAILERS..................................................................13
3.1.3 DRUG PROFESSIONALS (THE PHARMACISTS)
....................................................................14
3.1.4 INFORMAL DRUG
SELLERS....................................................................................................15
3.1.5 DRUG BUYERS
(CONSUMERS)...............................................................................................15
3.1.6 THE CONTROLLER (NAFDAC ENFORCEMENT)
..................................................................15
3.2 FACTORS INFLUENCING FAKE DRUG PRODUCTION, SALE AND DEMAND:...............16
CHAPTER 4: DRUG REGULATING AGENCIES IN OTHER COUNTRIES IN THE
FIGHT.......21 4.1 LICENSING OF PREMISES AND PERSONS..............................................................................21
4.2 INSPECTION OF MANUFACTURERS AND DISTRIBUTIONS..............................................22
4.3 PRODUCT REGISTRATION AND ASSESSMENT.....................................................................23
4.4 ENFORCEMENT.............................................................................................................................24
4.5 QUALITY CONTROL OF DRUGS................................................................................................25
4.6 PUBLIC AWARENESS
...................................................................................................................25
4.7 CONTROLLING FAKE DRUGS IN THE ILLEGAL MARKET................................................26
CHAPTER 5: FIGHTING FAKE DRUGS IN NIGERIA (STUDY RESULTS/FINDINGS)
..............28 5.1 NAFDAC ACTIVITIES AND INTERVENTIONS IN CONTROL OF FAKE DRUGS WITHIN
THE LEGAL MARKET:.......................................................................................................................28
5.1.1 INSPECTION PROCESSES AS A CHECK TO DRUG FAKING
...............................................28 5.1.2 DRUG PRODUCT REGISTRATION AS A CHECK TO DRUG
FAKING .................................29
5.1.3 ENFORCEMENT ACTIVITIES AS A CHECK TO DRUG
FAKING..........................................31
5.1.4 PUBLIC ENLIGHTENMENT
PROGRAM AS A CHECK TO DRUG FAKING.........................32 5.2 NAFDAC ACTIVITIES AND INTERVENTIONS IN CONTROL OF FAKE DRUGS WITHIN
THE ILLEGAL MARKET:....................................................................................................................34
5.3 SWOT ANALYSIS OF NAFDAC AS ORGANIZATION.............................................................35
CHAPTER 6.
DISCUSSION OF STUDY
RESULTS/FINDING............................................................37
6.1 DISCUSSION OF LESSONS LEARNT..........................................................................................37
CHAPTER 7.
CONCLUSION AND RECOMMENDATIONS
..............................................................39
7.1 CONCLUSION
.................................................................................................................................39
7.2. RECOMMENDATIONS (THE WAY FORWARD).....................................................................39
REFERENCES............................................................................................................................................43
ANNEX.........................................................................................................................................................48
LIST OF TABLES: TABLE 1: KEY HEALTH INDICATORS OF NIGERIA................................................. 5
TABLE 2: REASONS
ADDUCED FOR AVAILABILITY OF FAKE DRUGS IN NIGERIA....................................... 16
TABLE 3: MULTI-COUNTRY LICENSING OF PREMISES AND
PERSONS............................................................ 22
TABLE 4:MULTI-COUNTRY
INSPECTION OF MANUFACTURERS AND DISTRIBUTION.................................. 23
TABLE 5: MULTI-COUNTRY PRODUCT REGISTRATION AND ASSESSMENT.................................................. 24
TABLE 6: MULTI
