1

Establishment, Functions, Organization Structure and Powers

of the Pharmacy Council of Tanzania
 Pharmacy- Means any approved premises from which any service
pertaining to practice of a pharmacist is provided.

 Pharmacy practice - Means any acts pertaining to the scope of

practice of a pharmacist, pharmaceutical technician or
pharmaceutical assistant as approved by the Council.

 Medicines or Pharmaceutical products- Means any substance or

mixture of substances manufactured for diagnosis, treatment and
prevention of diseases or abnormal physical or mental state or their
symptoms in a man or animal.

 Register- Means a Register maintained under pharmacy act of

2011

 Registrar- Is a Senior Pharmacist in the public service appointed

by The Minister of health to be the Registrar of the Council

Reasons for the establishment of the pharmacy council of act 1 of

2011
 Trade liberization
 Development of science and technology
  The amendment of the pharmacy act of 2002
 The need to control the pharmacy field

The members of the Council

o A Chairman appointed from amongst persons registered as
pharmacists from private sector.
o The Chief Pharmacist from the Ministry of Health and Social
Welfare;
o Pharmaceutical Society of Tanzania’s representative;
o A Principal from a public higher learning institution that offers
training in pharmacy;
o A representative of the Attorney General;
o One Pharmaceutical Technicians from the Tanzania
Pharmaceutical Technicians Association
o One person from the public whose qualifications and experience
can assist the Council and the development of the pharmacy
profession.
 The Council may co-opt any person to attend its meetings but the
person shall not have a right to vote.
 The members shall elect one of their numbers to be the Vice-
Chairman of the Council and any member elected as Vice-Chairman
shall, subject to his continuing to be a member, hold office for a term
of one year from the date of his election, but shall be eligible for re-
election.
 MoCGEC

P. COUNCIL

MANAGEMENT & ADMIN.

REGISTRAR
DPT

REGISTRATION DPT
EDUC. & TRAIN.
DEPT.

PHARMACY PRACTICE &

PROFESSIONAL ETHICS

functions of the pharmacy council

 Uphold and safeguard the acceptable standards of pharmacy
practice
 Enquire into any query relating to a pharmacy practice raised by
the public;
 Maintain and enhance the dignity of the pharmacy profession
 Regulate standards and practices of the pharmacy profession;
 Keep and maintain registers, Rolls and Lists for the registration
 Promoting rational use of medicine
 Collection of annual registration fees
 Advising the minister
 Regulate pharmacy practice
 Ensure training institutions render quality education

The Powers of Pharmacy Council of Tanzania

 Registration of personnel.
 Removal of personnel from the register
 Setting of curriculums
 Settle disputes
 Appointment of officers to work on their behalf.
 Delegate power to appointed officers
 Allocation of power among appointed officers.
2
Requirements for Enlistment, Enrolment and
Registration of Pharmaceutical Personnel

Requirements for enlistment of pharmaceutical assistants

 certificate in pharmaceutical sciences
 six month practical experience
 Good conduct
 Pay the enlisting fee

Requirements for enlistment of pharmaceutical technician

 Diploma in pharmaceutical sciences
 9 month practical experience
 Good conduct
 Pay the enrollment fee

3
Requirements for Registration and Licensing of Premises for
Pharmacy Business

Business of a pharmacy- Professional pharmacy practice and any activity

carried on by a person in relation to medicines, medical device or herbal
medicines
BRELA: Business Registrations and Licensing Agency
 o Council: means the Council established under
section 3 of the Pharmacy Act 2011
o Dispense: means supply of medicines or medicinal
products in accordance with a prescription lawfully
given by a medical practitioners
o Inspector: means an Inspector appointed,
authorized or recognized by the pharmacy council.
o Superintendent: means a Pharmacist In-Charge
who supervises a pharmacy

sections that relate to registration of premises for

pharmacy business:
 Section 34, states the registration of premises
 Section 36 states the application of permits
 Section 18, of 2012, states conditions for establishment and
operation of a pharmacy
 Section 20, of 2012, states application for pharmacy
registration
 Section 21, of 2012, states registration of a pharmacy
 Section 27, of 2012, states categories of registers.

the conditions for establishment and operation

of a pharmacy:
o A person shall not establish and operate a business
of a pharmacist unless the premise is registered in
accordance with the Act.
o A premise registered under these regulations shall be
required to comply with the good pharmacy practice
and registration guidelines of a business of a
pharmacist
 o There shall be a separate application and registration
of each premises intended for use as pharmacy as
shall be prescribed by the council in the registration
guidelines.
o Each registered premises for establishment of a
pharmacy shall be issued with a registration
certificate which is non transferable.
 Types of premises/pharmacies: premises registered under section
34 of the Pharmacy Act and 27 of the pharmacy practice
regulations:
o Retail pharmacy
o Wholesale (distribution) pharmacy
o Institutional pharmacy
o Medical devices shops
o Vessel/ motor vehicles carrying medicines
o Consultant pharmacy

