THE REGULATOTY SYSTEM IN THE PHARMACY COUNCIL

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THE REGULATOTY SYSTEM IN THE PHARMACY COUNCIL

• OUTLINE
• THE COUNCIL
• FUNCTIONS
• VISION MISSION
• STRUCTURE
• MODE OF OPERATION
• REGULATORY SYSTEMS
• CHALLENGES
• CONCLUSION

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IDEAL SYSTEM

• INNOVATIVE
• RESPONSIE TO SOCIETAL NEEDS
• PROACTIVE
• INDEPENDENT
• LEGAL BACKING
• COST EFFECTIVE

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PHARMACY COUNCIL, GHANA

• INTRODUCTION
• The Pharmacy Council was inaugurated on 27th
  October 1995, with a clear mandate defined by the
  Pharmacy Act 1994 (Act 489). The ministerial
  responsibility rest in the Minister of Health.
• Historically it is one of the two regulatory
  organisations established from the Pharmacy
  Board.
• The establishment of the two organisations is a
  direct recognition of the growing needs of the
  nation with respect to the manufacturing,
  distribution, and rational use of medicines.
• The Pharmacy Council is a nine-member body
  appointed by the President upon the advice of the
  Council of State.

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THE FUNCTIONS OF THE PHARMACY COUNCIL

• The Council is charged with the primary
  responsibility for securing in the public
  interest the highest standards in the practice of
  pharmacy in Ghana.

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CONT

• Other objectives of the Council include
• Ensuring that courses of study and training in
  pharmacy at any institution in Ghana guarantee
  the necessary knowledge and skills needed for the
  efficient practice of pharmacy
• Determining, in consultation with the appropriate
  educational institutions, courses of instruction
  and practical training for pharmacy students
• Prescribing standards of professional conduct
• Exercising disciplinary power over pharmacists
• Upholding and enforcing professional standards
  through the disciplinary powers conferred on it
• Keeping a register of duly qualified and
  practicing pharmacists and
• Regulating the distribution of pharmacies in the
  country.

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VISION MISSION

• VISION
• TO GUARANTEE THE HIGHEST LEVELS OF
  PHARMACEUTICAL CARE.
• MISSION
• TO SECURE THE HIGHEST LEVEL OF PHARMACEUTICAL
  CARE BY ENSURING COMPETENT PHARMACEUTICAL CARE
  PROVIDERS WHO PRACTICE WITHIN AGREED STANDARDS
  AND ARE ACCESSIBLE TO THE WHOLE POPULATION.

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CONTD

• IN ADDITION WE SHALL COLLABORATE WITH RELATED
  LOCAL AGENCIES AND INTERNATIONAL PHARMACEUTICAL
  ORGANIZATIONS TO ENHANCE OUR EFFECTIVENESS AND
  CONTRIBUTION TO RATIONAL MEDICINES USE IN THE
  NATION. THIS MISSION SHALL BE CARRIED OUT WITH
  DEDICATION, INTEGRITY, AND PROFESSIONALISM.

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PRESENT STRUCTURE OF THE PHARMACY COUNCIL

• The nine presidential appointees constitute the
  highest policy and decision-making body.
• To facilitate effective operations of the
  Council, the Act grants the Council the power to
  appoint such committees and assign specific
  responsibilities as may be deemed necessary.
• In addition to the committees, inspecting
  pharmacists and other officers are appointed in
  consultation with the Public Services Commission
  for the effective and efficient execution of its
  functions.

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PHARMACY COUNCIL ORGANOGRAM

MINISTER
COUNCIL
REGISTRAR
DEPUTY REGISTRAR CIP
CHIEF ACCOUNTANT
PRIVATE SEC.
MANAGER Premises Licensing Enforcement
Dept. ACIP
MANAGER Information Management Research
Dept. ACIP
MANAGER Regional Co-ord. National
Inspections Dept ACIP
MANAGER Administration ACIP
MANAGER Training Education Department ACIP
PERSONNEL
TRANSPORT
STORES
ESTATE
REGIONAL MANAGERS
PIP
SECRETARIAL SUPPORT
DRIVERS
CLEANERS
SECURITY

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COMMITTEES OF THE COUNCIL

• Disciplinary Committee
• General Purpose Committee
• Registration Committee
• Education Committee
• Finance Committee and
• Management/Executive Committee.

