Journal of Public Health | Vol. 29, No. 3, pp. 258 –262 | doi:10.1093/pubmed/fdm037 | Advance Access Publication 19 June 2007
Returned medicines: waste or a wasted opportunity?
Adam J. Mackridge1, John F. Marriott2
1
Pharmacy Practice Research Group, School of Pharmacy and Chemistry, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, UK
Pharmacy Practice Research Group, School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham B4 7ET, UK
Address correspondence to Adam J. Mackridge, E-mail: [email protected]
2
A B S T R AC T
Background Re-use of unused medicines returned from patients is currently considered unethical in the UK and these are usually destroyed by
incineration. Previous studies suggest that many of these medicines may be in a condition suitable for re-use.
Methods All medicines returned over two months to participating community pharmacies and GP surgeries in Eastern Birmingham PCT were
assessed for type, quantity and value. A registered pharmacist assessed packs against set criteria to determine the suitability for possible re-use.
Results Nine hundred and thirty-four return events were made from 910 patients, comprising 3765 items worth £33 608. Cardiovascular drugs
(1003, 27%) and those acting on the CNS (884, 24%) were most prevalent. Returned packs had a median of 17 months remaining before expiry
and one-quarter of packs (1248 out of 4291) were suitable for possible re-use. One-third of those suitable for re-use (476 out of 1248) contained
drugs in the latest WHO Essential Drugs List.
Conclusion Unused medicines are returned in substantial quantities and have considerable financial value, with many in a condition suitable for
re-use. We consider it appropriate to reopen the debate on the potential for re-using these medicines in developing countries where medicines are
not widely available and also within the UK.
Keywords unused medicines, primary health care, equipment reuse
Introduction
Unused medicines pose a risk to public health through poisoning and suicide when allowed to accumulate in the
home1 and to the environment through poor disposal.2 – 4
Therefore, minimizing the quantity of unused medicines
generated and ensuring the safe disposal of unavoidable
unused medicines is an important public health concern.
Few published studies have attempted to measure unused
medicines in primary care in the UK. However, the limited
data indicate that large quantities are present in primary
care. One study reported 3099 items returned to a single
community pharmacy over a three-year period,5 whereas
another reported 1091 items returned to 30 pharmacies
over one month.6 A pilot study considering medicines
returned to a GP surgery reported 340 items returned to
eight community pharmacies and five GP surgeries over
four weeks.7
The cost of medicines dispensed in primary care in
England during 2005 was almost £8000 million.8 During
2004, over 580 tonnes of unused medicines were destroyed
in England through the community pharmacy Disposal
258
of Old Pharmaceuticals (DOOP) service.9 This scheme
involves removal of unused medicines by licensed waste carriers for high-temperature incineration and is funded by
the Department of Health at an estimated cost of over £1
million per annum.10 Additional costs are also incurred by
community pharmacies through collection and handling of
these unused medicines. Re-issuing these medicines is
currently considered unethical by both the British Medical
Association11 and the Royal Pharmaceutical Society of Great
Britain.12 The World Health Organisation Guidelines for
drug donations13 also state that sending medicines overseas
that would not otherwise be used within the source country
is unacceptable. However, the possibility of re-use has been
mooted a number of times14 – 17 and one UK charity has
been re-using patients’ unused medicines for humanitarian
aid for a number of years.18 Additionally, in the USA, some
schemes exist where medicines returned from patients are
recycled for use in developing countries.19
Adam J. Mackridge, Lecturer in Pharmacy Practice
John F. Marriott, Head of Pharmacy School
# The Author 2007, Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved.
RE TURN ED ME DICIN ES: WA STE O R A WA ST ED OPPO RTUN IT Y?
In the present study, we aim to provide detailed data on
the nature and scale of unused medicines in primary care,
including GP surgeries as a disposal route, and the potential
for re-use of these returned medicines.
Methods
Medicines returned to pharmacies and GP surgeries were
used as a surrogate marker of unused medicines in primary
care in line with previous studies in this field.5 – 7 Data were
collected over eight weeks in May and June 2003 in Eastern
Birmingham Primary Care Trust (PCT), a predominantly
urban PCT with an ethnic minority population of 20%.
The age and sex distribution of the PCT were similar to
those for the UK as a whole.20,21 All pharmacies and GP
surgeries in the PCT were invited to participate. The study
was not publicized to patients and no promotion of the
DOOP service was recorded locally or nationally in the 24
months prior to data collection.
