Changes to the return and storage of waste medicines
in Scotland
Currently, pharmacies are unable to accept waste medicines and sharps
returned from care homes offering nursing care (previously classified
as nursing homes) throughout the UK unless the pharmacy has a waste
management licence.
The Waste Management Licensing Amendment (Scotland) Regulations 2006
(“the Regulations”) which come into force on 1 December 2006,
allow pharmacies in Scotland to accept certain waste from care services,
subject to conditions (see below).
“Care services" for the purposes of the Regulations have the
same meaning as in Section 2 of the Regulation of Care (Scotland) Act
2001
and include a care home service which is a service which provides accommodation,
together with nursing, personal care or personal support, for persons
by reason of their vulnerability or need, but does not include a hospital,
a public, independent or grant-aided school, an independent health care
service or a service excluded from this definition by regulations.
The changes in the Regulations mean that pharmacies in Scotland can now
accept waste medicines and sharps back from care homes that offer nursing
care in Scotland, as well as from residential homes, without the need
for a waste management licence.
Waste medicines that have been returned to a pharmacy or to the premises
of a medical, nursing or veterinary practice or a needle exchange facility,
from care services, households or by individuals, can be securely stored
under the following conditions:
(a) The total quantity of returned waste at the pharmacy or premises
does not at any time exceed 10m3
(b) The total amount of waste returned in any 24-hour period does not
exceed 5 kilograms or, as the case may be, 5 litres
(c) Any waste so returned to the pharmacy or premises is stored there
for no longer than three months
The waste items (including those which are special waste) that can be
returned are: (i) those used in the diagnosis, treatment or prevention
of disease in humans; (ii) those used in the research, diagnosis, treatment
or prevention of disease involving animals; and (iii) those used in separately
collected fractions.
They include: sharps (except those whose collection and disposal is subject
to special requirements in order to prevent infection); cytotoxic and
cytostatic medicines; other medicines.
Pharmacies should have suitable measures in place to deal with the returned
waste and make arrangements with the local health board for the collection
and disposal of such pharmaceutical waste.
The Scottish Environment Protection Agency can be contacted for further
advice (tel 01786 457 700)
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Restrictions on personal control
Pharmacists are reminded that those who registered with the Society
by virtue of Section 4A of the Pharmacy Act 1954 (qualified under a European
diploma),
or under any corresponding provision relating to Northern Ireland, are not
able to be the pharmacist in personal control of premises in Great Britain
that have been a registered pharmacy for less than three years.
Personal control is a requirement of the Medicines Act 1968, but has not been
interpreted in the courts. A number of cases have been considered by the Statutory
Committee and. although each case is viewed on its merits, the following advice
is offered to pharmacists. All supplies of prescription-only medicines (POMs)
and pharmacy (P) medicines from registered retail pharmacy premises must be made
under the supervision of a pharmacist. Sales of general sale list (GSL) medicines
do not require supervision, but do require a pharmacist to be in personal control
of the pharmacy premises. Thus, if a pharmacist is not eligible to be in personal
control of a registered pharmacy, no sales of medicines can be made, and this
includes general sale list medicines.
In these circumstances the premises could remain open for trading as long as
nothing requiring the presence of a pharmacist (ie, POMs, Ps and GSLs) is sold.
In addition to the sale of any medicine being unlawful, unless there is a pharmacist
in personal control, the display of any restricted titles, such as “Chemist” or “Pharmacy,” in
connection with the sale of any goods by retail, is unlawful.
Once the relevant provisions of the Health Act 2006 come into force, pharmacists
by virtue of Section 4A of the Pharmacy Act 1954 or any corresponding provision
relating to Northern Ireland will not be able to be the “responsible pharmacist” in
charge of a pharmacy business whose premises have been registered for less than
three years.
With the recent increase in the number of new pharmacy premises coming on to
the register, pharmacy owners and superintendent pharmacists should ensure that
pharmacist staffing levels can be maintained. Pharmacists who own a pharmacy
and superintendent pharmacists are advised to check that the pharmacists they
intend to employ to work within their pharmacies, whether as contracted employees,
as locums or otherwise, are eligible to be the pharmacist in personal control.
The type of qualification held by registered pharmacists can be checked by contacting
the Society’s registration department (tel 020 7572 2532; e-mail registration@rpsgb.org).
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The
Pharmaceutical Journal