Evidence-based pharmacy in developing countries
Encyclopedia
Many developing nations have developed national drug policies, a concept that has been actively promoted by the WHO
. For example, the national drug policy
for Indonesia
drawn up in 1983 had the following objectives:
To achieve these objectives in Indonesia, the following changes were implemented:
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 program 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 favorable pharmacokinetic properties and is reliably produced locally. The avoidance of combination drugs is also encouraged.
The routine and irrational use of injections
should also be challenged. One study undertaken in Indonesia found that nearly 50% of infants and children and 75% of the patients aged five years or over visiting government health centers received one or more injections. The highest use of injections was for skin disorders, musculoskeletal problems and nutritional deficiencies. Injections, as well as being used inappropriately, are often administered by untrained personnel; these include drug sellers who have no understanding of clean or aseptic techniques.
Another group active in this area is the International Network for the Rational Use of Drugs (INRUD).http://www.inrud.org/ This organization, established in 1989, exists to promote rational drug use in developing countries. As well as producing training programs and publications, the group is undertaking research in a number of member countries, focused primarily on changing behavior to improve drug use. One of the most useful publications from this group is entitled Managing Drug Supply. It covers most of the drug supply processes and is built up from research and experience in many developing countries. There a number of case studies described, many of which have general application for pharmacists working in developing countries.
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 pharmacy staff who dispense, advise or encourage use of particular products. These issues have been highlighted in a study of pharmaceutical sales representatives (medreps) in Mumbai. This was an observational study of medreps' interactions with pharmacies, covering a range of neighborhoods containing a wide mix of social class
es. It is estimated that there are approximately 5000 medreps in Mumbai, roughly one for every four doctors in the city. Their salaries vary according to the employing organization, with the multinationals
paying the highest salaries. The majority work to performanace-related incentives. One medrep stated "There are a lot of companies, a lot of competition, a lot of pressure to sell, sell! Medicine in India is all about incentives to doctors to buy your medicines, incentives for us to sell more medicines. Even the patient wants an incentive to buy from this shop or that shop. Everywhere there is a scheme, that's business, that's medicine in India.'
The whole system is geared to winning over confidence and getting results in terms of sales; this is often achieved by means of gifts or invitations to symposia to persuade doctors to prescribe. With the launch of new and expensive antibiotics worldwide, the pressure to sell with little regard to the national essential drug lists or rational prescribing. One medrep noted that this was not a business for those overly concerned with morality. Such a statement is a sad reflection on parts of the pharmaceutical industry, which has an important role to play in the development of the health
of a nation. It seems likely that short-term gains are made at the expense of increasing problems such as antibiotic resistance
. The only alternatives are to ensure practitioners have the skills to appraise medicine promotion activities or to more stringently control pharmaceutical promotional activities.
or leprosy
.
Poverty
may force patients to purchase one day's supply of medicines at a time, so it is important to ensure that antibiotics are used rationally and not just for one or two day's treatment. Often, poor patients need help from pharmacists to understand which are the most important medicines and to identify the prescribed items, typically vitamins, that can be missed in order to reduce the overall cost of the prescription
to a more manageable level.
in 1975 as a scheme to extend the range of necessary drugs to populations who had poor access because of the existing supply structure. The plan was to develop essential drugs lists based on the local health needs of each country
and to periodically update these with the advice of experts in public health
, medicine
, pharmacology
, pharmacy
and drug management. Resolution number 28.66 at the Assembly requested the WHO Director-General to implement the proposal, which led subsequently to an initial model list of essential drugs (WHO Technical Series no 615, 1977). This model list has undergone regular review at approximately two-yearly intervals and the current 14th list was published in March 2005. The model list is perceived by the WHO to be an indication of a common core of medicines to cover most common needs. There is a strong emphasis on the need for national policy decisions and local ownership and implementation. In addition, a number of guiding principles for essential drug programs have emerged.
in alphabetical order. Recommendations are for drugs and presentations. For example, paracetamol
appears as tablets in strengths of 100 mg to 500 mg, suppositories 100 mg and syrup
125 mg/5ml. Certain drugs are marked with an asterisk (previously a ៛), which denotes an example of a therapeutic group, and other drugs in the same group could serve as alternatives.
The lists are drawn up by consensus and generally are sensible choices. There are ongoing initiatives to define the evidence that supports the list. This demonstrates the areas where RCTs (randomized controlled trials) or systematic review
s exist and serves to highlight areas either where further research is needed or where similar drugs may exist which have better supporting evidence
.