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MODE OF OPERATION

• The Registrar is the Chief Executive of the
  Council and assisted by a Deputy Registrar.
• Currently, the operations of the Council are
  carried out through four Departments at the Head
  Office and eight Zonal/Regional Offices
  throughout the country.
• The four Departments are
• Information Management and Research
• Premises Licensing and Enforcement
• Education and Training
• Regional Coordination and National Inspections

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CONT

• As part of its ongoing decentralisation
  programme under Section 10 of the Pharmacy Act,
  Act 489, the Council has so far established eight
  Zonal/Regional offices which serve all the ten
  Regions of Ghana
• Kumasi - Ashanti region
• Sekondi - Western region
• Cape Coast - Central region
• Ho - Volta region
• Sunyani - Brong Ahafo region
• Accra - Greater Accra region
• Koforidua - Eastern region and
• Tamale - Northern, Upper East
• Upper West regions

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REGULATORY SYSTEMS

• The Pharmacy Council seeks to regulate
  pharmacy practice through the following strategic
  operational activities
• Education and Training
• Licensing and Registration
• Inspections and Monitoring
• Enforcement
• Public Relations
• Information Management Research
• Management Administration
• Collaboration with Stakeholders

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EDUCATION TRAINING

• B. Pharm. Syllabus reviewed
• Accreditation policy for B.Pharm programs
  developed and being implemented.
• Similarly the accreditation policy for Pharm D
  program has been developed and it is envisaged
  that Pharm D shall become the minimum
  qualification for registration as a pharmacist in
  Ghana.
• Strengthened Internship program
• Accreditation policy for training of Medicine
  Counter Assistants (MCAs) developed implemented
• CE programs for Pharmacists reviewed through
  training needs assesment survey
• Conducts training programmes annually for
  pharmacists and Licensed Chemical Sellers
• Policies for the registration and training of
  Pharmacy Technicians and Medicine Counter
  Assistants developed and being implemented to
  ensure that all staff in a pharmacy are
  adequately trained to perform their respective
  roles.

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SERVICE PROVIDER TRAINING STATISTICS
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REGISTRATION OF PHARMACISTS IN GHANA

• The Pharmacy Council provides specific
  predetermined qualifications for licensure of
  pharmacists in Ghana.
• These include the following
• A minimum of a pharmacy degree (B Pharm) or its
  equivalent
• A twelve (12) month- period practical training
  in various disciplines of pharmacy practice, i.e.
  hospital, community, industry and or academia or.
• A three month (3) month practical exposure for
  foreign practising pharmacists only.
• Sit and pass the Ghana Pharmacy Professional
  Qualifying Examination (GPPQE)
• Undertake another twelve (12) month- period
  post-qualification District Hospital training
  before certification.
• Register as a pharmacist in Ghana.

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RE-LICENSURE OF PHARMACISTS

• Any pharmacist seeking to retain his/her name
  in the register of pharmacists and hence practice
  in Ghana, for every two years must satisfy the
  following
• Be in good standing in accordance with the
  regulations prescribed by the Pharmacy Council
  and any other statute.
• Satisfy the minimum 15 credits required for
  Continuing Education obtained from at least two
  CE sources
• Provide documents to prove credits obtained
• Pay the prescribed fee.

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LICENSING REGISTRATION

• PC licenses both premises and the service
  providers as follows to enforce standards
• Premises Yearly
• LCS - Yearly
• MCAs - Every 3 years
• PTs - Every 3 years
• Pcists - Every 2 years
• Policy on re-licensure for all pharmaceutical
  service providers developed and implemented.
• Policy on access to pharmaceutical care guides
  the registration of facilities service
  providers.

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LICENSING REGISTRATION

• Improved system of registration of Pharmacists
  i.e.. PreReg. manual
• Standards of practice for premises and service
  providers developed and implemented.
• Database of Pharmaceutical service providers
  improved.

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INSPECTIONS MONITORING

• Improved Inspections Monitoring through
  decentralization and prudent resource allocations
• Inspections Policy reviewed and implemented.
• Every licensed facility is inspected at least
  once yearly.
• Well trained and resourceful Inspectors.

