Pharmacological reality in northern Syria… hindrance of organizations’ work and absence of control

Mohamed Homos / Mais Hamad

 

Five years have passed since the occurrence of the biggest medical mistake in northern Syria, after opposition groups took control of it; an error killed 60 children and put 300 more at risk.

In September 2014, anti-measles doses during a campaign organized by the interim government led to the poisoning of children, provoking angry global and local reactions, and opening the door to talks about the problems faced in the pharmaceutical sector in areas controlled by opposition factions.

The need to regulate and increase the risk of drug control emerged at that time, necessitating moves by the opposition government to initiate steps to reduce drug shortages and lack of control, but violations continued for short periods.

Over the past years, the most prominent problems that have probably plagued the pharmaceutical sector in areas controlled by opposition factions were the proliferation of narcotics and sedative drugs, which are highly addictive. Pharmacies in different parts of Syria are now selling pentagon and tramadol tablets without prescription.

Recently, the “Salvation” and “Syrian Interim” governments running Idlib and Aleppo countryside areas in northern Syria have taken further steps to regulate the pharmaceutical sector and activate drug control, but these steps have been struck by the decision of one of the largest organizations supporting medical projects to cut their support, opening the door for a new challenge and fears that the crisis might re-emerge.

In this report, Enab Baladi opens the file of the pharmaceutical sector in northwestern Syria, highlighting the attempts to regulate it, the obstacles faced, and trying to monitor the impact of the interruption of support by pharmaceutical control bodies.

Aleppo northern countryside without a unified medical body

The lack of centralization makes it difficult to control the pharmaceutical sector

The rural areas of Aleppo have been suffering from the absence of oversight over the pharmaceutical sector and a lack of consensus on a unified body among the medical offices of local councils in the cities and towns of the region which are controlled by opposition factions supported by Turkey.

In spite of the actions taken by the specialists in the region, the reality of the drug is not optimized to ensure protection for the seller, distributor, and consumer.

Ahmed al-Abou, the director of the medical office in Al-Bab city, told Enab Baladi that drugs and pharmacists are the biggest problems in the region and that Medical offices have tried to take steps to control the issue but this attempt was fruitless due to the unilateral steps among the medical offices in the region.

Last March, at a meeting with the offices of the Euphrates Shield area (northern Aleppo countryside), the first steps were taken towards adjusting the pharmacological and pharmaceutical realities in the region. In fact, during the meeting it was agreed to license pharmacies, standardized records, and license warehouses on uniform terms between medical offices.

The meeting of heads of medical offices came up with several decisions to regulate Indian and Chinese medicines in order to form an oversight office that will license pharmacies and monitor and verify medicines. Moreover, practitioners took a test set by a specialized medical committee and the pharmacist obtained a professional certification issued by the medical office.

According to the decision of Akhtarin office, the cost of the annual license of the pharmacy is 50,000 Syrian pounds and a monthly fee for those pharmacists who work under a professional certification.

Al-Abou told Enab Baladi that five meetings were held after that meeting, in which several decisions were taken, some of which worked and some of which needed to be completed because there was an “unknown cause” of obstruction.

Distribution of pharmaceutical products: Warehouses’ task

In his talk, al-Abou pointed out to Enab Baladi that the licensing of medical products’ warehouses, in a unified manner and with unified conditions, was the major step taken by medical offices in the region.

Medical offices in the region require pharmacies to purchase medicines from licensed warehouses, provided that each drug depot verifies its product. The pharmacist or depot will be held responsible for the medication if it is entered from an unknown source.

According to al-Abou, unlicensed and mobile warehouses coming from Idlib were banned, and medical offices were circulated to the competent authorities to follow up on licenses and abuses. However, “commitment is not as required, and there is a commodity that interferes without the will of medical offices.”

Perhaps the biggest problems in the region are mobile warehouses, which may sell contaminated, expired or anonymous medical sources. According to al-Abou, medical offices do not require microscopic detection of chemical analysis, but there are contaminated medical medicines sold without pharmacy.

Medical offices require warehouses to provide monthly records, and pharmacies to present their records in numbers and quantities sold.

Regulation attempts hindered by the absence of  a central union

Last March, medical offices in Aleppo countryside launched a project for a central union of pharmacists, by expanding the pharmacists union in the city of al-Bab to include all the cities of the region.

According to al-Abou, the issue of the creation of a health directorate has delayed work for more than four months in the region.

