Pharmacovigilance in Healthcare Missions
Best Practice Guideline 5 Patient Safety-centered Field Operations This chapter looks cloely at the need to maintain Pharmacovigilance in healthcare missions
Chapter 9 of When Healthcare Hurts: An evidence based guide for best practices in global health initiatives
By Greg Seager
Fee ebook available at www.healthservicecorps.org
or a print version can be obtained on Amazon at http://www.amazon.com/When-Healthcare-Hurts-Practices-Initiatives/dp/146858121X/ref=tmm_pap_swatch_0?_encoding=UTF8&sr=&qid=
5.1 Stay within scope of practice
5.2 Maintain pharmacovigilance as an operational priority
5.3 Community-based healthcare initiatives—Ensure clinical practice guidelines, clinical pathways, and other evidence based recommendations are used to guide assessment and treatment and discourage variations in care.
Best Practice Guideline 1 referred to global health programs developing a culture of patient safety and the steps necessary to facilitate it within organizations that send out global health volunteers. This guideline is directed at creating and implementing healthcare delivery initiatives. There are many ways to improve safety in the operations and logistical flow with medically focused vertical global health initiatives. Developing patient-safety systems for short-term programs is a matter of maintaining all safety processes normally followed in the volunteer provider’s home country. Specific methods and processes of patient flow and logistical operations are open to collaboration and mutual design; however, those evidence-based performance measures practiced in the provider’s home country or set forth by WHO are required. The guidelines listed here are directed toward centering clinic flow and system operations on patient-safety principles. Many programs orient their patient flow around community-health education, general efficiency, and even evangelism with Christian projects. The primary point in the development of Best Practice Guideline 5 is that safety comes first in projects that involve healthcare delivery. Patient safety is best achieved by following clinical practice guidelines, clinical pathways, and other evidence-based recommendations.
5.1 Practice only within scope of practice
Maintaining scope of practice is a basic standard for practicing in all countries. Would a radiologist see and treat a patient as a primary care physician in his/her home country? Would an OB/GYN provide primary healthcare to pediatric patients in his/her home country? Would a floor nurse prescribe medications in his/her home country? Of course not, yet these are commonly seen role transitions when short-term volunteers participate in global health initiatives. These types of role transitions clearly do not support patient safety. These questions get to the heart of the common volunteer assumption discussed in an earlier section (i.e., “Something is better than nothing.”). However, one must seriously ponder that rationale when the something in question has the potential to cause harm. There remains on overriding practice standard in all global health projects. That is, patient-safety and regulatory standards that a provider is subject to in his/her home country apply wherever that professional practices; safety standards do not have international boundaries. If one would not, should not, or could not do it for a patient in one’s home country, one should not do it when providing care as part of a global health initiative. Healthcare students’ scope of practice is also governed under this guideline. That is, whatever their specific level of training allows them to do in their home country with that level of supervision is what they can do during service.
It goes without saying that permission to practice as a healthcare professional is required by law in all countries, and appropriate channels must be followed to obtain permission to practice. The specific professions that require permission vary from country to country, as do the procedures. The international Association of Medical Regulatory Authorities (see http://www.iamra.com/iamra.asp) has some credentialing resources listed by country. Partnering permanent healthcare facilities are likely aware of the process to obtain a temporary professional license if needed. Non-healthcare partners are rarely aware of these processes and procedures.
5.2 Maintain pharmacovigilance as an operational priority
If you question the rationale for these standards, remember that more than half of all medications are prescribed, dispensed, or sold inappropriately, and half of all patients fail to take medicines correctly (World Health Organization, 2010). It is no surprise then that most of the patient-safety concerns with community-based healthcare programs revolve around medication usage and dispensing practices.
Pharmacovigilance policies may vary according to respective global health organizational deployment strategy and type of group (e.g., medical, surgical, dental, or health education). However, all policies need to reflect WHO safety standards and guidelines and the safety practices volunteer providers use in their home country. There are a number of applicable standards that should be followed by all teams. It is also important to note the WHO makes no distinction between safety practices in developed versus developing countries. Examples of medication safety standards that need to be met by all healthcare providers include dispensing any and all potentially toxic medications in child-resistant containers (Poison Prevention Packaging Act (PPPA), 1970, as cited in The Consumer Product Safety Commission, 2005). They are inexpensive and weigh very little, making their transport with the visiting providers easy to accomplish. A list of places to purchase child-resistant containers can be acquired by searching for pharmacy supplies on the internet. Other such standards set by the WHO include giving patient instructions in closed, private consultation rooms free of distractions, not at open pharmacy counters in front of a crowd of people (WHO/UNICEF, 2005). The WHO also requires caregivers receiving medications for small children to verbally explain the dosing procedure and demonstrate the administration of the first dose to the child (WHO/UNICEF, 2005). These are minimum standards established by the WHO for the protection of children and families in developing countries.
