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In
the last issue we dealt with the forthcoming implementation of the requirement
for U.N. Type approved containers for Group A, B & C Clinical Wastes.
However, Group D Clinical Wastes
were not, as far as we understand, included in the derogation for yellow bags
and have been subject to the full requirement of C.D.G./C.P.L. since their
inception. However there has been
confusion on how this should be applied. SMDSA
has sought clarification and guidance from the HSE and DTLR, and, as promised in
the last issue, Dr Nick Williams provides a comprehensive guide to C.D.G./C.P.L. and
the management of waste pharmaceuticals. TRANSPORTATION OF PHARMACEUTICAL
and CYTOTOXIC WASTES
- Dr N J Williams GradMInstWM, DGSA and Environmental Advisor, PHS
Group Ltd The
widespread use of UN 3291 is inappropriate for waste chemicals and medicines
that do not contain infectious substances.
This view is upheld in the HSAC guidance The Safe Disposal of Clinical
Waste, and also in Scottish Hospital Technical Note 3 (SHTN3). It
should be noted that not all drugs and other pharmaceutical products are
sufficiently dangerous to be classified as dangerous for carriage.
Those that are deemed to be sufficiently dangerous should have already
been classified as such by the manufacturer or supplier and the following UN
numbers used in place of UN 3291 when transporting drugs and other
pharmaceutical products: UN
1851
MEDICINE, LIQUID, TOXIC, N.O.S. UN
3248
MEDICINE, LIQUID, FLAMMABLE, TOXIC, N.O.S UN
3249
MEDICINE, SOLID, TOXIC, N.O.S. However,
not all pharmaceutical manufacturers or suppliers know what classification to
assign to their products with regard to CDGCPL2 and therefore, obtaining such
information can prove somewhat problematical and is not always possible. Further
to this, there is the added complication of the return of old medicines, as in
DUMP campaigns, where the classifications have been mixed up or if the original
classification is unknown. In
such cases, a risk assessment (RA) must be carried out to determine the nature
of the goods for transport purposes. In
carrying out a RA on pharmaceutical wastes from DUMP campaigns it must be
assumed, applying worst case scenario, that at least one of the wastes would be
classified as dangerous for the purpose of transportation under CDGCPL2.
Following a RA, one of the UN numbers, UN 1851, 3248, or 3249, should be
assigned to the waste depending upon its composition. In
assigning UN 1851, 3248 or 3249 to the waste it should be noted that the ACL
also implements ‘Special Provisions’ in relation to these entries. These are
as follows: SP
109
relates to dangerous goods not named individually, i.e. N.O.S. entries SP 220
the technical name of the flammable liquid component only of this mixture
or solution shall be shown in parenthesis immediately following the proper
shipping name SP 221
states that substances included under the entry UN 1851, 3248 or 3249
shall not be of packing group I (PGI) and shall have a maximum net quantity per
package of 5 litres or 5 kilograms. SP 223
states that if the pharmaceuticals are not classified as dangerous then
they are not subject to CDGCPL2. However,
you could only apply this SP if you had specific knowledge of all
pharmaceuticals present in each and every container used for this waste. This
is, in practice, unrealistic when considering wastes. Therefore
any containers/packages used for such waste are required to meet UN approved
standards to Packing Group II (PGII) and to contain no more than 5 litres or 5
kilograms of waste. The
following statement was received from the HSE, Safety Policy Division, Transport
of Dangerous Goods on the selection and use of UN numbers for the transportation
of pharmaceutical wastes: ‘The
use of UN 3291 is wrong since pharmaceutical wastes are not infectious
substances. They would have to be classified as a toxic substance, which is
defined as a substance that is liable to either cause death or serious injury or
to harm human health if swallowed or inhaled or by skin contact.
