Challenges Providing Pharmaceutical Products to Syrian Refugees

Posted 24 May 2017 By Zeina Sahloul

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This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality.

Introduction

Providing healthcare aid to civilians during war and crisis is a complicated task. The Syrian war has impacted the healthcare system inside Syria and the neighboring countries. Large and small humanitarian organizations have worked hard to provide pharmaceutical products to Syrian refugees. Ensuring the quality and proper storage of medicinal products is a priority for these organizations.

The destructive war and resulting lack of security for people in Syria since hostilities began in March 2011 has forced millions to flee their homes. While many have become displaced inside Syria, many others seek refuge in neighboring countries, including Lebanon, Jordan, Iraq and Turkey. In 2016, the United Nations High Commissioner for Refugees (UNHCR) reported a total of 4.8 million refugees were displaced outside Syria while a projected 8.7 million persons have been displaced within Syrian borders.1 Among the many difficulties encountered during this conflict is the ability to deliver medicine to people in need both in Syria and in refugee host countries. This article, with comments from medical personnel currently working to help fill the medical needs of displaced populations, provides insight into the medical aspects of this humanitarian crisis.

Background

The Syrian crisis has impacted all aspects of life for the Syrian people. It also has impacted other countries as the numbers of Syrian refugees fleeing the conflict continue to increase. According to UNHCR, as of 23 October 2016, the total number of registered Syrian refugees in Jordan was 655,365. In the Za’atari camp in Jordan, 79,901 displaced persons struggle to survive. In Lebanon, 1,017,433 refugees are spread across this small country between, Beqaa, Beirut, North Lebanon and South Lebanon. Turkey hosts more than 1,017,433 refugees.2

Inside Syria, the war and resulting humanitarian crisis has impacted the healthcare of the Syrians. Unsanitary conditions have resulted in outbreaks of polio, scabies, tuberculosis, hepatitis and typhoid. Health issues, including kidney disease, bloody diarrhea and acute jaundice are associated with sanitary and hygiene issues. Delivering medicines and medical supplies, including vaccines and antibiotics, is problematic, especially in besieged areas. Hospitals and medical facilities are either partially functional or have been rendered out of service. The threat to healthcare workers also is a serious issue. According to “Physicians for Human Rights,” 560 medical personnel have been killed since the beginning of the crisis.3

The demand for medicines and health support is immense among this vulnerable refugee population with daily outbreaks of communicable diseases, such as measles, respiratory and gastrointestinal infections, and polio. Non-communicable diseases, such as diabetes, hypertension, and other cardiovascular diseases, are also increasing the demands for medicines and medical care.4

While safety is not the primary concern when delivering medicines to refugees beyond Syrian borders, refugees and aid workers must deal with bureaucratic and regulatory constraints imposed by their host countries. Figure 1 shows a map of Syria and neighboring countries.5 Major refugee populations are located in Turkey, Lebanon, Jordan and Iraq.

Figure 1. Syria and Neighboring Countries

Sahloul Figure 1

Regulatory Policy and Guidance for Drug Procurement and Quality

The United Nations High Commissioner for Refugees (UNHCR) is the primary agency responsible for addressing the major health issues and concerns among refugee populations, providing humanitarian aid and support for Syrian refugees through their offices and health centers located in refugee host countries. There are primarily two ways of providing medicines and medical supplies necessary for Primary Health Care (PHC) programs and services:

  1. centrally by UNHCR
  2. nationally through Ministry of Health central pharmacies

In response to this growing crisis, UNHCR published the Essential Medicines and Medical Supplies Policy, providing guidance on how to ensure good quality essential medicines and medical supplies are available, affordable and used rationally. The policy also provides guidance on medical selection.6

With implementation of the Essential Medicines and Medical Supplies Policy, all UNHCR Primary Health Care (PHC) programs assure medicines and medical supplies are selected, procured, distributed and used in accordance with the following quality requirements:

  1. manufacturing quality by demonstrating Good Manufacturing Practices (GMPs) through evidence of a GMP certificate
  2. product quality (registration status, certificate of pharmaceutical product)
  3. batch quality (certificate of analysis, labeling, appearance, packing and shelf life inspection, chemical analysis)

To ensure adequate quality of medicines and supplies at the end-user level, UNHCR guidance calls for ensuring implementation of proper storage of medicines and distribution procedures throughout every level of the supply chain. It also explains procedures for procurement of medicines and medical supplies. Important key points for drug procurement, such as selecting the most cost-effective essential medicines, obtaining the quantity needed, managing procurement and delivery, ensuring good product quality and monitoring the performance of the supplier and procurement system, must be considered.

