Article Text

PDF

Chapter 9: Evidence based pharmacy for developing countries
  1. Hao Lu1,
  2. Tommy Eriksson2,
  3. Phil Wiffen3
  1. 1Department of Pharmacy, Beijing United Family Hospital, Beijing, China
  2. 2Department of Clinical Pharmacology, Laboratory Medicine, Lund University, Lund, Sweden
  3. 3Pain Research Unit, Churchill Hospital, Oxford, UK
  1. Correspondence to H Lu, Department of Pharmacy, Beijing United Family Hospital, #2 Jiang Tai Road, Chaoyang, Beijing 100016, China; lu020202{at}hotmail.com

Statistics from Altmetric.com

About this chapter

At the time of writing, the healthcare industry in developing countries is rapidly catching up. While more new drugs and medical technologies are becoming available in these countries, the evidence supporting these healthcare interventions may be easily overlooked. The chapter starts with a description of a typical patient encounter in a developing country to set the context. The rest of the chapter aims to define the challenges faced in practising evidence based pharmacy in developing countries and proposes strategies to overcome these challenges. This chapter is aimed at pharmacy professionals in developing countries to steer their course. It may also help their counterparts in developed countries to gain a global perspective.

Evidence-based Pharmacy was first published as a textbook by Phil Wiffen in 2001. The first chapter was published in Eur J Hosp Pharm 2013;20:308–12. Other chapters have been published regularly.

A patient presents with a prescription for metronidazole 400 mg tablets three times daily for 7 days. The busy pharmacist quickly grabs the medication already prepared for the patient and gives it to the patient after calling the patient's name. The patient, with the medication in her hand, attempts to ask a question. The pharmacist quickly says ‘next’. Having seen the long queue of patients, the patient walks away. Then she opens the information leaflet accompanying the tablets. The leaflet says ‘pregnancy and breastfeeding: contraindicated’. She is now confused as she is 27 weeks’ pregnant. Should she take them or not? She goes back to the pharmacy looking for more information. There is a window marked ‘medication consultation’ with pharmacy staff and no one is queuing. The information she receives is the same as that on the information leaflet; she should not take this medication and is asked to go back and see her doctor. With her confusion and distrust in the doctor's judgment, she goes back to the doctor's office. The doctor insists that she should take the medication to treat her infection. However, the patient does not trust the doctor anymore, and asks for a refund of the medication.

The case above illustrates a typical visit to a hospital that a patient may experience in a developing country. It shows the challenges in healthcare in developing countries, such as the conflict of information between different resources, the limited time the pharmacist has during an interaction with a patient, the overflow of patients in hospitals and the intense doctor–patient relationship.

Challenges in practising evidence based pharmacy

Conflict of information between different resources

According to the approved product information leaflet for metronidazole in China,1 the drug is ‘contraindicated’ in pregnancy and during breastfeeding. According to the US Food and Drug Administration,2 metronidazole is categorised as pregnancy category ‘B’, which means it can be safely used for pregnant patients if indicated. One of the Cochrane reviews,3 updated in 2013, ‘Antibiotics for treating bacterial vaginosis in pregnancy’, concluded that antibiotic treatment can eradicate bacterial vaginosis in pregnancy while reducing the risk of late miscarriage. It is unclear why the Chinese product information leaflet listed ‘contraindicated in pregnancy’ for metronidazole. Possible explanations include defensive labelling for litigation purposes or outdated information. Outdated or misleading information acts as a barrier for the implementation of evidence based practice. Healthcare professionals who would like to practice according to the most up to date information may be constrained by the approved product information.

Limited pharmacist interaction

Countries and territories with less economic development tend to have a relatively lower density of pharmacists. This is demonstrated by a report in 2012 developed by the International Pharmaceutical Federation (FIP).4 The mean density of pharmacists per 10 000 population across 82 countries in the world is 6.02. This number for developing countries, such as Bangladesh, China and many African countries, is less than 3.4 The shortage has implications for inequalities in access to medicines and pharmacist expertise. Pharmacists would therefore need to ensure the adequate supply of medicines first, by engaging their roles in pharmaceutical production and dispensing of medications. Therefore, they may have limited time for patient interaction and clinical pharmacy.5 On the other hand, some countries have many more pharmacies than pharmacists. This calls for improvement in the supervision of medicines and their use in such countries.4

