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1 Introduction
1.1 Background
During conflicts and
natural disasters large quantities of pharmaceuticals are often donated as part of humanitarian assistance.Undoubtedly many of the pharmaceuticals save lives and alleviate
suffering, but some donations given by well-meaning but uninformed people may cause problems. Pharmaceuticals may arrive past or near their expiry date, may be
inappropriate for the needs, be unrecognisable because they are labelled in a foreign language or may have been sent in unwanted quantities. Donated pharmaceuticals with a
long shelf-life may be mismanaged, particularly in the confusion during and after armed conflict or a natural disaster. Staff and storage space may be lacking and the
pharmaceutical management system in disarray. Such problems also occur when drug donations form part of development assistance. Smaller quantities of pharmaceutical waste
may accumulate in the absence of emergency situations, due to inadequacies in stock management and distribution, and to lack of a routine system of disposal. Safe disposal
of these unwanted or expired drugs often creates a major problem.
These disposal
guidelines are based on a report on the safe disposal of unwanted and unusable drugs in Mostar, which had accumulated during the war in Bosnia and Herzegovina. Quantifying
pharmaceutical waste may be difficult. One report states that 50-60% of the 27,800-34,800 metric tons of medical supplies donated to Bosnia and Herzegovina between 1992
and mid-1996 were considered to be inappropriate, and by mid-1996 there were an estimated 17,000 metric tons of unusable drugs stockpiled in warehouses and clinics
throughout the country. (1)
These dramatic
figures are contested: something in the region of 1,000 metric tons is considered by some to be more reasonable. A recent figure of 2,000 metric tons of pharmaceutical
waste in Croatia is regarded as accurate. Unusable donated drugs hindered the efficient operation of pharmacies in many of the states of the former Yugoslavia and
represented a significant disposal problem.
1.2 Prevention of waste from pharmaceutical donations
Appropriate donations
Inappropriate donations may be minimized by donors adhering to the interagency Guidelines for Drug Donations(2)
The key principles
are that drugs donated shall address the expressed needs of the recipients and that the date of expiration on arrival shall be no less than one year, unless there is clear
evidence from the recipients that they have the logistic and managerial capacity to store and distribute shorter-dated drugs efficiently. The blind donation of
pharmaceuticals based on unsubstantiated assumptions of recipient needs and logistic capacities is a major factor in the production of pharmaceutical waste.
Good donations may be wasted
Mismanagement of received donations may turn a good donation into pharmaceutical waste.
1.3 The cost of disposal of waste pharmaceuticals
The cost of waste pharmaceutical high temperature incineration
Pharmaceuticals are ideally disposed of by high temperature (i.e. above 1,200ºC) incineration. Such
incineration facilities, equipped with adequate emission control, are mainly to be found in the industrialized world. Quotations for disposing of the pharmaceutical waste
in Croatia and Bosnia and Herzegovina in this way range from US$2.2/kg to US$4.1/kg. To incinerate the current stockpile of waste pharmaceuticals in Croatia would
therefore cost between US$4.4 million and US$8.2 million.
Quoted weights of pharmaceutical waste
The gross weights mentioned previously include packaging. Actual pharmaceutical contents may be half, or less than half, of the gross weight.
1.4 Purpose of the guidelines
These guidelines
provide advice on the implementation of safe disposal of unusable pharmaceuticals in emergencies and in countries in transition where official assistance and advice may
not be available. They are not meant to supersede local, regional or national laws regarding disposal of drugs, but to provide assistance where there is insufficient
guidance or none at all.
A number of methods
for safe disposal of pharmaceuticals are described. These are methods which involve minimal risks to public health and the environment, and include those suitable for
countries with limited resources and equipment. The adoption of the guidelines by ministries of health, environment and other relevant ministries, and their practical
application, will contribute to the safe and economical elimination of stockpiles of unusable pharmaceuticals.