UNHCR’s policy requires bidding on and purchase of medicines through international suppliers. These international suppliers are experts in procuring a high quality drug at the lowest cost. In countries without internationally cleared pharmaceutical companies, local procurement can be used by exception. After completing the necessary steps and ordering procedures for international procurement, inspection of medicines and medicinal supplies must be performed upon arrival to the warehouse. The number and condition of boxes received must be checked. Large shipments that cannot be checked immediately sealed, and undamaged boxes are placed into quarantine for later inspection. Damaged and unsealed boxes must be checked immediately. A detailed inspection based on predefined criteria is important.

A summary of the inspection criteria for the medicines received at the warehouse includes the following:

  • International Nonproprietary Name (INN) of the active ingredient
  • dosage form
  • batch number
  • date of manufacture
  • expiry date
  • instruction for storage

Labelling

Labeling should always be in English and if required one other official language.

A printed label on each ampoule should contain the following:

  • INN of the active ingredient, quantity of the active ingredient, expiry date and name of the manufacturer
  • Directions for use, warnings and precautions may be given in leaflets or package insert.

Packaging

  • Tablets and capsulesshould be packed in sealed, waterproof containers with replaceable lids, protecting the contents against light and humidity.
  • Liquidsshould be packed in unbreakable, leak-proof bottles or containers.
  • Containersfor all pharmaceutical preparations must conform to the latest edition of internationally recognized pharmacopeia standards.
  • Ampoulesmust have either break-off necks or sufficient files must be provided.

Expiry Date and Shelf Life

At the time of shipment, the product should have at least 75 percent of its validated shelf life.

Appearance of the product:

  • Capsules of the same medicine and dose must be identical in shape, size and color. There should be no visible defects, no empty capsules and no open or broken capsules.
  • After receiving the shipments and completing the check list, all medicines must be physically stored in the warehouse and they must be well documented.

The Essential Medicine Lists (EML)

The Essential Medicine List (EML) classifies medicines in two functional categories:

  • emergency kits, including the Interagency Emergency Health Kit (IEHK) basic, IEHK supplementary, interagency reproductive health kits, diarrheal disease kit, immunization kit
  • medications, such as oral medicines, injectable medicines, external use medicines and infusions

Médecins Sans Frontières (MSF) and Medical Product Procurement

Médecins Sans Frontières(MSF), otherwise known as ‘Doctors Without Borders,’ is an international medical organization providing medical and emergency aid to Syrians affected by the conflict. MSF provides patients with medical products through a program that it provides in several countries. As a non-profit organization, MSF has established its own procurement centers, which are responsible for purchasing, shipping and storing the medicines and medical equipment.7 Drug quality is a priority. For any medical product to be qualified by the MSF, it must be pre-qualified by the World Health Organization’s (WHO) Prequalification Program (PQ) or registered in a country with a robust drug regulatory program. MSF pharmacists must conduct their own evaluation of products that are neither WHO pre-qualified nor registered in highly regulated countries.

WHO Prequalification Program (PQ)

The WHO Prequalification Program (PQ) is designed to ensure quality priority medicines are available for the benefit of those in need.8 Originally, the list of prequalified products was used for HIV/AIDS, malaria and tuberculosis. The program was used by United Nation agencies, such as the Joint United Nation Programs on HIV/AIDS (UNAIDS) and the United Nations Children’s Fund (UNICIF) to guide procurement decisions. However, for any organization or agency involved in bulk purchasing of medicinal products, this list can be essential tool.

