Opiates Procedure revision history
Status :
Date :
Version:
Author
P. Dormans
Adopted
June 2012
PD-HRM 04. 2012
Date
12.2011
01.2012
03.2012
Description
DraftOpiates Procedure
Assessed: S. Seeldrayers (CPV); A.
Andela (CRISP)
Assessed: H.Hoepman, inspector IGZ,
R. van Lieshout (I&L)
Adopted J. Smits (CRISP)
version
01
02
03
04
Index
Opiates Procedure revision history ..................................................................................... 1
Index ................................................................................................................................... 1
Opiates Procedure ............................................................................................................... 2
1. The aim of the procedure ................................................................................................ 2
1.1. UM Actors ............................................................................................................... 2
1.2 Duties and responsibilities of UM actors .................................................................. 2
1.3 Definitions................................................................................................................. 3
2. Registration of changes in the type of opiates ................................................................ 3
3. Supplier conditions ......................................................................................................... 3
4. Purchasing ....................................................................................................................... 4
4.1 Ordering procedure, animal-related .......................................................................... 4
4.2 Ordering procedure for non-animal testing use ........................................................ 4
5. Inspection and registration of opiates on delivery .......................................................... 5
6. Distribution, dispensation procedure for animal testing-related products ...................... 5
7. Retention period for documents ...................................................................................... 6
7.1. Opiates log ............................................................................................................... 6
8. Management .................................................................................................................... 7
8.1 Monitoring the administration of the opiates ............................................................ 7
8.2 Misuse of opiates ...................................................................................................... 7
8.3 Collection of opiates ................................................................................................. 7
9. Storage requirements ...................................................................................................... 8
9.1 Research group/department ...................................................................................... 8
9.2 Stock ......................................................................................................................... 8
10. Disposal or destruction of opiates ................................................................................. 8
Appendix 1: Initials list ....................................................................................................... 9
Appendix 2: Opiates log – “name of medicine/substance” .............................................. 10
Document1
Page 1 of 10
Opiates Procedure
1. The aim of the procedure
In the scope of the Opium Act, Maastricht University (UM) must be an exemption
holder in order to be able to use opiates and other narcotics for medical
research,analytic chemicalresearch and other scientific purposes. The Ministry of
Health, Welfare and Sport (VWS) grants exemptions for the abovementioned
substances which are included in what is known as the List 1 and List 2substance list,
referred to as opiates hereinafter. One condition of this exemption is a clear
procedure establishing the methods of dealing with opiates.
This procedure has been developed in consultation withCRISP, CPV, I&Land
theHealthcare Inspectorate (IGZ).
1.1. UM Actors
-
The Occupational Health and Safety ExecutiveMUO-HRM
Purchasing and Logistics
Central animal testing facilities
Head, chair of research group1
Person who orders animal testing-related products and NON- animal testingrelated products
Administrator and his/her deputy at research group level
GROS administrator
1.2 Duties and responsibilities of UM actors
o
o
o
o
The Occupational Health and Safety Executive MUO-HRM isresponsible on behalf
of UMfor requesting and managing the exemption and is the contact in this
regard for both Farmatec and the Healthcare Inspectorate (IGZ).The
Occupational Health and Safety Executive also ensures that opiates other than
those intended for animal testing are included in the exemption.
Purchasing and Logistics (I&L) - FD is responsible on behalf of UM for purchasing
goods and checking that the suppliers are entitled to supply these opiates. I&L
verifies that there is a need for the requested goods, through an approval from
the Occupational Health and Safety Executive.
Central animal testing facilities are responsible for supervising the ordering and
dispensation of opiates which are used in (test) animal-related situations. Only
the CPV veterinarian or a designatedauthorised person or persons is/are entitled
within UM to give permission to order these goods. CPV is responsible forthe
centralstorageof these goods within the CPV area.The vet or designated
authorised person or persons also ensures that all the opiates ordered by CPV are
included in the exemption.
