Authors: Rafal Hechmann, Anne Bunde-Birouste[1] 1
Introduction: Drug Donations In Emergencies
In September 2004, the BBC News reported that the number of people affected by natural disasters is rising annually. According to the agency, the number of disasters has risen from 261 (53,000 deaths) in 1990 to 337 (83,000 deaths) in 2003.[1]
Three months later an earthquake located near the Sumatran coast, triggered the tsunami wave which led to a widespread and unprecedented catastrophe in South and South Eastern Asia, killing almost 300 thousand people. As that year progressed, the world witnessed earthquakes, hurricanes, typhoons, floods, tsunamis and the threat of flu pandemic. From January to October 2005, an estimated 97,490 people were killed in disasters
globally.[2]
While a large part of disasters and conflicts still passes virtually unnoticed by the outside world, a growing number of them are widely covered by media, gaining international attention. Along with attention, victims and survivors get generous and often extraordinary support from individuals and organizations from all parts of the world. In the face of human misery, donations are often regarded as the most concrete way to express solicitude and solidarity with affected people.
Among with many different types of aid, drug donations play one of the greatest roles in the humanitarian response of the international community.
Indeed, medicines are crucial elements in alleviating the suffering of people affected by cataclysm, as having the appropriate medications at the right time to treat injured or sick people in disaster or war affected regions is essential.
Although donors’ intentions are often unquestionable and drug donations play an important role in humanitarian relief efforts, the “anything is better than nothing” rule should not apply here. Almost every time an emergency situation occurs, affected countries experience an influx of medications and equipment often not relevant for the emergency situation, as well as expired drugs or medications labeled in other languages. The vast quantity of donations received, their irrelevance to the situation, and low quality, create tremendous problems which very often take more time to overcome than the actual emergency. Pharmaceutical assistance can be highly beneficial, but only when provided with respect to strict guidelines and the actual needs.
Guidelines For Drug Donations
The problem of appropriateness of drug donations was addressed in the “Guidelines for Drug Donations” issued in 1996 by the World Health Organization in cooperation with the major international humanitarian relief agencies.[3, 4] The Guidelines are not international regulations. They are intended to serve as a policy proposal to be reviewed and introduced by governments and donor organizations.[3] The document applies to donations made in emergency situations as well as those which are a part of development aid.
The twelve articles of the Guidelines are based on four core principles:
- Maximum benefit to recipient. Donated drugs are very often not relevant to the emergency situation or are donated in wrong quantities. Donations should benefit the recipient to the maximum possible extent and only essential medications should be sent.
- Respect for wishes and authority of the recipient. Donor agencies often ignore the existence of the local pharmaceutical industry and established administrative procedures for receiving and distributing of pharmaceuticals and medical equipment. Donations should comply with existing government and organizational policies.
- No double standards quality. Many donated drugs arrive expired, unsorted or labeled in languages unknown by local professionals. If the quality of drug is not acceptable in the donor country and does not comply with its standards, it is also not acceptable for the recipient.
- Effective communication between donor and recipient. Donations are very often sent without prior consultation or consent of the recipient. Donations should be based on an expressed need.[3]
In emergency situations, the Guidelines also recommend sending standardized Emergency Health Kits, which have been specifically designed for such situations by WHO. The Emergency Health Kits provide a complete spectrum of essential drugs and medical supplies specifically adapted to emergency
Although the WHO Guidelines have been public since 1996, recent responses of the international donors to humanitarian crises indicate that pharmaceutical assistance in emergencies still causes serious problems for the recipient countries.
Problems Created By Improper Donations
Pharmaceutical donations are often made with little regard to the procedures advised in the WHO Guidelines. Type and quantities are often inappropriate, thus problematic, and place very serious burdens on the recipient side. The affected country may be impacted by unsolicited donations in many different ways, reaching from direct additional costs to actual threat for its people, environment and industry.
Direct costs of unsolicited donations
For a recipient country, the most tangible consequences of inappropriate and excessive donations are related to efforts necessary to engage in storage, coordination and disposal of tons of medications. This translates to financial cost, as well as engagement of human resources and storage space, which are already scarce in every post-disaster setting.
