• Section 1 - Purpose and Context
• Scope
• Section 2 - Definitions
• Section 3 - Policy Reference
• Section 4 - Procedure
• Part A - Authority for S4 and S8 Drugs
• Request Authority
• Maintain Scheduled Drugs Authority Register
• Part B - Provide Information, Training and Supervision
• Part C - Secure Storage of Scheduled Drugs
• Part D - Maintain a Drugs Register
• Format of Drugs Register (S8 only)
• Data Entry in Drugs Register
• Retention of Records
• Inspection of Drugs Register
• Part E - Inventory of Scheduled Drugs
• Part F - Disposal of S4 and S8 Drugs
• Part G - Security and Reporting of Loss/Theft
• Loss or Theft of an S4 or S8 Drug
• Loss or Destruction of a Drugs Register
• Part H - Monitor Compliance
• Section 5 - Guidelines

Section 1 - Purpose and Context

(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.

Scope

(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:

1. NSW Health Pharmaceuticals Branch publication: Prescribed Restricted Substances (Schedule 4); or
2. NSW Health Pharmaceuticals Branch publication: Drugs of Addiction (Schedule 8).

(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.

Section 2 - Definitions

(4) For the purpose of this procedure, the following definitions and acronyms apply unless otherwise stated:

1. authorised personnel - refers to the person who has written authority from the Pharmaceutical Services Branch of NSW Department of Health (PSB) to possess and use S8 drugs for research and teaching activities at the University.
2. competent person - is defined in NSW WHS Regulation 2011 as:

1. approved personnel - refers to the person who has authority from the Dean or Director, Research Institute to manage the possession, use, storage and disposal of S4 drugs on behalf of the School or Research Instititue/Centre.
2. Schedule 4 (S4) - Prescribed restricted substances as per schedule maintained by the PSB. The PSB web site must be consulted for the current list of scheduled drugs.
3. Schedule 8 (S8) - Drugs of addiction as per schedule maintained by the PSB. The PSB web site must be consulted for the current list of scheduled drugs.

Section 3 - Policy Reference

(5) Refer to the University's Alcohol and Drug Control Policy.

Section 4 - Procedure

Part A - Authority for S4 and S8 Drugs

(6) Possession and use of S4 drugs is restricted to competent and approved personnel as designated by the Dean or Director, Research Institute.

(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.

Request Authority

(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 Dean or Director, Research Institute.

(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 Dean or Director, Research Institute 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:

(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.

Maintain Scheduled Drugs Authority Register

(14) The relevant Dean, Director, Research Institute, 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 Dean or Director, Research Institute.

Part B - Provide Information, Training and Supervision

(15) The Dean, Director, Research Institute 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.

Part C - Secure Storage of Scheduled Drugs

(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 Dean or Director, Research Institute, 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.

Part D - Maintain a Drugs Register

(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 Dean or Director, Research Institute 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.

Format of Drugs Register (S8 only)

(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.

Data Entry in Drugs Register

(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:

1. made on the day on which a person receives or uses an S4/S8 drug;
2. written indelibly in English;
3. legible, complete and in sufficient detail;
4. dated and signed by the person by whom it is used; and
5. true and correct.

(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 Dean or Director, Research Institute.

(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.

Retention of Records

(27) Drugs registers must be kept for at least 2 years, from the last date on which:

1. any entry was made in the register; or
2. any S4 or S8 drug was received, administered or used.

Inspection of Drugs Register

(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).

Part E - Inventory of Scheduled Drugs

(29) The person responsible for maintaining a drugs store and register must:

1. make an accurate inventory of S8 drugs in March and September of each year (or as specified by the PSB), and of S4 drugs in September of each year;
2. endorse the drugs register, immediately under the last entry for each S4 or S8 drug, with the quantity of each drug actually held and the date on which the inventory was made; and
3. sign each entry in the drug register.

(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:

1. in the event of loss or destruction of a drugs register [see clauses (35) and (36)]; and
2. when a person assumes control for a period of one month or more over any drugs store.

Part F - Disposal of S4 and S8 Drugs

(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.

Part G - Security and Reporting of Loss/Theft

(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 Dean or Director, Research Institute. The Dean or Director, Research Institute will further investigate (in conjunction with the relevant Chief Investigator), and report any unresolved discrepancies to the relevant authorities as described below.

Loss or Theft of an S4 or S8 Drug

(36) Any suspected or actual loss or theft of an S4 or S8 drug must be reported by the Dean, Director, Research Institute, or their nominee, to:

1. UWS Security for reporting to the Police; and
2. the Pharmaceutical Services Branch of NSW Department of Health.

Loss or Destruction of a Drugs Register

(37) Any suspected or actual loss or destruction of a drugs register must be reported to the Dean or Director, Research Institute 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).

Part H - Monitor Compliance

(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 Dean or Director, Research Institute for information and corrective action, as required.

Section 5 - Guidelines

(40) Refer to the Associated Information page for links to key pieces of legislation, forms and other related documentation.