Key points
1. Disposal of unwanted medicines is an essential service under the
new community pharmacy contract
2. Pharmacies do not have to start providing the service until their
primary care trust has made suitable arrangements to collect the
unwanted medicines from the pharmacy
3. Waste produced in the pharmacy will have to be separated from
unwanted medicines returned by the public
4. Pharmacy staff will have to separate waste into: solid dosage
form medicines and ampoules, liquids, aerosols and Controlled Drugs
(schedules 2 and 3)
5. Contractors will have to comply with waste management legislation
including registering their exemption to store waste medicines with
the Environment Agency |
Disposal of unwanted medicines is an
essential service under the new community pharmacy contract in England
and Wales. This means that it is something that all community pharmacists
will have to provide. However, pharmacies do not have to start providing
the service until the local primary care trust has made suitable arrangements
to collect the unwanted medicines from the pharmacy.
The aim of this service is to ensure that the public can easily and safely
dispose of unwanted medicines. This should reduce risk for a number of
reasons. First, if people keep large stocks of medicines at home, there
is an increased risk of accidental poisoning and of diversion of medicines
to someone not authorised to possess them. Second, if people try to dispose
of the medicines themselves they could choose a non-secure method that
results in other people being exposed to the unwanted medicine. Finally,
if someone uses an inappropriate method of disposal it could lead to environmental
damage.
What the service involves
The community pharmacy’s role will be to act as a collection point
for the public’s unwanted medicines. In this context, the “public” includes
individuals and care homes that were previously registered as residential
homes, but not nursing homes. Waste from nursing homes is classified as “industrial
clinical waste”. Pharmacies, unless they are specially licensed,
can only accept “household clinical waste” — hence waste
from individuals and residential homes.
Returned medicines should be stored in approved containers. These containers
will be provided to the pharmacy by the waste disposal contractor (arranged
by the PCT). Pharmacy staff will have to separate the waste into four
types: solid dosage form medicines and ampoules, liquids, aerosols and
some Controlled
Drugs. Liquids will have to be stored in special liquid waste containers
(also provided by the waste disposal contractor) and aerosols should
be stored separately from the other waste.
Controlled Drugs that are categorised in Schedule 2 or 3 should be segregated
from other medicines waste. These CDs have to be rendered irretrievable
(ie, denatured) before they can be disposed of since waste disposal contractors
will not be authorised to possess CDs. Until such time as these CDs are
denatured, the pharmacy will have to store them in a locked CD cupboard.
It is worth bearing in mind that the requirements around disposal of
CDs might change depending on the outcome of the Shipman Inquiry. Another
issue
yet to be resolved is how to allow pharmacies to denature CDs since this
activity currently requires a waste management licence. This is being
discussed by the Department of Health, the Department for the Environment,
Food and
Rural Affairs, and the Environment Agency.
Pharmacy staff will also have to deal with another category of waste
medicines. This is waste produced in the pharmacy: medicines held in
stock but not
dispensed. This waste should be stored separately from unwanted medicines
returned by the public.
The reason for the separation of waste that this service requires is
that the Special Waste Regulations 1996 say that different categories
of waste
should not be mixed. This also means that prescription-only medicines,
which are classified as “special waste”, should not be mixed
with pharmacy or general sale list medicines. P and GSL medicines only
become special waste if they possess hazardous properties, eg, they are
flammable, oxidising, irritant, harmful, toxic or corrosive.
As part of this service, community pharmacies will have to comply with
waste management legislation. First, they will have to register their
conditional exemption to store returned waste pharmaceuticals with the
local office
of the Environment Agency. If the pharmacy employs a driver or company
to collect waste medicines from peoples’ homes or residential homes,
then the driver or company will have to register as a waste carrier with
the local Environment Agency.
Other legislation requirements are that waste medicines have to be stored
securely, for no longer than six months and the amount stored must not
exceed 5 cubic
metres at any time. Pharmacies will have to retain special waste consignment
notes on a register for at least three years, and retain
descriptions and transfer notes for at least two years.
Pharmacy contractors will have to ensure that their staff are made aware
of the risk
associated with the handling of waste medicines. Correct procedures should
be put in place to minimise risks. This will include having appropriate
protective equipment, including gloves, overalls and materials to deal
with spills. All should be available at the place where waste medicines
are being stored. PCT responsibilities
The PCT is responsible for ensuring that suitable arrangements are in
place to collect unwanted medicines from the pharmacy and then to dispose
of
them afterwards. This will involve using a registered specialist contractor
to collect the waste from the pharmacy on a regular basis. The frequency
of collections should be agreed between the contractor and PCT, and
pharmacies should be able to request extra collections if a need arises.
The PCT
should also provide a point of contract for queries relating to the
disposal of returned medicines. In order to fulfil these roles, the PCT
will have
to register as a broker for the collection and disposal of medicines
with the local Environment Agency. Clinical waste
Clinical waste, such as used sharps and swabs for finger-prick blood
tests, falls into a separate waste category from medicines waste. As
diagnostic testing becomes more widespread in community pharmacy, disposal
of clinical waste is an issue that more pharmacists will have to consider.
Under the current regulations, pharmacies cannot store clinical waste unless
they have a full waste management
licence from the Environment Agency (this does not apply to needle exchange).
Doctors’ surgeries and nursing homes are exempt from this requirement
but an exemption has not been put in place for community pharmacies. DEFRA
is currently conducting a consultation on changing these regulations.
Next articles in series
This series has now covered all the essential and advanced services
in the new national contract. The service specifications for the
enhanced services, which will be commissioned locally by primary
care trusts, have yet to be finalised. Therefore, this series will
continue once the specifications have been agreed. It is hoped that
this will be in December. |
|
The
Pharmaceutical Journal