A return event was coded as any event where an individual returned a quantity of unused medicines for disposal
and was identified by a uniquely coded label attached at the
time of the return. An item was coded as all the packs of a
given medicine from one return event with the same date
and location of dispensing. All medicinal items that had previously been dispensed by a UK pharmacy, identified by the
presence of a dispensing label, were included in the study.
The person making each return event was asked to provide
the reason for return and relevant patient demographics (date
of birth, postcode); all other data were obtained from the label
and packaging of the returned medicines. Number of doses
remaining in the pack was based on the dosage reported on
the label and where no dose was identifiable, this was recorded
as missing data.
Financial value was calculated for all returned medicines
using the NHS reimbursement cost and categorized into
therapeutic class based on the British National Formulary
chapter structure.22
Returned medicines were assessed by a registered pharmacist (AJM) for their suitability for possible re-use using
the following criteria: over six months remaining before
expiry; complete and unadulterated patient pack; an unbroken security seal in the case of devices; no special storage
requirements.
Data were recorded in MS Access 2003 and analysed
using MS Excel 2003 and Minitab v14. The Spearman rho
test was used to determine significant correlation. Data are
presented as mean + standard deviation (range) where normally distributed or median (interquartile range) where the
data are non-normal.
259
Approval was obtained from East Birmingham Local
Research Ethics Committee prior to the study commencing.
Results
Three-quarters of the primary healthcare sites participated,
51/60 (85%) pharmacies and 42/61 (70.5%) GP surgeries.
During the eight-week study period, 934 return events were
made (190 GP surgeries, 744 pharmacies), comprising 3765
items (431 GP surgeries, 3334 pharmacies) and totalling
4934 individual packs. The medicines were valued at £33
608 ( £3432 GP surgeries, £30 176 pharmacies).
Medicines were returned from 910 patients with a mean
age of 63.5 + 0.78 years (10 months to 99 years) and there
was no detectable correlation between the mean number of
items returned per patient and their age (Spearman rho ¼
0.09, n ¼ 516). Multiple return events were attributed to 51
patients and medicines for between 1 and 10 patients were
present in each individual return event.
Medicines were returned from all therapeutic classes with
the exception of immunological products and vaccines. The
most commonly represented categories were cardiovascular
drugs (1003 items, 26.6%) and drugs acting on the central
nervous system (884 items, 23.5%). Table 1 shows the
number of items returned by the therapeutic class and the
reason given for return. Items from the majority of classes
were most commonly returned following a patient death, with
the exception of anti-infective drugs and those acting on the
eye, which were most often returned following a clearout.
The therapeutic categories with the greatest financial
value of returned items were inhaled corticosteroids (£2455,
7.3%) and opioid analgesics (£2091, 6.2%).
The most commonly returned drugs were aspirin (102
items), co-codamol (98), salbutamol (96), furosemide (90)
and glyceryl trinitrate (78). Additionally, almost 3000 tramadol and over 16 000 paracetamol tablets and capsules and
over 50 g of morphine and 4 g of diamorphine were also
returned.