It is estimated that approximately 125 children per day lose their lives as a result of poisonings, the vast majority of which are pharmaceutical related (WHO, 2008). One study from the United Arab Emirates found that 55% of childhood poisonings were medication related, with analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and antihistamines being the most common causes in the one-to-five-year age group (WHO, 2008). Another study from Turkey also showed accidental ingestion of medications was the most common cause of poisoning in children aged one to five years at 57.7%. This same study also confirmed the most frequent medications were analgesics and NSAIDs (WHO, 2008). Yet another study from Bangladesh, Colombia, Egypt, and Pakistan showed that medications were responsible for 31% of poisonings in children under 12 years of age (WHO, 2008). It is also important to note that prior to the 1970 PPPA, child poisonings were largely considered the leading cause of death in children age one to five in the U.S. with pharmaceuticals as the leading poisons (The Consumer Product Safety Commission, 2005). These studies are highly suggestive that some specific medications such as NSAIDs should be eliminated from the formularies of global health programs and that dispensing medications in Ziploc plastic bags is neither safe nor appropriate. Ziploc baggies are never acceptable for dispensing pharmaceuticals.
Where the team is placed (in or apart from local health services) should guide the program pharmacovigilance policies. What we know about patient safety and quality assessment from the Donabedian theory tells us patient safety is difficult to achieve even within functional health systems. When it comes to policy development, one assumption made by many global health programs is that their medication formularies should be based on the WHO Essential Medication List. If a short-term program is working in a permanent health system, this is a true, valid assumption. It is important to remember that all WHO materials and literature are directed at permanent health facilities. The WHO Essential Medication List is meant to define medications that should be available within permanent health facilities (WHO, 2012) (WHO, 2012). This list was not meant for short-term programs offering healthcare services apart from permanent healthcare delivery systems. Volunteers working in, and under the direction of, a permanent local health program may be able to safely use many of the medications on the WHO Essential Medication List. Short-term programs operating in schools or churches apart from the local healthcare system could safely dispense only a small fraction of the WHO Essential Medication List. According to the WHO document “Patient safety in African health services: Issues and solutions” (2008), globally, more than half of all medications are prescribed, dispensed, or sold improperly, and more than half of the patients fail to take them properly. The WHO also reports that in African countries, this is most often a result of cultural and societal views of healthcare and medicines, and when combined with high levels of illiteracy, they pose significant barriers to patient safety (WHO, 2008). Developing formularies for short-term medically focused global health initiatives should be based on patient safety and minimizing the potential for adverse outcomes. If a short-term program is not directly connected to a permanent health program, limiting medications to acute pathologies treatable within the context of one clinic visit is strongly advisable. Treating chronic diseases (e.g., HTN, epilepsy, DM, etc.) without collaboration with local healthcare providers is not considered safe or appropriate. Medically focused global health programs that treat chronic diseases (e.g., hypertension, COPD, diabetes, epilepsy) require close collaboration with permanent health systems and should do so from functional medical facilities and clinics (see Patient Safety Guideline 3).
There are 276 WHO medications on the WHO EssentialMedication List, which were designed to guide the development of national health system formularies (WHO, 2012). These 276 medications are not meant to be put in every rural health outpost and clinic. Many of the medications on the Essential Medication List require continued patient monitoring. The list includes drugs for palliative care; rheumatologic, neurologic, anticoagulation, and intravenous medications; contrast material, cardiac, contraceptive, serum/IGG, and obstetrical medications; as well as medications for TB, HIV, and leprosy. There is a growing body of evidence that supports significantly limiting prescribing by healthcare teams working apart from permanent healthcare programs and having those groups focus instead on prevention, health screening, and supporting horizontal program models. The following are basic evidence-based global health pharmacovigilance standards; each volunteer should review and understand these basic standards.
