May 2011 PQM News Updates

Liberia moves to ensure quality medicines
Dr. Clavenda Bright Parker, Acting Director of the Liberia Medicines Health Products Regulatory Authority (LMHRA), met with Promoting the Quality of Medicines (PQM) staff and other stakeholders in Monrovia to plan activities that will move the country further toward assuring the quality of its medicines.

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The newly-formed medicines authority examined options to improve medicines registration, expand post-marketing surveillance, and strengthen the national quality control laboratory (LMHRA) to better limit availability of counterfeit and substandard medicines. Poor results from medicines quality monitoring (MQM) conducted as part of a training workshop underscored the need for vigilance: Of 115 antimalarials collected from the Monrovia markets, 56 were tested; 32 failed basic tests, including some injection forms that contained no active pharmaceutical ingredient.

PQM Program Coordinator Dr. Latifa El Hadri displayed the counterfeit and failed medicines at a meeting of major stakeholders. She also pointed out that some antimalarials meant for the public sector were found in the private pharmacies. Dr. Parker promised to recall and incinerate all failed samples as an immediate response and led discussions to find long-term solutions. All those attending agreed on the urgent need to pass legislation and adopt enforceable medicine regulations.

PQM Scientist Sanford Bradby, Dr. El Hadri, and PQM Consultant Dr. Abdelkrim Smine trained five analysts from the LMHRA lab on basic compendial analytical methods, verification testing, and the critical principles of Good Laboratory Practices. The lab staff will regularly be performing verification testing on MQM samples collected in the field. Participants found the hands-on sessions particularly helpful and discussions at the end of each day’s session very instructive. After the weeklong training, they expressed their appreciation of the “critical importance of simple analytical tasks like weighing, pipetting, dilution, and sample transfer and the need to use correct techniques.”

To support the country’s continued efforts to protect the public health, Dr. Smine and PQM Consultant Teferi Lemma spent several days working with Dr. Parker and members of the LMHRA board to craft priority medicine regulations for the new agency. Their objective was to establish the regulations needed to start effective control of the pharmaceutical sector in Liberia based on the reality of the country’s market. Using World Health Organization publications and regulations from other African countries as a benchmark, guidelines were drafted covering the two areas considered top priorities: premise licensing and registration of pharmaceutical outlets, and pre-registration of medicine and health products in Liberia. The drafts must next be reviewed and approved by all members of the LMHRA board.

Mozambique takes steps to improve medicines quality
On a recent trip to Mozambique, PQM Consultant Dr. Abdelkrim Smine met with USAID mission staff and local partners to determine what technical assistance PQM could provide to help strengthen the quality assurance and quality control (QA/QC) of the country’s essential medicines. Toward that end, USAID/Mozambique agreed to build and furnish a new Medicines Quality Control Laboratory that would meet international standards. PQM will provide technical assistance to the Ministry of Health by helping to procure some needed equipment, hiring and training new staff, and establishing a quality system in the interim lab facility. When the new building is ready, the staff will also be ready and well trained.

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PQM also plans to help establish an MQM program in three sites—the northern and central regions and Maputo—in collaboration with USAID and The School of Pharmacy in Maputo. The MQM program will enable Mozambique to sample and test selected essential medicines from the market to ensure their quality.

As a recipient of grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), Mozambique must comply with the GFATM policy of maintaining quality assurance throughout the distribution chain for the medicines they procure. PQM is providing technical assistance to the Pharmaceutical Department of the Ministry of Health to draft a national quality assurance policy and conduct the sampling and testing of selected tuberculosis (TB), HIV, and malaria medicines needed to secure their GFATM funds.

KF training expands proficiency of Mali QC lab
In April, PQM Program Manager Dr. Mustapha Hajjou and Associate Program Manager Ms. Regina Okafor trained 16 laboratory analysts of the Laboratoire National de la Santé (LNS) in Bamako, Mali. Focusing on Karl Fischer (KF) titration, Good Documentation Practices, and Standard Operating Procedures (SOPs), the training helped strengthen LNS’ technical capacity and quality systems. By the end of the course, all of the participants were able to operate the KF titrator and identify quality problems with antimalarial samples. The trainees also drafted an SOP on the use of lab notebooks.

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Following the training, the PQM team and LNS management met to decide what steps to take next on the road to ISO/IEC 17025:2005 accreditation for the lab, a long-term goal that, once achieved, will publicly demonstrate the lab’s proficiency. The group decided to develop a comprehensive implementation plan to work toward ISO 17025 accreditation for High Performance Liquid Chromatography, Dissolution, Ultraviolet-visible Spectroscopy, and KF.

