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2b. Policy: Quality and Safety of Medicines in LMIC
Proposed Set of Indicators for Monitoring and Evaluation of Pharmacovigilance Activities
1University of Benin, Benin City, Nigeria (INRUD Nigeria), Nigeria; 2World Health Organization, Geneva; 3International Collaborating Centre, Uppsala, Sweden
Problem Statement: The thalidomide tragedy triggered global consciousness regarding the safety of medicines. The need to monitor safety issue s regarding the intake of medicines has resulted in the tremendous growth of pharmacovigilance (PV) structures and activities. However, there are no acceptable standard set of indicators to measure and monitor these activities. Furthermore, there are no indices for comparison of measures in relation to baseline periods or inter- and intra-country, region, and facility comparisons.
Objectives: To outline a set of indicators for monitoring PV activities
Design: A qualitative study with the identification of a set of candidate indicators.
Setting: The envisaged setting for use will include country, regional, and health facilities, and public health programmes.
Methods: The set of indicators were identified from several sources— initially from a detailed review of the established pharmacovigilance process/routine, contributions from pharmacovigilance experts, national pharmacovigilance centres, and groups including Pharmacovigilance sans Frontiers (PVSF), the World Health Organization (WHO) Advisory Committee on Safety of Medicinal Products (ACSoMP), WHO/Uppsala Medical Centre, and literature sources.
Results: A total of 64 candidate indicators were identified. The indicators were categorized into structural (19) which assesses the existence of key PV structures, systems, and mechanisms in the setting; process (26) which assesses the entire mechanisms and degree of PV activities; and outcome/impact (19) which measures the effects (results and changes) of PV activities indicators. A set of background information parameters (10) to put into perspective the PV milieu (demographics, economics, health care system, and pharmaceutical scenario) generating the indicator data was also noted. This will also serve to provide the denominator for measuring the indicators. A further categorization into core and complementary indicators were made. A further subset for use in public health programmes is also highlighted
Conclusions: The set of indicators provide a useful robust tool to monitor and evaluate PV activities at various levels of the healthc are system as well as to provide indices for comparison of PV activities at country, regional, and facility levels, and within public health programmes.
Quality of Medicines in South Africa: Perceptions vs. Reality
1Health Research for Action (HERA), Belgium; 2Department of Preventive and Social Medicine, University of Otago, New Zealand; 3School of Pharmacy, University of Otago, New Zealand
Problem statement: To date little is known about how consumers and health care providers understand the concept of quality of medicines and/or the extent to which such understandings affect peoples’ procurement and use behaviours. Such knowledge is needed, especially in light of the increasing availability of counterfeit and substandard medicines in low- and middle-income countries. Although these resource-limited countries face many challenges in dealing with this issue, one approach is to increase awareness of consumers and providers of the dangers associated with the use of poor-quality medicines. These awareness campaigns must be informed by local norms and practices.
Objective: To explore perceptions of medicines’ quality from the perspective of consumers and health care providers and to compare these perceptions to the actual quality of selected medicines in South Africa
Design: Qualitative study involving focus group discussions (n=12) and semi-structured interviews (n=15) to gain familiarity with perceptions of quality; in vitro analysis performed on 135 generic and brand name medicines (paracetamol, amoxicillin and hydrochlorothiazide) sourced from both the public and private sectors, to determine actual quality Identification and dissolution tests based on BP and USP methods were used.
Setting: Conducted at the local level in three cities: Johannesburg, Durban, and Cape Town
Study population: Purposive sampling was used to recruit consumer participants (n=73) representing low, middle, and high socioeconomic status (place of residence and type of employment were used as proxy measures of status: formal and informal). Random sampling was used to recruit health care providers from public and private sectors (n=15).
Results: Respondents described drug quality in relation to the effect on symptoms. Consumers preferred getting their medicines from the private sector. They perceived free and generic medicines supplied by the state as inferior, suggesting that their views of the quality of care in general influence their perception of medicines quality. Procurement and use behaviour of health care providers was influenced by prior experience, manufacturers’ names, and consumers’ ability to pay. All formulations passed the in vitro tests for quality.
Conclusion: The study showed a clear difference between how people perceive the quality of medicines and the actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Education and targeted public campaigns specifically addressing the information needs of consumers and health care providers is one solution to addressing the present mismatch between perception and reality.
Funding source(s): University of Otago Grant and School of Pharmacy
Study on Quality Assurance for Essential Medicines other than ARVs, Antimalarial and Antituberculosis Medicines
1The Global Fund to Fight HIV, Tuberculosis and Malaria, Switzerland; 2Quamed, Institute of Tropical Medicine, Antwerp, Belgium
Problem Statement: The Global Fund’s quality assurance policy for pharmaceutical products requires that ARVs, antituberculosis, and antimalarial medicines procured with grant funds meet internationally recognized quality norms and standards. However, less stringent requirements are in place for other essential medicines, which include life-saving medicines, such as anti-infectives.