Elements of the WHO Prequalification Program include:

  • unified standards of acceptable quality, safety and efficacy
  • comprehensive evaluation of the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites
  • prequalified sources of Active Pharmaceutical ingredients (APIs) by comprehensively evaluating the quality of the API based on information submitted by the manufacturers, and inspection of the corresponding manufacturing sites
  • prequalified quality control laboratories of pharmaceuticals
  • capacity of staff from national regulatory authorities, quality control laboratories and manufacturers or other private companies to ensure medicines quality

Medicine in Refugee Camps

Personal Accounts from Medical Providers

Demands for medical assistance continue to increase as the fighting in Syria intensifies and waves of refugees flee across Syrian borders to other countries. The delivery of medical aid to refugees can be restricted in a number of ways, including by the host country’s regulations, weak healthcare systems, high drug prices and unsafe access to areas where aid may be available. Too, maintaining quality control can be problematic under the difficult living conditions within the refugee camps.9

Inside Syria, major health issues from war-related injuries include burns, fractures, amputations and other serious injuries requiring immediate surgical intervention. A pharmacist who works at a medicine warehouse in North Syria supported by the Syrian Expatriate Medical Association (SEMA),10 described his working conditions.

“The problem is that hospitals, medical facilities and medical staff are being attacked.” “The number of hospitals to treat those injured are too few and they are not fully functional. Other health issues include malnutrition and problems due to unhealthy living conditions and water pollution. There is a demographic change due to the internal displacement of people inside Syria. People have left their cities and are gathered randomly in tents on the Syrian-Turkish border.”11

Drug shortages are another challenge inside Syria. “In the northern part of Syria 90% of the medical aid comes across the Turkish border from large organizations like the United Nations (UN), WHO and the International Rescue Committee (IRC). Shipments usually include the Interagency Emergency Health Kit (IEHK). These products are delivered randomly and do not cover the demands of the people who need them. For example, we received a large quantity of metronidazole syrup that we do not actually need. We need more of the intravenous infusion of metronidazole to treat severe infections and in this case we, as an organization, must purchase this product from Turkey.” Table 1 provides an example of the medicinal products included in the Interagency Emergency Health Kit (IEHK) delivered to Syria across the Turkish border.12

Table 1. Medicines in the IEHK
MedicineUnit of MeasureTotal Quantity
Magnesium Trisilicate 250mg and Aluminium Hydroxide 120mg in pack of 1000PAC10
Albendazole 400mg chew tablets/PAC-100PAC50
Metronidazole 200mg/5ml powder for oral suspension, bottle of 100mlEA800
Amoxicillin 250mg tablets/PAC-100PAC60
Folic Acid 5mg tablets; packs of 1000 eachPAC10
Ibuprofen 400mg tablets/PAC-100PAC200

Anesthesiology drugs also are difficult to obtain and in short supply, although outside agencies attempt to fill these gaps. The anesthetics collected and donated by the Syrian Expatriate Medical Association (SEMA) is shown in Table 2.

Table 2.Anesthesiology Drugs Donated to SEMA
MedicineDose
Atracurium50mg/5ml
Adrenaline1mg/1ml
Atropine1mg/1ml
Diazepam10mg/2ml
Ephedrine0.05g/1 ml
Fentanyl500mcg/10ml
Ketamine500mg/vial

Storing medicines under proper conditions can be a major challenge. In Jordan, for example, the local market is the main source of medicines supplied to refugee camps. It is difficult for humanitarian organizations to import medicines into Jordan due to regulatory and logistical impediments. The MSF must buy the medicines locally because it is almost impossible to obtain a license from the Jordanian authorities to import the medicines they need.

Another expatriate organization, the Syrian American Medical Society (SAMS),13 operates programs to support thousands of Syrian refugees in Jordan and also obtains medicines locally. A pharmacist and SAMS medical officer working at the Za’atari camp was contacted for his comments.

“Each medicine must be registered with the Jordan Food and Drug Administration (JFDA) in order to deliver it inside the Za’atari camp, and medicines must go to a licensed health center inside the camp.” “We buy the medicines and supply them to the camp almost every two months. When the shipments arrive to the camp’s warehouse, every medicine has to be documented in an item card. The item card must include the date of receiving the medicine, quantity, batch number and expiration date.14

Other major problems faced by humanitarian workers in Syria include power outages and the lack of fuel to run generators. Storage of the medicines inside the camp also can be a challenge. “Medicines are stored in temporary pre-fabricated buildings. During summer months the air conditioner is not efficient to keep medicine cool.” “We have refrigerators to store insulin and other medicines that require refrigeration.

Table 3 presents the number of healthcare cases seen by SAMS in one month (May 2016) at the Za’atari Camp in Jordan.