Overflow of patients in hospitals

In many developing countries, larger proportions of patients are treated at hospitals and specialised clinics. One reason is the limited access of the population outside major cities. Inefficient sharing between healthcare sectors may lead to poor outcomes. This is supported by evidence that countries with a higher proportion of primary care physicians have better health outcomes than countries with a higher proportion of specialist physicians.6

Pharmacists also have a role in overcoming this challenge. Pharmacists have expertise in recommending over the counter medications for minor ailments, and promoting a healthy lifestyle. Increased usage of community pharmacy services would help to reduce the overflow of patients in hospitals.

Intense doctor–patient relationship

The doctor–patient relationship is fundamental in improving patients’ health outcomes. There have been various reports on the intense doctor–patient relationship in China.7 According to figures from the Ministry of Health,8 violent attacks on doctors increased from 10 000 cases in 2005 to >17 000 in 2010, aimed at hospitals and hospital staff. Contributing factors include patient dissatisfaction with care, out of pocket costs from under insurance, unrealistic expectations, and overworked and underpaid hospital staff.8 With the increasing tension between healthcare professionals and patients, it is important to deliver evidence based care so that patients receive standardised treatments.

The doctor–pharmacist relationship

There is evidence that greater collaboration between doctors and pharmacists can lead to better patient outcomes.9 While many collaboration models have been discussed and experimented in developed countries, the team approach is lacking in most developing countries.5 A possible reason is that the tense patient–clinician relationship leads to concerns about litigation. The pharmacist may be concerned about the responsibility of any adverse events that the patient may experience. The doctor may be concerned about being responsible for what the pharmacist recommends. Also, the fee for service model of reimbursement does not provide incentives for a team approach for patient care. For example, the doctor has a financial incentive for the patient to come back to see him/her.6 For the pharmacist, there is usually no financial incentive for making a recommendation for therapeutic change.

This also calls for applying an evidence based approach in pharmacy practice. Therefore, any evidence based recommendations by pharmacists would serve the interests of both patient outcome and the litigation concerns of doctors.

Overcoming the challenges

Encouraging a team approach in medical care

Adoption of team based healthcare has been shown to improve health outcomes for patients as well as increase job satisfaction for professionals.6 As discussed previously, the physician–pharmacist relationship remains challenging. There is well documented research on how to overcome this challenge.

As specified in a handbook developed by the WHO and FIP,10 pharmacists need to adapt their knowledge, skills and attitudes to their new role as a member of the healthcare team. The new role in the healthcare team requires integration of traditional pharmaceutical science with clinical aspects of patient care, clinical skills, management and communication skills, active collaboration with medical teams and solving of medicine related problems. Pharmacists also need to show their commitment to fully integrate themselves into the healthcare team. This can be achieved by adopting the following essential attitudes: visibility, responsibility, accessibility in a practice aimed at the general population, commitment to confidentiality and patient orientation.10

Apart from developing their personal qualities, pharmacists need support on the regulatory side to foster team based care. As specified by research involving pharmacists in improving cardiovascular and renal outcomes, the collaborative practice laws can provide grounds for initiating conversations between pharmacists and other stakeholders. The following step in implementing team based care is to establish a scope of practice or collaborative practice agreement.11

Training and education of pharmacists

In many developing countries, the main focus of pharmacy education has been pharmaceutical sciences, rather than pharmacy practice.12 Training and education should be adapted to overcome the challenges illustrated above. To better serve the purpose of pharmacists’ roles in medication management and pharmaceutical care, the undergraduate education system in developing countries needs to be reshaped. Some implemented and proposed changes include adding ‘problem based pharmacotherapy’ training, more clinical knowledge training and extending the length of the degree to provide a masters or doctoral degree. While many of these initiatives may help to develop the pharmacy profession, each country should adapt their education to overcome the challenges they face in healthcare, rather than just following changes from developed countries.