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CONT

• Regular audit system for assessing effectiveness
  of inspections.
• Code of conduct for Inspecting Pharmacists been
  implemented
• Service provider education during inspections and
  monitoring visits.
• Policy on inspection monitoring of
  hospital/clinic dispensaries (both public and
  private) developed and implemented.

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ENFORCEMENT

• Policy on Enforcement developed and being
  implemented - Investigations, Sanctions
  prosecutions.
• Disciplinary procedures for all pharmaceutical
  service providers developed and implemented.
• Developed capacity to use legal system
• Developed guidelines for Legislative Instruments
• To educate the general public and service
  providers on some features of enforcement policy
• Avenues for complaints/redress by both
  pharmaceutical service providers and the general
  public provided.
• PC/FDB joint police swoops at market places and
  in buses to arrest medicines peddlers.

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INFORMATION MANAGEMENT RESEARCH

• Information management capacity developed.
• Regular evaluation of information needs flow
  system
• Effective management and update of Registers
• Pharmacy Council website launched.
• Head office networked.
• Head office Regional Offices to be networked
  for effective decentralization
• The use of PDAs for field work feeding into the
  main system.

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COLLABORATION

• Well-defined developed policies on the nature
  and outputs of collaboration.
• Currently the Council had formally signed MOU
  with FDB, PSGH and concluded terms for
  collaboration with TMPC.
• Continuing Education program for pharmacists is
  jointly organized by the PC PSGH
• Machinery for communicating and sharing relevant
  information with these strategic and
  collaborative partners developed and implemented
• Examples of collaborating institutions are as
  follows
• FDB,TMPC, HRU-GHS, MCP-MOH, GNDP, PSGH,
  DANIDA, WHO, GNCSA, AGs Dept, GPSA, NMC, MDC,
  GRNA, PHARMACY PROPRIETORS, CHAG, PHMHB, GSB,
  etc.

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STRATEGIC DIRECTION

• To improve access to pharmaceutical facilities
  esp. in needy and deprived areas (District
  Pharmacy Concept)
• To ensure quality service provision by
  pharmaceutical care providers
• To ensure compliance to practice standards.
• Foster partnership collaboration
• Empower consumers through IEC activities
• Develop institutional capacity

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CHALLENGES

• Inadequate comprehensive enabling legislation
  with regulations and supportive guidelines that
  applies to current environmental changes.
• Not well-informed consumers.
• Brain drain of Pharmacists
• Blatant flouting of rules and regulations
  governing the practice of Pharmacy.

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DRUG PEDDLING AT MARKET PLACES
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CONT

• A recent pharmacy practice research conducted
  by the Council in private hospitals/clinics in
  Accra gave the following key findings
• All the facilities visited provided
  pharmaceutical service without a license/permit
  to stock supply medicines to patients.
• No pharmacist engaged or employed by any of the
  facilities visited was present at the time of
  conducting the study.
• However, 20 of the facilities visited claim to
  have pharmacists in-charge of their dispensary
• 70 of the facilities visited had dispensaries
  managed by either a Dispensing Technologist/Techni
  cian, a nurse or a ward/health assistant.
• 30 of the facilities visited did not have
  separate dispensaries but they were dispensing
  from the consulting rooms.
• In general, the range of medications dispensed
  cut across all the categories of medicines
  approved for use in Ghana.

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CONT

• Other specific key challenges of the Pharmacy
  Council are
• Inadequate staff
• Lack of logistics and equipment to monitor and
  enforce regulations
• Inadequate funds to maintain programmes
• Low priority given Regulation within MOH

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Cont.

• Abuse of exemption clause -the
  supply of a drug by medical practitioner, dentist
  or vet surgeon to a patient in urgent need of
  treatment. (section 36 (2) (a)
• ..the right (subject to the provisions of any
  enactment) to prescribe and store dangerous and
  restricted drugs. ( Med and Dental Degree 1972)

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CONCLUSION

• The future for achieving our vision of
  guaranteeing the highest level of Pharmaceutical
  care is bright and we need to remain focused and
  continue to engage with stakeholders for a
  healthier population than before.

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THANK YOU