Table 3. SAMS Caseload at the Za’atari Camp, Jordan
Type of IllnessTotal Number of Cases
Chronic Diseases630
Gastro-Intestinal187
Central Nervous System (Neurological)129
Gynecological Diseases625
Leishmaniasis0
Physiotherapy30
Upper Respiratory Tract Infections0

Syrian refugees in Lebanon now represent 30 percent of the country’s population. The private sector manages the health system in Lebanon. The government of Lebanon has refused to establish formal and well-maintained camps, emphasizing that Lebanon is not a state for refugees. Refugees reside in informal camps cope with harsh living conditions and very weak infrastructure. Health issues among Syrian refugees in Lebanon include infectious diseases such as hepatitis A, typhoid, leishmaniasis and measles. Hypertension, diabetes and cardiovascular disease are affecting larger segments of the refugee population.15-18

The high cost of medicines is a serious obstacle to caring for refugees in Lebanon. Brand name drugs are very costly and only two percent of the drugs in Lebanon are generics. The Ministry of Health in Lebanon restricts humanitarian organizations from buying medicines from outside resources.

A physician working in the SAMS Lebanon office addressed the difficulties of providing medicines to refugees at SAMS sponsored centers in Lebanon. “Drugs are expensive and certain types of drugs, like psychiatric medications, are hard to get." The drug market is not sustainable. A certain drug may disappear from the market for months; as a result, patients will be treated with a different drug or no drug at all.”19

While the bureaucracy in Middle Eastern countries can cause delays in delivering drugs, SAMS was able to get the approval from the Ministry of Health to allow a large shipment of donated drugs from Direct Relief USA to enter Lebanon. The shipment sat for 50 days at the port before it was finally allowed by the Lebanese authorities to enter the warehouses in Lebanon. The shipments contained oncology drugs, intravenous antibiotics and antifungal drugs.

At pharmacies located in health centers, the assigned pharmacist is responsible to ensure quality control of the pharmaceutical products. A check list will include, expiration date, appearance of the product, medicines that require refrigeration and the source of the product. “It is important to inspect the source of the drug as some drugs can be counterfeit.”

While local market procurement can provide fast delivery of medicines to patients, it does not guarantee the quality of the drug. Counterfeit drugs in some parts of Africa, Asia and the Middle East are estimated to be more than 30 percent of all drugs in these regions.20 According to the head of the National Association for Social Health, Ismail Sukarieh, 30 to 40 percent drugs in the Lebanese market are either counterfeit or were recalled from the world market. There are several ways to identify counterfeit drugs according to the National Association of Boards of Pharmacy (NABP). These include packaging, labeling, pill appearance and pill taste.21

Conclusion

The 1946 Constitution of the World Health Organization (WHO) states: “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.”22 Today, the Syrian crisis is entering its sixth year and with an increased influx of refugees, the demand for quality healthcare is a monumental challenge. The UNHCR’s Essential Medicine list provides high standards of quality medicines, but it does not cover the current demand. The WHO Prequalification list assures quality for a small number of medicines to treat malaria, HIV and tuberculosis. A global prequalification system that includes a vast majority of essential drugs, especially for non-communicable diseases, is required to allow sharing of resources and access to reliable data between different Nongovernmental Organizations (NGOs). Many NGOs provide medicines and healthcare to refugees.

“Each NGO adopts a different protocol to treat patients.” “For example, MSF follows the WHO protocol, but some NGOs can only provide oral medicines. At SAMS we focus on consistency.”

Strict regulation coupled with a weak healthcare system in refugee host countries can cause drug shortages and delays in delivering medicines. Transportation of medicines into the besieged areas within Syria is very difficult and can put the life of the aid workers at-risk. Consequently, a more comprehensive and coordinated plan to provide pharmaceutical support to the Syrian people must be the priority of the NGOs as well as key international players, such as the UN. Together, with improved cooperation, these agencies can make a significant and positive contribution in ending the suffering of those affected by this conflict.

Acknowledgement

Iwould like to express my gratitude to Professor Gary C. du Moulin for his guidance and for giving me the opportunity to work on this project. I also wish to acknowledge Dr. Anne Roberti for her great assistance in reviewing the text and grammar of this work. Finally, I would like to thank the Syrian American Medical Society (SAMS) and the Syrian Expatriates Medical Association (SEMA) for their contribution to this project.

