Minist�re de la sant� et des services sociaux by HeMMu3

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									               Self-evaluation
  REGULATORY FRAMEWORK FOR RESEARCH ACTIVITIES
 THE MANAGEMENT OF EXPERIMENTAL DRUGS




             In connection with the
        MINISTERIAL ACTION PLAN ON
  RESEARCH ETHICS AND SCIENTIFIC INTEGRITY


                   Published by the
               Government of Quebec
       Department of Health and Social Services
Direction générale de la planification et de l’évaluation
                      June 1998
                                                                                                                                                                               2


1.       Introduction


In the ministerial action plan for research ethics and scientific integrity, the Department of Health and Social Services identifies the measures that must be set up by
establishments where research activities are taking place. They include the adoption of a regulatory framework by all establishments. The framework must (1) set out the
explicit responsibilities and a fair and transparent operating procedure with respect to research activities; and (2) contain specific standards on several points, including the
control of experimental drugs.

Among the measures to be implemented, it is expected that experimental drugs will be subject to the same control applicable to other prescription drugs so that the research
subjects do not incur additional risk (page 14, item 6, measure 16). Measure 16 reads as follows:
[Translation] “Submit experimental drugs to the same type of control as that required for prescription drugs, in accordance with the terms of sections 116 and 117 (Schedule
1) of the Act respecting health services and social services (HSSS)”.

Section 117 of the HSSS states:
“An institution which operates a hospital centre designated as a university hospital centre or university institute or which manages a research centre or research institute
recognized by the Fonds de la recherche en santé du Québec or which operates a centre designated as an affiliated university centre and which, under the terms of its
contract of affiliation, takes part in clinical and basic research activities may furnish medicines on conditions and in circumstances prescribed by regulation.”

The Organization and Management of Institutions Regulation (R.R.Q., 1981, c. S-5, r.3.01, s. 82-84) must provide for a pharmacy department headed by a pharmacist
appointed by the board of directors of the establishment (s.76(1) and (2)) in its organization plan of a hospital centre. The duties of the head of the pharmacy department
include the following: “lay down and enforce policies for preparing, distributing and controlling the use of medications, drugs and poisons in the hospital centre; inform the
council of physicians, dentists and pharmacists and the director of professional services of any breach of the rules for using medications or of the procedures governing the
issuing and filling of prescriptions in the hospital centre”.

These duties cover all drugs used in the establishment, regardless of their status (marketed, not marketed, experimental drug). The duties of the pharmacy department
relating to the safe management of experimental drugs include: the drafting and updating of policies and procedures on the control of experimental drugs (purchasing,
distribution and destruction), safe and separate storage of drugs, the keeping of a complete pharmacological profile and access at any time to relevant information on
research protocols.

For certain specific cases, operational problems were raised regarding the centralization of the management of experimental drugs in the pharmacy department, and more
specifically for out-patients. In order to respond safely to these particular cases, the principal investigator, after completing the self-evaluation tool for the management of
experimental drugs, may ask for an exemption to dispense experimental drugs, for a particular protocol.

Such a request for an exemption is only possible for research protocols which are conducted with out-patients for whom experimental drugs are given to the user in the
original container, labelled by the manufacturer.
                                                                                                                                                                                 3

2.       Method

    The principal investigator completes the self-evaluation tool
      Evaluate compliance as compared to an objective criteria; C – indicates compliance; PC – indicates partial compliance - in the case of partial compliance,
       quantify partial compliance with a percentage; NC indicates non-compliance – in the case of non-compliance, complete the comments section.
    The completed self-evaluation tool signed by the principal investigator is sent to the head of the pharmacy department. In the case of non-compliance, use of the
     pharmacy department's services will be required.
    The self-evaluation tool will be kept in accordance with the document conservation criteria related to this research protocol and may be provided during follow-up visits
     by the authorities.

