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ELEMENTS FOR THE CONTROL OF PHARMACEUTICAL PRODUCTS CONTAINING

By April Pierce,2014-05-19 15:46
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-Quantity used in quality control. -Quantity of material recovered during production ( i.e., recovered waste). -Quantity of non-recovered loss and reason

ELEMENTS FOR THE CONTROL OF PHARMACEUTICAL PRODUCTS

CONTAINING NARCOTICS AND PSYCHOACTIVE SUBSTANCES

2003

ELEMENTS FOR THE CONTROL OF PHARMACEUTICAL PRODUCTS

    CONTAINING NARCOTICS AND PSYCHOACTIVE SUBSTANCES

PREAMBLE

     Taking into account the problem of the abuse and diversion of pharmaceutical products containing psychotropic substances and narcotics (hereinafter “pharmaceutical substances and products”), the member states undertake to promote the effective control of such substances.

     The member countries should continue to implement controls and fulfill their 1obligations under international agreements, and should promote the signature of these

    agreements by member states that have not yet done so.

     Considering that national controls must be geared toward the particular problems of diversion and abuse identified in each country and that the member countries have achieved varying degrees of implementation, at the national and hemispheric levels, of legal and regulatory structures for the control of pharmaceutical substances and products.

     The member countries recommend the adoption of the following guidelines for a viable system of control. The proposed elements represent best practices implemented among a number of Member states. Although these elements are not compulsory, their adoption by the competent authorities, whether partial or total, is desirable.

I. INTRODUCTION

     Any control system should be based upon the following principles:

    ? To promote measures ranging from legislation and regulation to the application of

    corrective measures. ? To balance the control of pharmaceutical products against the need to ensure

    availability for medical, scientific, and other legitimate purposes.

    ? To foster international cooperation, which is essential to preventing diversion.

     1 “International agreements” means all applicable agreements and treaties, especially the 1961 Single Convention on Narcotic Drugs, amended by the 1972 Protocol of Amendment to that Convention; the 1971 Convention on Psychotropic Substances; and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

    II. LEGISLATIVE FOUNDATION AND REGULATORY FRAMEWORK

    A. Legislation

Principles:

    ? Legislation and regulations must:

    - Provide the authority to create a closed system of distribution by

    regulating pharmaceutical products at all stages, from importation and

    manufacture to distribution and final use.

    - Identify the government components responsible for control and

    regulation, to include the specific functions of each component in

    order to provide a complete, non-duplicative system of control.

    - Identify activities involving pharmaceutical products (e.g., manufacture,

    importation, sale) that are part of the system of control and are 2therefore subject to licensure or registration.

    - Prescribe a mechanism for licensing specific activities and the

    standards to be met by each class of licensee.

    - Identify which substances are to be controlled and provide the means

    to remove, transfer, or add substances as required.

    - Define violative conduct and establish administrative, civil, and

    criminal sanctions.

Measures:

? Countries should enact a reasonable system to control and monitor the flow of

    pharmaceutical products at all stages up to the final user or point of

    destruction

    ? Countries should consider as criminal activities:

     - the organization, management, direction and financing;

     - incitement, inducement, or advice;

     - conspiracy, collusion, participation, or aiding and abetting;

     - harboring, association, and accessory after the fact;

     - attempt; and

     - facilitation of illegal activities in which pharmaceutical products are

    involved.

    ? To address conduct contrary to the laws and regulations governing control of

    pharmaceutical products, and provide for administrative and civil penalties

    consisting of:

    - reprimands, fines, confiscation, suspension or revocation of licenses

    and

    permits (e.g., import/export permits),

    - temporary or permanent closure of establishments, and

     2 The drafters understand the terms “license” and “register” to be nearly

    synonymous. In order not to burden the text, we have chosen to use only the

    term “license” in this document.

    - imprisonment

    ? In addition, countries should provide for corrective actions and sanctions

    along the lines laid out in Part IV. C

    ? National laws should provide for the placement of substances on one of a

    series of lists or schedules with varying controls e.g. this document refers to

    five schedules. The scheduling of substances should be consistent with

    provisions set forth in international Conventions. The schedules should

    classify substances (including pharmaceutical products that contain them)

    according to the following criteria:

    o Health risks, including potential for abuse, addiction and diversion

    o Degree of accepted use under medical supervision in the country

B. Licensing

Principles:

    ? Only qualified persons, firms, and institutions should be authorized to conduct

    regulated activities with pharmaceutical products.