In addition to work to strengthen the evidence base, there is a proposal to encourage the development of Cochrane
reviews for drugs that do not have systematic review evidence.
Application of NNTs (numbers needed to treat
) to the underpinning evidence should further strengthen the lists. At present, there is an assumption among doctors in some parts of the world that the essential drugs list is really for the poor of society and is somehow inferior. The use of NNTs around analgesics in the list goes some way to disprove this and these developments may increase the importance of essential drugs lists.
to provide clear messages. A study by Thaver and Harpham described the work of 25 private practitioners in area around Karachi
. The work was based on assessment of prescribing practices, and for each practitioner included 30 prescriptions for acute respiratory infections (ARIs) or diarrhea
in children under 12 years of age. A total of 736 prescriptions were analysed and it was found that an average of four drugs were either prescribed or dispensed for each consultation. An antibiotic
was prescribed in 66% of prescriptions, and 14% of prescriptions were for an injection
. Antibiotics were requested for 81% of diarrhea cases and 62% of ARI cases. Of the 177 prescriptions for diarrhea, only 29% were for oral rehydration solution. The researchers went on to convert this information into clear messages for academic dealing back to the doctors. The researchers went on to implement the program and assessed the benefits. This was a good piece of work based on developing messages that are supported by evidence.
or because of extreme poverty
. Sympathetic individuals want to take action to help in a situation in which they would otherwise be helpless, and workers in difficult circumstances, only too aware of waste and excess at home, want to make use of otherwise worthless materials. The problem is that these situations do not lend themselves to objectivity. There are numerous accounts of tons of useless drugs being air-freighted into disaster areas. It the requires huge resources to sort out these charitable acts and often the drugs cannot be identified because the labels are not in a familiar language. In many cases, huge quantities have to be destroyed simply because the drugs are out of date, spoiled, unidentifiable, or totally irrelevant to local needs. Generally, had the cost of shipping been donated instead, then many more people would have benefited.
In response to this, the WHO has generated guidelines for drug donations from a consensus of major international agencies involved in emergency relief. If these are followed, a significant improvement in terms of patient benefit and use of human resources
will result.
, are important, many basic issues await significant change in developing countries.
comes in many forms and while the form most noticed is famine
and poor housing
, both of which are potent killers, medical and knowledge poverty
are also significant. Evidence-based
practice is one of the ways in which these problems can be minimized. Potentially, one of the greatest benefits of the internet
is the possibility of ending knowledge poverty and in turn influencing all the factors that undermine wellbeing. Essential drugs programs have been a major step forward in ensuring that the maximum number benefit from effective drug therapy for disease.
Who
Who may refer to:* Who , an English-language pronoun* who , a Unix command* Who?, one of the Five Ws in journalism- Art and entertainment :* Who? , a 1958 novel by Algis Budrys...
. For example, the national drug policy
National pharmaceuticals policy
A National Pharmaceuticals Policy is one that aims at ensuring that people get good quality drugs at the lowest possible price, and that doctors prescribe the minimum of required drugs in order to treat the patient's illness...
for Indonesia
Indonesia
Indonesia , officially the Republic of Indonesia , is a country in Southeast Asia and Oceania. Indonesia is an archipelago comprising approximately 13,000 islands. It has 33 provinces with over 238 million people, and is the world's fourth most populous country. Indonesia is a republic, with an...
drawn up in 1983 had the following objectives:
- To ensure the availability of drugs according to the needs of the population.
- To improve the distribution of drugs in order to make them accessible to the whole population.
- To ensure efficacy, safety quality and validity of marketed drugs and to promote proper, rational and efficient use.
- To protect the public from misuse and abuseDrug abuseSubstance abuse, also known as drug abuse, refers to a maladaptive pattern of use of a substance that is not considered dependent. The term "drug abuse" does not exclude dependency, but is otherwise used in a similar manner in nonmedical contexts...
. - To develop the national pharmaceutical potential towards the achievements of self-reliance in drugs and in support of national economic growthEconomic growthIn economics, economic growth is defined as the increasing capacity of the economy to satisfy the wants of goods and services of the members of society. Economic growth is enabled by increases in productivity, which lowers the inputs for a given amount of output. Lowered costs increase demand...
.
