(1) This document sets out the University's procedural requirements for the management of Scheduled 4 and 8 Drugs which are used at the University for research and teaching activities and are regulated in a manner consistent with legislative requirements in order to eliminate or control potential health, safety and security risks.
(2) This procedure applies to all University research and teaching activities that involve the use of drugs which are designated as Schedule 4 or 8 by the NSW Department of Health. For more information refer to the:
(3) This procedure details required practice in relation to the regulation of Schedule 4 and 8 drugs including: authorisation; information, training and supervision; storage; record-keeping; disposal; security and reporting.
(4) For the purpose of this procedure, the following definitions and acronyms apply unless otherwise stated:
"a person who has acquired through training, qualifications or experience, or a combination of them, the knowledge and skills to carry out that task."
(5) Refer to the University's Alcohol and Drug Control Policy.
(6) Possession and use of S4 drugs is restricted to competent and approved personnel as designated by the Head of School or Director, University Research Centre.
(7) Possession and use of S8 drugs is restricted to authorised personnel as designated by the Pharmaceutical Services Branch of the NSW Department of Health (PSB) who prohibit possession and use of S8 drugs without written authority from the PSB. Authority issued to a person is not transferable.
(8) Staff seeking authority to use scheduled drugs should fill out a Research Use of Scheduled Drugs Form and return it to the relevant Laboratory Manager or other officer nominated by the relevant Head of School or Director, University Research Centre.
(9) Where these scheduled drugs are to be used in animals or in materials of biological origin or in humans, staff must seek approval from the relevant Ethics and/or Biosafety Committee and must include the approval number, issued by the committee, when completing the Research Use of Scheduled Drugs Form.
(10) The relevant Head of School or Director, University Research Centre is responsible for official correspondence with the PSB in relation to requesting authority for the possession and use of S8 drugs.
(11) Application for authority should be sent to:
Pharmaceutical Services Branch
NSW Health Dept
PO Box 103
Gladesville NSW 1675
(12) A completed copy of the Research Use of Scheduled Drugs Form should be attached to the PSB request for authority for S8 drugs.
(13) Researchers with authority from the PSB (i.e. Authorised Personnel) are permitted to allow persons acting under their supervision to possess and use scheduled drugs for research and teaching.
(14) The relevant Head of School, Director, University Research Centre, or their nominee, should ensure that a record is maintained of Authorised Personnel (S8 drugs), Approved Personnel (S4 drugs) and all persons working with S4 or S8 drugs under their authority. The records will be held in a Scheduled Drugs Authority Register and maintained by the relevant Laboratoty Manager or other officer nominated by the relevant Head of School or Director, University Research Centre.
(15) The Head of School, Director, University Research Centre or their nominee, should ensure that all Authorised Personnel and Approved Personnel are provided with information and training in the secure storage, handling and record keeping of scheduled drugs.
(16) Authorised Personnel and Approved Personnel are responsible for the training and ongoing supervision of persons working with scheduled drugs under their authority and for compliance with the relevant legislative requirements.
(17) Approved Personnel must ensure that S4 drugs are stored in a lockable facility such as a cabinet, refrigerator or room.
(18) Authorised Personnel must ensure that S8 drugs are stored in a drug safe. The drug safe must be used for the storage of S8 drugs only. The drug safe must be secured at all times. A key to the drug safe will be issued to researchers authorised by the PSB, and a copy will be held by the relevant Laboratoty Manager or other officer nominated by the relevant Head of School or Director, University Research Centre, for the purpose of inspections and/or inventories.
(19) The activity of maintaining a drug store may be delegated in writing to a Competent Person.
(20) Authorised Personnel must ensure that the drugs register specifically for S8 drugs are kept at the place where the drugs are stored or used. The activity of maintaining a drugs register may be delegated in writing to a Competent Person. The name of the person responsible for maintaining a drugs register must be recorded on the register.