The director of the medical office in the city of al-Bab said that they started tours to pharmacists to monitor their commitment, because of the state of chaos that occurred during the four months of vacuum in the region, pointing out that there are problems of compliance, as the medical products list and the way of its purchase will be re-considered “imposing significant penalties” on warehouses that sell forged medicine.

According to al-Abou, things are moving in the right direction, but there are many obstacles, including the work manner of al-Bab office and other offices, as well as the absence of a health directorate and Ministry.

The medical office is having high expectations of the new ministry of the “Provisional Government” to play a significant role as the region is preparing to deal with it.

Hard steps to realize pharmacological security in Idlib

In this sector, the reasons for the decline are the discipline of the pharmaceutical market in the absence of oversight and regulation mechanisms, as well as the lack of powers given to executives or their inability to oblige pharmacies and warehouses to sell products within the health assets.

According to the head of the pharmaceutical control in the directorate, Mohammad al-Haj Hammoud, the Idlib Health Directorate licenses all pharmacies and closes the illegal ones.

Alal-Hadj Hammoud added that each newly licensed pharmacy is provided with a record of medicines, and the control inventory of these drugs to be audited by periodic statements, or control tours to regulate the dispensation of these drugs.

The Pharmacists Syndicate was established on May 17, 2016, as a miniature nucleus in the city of Idlib then expanded to include the governorate in 2017. Since its inception, the union has worked to organize trade union work, organize pharmacists, detect counterfeiters, prosecute offenders, organize pharmacies, detect and disseminate counterfeit medicines. In its work, the union did not address social work and recreational activities and its role was limited to the organizational process

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Al-Haj Hammoud Considered that reaching a better reality in the medicines sector is not only the responsibility of the healthcare sector, pointing out to the need for the integration of several bodies concerned with the economy and internal trade in addition to the control of the crossings and several matters related to this field.

Price inconsistency

The medicines market is generally witnessing an inconsistency in selling prices, due to the lack of strict mechanisms regulating the process, either from the direct seller or from the supply warehouses. Moreover, the entry of some types of medicines from the regime-controlled areas to Idlib Governorate and the countryside of Aleppo is subject to royalties imposed customarily from the military at the crossings and barriers in regime-controlled areas.

The head of the pharmaceutical control department at Idlib Health Directorate, Mohamed al-Haj Hammoud, said that in the past (before 2011), the prices used to be fixed by the Ministry of Health, and the medicine prices used to be fixed at a certain price written on each medical item.

In contrast, the current conditions in Idlib, the reality of import, and the change in the value of the Syrian Pound have led to price fluctuations, in addition to the manipulation of prices by some pharmacies and distribution warehouses sometimes, according to al-Hammoud.

In general, it is not possible to determine an accurate price for each piece of medicine, according to al-Hammoud, who pointed out that the supervision process currently depends on citizens’ complaints.

Al-Hammoud added that the supervision has left an acceptable margin taking into account the differences in the prices of medicines so that it is not exceeded. In case of excesses, the supervision will follow up the complaint and ask for an invoice from the pharmacist. The item’s price in the invoice is then compared with the price at which the item is supposed to be sold, and in case of any violation, the violators will be held accountable.

 

Prices of common medicines among regime-controlled areas and northern Syria

 

Organization of pharmaceutical work

Pharmaceutical work has been in a state of chaos due to infringers in the profession and exploiters of lack of supervision and regulation in the region. This chaotic situation posed great challenges to the administrative authorities, which have recently started regulating the medicine reality.

Idlib Directorate of Health has worked on organizing the pharmaceutical work and medicine sales outlets including warehouses and pharmacies. This has raised protests by some pharmacists who do not have certificates and opened pharmacies on the basis of academic years they spent studying in the pharmacy branch and they could not pursue their studies.

Talking to Enab Baladi, the head of Idlib Pharmacists Syndicate, Yahya Neameh, said that the great challenges the pharmaceutical work faced are caused by the state of chaos and infringement of the violators.

According to Neameh, the organization of the medicine sales outlets needed hard work that lasted more than three years, during which the Syndicate recruited graduate pharmacists who meet the international standards and those of neighboring countries.

To start the job, a pharmacist is supposed to have a pharmacy degree and pass a collegiums examination if he is a graduate of a non-governmental university. In case he is a graduate of a public university, he must pass a special exam to check his scientific level.

Pharmacists who have not completed their studies and have not yet graduated are returned to other universities in the region to complete the required academic qualification.

Neameh considered that the pharmacist is the safety valve after the doctor in the dispensing of the medicine and the way it is to be used by patients.