The chair of the research group working with substances and medicines covered
by the Opium Act is responsible for the correct purchase, storage, use and
registration of them.
Where it says research group/chair, this should be read as facility service, head of facility service
respectively and/or department, head of department respectively.
1
Document1
Page 2 of 10
o
o
o
o
The administrator (and his/her deputy(ies)) is responsible on behalf of the chair
of the research group.The administrator is formally appointed by the chair and is
responsible to them for the storage and management of the opiates, and
updating the Opiates log and initials list. The administrator is authorised by the
chair to appoint persons as deputies and include them in the initials list.
The researcher (Article 9), as an (end) user for animal related use, is responsible
for the implementation of the procedure with regard to the procedure as
described in the research plan.
The researcher for non-animal related use is responsible for applying the
research plan applicable to the experiment.
For animal as well as non-animal related use, the researcher should report
incidents which are connected to the use of Opium Act drugs to the opiate
administrator of the applicable research group.
1.3 Definitions
Animal testing-related products
Animal testing-related products are the medicines, opiates and other drugs – this
procedure-, which are used for the anaesthetising and pain relief of test animals as
intended/explained in the research plan applicable to the experiment in question.
NON-animal testing-related products
Non-animal testing-related products are the medicines, opiates and other drugs –
this procedure-, which are used NOT for the anaesthesia and pain relief of test
animals but for scientific research as intended/explained in the research plan
applicable to the experiment in question.
2. Registration of changes in the type of opiates
The Occupational Health and Safety Executive ensures that the list of opiates granted
exemption is up-to-date. If there are changes, the Occupational Health and Safety
Executive passes them on as soon as possible, but within two weeks after a positive
decision by the Occupational Health and Safety Executive or the vet regarding the
Opium Act drugs for the purpose of anaesthesia and/or pain relief to Farmatec.
Farmatec is the department of theMinistry of VWS that is responsible for granting
pharmaceutical licences and opium exemptions.
3. Supplier conditions
The supplier must possess a valid exemption for the substances supplied. Each year
in January, s/he must demonstrate that s/he still possesses a valid exemption by
sending a copy of it to the UM, the Purchasing & Logistics department/FD 2.
The supplier will vice versa requesta copy of the valid exemption from UM.
2CPV
supplies (if necessary) I&L with the address details of suppliers of the ‘animal test-related’
substances under the Opium Act.
Document1
Page 3 of 10
New suppliers must present a copy of the exemption before the supply commences.
If the supplier cannot present the correct exemption s/he will not be appointed
supplier.
4. Purchasing
This concerns the initial purchase and replacement on expiry.
4.1Ordering procedure, animal-related
Prescribing Opium Act drugs for anaesthesia and/or pain relief – this procedure –
which have not been obtained via the Opium Act drugs controller of the CPVfaculty
service is prohibited.
Opium Act drugs for anaesthesia and/or pain relief for animal use fall under the
licensee Maastricht University and can be ordered by the group managers using the
appropriate (internal) CPV order form and then only if they are mentioned in
approved (DEC) protocols/research plans.
(see also 6).
Orders from external suppliers must be made by the appointed administrator of the
CPV, and normally via the UM ordering system,SAP3.
4.2Ordering procedure for non-animal testing use
The use of Opium Act drugs without valid permission – this procedure- is prohibited.
If opiates are ordered for research, analytic-chemical research or other scientific
uses, NOT for anaesthesia and/or pain relief, the UM SAP-SRM ordering system
applies.Opium Act drugs can only be ordered if valid permission from the
Occupational Health and Safety Executive can be presented.
The person ordering requests the opiates via SRM and submits the request using a
“description request” with goods group 25 “Opiates” to the Purchasing department,
where it is assessed for completeness. The applicant is responsible, if the approval or
permission is not present or has expired, for obtaining the permission from the
Occupational Health and Safety Executive.
Only once the request is complete with regard to this permission will the Purchasing
department continue with the purchase.
