Problem   Should Short-term healthcare mission team members obtain licenses to practice within a host country?   Consider the following report. A local doctor arrested this month in Zimbabwe on charges of practicing without a license during a mission trip was released this week, say officials. Dr. Ed Montgomery and his wife, Sara Jane, a nurse, have both been given back their passports, confirmed Senator Mitch McConnell's office Tuesday. The pair had been relieved of their passports approximately two weeks ago while on a medical mission trip in the African country. According to his friends, Dr. Montgomery had been looking forward to the trip with friends. A retired urologist, Dr. Montgomery and his wife had participated in several other medical missions around the world.   According to Dr. Montgomery's former partner, Dr. Scott Scutchfield, after Dr. Montgomery's charges were dropped he headed with his wife to South Africa.   Julie Adams, deputy press secretary for McConnell's office, said the doctor had worked with the embassy and Zimbabwe officials to obtain a license to practice in that country and hence the charges were dropped. It was definitely a happy ending, said Adams. For the friends and family waiting at home for the Montgomerys, the couple's release comes after days of prayer and concern. "I'm thankful to God," said Scutchfield, after many prayers and well wishes were sent their way from the medical community. "Everyone will be relieved.” Family friend Dr. Chris Jackson also applauded the good news, and those who had helped to bring it about. "We're very pleased for all the efforts made for us," said Jackson, including the help of the newspapers and politicians. The recent news was "wonderful," said Jackson. "I can't wait to get him home." (BURTON, 2004)   We might also consider how we, as healthcare professionals in the United States would respond if we were to reverse the situation.  How would we respond if a group of doctors and nurses from Myanmar came to the United States and started holding medical clinics at a local church?    Research   Health Professional Regulatory Agencies   One of the central tenants held by the patient in the healer-patient relationship is that the healer is skilled and trustworthy. In developed countries there is an increased emphasis on licensing and competency assessment so that the patient can be assured that a healer has at least the basic knowledge needed to successfully manage health-related problems.  End of training examinations, board and sub-board examinations have long been a standard to assess competency. Boards act to screen-out individuals who need to study more or may be poorly suited for medicine. (Hechel, 1979)   Nursing, Psychology, Dental and Medical Boards regulate professional licenses. In some countries, like the United States, the regulatory bodies function at the state/province level making it such that a healthcare professional’s license is only valid in the state in which it was issued. Professional boards not only provide the initial license, but ensure that a practitioner participates in continuing education on a yearly basis. Demonstrating one’s current license to an employer is the only means by which one will be allowed access to provide care in a hospital or clinic setting. Without the license the individual cannot be employed in the United States. (Johnson, 2005)   Care provided by medical missions must meet the legal requirements and medical standards and practice guidelines of the host country. Until relatively recently, very few standards and guidelines were available, and those were rarely enforced. Over the past several years, numerous standards and guidelines have been established for the care of patients in developing countries.  Just as in the U.S.A. where harsh penalties exist for practicing medicine without proper permission, developing countries are beginning to enforce licensure requirements.   Solution   Country/State Specific Requirements for Practice   So we are increasingly asked: “How and where do I apply for a license or legal permission to practice in _______?”  Until relatively recently this question was very difficult to answer, as just as in the U.S.A., the contact information and licensing requirements are often different for different states or regions within the same country.   Fortunately for medical professionals, this information is now provided by the International Association of Medical Regulatory Authorities (IAMRA), www.iamra.com.  This site provides very important contact information for obtaining licensing/legal permission to practice medicine in host countries.  The site includes an “International Directory of Medical Regulatory Authorities” to assist medical regulatory authorities in the exchange of important physician information. The directory provides core information for all known medical regulatory authorities, such as addresses and communication sites/portals, as well a brief description of the legal authority by which the organization received its regulatory powers and the regulatory services provided by the organization   For nursing, the International Council of Nurses, www.icn.ch, maintains a list of nursing councils and their contact information.  Contacting the nursing council for the host country will help begin the process of obtaining a license.  Nurses going on short term trips can often be given a temporary license.  For nurses who seek to practice longer term in country, there may be additional education and practice requirements, such as midwifery, that are not included in basic nursing education in the US.  Expatriate nurses wishing to practice nursing in the US are required to demonstrate that they have graduated from an approved nursing program and met the licensure requirements of the country of origin, or pass the NCLEX examination in the US. (Mc Dougal, October 2011)  Likewise US nurses going abroad should respect their host country’s nursing authorities.   Case in point   Arriving in Uganda in 1985, during the middle of the civil war, neither my sending organization nor my host organization encouraged me to pursue getting a nursing license to practice.  Our community health development work operated in close cooperation with the district health office.  