HEALTH & SAFETY EXAMPLE OF A COMPLETED POISONS CONTROL PLAN – PART ONE This example of a completed Poisons control plan – Part One is published as an attachment to the University of Melbourne’s Chemical Management Guidelines (Section 7.4.3. Develop and Maintain a Poisons Control Plan). The original Poisons Control Plan (blank) document is published by the Department of Health and Human Services and available via http://www.health.vic.gov.au/dpcs/industrial.htm If you are converting this example document into an actual Poisons control plan, please ensure it is the most current version on the Department of Health and Human Services website: http://www.health.vic.gov.au/dpcs/industrial.htm You will also need to remove this first page. safety.unimelb.edu.au HEALTH & SAFETY: EXAMPLE OF A COMPLETED POISONS CONTROL PLAN – PART ONE 1 Date: November 2015 Version: 1.0 Authorised by: Associate Director, Health & Safety Next Review: November 2018 © The University of Melbourne – Uncontrolled when printed. Poisons Control Plan For a Permit – Part One Poisons Control Plan (PCP) for a Permit to Purchase or Obtain and Use Poisons or Controlled Substances for Industrial, Educational, Advisory or Research Purposes - Part One Note: This section is for the Department of Health, Drugs and Poisons Regulation use ONLY Details of the permit to which this Poisons Control Plan relates: Permit Holder: Permit Number(s): The registered version of the Poisons Control Plan contains the Department of Health, Drugs and Poisons Regulation. pages, each of which has been stamped by Poisons Control Plan A Poisons Control Plan (also abbreviated in this document to PCP) must be submitted for registration in relation to all permits to indicate how the permit holder proposes to comply with the Drugs, Poisons and Controlled Substances Act 1981 (The Act), the Drugs, Poisons and Controlled Substances Regulations 2006 (The Regulations), the conditions of the permit plus relevant codes and standards. The Act and The Regulations are administered by the Department of Health, Drugs and Poisons Regulation. It is the responsibility of the permit holder to ensure compliance with The Act and the Regulations. Important Information References in this PCP made to a permit or permit holder should equally be read as referencing a permit application or permit applicant. Notes: The electronic version of this PCP is accessible, in Word® format, from the Department of Health, Drugs and Poisons Regulation website at www.health.vic.gov.au/dpu The PCP is an integral part of permits to purchase or obtain and use substances in any combination of Schedules 2, 3, 4, 7, 8 and/or 9. A version of this PCP is available for manual completion and submission, for use when a permit holder or permit applicant is unable to prepare the PCP by or on computer. Contact the Department of Health, Drugs and Poisons Regulation to obtain this version. Instructions • Download the PCP and save it (as a Word® document) to your computer. • Questions are asked seeking true and accurate responses. The questions are in green font. • Sample responses have been included, in blue font, to provide examples of responses that may be acceptable to the Department of Health, Drugs and Poisons Regulation, and to indicate the expected length and detail of the responses. One or more of the sample responses may be retained, with or without amendment, but only if they are true and accurate. Additional or alternative responses should be made, where required, to reflect accurately specific circumstances that apply to the permit holder. • Some items or sections of the PCP may not be relevant to all permits. Where this is the case, delete the sample responses and respond with ‘Not Applicable’, so that the completed PCP will not be confusing and will serve as a meaningful reference document to relevant personnel. Do NOT leave any question with a response that is blank. • Save the completed PCP on your computer, to facilitate any necessary and/or future amendments. • Transmit the completed PCP (as a Word® document) as an email attachment to the Department of Health, Drugs and Poisons Regulation email address at dpu@health.vic.gov.au or alternatively, if it forms part of a permit application, forward it together with the remaining required documentation. • Other relevant documentation may also be transmitted electronically, other than application forms or documents that require original signatures. • If a PCP has been completed manually, it will need to be posted to the Department of Health, Drugs and Poisons Regulation, GPO Box 4541, Melbourne 3001 or delivered to 50 Lonsdale Street, Melbourne. Notes: • The PCP must be completed and submitted in the format provided. A document comprised only of a list of responses to the PCP questions will NOT be accepted because, after being assessed and registered by the Department of Health, Drugs and Poisons Regulation, the PCP will be returned to the permit holder for use as a reference document, showing how the permit holder proposes to comply with the legislation and related standards. • The permit holder will be required to review the PCP periodically, including at the time of annual permit renewal. • Avoid providing too much detail and do NOT include the names of personnel or other information, which may result in additional paperwork to amend the PCP in the future. When required to identify key personnel, use position titles or a description of the role, as these are less likely to change. • Where a reference