    ? Each competent authority should issue licenses to persons, firms, and

    institutions (including academic and research facilities) that apply and meet

    the legal and regulatory criteria.

    ? Each competent authority may consider issuing a license to handle controlled

    substances separately from other professional or business licenses. This will

    provide the competent authority with a means to take action on a licensee’s

    authority to handle controlled substances while allowing the licensee to

    continue other aspects of business or practice

    ? Licensure to conduct activities with controlled substances (this is a privilege,

    not a right) may be conditioned, suspended, or revoked, subject to due

    process, in order to protect the public.

    ? All competent authorities should establish activity-specific security standards

    for licensees to provide effective controls and procedures to guard against

    theft and diversion of pharmaceutical products.

    ? Each competent authority should establish procedures for the proper and

    documented destruction of controlled substances and products that are

    expired, outdated, or contaminated.

Measures:

    ? Persons, firms, and institutions engaged in the following activities should be

    required to be licensed with the competent authority. The following is one

    suggested system to match each activity with a license category.

     3Activities License Category

    Import Importer

    Export Exporter

     3 For Practitioners and Pharmacies, the competent authority may delegate this authority to

    provincial or

    state licensing authorities for health professionals.

Manufacture, Production, Cultivation, Manufacturer

    Preparation, and Repacking

    Distribution, Wholesaling, Marketing, Sale, Distributor

    Destruction (special procedures apply) Prescribing, Dispensing, and Administering to Practitioner (doctor, veterinarian, dentist, etc.)

    patients

    Dispensing at retail to, or on behalf of, the final Pharmacies

    user (i.e., patient); Dispensing for

    administration in a healthcare institution Analytical Laboratories and Research Analyst / Researcher

    Transportation Transporter (as appropriate)

    Note: Brokers or their representatives who do not take legal ownership of the

    pharmaceutical product are not required to be licensed. Brokers who do take

    legal ownership are required to be licensed for the category of registration

    applicable to their activities.

    ? An up-to date registry of persons, firms, and institutions (preferably

    automated) authorized to conduct each licensed activity should be

    maintained by or accessible to the competent authority.

    ? The competent authority should establish appropriate criteria for licensing,

    including for example:

    o Maintenance of effective controls (e.g. inventories and transaction

    records) against diversion of pharmaceutical products into illicit

    channels.

    o The applicant’s history of compliance with applicable laws and

    regulations

    o Prior conviction record of offenses relating to pharmaceutical products

    or other significant crimes (felonies) by an individual applicant or the

    principals in a firm applying for a license.

    ? Licenses should be subject to periodic renewal.

    ? A reasonable fee should be charged for registration and renewal. (Note:

    Countries may seek to set fees at levels to cover the costs of administering

    the control program, including registration activities, monitoring, and

    enforcement.)

    ? Licenses may be denied, suspended, or revoked, subject to due process,

    based on violation of the country’s applicable laws and regulations, and for

    other specified circumstances, for example:

    o That the original application for licensure or any renewal contains

    material false statements

    o A principal of the licensee has been convicted of an offense relating to

    pharmaceutical products or another significant crime (felonies)

    o Another government entity has taken adverse action against the

    licensee or one of its principals

    o The licensee has engaged in acts that would render its continued

    licensure in violation of the public interest

    ? Each competent authority should establish a time interval for each category

    of licensee to take periodic physical inventories of pharmaceutical products

    (e.g., annually, biennially).

    ? Each competent authority should establish a system of records that each

    licensee should maintain so as to provide for full accountability of

    pharmaceutical products that are imported, exported, manufactured,

    distributed, dispensed, lost/stolen, destroyed, or disposed.

    ? Persons and firms licensed to conduct activities with pharmaceutical products

    are deemed to consent to inspections of business premises and of required

    records (in paper or electronic form), stocks, inventories, equipment, security

    systems, and other business records relevant to compliance with applicable

    laws.

    III. ACTIVITIES COVERED

    A. Import/Export

Principles:

? Quantities and procedures for importing and exporting pharmaceutical products (raw

    of finished forms) should be consistent with International Conventions.

    ? Quantities of imported pharmaceutical products (raw or finished forms) should be

    consistent with medical, scientific, or other legitimate needs.

    ? The competent authorities should establish a mechanism for supervising imports and

    exports of pharmaceutical products.