Objectives: The study aimed to determine the current quality assurance status of essential medicines other than ARVs, antimalarial, and anti-TB medicines, and to identify areas for improvement to inform policy development.
Design: This descriptive study entailed a questionnaire survey and visits to five recipient countries (Armenia, Burkina Faso, Cambodia, Nepal, and Nicaragua).
Setting: The questionnaire survey was conducted among key donors, grant implementers and organizations with procurement activities. Relevant stakeholders were interviewed during the country visits, including representatives of facilities across levels of health care, regulatory authorities, local manufacturers, recipients of Global Fund grants, WHO country offices, and disease programmes.
Study Population: The questionnaire survey was completed by 27 of 53 organisations contacted. Key informants were interviewed during each of the five one-week country visits.
Results: Based on the outcomes of the study, national regulatory authorization of essential medicines does not by itself give reasonable assurance that pharmaceutical products used in grant-funded programmes meet internationally recognized quality standards. Procurement agencies assume responsibility for quality assurance of the products that they deliver, but many lack the specific pharmaceutical capacity, insight and/or access to information required for this purpose. Quality control testing is overemphasized in relation to more proactive measures such as qualification of sources based on evaluation of product documentation and production sites assessment. Key stakeholders recognize the need for a more stringent approach to quality assurance for essential medicines; however they expressed concerns about possible price increases, reduced access to medicines if the market were to be limited, the impact on local pharmaceutical industries, and the creation of multiple quality standards for these widely-used medicines.
Conclusions: A global harmonized approach is needed to promote adherence to internationally recognized quality norms and standards for essential medicines. Major donors should work together to develop a policy approach and to phase in quality assurance requirements on a risk basis. These donor-driven measures should benefit the wider national health and medicines regulatory systems of recipient countries.
Funding Source: The Global Fund to Fight AIDS, Tuberculosis and Malaria
Interventions to Improve Medication Safety in a University Hospital in Thailand
Pharmacy Department, Siriraj Hospital, Mahidol University, Thailand
Problem statement: Adverse drug events were found to be a major complication for hospitalized patients and most of them were preventable. Several interventions were implemented in Siriraj Hospital during 2000-2010. Medication error (ME) reporting system, drug information service and poison control center (DIS&PCC), adverse drug reaction (ADR) monitoring, and staff and patient education programs were implemented. Some of these interventions are highly accepted and successful, but there is no study to compare and conclude the success factors.
Objectives: To study common success factors of interventions to improve medication safety
Design: Observational descriptive study
Setting: Siriraj Hospital, the 2,300 beds tertiary-care teaching hospital of Mahidol University, Thailand
Study population: Interventions used for medication safety improvement in the hospital during 2000 to 2010
Method: Reports and minutes of team meeting review and discussion with key persons of each team
Policy: Patient safety is a goal of the hospital administration.
Outcome measures: Number of ME reports, ADR prevention reports, phone calls to DIS&PCC, scores of tests in education programs, and factors influenced success of each intervention
Results: ME reporting increased significantly when the manual reporting was changed to an on-line system and manual monthly reports were gathered from nursing and pharmacy departments and sent to the risk management office (p < 0.05). The number of phone calls received by DIS&PCC increased from 2,057 calls to 20,054 calls per year, after the service was changed from 8 hours to 24 hours; the services of toxicologists and staff education programs were also provided. The ADR monitoring team could prevent more repeated known allergy from 152 cases to 3,139 cases per year after a computerized alert in the pharmacy prescription process was implemented and patients were asked a prime question for known allergies. Staff education programs were provided and scores were significantly increased from pre-test to post-test, 68.1% to 88.7% and 63.5% to 81.8% in high-alert drugs and drug administration training, respectively. Patients were empowered to use their medicines correctly and monitor themselves. Patients increased their knowledge scores from 29% to 55% (N = 70, p < 0.05) and from 58.60% to 93.33% (N = 1,502, p < 0.05) in the transplant clinic and anticoagulation clinic drug counseling program, respectively. There were the terms of standards, quality, accreditation survey, multidisciplinary, computer program, counseling, and education in the meeting minutes and discussions. Key persons of each intervention worked after office hours to improve the interventions.
Conclusion: Accreditations from external organizations, multidisciplinary team approach, information technology, patient participation, and devoted personnel are common success factors of interventions to improve medication safety.
Funding source: No funding for this study