The permission of the Occupational Health and Safety Executive is given on the basis
of a request which includes at least the following:
- The approved research plan accompanying a DEC procedure or a
protocol/research plan approved by or behalf of the research group chair;
- The signature of the administrator –this procedure- of the research group to
whom the Opium Act drugs are supplied;
3
Deviation from the regular ordering procedure is only possible if there is a demonstrable compelling need and then only
with the approval of the (GROS) administrator of the UM registration system for hazardous substances/chemicals.
Document1
Page 4 of 10
-
The calculation of the maximum dose of Opium Act medicine(s)
accompanying the research plan.
5. Inspection and registration of opiates on delivery
If the opiates are delivered to UM, there is a standard inspection at item level by I&L.
I&L ensures that the shipping documents are handled as appropriate, ensuring that
these documents are stored for the standard period of six years. If the medicines are
not supplied immediately, they are stored temporarily in such a way that they cannot
be appropriated improperly.
I&L supplies the opiates to the ordering person/research group.
The opiates are booked into the opiates log on delivery to the appropriate research
group. The quantity and quality of the delivery is also checked by the administrator
using the papers supplied and the purchase order. The person ordering signs on
receipt.
The papers accompanying the delivery are stored for a minimum six years in the
‘Opiates management’ folder. The opiates log is part of this folder.
6. Distribution, dispensation procedurefor animal
testing-related products
If Opium Act drugs for the purpose of anaesthesia or pain relief are to be supplied for
use outside the CPV area, the CPV opiates administrator must first ascertain the
need.
TheCPV orders theopiates for the purpose of anaesthesia or pain reliefwithin theUM
exemption (See 4).
The following conditions apply to the distribution of animal testing-relatedopiates:
o The supply request is only made by persons (the opiates administrator or
deputies) authorised to do so by the chair of their research group.
The opiates administrator issues on behalf of the chair a list of names with
initials and handwriting specimen to the CPV opiates administrator (see
appendix 1).
o The request is made according to the CPV medicine dispensation procedure
and the appropriate medicine order form (see appendix 3).
-The first time the order is placed, theadministrator of the ordering research
group must state the maximum usage of the Opium Act drug in question
within this research plan (with a margin of up to 10%) on the basis of the
approved research plano The request is sent in digital form to orders CPV
o The request is assessed by theCPV opiates administrator
o Once approved, with verification of the usage for the approved research plan,
the CPV opiates administrator can supply the medicines.
Document1
Page 5 of 10
o
o
o
Medicines are only dispensed to the authorised persons (see initials list in
appendix 1), and this is recorded in the CPV opiates log. This log includes the
following columns: supplied to, signature/initials, name and
group/department. The research group opiates administrator or his/her
appointed deputy(ies) initial on receipt.
The opiates administrator of the research groupthen ensures that the opiates
are registered in the research groupopiates log (see appendix 2)and are
stored correctly.
On receipt of theopiates, the following details are registered in the research
groupopiateslog (see 7.1):
- The supply date
- The origin (CPV/or ext. supplier)
- The name of the employee who has stored the opiates in the safe
- The employee’s initials
- The expiry date
- The batchnumber
- The quantity + unit
- In (booked in)
- Out (used for research plan xx/other/destroyed)
- Cumulative (the quantity in the safe)
7. Retention period for documents
Documents concerning the supply, dispensation or destruction ofopiates are kept for
at least six months in the ‘Opiates management’ folder.
This folder contains:
- The signed and dated appointment (letter) of the opiates administrator
of the groupwhereopiatesare stored or used
- An authorised initials list (signed and initialled by the
opiatesadministrator)
- The folder of receipts for the supply ofopiatesby external suppliers
- Theopiateslog
7.1. Opiates log
The opiates log must in all cases demonstrate what has happened to the opiates.