    ? Imports and exports should only take place between duly licensed persons,

    companies, and institutions

    ? Due to the inherently international nature of import and export transactions,

    international cooperation between competent authorities is essential.

    ? Countries should apply measures to monitor shipments of pharmaceutical products

    and to detect and suppress illicit traffic in pharmaceutical products in free ports and

    free trade zones

    ? Countries through which pharmaceutical products are shipped in transit are treated

    as part of the international control system

Measures:

? The competent authority of each country should establish a mechanism to assess

    medical, scientific, and other legitimate needs for pharmaceutical products to be

    imported.

    ? The competent authorities should develop mechanisms for issuing import and export

    permits, as well as other procedures in accordance with International Conventions,

    with particular respect to the following areas:

    o Total annual imports will not exceed the estimates declared by the competent

    authority based on the national assessment of needs.

    o A mechanism should be established for reporting to the competent authority

    the details of the actual import or export shipment, including date, quantity,

    product, packaging, and routing. For example, the law might require

    Customs to file a report (or “return”) on imports, and the exporting firm to file

    a report (or “return”) on exports.

    ? The exporter should ensure that appropriate security controls are in place during

    transit of the pharmaceutical product, and should select a carrier that has adequate

    controls, to safeguard against loss or theft.

    ? Where a pharmaceutical product is controlled in one country (import/export) but not

    in the other country, competent authorities are encouraged to provide a

    letter/certificate of no objection to the requesting country.

    ? A substance or pharmaceutical product may transit a country (including free ports

    and free trade zones) only if the competent authority of the exporting country notifies

    the competent authority of the transit and importing countries in advance and the

    export permit with reference to this notification accompanies the shipment

B. Manufacture/Production

Principles:

? Only licensees authorized to do so should manufacture/produce pharmaceutical

    products.

    ? Each competent authority should develop a system to sure that the yearly quantity of

    each controlled substance manufactured and produced does not exceed the total

    estimated needs for:

    o Domestic medical, scientific, research or industrial needs

    o Exports to foreign countries

    ? Competent authorities should determine appropriate records to be kept by

    manufacturers to ensure accountability and avoid diversion.

    ? Manufacturers should be authorized to distribute only those pharmaceutical products

    they manufacture. Distribution of other products should require a separate license

    as a distributor.

     Measures:

    ? Each competent authority should develop a system for the procurement of

    controlled substance raw materials to be used in the manufacture of

    pharmaceutical products.

    ? Each manufacturer should maintain records to provide accountability for

    controlled substances used through each stage of the manufacturing process,

    including:

    - Manufacture/production of bulk material

    -Manufacture of finished product

    -Packaging of finished product

    ? Each manufacturer should take a complete physical inventory of all

    pharmaceutical product stocks on at least a yearly basis including:

    - Raw material

    -In-process material

    -Bulk dosage form

    -Packaged goods

    -Waste material awaiting destruction

    - Pharmochemicals used in the manufacturing process

? Manufacturers should maintain records at each stage of the manufacturing

    process to account for the use of controlled substances. Records should include:

    -Identification of product to be manufactured, including name and strength

    of product

    -Batch number and date started and completed

    -Theoretical yield

    -Quantity of raw material entered into production

    -Actual yield

    -Quantity used in quality control

    -Quantity of material recovered during production ( i.e., recovered waste)

    -Quantity of non-recovered loss and reason for loss, if known

    -Such other information as is necessary to account for all controlled

    substances, including destruction ? Manufacturers should maintain a record of pharmaceutical product (bulk or

    finished form) distributed to other persons in accordance with the provisions of

    Section III.C., Distribution.

    ? If a manufacturer holds more than one license (e.g., exporter) the manufacturer

    should maintain a record of pharmaceutical products transferred to the activities

    covered by the other license.

    ? Manufacturing records should be maintained in either manual hard copy or

    electronic form, or both.

    ? Competent authorities should ensure that all records and reports of

    manufacturers comply with pertinent international Conventions and obligations.

    C. Distribution

    Principle:

    ? Distributors should be regulated as part of a closed system of distribution.

    Measures:

    ? Only licensees authorized to do so should distribute or supply pharmaceutical

    products to other licensees.