To achieve these objectives in Indonesia, the following changes were implemented:
- A national list of essential drugs was established and implemented in all public sectorPublic sectorThe public sector, sometimes referred to as the state sector, is a part of the state that deals with either the production, delivery and allocation of goods and services by and for the government or its citizens, whether national, regional or local/municipal.Examples of public sector activity range...
institutions. The list is revised periodically. - A ministerial decree in 1989 required that drugs in public sector institutions be prescribed generically and that pharmacyPharmacyPharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
and therapeutics committees be established in all hospitals. - District hospitals and health centers have to procure their drugs based on the essential drugs list.
- Most drugs are supplied by three governmentGovernmentGovernment refers to the legislators, administrators, and arbitrators in the administrative bureaucracy who control a state at a given time, and to the system of government by which they are organized...
-owned companies. - TrainingTrainingThe term training refers to the acquisition of knowledge, skills, and competencies as a result of the teaching of vocational or practical skills and knowledge that relate to specific useful competencies. It forms the core of apprenticeships and provides the backbone of content at institutes of...
modules have been developed for drug management and rational drug use and these have been rolled out to relevant personnel. - The central drug laboratory and provincial quality controlQuality controlQuality control, or QC for short, is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects:...
laboratories have been strengthened. - A major teaching hospitalTeaching hospitalA teaching hospital is a hospital that provides clinical education and training to future and current doctors, nurses, and other health professionals, in addition to delivering medical care to patients...
has developed a program on rational drug use, developing a hospital formularyFormularyThe term formulary can refer to:*Formulary , ancient and medieval collections of models for official writings.*Formulary , List of prescription drugs covered by a particular drug benefit plan.*certain modern reference works, e.g.:...
, guidelines for rational diagnosisDiagnosisDiagnosis is the identification of the nature and cause of anything. Diagnosis is used in many different disciplines with variations in the use of logics, analytics, and experience to determine the cause and effect relationships...
and treatment guidelines for the rational use of antibiotics. - Generic drugs have been available at affordable costs to low-income groups.
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. WHO has actively promoted rational drug use as one of the major elements in its Drug Action Programme. In its publication A Guide to Good Prescribing the process is outlined as:- define the patientPatientA patient is any recipient of healthcare services. The patient is most often ill or injured and in need of treatment by a physician, advanced practice registered nurse, veterinarian, or other health care provider....
'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 program seeks to promote appraisal of evidence in terms of proven efficacy and safety from controlled clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
data, and adequate consideration of quality, cost and choice of competitor drugs
DRUGS
Destroy Rebuild Until God Shows are an American post-hardcore band formed in 2010. They released their debut self-titled album on February 22, 2011.- Formation :...
by choosing the item that has been most thoroughly investigated, has favorable pharmacokinetic properties and is reliably produced locally. The avoidance of combination drugs is also encouraged.
The routine and irrational use of injections
Injection (medicine)
An injection is an infusion method of putting fluid into the body, usually with a hollow needle and a syringe which is pierced through the skin to a sufficient depth for the material to be forced into the body...
should also be challenged. One study undertaken in Indonesia found that nearly 50% of infants and children and 75% of the patients aged five years or over visiting government health centers received one or more injections. The highest use of injections was for skin disorders, musculoskeletal problems and nutritional deficiencies. Injections, as well as being used inappropriately, are often administered by untrained personnel; these include drug sellers who have no understanding of clean or aseptic techniques.
Another group active in this area is the International Network for the Rational Use of Drugs (INRUD).http://www.inrud.org/ This organization, established in 1989, exists to promote rational drug use in developing countries. As well as producing training programs and publications, the group is undertaking research in a number of member countries, focused primarily on changing behavior to improve drug use. One of the most useful publications from this group is entitled Managing Drug Supply. It covers most of the drug supply processes and is built up from research and experience in many developing countries. There a number of case studies described, many of which have general application for pharmacists working in developing countries.
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 pharmacy staff who dispense, advise or encourage use of particular products. These issues have been highlighted in a study of pharmaceutical sales representatives (medreps) in Mumbai. This was an observational study of medreps' interactions with pharmacies, covering a range of neighborhoods containing a wide mix of social class
Social class
Social classes are economic or cultural arrangements of groups in society. Class is an essential object of analysis for sociologists, political scientists, economists, anthropologists and social historians. In the social sciences, social class is often discussed in terms of 'social stratification'...
es. It is estimated that there are approximately 5000 medreps in Mumbai, roughly one for every four doctors in the city. Their salaries vary according to the employing organization, with the multinationals
Multinational corporation
A multi national corporation or enterprise , is a corporation or an enterprise that manages production or delivers services in more than one country. It can also be referred to as an international corporation...
paying the highest salaries. The majority work to performanace-related incentives. One medrep stated "There are a lot of companies, a lot of competition, a lot of pressure to sell, sell! Medicine in India is all about incentives to doctors to buy your medicines, incentives for us to sell more medicines. Even the patient wants an incentive to buy from this shop or that shop. Everywhere there is a scheme, that's business, that's medicine in India.'