Types of improper donations
Probably the greatest problem for recipient countries is created by donations of tons of medications not relevant to the emergency situation, or relevant drugs sent in excessive quantities. Drugs also arrive either already expired, close to their expiry date or without any expiry date indicated, thus causing nothing but additional trouble for the emergency-struck country, as they are virtually useless for the relief efforts. It is worth noting that the manufacturer expiry dates of medications apply only when certain storage requirements are met, and are based on rate of deterioration under standard conditions (temperature, humidity, light). In case of drugs stored in temporary, provisional warehouses it is very hard to rely on the quoted expiry date, and it is almost impossible to assess what is the actual potency of the active ingredient in the product.[9]
Treating patients with expired drugs results in a reduction in therapeutic response and if degradation of a drug is significant, the consequences can be very serious. According to WHO, consumption of low quality antibiotics (including expired and counterfeit ones) is one of the major problems in development of antimicrobial resistance in developing countries. [10] Another problem arises with medications labeled in languages different to that of the area. As these medications are not recognized by local professionals, they pose serious threat for patients due to their potential misuse.
Storage
Even proper and relevant drugs can be troublesome for a recipient country when sent in excessive quantities. Local medical storage capacity is often insufficient to house an enormous influx of drugs. Very often additional storage space has to be rented at extra cost, or space in existing health care facilities has to be sacrificed to accommodate donations. A report on drug donations to post- tsunami Banda Aceh province in Indonesia issued recently by Pharmaciens Sans Frontiers –Comite International (PSF-CI) reveals that in the surveyed districts, health personnel in three hospitals and one health center had to sacrifice office space and/or patients’ rooms to store inappropriate drugs. [6]
Sorting
As masses of donations arrive very quickly and human resources are usually in short supply, medications are virtually impossible to sort in the normal course. As a result, tons of useless and unsuitable medications hinder the usage and management of the useful ones. The situation is made worse by the fact that the proportion of inappropriate drugs is often high, which creates problems not only in management of donations during the emergency, but also in their disposal after the crisis.
One of the most troublesome types of donations, in terms of workload required for its management, consists of small and nonprofessional consignments of unsorted drugs and free, doctor samples collected from health professionals, individual donors, and charities.[7] As these donations often contain the whole spectrum of different medicines with various expiry dates, sent in different quantities and labeled in different languages, they are also tend to be inappropriate and take immense amounts of time to sort. In Venezuela, after floods in 2000, 70% of pharmaceutical assistance sent had to be destroyed. The government had to spend $ 16 000 on hiring extra staff in order to sort the drugs whilst a telephone support line set up to provide psychological counseling for the victims of the disaster had to be shut down due to lack of funds.[8]
Disposal
As the potential consequences of this influx of non-essential, expired or poorly labeled drugs pose serious threat, most need to be disposed, adding yet further costs to the local governments. In Eritrea during the 1980 war for independence, seven truckloads of expired aspirin tablets were sent. It took six months to burn them. Eritrea also received a whole shipping container of cardiovascular drugs with only a two month’s expiry date.[11]
Twenty-five years later, the report of PSF-CI from post-tsunami Banda Aceh, reveals that 25 percent of the medications donated to the region after December 2004 had inadequate expiry date (expired, too short or no expiry date), and 70 percent were labeled in foreign languages. Taking into account the expired drugs, those due to expire in 6 months and those with no expiration date, 600 tons had to be destroyed at the total cost of 2,400,000 euros (approximately 3,000,000 US Dollars).[6]
Indirect costs of unsolicited donations
The direct costs and efforts which need to be spent on management and disposal of improper donations are not the only burdens brought by tons of unwanted medications to the receiving country. There are some other, long term, negative consequences of uncontrolled influx of donations to a country.
According to the “Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies” issued by WHO in 1999, pharmaceuticals are ideally disposed of by high temperature (above 1,200 Celsius degrees) incineration. As such facilities equipped with emission control are to be found mainly in the industrialized world, the Guidelines describe a number of alternative methods for safe disposal of useless medications suitable for developing countries (landfills, encapsulation, burning in alternative incinerators, chemical decomposition etc.).[12] These alternative methods are not without risk either. Medications may be hazardous when they contaminate water supplies or sources used by local communities or wildlife. If discarded insecurely in landfills, drugs may come into the hands of scavengers or children and be diverted to the market for resale to the general public.[12] Accumulation of unused medications and delayed disposal can also lead to pilfering and black markets sales, which in turn encourage self-medication and misuse of drugs, causing serious threat for the health of a country’s population.
