Transcript National Drug Control Framework - The experience of Ghana

NATIONAL DRUG CONTROL
FRAMEWORK: THE
EXPERIENCE OF GHANA
Presented by Olivia Agyekumwaa Boateng (Mrs.)
Head, Tobacco and Substances of Abuse Dept.
19th June 2013
Overview
 Introduction
Categories Of Controlled Substances
International Narcotics Control Board (INCB) and its functions
Food And Drugs Authority (FDA) Legal Mandate
Tools and Procedures For Regulating Controlled
Substances
Reporting to INCB
GMP considerations for Controlled Substances
Challenges and adopted measures
Conclusion
INTRODUCTION
•Drugs though generally beneficial, are
products that if misused could result in serious
consequences.
Some
of
the
serious
consequences are abuse and addiction
occasionally resulting in fatalities such as
death.
•Substance abuse is a maladaptive pattern of
use of any substance that persists despite
adverse social, psychological or medical
consequences.
The
pattern
may
be
intermittent with or without tolerance and
physical dependence.
INTRODUCTION CONT.
• The drug or substances most often associated with abuse are
psychoactive substances which may be defined as chemical
substances that alter mood or emotion, perception, cognition
and general brain function.
• The major psychoactive substances are classified
pharmacologically as follows:
 Central Nervous System (CNS) Stimulants: E.g. Amphetamine,
Cocaine, Nicotine
 Central Nervous System (CNS) Depressants E.g. Alcohol,
Benzodiazepines (sedative, hypnotic and anxiolytic drugs),
diazepam (valium), alprazolam (Xanax)
 Narcotic Drugs or Opiates E.g. Opium, Morphine, Codeine,
Heroin, Pethidine, Methadone, Pentazocine
 Cannabis and Hallucinogens: E.g. Cannabis/Marijuana, LSD (dlysergic acid diethylamide), Mescaline, Psilocybin-Psilocin
CATEGORIES OF CONTROLLED SUBSTANCES
• Many of the narcotics, depressants, and
stimulants manufactured for legitimate medical
uses are subject to abuse and diversion to illicit
trade and have therefore been brought under
legal control.
• Hence a controlled substance can be said to be
a drug which has been declared by law to be
illegal for sale or use, but may be dispensed
under a physician's prescription.
• The goal of control is to ensure that these
"controlled substances" are readily available for
medical
use,
while
preventing
their
distribution for illicit sale and abuse.
CATEGORIES OF CONTROLLED SUBSTANCES CONT.
• There are three (3) main categories of drugs which are under control
and regulation in Ghana. These are as follows;
 “Narcotic drugs” means substances listed in Schedules I and II of the
1961 Convention. The esters and ethers and the salts of esters and
ethers of the narcotic drugs in Schedule I are also subject to control.
e.g morphine, pethidine, fentanyl etc
 “Psychotropic substance” means those natural or synthetic
substances or any natural material listed in the four Schedules of the
1971 Convention. The salts of those substances, where they exist, as
well as preparations containing those substances, are subject to the
same control requirements as the base substance. eg. diazepam,
lorazepam, methylphenidate, midazolam etc
 “Precursor chemical” means those substances listed in Tables I and
II of the United Nations Convention against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances, 1988 (1988
Convention) frequently used in the illicit manufacture of narcotic
drugs and psychotropic substances under the international control.
e.g norephedrine, pseudoephedrine, potassium permanganate etc
INTERNATIONAL NARCOTICS CONTROL BOARD (INCB)
• The International Narcotics Control Board (INCB) is the
independent and quasi-judicial control organ for the
implementation of the United Nations drug conventions
which are:
• The Single Convention on Narcotic Drugs of 1961 (1961
Convention), as amended by the 1972 Protocol;
• The Convention on Psychotropic Substances of 1971 (1971
Convention) and, adopted in 1988,
• The United Nations Convention against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances (1988
Convention).
There are currently more than 180 parties to the conventions.