3.   Profile

Title of protocol and MSN #
Date approved by Research Ethics Board

Name of principal investigator
Coordinates of principal investigator (address and
telephone number)
Where are the experimental drugs stored?
In the case of narcotics, controlled drugs and targeted
substances, are the experimental drugs stored in a
                                                                     Yes               No
narcotics cabinet?
(yes / no)
Will the experimental drugs be served in their original
                                                                     Yes               No
container, as delivered by the manufacturer? (yes / no)
Is the label on the experimental drug container compliant?
                                                                     Yes               No
(yes / no)

If you answered YES to all these questions, you may continue to complete the self-evaluation tool.

The self-evaluation tool facilitates the identification of compliance with the minimum criteria for the safe management of experimental drugs and is not a tool for conducting
an exhaustive analysis of compliance with all the criteria required to manage experimental drugs.
                                                                                                                                          4

Self-evaluation tool
                                                                                Self-evaluation

Purchasing and storage (steps 1 to 11)

               (Step number) Step                                               Compliance criteria                          Comment(s)
                                                     The receipt of experimental drugs is recorded in a register for    C
                                                     such purpose and includes the date of receipt, lot number          PC
(1) Receipt of experimental drug and traceability
                                                     and expiry date, as well as the signature of the person            NC
                                                     acknowledging receipt
                                                     Drugs that are recalled by the manufacturer are quickly            C
(2) Receipt of experimental drug and traceability    traced and taken out of circulation according to the               PC
                                                     established procedure                                              NC
                                                     Drugs are stored in a safe place (locked) and are accessible       C
(3) Storage of experimental drug                     to authorized staff only. There is a register of staff having      PC
                                                     access to the storage place                                        NC
                                                                                                                        C
                                                     Experimental drugs are stored in a safe place (locked)
(4) Storage of experimental drug                                                                                        PC
                                                     separate from other drugs
                                                                                                                        NC
                                                                                                                        C
                                                     Refrigerators in which the drugs are stored have a
(5) Storage of experimental drugs                                                                                       PC
                                                     refrigerated product temperature recorder
                                                                                                                        NC
                                                                                                                        C
                                                     The (average, ideally min/max) temperature of the
(6) Storage of experimental drugs                                                                                       PC
                                                     refrigerators in which the drugs are stored is checked daily
                                                                                                                        NC
(7) Management of narcotics, controlled drugs and    The stocks of narcotics, controlled drugs and targeted             C
     targeted substances according to Health         substances received are checked by a designated person at          PC
     Canada rules and regulations                    reception and the receipt is counter-signed by a witness           NC
 (8) Management of narcotics, controlled drugs and   The stocks of narcotics, controlled drugs and targeted             C
     targeted substances according to Health         substances received are stored in a narcotics cabinet, in          PC
     Canada rules and regulations                    accordance with Health Canada rules                                NC
(9) Management of narcotics, controlled drugs and                                                                       C
                                                     A register is kept by the principal investigator to identify the
     targeted substances according to Health                                                                            PC
                                                     staff that has access to the narcotics cabinet
     Canada rules and regulations                                                                                       NC
                                                                                                                                        5



Purchasing and storage (steps 1 to 11)

               (Step number) Step                                              Compliance criteria                         Comment(s)
(10) Management of documentation including            100% of administrative records of narcotics, controlled drugs   C
     narcotics, controlled drugs and targeted         and targeted substances are kept according to the schedule      PC
     substances                                       set out in the policies and procedures                          NC
(11) Management of narcotics, controlled drugs                                                                        C
                                                      The stocks are destroyed in accordance with Health Canada
     and targeted substances according to Health                                                                      PC
                                                      rules
     Canada rules and regulations                                                                                     NC
Distribution (steps 12 to 14)