5.2a. Medications should only be prescribed when absolutely necessary and dispensed in child-resistant containers (not Ziploc plastic bags).
Remember, there are no double standards for patient safety; standards that exist in developed countries also apply in developing countries. PPNN (a pill for every problem and a needle for every need) thinking should never be part of global health initiatives for both patient-safety and developmental reasons.
5.2b. Know the country’s pharmaceutical dispensary laws, and respect them. Ideally, a local pharmacist, or team pharmacist, should oversee the dispensing of medication. Unlicensed staff should never package, label, or dispense medication.
5.2c. No central pharmacy medication dispensing—This means that prescriptions may be filled in a central pharmacy area; however, medications should only be dispensed in the private consultation rooms or exam rooms. A licensed provider, pharmacist, or nurse may provide medication education and counseling. One-time dose medications (e.g., parasite prophylaxis, vitamin A supplementation) may be dispensed at a central location.
5.2d. Mothers or caretakers of children prescribed home medication must (for each child) verbalize the medication instructions, demonstrate measuring the dose of medication, and administer the first dose of the medication under the supervision of a licensed provider (nurse or physician). Again, this must happen in private pharmacy consultation rooms or exam rooms. Attempt to limit the number of prescriptions for each family. Each child treated should have medication dosages labeled with each child’s name and age. Education before medication! The system we have deployed to prevent overprescribing and ensure the WHO private consultation requirements are met is to have a healthcare provider go to the pharmacy, get the medication, and go back and instruct the patient himself or herself. Prior to leaving the clinic, the patient who receives medication is asked to explain the use of his/her medications by another team member to ensure full understanding. The educator then reinforces medication usage and provides education on one or two priority health-education areas. To some, this sounds like it impedes patient flow; however, we have found it does not significantly decrease the number of patients seen. Even if it did, the improvements in patient safety would far outweigh any decreased numbers. Remember, one of the central culprits in adverse outcomes in healthcare projects is prioritizing the number of patients seen over patient safety. It is better to see one hundred patients well than a thousand patients and end up with a story like Maria’s.
5.2e. No expired medications should ever be taken into a country—This is unlawful, and some countries have restrictions on the use of short dates—know the country’s standards. The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President April 12, 1988. The PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and effective, and (2) to avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, sub-potent, or expired drugs. The legislation was necessary to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs. It also banned the distribution, transportation, exportation, or dispensing of any expired medications into or out of the United States under any circumstances. This makes it a crime for anyone to ship expired drugs anywhere, except back to the manufacturer for destruction, or to a facility for destruction. People on both short-term AND long-term missions are subject to the PDMA, and it includes drugs intended for shipment outside the United States.
5.2f. No sample or unlabeled medications should ever be used unless a complete dosing regimen can be given.
5.2g. Know and adhere to the WHO/UNICEF standards of practice in developing countries.
5.2h. A detailed inventory of pharmaceuticals (with expiration dates) and/or medical supplies should be with the team at all times. This often facilitates customs transfers and can avoid many potential legal problems. Medications should be left in their original containers and never re-packaged for distribution.
5.2i. Surplus medications should never be left with unqualified healthcare personnel. If supplying medications to horizontal community health worker CHW programs, it is important to ensure adequate training on medications dispensing and the need for safe storage. Supplying medications for such programs comes with the responsibility of supplying child-resistant containers. Usually, families are instructed to keep such containers so they later can be refilled with other medications and relabeled. Pharmaceuticals should be carefully secured throughout the mission, and patients must receive training on safe home storage to keep them away from children.
5.2j. Never attempt to sneak medications into a country. Think about what would happen to you if you were caught smuggling drugs into your home country. Pharmacy laws vary from country to country, but the least you can expect is for medications to be confiscated; in some countries, imprisonment is very likely. Medications can often be purchased at very low cost in local pharmacies, and it is very helpful to develop relationships with local pharmacists.
There are 26 specific medications recommended by the WHO for the treatment of children at clinics in developing countries. They include the following, many of which are unfamiliar to physicians from developed countries or are considered antiquated or too dangerous to use in light of much safer alternative medication choices available in developed countries. Nevertheless, they remain the gold standard for practice in developing countries. Drugs like chloramphenicol were abandoned decades ago in most developed countries, but their effectiveness and very low cost keep them in use in resource-poor communities. We will also discuss the use of a few medications (specifically, the micronutrient therapies such as iron, Vitamin A, and zinc) that need to be prescribed for children in developing countries in the following section.