The best
environmental option for pharmaceutical destruction is purpose-built high temperature incineration with adequate flue gas cleaning. However, this is not the only method
that can be used to achieve adequate disposal. Indeed many countries do not possess such a facility. It is for this reason that these guidelines are suggested as practical
interim alternatives to assist those charged with the safe disposal of unwanted pharmaceuticals. The current guidelines propose a number of marginally less safe treatments
and disposal methods, which are however acceptable from the relative risk point of view, when balanced against the risks related to improper or non-disposal(see Section 1.8).
What the guidelines do not cover
There is no attempt to cover the management of other wastes generated by health institutions, for example,
infectious waste, photographic chemicals, solvents, wastes with a high content of heavy metals (e.g. mercury and cadmium), chemical laboratory wastes, or radioactive
waste. The management of health care wastes generated in normal conditions (i.e. neither during nor after emergencies) is not included. Specialized advice for these
categories of waste is available from WHO(3),(4),(5).
The wider subject of
normal drug supply and management(6) is not covered. This includes drug waste minimization and waste separation within the health institution. It is assumed that
management procedures and staffing are in place to cover these aspects. In the event of insufficient qualified staff and management capacity to undertake safe disposal
then the pharmaceutical waste must be securely stored.
1.5 Who will find the guidelines usefull?
These guidelines can
be used by all relevant health authorities, competent to authorize the use or disposal of drugs. In many countries drug disposal will also involve environmental and waste
management authorities, and experts at ministerial, regional and local level. Depending on the situation in the country, the appropriate authority may be a department
responsible for pharmaceutical management within the ministry of health, the drug regulatory authority (if different from the former), a regional or local health authority
(pharmaceutical officer) or the ministry of environment, etc. It is the responsibility of the qualified appropriate authority to implement the guidelines in coordination
with regional and local health authorities, as well as with the directors of health facilities that face the problems of drug disposal.
A local task force or
advisory committee should be established at an early stage to assess, analyse and address the problem of drug disposal, and to monitor activities. Furthermore, it is
suggested that such a task force has a maximum of five members and that meetings are held as near to the site of the stockpile as possible.
Members may be chosen from:
- the drug regulatory authority or ministry of health
- the ministry of the environmentthe
- audit section of the ministry of health
- institutional pharmacists
- a qualified hazardous waste expert may be
appointed by the authority to be responsible for pharmaceutical waste disposal.
If this is done the
person appointed should become a member of the task force. The individual can be an expert in environmental management, a registered water chemist, hydrogeologist or
sanitary engineer. The choice of expert depends on the technical problems to be faced.
Nongovernmental
organizations with pharmaceutical programmes may also have to deal with unusable waste stocks of pharmaceuticals that require disposal. Disposal should be undertaken in
conjunction with the relevant authority where such exists.
In non-emergency
situations large stockpiles do not usually accumulate, and waste pharmaceuticals are best disposed of on a routine basis, small quantities at a time. This should be
organized on a local and institutional level.
1.6 Administrative aspects of writing-off unwanted pharmaceuticals
Few countries have
adequate administrative provisions for writing-off pharmaceutical stock. In the public sector drugs are the property of the state, for which strict accounting procedures
are necessary. If procedures exist at all, they tend to be complicated and time-consuming, and in practice the disposal of expired stock is difficult. This applies both to
drugs that are procured through the normal channels and to donated drugs.
Administrative and
regulatory procedures concerning safe disposal of pharmaceuticals, that are in line with national drug and environment legislation, should be adopted and implemented in
countries that receive drug donations.
Simplifying
procedures in general would probably be the best solution. One approach would be to state that donated drugs are not entered into the government inventory or considered
state property unless specifically accepted as such. In this case any drug that is not officially accepted can be destroyed without the need for governmental approval;
however, correct disposal procedures must be followed. A further solution would be to establish special, simplified, administrative procedures for writing-off unwanted
donations.
1.7 Steps to be taken
A series of steps
need to be taken when disposing of unwanted pharmaceuticals, and these are briefly summarized below.
Decision
The hospital, district or regional pharmacist or organizations with pharmaceutical programmes decide when
action needs to be initiated, because of an accumulation of unwanted pharmaceuticals which are unfit for human consumption and for veterinary treatment.