The whole system is geared to winning over confidence and getting results in terms of sales; this is often achieved by means of gifts or invitations to symposia to persuade doctors to prescribe. With the launch of new and expensive antibiotics worldwide, the pressure to sell with little regard to the national essential drug lists or rational prescribing. One medrep noted that this was not a business for those overly concerned with morality. Such a statement is a sad reflection on parts of the pharmaceutical industry, which has an important role to play in the development of the health
Health
Health is the level of functional or metabolic efficiency of a living being. In humans, it is the general condition of a person's mind, body and spirit, usually meaning to be free from illness, injury or pain...
of a nation. It seems likely that short-term gains are made at the expense of increasing problems such as antibiotic resistance
Antibiotic resistance
Antibiotic resistance is a type of drug resistance where a microorganism is able to survive exposure to an antibiotic. While a spontaneous or induced genetic mutation in bacteria may confer resistance to antimicrobial drugs, genes that confer resistance can be transferred between bacteria in a...
. The only alternatives are to ensure practitioners have the skills to appraise medicine promotion activities or to more stringently control pharmaceutical promotional activities.
Rational dispensing
In situations where medicines are dispensed in small, screwed-up pieces of brown paper, the need for instructions to the patient takes on a whole new dimension. Medicines should always be issued in appropriate containers and labelled. While the patient may be unable to read, the next healthcare worker who seeks to help the patient it is probably literate. There are many tried-and-tested methods in the literature for using pictures and diagrams to aid patient compliance. Symbols such as a rising or setting sun to depict time of day have also been used, particularly for treatments where regular medication is important, such as cases of tuberculosisTuberculosis
Tuberculosis, MTB, or TB is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis usually attacks the lungs but can also affect other parts of the body...
or leprosy
Leprosy
Leprosy or Hansen's disease is a chronic disease caused by the bacteria Mycobacterium leprae and Mycobacterium lepromatosis. Named after physician Gerhard Armauer Hansen, leprosy is primarily a granulomatous disease of the peripheral nerves and mucosa of the upper respiratory tract; skin lesions...
.
Poverty
Poverty
Poverty is the lack of a certain amount of material possessions or money. Absolute poverty or destitution is inability to afford basic human needs, which commonly includes clean and fresh water, nutrition, health care, education, clothing and shelter. About 1.7 billion people are estimated to live...
may force patients to purchase one day's supply of medicines at a time, so it is important to ensure that antibiotics are used rationally and not just for one or two day's treatment. Often, poor patients need help from pharmacists to understand which are the most important medicines and to identify the prescribed items, typically vitamins, that can be missed in order to reduce the overall cost of the prescription
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
to a more manageable level.
The essential drugs concept
The essential drugs list concept was developed from a report to the 28th World Health AssemblyWorld Health Assembly
The World Health Assembly is the forum through which the World Health Organization is governed by its 194 member states. It is the world's highest health policy setting body and is composed of health ministers from member states....
in 1975 as a scheme to extend the range of necessary drugs to populations who had poor access because of the existing supply structure. The plan was to develop essential drugs lists based on the local health needs of each country
Country
A country is a region legally identified as a distinct entity in political geography. A country may be an independent sovereign state or one that is occupied by another state, as a non-sovereign or formerly sovereign political division, or a geographic region associated with a previously...
and to periodically update these with the advice of experts in public health
Public health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population health...
, medicine
Medicine
Medicine is the science and art of healing. It encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness....
, pharmacology
Pharmacology
Pharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...
, pharmacy
Pharmacy
Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
and drug management. Resolution number 28.66 at the Assembly requested the WHO Director-General to implement the proposal, which led subsequently to an initial model list of essential drugs (WHO Technical Series no 615, 1977). This model list has undergone regular review at approximately two-yearly intervals and the current 14th list was published in March 2005. The model list is perceived by the WHO to be an indication of a common core of medicines to cover most common needs. There is a strong emphasis on the need for national policy decisions and local ownership and implementation. In addition, a number of guiding principles for essential drug programs have emerged.
- The initial essential drugs list should be seen as a starting point.
- Generic names should be used where possible, with a cross-index to proprietary names.
