Evidence-based pharmacy in
developing countries
From Wikipedia, the free 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[1] 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 abuse.
- To develop the national pharmaceutical potential towards the achievements of self-reliance in drugs and in support of national economic growth.
To achieve
these objectives in Indonesia, the following changes were implemented:
- A national list of essential drugs was established and implemented in all public sector institutions. The list is revised periodically.
- A ministerial decree in 1989 required that drugs in public sector institutions be prescribed generically and that pharmacy 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 government-owned companies.
- Training 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 control laboratories have been strengthened.
- A major teaching hospital has developed a program on rational drug use, developing a hospital formulary, guidelines for rational diagnosis and treatment guidelines for the rational use of antibiotics.
- Generic drugs have been available at affordable costs to low-income groups.
Contents
- 1 Encouraging rational prescribing
- 2 Rational dispensing
- 3 The essential drugs concept
- 4 Communicating clear messages
- 5 Drug donations
- 6 Evidence-based pharmacy practice
- 7 Conclusions
- 8 References
- 9 See also
- 10 External links
- 11 Useful sources of information
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[2] 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 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.[3] 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).[1] 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.[4] 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.[5] This was an observational study of medreps' interactions with pharmacies, covering a range of neighborhoods containing a wide mix of social classes. 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.
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.[3] 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).[1] 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.[4] 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.[5] This was an observational study of medreps' interactions with pharmacies, covering a range of neighborhoods containing a wide mix of social classes. 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.
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 tuberculosis or leprosy.[6]
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.
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.
The essential drugs concept
The essential
drugs list concept was developed from a report to the 28th World Health Assembly 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[7] 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.[8] 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 stability and bioavailability, 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 hospitals 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.
- Research 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 English 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 reviews 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.
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 reviews 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.
Communicating clear messages
The impact of
pharmaceutical representatives and the power of this approach has led to the
concept of academic detailing to provide clear messages. A study by
Thaver and Harpham[9] 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.
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 catastrophe 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.
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.
WHO guidelines for drug donations 2005
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 quality of pharmaceuticals should be used.
- No returned drugs from patients should be used.
- All drugs should have a shelf life 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 form, 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 shipping 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.
- 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 price.
- Cost of international and local transport, 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
pharmacy, 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 vermin such as rats.
- Dispensary 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. Poverty 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.
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DƯỢC BẰNG CHỨNG
TẠI CÁC NƯỚC
ĐANG PHÁT TRIỂN
Nhiều nước đang
phát triển có chính sach về thuốc theo
khuyến cáo Tổ chức y tế thế giới như chính sách về thuốc của Indonesia 1983
theo các mục tiêu sau:
Bảo đảm tính
khả thi về nhu cầu thuốc của dân chúng.
Cải thiện sự
phân phối thuốc trên toàn thể dân chúng
Đảm bảo tính
hiệu quả, an toàn, giá trị của thuốc để sử dụng hiệu quả từ trung ương đến địa
phương
Bảo vệ cho dân
chúng không sử dụng sai hay lạm dụng
Phát triển khả
năng dược tự chủ trong nước theo sự phát
triển kinh tế của quốc gia
Để đạt được
những điều này Indonesia đã trãi qua những thay đổi :
Danh mục thuốc
thiết yếu-bổ sung theo thời gian
Danh mục thuốc
generic của khu vực công thông qua Hội đồng thuốc và điều trị của bệnh viện
theo Nghị đính 1989
Bệnh viện
huyện-trung tâm chăm sóc sức khỏe dựa váo danh mục thuốc thiết yếu
Phần lớn thuốc
được cung cấp bởi 3 công ty của nhá nước
Có khóa huấn
luyện về quản lý và sử dụng thuốc theo danh mục của các tuyến đến nhân viên
Quản lý chất
lượng thuốc tứ trung ương đến tỉnh phải tăng cường
Bệnh viện hướng
dẩn sử dụng thuốc theo tuyến –sách hướng dẩn chẩn đoán và điều trị sử dụng
kháng sinh theo tuyến
Thuốc gốc phải
được cung cung cấp và khả thi về giá cho các đối tược có thu nhập thấp
Nội dung:
1.
Khuyến khích kê đơn điều trị căn nguyên-theo dõi điều
trị-cần dữ liệu về thử nghiệm lâm sàng- cập nhật chứng cứ-phối hợp nhiều thuốc
phải thận trọng.Nên chú ý đến giá thành trong điều trị Indonesia nghiên cứ 50%
trẻ em và 75% trên 5 tuổi đến điều trị tại tram y tế nhận ít nhất mũi tiêm.
Tiêm có thể là không cần thiết. Tiêm ảnh hưởng đến da-cơ(teo cơ delta) và suy
dinh dưỡng. Trình dược viên các công ty dược và bác sĩ kê đơn làm tăng sử dụng
thuốc có thể nói chưa cấn thiết. Là hậu quả của sự kháng kháng sinh
2.
Điều trị căn nguyên : Nhiều bệnh nhân nghèo mua thuốc
từng ngày khi không có tiền không mua được thuốc không tuân thủ điều trị nhất
là bệnh lao, cùi...Cân nhắc sử dụng vitamine để giúp người nghèo giảm chi phí
điều trị
3.
Khái niệm về danh mục thuốc thiết yếu và danh mục:Theo
alphabet 27 nhóm. Ví dụ P-Paracetamol: dạng viên-đặt- sirop..Khảo sát sử dung
thuốc này cho thấy Nhu cầu thuốc điều trị NNTs (numbers needed to treat) cho thấy gia
tăng nhưng chứng minh là không cần thiết nhất là người nghèo
4.
Thông tin công khai trong cộng đồng:không nên dùng thuốc
tiêm khi có thể dùng đường uống-không dùng kháng sinh bừa bãi –phải theo đơn
thuốc bác sĩ. Thông tin phản hồi từ nghiên cứu tại địa phương đến các BS, nhân
viên y tế cũng như công chúng như việc không cần sử dung kháng sinh trong một
số bệnh tiêu chảy, viêm hô hấp..
5.
Thuốc tặng.TCYTTG khuyến cáo 2005: chọn lọc thuốc-chất
lượng-bao bì nhãn gói –thông tin và quản lý
6.
Thực hành dược
chứng cứ
Dược lâm sàng khuyến cáo nên:
Sắp xếp theo nhóm tác dụng hơn là alphabet
Khoảng đông lạnh không đủ chổ
Thuốc đóng gói để ngoài cảnh giác với chuột
Thuốc ngoại trú về bao bì nhãn-hướng
dẫn sử dụng trong 1 tuần cho bệnh nhân chưa thực hiện hoàn chỉnh về tuân thủ
điều kiện của thuốc do bệnh nhân
Phải thận trọng với thuốc đã ra khỏi gói
Các tờ hướng dẫn về thuốc rất ít khi tìm thấy- phải có trong các gói thuốc
Dược sĩ hướng dẫn không có mặt thường
xuyên mặc dầu nhà thuốc mở cửa 24/24 tại Mumbay-Ấn độ
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