The head of Idlib Pharmacists Syndicate said that the number of pharmacists and pharmacies in Idlib is sufficient to cover the governorate, and there is no shortage. “In contrast, before the Syndicate’s work, there had been unemployed pharmacists due to intruders in this profession.”

 Technical conditions

The Pharmacists Syndicate requires pharmacies to be opened to meet technical and scientific conditions. The pharmacy area must be sufficient for the presence of a laboratory, a patient space, a work area, and a place for prescribing medicines. It should also include a permanently power-plugged refrigerator for drugs that require a specific preservation degree.

According to Neameh, the Syndicate also requires the existence of records of psychiatric and narcotic medicines and a dedicated locker, a thermometer, a hygrometer, a sign, in addition to hygiene, insulation and ventilation, and air conditioning if possible.

Among the conditions for obtaining a license to open the pharmacy is the existence of a distance between the pharmacy and the other nearest pharmacy, in a way guaranteeing that pharmacies are not gathered in a limited area and do not leave the rest of the areas without pharmacies.

The head of the Pharmacists Syndicate considered that the procedures for licenses and conditions imposed by the Syndicate are sufficient and effective if applied well, saying that “the adopted procedures are comparable to global procedures.”

Four sources of medicine in northern Syria

There are no clear contracts between pharmaceutical Turkish or local companies and suppliers with distribution warehouses in northern Syria. The region in Idlib Governorate and opposition-controlled Aleppo countryside depend on three main sources of medicine, coming from more than one origin, while there is a fourth illegal source.

Locally-made

The head of the pharmaceutical control department at Idlib Health Directorate, Mohamed al-Haj Hammoud, stressed to Enab Baladi that the medicines spread in the area are either locally-made originating from pharmaceutical laboratories that are already in the “liberated” areas, such as al-Mansura factories in Aleppo, newly-licensed factories by Idlib Health Directorate, or from regime-controlled areas.

According to a document issued by Idlib Health Directorate showing the proportion of medicines in the pharmaceutical market in the north of Syria, the proportion of medicines produced from previously-licensed companies was about 40% in 2016 and rose this year to reach 53%. In contrast, there was no pharmaceutical production from new pharmaceutical companies in 2016, but this year they reached 7%.

The document indicates that 60% of medicines are manufactured from laboratories in the region.

From regime-controlled areas

According to the head of the pharmaceutical control department at Idlib Health Directorate, part of the medicines sold in northern Syria originating from pharmaceutical factories in regime-controlled areas enter the governorate from the crossings that connect the two regions.

According to the document issued by Idlib Health Directorate, 30% of medicines in the north arrive through the crossings between regime-controlled and opposition-controlled areas.

Through Bab al-Hawa and Bab al-Salameh

Some of the medicines enter northern Syria through the border crossings of Bab al-Hawa and Bab al-Salameh with Turkey, and include medicines that come through health sector organizations, according to the head of the pharmaceutical control department at Idlib Health Directorate, Mohamed al-Haj Hammoud.

Hammoud pointed out that most of the medicines imported through Bab al-Hawa crossing from Turkey is subject to “strict” drug control, and can be granted an entrance permit only after obtaining a “conformity certificate compatible with the constitutional specifications.”

The document obtained by Enab Baladi from the Idlib Health Directorate of Health showed that 35 percent of the drugs were reaching the northern sector through Bab al-Hawa crossing in 2016. However, this proportion dropped to 10 percent this year; while the share of non-local medicines remained equal to 30 percent, in north-western Syria, with an increase of 5 percent over the proportion of medicines imported in 2016.

Through smugglers

The fourth source of medicines entering northern Syria is smuggling from Turkish territory to Syria. According to the document obtained from the Idlib Health Directorate, the percentage of drugs smuggled in the region declined this year to 0 percent. However, the locals in the governorate denied such information and assured to Enab Baladi that some pharmacies still sell contraband drugs.

Smuggled drugs are often found in unlicensed private pharmacies, as the Secretary of the Aleppo Pharmacists Syndicate, Salim Abdul Mutti, indicated that public pharmacies operate under the supervision of hospitals, medical centers and are affiliated with organizations. Thus, these pharmacies get their medicine supplies in the form of aid provided by organizations.

Private pharmacies owned by pharmacists have a variety of sources. In fact, some medicines are imported through warehouses, while others are illegally entering from the Turkish-Syrian border.