COUNTRY QUALITY CONTROL OF DRUGS............................................................................ 25
TABLE 7: MULTI
COUNTRY PUBLIC AWARENESS OF DRUGS..................................................................... 26
TABLE 8: SWOT ANALYSIS OF NAFDAC AS ORGANIZATION............................................................................ 35
LIST OF FIGURES:
FIGURE 1. PROBLEM ANALYSIS DIAGRAM OF THE FACTORS INFLUENCING
SALE OF FAKE DRUGS ...................12
FIGURE 2: LEGITIMATE SUPPLY CHAIN ..........................................................................................................18
FIGURE 3: ILLEGITIMATE
SUPPLY CHAIN ........................................................................................................18
FIGURE 4: STUDY FRAMEWORK SHOWING KEY COMPONENTS OF DRUG
REGULATION FUNCTIONS..................21
FIGURE 5: GOOD GOVERNMENT DIAGRAM ....................................................................................................42
LIST OF
ANNEX:
ANNEX 1: FUNCTIONS OF VARIOUS DIRECTORATES IN NAFDAC:................................................48
ANNEX 2: GLOBAL PERSPECTIVE ON FAKE DRUGS..........................................................................53
ANNEX 3: NAFDAC LIST OF SOME IDENTIFIED FAKED DRUGS......................................................56
ANNEX 4:NIGERIAN MEDICINE LAWS..................................................................................................57
ANNEX 5: NAFDAC STANDARD OPERATING PROCEDURES (SOP).................................................59
ABBREVIATIONS
ABPI :
Association of the British Pharmaceutical Industry
ADDO
: Accreditation of Drug
Dispensing Outlets
ASEAN :
Association of South-East Asian Nations
BMJ :
British Medical Journal
COPP
: Certificate of
Pharmaceutical Product (COPP)
CSFDA : Chinese State Food and Drug Administration
DRA
: Drug Regulatory
Agency
DCA
: Drug Control
Authority (Malaysia)
EAASM : European Alliance for Access to Safe Medicines
EDM
: Essential Drug
Monitor
EID : Establishment Inspectorate Directorate
FRD :
Federal Research Division
GDP
: Good Distribution
Practices
GFDB : Ghana Food and Drug Board
GMC :
General Medical Council
GMP
: Good Manufacturing
Practices
HAI : Health Action International
IMPACT : International Medicinal product Anti-counterfeiting
Taskforce
IT : Information Technology
MCA
: Medical Control
Agency
MCC
: Medicines Control
Council (South Africa)
MHRA : Medicine and Healthcare products Regulatory Agency
NAFDAC : National Agency for Food and Drug Administration and Control
NBA
: Nigerian Bar
Association
NDHS :
Nigeria Demographic and Health Statistics
NDLEA :
Nigeria Drug Law Enforcement Agency
NHIS
: National Health Insurance
Scheme
NNPC
: Nigeria National
Petroleum Cooperation
NoMA
: Norwegian Medicines
Agency
NPC :
National Pharmacovigilance Centre
OTC : Over The Counter
PID : Port Inspectorate Directorate
PMS
: Post marketing
surveillance
POA
: Power of
Attorney
PRS : Planning Research and Statistics
PSN : Pharmaceutical Society of Nigeria
QC : Quality Control
RPSGB : Royal Pharmaceutical Society of Great Britain
SAP :
Structural Adjustment Program SON : Standard Organization of Nigeria
TFDA
: Tanzanian Food and
Drug Authority
UNESCAP : Economic and Social Commission for Asia and the Pacific
UNODC (CP) : United Nations Office for Drug Control
and Crime Prevention
USFDA :
United States Food and Drug Agency
WHA
: World Health
Assembly
WHO :
World Health Organization
WIPO
: World Intellectual
Property Organization
INTRODUCTION
GENERAL INTRODUCTION
Drug Faking is a global public health problem, because the
effects can be felt from both the country of manufacture to the recipient
countries. Hence, national measures for combating of fake drugs in country
might be insufficient because of the advanced sophistications of those who
manufactures and sells them (bates, 2008).
Nigeria is not an exception in the problems of fake drugs
till date. Some
people still prefer to self medicate when they are ill, and often time the
drugs are bought from unlicensed drug vendors, whose drug quality is not sure.
