NATIONAL DRUG CONTROL FRAMEWORK: THE

EXPERIENCE OF GHANAPresented 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 (d-lysergic 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.

• 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

CATEGORIES OF CONTROLLED SUBSTANCES CONT.

• 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.

INTERNATIONAL NARCOTICS CONTROL BOARD (INCB)

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.

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

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.