- Concise and accurate drug information should accompany the list.
- Quality, including drug content stabilityChemical stabilityChemical stability when used in the technical sense in chemistry, means thermodynamic stability of a chemical system.Thermodynamic stability occurs when a system is in its lowest energy state, or chemical equilibrium with its environment. This may be a dynamic equilibrium, where individual atoms...
and bioavailabilityBioavailabilityIn pharmacology, bioavailability is a subcategory of absorption and is used to describe the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered...
, should be regularly assessed for essential drug supplies. - Decisions should be made about the level of expertise required for drugs. Some countries make all the drugs on the list available to teaching hospitalTeaching hospitalA teaching hospital is a hospital that provides clinical education and training to future and current doctors, nurses, and other health professionals, in addition to delivering medical care to patients...
s and have smaller lists for district hospitals and a very short list for health centers. - Success depends on the efficient supply, storage and distribution at every point.
- ResearchResearchResearch can be defined as the scientific search for knowledge, or as any systematic investigation, to establish novel facts, solve new or existing problems, prove new ideas, or develop new theories, usually using a scientific method...
is sometimes required to settle the choice of a particular product in the local situation.
The model list of essential drugs
The model list of essential drugs is divided into 27 main sections, which are listed in EnglishEnglish language
English is a West Germanic language that arose in the Anglo-Saxon kingdoms of England and spread into what was to become south-east Scotland under the influence of the Anglian medieval kingdom of Northumbria...
in alphabetical order. Recommendations are for drugs and presentations. For example, paracetamol
Paracetamol
Paracetamol INN , or acetaminophen USAN , is a widely used over-the-counter analgesic and antipyretic . It is commonly used for the relief of headaches and other minor aches and pains and is a major ingredient in numerous cold and flu remedies...
appears as tablets in strengths of 100 mg to 500 mg, suppositories 100 mg and syrup
Syrup
In cooking, a syrup is a thick, viscous liquid consisting primarily of a solution of sugar in water, containing a large amount of dissolved sugars but showing little tendency to deposit crystals...
125 mg/5ml. Certain drugs are marked with an asterisk (previously a ៛), which denotes an example of a therapeutic group, and other drugs in the same group could serve as alternatives.
The lists are drawn up by consensus and generally are sensible choices. There are ongoing initiatives to define the evidence that supports the list. This demonstrates the areas where RCTs (randomized controlled trials) or systematic review
Systematic review
A systematic review is a literature review focused on a research question that tries to identify, appraise, select and synthesize all high quality research evidence relevant to that question. Systematic reviews of high-quality randomized controlled trials are crucial to evidence-based medicine...
s exist and serves to highlight areas either where further research is needed or where similar drugs may exist which have better supporting evidence
Evidence
Evidence in its broadest sense includes everything that is used to determine or demonstrate the truth of an assertion. Giving or procuring evidence is the process of using those things that are either presumed to be true, or were themselves proven via evidence, to demonstrate an assertion's truth...
.
In addition to work to strengthen the evidence base, there is a proposal to encourage the development of Cochrane
Cochrane Collaboration
The Cochrane Collaboration is a group of over 28,000 volunteers in more than 100 countries who review the effects of health care interventions tested in biomedical randomized controlled trials. A few more recent reviews have also studied the results of non-randomized, observational studies...
reviews for drugs that do not have systematic review evidence.
Application of NNTs (numbers needed to treat
Number needed to treat
The number needed to treat is an epidemiological measure used in assessing the effectiveness of a health-care intervention, typically a treatment with medication. The NNT is the average number of patients who need to be treated to prevent one additional bad outcome...
) to the underpinning evidence should further strengthen the lists. At present, there is an assumption among doctors in some parts of the world that the essential drugs list is really for the poor of society and is somehow inferior. The use of NNTs around analgesics in the list goes some way to disprove this and these developments may increase the importance of essential drugs lists.
Communicating clear messages
The impact of pharmaceutical representatives and the power of this approach has led to the concept of academic detailingAcademic detailing
Academic detailing is “university or non-commercial-based educational outreach.” The process involves face-to-face education of prescribers by trained health care professionals, typically pharmacists, physicians, or nurses...
to provide clear messages. A study by Thaver and Harpham described the work of 25 private practitioners in area around Karachi
Karachi
Karachi is the largest city, main seaport and the main financial centre of Pakistan, as well as the capital of the province of Sindh. The city has an estimated population of 13 to 15 million, while the total metropolitan area has a population of over 18 million...