is made to external auditors, other licences, standards or forms of accreditation (e.g. NATA, ISO 9002, TGA Licence), ensure that you clearly and unambiguously identify the reference. • Do not use abbreviations unless these are clearly defined in the document. Permitted Activities Notes: • Poisons schedules should not be confused with similar numbering of classes of poisons in Dangerous Goods legislation. • A permit is required in relation to each location at which purchasing or obtaining of permitted poisons occurs. All premises at which substances in Schedules 4, 8 and/or 9 plus Listed Regulated Poisons in Schedule 7 are stored must be covered by a permit. • A permit is required to possess substances in Schedules 4, 8 and 9 plus Listed Regulated Poisons in Schedule 7 (e.g. arsenic, benzene, cyanides). • When a permit expires or is cancelled, any remaining substances in Schedules 4, 8 and/or 9 plus Listed Page 3 Regulated Poisons in Schedule 7 must be disposed of, in an appropriate manner. • A permit holder is not authorised to supply scheduled poisons. • The permit document specifies which poisons may be purchased or obtained and contains a number of conditions that must be observed by the permit holder. Responsible Person(s) The permit document will identify one or more Responsible Persons, who have been nominated by the permit holder (and approved by the Department of Health, Drugs and Poisons Regulation) to fulfil the following tasks: • Ensure maintenance of the accuracy and currency of the registered PCP, • Provide annual confirmation (as required by the Department of Health, Drugs and Poisons Regulation) that the permit holder is operating in a manner consistent with the registered PCP, • Ensure that there is a periodic review (at least annually, e.g. at the time of licence renewal) of the permit and the registered PCP to confirm that the permit holder continues to comply with the conditions of the permit, the legislation, relevant codes and required standards and to retain documentary records of such reviews, • Notify the Department of Health, Drugs and Poisons Regulation of any amendments, which may be required to the permit or to the conditions of the permit (e.g. change of company name, change of address, change of Responsible Person), and • Submit for assessment to the Department of Health, Drugs and Poisons Regulation any proposed amendments to the registered PCP. Sections of the Poisons Control Plan Part One (relates to all permits) 1. Documentation 2. Purchasing or Obtaining Permitted Poisons 3. Security and Storage 4. Records of Transactions 5. Staff Training 6. Waste Disposal Part Two (relates to permits with Schedule 8 and/or Schedule 9 poisons only) 7. Storage and Access 8. Records of Transactions 9. Disposal/Destruction of Schedule 8 and/or Schedule 9 Poisons Part Three (relates to permits with additional campuses) 10. Multiple Campuses Page 4 1. Documentation References Current versions of the following source material may be accessed on the indicated websites: • The Drugs, Poisons and Controlled Substances Act 1981 (The Act) and the Drugs, Poisons and Controlled Substances Regulations 2006 (Regulations) may be accessed at: http://www.legislation.vic.gov.au/ • The Department of Health, Drugs and Poisons Regulation website contains application forms and information relating to licence and permit requirements in Victoria and may be accessed at http://www.health.vic.gov.au/dpu • The current edition and amendments of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), which is the source document for poisons schedules plus labelling and packaging requirements, may be accessed at http://www.tga.gov.au/industry/scheduling-poisons-standard.htm • The Poisons Code may be accessed at http://www.health.vic.gov.au/dpu/poicode.htm Notes: • Key aspects of the preceding reference documents are addressed in this PCP but reference must be made to the source material for full details of requirements. Location of the Permit and Poisons Control Plan documents The registered PCP, which will be stamped and returned by the Department of Health, Drugs and Poisons Regulation, must be maintained by a Responsible Person (who will be named in a condition on the permit). The current permit and registered PCP documents must be readily available and able to be located for reference and review. 1.01 Indicate the intended or actual locations of the current permit and registered version of the PCP: The permit will be held by the [Local area location, including Department name, Building name, room number(s) etc.] under the control of the nominated responsible person. (Ensure to also include the room number of the responsible person. The poisons control plan (PCP) will be located in the office of the responsible person with the permit documentation. The Responsible Person must ensure that there is a periodic review (at least annually, such as at the time of permit renewal) of the permit and the registered PCP to confirm that the permit holder continues to comply with the conditions of the permit, the legislation, relevant codes and required standards. Proposed or required amendments to the PCP must be submitted to the Department of Health, Drugs and Poisons Regulation for assessment. Confirmation that each review has occurred is to be recorded in a document and is to be signed and dated by the person who conducted the review. It is to be retained for the life of the PCP (and not less than three years) and is to be provided to the Department of Health, Drugs and Poisons Regulation, upon request. 