Another problem is the impact of drug donations on local economies. Many countries afflicted by crisis have their own pharmaceutical industries supplying essential drugs that are widely used on a local market. The influx of foreign medications, particularly those in excess quantities, can undermine the local industry and weaken the economy. After the South Asian tsunami, the Province of Aceh was given a 4 year supply (based on the current consumption rate) of Tetracycline, 250mg and a 6 year of supply of Dextromethorphan, 15mg, as a relief effort.[6] These medications could have been purchased from the local manufacturers, supporting local economy instead of weakening it. Such bulk donations (in many instances donated by pharmaceutical corporations) have an adverse effect on production and usage of local, generic drugs familiar to native medical professionals.
An additional consequence of the immense influx of foreign medications is that the prescribing patterns of local physicians changes, which promotes the use of the more expensive, foreign brands. This change in prescribing often continues even after the donation stock ends. Drug donations to developing and disaster affected regions are thus used by pharmaceutical corporations as a means of building brand recognition to develop new markets. [8] Some companies don’t even try to hide their true intentions. When in 1993, the US pharmaceutical company Connaught Laboratories donated $13 million dollars of polio vaccines to Russia, its president at the time, David Williams explained: “Someday Russia will be a market. So while meeting a need, maybe we can plant seeds.” [8, 13]
Examples From The Field: Drug Donations To Post-Tsunami Sri Lanka
In July 2006 the authors of this paper conducted research in Sri Lanka in order to examine the background research in relation to the Sri Lankan experience in the management of donations and their appropriateness during the post tsunami period in the country. The authors aimed to explore the experiences of different Sri Lankan institutions managing the influx of post-tsunami drug donations as well as to investigate appropriateness of the pharmaceutical assistance after the disaster. To research the problem, key stakeholders in charge of donations management on the central and local level were identified and interviewed with the standard format interview. In addition, some storage and dispensary facilities across the country were visited, and standard format interviews with personnel were conducted.
Sri Lanka – Country profile
Sri Lanka is a multi-ethnic and multi-religious island country situated off the southern coast of India and about 880km north of the equator. The country’s population is about twenty million, composed of Sinhalese (74%), Sri Lankan and Indian Tamils (12% and 6% respectively), Muslims (8%) as well as other groups (4%). [14] Sinhala and Tamil are the official languages. English is widely spoken and understood. Place names and sign-boards on transport are usually in all three languages. From 1983 to 2009 the northern part of the country has been stricken by civil war, between the government forces and Liberation Tigers of Tamil Eelam (LTTE), who aimed to create an independent Tamil state in the north and east of the island.[15]
Health care in Sri Lanka is provided both by the private and public sectors. Sri Lanka possesses an extensive network of health care institutions. A health care unit can be found on average not further than 1.4 km from any home and free government, western style health care services are available within 4.8 km of a patient’s home.[16] The Medical Supplies Division (MSD), which comes under the jurisdiction of the Ministry of Health, is responsible for the central purchasing, storage and distribution of drugs for the public sector. The MSD main office is located in Colombo and the main storage facilities are scattered in a few different places in the capital. The main office stocks the regional branches of Medical Supplies Division (RMSD), which in turn supply drugs and equipment to hospitals and dispensaries throughout the country. The nineteen largest hospitals, coming under the jurisdiction of Ministry of Health, are supplied directly from the main office in Colombo.[17]
It is important to note that Sri Lanka was largely self-sufficient in pharmaceutical supply, with its own pharmaceutical industry and large domestic drug manufacturers such as the State Pharmaceutical Manufacturing Corporation (SPMC). These companies produce the entire spectrum of what are considered as essential drugs.
