Posted: September 25, 2009

Amazon regional labs share QA experiences–For three days, 25 directors, key staff, or analysts from the Official Medicine Control Laboratories (OMCLs) of eight countries–Brazil, Colombia, Ecuador, Guatemala, Guyana, Jamaica, Panama, and Peru–looked for common ground to strengthen their own institutions and improve communications among them for future collaborations. Staff from DQI and the Pan American Health Organization (PAHO), partners in the Amazon Malaria Initiative (AMI), facilitated discussions as participants explored possible networking opportunities, shared technical expertise, and exchanged medicine quality data to enhance the ability of all the OMCLs in the region to assure medicine quality.

Significant disparities in the participating OMCLs' technical abilities in quality assurance and quality control (QA/QC) have come to light during PAHO and USP capacity-building activities over the last few years. While previous national and regional trainings had focused on analytical methods and quality management system assessments, this workshop provided the OMCLs an opportunity to identify their individual lab's needs, discuss practical solutions, and exchange technical and managerial approaches to building sustainable QA/QC mechanisms. In the concluding exercise, each OMCL generated a recommendation letter to their country's medicine regulatory authority specifying what actions needed to be taken to implement change and suggestions on how they might advance through interaction with their regional counterparts.

"Fostering interaction among the AMI OMCLs will allow each lab to more effectively make use of the limited human and financial resources available to them," said DQI Program Manager Adrian Barojas. "That will not only improve the capacity of each participating country, but build a stronger regional structure to ensure the availability of good quality medicines." Barojas, along with Program Director Patrick Lukulay and Regional Manager-Latin America Programs Victor Pribluda, facilitated discussions and working groups for DQI; Jose Maria Parisi, Specialist, Quality Assurance and Safety of Pharmaceuticals, and Victoria de Urioste, Subregional Advisor for Medicines, Vaccines and Health Technology–Andean Region, served the same function on behalf of PAHO.

On the final day, Peru's Centro Nacional de Control de Calidad (CNCC) or National Center for Quality Control, hosted a tour of their ISO-accredited laboratory. (The CNCC attained the internationally recognized accreditation for testing and calibration laboratories, ISO/IEC 17025:2005, for five critical analytical tests in March 2009). There, participants took part in a mock audit, learning how to evaluate a laboratory's quality management system against international standards and discussing where their OMCL would need to advance to qualify for accreditation.

Lukulay addresses commonwealth pharmacists © 2009 CPAC

DQI Director Speaks to Pharmacist's Conference in Ghana–Speaking to more than 2,000 pharmacists at an annual conference in Ghana, DQI Director Dr. Patrick Lukulay reiterated the threat that substandard and counterfeit medicines present to global health. As a plenary speaker, Dr. Lukulay emphasized the challenges health care systems face dealing with such substandard and counterfeit medicines, describing how they undermine investments to health care systems, erode patient trust in medicines, and can lead to sub-potent treatment, drug resistance, treatment failure, and death. Dr. Lukulay talked about DQI's role in detecting the counterfeit antimalarial Coartem recently found in Kumasi, Ghana, and encouraged the citizens of African countries when buying medicines to "not put undue focus on price over quality."

The 10th Commonwealth Pharmacists Association Conference and the 74th Pharmaceutical Society of Ghana Annual Conference were held in Accra, Ghana, August 3-9, 2009. The theme of this year's conference was "Managing Threats and Crises: The Role of Pharmacy in an Unstable World." The conference was attended by the Vice President of Ghana, John Dramani Mahama; the Deputy Director-General of WHO, Anarfi Asamoa-Baah; Global Health Cognizant Technical Officer for USAID/Washington, Anthony Boni (DQI's CTO); as well as USP board member, Mary Anne Koda-Kimble.

Centers of Excellence offer trainings for healthcare workers in Southeast Asia–Two recent trainings–conducted by members of the Asian Network of Excellence in Quality Assurance of Medicines (ANEQAM) that was established with DQI support to serve as a regional resource for medicine quality assurance–highlighted the importance of good quality medicines toward protecting the public health in the SEA region.

The Faculty of Pharmacy of Mahidol University conducted a "Center of Excellence Training on Good Manufacturing Practices (GMP)" in August for 10 inspectors–seven from the medicine regulatory authorities and three internal GMP auditors for private companies–from Cambodia and Laos. Participants learned about GMP compliance through classroom lecture and hands-on training, and performed a GMP inspection during a site visit to the Thailand public medicine manufacturing factory. The group also shared ideas and experiences about the challenges and opportunities they encounter implementing GMP in Southeast Asia. The President of Mahidol and Minister Counselor to the Ambassador of the Lao PDR gave opening remarks, commending the training as an "important step toward building expertise in medicine quality in the region."

