Narcotic Analgesics: Procurement,
Distribution, Dispensing practices
and Rules.
By
USMAN LARAI BABA (B.Pharm)
INTERN PHARMACIST,NATIONAL
ASSEMBLY CLINIC,ABUJA.
OBJECTIVES
At the end of this presentation , participants
should be able to understand;
• what Narcotic analgesics are
• Challenges facing its procurement
distribution and effective use.
• Our role as Pharmacist in the chain of
distribution of narcotic analgesics to the
patients for effective pain management and
treatment.
OUTLINE
Introduction
Definition of Narcotic analgesics
Classification of Narcotic analgesics
Procurement and Distribution pattern of Narcotic Analgesics.
Challenges due to control agencies
Salient requirements under the international treaties.
The drug procurement/Distribution system
Examples of drug distribution barriers.
Dispensing Practices and rules Governing Narcotics and the
role of the Pharmacist.
Barriers to Pharmacists dispensing practices.
Opioid Analgesics in Nigeria
Role of NAFDAC and FMOH.
Conclusion
References
INTRODUCTION
Narcotic agents are potent analgesics which are
effective for the relief of severe pain. Analgesics
are selective central nervous system depressants
used to relieve pain. The term analgesic means
"without pain".
These drugs often induce a state of euphoria or
feeling of extreme well-being, and they are
powerfully addictive. The body quickly builds a
tolerance to narcotics in as little as two to three
days, so that greater doses are required to achieve
the same effect. Because of the addictive qualities
of these drugs, most countries in the twenty-first
century have strict laws regarding the production,
procurement and distribution of narcotics.
Classification of Narcotics
Natural derivatives of opium: e.g morphine
and codeine.
Partially synthetic drugs derived from
morphine: e.g heroin, oxycodone
(OxyContin), hydromorphone (Dilaudid), and
oxymorphone (Numorphan).
Synthetic compounds that resemble
morphine in their chemical structure: e.g
fentanyl (Duragesic), levorphanol (Levo-
Dromoran), meperidine (Demerol),
methadone, and propoxyphene (Darvon).
PROCUREMENT AND DISTRIBUTION
OF NARCOTIC ANALGESICS
Narcotic drugs and psychotropic substances are regulated by
international treaties and national drug control policies . Example
are;
SingleConventionon Narcotic Drugs, 1961, as amended by the 1972
Protocol Amending the Single Convention on Narcotic Drugs, 1961
(Single Convention)-is the principal international treaty regulating
availability of opioids. The dual aims of the Single Convention are to
control the use and trafficking of substances with abuse potential
while ensuring the availability of these drugs for scientific and
medical purposes.
The International Narcotics Control Board (INCB)- functions by
liasing with competent National authorities and administering
national regulations relating to controlled substances for medical use
is the national drug/pharmaceutical regulatory authority, which is
usually a part of the Ministry of Health. There are exceptions to this,
however.
The World Health Organisation(WHO).
CHALLENGES DUE TO CONTROL
AGENCIES
The need for controlling narcotic drugs and
psychotropic substances makes ‘access’ to these
products highly challenging due to;
•The market size of these products.
•The documentation and approvals required prior to
shipping. This makes procurement a slow and
bureaucratic process.
Salient requirements under the international
treaties
The international treaties require that all individuals and enterprises in
the procurement, manufacture and distribution system should meet
up with the following ;
Be licensed or otherwise appropriately authorized.
Transfers of controlled substances take place only between
properly registered parties.
Patients may use controlled substances only according to a
physician’s prescription.
Records must be kept, and reports on consumption must be filed
with the competent national authority. These, along with security
arrangements and inspections, are designed to prevent diversion
from the legitimate system of drug distribution.
THE DRUG
PROCUREMENT/DISTRIBUTION SYSTEM
EXAMPLES OF DRUG DISTRIBUTION SYSTEM
BARRIERS
Government has not made procurement arrangements for the
importation or domestic manufacture of needed opioids.
There are delays in government decision making about
procurement.
Government's official estimate of type and quantity of opioids
required is insufficient.
The government's method for estimating opioid requirements
does not take into consideration the actual needs.
Manufacturers and distributors do not distribute opioids in a
timely way.
The number of health professionals, pharmacies, and patient care
facilities authorized to procure and dispense opioids to patients
who need them is insufficient.
Governments do not have the systems in place to guarantee a
safe and effective transfer of medications from wholesalers to
retailers.