               (Step number) Step                                              Compliance criteria                         Comment(s)
                                                                                                                      C
                                                      Experimental drugs are served in the original container, as     PC
(12) Distribution of experimental drugs
                                                      delivered by the manufacturer                                   NC
                                                                                                                      C
                                                      Injectable experimental drugs which are not administered        PC
(13) Preparation by lot, when required (sterile/not
                                                      immediately are prepared according to aseptic techniques in     NC
     sterile)
                                                      an aseptic preparation area under a sterile fume hood
                                                      The label on the container of the experimental drug complies    C
(14) Labelling of experimental drugs                  with the regulation and includes:                               PC
                                                      Patient's last name and first name                              NC
                                                      Date of service and Rx #
                                                      Generic name
                                                      Product concentration
                                                      Dosage
                                                      Delivery system
                                                      Particular method of conserving drug
                                                      Specific precautions
                                                      Quantity
                                                      Renewal authorized
                                                      Expiry date
                                                                                                                                           6


Keeping of file (steps 15 to 23)

               (Step number) Step                                                Compliance criteria                          Comment(s)
(15) Prescription checked for the presence of all      The investigator is responsible for ensuring that all the         C
     the elements required by the regulation           elements prescribed by the regulation respecting the              PC
     respecting the standards relating to              standards relating to prescriptions made by a physician           NC
     prescriptions made by a physician                 appear on the prescription
(16) Prescription checked for the presence of drug     The investigator is responsible for ensuring that there are       C
     interactions, counter-indications and allergies   no drug interactions, counter-indications or allergies to the     PC
     to the drug                                       drug                                                              NC
                                                                                                                         C
                                                       The prescription written for a user of the establishment is put
(17) Prescription document in user's file                                                                                PC
                                                       in his user file
                                                                                                                         NC
                                                                                                                         C
                                                       The doses dispensed to the user are entered in the register
(18) Recording of drugs given to user                                                                                    PC
                                                       kept for such purpose
                                                                                                                         NC
                                                       The original prescription is kept, according to the               C
(19) Conservation of prescription                      conservation schedule required by the Ordre des                   PC
                                                       pharmaciens du Québec                                             NC
                                                                                                                         C
(20) Management of documentation and archives          Management of the documentation relating to the research
                                                                                                                         PC
     according to conservation schedule                protocol complies with the conservation schedule
                                                                                                                         NC
                                                                                                                         C
(21) Management of documentation and archives          The paper waste handled by the investigator with nominative
                                                                                                                         PC
     according to conservation schedule                information (ex: labels) is shredded
                                                                                                                         NC
                                                       The incidents/accidents regarding the drug which have to be       C
(22) Declaration of incidents/accidents (if
                                                       recorded in the local register are recorded in accordance with    PC
     applicable)
                                                       the law.                                                          NC
                                                       The incidents/accidents regarding drugs which must be             C
(23) Disclosure of incidents/accidents (if
                                                       disclosed to the user are disclosed in accordance with the        PC
     applicable)
                                                       law.                                                              NC
                                                                                                                                      7

Destruction (Steps 24 to 25)

              (Step number) Step                                              Compliance criteria                        Comment(s)
                                                                                                                    C
                                                   The drugs returned by the user are managed according to
(24) Management of returns of experimental drugs                                                                    PC
                                                   the procedure established in the protocol
                                                                                                                    NC
                                                   The drugs returned by the user are disposed of in a container    C
                                                   for safe disposal, according to the establishment's              PC
(25) Management of returns of experimental drugs
                                                   procedures (incineration/burial), or recovered by the sponsor,   NC
                                                   at the sponsor's expense.



                                   Steps where the             Number of steps
                               situation is considered
                                      compliant                      Step #
                                   Steps where the             Number of steps
                               situation is considered
                                  partially compliant                Step #
                                   Steps where the             Number of steps
                               situation is considered
                                    non-compliant                    Step #



                       Name and signature of principal investigator Name:                 Signature:

                                       Self-evaluation completed on

       Self-evaluation sent to head of the pharmacy department on

               Self-evaluation received by pharmacy department on

                                               Decision rendered on
                                     8



                 Title of protocol


            Principal Investigator

Approved by Pharmacy Department

 Refused by Pharmacy Department

                             Date

								
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