Healthcare reform

In the recent years, many countries have reformed their healthcare system. The reasons for healthcare reforms usually include improving efficiency and governance in the healthcare system. Different reforms have targeted cost, quality and access aspects of healthcare. For example, in the USA, the emphasis was on lowering costs and improving quality while extending more coverage to uninsured people.6 The reform specifically included elements that changed the incentive for clinicians from providing unnecessary services to improving outcomes for patients. Pharmacists can use evidence based practice to provide better patient outcomes. It is also an excellent opportunity for pharmacists to engage in clinical services when doctors are working towards providing higher quality healthcare. While the reforms could include specific policies and legislation to support pharmacists’ roles, the pharmacy profession needs to prove their economical value in different healthcare settings with good evidence.

Research on pharmacoeconomic analysis

With the increasing financial burden of healthcare, it is important to evaluate which treatments are most cost effective. Spending excessive amounts of money on expensive new drugs that can only marginally extend life may not be justified in the current economic situation. There are different ways to measure cost effectiveness. One of the most common is called ‘quality adjusted life years’. This approach is used by the National Institute for Health and Care Excellence to evaluate different interventions.13 It takes into account both quantity and quality of life, and hence the cost effectiveness of each drug can be calculated. Adopting these pharmacoeconomic analysis approaches can better utilise the resources available. In the current climate, there is a wealth of established evidence based guidelines from developed countries and the WHO. It calls for more research on the pharmacoeconomics of any developing country that has many deviations from the norm.

Utilisation of information technologies

Advancement in information technologies has led to many changes in the healthcare industry. Adoption of health information technologies in electronic health records has been proven to save costs while improving health outcomes. There is also evidence that electronic prescribing safeguards medication usage.14 While there may be concerns that the technology can make the pharmacist profession redundant, the technology has many advantages. First, automation in pharmacy means less repetitive dispensing duties for pharmacists. This will release more pharmacists to carry out clinical duties. Health information technologies can also be used to improve access to clinical information and support clinical decision making. Pharmacists’ roles can be strengthened by the support of prompt evidence as well as improved access to vital information.

Encourage responsible use of medicines: learn from the success and failures of other countries’ experiences

‘Responsible use of medicines’ is defined as aligning the activities, capabilities and existing resources of health system stakeholders to ensure patients receive the right medicines at the right time, use them appropriately and benefit from them. This incorporates the importance of stakeholder responsibility and recognises the challenge of finite resources. Conversely, suboptimal use is the opposite of what is meant by responsible use.15 There have been structured reviews of cases in different countries to evaluate what works and what does not work. The WHO has taken the initiative to put these together to develop the recommendations outlined in box 1.

Box 1

Strategic recommendations from ‘The pursuit of responsible use of medicines: sharing and learning from country experiences’15

  1. Develop and mandate a list of essential medicines at the national level to inform reimbursement decisions and ensure access to essential medicines.

  2. Invest to ensure national medicines procurement and supply systems are efficient and reliable to support the responsible use of medicines.

  3. Promote a shift in focus to early screening and accurate diagnosis to guide/inform medicines prescription and avoid overuse, underuse and misuse of medicines.

  4. Facilitate the implementation of evidence based treatment guidelines; where they exist, remove regulatory or administrative barriers and directly target all key stakeholders: prescribers, dispensers and patients.

  5. Promote initiatives that put patients at the centre of treatment in order to maximise adherence to therapy.

  6. Monitor medicine use, from purchase to health outcome, to evaluate the real world efficacy of treatment and guide evidence based policy making.

  7. Ensure sustained, top down commitment of national authorities and promote active, bottom up engagement of prescribers, patients and dispensers to the principles and policies fostering the responsible use of medicines.

Encouraging rational prescribing

One of the first challenges is to promote and develop rational prescribing, and a number of international initiatives exist in this area. The WHO has actively promoted rational drug use as one of the major elements in its Drug Action Programme. In its publication, Guide to good prescribing,16 the process is outlined as:

  • Define the patient's problem

  • Specify the therapeutic objectives

  • Verify whether your personal treatment choice is suitable for this patient

  • Start the treatment

  • Give information, instructions and warnings

  • Monitor (stop) the treatment.

The emphasis is on developing a logical approach, and it allows for clinicians to develop personal choices in medicines (a personal formulary) which they may use regularly. The programme seeks to promote appraisal of evidence in terms of proven efficacy and safety from controlled clinical trial data, and adequate consideration of quality, cost and choice of competitor drugs by choosing the item that has been most thoroughly investigated, has favourable pharmacokinetic properties and is reliably produced locally. Avoidance of combination drugs is also encouraged.