The mean financial value of returned items was £8.93 +
18.21 (£0.00 – 358.20). Items contained sufficient remaining
doses for a median 21 (0 –42.7) days of treatment and
one-third of items (1272, 33.8%) had less than two days
treatment removed. Almost three-quarters (2154, 71.1%) of
the 3030 items with a dispensing date were returned within
one year of supply with the median time from dispensing to
return being 128 (1 – 437) days. The 4291 packs with expiry
dates had a median of 17 (0 – 28) months remaining before
expiry. Half (2627, 53.2%) of the returned packs were unopened and 1248 (25.3%), with a financial value of £10 415,
met the criteria for re-use. Of the packs classified as suitable
260
J O U RN A L O F P U B L I C H E A LTH
Table 1 Number of items (%) returned by their therapeutic class and the reason given for return with number of items prescribed during the data
collection period in Eastern Birmingham PCT
Therapeutic class
Reason for return
ADR
Clearout of
Patient
Patient
Change in
Supplied
No reason
old or
death
stopped
Prescription
in error
recorded
expired
Total
Total
returned
prescribed
items
items (EBPCT
– May/Jun 03)
medicine
medicines
Gastro-intestinal
6 (1.7)
119 (33.2)
146 (40.8)
17 (4.7)
35 (9.8)
1 (0.3)
34 (9.5)
358 (9.5)
42,079 (7.7)
14 (1.4)
262 (26.1)
310 (30.9)
73 (7.3)
227 (22.6)
8 (0.8)
109 (10.9)
1003 (26.6)
134,883 (24.6)
system
Cardiovascular
system
Respiratory System
Central Nervous
3 (0.8)
105 (29.3)
127 (35.5)
17 (4.7)
76 (21.2)
1 (0.3)
29 (8.1)
358 (9.5)
58,373 (10.6)
20 (2.3)
267 (30.2)
313 (35.4)
65 (7.4)
136 (15.4)
5 (0.6)
78 (8.8)
884 (23.5)
103,558 (18.9)
System
Infections
11 (6.7)
48 (29.1)
31 (18.8)
17 (10.3)
27 (16.4)
2 (1.2)
29 (17.6)
165 (4.4)
35,276 (6.4)
Endocrine System
2 (0.8)
60 (23.3)
97 (37.7)
13 (5.1)
45 (17.5)
6 (2.3)
34 (13.2)
257 (6.8)
39,185 (7.1)
Obs., gyn. and
3 (5.1)
12 (20.3)
14 (23.7)
14 (23.7)
12 (20.3)
1 (1.7)
3 (5.1)
59 (1.6)
11,741 (2.1)
0 (0.0)
1 (5.0)
12 (60.0)
2 (10.0)
2 (10.0)
0 (0.0)
3 (15.0)
20 (0.5)
2,417 (0.4)
Nutrition and blood
6 (5.2)
33 (28.4)
44 (37.9)
5 (4.3)
13 (11.2)
0 (0.0)
15 (12.9)
116 (3.1)
19,705 (3.6)
Musculoskeletal
5 (2.1)
61 (26.0)
74 (31.5)
22 (9.4)
32 (13.6)
2 (0.9)
39 (16.6)
235 (6.2)
27,000 (4.9)
urinary-tract
disorders
Malignant disease
and
immunosuppression
and joint diseases
Eye
0 (0.0)
29 (44.6)
19 (29.2)
4 (6.2)
4 (6.2)
0 (0.0)
9 (13.8)
65 (1.7)
15,789 (2.9)
Ear, nose, and
0 (0.0)
11 (19.0)
29 (50.0)
2 (3.4)
6 (10.3)
0 (0.0)
10 (17.2)
58 (1.5)
11,482 (2.1)
Skin
0 (0.0)
46 (37.1)
57 (46.0)
4 (3.2)
6 (4.8)
2 (1.6)
9 (7.3)
124 (3.3)
42,860 (7.8)
Anaesthesia
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
5 (0.1)
4,227 (0.8)
Other
1 (1.7)
8 (13.8)
17 (29.3)
3 (5.2)
4 (6.9)
0 (0.0)
25 (43.1)
58 (1.5)
Total
71 (1.9)
1062 (28.2)
1295 (34.4)
258 (6.9)
625 (16.6)
28 (0.7)
426 (11.3)
3765 (100.0)
oropharynx
5 (100.0)
for re-use, 476 contained drugs listed on the WHO model
list of essential drugs23 and had a financial value of £2452.
The total weight of medicines returned was 294 kg.
However, no correlation was found between the weight of
unused medicines and any clinical or financial value
assessed.
463 (0.1)
54,9038 (100)
be made each year in the UK, incorporating 8 million items
with a value of £75 million. Indirect costs associated with
both the supply of medicines which are unused and their
destruction by high-temperature incineration further add to
the financial burden on the NHS.
What is already known on this topic
Discussion
Main findings of this study
Patients in primary care routinely return substantial quantities of unused medicines to both community pharmacies
and GP surgeries. Extrapolating the data by population
suggests that over 2 million return events of this type may
Data from the DOOP scheme9 and other published studies
have already highlighted the issue of unused medicines.5 – 7
However, data are limited to crude weight measurements or
from small studies, and the specific quantities and types of
unused medicines are not clearly known. The possibility for
re-use of these medicines cannot be estimated without such
data.
RE TURN ED ME DICIN ES: WA STE O R A WA ST ED OPPO RTUN IT Y?
What this study adds
The data in the present study represent a large-scale assessment of unused medicines in primary care and allow an estimation of the potential for re-use of these medicines.
Additionally, the data provide a basis for a better understanding of the reasons leading to unused medicines.