WHO Child Health Formulary
1 Artemether/Lumefantrine
2 Amodiaquine Tabs (200mg)
3 Quinine (inj.) (vials) (600mg/2ml)
4 Amoxicillin Tabs (250mg)/syrup 250mg or 125/5ml
5 Chloramphenicol (inj) 1-g vials
6 Chloramphenicol syrup (600ml bottles) 125mg/5ml
7 Gentamicin vials (80mg/2ml)
8 Crystalline penicillin 100,000-unit vials
9 Oral Rehydration Salts (ORS) 500-ml sachet
10 Hartmann’s solution 500-ml bottles
11 Nalidixic acid (250-mg tabs)
12 Metronidazole (200-mg tabs)
13 Erythromycin (250-mg tabs)
14 Mebendazole 500-mg tabs
15 Iron 200mg
16 Cotrimoxazole (80mg:400mg)
17 Folic acid tabs (5mg)
18 Paracetamol tabs (500mg)
19 Gentian violet
20 Mycostatin (20ml)
21 Diazepam—vials
22 10% glucose half-liter bottle
23 Salbutamol (tabs) 2mg
24 Salbutamol inhaler
25 Salbutamol nebulization solution (50-ml bottle)
26 Vitamin A (soft gelatinous capsules) 100,000 and 200,000 units
see http://www.who.int/child_adolescent_health/documents/IMCI_chartbooklet/en/
There is more to chapter 9 of When Healthcare Hurts, you can get your free ebook copy today at www.healthservicecorps.org
References
Consumer Product Safety Commission. (2005). Poison prevention packaging: a guide for healthcare providers. Washington D.C.
The US Consumer Product Safety Commission Luis, H., Robert, S., A Mwansa, N., & Cesa, R. V. (2008).
WHO. (2012). Essential Midicines. Retrieved January 2nd, 2012, from World Health Organization : http://www.who.int/medicines/services/essmedicines_def/en/index.html
World Health Organization. (2008). Patient safety in African health services: issues and solutions. Yaounde, Republic of Cameroon : WHO Regional Comittee for Africa.
WHO/UNICEF. (2005). IMCI Handbook. Geneva: WHO Press.
Chapter 9 of When Healthcare Hurts: An evidence based guide for best practices in global health initiatives
By Greg Seager
Fee ebook available at www.healthservicecorps.org
or a print version can be obtained on Amazon at http://www.amazon.com/When-Healthcare-Hurts-Practices-Initiatives/dp/146858121X/ref=tmm_pap_swatch_0?_encoding=UTF8&sr=&qid=
5.1 Stay within scope of practice
5.2 Maintain pharmacovigilance as an operational priority
5.3 Community-based healthcare initiatives—Ensure clinical practice guidelines, clinical pathways, and other evidence based recommendations are used to guide assessment and treatment and discourage variations in care.
Best Practice Guideline 1 referred to global health programs developing a culture of patient safety and the steps necessary to facilitate it within organizations that send out global health volunteers. This guideline is directed at creating and implementing healthcare delivery initiatives. There are many ways to improve safety in the operations and logistical flow with medically focused vertical global health initiatives. Developing patient-safety systems for short-term programs is a matter of maintaining all safety processes normally followed in the volunteer provider’s home country. Specific methods and processes of patient flow and logistical operations are open to collaboration and mutual design; however, those evidence-based performance measures practiced in the provider’s home country or set forth by WHO are required. The guidelines listed here are directed toward centering clinic flow and system operations on patient-safety principles. Many programs orient their patient flow around community-health education, general efficiency, and even evangelism with Christian projects. The primary point in the development of Best Practice Guideline 5 is that safety comes first in projects that involve healthcare delivery. Patient safety is best achieved by following clinical practice guidelines, clinical pathways, and other evidence-based recommendations.