Pharmaceuticals would have to be classified to ascertain their qualities
and determine what precautionary measures need to be taken before transporting
the goods.” Thus,
as previously stated the UN numbers UN 1851, 3248, or 3249 should be used
accordingly following a RA. “However,
the carriage of most medicines is unaffected as such goods are not considered to
pose any significant hazard. Those
which are regarded as dangerous for carriage can have the associated
requirements reduced significantly if they are carried in receptacles small
enough to fall under the exemptions allowed for limited quantities.” Using
CDGCPL2, Consignment of Dangerous Goods in Packages: Regulation
6(1)(e) subject to paragraph (3)- (i)
the packages are of a design type which has been tested by an approved
testing laboratory using approved tests, (ii)
the competent authority which approved the tests referred to in head (i)
of this sub-paragraph has issued a certificate confirming that they have been
satisfactorily completed, and (iii)
the packagings have been allocated an ADR mark, a RID mark, a UN mark or
a joint ADR and RID mark by a competent authority and bear that mark, or,
alternatively, the packagings are packagings which meet the requirements of
heads (i) to (iii) above, and which have been reconditioned in accordance with a
specification approved by a competent authority and have been allocated an ADR
mark, a RID mark, a UN mark or a joint ADR and RID mark by that competent
authority and bear that mark. Regulation
6(3)- Packagings
shall not be required to meet the requirements of paragraph (1)(e) if – (c)
they contain goods which appear in or have a classification which is
specified in column 1 of Schedule 3 – (i)
insofar as they are within the packing group, if any, specified in the
corresponding entry in column 2 of that Schedule, and (ii)
are contained in individual receptacles containing quantities not
exceeding those specified in the corresponding entry in column 3 of that
Schedule (or, in the case of a gas, contained in individual receptacles not
exceeding the volumes specified in that column), provided
that the total gross mass of any package containing any receptacles such as are
referred to above shall not exceed 30 kilograms. Schedule
3 Toxic
substance (solid) II
500g Toxic
substance (liquid) II
100ml As
can be seen, to apply the exemptions allowed for limited quantities, the volume
of pharmaceutical product in receptacles is required to be small i.e. 500g or
100ml. Using
the definition of ‘receptacle’ from CDGCPL2:
‘receptacle’ means a vessel or the innermost layer of packagings
which is in contact with any dangerous goods therein and includes any closure or
fastener. On
further consultation with the HSE, a receptacle can be defined as an individual
‘blister’ within a blister pack of pharmaceutical product, and the
exemptions allowed for limited quantities can be applied.
This would allow for up to 500g of loose pharmaceutical product to be
present in a large receptacle (e.g. a pharmaceutical container) alongside
blister packs. In
this case, the container/packaging utilised for the carriage of pharmaceutical
wastes does not have to be UN approved to PGII, and labelling requirements are
as follows: Dangerous
Goods In Limited Quantities Class 6.1
Class 6.1 UN 1851
UN 3249 If
applying the limited quantities exemptions.
This also negates the use of a container/package with a maximum capacity
of 5 litres or 5 kilograms. Further
Considerations
If
considering the transportation of cytotoxic wastes from the treatment of
patients, then this can be classified as potentially infectious since the
material has usually been in direct contact with a patient undertaking
treatment. Therefore, the use of UN 3291 is acceptable in this case. Also,
opened/used containers of any waste pharmaceuticals containing residues arising
from the medical treatment of individuals can be safely transported in UN3291
“sharps” containers. No
free liquids should be present, therefore there must be sufficient absorbent
material to absorb the entire amount of liquid present.
“Residues” infers small quantities where the toxicity risk is
disproportionate to the infection risk.
This is because, during the treatment process there is a chance that
containers could become contaminated and thereby present a greater potential
hazard than the waste pharmaceuticals innate toxicity. However,
if highly toxic materials (i.e.
Packing Group I) are to be disposed of, companies should contact their service
provider for further advice; it is unlikely that these types of materials will
arise during normal medical treatments, as the threshold for Packing
Group I compounds is a very low LD50 (LD 50 £
5 mgkg-1 oral and LD50 £
40 mgkg-1 dermal). In
the case of failed, expired or controlled stock from industrial arisings
(non-healthcare sources), consignments should be classified on a case-by-case
basis.
Waste pharmaceuticals do not normally exceed the toxicity threshold for
Class 6, packaging Group III and are therefore not dangerous for carriage. Controlled
Drugs
must never be transported by road in the normal pharmaceutical waste streams
unless they are already “denatured” i.e. rendered inactive.
Once denatured, they can be transported as discussed under the “dump
campaign” provisions. There
may be rare occasions when Controlled Drugs may be requested to be carried by
service providers whilst accompanied by a Police Officer, Customs and Excise
Officer, Member of the Home Office Drugs Branch or members appointed by them.
In such circumstances “the waste” is transported from the
“arising” directly to the point of disposal, and must be assessed and
suitably classified as to its toxicity as for any other transport process.
Controlled Drugs are subject to The Misuse of Drugs Regulations 1973 and
must never be disposed in amongst pharmaceutical waste arising in medical
treatment; dump campaigns and /or industrial arisings. |