Requirements for Registration of Premises for Pharmacy Business

 Location:
 300m between retail pharmacy
 For wholesale no distance regarded
 Permanent building materials
 White washable paint
 Descent logo at the entry
 Confining the premises with in malls
 No direct contact with other medical facilities.
 Premise design:
 Safety
 Durability
 Proper roofing
 Smooth washable finishing
 Sufficient lighting
 Security (no smoking)
 Sufficient ventilation
  Dustless surroundings
 Premises layout:
 Retail pharmacy
- 3 rooms
- 25m2 area
- atleast 2.5m height
- enough pallets and shelves as the checklist
- extra room for extra services

 Wholes sale premises lay out

- Atleast 3 rooms
- 40m2 area
- 2.5 m height
- Adequate shelves and pallets
 Warehouse
- Good storage conditions
- Sufficient capacity
- Durability
- Easy to clean
- Well ventilated
- Enough shelves and pallets
- Wall thermometer
 Vehicle
- Light colored
- Waterproof
- Easy to clean
- Temperature control system
- Dustproof
- U.V free
- Good ventilation
 Storage facility
- Pest free
- Adequate space
- Controlled storage environment
 - off- floor storage of the products
- lockable shelves

o Distribution (Wholesale) Premises

o Retail and Distribution (Wholesale) Premises
o Warehouse Premises
o vehicle for carriage or transportation of pharmaceuticals
o storage facilities

Requirements for Licensing of Premises for Pharmacy

Business

 The permit must be annually renewed unless suspended by the council

 Every premise registration certificate shall expire on the 30 th June @
three years
 Applications for renewal of permits shall be three (3) months before 30 th
June.
 Pay the respective annual permit fee prescribed
 25% penalty for delayed fee payment

4
 Importance of Pharmacy Practice

 In geriatric pharmacy practice:

 Pediatric pharmacy practice

 The practice of pharmacy may include

o The custody, preparation and dispensing of medicines and pharmaceutical products;
o The selection and provision of non-prescription medicine therapies and therapeutic aids;
o Health promotion, including health screening;
o Administration of medicines, including injectable medicines;
o Researching and evaluating information and providing evidence-based advice and
recommendations on medicines and medicine-related health issues;
o Teaching and advising;
o Policy development;
o Management;
o Manufacturing; and
o Auditing
5
Profession: an occupation whose core element is work based upon the
mastery of a complex body of knowledge and skills.
 Components of the pharmacist profession
o Meet a social need or necessity within the practice;
o Stance to professional responsibilities (msimamo)
o The expectation to work in the patient’s interest
o A requirement to work within the healthcare concepts..(paradigm)

Standards of Pharmacy Practice

The provision of pharmaceutical care

o Therapy evaluation
o Dispensing
 o Advice to clients
o Monitoring compliance
o Provision of pharmacist initiated therapy

Functions of pharmacy practice

 The provision of pharmaceutical care
 Compounding
 Manufacturing
 Consultation
 Promotion of medicine
 Distribution of medicine by selling
 Custody
 Education

STEP 7: Evaluation
 What is profession?
 What are the standards of pharmacy practice?
 What are the acts pertaining profession of pharmacy?

6
Terminologies:

 Pharmaceutical personnel: Means registered pharmacist,

enrolled pharmaceutical technician, enlisted pharmaceutical assistant
and intern pharmacist.
  Pharmacist: Means a person registered under section 16 as per
Pharmacy Act 2011
 Pharmaceutical technician: Means a person enrolled under section
24 as per Pharmacy Act 2011,

 Pharmaceutical assistant: : Means a person enlisted under section

28 of Pharmacy Council Act 2011,

 Intern Pharmacist: Means any person registered as such under

section 17 of Pharmacy Council Act 2011,

 Professional misconduct: Means any conduct which is in breach of

the code of conduct, prescribed under the Pharmacy Council Act
2011,

 Pharmacy Practice: Means any act pertaining to the scope of

practice of a Pharmacist, Pharmaceutical Technician and
Pharmaceutical Assistant as approved by the council

 Professionalism: Means active demonstration of the following traits:

Knowledge and skills of a profession, Commitment to self-
improvement of skills and knowledge Service orientation, Pride in the
profession, Collaborative relationship with the patient Creativity and
innovation, Conscience and trustworthiness, Accountability for
his/her work, Ethically sound decision making, and Leadership.