The routine and irrational use of injections should also be challenged. It is estimated that in the over 1 billion population of India, 3 billion injections were administered annually based on data from a survey.17 Eighty-two per cent of the injections were administered for curative purposes. Most of these were prescribed for common symptoms, such as fever, cough or diarrhoea. The frequency of injections was almost twice among infants (5.6; 95% CI 5.0 to 6.2) compared with older subjects (2.8; 95% CI 2.6 to 3). Of all the injections administered in India, 31.6% carried a potential risk of blood borne viral transmission. Unsafe injection procedures due to poor technique were observed in 53.1% of administrations. Exit interviews revealed that the highest proportion (57.5%) of injection prescriptions were seen at clinics of non-formal prescribers. Having recognised this issue, the WHO has initiated a programme called ‘Injection safety’ to tackle this problem. The underlying issues are thought to be that patients prefer injections, thinking they are stronger and faster medications. Patients also believe that doctors regard injections as the best treatment. Doctors overprescribe injections because they believe this best satisfies the patient, even though patients are often open to alternatives. Prescription of an injection sometimes allows charging a higher fee for the service. The WHO programme recommends that better communication between patients and providers can clarify misunderstandings and help to reduce injection overuse.18

Another group active in this area is the International Network for Rational Use of Drugs (INRUD, http://www.inrud.org). This organisation, established in 1989, exists to promote rational drug use in developing countries. As well as producing training programmes and publications, the group is undertaking research in a number of member countries, focused primarily on changing behaviour to improve drug use. One of the most useful publications from this group is entitled Managing drug supply,19 which continues to be the leading reference on how to manage essential medicines in developing countries. It covers most of the drug supply processes, and is built up from research and experience in many developing countries. There are a number of case studies described, many of which have general application to pharmacists working in developing countries. In response to the wide variety of issues that are important to health practitioners and policy makers today, references on areas such as pharmaceutical benefits in insurance, pricing, intellectual property, drug seller initiatives, and traditional and complementary medicine were also added.

In all the talk of rational drug use, the impact of the pharmaceutical industry cannot be ignored, with its many incentive schemes for doctors and chemist shop staff who dispense, advise or encourage the use of particular products. In a qualitative study on drug promotional practices in Mumbai,20 it was suggested that medical representatives (MRs) plays a critical role in carrying out the company's programme, building up relationships with individual doctors and negotiating with chemists. The list of products stocked in a chemist's shop also depends on negotiations between the chemist’s organisation and the drug company, and how well the drugs are promoted to doctors. MRs are often the only source of information on the latest developments in therapeutics for doctors, as doctors in India, compared with their western counterparts, have no legal requirement to undergo continuing medical education or periodic recertification. According to doctors, MRs rarely mention drug interactions or adverse effects. But doctors were otherwise usually satisfied with the information provided, and accepted the MR's role. Ironically, there were printed handouts from a drug manufacturer, shown to the doctor during the study interview, in which they were offered a cell phone for prescribing 1000 tablets, an air cooler for 5000 tablets and a motorcycle for 10 000 tablets. Many chemists in India dispense medicines without prescriptions, justifying this action by stating that poor patients cannot afford to see a doctor. MRs in India are also under great pressure to meet sales targets, and are often concerned about their job security. Both of these reasons force them to sell drugs with their only regard to increase their market share. The whole system is incentivised to sell more medications. Therefore, misleading information, incentives and unethical trade practices by drug companies, chemists and doctors are threatening the health outcomes in these developing countries. This is also a barrier to rational prescribing practice.

The only alternative is to ensure practitioners have the skills to appraise medicine promotion activities, or to more stringently control pharmaceutical promotional activities. In the study in Mumbai,20 MRs noted inconsistencies in what they had been told by the doctor, what was written in the flip charts and what was in the literature. Also, doctors noted that they received literature from MRs only after repeated requests. The recommendation to promote better practice is that healthcare practitioners should develop critical thinking and appraisal skills by using evidence based medicine, as well as patient oriented considerations.