. The work was based on assessment of prescribing practices, and for each practitioner included 30 prescriptions for acute respiratory infections (ARIs) or diarrhea
Diarrhea
Diarrhea , also spelled diarrhoea, is the condition of having three or more loose or liquid bowel movements per day. It is a common cause of death in developing countries and the second most common cause of infant deaths worldwide. The loss of fluids through diarrhea can cause dehydration and...
in children under 12 years of age. A total of 736 prescriptions were analysed and it was found that an average of four drugs were either prescribed or dispensed for each consultation. An antibiotic
Antibiotic
An antibacterial is a compound or substance that kills or slows down the growth of bacteria.The term is often used synonymously with the term antibiotic; today, however, with increased knowledge of the causative agents of various infectious diseases, antibiotic has come to denote a broader range of...
was prescribed in 66% of prescriptions, and 14% of prescriptions were for an injection
Injection (medicine)
An injection is an infusion method of putting fluid into the body, usually with a hollow needle and a syringe which is pierced through the skin to a sufficient depth for the material to be forced into the body...
. Antibiotics were requested for 81% of diarrhea cases and 62% of ARI cases. Of the 177 prescriptions for diarrhea, only 29% were for oral rehydration solution. The researchers went on to convert this information into clear messages for academic dealing back to the doctors. The researchers went on to implement the program and assessed the benefits. This was a good piece of work based on developing messages that are supported by evidence.
Drug donations
It is a natural human reaction to want to help in whatever way possible when face with human disaster, either as a result of some catastropheDisaster
A disaster is a natural or man-made hazard that has come to fruition, resulting in an event of substantial extent causing significant physical damage or destruction, loss of life, or drastic change to the environment...
or because of extreme poverty
Extreme poverty
Extreme poverty, as defined in 1996 by Joseph Wresinski, the founder of ATD Fourth World, is:"The lack of basic security connotes the absence of one or more factors enabling individuals and families to assume basic responsibilities and to enjoy fundamental rights. The situation may become...
. Sympathetic individuals want to take action to help in a situation in which they would otherwise be helpless, and workers in difficult circumstances, only too aware of waste and excess at home, want to make use of otherwise worthless materials. The problem is that these situations do not lend themselves to objectivity. There are numerous accounts of tons of useless drugs being air-freighted into disaster areas. It the requires huge resources to sort out these charitable acts and often the drugs cannot be identified because the labels are not in a familiar language. In many cases, huge quantities have to be destroyed simply because the drugs are out of date, spoiled, unidentifiable, or totally irrelevant to local needs. Generally, had the cost of shipping been donated instead, then many more people would have benefited.
In response to this, the WHO has generated guidelines for drug donations from a consensus of major international agencies involved in emergency relief. If these are followed, a significant improvement in terms of patient benefit and use of human resources
Human resources
Human resources is a term used to describe the individuals who make up the workforce of an organization, although it is also applied in labor economics to, for example, business sectors or even whole nations...
will result.
Selection of drugs
- Drugs should be based on expressed need, be relevant to disease pattern and be agreed with the recipient.
- Medicines should be listed on the country's essential drugs list or WHO model list.
- Formulations and presentations should be simiar to those used in the recipient country.
Quality assurance (QA) and shelf life
- Drugs should be from a reliable source and WHO certification for qualityQuality AssuranceQuality assurance, or QA for short, is the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the production process...
of pharmaceuticals should be used. - No returned drugs from patients should be used.
- All drugs should have a shelf lifeShelf lifeShelf life is the length of time that food, drink, medicine, chemicals, and many other perishable items are given before they are considered unsuitable for sale, use, or consumption...
of at least 12 months after arrival in the recipient country.
Presentation, packing and labelling
- All drugs must be labelled in a language that is easily understood in the recipient country and contain details of generic name, batch number, dosage formDosage form-Introduction:Dosage forms are a mixture of active drug components and nondrug components. Depending on the method of administration they come in several types. These are liquid dosage form, solid dosage form and semisolid dosage forms. A Liquid dosage form is the liquid form of a dose of a...
, strength, quantity, name of manufacturer, storage conditions and expiry date. - Drugs should be presented in reasonable pack sizes (e.g. no sample or patient starter packs).
- Material should be sent according to international shippingShippingShipping has multiple meanings. It can be a physical process of transporting commodities and merchandise goods and cargo, by land, air, and sea. It also can describe the movement of objects by ship.Land or "ground" shipping can be by train or by truck...
regulations with detailed packing lists. Any storage conditions must be clearly stated on the containers, which should not weigh more than 50 kg. Drugs should not be mixed with other supplies.