INCB FUNCTIONS
•
As regards the licit manufacture of, trade in and use of
drugs, INCB endeavours, in cooperation with Governments,
to ensure that adequate supplies of drugs are available for
medical and scientific uses and that the diversion of drugs
from licit sources to illicit channels does not occur. INCB
also monitors Governments' control over chemicals used in
the illicit manufacture of drugs and assists them in
preventing the diversion of those chemicals into the illicit
traffic;
•
As regards the illicit manufacture of, trafficking in and use
of drugs, INCB identifies weaknesses in national and
international control systems and contributes to correcting
such situations. INCB is also responsible for assessing
chemicals used in the illicit manufacture of drugs, in order to
determine whether they should be placed under
international control.
FOOD AND DRUGS AUTHORITY (FDA) LEGAL
MANDATE
• The regulation of narcotic drugs, psychotropic substances and
precursor chemicals in Ghana is under Section 126 of the Public
Health Act 2012, (Act 851), which is stated as follows:
The Authority shall regulate narcotic drugs, psychotropic
substances for legal or medical use and precursor chemicals
in accordance with the international conventions and any
other relevant guidelines and protocols to which Ghana
subscribes, including
a) the Single Convention on Narcotic Drugs of 1961 (1961
Convention) as amended by the 1972 Protocol,
b) the Convention on Psychotropic Substances of 1971
adopted in 1988, and
c) the United Nations Convention against Illicit Drugs
Trafficking and Psychotropic substances, 1988.
FOOD AND DRUGS AUTHORITY (FDA) LEGAL MANDATE CONT.
• It is FDA's responsibility to promote government compliance
with the provisions of the drug control treaties and to assist in
this effort.
• The Food and Drugs Authority working together with the
Narcotic Control Board is the competent national authority in
Ghana under the INCB.
• Empowered to issue certificates and authorizations for the
import and export of narcotic drugs and psychotropic
substances in accordance with the provision of article 18 of
the single Convention on Narcotic Drugs of 1961, and of the
Convention on Psychotropic Substances of 1971.
• Empowered to regulate or enforce national controls over
precursors and essential chemicals in accordance with the
provisions of article 12 of the United Nations Convention
against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances in 1988.
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED
SUBSTANCES
1. National Quota Allocations to local manufacturing companies
National Quota
•
It is an annual estimate of how much of each controlled substance
is required by a country (Ghana) to meet the demands for medical
treatment of its population and for scientific research (licit purposes)
•
The Competent Authority (FDA) furnishes INCB with data used to
determine the National Quota using specially designed INCB
reporting forms and the estimates are confirmed by the INCB
Allocations
• They are specific quantities of controlled substances assigned to an
importer of controlled substances which represent the total quantity
of that controlled substance which can be imported by that company
in a given year
•
Allocations to companies are to be within the National Quota i.e.
importation of controlled substances by companies are not to be in
excess of the national quota
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
PROCEDURES FOR ALLOCATION OF CONTROLLED SUBSTANCES
•
Manufacturing companies submits their letters requesting for
allocation of controlled substances for the following year to FDA.
•
FDA receives a correspondence from INCB requesting her to submit
requirements for the controlled substances for the upcoming year.
•
FDA responds accordingly by submitting a letter, stating allocation for
the year to INCB based on previous data and requisitions from
manufacturers.
• Based on previous utilization and distribution records received from
companies, FDA allots to companies the needed quantities for the
impending year.
• New Importers formally request for an allocation of a controlled
substance after satisfying the general requirements (Registration and
Facility Licensing requirements)
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
2. Vetting/Issuance of permits
Companies apply for a controlled substance permit through the
Ghana Community Network (GCNet) electronic permit system and
it’s vetted. Upon approval of the controlled substance permit
application by FDA, a final import permit (hard copy) is prepared
and collected by an authorized person of the importing company.
 Rejection of Import Permit Application:
An application for importation of a product may be rejected for
several reasons. This may include, but not limited to:
o when the National quota for that particular controlled substance is
exhausted,
o when the returns for previous import(s) have not been submitted,
o when the product to be imported has not been registered with
FDA,
o when Drug Evaluation and Registration Department (DERD) and
Drug Enforcement Department (DED) raises registration or GMP
objections to the importation of the product due to registration
anomalies.