Through the past two decades in Nigeria, the problem of fake drugs has been a
very big issue. In addition, fake drugs proved a major factor in contributing
to high death rates. Over 150 children died in 1989 as a result of a
formulation error in a drug. Such problems led to the establishment of NAFDAC,
which would help create a fake-drug-free environment (NAFDAC consumer safety,
2003). The intent was to ensure effective registration of good quality drugs
that are inexpensive in Nigeria. Since the inception of the new NAFDAC in April
2001, Professor Dora Akunyili the Director General has worked hard in combating
the problems of sale of fake drugs, but yet the existence of such still
continues and this makes me to wonder why. My questions are, ‘why does Nigeria still
have in existence open drug markets? Why do Nigerians in Drug Business breech
the stipulated drug laws and still get away with it and continue with their
business, committing mass murder and smiling to their banks? How long do we
fight the battle of fake drug even with the threats on our lives who want to
preserve the health of the Nation?
The consistent raids by my organization on fake drug dealers
who contravene the applicable laws and regulations, have helped in clamping
down on the illegal drug traders But when things seems as if its getting
better, these illegal drug sellers begin to emerge from their hideouts. I
continue to wonder, why? Could it be that the Agency is not doing enough to
stop the evil activities, or could the problem be from the drug sellers
themselves. The tragic irony is that the problems of fake drug have refused to
go away from the shores of Nigeria.
My thesis is by no means going to provide a solution to the
drug problems in Nigeria. However, it prepares me on the challenges to be faced
at home in finding the next alternative solution to the problem, and insight to
my colleagues in combating the menace of fake drugs sold in the streets and
open markets resulting in adverse effects to the consuming public. My work is
therefore to review the program at my workplace and the way forward for a
lasting solution.
CHAPTER 1.
1.1 BACKGROUND INFORMATION ON NIGERIA
This chapter provides information on Nigeria demographic,
economy, and health profile. The aim of this chapter is to elicit the
situational analysis of the country.
Background
The influence and control by British Empire over what would
become Nigeria grew through the 19th century. In addition, 1 October 1960,
Nigeria gained their independence. In 1999, a new constitution was adopted,
after nearly 16 years of military rule that resulted to a peaceful transition
to civilian government. The government continues to face the daunting task of
reforming a petroleum-based economy, whose revenues have been mismanaged. In
addition, ethnic and religious tensions is a long-standing experience in
Nigeria, although both the 2003 and 2007 presidential elections were marred by
significant irregularities and violence, Nigeria is currently experiencing its
longest period of civilian rule since independence. The general elections of
April 2007 marked the first civilian-to-civilian transfer of power in the
country's history. (FRD, 2006)
Demography
Nigeria is the most populous country in the African
continent and has a population of over 135million people with birth rate of
40.2 births/1,000 population in 2006. The population growth rate is 2.3%. Life
expectancy at birth is 47 years. It is made up of 36 states and 1 territory,
with more than 250 ethnic groups, the most populous and politically influential
are the Hausa & Fulani 29%, Yoruba 21%, Igbo (Ibo) 18%, Ijaw 10%, Kanuri
4%, Ibibio 3.5%. Tiv 2.5%. The
religions: are Muslim 50%, Christian 40%, indigenous beliefs 10%. The literacy
level in the population among male is 75.7% and female is 60.6 % (NBS, 2005).
The death rate is 16.6% death(s)/1,000 populations (HAI Africa, 2008).
Economy
Nigeria possesses a wealth of natural resources including
oil and gas deposits, long hobbled by political instability, corruption,
inadequate infrastructure, and poor macroeconomic management. It is undertaking
some reforms under a new reform-minded administration. Although the country is
primarily agrarian, the economy is now over- dependent on the capital-intensive
oil sector because of failure of former military rulers to diversify the
economy; the oil sector provides 20% of GDP, 95% of foreign exchange earnings,
and about 80% of budgetary revenues. The largely subsistence agricultural
sector has failed to keep up with rapid population growth - once a large net
exporter of food, now must import food (FRD, 2006). The National poverty rate
is estimated at 34.1% and 70.2% live on less than one dollar a day. The level
of poverty affects everything from social cohesion and security to health (FRD,
2006).