Information and management
- Recipients should be informed of all drug donations that are being considered or under way.
- Declared value should be based on the wholesale price in the recipient country or on the wholesale world market priceMarket priceIn economics, market price is the economic price for which a good or service is offered in the marketplace. It is of interest mainly in the study of microeconomics...
. - Cost of international and local transportTransportTransport or transportation is the movement of people, cattle, animals and goods from one location to another. Modes of transport include air, rail, road, water, cable, pipeline, and space. The field can be divided into infrastructure, vehicles, and operations...
, warehousing, etc., should be paid by the donor agency unless otherwise agreed with the recipient in advance.
Evidence-based pharmacy practice
While modern practices, including the development of clinical pharmacyClinical pharmacy
Clinical pharmacy is the branch of Pharmacy where pharmacists provide patient care that optimizes the use of medication and promotes health, wellness, and disease prevention. Clinical pharmacists care for patients in all health care settings but the clinical pharmacy movement initially began inside...
, are important, many basic issues await significant change in developing countries.
- Medicines can often be found stored together in pharmacological groups rather than in alphabetical order by type.
- Fridge space is often inadequate and refrigerators unreliable.
- There are different challenges, such as ensuring that termites do not consume the outer packages and labels or that storage is free of other verminVerminVermin is a term applied to various animal species regarded by some as pests or nuisances and especially to those associated with the carrying of disease. Since the term is defined in relation to human activities, which species are included will vary from area to area and even person to person...
such as rats. - DispensaryDispensaryA dispensary is an office in a school, hospital or other organization that dispenses medications and medical supplies. In a traditional dispensary set-up a pharmacist dispenses medication as per prescription or order form....
packaging and labelling can be woefully inadequate and patients leave with little or no understanding of how to take medicines which may have cost them at least one week's earnings. - Medicines are often out of stock, not just for a few hours but for days or even weeks, particularly at the end of the financial year.
- Protocols and standard operating procedures are rarely found.
- Even when graduate pharmacists are employed, they often have little opportunity to perform above the level of salesperson, simply issuing medicines and collecting payment. For example, several hospital pharmacies in Mumbai, India, are open 24 hours per day for 365 days per year but only to function as retail outlets selling medicines to outpatients or to relatives of inpatients who then hand over the medicines to the nursing staff for administration.
Conclusions
Evidence is just as important in the developing world as it is in the developed world. PovertyPoverty
Poverty is the lack of a certain amount of material possessions or money. Absolute poverty or destitution is inability to afford basic human needs, which commonly includes clean and fresh water, nutrition, health care, education, clothing and shelter. About 1.7 billion people are estimated to live...
comes in many forms and while the form most noticed is famine
Famine
A famine is a widespread scarcity of food, caused by several factors including crop failure, overpopulation, or government policies. This phenomenon is usually accompanied or followed by regional malnutrition, starvation, epidemic, and increased mortality. Every continent in the world has...
and poor housing
House
A house is a building or structure that has the ability to be occupied for dwelling by human beings or other creatures. The term house includes many kinds of different dwellings ranging from rudimentary huts of nomadic tribes to free standing individual structures...
, both of which are potent killers, medical and knowledge poverty
Poverty
Poverty is the lack of a certain amount of material possessions or money. Absolute poverty or destitution is inability to afford basic human needs, which commonly includes clean and fresh water, nutrition, health care, education, clothing and shelter. About 1.7 billion people are estimated to live...
are also significant. Evidence-based
Evidence-based medicine
Evidence-based medicine or evidence-based practice aims to apply the best available evidence gained from the scientific method to clinical decision making. It seeks to assess the strength of evidence of the risks and benefits of treatments and diagnostic tests...
practice is one of the ways in which these problems can be minimized. Potentially, one of the greatest benefits of the internet
Internet
The Internet is a global system of interconnected computer networks that use the standard Internet protocol suite to serve billions of users worldwide...
is the possibility of ending knowledge poverty and in turn influencing all the factors that undermine wellbeing. Essential drugs programs have been a major step forward in ensuring that the maximum number benefit from effective drug therapy for disease.
See also
- Essential medicinesEssential medicinesEssential medicines, as defined by the World Health Organization are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford."The WHO...
- WHO Model List of Essential Medicines
- Department of Essential Drugs and MedicinesDepartment of Essential Drugs and MedicinesThe mission of the Department of Essential Drugs and Medicines of the World Health Organization is "to help save lives and improve health by closing the huge gap between the potential that essential drugs have to offer and the reality that for millions of people -- particularly the poor and...