Through the assistance of the President’s Malaria Initiative and USAID/Mali, PQM has been assisting Mali’s Ministry of Health since 2008 to strengthen its medicine quality assurance systems. Activities focus on building the capacity of the Direction de la Pharmacie et du Médicament and LNS in pharmacovigilance, medicine registration, and medicine quality control.

AMI partners reveal vision for the future of malaria control
Partners and stakeholders of the Amazon Malaria Initiative and Amazon Network for the Surveillance of Antimalarial Drug Resistance (AMI/RAVREDA) met in Panama in March for their annual review meeting. There they shared experiences, achievements, and lessons learned from the first 10 years of their malaria control efforts in the Latin American and Caribbean region and planned future strategies and activities.

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PQM staff—Dr. Victor Pribluda, Dr. Lawrence Evans, and Mr. Joselin Quintana—provided an update on the QA/QC of antimalarial medicines in AMI countries and presented the early results from “Case Studies of Malaria Medicine Quality in the Private and Informal Markets of Colombia, Guyana, and Suriname.” The meeting also offered the opportunity to announce the April launch of the Medicines Quality Database, a publicly accessible online resource, and demonstrated how to use the Virtual Forum, a communications tool for quality control laboratories. Both projects were designed to enhance information-sharing about the quality of medicines to safeguard the public from counterfeit and substandard medicines.

At a later AMI Steering Committee meeting, the partners discussed future strategic approaches, including the plan for the quality assurance of antimalarial medicines procured through the “Regional Revolving Fund for Strategic Public Health Supplies (the Strategic Fund).” The Strategic Fund, managed by the Pan American Health Organization (PAHO), is a mechanism to promote access to quality essential public health supplies, including medicines, in the Americas. PQM is exploring potential areas to support ensuring the quality of medicines procured through the Strategic Fund for the next fiscal year.

SAIDI develops plan to control TB in Latin America
International partners in the South American Infectious Disease Initiative (SAIDI) met with country stakeholders in Madre de Dios, Peru, to develop a plan forTB prevention and control that is suitable for local conditions in this decentralized region. The 64 meeting participants identified what assistance each partner can provide over the next two years and determined priority actions. For its part, PQM will provide a Minilab® and work with the Peru Regional Office of Medicines (DIREMID) to establish a program of basic tests to analyze the TB medicines in the region.

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The SAIDI Steering Committee selected the region of Madre de Dios to implement its systemic approach—which has proven successful in addressing antimicrobial resistance in Bolivia, Paraguay and Peru—because of the region’s high levels of TB and multidrug-resistant TB. Madre de Dios has a large migrant population working in the gold mining areas and living in overcrowded conditions. They often lack access to public health services, or even proper information about TB and treatment options, or do not seek medical attention to avoid losing wages. These and other factors exacerbate the spread of the disease and development of drug-resistant strains.

PQM staff also visited the DIREMID, local health facilities, and one of the mining camps. DIREMID performs surveillance of medicines in the private market, but only by visual inspection. Although it removes damaged medicines, or those suspected of being counterfeit, quality testing results from the official medicine control laboratory in Lima can take a year or more to be returned. This affects the timeliness of corrective actions. Conditions in the public health facilities vary; some are modern and have appropriate storage conditions, but others have serious deficiencies. The informal market thrives in the mining area. With the coordinated activities planned during the meeting, the SAIDI partners hope to improve these conditions and reduce the impact of TB in this region.

PQM expands activities in Indonesia

Indonesian anti-TB medicine makers pursue WHO prequalification
PQM Program Manager/GMP Specialist Edwin Toledo traveled to Indonesia in early March to evaluate two manufacturers of first-line anti-tuberculosis medicines for compliance with Good Manufacturing Practices (GMP). Both companies are pursuing endorsement by the World Health Organization (WHO) Prequalification Programme, an achievement that will demonstrate to procurement agencies that the medicines the companies produce meet unified standards of quality, safety, and efficacy. PQM had inspected these firms in November 2010; this follow-up visit evaluated the progress in implementing corrective actions and identified new opportunities for improvement. As part of the technical assistance it provides to companies on the road to WHO prequalification, PQM also reviews the dossiers that manufacturers are required to submit to WHO during the prequalification process. While in Jakarta, Mr. Toledo also met with a third company to review its product dossier and provide suggestions to strengthen documentation in light of recent facility upgrades.