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
3. Monitoring of Advice of receipts and Returns
on imported controlled substances
Advice of Receipt
• It is a document that an importer of a controlled substance is
required to submit upon receipt of a consignment of a controlled
substance covered by an import permit
• To be submitted not later than two weeks after clearance of the
controlled substance from the port of entry
Information required on the Advice of Receipt
• All the details on the Import permit issued by FDA i.e. Permit
number, Importer and Exporter Address, Description and Quantity
of Controlled Substance being Imported
• Bill of Lading / Waybill Number
• Port of Entry
• Date of Arrival at Port
• Date of Clearance from Port
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
Returns
 Returns are documents submitted by importers of controlled
substances that show how the controlled substance has been
utilised. Returns cover the following
• Stock utilisation records (for raw- materials) – every batch is to
be accounted for
• Stock distribution records (for finished product)
• Quantities utilised for R&D
• Quantities submitted to QC for analysis e.t.c
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
 N/B: Submission of returns is key as it serves as evidence
from the importer that the controlled substance was
utilised within the LICIT distribution channel.
 Returns are verified to ensure they are authentic and are
not just arbitrary figures cooked up in the comfort of
someone’s waterbed.
This is done through follow-up visits to manufacturing
facilities to confirm the authenticity of Returns submitted
on controlled substances where Officers check whether;
• stock controlled cards/documents covering the utilization
of materials are satisfactorily maintained and are
traceable to the batches of the products.
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES
CONT.
• satisfactory BMR’s have been developed for all batches
and percentage yield on productions are within acceptable
limits i.e NLT 97%.
• retained samples of all batches of the products
manufactured are available at the time of the audit.
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
4. Pre-export Notification
• Pre-export notification is a very important tool used to
monitor the movement of precursor chemicals in
international trade aimed at preventing diversion and
subsequent use in illicit manufacture of narcotics and
psychotropic substances
• In this system, regulatory agencies in the exporting
countries notify the importing country (FDA) of an
impending shipment of precursor chemicals into their
territories and requests that the legitimacy of such
shipments be verified
• Notifications are received and responded to through an
automated online portal called the Pre- Export
Notification (PEN Online) accessible to only regulatory
agencies who have signed up.
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
• FDA oversees the issuing of import permits for importation of
precursor chemicals required for pharmaceutical purposes e.g
Ephedrine (Ephedrine Nasal Drops), Pseudoephedrine (Cough
Mixtures), Phenylpropanolamine.
• The Environmental Protection Agency (EPA) issues permits for
other chemicals considered precursor chemicals but are used for
non-pharmaceutical purposes like as industrial solvents,
laboratory reagents such as Acetone, HCl, Sulphuric Acid, Acetic
Anhydride
• NACOB exercises some control over the importation of these
chemicals as well and are signed up on the PEN Online
• Collaboration between the FDA, EPA and NACOB is maintained
to respond satisfactorily to PENs
• The INCB also sends queries verifying the authenticity of
shipments of precursor chemicals as the need arises and the
responses are sent directly (not on the PEN Online)
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES
CONT.
5. Endorsement of Export Authorisation
• In accordance with articles 31 of the 1961 Convention and 12 of the
1971 Convention, it is requested that an import authorization form
and/or export authorization form which authorize the import/or the
export of Controlled Substances into a country (e.g. Switzerland)
respectively to another country (e.g. Ghana) be certified that the
Controlled Substances detailed in the authorization form have been
duly imported.
• The timely submission of an Advice of Receipt by an importer in
Ghana facilitates the ready endorsement and certification of the
export authorization form.
• This continues to be an effective tool for detecting and preventing
attempted diversions. It also expedites communications between the
governments of exporting and importing countries.
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
6. Precursors Incident Communication System (PICS)
• The Precursors Incident Communication System (PICS) is a secure
online tool developed by the INCB to enhance real-time
communication and information sharing between national authorities
on precursors incidents.