(21) The inclusion of S4 drugs in the S8 drugs register is not a mandatory legislative requirement. However, the University requires that records for S4 drugs be kept in a suitable format or separate register, and made available to the Head of School or Director, University Research Centre for annual auditing.
(22) Drug registers for S8 drugs can be purchased through Salmat Document Management Solutions P/L (whom acquired NSW Govt Printing Services). Salmat can be contacted on 9743-8777 or by fax on 9743-8603.
(23) The drugs register must be a bound book with consecutively numbered pages and space for the particulars required to be entered. A separate page must be used for each drug and for each form and strength of drug.
(24) The person who received, administers or uses a scheduled drug is responsible for entering the details in the relevant drugs register. Each entry must be:
(25) The balance recorded in the S8 register should always coincide with the actual stock on hand. A mistake in any entry in a drug register must be corrected by making a marginal note or footnote and by initialling and dating it. If the cause of the discrepancy is identified and found to involve a minor error (e.g. arithmetic) or departure from procedures (e.g. omission of recent use) include a comment to that effect against the amending entry. Alterations, obliterations or cancellations in a register are not permitted. Although it is not required by regulation, multiple repeated errors must be reported to the relevant Head of School or Director, University Research Centre.
(26) For S8 drugs opening and closing balances should be verified and signed when the drug register is completed and a new drug register is commenced. In addition balances should be checked and verified from page to page. Whenever possible balances carried forward to a new page or book should be verified by a second authorised person.
(27) Drugs registers must be kept for at least 2 years, from the last date on which:
(28) Drugs registers must be made available for inspection on demand by the PSB, the Police or any authorised UWS officer (e.g. OHS Representative).
(29) The person responsible for maintaining a drugs store and register must:
(30) When checking stock, physically count opened containers of drugs, do not open sealed packs but rather check that the seals are intact and, if they are sealed record the quantity as labelled. Measure the volume of drugs in liquid form only when removing the last of the contents, if there is reasonable discrepancy (e.g. up to 3%), make a note of that fact against the entry. Up to that point estimate the volume by observation and note the entry as "estimated".
(31) There are two additional circumstances in which an inventory must be made:
(32) Authorised Personnel must ensure that S8 drugs are not wilfully destroyed except under the direct personal supervision of a PSB officer or a police officer.
(33) The disposal of S8 drugs should be arranged by contacting the Duty Pharmaceutical Advisor at PSB. The PSB will arrange a suitable time to collect the S8 drugs and will make the required entry in the drugs register as a record of the authorised destruction.
(34) The disposal of S4 drugs must be conducted in a manner that is not likely to constitute a risk to the health and safety of staff, students and the general public. Disposal should be arranged through a licensed hazardous waste contractor and recorded in the drugs register by Approved Personnel.
(35) S4 and S8 drugs and associated records must be maintained in a secure manner. Discrepancies in S8 drugs must be immediately and thoroughly investigated by those involved. Any unresolved discrepancy should be reported to the Head of School or Director, University Research Centre. The Head of School or Director, University Research Centre will further investigate (in conjunction with the relevant Chief Investigator), and report any unresolved discrepancies to the relevant authorities as described below.
(36) Any suspected or actual loss or theft of an S4 or S8 drug must be reported by the Head of School, Director, University Research Centre, or their nominee, to:
(37) Any suspected or actual loss or destruction of a drugs register must be reported to the Head of School or Director, University Research Centre for the purpose of reporting to the PSB.
(38) In the event of loss or destruction of a drugs register an accurate inventory must be made of all S4 or S8 drugs held (see Part E) and the details entered into a new drugs register (see Part D).
(39) The Schedule Drugs Checklist should be used as a compliance monitoring tool. It should be completed by the Authorised Personnel (or delegate) at the time of an inventory of S8 drugs. The checklist should be forwarded to the Head of School or Director, University Research Centre for information and corrective action, as required.
(40) Refer to the Associated Information page for links to key pieces of legislation, forms and other related documentation.