I was told by the district medical officer that a license was not required.  Still I persisted.  I learned where the nursing council who regulated nursing practice was located in the capital city of Kampala.  On my next trip to the capital, I went there with my documents.  The director looked at my documents and thanked me for pursuing a nursing license.  She said that not many expatriates respected the efforts of the Ugandan nursing council to regulate nursing practice and that enforcing their regulations on expatriates was difficult, especially during the war.  Then she confessed that she really didn’t have a reference for how to evaluate American nursing education and licensure.  Having been involved in nursing education in the US, I explained the various nursing education programs that led to professional licensure.  She was so grateful and gave me my license.    Later, when the war had ended, I received an invitation to work with the Ministry of Health in Uganda to revise the nursing curriculum and again several years later to work with them to begin the first baccalaureate nursing program in East Africa.  If I had not pursued getting a nursing license, I would never have been offered the opportunity to come along side of the Ugandan nursing leaders to advance nursing education in my host country.   Conclusion   Recommendations.   1.  The BEST practice is to obtain appropriate licensing in the host country for each team member. Although time consuming, it places the team on a firm footing within the country   Given the coordination requirements, it would be best if the team leader(s) and the Church/sending organization take initial responsibility for this task.  It is important to discuss this issue with the in-country partner early so they can communicate with the host governing authorities regarding visiting healthcare teams.  Healthcare professionals going on the short term missions projects should be ready to submit their credentials – educational transcripts and/or licenses to practice – to the sending organization and/or in country partner or host governing authority.     If the in-country partner is not engaged professionally in providing healthcare, it is inappropriate to assume that they will be knowledgeable about licensing issues for expatriates or that they will automatically take responsibility for obtaining licensing/permission to practice.  For example, groups that partner with churches, orphanages, or economic development programs in host countries, should discuss with their host organizations the importance of getting permission for visiting teams to practice their professions while in country.   2.  A BETTER practice when the healthcare professional is unable to obtain official licensing is to obtain approval through local authorities who are in a position to approve team practice.    Some partners, particularly in creative access countries, may indicate that obtaining licenses brings greater scrutiny to their work/organization than they would like. They may have local governmental contacts that provide coverage should there be any questions or problems. In these cases, the healthcare professional and the sending organization must assess the risk to both themselves and the host organization.  It is also important to factor into the equation relationships between the sender and receiving countries. Governments may express their displeasure by detaining or expelling missionaries, even medical mission teams to make a political point.   3.  A GOOD practice is to proceed with caution in countries where there is no stable government or health ministry/licensing organ.  Some team leaders would rather go without licenses, thinking that should there be a problem, they can plead ignorance and ask for forgiveness. This strategy is very risky and can lead to problems.   Consequences of not becoming licensed.   There can be significant amount of fall out for the people served, churches, participating local doctors, partners and governmental officials in-country.  For the people served, the exposure of the team’s lack of licensing may lead to concerns about the adequacy of their care. They may even wonder if their participation in such a situation may negatively impact them.  Churches can be negatively impacted by the perception of wrong-doing by short-term healthcare mission team.  For the participating local doctors, the disclosure that their short-term mission team partners have not followed the law, can create a perception of loss of reputation within the community.  Trust in the mission partner can be negatively impacted.   For partners, the disclosure that their short-term mission team partners have not followed the law can cause profound problems. From the government’s perspective, the partner is primarily responsible for the short-term mission team. Licensing for the partnership organization may be lost or even missionaries may be imprisoned or deported.   For the governmental officials, the disclosure that their short-term mission team has not followed the law, creates a question of who is responsible. If a mission partner is responsible, then prosecution of the mission partner is a possible route. If a governmental official is thought to be responsible, then they are at risk of losing credibility or even their position. For this reason, local governmental officials may be skittish about approving mission team visits. There can be a perception that there is more to lose than to gain unless the mission partner has a very strong relationship with the governmental official.   The major impact of problems related to no in-country licensing is a lack of trust that can destroy relationships. Works Cited BURTON, E. (2004, July 21). Dr. Montgomery released in Zimbabwe, charges dropped. Retrieved from The Zimbabwe Situation: http://www.zimbabwesituation.com/jul22_2004.html#link8 Hechel, H. &. (1979). Specialty certification in North America: a compartive analysis of examination results. Journal of Medical Education, 69-74. Johnson, D. A. (2005). Role of state medical boards in continuing medical education. Journal of Continuing Education in the Health Professions, 183-9. Mc Dougal, B. e. (October 2011). The 2011 Uniform Licensure Requirements for Adoption. Journal of Nursing Regulation, 10-22.      

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.