Some countries are actively tackling the issues of bribery in the pharmaceutical industry. For instance, in China, a multinational drug company, GlaxoSmithKline (GSK), was allegedly involved in passing bribes totalling ¥3 billion (US$489 million) to government officials, medical associations and foundations, hospitals and doctors. The Chinese government fined GlaxoSmithKline a record ¥3 billion (the exact amount of the total bribery). This act has certainly shown the government's determination in tackling bribery.21

One of the reasons contributing to this is the disproportional financial incentives. One case revealed that a doctor would receive money from the drug sales representative for every box of drug prescribed, while also receiving money for every new patient using the drug. The bribery price on each box of the drug was ¥20 (€3), whereas the fee for the patient for the doctor's visit was usually less than ¥10 (€1.5).22 Having a healthcare system that shifts incentives away from prescribing more drugs would help to improve rational prescribing.

Rational dispensing

Dispensing includes all activities that occur between the time the prescription is presented to the time the medicine or other prescribed items are issued to the patient.23 Pharmacies are often a patient's first source of advice on medicines. The success of treatment depends on the accuracy and effectiveness of the dispenser's communication with the patient. Therefore, dispensers can greatly influence rational medication use in the community. They must be qualified for dispensing by improving their knowledge, communication skills and practices.

In many developing countries, poverty may prevent patients getting enough treatment. In these cases, the pharmacist’s role should be to maximise the effects of the drugs by good counselling and patient education. Poor patients may purchase only 1 or 2 days’ supply of antibiotics for financial reason, so it is important to ensure that the antibiotics are used rationally, and not just for 1 or 2 days of treatment. Pharmacists can proactively help them identify and understand which medicines are the most important—typically vitamins can be missed in order to reduce the overall cost to a more manageable level. Furthermore, the medicine should be given with clear instructions and any appropriate advice about the medicine.

A survey aimed at the quality of pharmaceutical services in six resource limited countries showed that few patients had received further information other than the name, purpose and duration of medication.23 Advice on when to take (particularly in relation to food and other medicines) and how to take (chewed, swallowed whole, etc) as well as how to store the medicine should be given, while warning of the possible side effects should be given cautiously. Also, very effort should be made to ensure that patients really understand the instructions and advice. Apart from written labels, pictorial or graphic labels could be considered, especially in areas where levels of illiteracy are high. The patient’s need for privacy and confidentiality must also be recognised. For instance, installation of private counselling booths can facilitate improvement in dispensing by providing a welcoming and secure atmosphere. In contrast, patients crowding at windows will distract dispensing staff and make confidential counselling impossible.

Dispensing is one of the vital elements of the rational use of medicines. All of the resources involved in patient care prior to dispensing may be wasted if dispensing does not result in the named patient receiving an effective form of the correct drug, in appropriate packaging, and with the correct dose and advice. In developing countries where resources are limited, improving dispensing practice is especially important.

The essential medicine concept

The essential medicines (previously ‘essential drugs’) concept was developed from a report to the 28th World Health Assembly in 1975 as a scheme to extend the range of necessary medicines to populations who had poor access because of the existing structure. Essential medicines are those that satisfy the priority healthcare needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost effectiveness.24

There have been many achievements since the initiation of the essential medicines concept. In terms of medicine policies, clear global guidance is available on developing and implementing national medicine policies; over 100 countries have developed national policies. In terms of access, the standard indicators for assessing availability, price and affordability have been used in more than 50 countries and are now accepted as the global WHO standard for measuring access. For quality, norms and standards, there are standard procedures from the WHO, with a focus on new essential medicines.25

The concept of essential medicines is forward looking. It incorporates the need to regularly update medicine selections to reflect new therapeutic options and changing therapeutic needs; the need to ensure drug quality; and the need for continued development of better medicines, medicines for emerging diseases and medicines to meet changing resistance patterns, as well as updated evidence on efficacy and safety.26 Figure 1 is an example of using lists of common diseases and complaints to implement essential medicines leading to improved patient care.

Figure 1

List of common health problems guides the formulation of clinical guidelines, the list of essential medicines, training, financing and supply, leading to improved patient care. Adapted from WHO.26

As well as these achievements, there are further improvements on the way in the form of the ‘WHO Medicines Strategy’ which was published 2008–2013 with the following strategic directions:25

  • Organisation wide expected result (OWER) 11.1 Formulation and monitoring of comprehensive national policies on access, quality and use of essential medical products and technologies advocated and supported.