Approval
Approval and sanctioning of disposal of pharmaceuticals must be sought from the appropriate authority. This
authority will differ from country to country and may be the department responsible for pharmaceutical management within the ministry of health, the drug regulatory
authority, or the regional or local health authority (pharmaceutical officer). In some countries the ministry of the environment should be involved. The guidelines are
particularly useful in emergency situations or for countries in transition where official regulations have not yet been developed. In non-emergency situations when
significant quantities of donated pharmaceuticals are disposed of, for whatever reason, it may be necessary and judicious to inform the donor.
Planning
Planning, in terms of funding, necessary expertise, human resources, professional time, space, equipment,
material and available disposal options will be required. This is essential before practical steps can be taken to start disposal. To obtain a rough estimate of the volume
of materials to be sorted, it is recommended that measurements are made using a tape measure, and conversion from volume of material to weight is made using a density
figure of 0.2 metric tons/cubic metre.
Forming work teams
Work should be conducted by teams consisting of supervising pharmacists and general medical workers, who are
preferably pharmaceutical technicians or experienced pharmaceutical warehouse personnel. The size of each team, and the ratio of experts to workers, will be determined by
the volume and composition of the stockpiles, and working conditions at the sites.
Health and safety of work teams
All workers should wear appropriate protective equipment including overalls and boots at all times, and
gloves, masks and caps when appropriate. Masks should be worn when tablets or capsules are being crushed as part of the disposal technique (for example, inertization, see
Section 2.4) and when there is a risk of powders being liberated. Particular care is required when handling antineoplastics.
Sorting
The objective of sorting is to separate the pharmaceuticals into separate categories for which different
disposal methods are required. The separation should be made into those that can be safely used and returned to the pharmaceutical supply system and those that require
disposal by different methods. For example, controlled drugs (e.g. narcotics), antineoplastic drugs and antibiotics all require special methods of disposal. Substantial
investment in human resources may be required for identifying and separating pharmaceuticals.
Disposal
Disposal options vary considerably between situations, and the ideal solution may not be feasible. The aim
of these guidelines is to propose the simplest, safest and most practical alternatives.
Security
Controlled substances (e.g. narcotics and psychotropics) require tight security and control. In some
countries, scavenging of material from landfills is a frequent problem, and, disposed drugs may be recovered and sold by the scavengers. Measures are therefore necessary
to prevent diversion during sorting, and pilfering of drugs from landfills. Immobilization (see Sections 2.3 and 2.4) is the best method of preventing pilfering from a
store or landfill. If, as a last resort, pharmaceuticals must be discarded direct to a landfill then they must be covered immediately with a large quantity of municipal
waste.
1.8 Consequences of improper disposal or non-disposal
In general, expired
pharmaceuticals do not represent a serious threat to public health or to the environment. Improper disposal may be hazardous if it leads to contamination of water supplies
or local sources used by nearby communities or wildlife. Expired drugs may come into the hands of scavengers and children if a landfill is insecure. Pilfering from a
stockpile of waste drugs or during sorting may result in expired drugs being diverted to the market for resale and misuse. Most pharmaceuticals past their expiry date
become less efficacious and a few may develop a different adverse drug reaction profile. There are some categories of expired drugs or defective disposal practices that
carry a public health risk.
The main health risks are summarized below.
- Contamination of drinking water must be
avoided. Landfills must be sited and constructed in a way that minimizes the possibility of leachate entering an aquifer, surface water or drinking water system.
- Non-biodegradable antibiotics, antineoplastics
and disinfectants should not be disposed of into the sewage system as they may kill bacteria necessary for the treatment of sewage. Antineoplastics should not be
flushed into watercourses as they may damage aquatic life or contaminate drinking water. Similarly, large quantities of disinfectants should not be discharged into a
sewerage system or watercourse but can be introduced if well diluted.
- Burning pharmaceuticals at low temperatures or
in open containers results in release of toxic pollutants into the air. Ideally this should be avoided.
- Inefficient and insecure sorting and disposal
may allow drugs beyond their expiry date to be diverted for resale to the general public. In some countries scavenging in u
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