1.02 Indicate the position or role of the person(s) to be responsible for the periodic review of the registered PCP and the frequency with which the review is to occur: The nominated responsible person in conjunction with senior staff will be responsible for a review of the plan which will take place at least two yearly o when significant changes to an area occur, such as changes to work activities. 1.03 Indicate the manner in which the review of the PCP is to be documented and where the corresponding records are to be retained: All copies of permits and PCPs will be retained with the permit holder. The date of the review will be indicated Page 5 by a footer or other signatory means where required Purpose for which poisons are required 1.04 Indicate the type(s) of activities for which the permitted poison(s) may be required: The sole purpose for the use of scheduled drugs and poisons are for research and teaching purposes of tertiary students only. At no time will scheduled drugs or poisons be administered to any living person. At no time will any scheduled drugs or poisons be administered to any animal for professional veterinary purposes. At no time will any scheduled drugs or poisons be sold for profit. Research may be conducted on the chemical structure and function of Scheduled Poisons. Research conducted in vitro will use animal and human tissue only. Research conducted in vivo will be conducted on controlled animals required for experimental purposes only. These animals are destroyed in accordance with ethical requirements at the completion of research activities. Teaching will be limited to demonstration on animal or human tissue and live animals. Teaching practices involving the use of scheduled poisons are conducted only for tertiary students. Specific requirements for Schedule 4,7,8 & 9 poisons will be documented in accordance with the individual permit holder. 2. Purchasing or Obtaining Permitted Poisons The acquisition of scheduled poisons, to which the permit relates, must only occur in accordance with a documented procedure or at the direction of the Responsible Person(s). 2.01 Indicate the position or role of the person(s) to be responsible for ordering scheduled poisons from suppliers: All purchases of Schedule 4 Poisons require approval from the Laboratory Supervisor (Laboratory Head). The Laboratory Head is the senior member of the laboratory and reports directly to the nominated Permit Holder. Approval must be in the form of a signed purchase requisition form. All purchases of Schedule 7, 8 or 9 Poisons require approval from the Laboratory Supervisors AND the Permit Holder. All purchases are recorded the signed purchase requisition form. 2.02 Indicate what records are to be retained in relation to the acquisition of scheduled poisons: All purchases are recorded using an online financial accounting system. This system can be searched to identify purchases of all items through a designated account. Hard copies of all purchase requisition forms are maintained for a period of not less than 7 years. 3. Security and Storage Scheduled poisons must be stored securely in order to prevent unauthorised access and illegal diversion. More stringent security provisions are required for Schedule 8 and 9 poisons, details of which are to be provided in Part Two of this document (if applicable). 3.01 Indicate what security measures are applicable to the premises: All areas are limited access and not open to the general public. Staff and postgraduate students are required to wear identification. Page 6 All areas (laboratories) are self contained lockable facilities. Key access is provided to laboratory supervisors and their direct staff only. All areas are locked during the hours of 7:00 pm to 7:00 am An alarm system is in place and audible All areas are security patrolled after hours Schedule 4 poisons The Regulations require a lockable facility for the storage of Schedule 4 poisons. 3.02 Indicate how Schedule 4 poisons are to be stored: Schedule 4 Requiring Refrigeration: The refrigerator will be in a lockable laboratory facility The refrigerator will contain a lockable box inside - the box will be made of a high grade plastic or metal - the box will be locked with a chain and padlock or keylock The lockable box will be secured to a shelf within the refrigerator - this shelf will be difficult to remove from the refrigerator without major disruption Schedule 4 NOT Requiring Refrigeration: The cabinet will be in a lockable laboratory facility The cabinet will be secured to the wall by screws or bolts fitted to the internal part of the cabinet The cabinet will be locked with a chain and padlock or key lock Schedule 4 poisons will not require temperature monitoring. The storage facility, for Schedule 4 poisons, must remain locked and secured to prevent access by any unauthorised person at all times, except when it is necessary to open it to carry out essential operations. 