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Posted: August 25, 2009


LCDR. Hardin presents USP-NF to Dr. Sultani ©2009 USN

U.S. military and DQI aid Afghani national lab—Dr. Brandon W. Hardin saw a need in Afghanistan and stepped in to fill it. Lieutenant Commander Hardin, a pharmacist with the U.S. Navy currently assigned to the 400-bed Afghan National Army (ANA) hospital in Kabul, mentors the hospital pharmacy staff and advises the ANA medical leadership on pharmaceutical acquisition and distribution. He recently went “above and beyond” to acquire a current edition of the U.S. Pharmacopeia-National Formulary (USP-NF) for Dr. Kamela Sultani, Director of the Food and Drug Laboratory (FDL), a reference much needed to ensure the safety and well-being of her patients.

LCDR. Hardin initially visited Dr. Sultani to explore the possibility of the FDL and ANA hospital working together to improve medicine quality for the ANA soldiers. In discussing the challenges Dr. Sultani encountered in performing her duties, one issue quickly came to light—outdated references. The FDL is the official medicine quality control laboratory of the Islamic Republic of Afghanistan, yet the only USP-NF available to the lab was nine years old. LCDR. Hardin contacted USP’s Drug Quality and Information (DQI) staff inquiring about how he could help the FDL obtain an updated USP reference. DQI sent him a 2009 USP-NF in June, which he presented to Dr. Sultani who was very happy and grateful to receive it.

The FDL performs quality testing on medications imported into the country. “They seem to me to be doing a great job of testing the products with the staffing and equipment they have,” said LCDR. Hardin.

DQI applauds LCDR. Hardin’s efforts to keep medicine quality in the forefront under such difficult circumstances. “We were very happy we could assist in this effort and support one of our soldiers in Afghanistan,” said Patrick Lukulay, Ph.D., DQI Program director. “It is very rewarding to see how USP–NF is used throughout the world to promote good quality medicines.”

Lao making progress in monitoring medicines—Early in July Dr. Souly Phanouvong, Drug Quality and Information (DQI) Regional Manager—Asia, made first-time visits to four sentinel sites in the Lao People’s Democratic Republic (PDR) that participate in DQI’s medicine quality monitoring (MQM) program. Accompanied by two staff from the Lao Food and Drug Department and the Food and Drug Quality Control Centre, Dr. Phanouvong traveled to Luangnamtha, Xiengkhouang, Savannakhet, and Champasak provinces to obtain a better understanding of the situation in those remote areas. The team provided technical guidance to the sentinel site staffs and followed up on the progress of the MQM program in those regions.



Dr. Phanouvong, Dr. Sengaloundeth (FDD), Mr. Sengmany and Mr. Phoummanivong (FDQCC) visit sentinel sites and pharmacies in remote areas ©2009 FDD staff

Meeting with provincial and district health authorities at each site, the team learned firsthand what progress has been achieved and the challenges that still lay ahead. All four sites use Minilabs® supplied by DQI to test medicine samples collected from the surrounding area. Dr. Phanouvong and the Lao officials observed the sentinel site staffs to ensure that they were following the proper DQI protocol for sampling, testing, documenting, and reporting results. Provincial health authorities told the visitors that they consider the MQM program an essential tool to obtain evidence on the quality of medicines sold in their respective provinces. MQM data is used to influence policy makers to act against violators through seizures, market withdrawals, product destruction, or other appropriate regulatory measures.

The provincial authorities report that the quality of medicines in Laos has improved in recent years, with fewer counterfeit and substandard samples being found by the MQM program. Manufacturers, distributors, retailers, health care professionals, and consumers are increasingly aware of the dangers of substandard medicines. Despite these advances, provincial authorities said that much remains to be done; they have requested that the DQI program expand to include more provinces, reaching even more remote areas.

DQI began implementing the MQM program in the Mekong region in 2003. The program has grown from 17 to 39 sentinel sites in four countries (Cambodia, Laos, Thailand, and Vietnam) and has broadened its scope to include antimalarial, antiretroviral, and anti-tuberculosis medicines, as well as oseltamivir (for treatment of avian influenza) and some commonly used antibiotics.

Senegal health authorities take a message against illicit medicines to the streets—Music, dramatic sketches, banners, and speeches marked the launch of Senegal’s National Campaign of Sensitization against “street” drugs, counterfeits and unauthorized medicines circulating in the country’s markets. The week of festivities, held in Dakar and nearby regions July 20-24, were intended to educate the public about the importance of buying drugs from authorized retailers and alert illicit vendors of the crime they are committing and the penalties that could ensue. The campaign continued through August 15 with radio announcements and TV spots.


Dr. El Hadri, Pr. Diop and others look on as counterfeit medicines burn just outside Dakar ©2009 DPL staff

Red Black rapped dangers of counterfeits and confiscated products burned in Senegal IEC campaign © 2009 DPL staff

“These street drugs are a real poison,” said DPL Director Prof. Pape Amadou Diop. “Indeed, the wrong dose can make the same product toxic just as the right dose can be used to relieve the sick.” Prof. Diop urged top public officials to counteract “this scourge” by “tracking down counterfeiters, punishing them and seizing products.”