• Ghana being a member state has the following agencies registered
on this tool:
-FDA ,NACOB, CEPS and EPA
• It provides actionable intelligence and facilitates immediate and
direct contact between law enforcement and regulatory authorities
from concerned countries in order to help launch bilateral/regional
investigations into seizures and suspected cases of diversion.
TOOLS AND PROCEDURES FOR REGULATING CONTROLLED SUBSTANCES CONT.
7. Follow-up Audit inspections
Follow-up Audit inspections are conducted at the importers premises
and a series of questions i.e a checklist is used to cross examine the
reporting documents that have been previously submitted by them to
the Authority to validate authenticity of the usage of the controlled
substances. This gathered information is then used to cross check the
actual documents which includes; finished products manufactured and
the distribution records as at the time of the audit inspection. This
exercise helps to trace the authenticity of the usage of the controlled
substances when they are duly imported and also detect if there are
any illicit diversions.
REPORTING TO INCB
Accurate reporting to INCB is of utmost importance. Below are some
reports and statistics submitted to INCB:
• FORM C - Annual Statistics of Production, Manufacture,
Consumption, Stocks and Seizures of Narcotic Drugs
• FORM P – Annual Statistical Report on Psychotropic substance
• FORM D – Annual Informational on Substances frequently used in
illicit Manufacture of Narcotics Drugs and Psychotropic Substances
• FORM A – Quarterly Statistics of Imports and Exports of Narcotics
Drugs
• FORM A/P – Quarterly Statistics of Imports and Exports of
Psychotropic Substances listed in Schedule II of the 1971
Convention
REPORTING TO INCB CONT.
• FORM B- Assessment of Annual Medical and Scientific
Requirements for Narcotic Drugs
(Collates data from other government institutions
including Ghana Pharmacy Council, Medical and Dental
Council, Ghana Veterinary Services, Council for Health
and Information Services.)
• FORM B/P- Assessment Annual Medical and Scientific
Requirements for substances in Schedule II, III and IV
of the Convention of Psychotropic Substances 1991
GMP CONSIDERATIONS FOR CONTROLLED
SUBSTANCES
• Controlled substances should be stored in dedicated
areas that are subject to appropriate additional safety
and security measures to avoid theft cases that may
occur since these substances can be easily
channeled into illicit manufacture of cocaine, heroin
etc.
• Storage conditions- temperature mapping should
show uniformity of the temperature across the storage
facility and documented (written instructions and
records including calibration of equipments). For
example, Chlordiazepoxide and most of the controlled
substances are to be protected away from light.
GMP CONSIDERATIONS FOR CONTROLLED SUBSTANCES CONT.
• Comprehensive records should be maintained showing all
receipts and issuances of the finished products to clients and
arrival of raw materials from ports of entry (submitting the
Advice of receipts and Returns).
• Appropriately trained and qualified personnel should be
solely responsible for the handling of controlled substances.
For e.g. Chlordiazepoxide HCl powder when not handled
well and inhaled could cause thyroid conditions.
• Materials should be transported in such a way that their
integrity is not impaired and that storage conditions are
maintained.
CHALLENGES ENCOUNTERED WHEN COLLATING DATA AND MEASURES THE FDA
HAS ADOPTED TO OVERCOME THE CHALLENGES
CHALLENGES:
•
Delay in the submission of advice of receipts and returns on
imported controlled substances from importers hence affecting
timely submissions to the INCB.
•
Delayance in data submission from other government institutions
when collating data for estimates requirements.
ADOPTED MEASURES:
• Training workshops are organized for importers of controlled
substances.
• Importers of controlled substances are regularly prompted to
submit reporting documents on time to facilitate data
compilation.
• Import permits/authorisations are withheld from importers
when there are outstanding reporting documents from previous
issued import permits/authorisations.
CONCLUSION
The basis for control and regulation
would ensure that adequate supplies
of drugs are available for medical and
scientific uses whilst preventing
diversion from licit sources to illicit
channels.