While patient death was responsible for the single largest
proportion of the unused items, two-thirds of items were
returned as a result of potentially predictable factors, including medicines stopped owing to ineffective therapy and
adverse drug reactions. For example, one-third of the
cardiovascular items was returned through a clearout of
accumulated medicines or because the patient stopped
taking the medicine and a further one-fifth was unused as a
result of changes in prescription. Ensuring appropriate
supply quantities, by taking account of factors such as the
likelihood of treatment success, possible dose changes and
adverse drug reactions may help to reduce quantities of
unused medicines to a minimum.
The traditional NHS repeat prescribing system presently
used in GP surgeries throughout the UK may, in some
cases, contribute to surplus supply of medicines.24 It has
been shown that the supply of newly prescribed medicines
in small instalments25 and using the new pharmacy-based
repeat dispensing procedure, implemented across England
and Wales in 2005,26 can lead to a reduction in unused
medicines without unduly increasing workload. It is possible
that extending these practices could help to minimize
unused medicines generated through excess supply.
It is unlikely that unused medicines would be entirely
eliminated in any system, and the data indicate that approximately one-quarter of returned medicines is in a condition
potentially suitable for re-use with almost two-fifths of these
being essential medicines as defined by WHO.23 This
concurs with data from a similar study performed in
France.27 It is possible that returned medicines may not
have been stored in accordance with the manufacturer’s
instructions and while the likelihood of this leading to a significant change to the medicine is slim, it cannot be ignored.
However, with current stability testing guidance28 and by utilizing modern packaging techniques, including tamperevident seals and ‘smart’ labels that react to temperature and
humidity, it would be possible to identify inappropriately
stored medicines. Additionally, if formulations are deemed
unstable such as to render them unusable following reasonable storage in the home, this would raise questions regarding the normal use of such medicines for the primary
recipient within the expiry date. These findings lead us to
suggest that the potential re-use of medicines should be
reconsidered by UK authorities.
261
The weight of medicines returned in this study was consistent with available data from the DOOP scheme,9
although it was shown to bear no relationship with any clinical or financial factors assessed. It should be noted that the
rising weight of unused medicines collected through the
DOOP scheme is likely to lead to increasing costs of disposal since this is based upon weight of medicines handled.
Therefore, reducing the quantities of unused medicines and
sorting medicines for re-use would help to minimize the
growth in this expenditure and costs of undertaking such
tasks would therefore be partially offset.
While formal mechanisms exist for collection of unused
medicines from community pharmacies, there is no equivalent service for GP surgeries. However, if the patient actions
seen in this PCT are replicated throughout the UK, the data
indicate that 400 000 return events comprising 1 000 000
items are routinely made to GP surgeries each year. The
final fate of such medicines is not currently known, but in
light of current hazardous waste legislation,29 this issue also
needs to be considered in more depth.
Limitations of this study
This study did not attempt to quantify disposal by other
routes or to estimate quantities of unused medicines in
patients’ homes, therefore it is likely to have substantially
underestimated the extent of unused medicines present in
primary care. Furthermore, the reasons identified for return
of medicines, while providing some indication of the true
causes of unused medicines, may have been open to differing interpretation by patients. A complementary study in the
same populations investigated some of these issues using a
postal questionnaire and identified that just one in three
patients routinely disposed of medicines through pharmacies
and general practices.30
The use of returned medicines as a surrogate marker for
unused medicines, although standard in studies investigating
this issue,5,6,31 may have introduced some unknown bias.
However, through the inclusion of GP surgeries and a large
number of community pharmacies, we have minimized this
potential. While this study is the most comprehensive
assessment of unused medicines in the UK and possibly
worldwide, the data were only collected in a single PCT over
two months and therefore extrapolation of the findings
should be viewed with caution.
Acknowledgments
The authors wish to thank the staff of participating community pharmacies and GP surgeries for their help and
262
J O U RN A L O F P U B L I C H E A LTH
support. Our gratitude is also expressed to Dr C. Langley for
his contribution during the design phase and to the Royal
Pharmaceutical Society of Great Britain who funded the study.
14 James JS. Unused drugs sought for donation abroad. AIDS Treat
News 1997;(No. 280):3 – 4.
15 Crumplin G. Waste medicines v unwanted medicines – incineration
or altruism? Pharm J 2000;264:467.
16 Dunkley R. Drug donations: let us get it right. Pharm J
2005;274(7332):54.