Following the first day's session, observer Dr. Charles Delacollette of the World Health Organization Mekong Malaria Programme, Dean of the Mahidol Faculty of Pharmacy Chuthamanee Suthisisang, and DQI Consultant-Southeast Asia Chris Raymond were interviewed by Radio Thailand and The Nation newspaper. Each spoke about the training activities, the important role GMP plays in ensuring quality medicine in the supply chain, and Mahidol's high standard of teaching and the role it plays to improve medicines in Thailand and the region.

The Faculty of Pharmaceutical Sciences of Chulalongkorn University, just weeks before, had partnered with DQI to deliver a "Workshop on Advanced Testing of Tuberculosis Medicines" for 13 drug quality control analysts from Cambodia, Laos, Thailand, and Vietnam. Ensuring the good quality of medicines for tuberculosis (TB) is particularly important to these countries because strains of multi-drug resistant and extensively-drug resistant TB have developed in the region.

Dr. John MacArthur, Infectious Diseases Team Leader for the United States Agency for International Development/Regional Development Mission for Asia (USAID RDM/A) opened the Chulalongkorn training, saying:

"Through the work of partners such as ANEQAM, we know that counterfeit and substandard drugs are a large problem in Asia. We need to continue to ensure that there are sufficient qualified drug quality specialists who will commit themselves to the important work of surveillance. Without this constant vigilance, unscrupulous characters will continue to flood the region with poor quality drugs and negatively impact the advances that have been made in TB control."

Mahidol University and Chulalongkorn University–both located in Bangkok, Thailand–have delivered training sessions with DQI on good laboratory practices, advanced testing methods, and good manufacturing practices for healthcare workers from the region.

Toledo conducts GMP audit with Sintez lab management. Sintez staff discusses findings with DQI. © 2009 Sintez staff

DQI provides TA to Russian manufacturer of anti-TB medicines–Program Manager and GMP Specialist Edwin Toledo conducted a baseline assessment of Sintez Pharmaceuticals in August to evaluate the company's Good Manufacturing Practices (GMP) in production of two second-line anti-tuberculosis medicines. The company is pursuing approval from the World Health Organization (WHO) Prequalification Programme for their Kanamycin Powder and Levofloxacin Tablets, two medicines in short supply for the treatment of multidrug-resistant tuberculosis (MDR-TB).

The USAID/Global Health-TB team affirmed Sintez as a potential manufacturer to seek WHO Prequalification for the much-needed MDR-TB medicines following a Global Drug Facility (GDF) Super Team meeting in March. Mr. Toledo and Program Manager Kirill Burimski visited the company's JSC manufacturing site in Kurgan and met with Sintez Technical Director Ivchenko Sergey to evaluate the status of their compliance with GMP standards in manufacturing kanamycin and levofloxacin. DQI will recommend a corrective action plan for the non-critical deficiencies it found and will provide technical assistance to Sintez in preparing the required dossiers for submission to the WHO Prequalification team.

DQI has been providing technical assistance to manufacturers of second-line anti-TB medicines at the request of the GDF, supporting its efforts to increase the availability of good quality second-line anti-TB medicines at an affordable price. Russia ranks 12th on the list of 22 high-burden TB countries in the world and has the third largest number of MDR-TB cases. While in Russia, the DQI team also met with the staffs of USAID/Russia Mission and ROSZDRAVNADZOR (Russia's FDA) in Moscow to discuss DQI activities and to ask their assistance identifying other manufacturers willing to pursue WHO Prequalification.

USAID Responds to Menace of Avian Flu—USAID will award up to $35 million over three years to the Food and Agriculture Organization (FAO) for enhanced coordination of the international response to Avian Influenza. Forty-five (45) new cases of human H5N1 infection have been confirmed in three countries in Asia and North Africa so far in 2009, bringing the total to 440 since reporting began in 2003; 262 of those have resulted in death. (From the World Health Organization Web site, August 31, 2009.) Visit the USAID Web site for details about the USAID preparedness and response.

The Drug Information Center (DIC) of Cluj, Romania, has developed informational pamphlets on avian influenza (bird flu) H5N1, which has reportedly been identified among poultry in Turkey and Romania, as well as in several Asian countries. Though spread of H5N1 virus from person to person has been rare, the Cluj DIC prepared two leaflets, targeted toward patients and toward pharmacists and doctors, that provide background on the flu, alert readers about flu symptoms, and describe preventive measures and alternative treatments. The patient  (138KB) and professionals  (360KB) pamphlets are being distributed [in Romanian] throughout pharmacies in Cluj and neighboring counties.

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