- Campaign for Access to Essential MedicinesCampaign for Access to Essential MedicinesThe Campaign for Access to Essential Medicines is an international campaign started by Médecins Sans Frontières to increase the availability of essential medicines in developing countries. MSF often has difficulties treating patients because the medicines required are too expensive or are no...
- Universities Allied for Essential Medicines
Useful sources of information
The following is a list of useful publications from the WHO Department of Essential Drugs and Medicines Policy about essential drugs programs.General publications
- Essential Drugs Monitor - periodical issued twice a year, covering drug policy, research, rational drug use and recent publications.
- WHO Action Programme on Essential Drugs in the South-East Asia Region - report on an Intercountry Consultative Meeting, New Delhi, 4–8 March 1991. 49 pages, ref no SEA/Drugs/83 Rev.1.
National drug policy
- Report of the WHO Expert Committee on National Drug Policies - contribution to updating the WHO Guidelines for Developing Drug Policies. Geneva. 19–23 June 1995. 78 pages, ref no WHO/DAP/95.9.
- Guidelines for Developing National Drug Policies - 1988, 52 pages, ISBN 92-4-154230-6.
- Indicators for Monitoring National Drug Policies - P Brudon-Jakobowicz, JD Rainhorn, MR Reich, 1994, 205 pages, order no 1930066.
Selection and use
- Rational Drug Use: consumer education and information - DA Fresle, 1996, 50 pages, ref no DAP/MAC/(8)96.6.
- Estimating Drug Requirements: a practical manual - 1988, 136 pages, ref no WHO/DAP/88.2.
- The Use of Essential Drugs. Model List of essential drugs - updated every two years. Currently 14th edition, 2005. The list is available at: www.who.int/medicines
- Drugs Used in Sexually Transmitted Diseases and HIV Infection - 1995, 97 pages, ISBN 92-4-140105-2.
- Drugs Used in Parasitic Diseases (2e) - 1995, 146 pages, ISBN 92-4-140104-4.
- Drugs Used in Mycobacterial Diseases - 1991, 40 pages, ISBN 92-4-140103-6.
- Drugs Used in Anaesthesia - 1989, 53 pages, ISBN 92-4-14101-X.
- Guidelines for Safe Disposal of Unwanted Pharmaceuticals In and After Emergencies - ref no WHO/EDM/PAR/99.4.
Supply and marketing
- Guidelines for Drug Donations - interagency guidelines, revised 1999. Ref no WHO/EDM/PAR/99.4.
- Operational Principles for Good Pharmaceutical Procurement - Essential Drugs and Medicines Policy / Interagency Pharmaceutical Coordination Group, Geneva, 1999.
- Managing Drug Supply - Management Sciences for Health in collaboration with WHO, 1997, 832 pages, ISBN 1-56549-047-9.
- Ethical Criteria for Medicinal Drug Promotion - 1988, 16 pages, ISBN 92-4-154239-X.
Quality assurance
- WHO/UNICEF Study on the Stability of Drugs During International Transport - 1991, 68 pages, ref no WHO/DAP/91.1.
Human resources and training
- The Role of the Pharmacist in the Health Care System - 1994, 48 pages, ref no WHO/PHARM 94.569.
- Guide to Good Prescribing - TPGM de Vries, RH Henning, HV Hogerzeil, DA Fresle, 1994, 108 pages, order no. 1930074. Free to developing countries.
- Developing Pharmacy Practice: a Focus on Patient Care - 2006, 97 pages, World Health Organization (WHO) and International Pharmaceutical Federation (FIP). http://www.who.int/medicines/publications/WHO_PSM_PAR_2006.5.pdf
Research
- No 1 Injection Practices Research - 1992, 61 pages, ref no WHO/DAP92.9.
- No 3 Operational Research on the Rational Use of Drugs - PKM Lunde, G Tognoni, G Tomson, 1992, 38 pages, ref no WHO/DAP/92.4.
- No 24 Public Education in Rational Drug Use: a global survey - 1997, 75 pages, ref no WHO/DAP/97.5.
- No 25 Comparative Analysis of National Drug Policies - Second Workshop, Geneva, 10–13 June 1996. 1997, 114 pages, ref no WHO/DAP/97.6.
- No 7 How to Investigate Drug Use in Health Facilities: selected drug use indicators - 1993, 87 pages, order no 1930049.