Health
Nigeria runs a decentralized system with three levels of
government. The federal that handles university teaching hospitals, the state
handles general hospitals and local governments are mostly dispensaries. All
three levels of government are responsible for provision of health care
services. Although the country
has tremendous potentials for growth and development, the health system still
lacks basic amenities due to problems of inadequate funding, lack of political
commitment and poor implementation plans. The total expenditure on health as
percentage of GDP is 4.6%, and from government expenditure, it is about 1.5%
(FRD, 2006). The Nigerian health system has been under reorganization. It
promoted community-based methods of increasing accessibility of drugs and
health care services to the population partly by implementing user fees. The
idea was to increase access through community-based healthcare reform, but it
was not working (Uzochukwu et al, 2002). The introduction of the National
Health Insurance Scheme (NHIS) became a major concern to government due to the
suffering from medical negligence of Nigerians especially the poor who cannot
afford basic health need. The majority of people still pay out of pocket for
their medicine purchase as the NHIS is still in its pilot stage (Iyioha,
2007). Major illnesses are childhood
diseases, malaria and HIV/AIDS with infant mortality estimated as 100 per 1,000
live births (NDHS, 2003)
TABLE 1: KEY HEALTH INDICATORS OF
NIGERIA
|
|
|
|
191
|
|
|
|
|
99
|
|
|
|
-
|
278
|
|
|
|
%
|
15.7
|
|
|
|
%
|
6.3
|
|
|
|
%
|
24.1
|
|
|
|
%
|
20.1
|
|
|
|
%
|
26.1
|
|
|
|
%
|
5.0
|
|
|
!
|
|
3547
|
|
|
|
|
1100
|
|
|
|
|
209
|
|
|
|
|
615
|
|
#
|
"
|
$
|
47
|
|
|
|
$
|
30
|
Source: World Health Statistics, 2008
Definition of terms:
NAFDAC: National Agency for Food and Drug Administration and Control.
It is a Nigerian
government agency responsible for regulating and controlling the manufacture,
importation, exportation, advertisement, distribution, sale and use of food,
drugs, cosmetics, medical devices, chemicals and prepackaged water. Its
creation was inspired by a 1988 World Health Assembly resolution requesting
countries' help in combating the global health threat posed by counterfeit
pharmaceuticals, and amidst growing concerns about the growing problem of fake
and poorly regulated drugs in Nigeria. (Nigeria First 2003)
In December 1992, NAFDAC's first governing council was
formed. In January 1993, supporting legislation was approved as legislative
Decree No. 15 of 1993, and January 1, 1994 NAFDAC was officially established,
as a “parastatal of the Federal Ministry of Health”. NAFDAC replaced an earlier
Federal Ministry of Health body, the Directorate of Food and Drug
Administration and Control, which had been deemed ineffective, largely due to a
lack of laws concerning fake drugs and political issues. (NAFDAC 2005)
Fake/counterfeit drug:
World Health
Organization defines a “counterfeit” as “A
medicine, which is deliberately and fraudulently mislabeled with respect to
identity and/or source. Counterfeiting can apply to both branded and generic
products and counterfeit products may include products with the correct
ingredients or with the wrong ingredients, without active ingredients, with
insufficient active ingredients or with fake packaging.” (WHO, 2006).
There
is no universal definition of fake drug as every country has there own meaning.
In this thesis the definition of fake drug as defined by the Nigerian
Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous
Provisions) will be used which is:
•
Any drug product which is purported to be; or
•
Any drug or drug product which is so colored,
coated, powdered or polished that the damage is concealed or which is made to
appear to be better or of greater therapeutic value than it really is, which is
not labeled in the prescribed manner or which label or container or anything
accompanying the drug bears any statement, design, or device which makes a
false claim for the drug or which is false or misleading; or
•
Any drug or drug product whose container is so
made, formed or filled as to be misleading; or
•
Any drug product whose label does not bear
adequate directions for use and such adequate warning against use in those
pathological conditions or by children where its use may be dangerous to health
or against unsafe dosage or methods or duration of use; or
•
Any drug product which is not registered by the
Agency in accordance with the provisions of the Food, Drugs and Related
Products (Registration, etc) Decree 1993, as amended. (WHO, 2008)
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