Competing interests
17 Woolford CC. Unused drugs for developing countries. Lancet
1988;1(8588):768.
A J Mackridge: none; J F Marriott: none.
18 Bradshaw P, Jarvis A. Reissuing returned medicines to developing
countries. Pharm J 2004;273:514– 5.
19 Lerner S. A desperate global scavenger hunt to keep AIDS patients
alive. New York Times 2003, 23 July 2003.
References
1 Department of Health. National Suicide Prevention Strategy for England.
London: The Stationary Office, 2002.
2 Holm JV, Rugge K, Bjerg PL et al. Occurrence and distribution of
pharmaceutical organic compounds in the groundwater downgradient of a landfill, Grendsted, Denmark. Environ Sci Technol
1995;29(5):1415.
3 Heberer T, Reddersen K, Mechlinski A. From municipal sewage to
drinking water: fate and removal of pharmaceutical residues in the
aquatic environment in urban areas. Water Sci Technol 2002;46(3):
81– 8.
4 Heberer T. Occurrence, fate, and removal of pharmaceutical residues in the aquatic environment: a review of recent research data.
Toxicol Lett 2002;131(1–2):5 – 17.
5 Grant P. Return of waste medicines to a community pharmacy.
Prescriber 2001;12(4):29– 38.
6 Hawksworth G, Wright D, Chrystyn H. A detailed analysis of the
day to day unwanted medicinal products returned to community
pharmacies for disposal. J Soc Admin Pharm 1996;13(4):215– 22.
7 Langley C, Marriott J, Mackridge A et al. An analysis of returned
medicines in primary care. Pharm World Sci 2005;27(4):296 – 9.
8 Department of Health. Prescription Cost Analysis, 2005. London:
NHS Health and Social Care Information Centre, 2006.
9 Department of Health. General Pharmaceutical Services in England and
Wales 1994 – 95 to 2003 – 2004. London: The Stationary Office,
2005.
10 McGrandles J. Eastern Birmingham Primary Care
Birmingham, 28 June 2005: Personal Communication.
Trust.
11 Abel J. Public Information Officer: British Medical Association, 16
July 2004: Personal Communication.
12 Royal Pharmaceutical Society of Great Britain. Medicines Ethics and
Practice. 28th ed. London: Pharmaceutical Press, 2004.
13 World Health Organisation. Guidelines for Drug Donations. Geneva:
World Heath Organisation, 1999.
20 National Statistics Office. Neighbourhood Statistics (NeSS).
London: Available from: http://www.neighbourhood.statistics.gov.
uk, 2005.
21 National Statistics Office. 2001 United Kingdom Census: Available
from: http://www.statistics.gov.uk/census2001/, 2001.
22 Mehta DK ed. British National Formulary. 43 ed. London: British
Medical Association & Royal Pharmaceutical Society of Great
Britain, 2002.
23 World Health Organisation. Essential Medicines WHO Model List.
14th ed. Geneva: World Health Organisation, 2005.
24 Zermanski A. Who controls repeats. Br J Gen Pract 1996;46:643– 7.
25 Millar J, MacKinnon W, Struthers M et al. A pilot study to investigate the use of instalment dispensing as a method of reducing drug
wastage owing to adverse drug reactions. Br J Gen Pract
2003;53:550 – 2.
26 Morecroft CW, Ashcroft DM, Noyce P. Repeat dispensing of prescriptions in community pharmacies: a systematic review of the UK
literature. Int J Pharm Pract 2006;14:11 –9.
27 Marchiset-Ferlay N, Gerbaud L, Sauvant MP et al. Description of
unused drugs collected in pharmacies in the Puy-de-Dome region
in France. Revue D Epidemiologie Et De Sante Publique
2001;49(6):551– 8.
28 ICH. ICH Harmonised Tripartate Guideline – Stability testing of
new drug substances and products Q1A(R2): International
Conferences on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use, 2003.
29 The Hazardous Waste (England and Wales) Regulations 2005.
Statutory Instrument 2005 No. 894, 2005.
30 Mackridge A, Marriott J. Unused medicines in primary care: a
postal questionnaire. Int J Pharm Pract 2006;14(S1):A23 – 4.
31 Ekedahl A, Wergeman L, Rydberg T. Unused drugs in Sweden
measured by returns to pharmacies. J Soc Admin Pharm
2003;20(1):26– 31.