5.1 Practice only within scope of practice
Maintaining scope of practice is a basic standard for practicing in all countries. Would a radiologist see and treat a patient as a primary care physician in his/her home country? Would an OB/GYN provide primary healthcare to pediatric patients in his/her home country? Would a floor nurse prescribe medications in his/her home country? Of course not, yet these are commonly seen role transitions when short-term volunteers participate in global health initiatives. These types of role transitions clearly do not support patient safety. These questions get to the heart of the common volunteer assumption discussed in an earlier section (i.e., “Something is better than nothing.”). However, one must seriously ponder that rationale when the something in question has the potential to cause harm. There remains on overriding practice standard in all global health projects. That is, patient-safety and regulatory standards that a provider is subject to in his/her home country apply wherever that professional practices; safety standards do not have international boundaries. If one would not, should not, or could not do it for a patient in one’s home country, one should not do it when providing care as part of a global health initiative. Healthcare students’ scope of practice is also governed under this guideline. That is, whatever their specific level of training allows them to do in their home country with that level of supervision is what they can do during service.
It goes without saying that permission to practice as a healthcare professional is required by law in all countries, and appropriate channels must be followed to obtain permission to practice. The specific professions that require permission vary from country to country, as do the procedures. The international Association of Medical Regulatory Authorities (see http://www.iamra.com/iamra.asp) has some credentialing resources listed by country. Partnering permanent healthcare facilities are likely aware of the process to obtain a temporary professional license if needed. Non-healthcare partners are rarely aware of these processes and procedures.
5.2 Maintain pharmacovigilance as an operational priority
If you question the rationale for these standards, remember that more than half of all medications are prescribed, dispensed, or sold inappropriately, and half of all patients fail to take medicines correctly (World Health Organization, 2010). It is no surprise then that most of the patient-safety concerns with community-based healthcare programs revolve around medication usage and dispensing practices.
Pharmacovigilance policies may vary according to respective global health organizational deployment strategy and type of group (e.g., medical, surgical, dental, or health education). However, all policies need to reflect WHO safety standards and guidelines and the safety practices volunteer providers use in their home country. There are a number of applicable standards that should be followed by all teams. It is also important to note the WHO makes no distinction between safety practices in developed versus developing countries. Examples of medication safety standards that need to be met by all healthcare providers include dispensing any and all potentially toxic medications in child-resistant containers (Poison Prevention Packaging Act (PPPA), 1970, as cited in The Consumer Product Safety Commission, 2005). They are inexpensive and weigh very little, making their transport with the visiting providers easy to accomplish. A list of places to purchase child-resistant containers can be acquired by searching for pharmacy supplies on the internet. Other such standards set by the WHO include giving patient instructions in closed, private consultation rooms free of distractions, not at open pharmacy counters in front of a crowd of people (WHO/UNICEF, 2005). The WHO also requires caregivers receiving medications for small children to verbally explain the dosing procedure and demonstrate the administration of the first dose to the child (WHO/UNICEF, 2005). These are minimum standards established by the WHO for the protection of children and families in developing countries.
It is estimated that approximately 125 children per day lose their lives as a result of poisonings, the vast majority of which are pharmaceutical related (WHO, 2008). One study from the United Arab Emirates found that 55% of childhood poisonings were medication related, with analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and antihistamines being the most common causes in the one-to-five-year age group (WHO, 2008). Another study from Turkey also showed accidental ingestion of medications was the most common cause of poisoning in children aged one to five years at 57.7%. This same study also confirmed the most frequent medications were analgesics and NSAIDs (WHO, 2008). Yet another study from Bangladesh, Colombia, Egypt, and Pakistan showed that medications were responsible for 31% of poisonings in children under 12 years of age (WHO, 2008). It is also important to note that prior to the 1970 PPPA, child poisonings were largely considered the leading cause of death in children age one to five in the U.S. with pharmaceuticals as the leading poisons (The Consumer Product Safety Commission, 2005). These studies are highly suggestive that some specific medications such as NSAIDs should be eliminated from the formularies of global health programs and that dispensing medications in Ziploc plastic bags is neither safe nor appropriate. Ziploc baggies are never acceptable for dispensing pharmaceuticals.