Indicators of Professionalism:

o Knowledge and skills of a profession

 o Commitment
o Pride in the profession
o Trustworthiness
o Accountability
o Creativity

 Pharmacy Council: Means a council established under Section 3 of

Pharmacy Council Act 2011,

 Breaches: Means an act of breaking, violating or disregarding any

obligation of code of ethics and professional conduct.

 To practice as pharmaceutical personnel means undertaking any

role, whether remunerated or not, in which an individual uses his
professional skills and knowledge

Explanation of Codes of Ethics

1. Must have regard for human life
2. Must honor and dignify the profession
3. Should ensure availability of safe, efficacious and quality
medicines.
4. Should ensure access to essential medicines
5. Should promote and ensure rational use of medicines
6. Should have good personnel – patient/clients relationship
7. Must ensure privacy and confidentiality
8. Should be competent and have a lifelong learning
 9. Should have good pharmaceutical personnel-other health care
providers relationship
10. Must ensure well-being of the community
GENERAL OBLIGATION
In the areas of practice pharmaceutical personnel must promote to
ensure provision of quality pharmaceutical care services.
For example develop, implement and maintain policies, laws,
regulations that are designed

STEP 6: Evaluation (5 minutes):

• What is
o Pharmaceutical personnel?
o Pharmacist?
o Pharmaceutical technician?
o Pharmaceutical assistant?
o Intern pharmacist?
o Professional misconduct?

7
1: Definition of Health Care System
 Health care system is a system which consists of all organizations,
people and actions whose primary intention is to promote, restore or
maintain health
 Source WHO 2005
2: Goals of Health Care System
The goals of health care system are;
 To promote universal health care
 To ensure easy service and its payments.
 To ensure good health for the citizens,

3: Levels of Health Care Delivery System

 The organization structure includes five levels as follows:

o National Level
 The central level, is the Ministry of Health and social Welfare

o Regional Level
 This level sometimes referred to as an extension of the MOH. It
has the regional secretariat and one hospital in the region.

o District hospital level

 The district is the focal point for the implementation of the
national health policy managed by the local authorities.

o Divisional Level
 This consist of a health centre which provides both curative and
preventive
 o Ward Level
 This is the lowest level (dispensary) of the formal health care
delivery system.

4: Referral System in Health Care Delivery

 Referral System is an organizational structure for coordinating,

linking, & transferring responsibility of care.
 Dispensary Services
The dispensary caters for 6,000 to 10,000 people and supervises all the
village health posts in its ward
o Health Centre Services
A health Centre is expected to cater for 50,000 people which is
approximately the population of one administrative division
o District Hospitals
o Regional Hospitals
o Referral/Consultant Hospitals

STEP 7: Evaluation (10 minutes)

ASK questions based on the learning tasks
 What is health care delivery system?
 What are the goals of health care system?
 How many level s of health delivery system that respond to health
needs?
 What are the health facilities that are involved in referral system?
9
1: Roles of Pharmaceutical Dispensers
They assist in:-
  the sale of pharmacy
 compounding
 health education
 distribution of medicines
 control of stock

2. Role of Pharmaceutical Technicians

 Sale of pharmacy
 Compounding
 manufacturing of sterile or non-sterile medicines
 Repackaging of medicines
 The distribution and control of stock
 The ordering of medicine
 Interpretation and evaluation of prescription
 education
 Supervision of pharmaceutical Assistant

3. Role of Pharmacists
 formulation of any medicine
 distribution of any medicine
 re-packing of medicines
 pharmaceutical research
 The promotion of public health
 promotion of medicines and medical devices

STEP 7: Evaluation (5 minutes)

 What are the roles of pharmaceutical dispensers?
 What are the roles of pharmaceutical assistants?
 What are the roles of pharmaceutical technicians
 What are roles of a Pharmacist?
 10

Laws Relating to Storage and Distribution of Medicines and

Medical supplies

 Storage of medicines and medical supplies

o Storage means putting and safe keeping of medicines and medical
supplies up to the point of use.
 Good Storage Practices (GSP) means part of quality assurance that
ensures that the quality of pharmaceutical products is maintained by
means of adequate control throughout the storage thereof.
 Distribution
Distribution means a business of dealing in human medicines or
medical devices in bulk or wholesale but does not include importers of
human medicines, medical devices, food, cosmetics and veterinary
medicines.
 Good distribution practices (GDP)
Are practices that ensure that the quality of a pharmaceutical product is
maintained

 Section 34 Registration of premises

 Section 36 Application of permits
 Section 44 Conditions for body corporate to become authorized seller
of medicines and pharmaceutical products

Evaluation
 What is storage and distribution according to the Pharmacy Act 2011?
 What sections in the Pharmacy Act 2011 are related to storage and
distribution of medicines and medical supplies?
 What do sections 34, 36 and 44 states relating to storage and
distribution of medicines and medical supplies?

