what is current practice of pharmacovigilance in hana › 2012 › 04 › day-2_4... ·...
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WHAT IS CURRENTPRACTICE OFPHARMACOVIGILANCE INGHANA?
Adela Gwira(Food and Drugs Board, Ghana
FRAMEWORK, TOOLS, ANDGUIDELINES IN USE IN GHANA
REFLECT ON KEY FINDINGS OF THE SUB-SAHARANAFRICA STUDY REPORT IN TERMS OFPHARMACOVIGILANCE SYSTEM IN GHANA• Dedicated PV Budget at all Levels
• National has dedicated budget for PV• Some PHPs have dedicated budget e.g. Malaria, HIV, EPI, Family Health• Health facilities may not have
• PV training for health care workers: • PV sensitization to all healthcare providers is one of the basic routine activities of the Ghana PV center since 2006.
• Government Health Institutions (Doctors, Pharmacists & Nurses), Licensed Chemical Sellers, PHP (TB, Family Health, EPI)• Private sector not trained (private health care institutions and pharmacies)
• Revising legislation to adequately address safety monitoring: • A new bill is before the Ghana Parliament. It makes specific provision for PV and safety monitoring of products under
section 147 l. It also makes provision mandatory reporting by industry and specifies the responsibilities of industry.• Guidelines which will be made legally binding when the bill is passed also makes provision for all PV stakeholders
including healthcare professionals.
• Developing a comprehensive national guideline• A comprehensive guidelines is in place that identifies the roles of all stakeholders
• MAH, Healthcare professionals, Sponsor / Investigator, Consumers• Provides scope and timelines for reporting• Guidelines reviewed in 2011
• Poor data management and analysis of reports• Update of database to an access system• Arrangements of obtaining an E2B compliant system to enable easy reporting by industry
REFLECT ON KEY FINDINGS OF THE SUB-SAHARAN AFRICA STUDY REPORT IN TERMS OFPHARMACOVIGILANCE SYSTEM IN GHANA• Improving coordination of stakeholders
• Decentralized PV system. • Regional PV offices that collaborate with stakeholders at closer levels
• A single AR reporting form for all drug related problems:• adverse events such as product quality, medication errors, and therapeutic ineffectiveness are all reported using this form. • Education on the use of this form enhanced leading to about 50% of all product quality issues reported using this form• Medication Error under reported, however increasing with increased awareness creation
• Collate reports from PHP routinely collected data and make them available to the PV center. • Collated from EPI , Malaria , Family Health and Ghana Integrated childe health Campaign• Not collated : TB, *HIV , Yaws
• strengthening the DTC’s role in health facilities• Adaptation of a new approach to ensure PV activities are coordinated by the DTCs in all healthcare institutions
• Communication channel, such as a safety newsletter or bulletin, to regularly disseminate safety alerts or the outcome of PV activities in Ghana.
• Use of dear healthcare professional letters • Posting alerts on website• Newsletter (being developed)
• Implementing interventions to improve spontaneous reporting. • Increased public awareness on drug safety (TV and radio interviews) – being designed• Collaborating with organizers of other active studies e.g. INESS
CURRENT PRACTICES
• Regulatory framework addressing post‐market safety and quality surveillance• The existing law addresses issues of product quality
• Tools • Adverse Reaction Reporting form• AEFI Reporting Form• PV Training Manuals for
• Primary Reporters• Institutional Contact Persons and • Qualified Person for Pharmacovigilance
• PV IE&C (Consumer & Healthcare professionals)
CURRENT PRACTICES
• Guidelines • Roles of all stakeholders identified
• Guide to reporting including • Scope• Timelines
TIMELY USE OF INFORMATION FROM WHO AND SRAS
• Sources • WHO Alerts • UMC• FDA• EMA
• With 7 days information circulated to• Registration Department• Post Marketing Surveillance Department• Primary Reporters / Healthcare Professionals• MAH Representatives
• Daily review of websites of these SRAs for safety information of relevance (real time)
COMMUNICATING AND SHARINGPHARMACOVIGILANCE INFORMATION WITHHEALTH CARE WORKERS, CONSUMERS, ANDOTHER STAKEHOLDERS)
• Use of Dear healthcare professional letters :Healthcare workers and DTC
• Posting on FDB website
• Press releases : For product quality issues
• Newsletter (being developed)
SHARE EXPERIENCE IN MEDICINE SAFETYPROJECTS AND ACTIVE SURVEILLANCES INGHANA
• Drugs• 3 CEM of Antimalarials• 2008 ‐ All antimalarials• September 2011 ‐AMFm Antimalarials• February 2012‐ All antimalarials
• Comments• Difficulty in study team reporting events and not reactions• Lost to follow up (wrong phone numbers)• Funding• Availability of medicines• Time intensive (study team)
ACTIVE SURVEILLANCE OF AEFIS TO H1N1-2010• Immunization Campaigns
• Healthy people• A lot of people in a short time
• Collaborated with the EPI• Late initiation of active surveillance activities• Lack of structured system at lower levels for active surveillance• Helped improve the AEFI reporting culture in NIDs and
campaigns and served as platform for the YF campaign• Budget constraints
• Rumors from health activists on radio stations • Conspiracy theory
ACTIVE SURVEILLANCE OF AEFIS TONATIONWIDE YELLOW FEVER IMMUNIZATION -2011• Comprehensive system developed in all 8 regions involved in the immunization out
of 10 region in country
• Institutions not directly involved in active monotoring were reluctant in collaboration
• Assessment of training and information disseminated very helpful in correcting misunderstanding
• Late cascaded training resulting in information dilution which could not be corrected for start of campaign
• Need for clear IE & C messages to be developed early for the general public
• Active monitoring helped identify some structural deficiencies in EPI distribution system
ACKNOWLEDGMENTS
• Mrs. Delese Mimi Darko (Head, National Pharmacovigilance Centre)
• National Pharmacovigilance Centre• Expanded Programme on Immunization