 

 

Drug control authorities in northern Syria threatened

The deadline set by the German organization GIZ to support the “Empowerment of Health Directorates Project”, which covers a range of medical services in the north of Syria, including the drug control departments in the health directorates of Aleppo, Idlib, and Hama, expires at the beginning of November.

The decision to suspend subsidies directed to the authorities that oversee the drug control process has raised concerns among some citizens, amid doubts about the ability of the directorates to follow up their work in regulating the pharmaceutical sector and combating uncontrolled medicines.

Previously, the decline of activities carried out by the drug control authorities facilitated trade in narcotic drugs, contributed to spreading addiction, and caused numerous drug poisonings in northern Syria.

Fears of going back to ground zero

“Drug control has been instrumental in analyzing and detecting counterfeit medicines, identifying expired and anonymous medicines, food samples, baby milk and vaccines,” said Khaled al-Yaman, a pharmacist in Idlib.

Al-Yaman conveyed in an interview with Enab Baladi that the imposition of drug control previously led to halting the entry of counterfeit and infringing drugs, while the lack of support directed the drug control authorities will open the door for the re-emergence of those problems, which signifies the return to ground zero. He also referred to the need for having active drug control bodies, even on the pharmacist’s own expenses.

Mustapha al-Daghaim, director of drug control at the Idlib Health Directorate, also told Enab Baladi that the suspension of subsidies has negative consequences for the drug control sector. However, he played down the impact of such a step, saying that “most of the workers in the drug control sector are currently volunteering in the hope of finding a new sponsor.”

As for operational costs, al-Daghaim stated that such expenses can be collected through the charges for drug samples’ analysis, i.e. the procedure will not be free of charge.

Auto-drug control

In the absence of support for drug control authorities, there are concerns that organized regulatory action, implemented mainly at warehouses, which are considered by the drug control as the main “gatekeeper”, will further decline, obliging the pharmacists to be partly responsible for ensuring drug control themselves.

A pharmacist working in the northern countryside of Aleppo, who spoke on condition of anonymity for security reasons, told Enab Baladi that government drug control is still in place. However, the absence of future regulatory committees could have a negative impact on the pharmaceutical sector.

Pharmacists are the ones who play the biggest role in realizing the drug control process. If any items are found in the market, data are circulated not to dispense medicines on the market, and the pharmacists are prevented from selling it; and if a pharmacist decides to breach the norm, he is subjected to penalties ranging from fines to imprisonment, or both. Thus, pharmacists are trying to avoid sanctions by staying away from suspicious medicines, i.e. they implement auto-drug control.

According to the pharmacist, most pharmacies in Idlib and the Euphrates Shield areas are licensed and operate under Turkish supervision. However, the areas administered medically by the Aleppo Health Directorate are uncontrolled, as there are still unlicensed pharmacies, raising fears of the increase of such phenomenon in the future.

Medicine sources are part of drug control process

Despite the role that a pharmacist can play in the field of drug control, the pharmacy remains a “profitable” institution, according to the pharmacist working in the northern countryside of Aleppo. The pharmacist is not required to determine the extent to which the product complies with the standards, and may not have the possibility to find out.

Each pharmacy is supposed to be provided with a pharmaceutical guide identical to that provided by the regime’s government to pharmacies in the areas under its control, i.e. the pharmacist must sell drugs by the provisions of this guide.

Therefore, the process of drug control carried out by pharmacists is based on their willingness to avoid getting into trouble. A pharmacist focuses on taking medicines from sources he identifies in 80 percent of the cases.

Most pharmacists tend to procure from well-known local companies, such as Alpha-Pharma, Al Razi, Unipharma, Aubrey, Al Shahba and other companies deemed reliable, as they are primarily controlled, in order to ensure the safety of their practice.

 Complaints are a basis of drug control

 Pharmacist al-Yamani, who works in Idlib, pointed out that supervising pharmacies takes two different forms. The first method is oversight, i.e. by sending a person to buy medicine of a specific type that the authority wants to examine. If there is a problem, the authority requires the pharmacist to submit several samples in addition to the generalizing a memorandum to stop selling the medicine in case it does not comply with the constitutional specifications.  The second method is when the pharmacist sends medicine to be checked by the drug control authority in case of doubting its validity.

With suspending the support directed to drug control authorities, the second method will be the most adopted, while the most effective booster of drug control, currently, are the complaints made about medications.

This type of drug control includes two levels, the citizens’ observance of the pharmacists’ practices, in the event of buying invalid or expired drugs, or knowing about the distribution of illegal drugs, and drug control practiced by pharmacists on warehouses that distribute drugs of unknown origins.