The tsunami disaster
In the morning of 26th of December 2004 a massive earthquake struck off the Sumatran coast triggered a series of tsunami waves which struck 11 countries in the South and South-East regions of Asia resulting in a natural disaster of apocalyptic proportions. One of the worst cataclysms in living memory, it took almost 300,000 lives across Asia. With 31,547 killed, 23,059 injured, and more than half a million displaced people, Sri Lanka was the second worst affected country. [18]
The health system was severely affected by the disaster. Several health sector personnel were killed which created gaps in service provision following the disaster. Ninety two clinics, hospitals and drug stores were either destroyed or damaged. Regional Medical Supplies Division stores, RMSD Kalmunai and RMSD Matara, were also among the damaged. Losses also included the preventive health care offices, health staff accommodation facilities, vehicles, district health offices and medical equipment. [17, 19]
Post-tsunami emergency drug management in Sri Lanka
The distribution of drugs and other medical supplies in the first hours after the disaster was not an easy task and as a main distributor of medications, the Medical Supplies Division, faced several serious problems. The catastrophe occurred during a long holiday weekend, when most of the employees were on leave and thus hard to contact with. Due to destroyed telephone lines, cellular telephony network, roads, railway and other communication media there was no accurate information about the disaster, its size, and thus medical requirements in affected areas. On the day of disaster an emergency committee was set up in the MSD office in order to plan distribution of the buffer stock to affected areas. The MSD employees and volunteers were called through the mass media announcements.
The distribution of medical supplies to affected areas started the next day, with the help of Sri Lankan air force’s helicopters as many locations (e.g. Batticaloa, Trincomalee) were difficult or impossible to access by land. [17] In this special occasion MSD did not confine itself to its usual distribution pattern of working through specified distribution centers. To meet emergency needs, medical supplies were distributed directly to health institutions in affected areas. During the first two days after the Tsunami, the country relied almost entirely on buffer stocks of drugs available in the MSD and some donations received from local organizations and individuals. [17] On the third day, the 28th of December 2004, after the initial assessment of the situation, the list of medications needed for further relief effort was issued by the Ministry of Health. The list was published through all state media along with the Ministry of Health, presidential and Prime Minister Offices’ websites.[20]
Donations: Another wave arrives
Within a few days tons of drug donations started to arrive to the country from different parts of the world. Initially donations were received and distributed by several different organizations but to minimize chaos, donations were soon to be channeled directly to the MSD. According to the MSD data, during the 5 months after the tsunami an estimated 3500 truckloads of donations were received.
Storage and sorting of donations
The existing MSD storage capacity and human resources were not adequate for such an influx of donations, thus additional warehouses in Colombo were rented at the cost of the MSD. These sites were crowded with unsorted boxes with little space for the teams of volunteers assisting in sorting and dispatching the medications to move among the stock. As many of the donated drugs had not been registered in the country before, special teams were set up to allow their admission and distribution in Sri Lanka. A special police unit was required to watch the warehouses and protect the donations from theft. The huge and unprecedented quantities of medications (up to 100 plane loads a day) created disorder and confusion, particularly in first days of the relief influx.
The tons of medications were impossible to sort in the normal course, and any kind of cataloging was un-manageable. Serious problems in this initial stage were also created by shortages of transport and means of communication.
After two weeks the public health aftermaths of the disaster were under control and the Sri Lankan authorities requested Pharmaciens Sans Frontiers (PSF)
Germany and PSF Switzerland to pass on the message that they wished not to receive any more donations. The message went unheeded, as for the next five months unprecedented quantities of pharmaceuticals flowed into the country. [17, 21]
In order to make the most out of these donations, the medicines were distributed by MSD not only to the tsunami affected regions but to every single public hospital, dispensary and health office in Sri Lanka. Unfortunately, in addition to useful and needed stock, most of the hospitals were given a great deal of inadequate medications, or quantities so large as to be impossible to use. In many places special spaces had to be assigned and adopted to accommodate the donations. All hospital and medical offices staff, interviewed by the authors 18 months after the disaster, stressed the huge workload associated with sorting and management of donations. For example, in District Hospital in Weligama (100 beds, affected region) where 500 people were admitted after the disaster and 90% were discharged within one week, 15 volunteers were still sorting medications 3 months later.
Appropriateness and disposal of donations
During 5 months following the disaster the MSD office was opened 24 hours a day trying to sort out and distribute medications. Approximately 150 metric tons (130 truck loads) of unusable medications were destroyed in Colombo in the local cement kiln at the cost of 120-180 US dollars a ton. Unfortunately, drugs destroyed in the cement factory appear to be only a small part of improper and unusable donations received by Sri Lanka after the tsunami.