References

  1. United Nations High Commissioner for Refugees (UNHCR). Syria Emergency. UNHCR website http://www.unhcr.org/en-us/syria-emergency.html. Accessed 11 May 2017.
  2. United Nations High Commissioner for Refugees (UNHCR). Syria Regional Refugee Response. UNHCR website. http://data.unhcr.org/syrianrefugees/regional.php#_ga=1.185485098.2000848447.1475375699. Accessed 11 May 2017.
  3. Physicians for Human Rights. Syria Medical Community Under Assault. PHR website. https://s3.amazonaws.com/PHR_other/Syria%27s-Medical-Community-Under-Assault-October-2014.pdf. October 2014. Accessed 11 May 2017.
  4. United Nations High Commissioner for Refugees (UNHCR). 2014 Syria Regional Response Plan. Strategic Overview. UNHCR website. http://www.unhcr.org/en-us/partners/donors/52b170e49/2014-syria-regional-response-plan-rrp6-january-december-2014.html?query=medicines%20to%20syrian%20refugees. Accessed 11 May 2017.
  5. Central Intelligence Agency. Map of Syria. CIA website. https://www.cia.gov/library/publications/the-world-factbook/geos/sy.html. Accessed 11 May 2017.
  6. United Nations High Commissioner for Refugees (UNHCR) Essential Medicines and Medical Supplies Policy and Guidance 2013. http://www.unhcr.org/en-us/protection/health/527baab09/unhcrs-essential-medicines-medical-supplies.html?query=%20Essential%20Medicines%20and%20Medical%20Supplies%20Policy%20guidance. Accessed 10 May 2017.
  7. Médecins Sans Frontières (MSF) Medical Product Procurement. August 2016. MSF website. http://www.msf.org/en/article/msf-medical-product-procurement. Accessed 11 May 2017.
  8. World Health Organization (WHO). Prequalification Program. WHO website http://apps.who.int/prequal/default.htm. Accessed 11 May 2017.
  9. Sukkar, E. “Supplying Medicines to Refugees: a Logistical Nightmare.” Pharm J. 2015; 294(7851). http://www.pharmaceutical-journal.com/news-and-analysis/features/supplying-medicines-to-refugees-a-logistical-nightmare/20067972.article. Accessed 11 May 2017.
  10. Syrian Expatriate Medical Association (SEMA) website. http://syriareliefnetwork.com/en/syrian-expatriate-medical-association-sema/. Accessed 12 May 2017.
  11. Personal communication. 1 November 2016.
  12. United Nations Children’s Fund (UNICEF). Technical Bulletin No. 11. Interagency Emergency Health Kit 2011. https://www.unicef.org/supply/files/Interagency_Emergency_Health_Kit_2011.pdf. Accessed 11 May 2017.
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  14. Personal communication. 25 October 2016.
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  16. Cherri, Z., González, P.A. and Delgado, R.C. “The Lebanese-Syrian Crisis: Impact of Influx of Syrian Refugees to an Already Weak State.” Risk Management and Healthcare Policy. 2016; 9:165-172. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4948691/. Accessed 11 May 2017.
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  18. Médecins Sans Frontières (MSF). Treating Chronic Diseases Among Syrian Refugees. April 2014. MSF website. http://www.doctorswithoutborders.org/news-stories/field-news/treating-chronic-diseases-among-syrian-refugees. Accessed 11 May 2017.
  19. Personal communication. 27 October 2016.
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About the Author

Zeina Sahloul was born and raised in Homs, Syria. After the Syrian crisis started in March 2011, Sahloul became involved in different humanitarian projects including a humanitarian mission in Turkey to serve the Syrian Refugees. In 2017, she completed her MS in regulatory affairs and health policy at the Massachusetts College of Pharmacy and Health Sciences University (MCPHS).

Cite as: Sahloul, Z. “Challenges Providing Pharmaceutical Products to Syrian Refugees.” Regulatory Focus. May 2017. Regulatory Affairs Professionals Society.

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Categories: Drugs, Crisis management, Submission and registration, Features, Middle East, WHO

Tags: Syrian Refugee Crisis, Prequalification, UNHCR, Essential Medicines, MSF

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