The Direction de Pharmacie et Laboratoires (DPL), Board of Pharmacists of Senegal (BPS), and Service National de l'Éducation et de l'Information pour la Santé (SNEIPS) organized the campaign, which also targets policymakers, administration officials, and health authorities. This is an attempt to sensitize them to the negative effect on the public health when medicine regulations are not upheld. Such notables as the General Secretary of the Ministry of Health, the Governor of Dakar, World Health Organization (WHO), U. S. Agency for International Development (USAID), and BPS spoke out about the importance of buying medicine from authorized retailers.


Dr. El Hadri teaches Touba site staff how to report MQM data ©2009 DPL staff

Dr. Latifa El Hadri, DQI Program Coordinator for Africa, attended the National Sensitization Campaign celebrations, as did USAID/Senegal Acting Mission Director Peter Trenchard. DQI had provided support by funding the production of the troupe “LIBIDOR” sketch, broadcasting radio announcements, and producing flyers, t-shirts, banners, and posters. Other activities included a bonfire, where thousands of illicit antimalarial, analgesic, and other medicines seized during enforcement actions were publicly destroyed; a student march; and, press conferences by the Ministers of Health and the Interior.

Dr. El Hadri has been working with Pr. Yerim Diop and Pr. Mounirou Ciss, also from the DPL, to establish a medicine quality monitoring (MQM) program in the country. Government health program directors and other stakeholders involved have signed off on the MQM protocol, and Dr. El Hadri has trained the staff from the Touba sentinel site, who will perform the sampling, on how to implement the new protocol and perform testing using one of the six GPHF Minilabs® DQI has provided for the program.

Counterfeit antimalarials found in Ghana with DQI help—Prescription antimalarial medicines found in Ghana in July were identified as lacking any of the claimed active pharmaceutical ingredients of the Novartis Coartem® product it was being sold as, posing a significant health threat to patients relying on the medication. The products were removed from the market after being confirmed as fake by the Ghana Food and Drug Board (FDB).


© 2009 Photo courtesy of Ghana Food and Drug Board

The discovery was made by a vigilant citizen who brought a suspicious sample of Coartem® to one of five sentinel sites set up in coordination with the Ghana FDB and other partners, with funding from USAID/Ghana under the President’s Malaria Initiative. The sites are part of the Medicine Quality Monitoring program established by the Drug Quality and Information (DQI) Program supported by the U.S. Agency for International Development (USAID) and implemented by U.S. Pharmacopeia. After failing initial testing at the site, further testing by FDB confirmed the medicine was indeed counterfeit.

“This episode illustrates that the system the DQI Program established to improve drug quality by removing counterfeits is working,” said Rev. Jonahan Martey, head of the FDB’s Quality Control Laboratory. “Our joint efforts have only just begun to improve the public health situation here in Ghana, which has been continually challenged by the overwhelming presence of poor quality medicines. I look forward to continuing our work together to address malaria and other neglected diseases in the country—among the biggest threats to the citizens of Ghana.”

The FDB has seized drugs from wholesale and retail pharmacies as well as from licensed chemical sellers and has warned patients about the presence of the fake Coartem® tablets.

DQI assists Mali with QA/QC, drug registration and PV—Dr. Mustapha Hajjou and Mr. Sanford Bradby traveled to Bamako, Mali, in May to work with the country’s drug regulatory authority on its drug quality assurance programs. A DQI assessment, carried out in November 2008, had determined that the highest priorities to improve overall quality assurance systems would be strengthening the capacity of the National Quality Control Laboratory (LNS) and the drug registration system, and establishing a pharmacovigilance program.


Dr. Hajjou trains Mali analysts at National Quality Control Laboratory ©2009 S. Bradby

The assessment revealed that the LNS needed essential materials and the LNS staff needed training to function more efficiently. DQI provided reagents, reference standards, and lab equipment; helped qualify their existing equipment; and will continue to help LNS maintain their instruments. The DQI team also trained ten LNS analysts on Good Laboratory Practices, HPLC, and dissolution. Future trainings in analytical methods and quality systems aim to lay the groundwork for bringing the lab up to the level of World Health Organization (WHO) standards.

In other activities DQI staff conducted in May, a workshop brought together stakeholders working to establish a pharmacovigilance (PV) program in Mali. The participants learned the basic principles of PV, defined roles and responsibilities of the national PV center, and developed a “national action plan.” DQI joins the drug regulatory authority (DPM), the Centers for Diseases Control (CNAM), the World Health Organization (WHO), and other local partners in these efforts to help monitor the safety of Mali medicines.

DQI also facilitated installation of the newest version of SIAMED, WHO’s drug registration software and a training course for all six DPM staff involved with drug registration and drug import verification. The software will help improve the effectiveness of Mali’s drug registration function and streamline this component of the QA/QC the country’s quality assurance systems.



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