    ? Distributors should maintain records of their activities involving

    pharmaceutical products

    ? Records should contain, at a minimum, the following information (including as

    appropriate, dates, names, quantities, dosage form, presentation,

    concentration etc):

    o An inventory conducted at regular intervals (e.g., biennial, monthly).

    o The following documents:

    - Purchase Invoices

    - Sales Invoices

    - Returns of Distributed Products

    - Destruction Records, and

    - Theft or Lost Records.

    ? Normal business records, if they meet the above standards, should be

    deemed sufficient.

    ? Records should be updated on a timely basis, (e.g., within 24 hrs.)

? Records should be retained and be available for inspection for a reasonable

    time period (e.g., 3 years).

    ? Distributors should design a system to detect suspicious or unusual orders

    i.e., orders of a volume, type, or nature not in keeping with normal commerce

     and should report such suspicious orders to the competent authority

    promptly upon discovery.

    ? Competent authorities should develop guidelines of good practices for

    distribution, including circumstances where (if feasible) a suspicious or

    unusual order should not be filled.

    ? All distributors should report thefts or loss of pharmaceutical products,

    immediately upon discovery, to the competent authority and, if different, to

    the designated law enforcement authority responsible for investigating such

    incidents.

    D. Prescribing

    Principles:

    ? The primary responsibility for proper prescribing, and dispensing rests upon the

    prescribing practitioner, but a corresponding liability rests upon the pharmacy

    that fills the prescription

    ? A prescription for a controlled substance may be issued only for a legitimate

    medical purpose by an authorized practitioner acting in the usual course of his

    professional practice, and based upon an established face-to-face relationship

    with the patient

    Measures:

? Legislation adopted by countries should define the acceptable means

    through which prescriptions may be issued, e.g. written, verbal, electronic.

    These means may vary by drug schedule.

    ? Countries should periodically review authority and provisions for prescribing

    (e.g. what type or specialty of health practitioner should be able to prescribe

    what drugs)

    ? An Authorized Practitioner means any health practitioner who, under the

    national law (including reference to the laws of states or provinces, where

    applicable), may prescribe pharmaceutical products (Note: As used in Part IV,

    B, practitioner and prescriber mean the same as authorized practitioner) ? A prescription issued other than for a legitimate medical purpose and outside

    the usual course of professional practice is invalid, and persons knowingly

    issuing or filling such prescriptions may be subject to penalties. ? When issuing a prescription, the practitioner should include the following

    information as a minimum:

    - Identification of the patient

    - Identification of the practitioner

    - Date of issue

    - Name, strength, and total quantity of drug

    - Directions for use ? A practitioner should keep a record of the prescription he or she issues for a

    period of time as determined by the competent authority. ? The pharmacy filling the prescription should maintain the original prescription

    on site for a minimum period of time as determined by the competent

    authority.

    ? .

    ? A practitioner may dispense pharmaceutical products directly to the patient

    and should maintain dispensing records, including at a minimum, drug name,

    strength, quantity, and date dispensed.

    ? Competent authorities should establish procedures for patients who use

    pharmaceutical products and travel or settle temporarily in another country, to

    carry or obtain their prescription drugs in accordance with International

    Conventions.

    ? Practitioners and pharmacies may not send controlled substances through

    the mail or by common carrier directly to citizens of another country unless

    authorized by national competent authorities, in accordance with International

    Conventions.

    ? Dispensers should maintain a record of pharmaceutical products purchased,

    obtained, or entered into stock/inventory.

    ? Dispensers should take a physical inventory of pharmaceutical products on a

    periodic basis as established by the competent authority (yearly, biennially).

    E. Dispensing

    Principles:

? Pharmaceutical products may only be dispensed upon issuance of a lawful

    prescription or medical order

    ? A prescription may only be dispensed by a licensed and authorized pharmacy or

    authorized agent.

    ? A prescription for a controlled substance may be issued only for a legitimate

    medical purpose by an authorized practitioner acting in the usual course of his

    professional practice, and based upon an established face-to-face relationship

    with the patient

    ? The primary responsibility for proper prescribing, and dispensing rests upon the

    prescribing practitioner, but a corresponding liability rests upon the pharmacy

    that fills the prescription.

    Measures:

    ? A supposed prescription issued other than for a legitimate medical purpose

    and outside the usual course of professional practice is invalid, and persons

    issuing or filling such prescriptions may be subject to penalties. ? The pharmacist who fills the prescription should sign or initial the prescription

    and should date it as of the date of filling or refilling.

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