Workshop introduces more manufacturers to prequalification
Fifty-five people participated in a workshop in Indonesia that presented information about the WHO Prequalification Programme and the availability of PQM technical assistance to manufacturers of several anti-TB medicines. At the workshop, held jointly with WHO, the United Nations International Drug Purchase Facility for HIV/AIDS, TB and Malaria (UNITAID), and the Global TB Drug Facility (GDF), PQM staff led discussions to learn how more manufacturers in Southeast Asia could be encouraged to actively participate. Some 38 individuals, representing 17 manufacturers from seven countries in the region, attended the workshop to learn of the need for quality-assured anti-TB medicines to overcome the current limited availability and contribute to the global control of TB and TB resistance. After hearing about the assistance that PQM could provide to help manufacturers meet WHO Good Manufacturing Practices and prepare the documentation required for submission, 16 manufacturers expressed interest in the WHO program and in receiving PQM technical assistance for anti-TB medicines on the GDF/WHO priority list. Seeing the number of companies that stepped forward, UNITAID Supply Advisor Lorenzo Witherspoon expressed his optimism that “solutions to the supply of acceptable quality anti-TB medicines are on the horizon” and reaffirmed the agency’s commitment to its partnership with PQM in the war against tuberculosis.

PQM trains analysts for study on quality of oxytocin
At the request of the Indonesia Ministry of Health, PQM taught 11 laboratory analysts how to evaluate the quality of oxytocin injection in ampoules using USP compendial analytical methods and procedures. The analysts will be conducting a study to assess the quality of existing oxytocin in selected regions of the country, following anecdotal evidence that the ampoules are not being stored properly in some remote health facilities. Oxytocin is an essential medicine used to prevent post-partum hemorrhaging (PPH).

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The course provided refresher training on good laboratory practices and sampling methodology and expanded their analysts’ technical knowledge on the quality control of oxytocin injections. PQM Manager-Asia Programs Dr. Souly Phanouvong instructed them on the study design and methodology, providing detailed descriptions and explanations on the sampling protocol and procedures. Dr. Phanouvong, Chemist Dr. Yanga Dijiba, and PQM Consultant Dr. Asawin Likhitsup first introduced participants to theoretical discussion, followed by two days of practical, hands-on learning of analytical methods. By day four, the analysts could perform the tests independently with a high level of reliability, accuracy, and precision.

A visit to a district health center warehouse and some private midwife clinics in Jakarta in November 2010 revealed that there was no QA or QC in place for the acquisition, distribution, and storage of oxytocin injections. That called into question whether the stocked products in these areas remained potent enough to prevent PPH. The study is a collaborative effort of PATH, PQM, the National Institute of Health Research and Development, and the National Quality Control Laboratory for Drug and Food, supported by the USAID Maternal and Child Health Integrated Program (MCHIP) which focuses on reducing maternal, neonatal and child mortality.

Ghana, Ethiopia labs pursue ISO accreditation
As part of the technical assistance PQM provides, Program Manager Mr. Adrian Barojas recently evaluated the Quality Management Systems (QMS) of the medicine quality control laboratories for Ghana and Ethiopia. Both labs are working to obtain ISO/IEC 17025:2005 accreditation and, eventually, to be listed by WHO as prequalified quality control labs.  Being prequalified by WHO demonstrates that a lab complies with quality assurance policies of the GFATM policies, and therefore, is able to test GFATM-procured medicines, as well as those procured by United Nations agencies and others.

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Mr. Barojas trained the staff of the Ghana Food and Drugs Board (FDB) lab on internal audit procedures, external audit expectations, and other pertinent QMS topics and evaluated their compliance with standard operating procedures. He also worked with the FDB to prepare an ISO 17025 Accreditation and WHO Prequalification Implementation Plan, an important internal document establishing a timeline and guidance through the necessary steps to achieve prequalification.

This was a follow-up visit to the Product Quality Assessment Directorate (PQAD) of Ethiopia’s Food, Medicine, Health Administration and Control Authority. The PQAD had made significant progress in implementing a QMS compliant with ISO/IEC 17025:2005 and WHO Good Practices for Pharmaceutical Quality Control Laboratories since the previous evaluation. Mr. Barojas identified a few nonconformities, suggested corrective actions and timelines to remediate them, and will work with PQAD to prepare for a pre-audit visit in July by ACLASS, an internationally recognized accrediting body.