Where the team is placed (in or apart from local health services) should guide the program pharmacovigilance policies. What we know about patient safety and quality assessment from the Donabedian theory tells us patient safety is difficult to achieve even within functional health systems. When it comes to policy development, one assumption made by many global health programs is that their medication formularies should be based on the WHO Essential Medication List. If a short-term program is working in a permanent health system, this is a true, valid assumption. It is important to remember that all WHO materials and literature are directed at permanent health facilities. The WHO Essential Medication List is meant to define medications that should be available within permanent health facilities (WHO, 2012) (WHO, 2012). This list was not meant for short-term programs offering healthcare services apart from permanent healthcare delivery systems. Volunteers working in, and under the direction of, a permanent local health program may be able to safely use many of the medications on the WHO Essential Medication List. Short-term programs operating in schools or churches apart from the local healthcare system could safely dispense only a small fraction of the WHO Essential Medication List. According to the WHO document “Patient safety in African health services: Issues and solutions” (2008), globally, more than half of all medications are prescribed, dispensed, or sold improperly, and more than half of the patients fail to take them properly. The WHO also reports that in African countries, this is most often a result of cultural and societal views of healthcare and medicines, and when combined with high levels of illiteracy, they pose significant barriers to patient safety (WHO, 2008). Developing formularies for short-term medically focused global health initiatives should be based on patient safety and minimizing the potential for adverse outcomes. If a short-term program is not directly connected to a permanent health program, limiting medications to acute pathologies treatable within the context of one clinic visit is strongly advisable. Treating chronic diseases (e.g., HTN, epilepsy, DM, etc.) without collaboration with local healthcare providers is not considered safe or appropriate. Medically focused global health programs that treat chronic diseases (e.g., hypertension, COPD, diabetes, epilepsy) require close collaboration with permanent health systems and should do so from functional medical facilities and clinics (see Patient Safety Guideline 3).
There are 276 WHO medications on the WHO EssentialMedication List, which were designed to guide the development of national health system formularies (WHO, 2012). These 276 medications are not meant to be put in every rural health outpost and clinic. Many of the medications on the Essential Medication List require continued patient monitoring. The list includes drugs for palliative care; rheumatologic, neurologic, anticoagulation, and intravenous medications; contrast material, cardiac, contraceptive, serum/IGG, and obstetrical medications; as well as medications for TB, HIV, and leprosy. There is a growing body of evidence that supports significantly limiting prescribing by healthcare teams working apart from permanent healthcare programs and having those groups focus instead on prevention, health screening, and supporting horizontal program models. The following are basic evidence-based global health pharmacovigilance standards; each volunteer should review and understand these basic standards.
5.2a. Medications should only be prescribed when absolutely necessary and dispensed in child-resistant containers (not Ziploc plastic bags).
Remember, there are no double standards for patient safety; standards that exist in developed countries also apply in developing countries. PPNN (a pill for every problem and a needle for every need) thinking should never be part of global health initiatives for both patient-safety and developmental reasons.
5.2b. Know the country’s pharmaceutical dispensary laws, and respect them. Ideally, a local pharmacist, or team pharmacist, should oversee the dispensing of medication. Unlicensed staff should never package, label, or dispense medication.
5.2c. No central pharmacy medication dispensing—This means that prescriptions may be filled in a central pharmacy area; however, medications should only be dispensed in the private consultation rooms or exam rooms. A licensed provider, pharmacist, or nurse may provide medication education and counseling. One-time dose medications (e.g., parasite prophylaxis, vitamin A supplementation) may be dispensed at a central location.
5.2d. Mothers or caretakers of children prescribed home medication must (for each child) verbalize the medication instructions, demonstrate measuring the dose of medication, and administer the first dose of the medication under the supervision of a licensed provider (nurse or physician). Again, this must happen in private pharmacy consultation rooms or exam rooms. Attempt to limit the number of prescriptions for each family. Each child treated should have medication dosages labeled with each child’s name and age. Education before medication! The system we have deployed to prevent overprescribing and ensure the WHO private consultation requirements are met is to have a healthcare provider go to the pharmacy, get the medication, and go back and instruct the patient himself or herself. Prior to leaving the clinic, the patient who receives medication is asked to explain the use of his/her medications by another team member to ensure full understanding. The educator then reinforces medication usage and provides education on one or two priority health-education areas. To some, this sounds like it impedes patient flow; however, we have found it does not significantly decrease the number of patients seen. Even if it did, the improvements in patient safety would far outweigh any decreased numbers. Remember, one of the central culprits in adverse outcomes in healthcare projects is prioritizing the number of patients seen over patient safety. It is better to see one hundred patients well than a thousand patients and end up with a story like Maria’s.