DISPENSING PRACTICES AND RULES;
THE ROLE OF THE PHARMACIST
The pharmacist is a critical link in the chain of drug
distribution to the patient, dispensing drugs that are
available by prescription only. To dispense opioid analgesics,
pharmacists must comply with the requirements of federal
and state drug, pharmacy, and controlled substances laws.
Pharmacists are “personal health care advisers” to their
patients, but they are also “gatekeepers” who must
determine whether dispensing a prescription order will
serve a legitimate medical purpose and be in the usual
course of professional practice.
However, the pharmacists have the potential to act as
barriers to patients seeking legitimate access to opioids for
pain management.
Barriers to Pharmacist
dispensing Practices
There are three(3) main categories;
Attitudes and misconceptions among health
care workers and patients
Lack of access to common effective narcotic
analgesics and
The legal and regulatory environment.
Opioid Analgesics in Nigeria-
Role of NAFDAC
• National Agency for Food and Drug
administration and Control (NAFDAC)
mandated- 1993 decree to:-
* Ensure use of narcotics and psychotropic
drugs limited to medical and scientific
purposes
* grant authorizations for importation,
manufacture, distribution, sale and use of
narcotic drugs and substances.
* Collaborate with NDLEA on measures to
eradicate drug abuse.
Opioid Analgesics in Nigeria- Role
of FMOH
The Federal Ministry of Health is sole importer
of finished narcotic drugs for the nation’s
legitimate medical and scientific purpose.
Quantity to be imported depends on national
consumption estimate prepared by NAFDAC in
line with INCB guidelines
Drugs stored in Central Federal Medical stores,
Oshodi, Lagos.
Legitimate institutions normally apply to
Narcotic control division, NAFDAC for
purchase.Endorsements required.
If satisfied, authorization issued to purchase
from Federal Medical stores
Continuation
Supply erratic since 1993 – mainly due to
government bureaucracy (DF118, tramadol,
pentazocine available)
Advocacy efforts (UCH Pain/Palliative care
group, Society for the Study of Pain,
Nigerian Society of Anaesthetists, David
Joranson).
New NAFDAC Director- Prof Akunyili
December 2001- parenteral opioids import
September 2004 – Supply expired. No new
supply!
ESTIMATED REQUIREMENTS OF
NARCOTIC DRUGS IN GRAMS FOR 2011
(February update) obtained for Nigeria,Ghana ,India and
USA amongst others.
Nigeria*
Cocaine 375
Codeine 1 125 000
Dihydrocodeine 750
Etorphine 8
Fentanyl 38
Morphine 80 000
Pethidine 300 000
Pholcodine 14 250
Ghana
Cocaine 10
Codeine 200 000
Dextropropoxyphene 150 000
Dihydrocodeine 500
Fentanyl 10
Heroin 2
Methadone 2
Morphine 10 000
Opium 20
Pethidine 150 000
Thebaine 1
United states of America
Cocaine 78 444
Codeine 90 411 030
Dihydrocodeine 58 219
Dihydromorphine 2 549 310
Diphenoxylate 1 412 000
Ethylmorphine 2
Etorphine 7
Fentanyl 1 428 000
Heroin 73
Hydrocodone 41 066 910
Morphine 103 957 036
Normorphine 10
Oxycodone 66 026 196
Oxymorphone 1 322 000
Pethidine 8 600 000
Thebaine 81 348 535
Conclusion
We can say that the incorrect knowledge and
inappropriate attitudes of some pharmacists could
contribute to a failure to dispense valid prescriptions
for opioid analgesics to patients in pain. Thus;
Pharmacist have to understand the Legitimate
dispensing practices in certain situations according
to the various international, National(Federal and
State) policies of Narcotic analgesics and the
requirements for the dispensing in the management
of pain. We CAN and SHOULD play a pivotal role in
ensuring patient access to medications.
REFERENCES
A ‘step-by step’ Algorithm for the Procurement of Controlled
Substances For Drug Substitution Treatment.
Access to Controlled Medications Programme: briefing note.
World Health Organization.
Web site.
http://www.who.int/medicines/areas/quality_safety/access_to_co
ntrolled_medications_brnote_english.pdf. March 2007. Accessed
January24, 2011.
Journal of the American Pharmaceutical Association,vol.41,no.2
March/April 2001.
Joranson DE, Ryan KM. Ensuring Opioid availability: Methods and
Resources. J pain symptom manage. 2007;33(5):527-532.
http://www.bonicasmanagement of pain.com/.
www.incb.org
Pharmacy and Drug Laws in Nigeria; compilation by Pharmacist
Council of Nigeria
THANK YOU