  • OWER 11.2 International norms, standards and guidelines for the quality, safety, efficacy and cost effective use of medical products and technologies developed and their national and/or regional implementation advocated and supported.

  • OWER 11.3 Evidence based policy guidance on promoting scientifically sound and cost effective use of medical products and technologies by health workers and consumers developed and supported within the secretariat and regional and national programmes.

Essential Medicines List

The evolution of the Essential Medicines List (EML) was marked by the first WHO medicines strategy in 2001. The strategy27 specified the revised procedure for updating the WHO's model EML. The key features of the new procedure included a more systematic and transparent approach in selecting medicines, and linking the process to clinical guidelines disseminated by the WHO. The Essential Medicines List Expert Committee now meets every 2 years to update the model list, using a transparent process. The report28 on the selection and use of essential medicines is published. They provide evidence of the safety, efficacy and cost effectiveness of additional drugs, showing the results of systematic reviews or randomised controlled trials, or they show that no evidence exists and further research is needed. Priority healthcare needs and availability are also considered and discussed in the report. The new procedure also included the development of the WHO Essential Medicines Library. The Essential Medicines Library has since been updated, as illustrated in figure 2.

Figure 2

Creating the WHO Essential Drugs Library to facilitate the work of national committees. Adapted from WHO.29

The current model list of essential medicines30 is divided into 30 main sections, based on pharmacological effects. Medicines and dosage forms are listed in alphabetical order within each section. Recommendations are for drugs and presentations. For example, paracetamol appears as tablets in strengths of 100–500 mg, suppositories of 100 mg and oral liquid 125 mg/5 mL. The square box symbol ‘□’ for certain drugs is primarily intended to indicate similar clinical performance within a pharmacological class. The listed medicine should be the example of the class for which there is the best evidence for effectiveness and safety. Where there is no difference in terms of efficacy and safety data, the listed medicine should be the one that is generally available at the lowest price, based on international drug price information sources.

The current EML includes an adult version and a children's version, as well as an accompanying model formulary for the EMLs. The model formulary contains rational prescribing guidance, drug monographs and useful appendices. For the drug monographs, the formulary lists uses, contraindications, precautions, doses and adverse effects. The appendices include drug interactions, safety in pregnancy and lactation, renal impairment and hepatic impairment. The formulary is accessible online for countries or organisations to develop their own formulary.

The model list of essential medicines is a guide for the development of national and institutional EMLs, which has led to a global acceptance of the concept of essential medicines as a powerful means to promote health equity. The WHO has also made a recommendation26 on how to implement EML, as shown in box 2.

Box 2

Key factors for successful implementation of an essential medicines list26

  • Establish a transparent process for creating and updating the list of essential medicines, provide a voice for key stakeholders, but ensure a scientific evidence based process.

  • Link the essential medicines list to clinical guidelines for diagnosis and treatment, involving both specialists and primary care providers.

  • Actively engage support from medical opinion leaders, senior clinicians, training institutions, professional organisations, non-governmental organisations and the public.

  • Make the list of essential medicines, formulary manuals and clinical guidelines widely available in all healthcare facilities and to all healthcare providers in both printed and electronic versions.

  • Consider launching new or revised lists with the involvement of government officials, such as the minister of health or the president, and intensive press coverage.

  • Make clear the specific legal or administrative authority of the essential medicines list for training, procurement, reimbursement and public information.

  • Consider establishing an administrative or budgetary ‘safety valve’ for the limited supply and use.

  • Regularly update the list so that it reflects therapeutic advances and changes in cost, resistance patterns and public health relevance.

Medicine donations

It is a natural human reaction to want to help in whatever way possible when faced with human disaster, either as a result of some catastrophe or because of extreme poverty. Sympathetic individuals want to take action to help in situations in which they would be otherwise helpless, and workers in difficult circumstances, only too aware of waste and excess at home, want to make use of otherwise worthless materials. Good medicine donation practice is of interest to both donors and recipients. Unfortunately, there are many examples of medicine donations that have caused problems instead of bringing relief, as shown in box 3.