3.03 Indicate how unauthorised or unsupervised access to Schedule 4 poisons is to be prevented: All visitors to the laboratory will be escorted The laboratory will not be left unlocked if unattended by laboratory personnel. Signage will indicate that the area is Authorised Access Only. Both the refrigerator storage box and the cabinet will be kept locked unless directly being accessed by an authorised member of the laboratory. Keys to open both the refrigerator storage box and the cabinet will be kept in a separate location within the laboratory that is known only to the Laboratory Supervisor and nominated staff. This key will NOT be labelled with any identifier to indicate that it will open a secure storage facility for Schedule 4 Poisons. Listed Regulated Poisons in Schedule 7 Schedule 7 poisons (also referred to as Dangerous Poisons) fall into two categories - Listed Regulated Poisons and Schedule 7 poisons (other than Listed Regulated Poisons). Listed Regulated Poisons are those Schedule 7 poisons that are more strictly controlled and are the Schedule 7 poisons that are listed in Chapter 1, Part 2 of the Victorian Poisons Code, which may be accessed at: http://www.health.vic.gov.au/dpu/poicode.htm Listed Regulated Poisons in Schedule 7 must be stored in a lockable facility that must remain locked and secured to prevent access by any unauthorised person at all times, except when it is necessary to open it to carry out essential operations. Page 7 3.04 Indicate how Listed Regulated Poisons in Schedule 7 are to be stored: A list of the Listed Regulated Poisons in Schedule 7 are available from: http://www.tga.gov.au/industry/scheduling-st-schedule7.htm Specific requirements will be indicated for Schedule 7 LISTED Poisons by the individual departments in accordance with their needs. All requirements will be as good or better than those listed below. 3.05 Indicate how unauthorised or unsupervised access to Listed Regulated Poisons in Schedule 7 is to be prevented: Keys to be held only by a person(s) designated by the Permit Holder. Special storage facilities 3.06 Indicate what special storage facilities (if any) are to be used for specific poisons: Schedule 7 requiring refrigeration: - The refrigerator will be in a lockable laboratory facility - The refrigerator will be locked with a padlock or keylock affixed to the external door Schedule 7 NOT requiring refrigeration: - The cabinet will be in a lockable facility - The cabinet will be made of metal - The cabinet will be affixed to the wall with bolts - The cabinet will have an external keylock or padlock Loss or Theft of Permitted Poisons The loss or theft of all permitted poisons must be promptly reported to Victoria Police and, in writing, to the Department of Health, Drugs and Poisons Regulation. 4. Records of Transactions The definition of a "transaction" includes the preparation, use, transfer within and between premises, administration, disposal or destruction of a substance. Details of all transactions, relating to substances in Schedule 4 (e.g. antibiotic substances) and Listed Regulated Poisons in Schedule 7 (e.g. arsenic, benzene, cyanide) must be kept for a minimum of 3 years and produced on demand to an Authorised Officer of the Department of Health, Drugs and Poisons Regulation. 4.01 Indicate how records of transactions are to be retained: Schedule 4 transactions: Each laboratory will have a laboratory record book The record book will be overseen by the laboratory supervisor Each schedule 4 will have a separate page on the record book Each use will have a record of: - amount used - person using - date used Schedule 7 transactions: Each laboratory supervisor will have a record book Page 8 The record book will be signed by both the user and the laboratory supervisor for each use The record will contain: - amount used - amount remaining in the container - person using signature - laboratory supervisor approval signature - date used 5. Staff Training Relevant personnel should be trained in all procedures, which relate to their roles and responsibilities for the storage, handling and use of scheduled poisons. 5.01 Indicate how staff training and information relating to permitted poisons are to be provided to employees: All staff and students working in a laboratory are required to undertake a chemical management course. The course contains components on Scheduled Drugs and Poisons containing the following modules: - what are scheduled poisons - why are they restricted for access and use - which schedules require specialised storage - how to records usage Staff and students are then supervised in the laboratory by the Laboratory Supervisor who will instruct on the protocols and procedures for the use of the scheduled poisons. Staff and students follow documented safe work procedures and have taken part in the conduct of risk assessments for the storage, handling and disposal of chemicals. 6. Waste Disposal Waste material, which might contain poisons in Schedules 2, 3, 4 and/or 7, must be disposed of in an appropriate manner and must not be disposed of via normal waste collection agencies (eg. garbage collection). Where permitted poisons are to be provided to another agency specifically for the purposes of destruction, that agency must hold the relevant licence or permit to lawfully possess those poisons. 6.01 Indicate the means of disposal of waste material containing scheduled poisons: Unwanted Scheduled Poisons are collected for disposal by an approved waste contractor. - A waste manifest is prepared prior to the disposal of all chemicals Waste products from processes using Scheduled Poisons are collected monthly through a University of Melbourne approved contractor for disposal. Note: Parts Two and Three of the PCP are applicable only to permits that relate to those specific activities of the permit holder (or applicant) and may otherwise be discarded. Authorised by the Victorian Government, Melbourne. To receive this publication in an accessible format phone 1300 364 545 Drugs and Poisons Regulation. Page 9