The opiates log includes at least the following data:
- The supply date
- The origin (CPV/or ext. supplier)
- The name and initials of the employee booking the opiates into the
safe
- A name and initials of the employee booking out the opiates
- The expiry date
- The batchnumber
- The quantity + unit
 In (booked in)
 Out (booked out)
- Cumulative (the quantity in the safe)
Document1
Page 6 of 10
8. Management
The research groupsorderingopiatesappoint an opiatesadministrator and deputy (or
deputies). This must be set out in writing. The opiates administrator ensures that the
procedures are complied with as described in this opiatesprocedure.
8.1 Monitoring the administration of theopiates
Once a year, Farmatec sends a request for a list of the Opium Act substances
present at that moment. The opiates administrator must supply immediately at the
first request a list of the Opium Act substances in their possession in order to comply
with this requirement.
The Occupational Health and Safety Executive reserves the right to inspect the
administration with prior announcement or giving a reason at any time during the
year.
8.2 Misuse ofopiates
If you suspect the misuse, theft or loss of opiates, then as soon as this is observed
you must report this to the Occupational Health and Safety Executive,who is then
obliged to report it to the Healthcare Inspectorate.
8.3 Collection ofopiates
If the work involving opiates in a group or department is discontinued, the opiates
which are still in possession are collected or destroyed (see further 10).
Whenopiatesare collected, the opiates administrator of the group (often CPV)
collecting the opiates records the following details in the opiateslog:
• The surrender date
• The quantity
• The name of the substance
• The group/departmentfrom which theopiatesoriginate
• The employee who has stored the opiatesin the safe
• The employee’s initials.
Document1
Page 7 of 10
9. Storage requirements
9.1Research group/department
Whenopiatesare stored:
o The groupprovides reliable, lockable internal storage (e.g. a lockable safe) which
prevents thirdparties from accessing the opiates. Access to the Opium Act
substances is only possible for those persons who are authorised to do so, i.e.
the opiates administrator and his/her (registered) deputy(ies).
9.2 Stock
o
o
o
Non-expiredopiates
The stock of non-expired opiatesis stored as described above.
Opiates past the expiry date
Theopiateswhich are past the expiry date are destroyed. The expired or unusable
opiatesmust be marked clearly.
There must be a key management plan in place for the access to the storage
(e.g. a lockable safe), which limits access to the storage facility to only a few
persons (such as vets, the administrator and his/her deputy(ies).
10. Disposal or destruction of opiates
Theopiates administrator orders the destruction of opiates which have expired or are
no longer needed. When opiates, or remnants of opiates,are destroyed, there must
be at least two persons present and this should be noted in the opiate log. The
quantity destroyed must be recorded under OUT and this must be confirmed by the
initials of the persons present at the destruction. The authorised persons are
mentioned on the initials list (see appendix1).
Destruction entails tipping the packaging of the opiatesout into a ‘blue barrel’. If this
concerns a large amount of liquid, absorbent materials are added to the barrel. The
packaging is also added to the blue barrel. This is then sealed up and taken away for
destruction to the company appointed by UM.
Two persons who are on the initials list must sign and initial the opiateslist/log.
Document1
Page 8 of 10
Appendix 1: Initials list
Group:
……………………………
Date:
administrator (name):
Persons authorised to initial with regard to the use of opiates
Date
Name + personnel
Handwriting
number
write: this is my handwriting
Document1
Page 9 of 10
Xx/xx/xxxx
Initials
Appendix2: Opiateslog –“name of medicine/substance”
A separate registration card is kept for each medicine or substance
Initial 2
Initial 1
Cumulative
(Volume) used
(Volume) added in
store
Source
Animal Species/
number
Reason of use,
protocolnumber
Name user
-Exp. date
-Batchnumber
Date
“Name of substance or opiate”:
Department/research group:
When stock is added or when checking the stock, the administrator signs the
register.
In all cases of disposal or destruction two persons are responsible. Both need to sign
the register after completing this task.
Once a year, a copy of the log has to be sent to the Occupational Health and Safety
Executive of MUO-HRM.
The log must be saved for at least six years.
Document1
Page 10 of 10