According to research conducted by the team of Professor Rohini Fernandopulle Journal of Humanitarian from the Pharmacology Department at University of Colombo, there were 772 active pharmaceutical ingredients (the unique drug products) received as part of the relief. However only 465 (60%) of them were ever registered in the country. Moreover, only about 10% of drugs sent as part of the emergency relief were on the Ministry of Health expressed list of medications, issued two days after the disaster.[22] The report findings indicate that only 50.5% of the medications received had expiry dates on the packaging, with 5% either expired on arrival within a few days of arrival. According to Dr Beneragama, the head of the MSD, some medications sent from overseas had expiration dates of 2001, three years before the Tsunami.
As donations were arriving from all parts of the world, a serious problem was also created by their improper labeling. Approximately 62% of the medications were labeled in a language other than English, which is read and understood by most of Sri Lankans. The other languages included Arabic, Chinese, Danish, French, Korean, German, Spanish, Italian, Turkish and others. Also about 15 percent of medications did not have generic names on the packaging. [22]
The above data collected by the MSD from March to July 2005 indicates the how difficult the international pharmaceutical donations were for authorities to manage, not only in Colombo but throughout the country. At the time of this research, more than a year later, unused donations were to be found in three out of four hospitals visited. In two hospitals special spaces had to be assigned and adopted for storage of expired and unusable medications and equipment. Personnel in these hospitals reported that approximately 25% of donations they had received had needed to be destroyed for reasons such as past-expiry dates, labels in unknown languages, and excessive quantities. The majority of people interviewed emphasized feelings of confusion and uncertainty about appropriate methods to dispose of unused donations. The Sri Lankan experience with post-tsunami pharmaceutical assistance resembles situations in many other countries struck by an emergency. The compliance of drug donations with WHO Guidelines was poor, and this created many problems.
Indirect costs of donations
Tremendous human resources are needed to sort the essential medications from the tons of donations. Important financial resources are needed by local government to lease storage space, provide transport and dispose of unusable donations. There are additional consequences of these unsolicited donations for Sri Lanka. More than 18 months after the disaster tons of expired or unidentified medications, distributed in the post-disaster chaos are being stored in hospitals across the country, taking space and waiting for the disposal. Because of limited funds, there is no guarantee that they will be disposed without harm to the environment.
The huge inflow of donations and their distribution across the country also seriously affects the use of locally manufactured medications. Unlike Banda Aceh, Sri Lanka experienced a particularly large influx of foreign antibiotics.
Consequently, these were often used rather than the locally manufactured antibacterial preparations according to informants. Some professionals interviewed also expressed the concern that the influx and continued presence of expensive foreign pharmaceuticals, often never registered in Sri Lanka before, may also alter the prescribing patterns among domestic physicians.
Taking into account all these facts, it is difficult to consider if donations in Sri Lanka assisted, or rather hindered, the disaster relief efforts.
Discussion
Sri Lanka’s experience reiterates the urgent need for international action promoting better pharmaceutical emergency relief practice. To plan such action it is crucial to understand the factors which contribute to the situation, where tons of unsolicited drugs flow into emergency affected regions.
Reasons of unsolicited donations
There are several underlying reasons for the problem of inappropriate drug donations in emergencies. As the authors of the “Guidelines for drug donations” point out, probably the most important one is the prevalent but false belief that in an emergency situation any drugs are better than none at all. Another crucial factor leading to many unsolicited donations is a general lack of communication between the donor and the recipient, or rather, as the Tsunami example showed, the lack of effective communication.[3] Also very often in countries affected by disasters there are no proper disaster preparedness plans and drug policies in place when emergency situation strikes. For example, there was no drug policy in Sri Lanka before the disaster, and process of its formulation started only after the tsunami.
Another underlying reason for inappropriate drug donations is the absence of international agreements regulating the transfer of pharmaceuticals across borders. However, expired and spoiled pharmaceuticals as hazardous waste are subject to the ‘Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal’, which states that permission to cross international borders must be obtained from all states on the travel route before shipping expired or spoiled medications abroad. As these procedures can take several months to complete, they are often disregarded.[23, 24]
As there are no criteria governing who can get involved in supplying drug donations, virtually any individual or organization can supply medications to affected regions without any prior consultations and knowledge of actual needs. This is often one of the main contributors to the hodge-podge of no useful donations.