Box 3

Examples of problems of medicine donation

  • Donated medicines were not relevant to the emergency situation, to the disease pattern or to the level of care that was targeted.

  • Medicines have been provided that were unknown to local health professionals and patients, or that did not comply with locally agreed policies and standard treatment guidelines.

  • Donated medicines have arrived unsorted and labelled in a language that was not well understood.

  • Medicines returned to pharmacies by patients, or free samples derived from health professionals, have been collected and donated to countries.

  • Medicines have been donated in the wrong quantities, leading to situations where the large stocks could not possibly be used within their remaining shelf life.

  • Donated medicines with a very short remaining shelf life have been received in countries. In some cases they have expired before they reached the patients. Some stocks have had to be destroyed, sometimes at the cost of the recipient governments.

In response to this, the WHO has generated guidelines for medicine donations from a consensus of major international agencies involved in emergency relief. The guidelines were revised in 2010 to focus on the responsibilities and involvement of both donors and recipients. If these are followed, a significant improvement in terms of patient benefit and use of human resources will result.

WHO guidelines for medicine donations31 2010

Selection of medicines

  • All medicine donations should be based on an expressed need, should be relevant to the disease pattern in the recipient country and quantities should be agreed between donor and recipient.

  • All donated medicines or their generic equivalents should be approved for use in the recipient country and should appear on the national list of essential medicines or equivalent, or in the national standard treatment guidelines, if the national EML is not updated. Or, if a national list is not available, it should appear on the WHO model lists of essential medicines, unless specifically requested otherwise and provided with a justification by the recipient.

  • The presentation, strength and formulation of the donated medicines should, as far as possible, be similar to those of medicines commonly used in the recipient country.

  • All donated medicines should be obtained from a quality ensured source and should comply with quality standards in both the donor and recipient countries. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce should be used.

  • No medicines should be donated that have been issued to patients and then returned to a pharmacy or elsewhere, or that have been given to health professionals as free samples.

  • After arrival in the recipient country, all donated medicines should have a remaining shelf life of at least 1 year. Large quantities of donated medicines become a logistical challenge, even with a long shelf life. Therefore, based on the national consumption and available quantities in stock or in the supply chain pipeline, all donated quantities should match the needs to be consumed before they are expired.

Presentation, packaging and labelling

  • All medicines should be labelled in a language that is easily understood by health professionals in the recipient country. The label on each container should contain at least the international non-proprietary name or generic name, batch number, dosage form, strength, name of manufacturer, country of manufacture, quantity in the container, storage conditions and expiry date.

  • Donated medicines should be presented in pack sizes that are suitable for the recipient and appropriate to the setting in which they will be distributed or dispensed.

  • All medicine donations should be packed in accordance with international shipping requirements and should be accompanied by a detailed packing list that specifies the contents. The weight per carton should preferably not exceed 30 kg. Shipments of medicines should not be mixed with other supplies, unless they are shipped as kits with predetermined contents

Information and management

  • Medicine donations should be jointly planned, and collaboration between donors and recipients should begin early. Medicines should not be sent without prior consent of the recipient.

  • In the recipient country the declared value of a medicine donation should be based on the wholesale price of its generic equivalent in the recipient country or, if such information is not available, on the wholesale world market price for its generic equivalent.

  • Costs of international and local transport, warehousing, port clearance and (customs) storage, handling and disposal or reverse logistics of expired donated products should be paid for by the donor agency, unless specifically agreed otherwise with the recipient in advance.

Conclusions

There are always challenges to be faced in improving health outcomes; these challenges may be more prominent in the developing world. In the era of rapid development of healthcare in developing countries, it is particularly important to follow the principles of evidence based practice to ensure health outcomes are improved. As more and more evidence of effective strategies have surfaced, the WHO has made detailed and comprehensive recommendations, such as the essential medicine concept, responsible use of medicines and medicine donations. Comprehensive implementation of these strategies combined with tackling of the country specific challenges will help healthcare improvements to stay on course for developing countries.

References

View Abstract

Footnotes

  • Contributors Hao Lu drafted the paper, and all authors agreed the final paper. We acknowledge the advice and input of Jinjin Mou in preparing this chapter.

  • Competing interests None.

  • Provenance and peer review Commissioned; internally peer reviewed.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.