5.2e. No expired medications should ever be taken into a country—This is unlawful, and some countries have restrictions on the use of short dates—know the country’s standards. The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President April 12, 1988. The PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and effective, and (2) to avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, sub-potent, or expired drugs. The legislation was necessary to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs. It also banned the distribution, transportation, exportation, or dispensing of any expired medications into or out of the United States under any circumstances. This makes it a crime for anyone to ship expired drugs anywhere, except back to the manufacturer for destruction, or to a facility for destruction. People on both short-term AND long-term missions are subject to the PDMA, and it includes drugs intended for shipment outside the United States.
5.2f. No sample or unlabeled medications should ever be used unless a complete dosing regimen can be given.
5.2g. Know and adhere to the WHO/UNICEF standards of practice in developing countries.
5.2h. A detailed inventory of pharmaceuticals (with expiration dates) and/or medical supplies should be with the team at all times. This often facilitates customs transfers and can avoid many potential legal problems. Medications should be left in their original containers and never re-packaged for distribution.
5.2i. Surplus medications should never be left with unqualified healthcare personnel. If supplying medications to horizontal community health worker CHW programs, it is important to ensure adequate training on medications dispensing and the need for safe storage. Supplying medications for such programs comes with the responsibility of supplying child-resistant containers. Usually, families are instructed to keep such containers so they later can be refilled with other medications and relabeled. Pharmaceuticals should be carefully secured throughout the mission, and patients must receive training on safe home storage to keep them away from children.
5.2j. Never attempt to sneak medications into a country. Think about what would happen to you if you were caught smuggling drugs into your home country. Pharmacy laws vary from country to country, but the least you can expect is for medications to be confiscated; in some countries, imprisonment is very likely. Medications can often be purchased at very low cost in local pharmacies, and it is very helpful to develop relationships with local pharmacists.
There are 26 specific medications recommended by the WHO for the treatment of children at clinics in developing countries. They include the following, many of which are unfamiliar to physicians from developed countries or are considered antiquated or too dangerous to use in light of much safer alternative medication choices available in developed countries. Nevertheless, they remain the gold standard for practice in developing countries. Drugs like chloramphenicol were abandoned decades ago in most developed countries, but their effectiveness and very low cost keep them in use in resource-poor communities. We will also discuss the use of a few medications (specifically, the micronutrient therapies such as iron, Vitamin A, and zinc) that need to be prescribed for children in developing countries in the following section.
WHO Child Health Formulary
1 Artemether/Lumefantrine
2 Amodiaquine Tabs (200mg)
3 Quinine (inj.) (vials) (600mg/2ml)
4 Amoxicillin Tabs (250mg)/syrup 250mg or 125/5ml
5 Chloramphenicol (inj) 1-g vials
6 Chloramphenicol syrup (600ml bottles) 125mg/5ml
7 Gentamicin vials (80mg/2ml)
8 Crystalline penicillin 100,000-unit vials
9 Oral Rehydration Salts (ORS) 500-ml sachet
10 Hartmann’s solution 500-ml bottles
11 Nalidixic acid (250-mg tabs)
12 Metronidazole (200-mg tabs)
13 Erythromycin (250-mg tabs)
14 Mebendazole 500-mg tabs
15 Iron 200mg
16 Cotrimoxazole (80mg:400mg)
17 Folic acid tabs (5mg)
18 Paracetamol tabs (500mg)
19 Gentian violet
20 Mycostatin (20ml)
21 Diazepam—vials
22 10% glucose half-liter bottle
23 Salbutamol (tabs) 2mg
24 Salbutamol inhaler
25 Salbutamol nebulization solution (50-ml bottle)
26 Vitamin A (soft gelatinous capsules) 100,000 and 200,000 units
see http://www.who.int/child_adolescent_health/documents/IMCI_chartbooklet/en/
There is more to chapter 9 of When Healthcare Hurts, you can get your free ebook copy today at www.healthservicecorps.org
References
Consumer Product Safety Commission. (2005). Poison prevention packaging: a guide for healthcare providers. Washington D.C.
The US Consumer Product Safety Commission Luis, H., Robert, S., A Mwansa, N., & Cesa, R. V. (2008).
WHO. (2012). Essential Midicines. Retrieved January 2nd, 2012, from World Health Organization : http://www.who.int/medicines/services/essmedicines_def/en/index.html
World Health Organization. (2008). Patient safety in African health services: issues and solutions. Yaounde, Republic of Cameroon : WHO Regional Comittee for Africa.
WHO/UNICEF. (2005). IMCI Handbook. Geneva: WHO Press.
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