Finally, as mentioned earlier, there is the problem of pharmaceutical industry donating ‘hard-to-sell medications’ usually done to receive tax rebates and/or promote a “socially concerned” corporate image.
What can be done to improve donations practices?
To assure the implementation of the good practice in drug donations the WHO Guidelines should be introduced and explained to all potential stakeholders. For effective dissemination of the Guidelines’ principles, it is essential to provide media with accurate, well developed information. Organizations concerned with appropriate drug donations should prioritize linkages with international and local media. Many in-kind donations to crises- affected countries come from the general public during various charity collections. However good the intentions may be, emptying drug cabinets in order to help those in need is not necessarily the best idea and causes far more problems than it solves. Media, donor organizations and pharmaceutical boards should promote education and information activities concerning the contents of the Guidelines in the community to reduce unwanted donations.[25]
Donations in cash, recommended by the WHO Guidelines and specifically designated to purchasing local drugs should be encouraged rather than drug donations in kind. An example of positive influence of such policy comes from India. After the earthquake in State of Gujarat in 2001 most of donated drugs were manufactured locally, even if funding came from overseas. As a result, medical personnel were familiar with the vast majority of drugs, and less than 5 percent of the total quantity of donations was reported as inappropriate.[23]
Another crucial step in building of “drug donation good practice” is to ensure effective cooperation between all parties involved in the process. As there is a huge spectrum of organizations involved in pharmaceutical assistance, this difficult task requires multidirectional action and involvement of many groups on both donor and recipient side. Good communication between all stakeholders has to be developed and maintained. This is crucial during emergencies, but it is also very important in strengthening the emergency preparedness at the both donors and recipients level.
Governments of affected countries should be fostered and assisted by international agencies to clearly express their needs during emergencies and these needs should be actively listened to by donors. All countries should also be encouraged to formulate their national drug policies to contain donations strategies in the event of emergencies. These strategies should be based on the WHO “Guidelines for Drug Donations” principles. It is essential to seek involvement and counseling of local NGOs, health care personnel and local pharmaceutical industry in expression of needs during the crises and creation of preparedness plans and policies for future emergencies. International agencies and local governments should also provide training activities for local personnel and NGOs in order to equip them with a strong foundation in good drug donation management practices. Such activities also contribute to capacity building and empowerment of local structures.
To assure appropriate donations in the long term, some more radical steps might have to be taken and introduction of international regulations based on the WHO Guidelines should be considered. These regulations could specify the criteria that enable organizations to be involved in drug donation process. The strict criteria should assure that organizations wanting to provide pharmaceutical assistance are well prepared to do it. Organizations should be obligated to act in accordance with WHO recommendations, and accompany donations with logistic and professional assistance if required. To assure better synchronization of the work, a coordinating body (e.g. under jurisdiction of WHO) should be designated, or if necessary, created. This body would also certify donor organizations through regional offices of WHO or local Ministries of Health. As such, as organized network of donors would provide the pharmaceutical assistance in much more effective and coordinated way in emergency situations. The resulting improved information exchange and cooperation between agencies, would maximize the impact of development and emergency pharmaceutical assistance. For such solutions to be effective requires international agreements (or national regulations in the biggest donor countries) which would allow drug donations only through the certified organizations. In addition, pharmaceutical companies should be required to vehicle medications only through specialized organizations.
These changes could not only improve donations, their management and professional support of donors, but would also increase donations of financial support instead of medicines.
Concluding Remarks
Well planned and implemented pharmaceutical relief to post-disaster areas has the capacity to meet basic human needs and improve welfare, particularly among the worst affected and the poorest people. On the other hand, chaotic and unwanted donations can create additional costs, waste, and confusion for already stricken regions and weaken affected economies. To improve donations practices, minimize their negative impacts, and maximize benefits, implementation of the WHO Guidelines’ principles is essential. Communication and education are key if the quality of drug donations is to be improved. This difficult task requires multidirectional action and involvement of many different groups of stakeholders on both donor and recipient sides. In the long term it might be necessarily to consider an avenue of legal enforcement of proper donations, as this problem, clearly hindering relief efforts in emergencies, is still unregulated by international law
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