11

Procedures for Handling of Unfit Medicines and Cosmetic products

o Medicines and Cosmetic products shall be considered as unfit

when they are:
 expired
 improperly sealed
 damaged, unexpired and improperly stored
 improperly labelled
 counterfeit, substandard and adulterated
 prohibited
 unauthorized

In order to manage properly unfit medicines and cosmetic products at

a facility level, the following requirements shall be adhered to:
- Maintain a register book
- Keep them into different categories by dosage form
- Keep separately medicines which fall under controlled drugs
- Keep in containers according to their dosage
- Demarcate an area for keeping containers of unfit medicines
- Maintain safe custody
- The decision of when to initiate disposal
- Application for disposal of unfit medicines from Government
institutions
3: Procedures for Application to Dispose off Unfit Medicines and
Cosmetic products
 Request in writing to the Director General of TFDA
 A request shall be accompanied with a list of products to be
disposed
 verification of the product
 Processing of the information submitted by TFDA.
4: Format of the Register Book of Unfit Medicines /Cosmetic
products
Minimum important information in the Register book:
 Name of the product
o trade name
o generic name
 Strength of the product(where applicable)
 Dosage form: suspension, cream, ointment, tablet ...
 Pack size
 Quantity
 Batch number, and
 Value(Tshs.)

5: Model of Application form for Disposal of Unfit products

Minimum important information in Application Form for Disposal
 Form number
 Postal address of TFDA
 Postal address of the applicant
 Specification of type of business of the applicant
 Type of products to be disposed
 License number
 Date of issue
 Location of business
 Name of in-charge and reg. number
 Reason for disposal
 Weight of the total products in Kg
 Value of the total products in Tshs
 Declaration by the applicant
 Name of the receiving officer, signature and official stamp.

STEP 8: Evaluation (5 minutes)

 What is an unfit product?

 What are the procedures for application of unfit products disposal?

 What are the requirements for proper management of unfit medicines
and cosmetic products?

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Sorting and Verification Exercise of Unfit Medicines and Cosmetic
Products
 Sorting of medicines and cosmetic products means to separate the
medicines and cosmetic products into separate categories for which
different disposal methods are required.

S/N Categories Disposal methods

 1. Solids, semi-solids Landfill, incineration and waste
and Immobilization
Powders
2. Liquids Sewer, high temperature
incineration
and treated waste
3. Antineoplastics Treated waste and landfill, high
temperature incineration and return
to manufacturer
4. Controlled drugs Treated waste and landfill, high
temperature incineration
5. Aerosols and Landfill without waste inertization
inhalers
6. Disinfectants Sewer or fast-flowing watercourse
7. PVC plastics, glass Landfill and re-cycling
(ampoules, bottles
and
vials)
8. Paper, cardboard Recycle, burn, landfill

3: Sorting process of Unfit Medicines and Cosmetic Products

 Choose a well ventilated area
 Wear protective gears
 Pack the unserviceables ready for disposal
4: Verification Exercise of Unfit Medicines and Cosmetic Products
 Verification process shall involve the following stages:
o Identification of the product.
o Separate medicines which fall under controlled drugs,
antineoplastics, antibiotics and any other hazardous medicinal or
cosmetic products.
o Sort according to Destruction Method (Annex IV).
o The applicant is informed on the chosen method
o Pay the fee for disposal

STEP 7: Evaluation (5 minutes)

 What is sorting of unfit medicines and cosmetic products?

 What are sorting categories and the recommended disposal methods?

 What important things are to be followed during sorting process of
unfit medicines and cosmetic products?
 What are the stages of verification exercise of unfit medicines and
cosmetic products?
 What are parts of the Model of the Verification form ?

13
Identification of Different Participants Involved in the Destruction
Process
o the drug regulatory authority
o the ministry of health;
o the police authority
o institutional pharmacists;
o A qualified hazardous waste expert

Procedures for Destruction of Unfit Medicines and Cosmetic

Products
 A Drug Inspector, Health Officer, Environmental Officer and
Policeman shall supervise the transport of consignment from the
owner’s premises to the disposal site for destruction exercise.
 The destruction exercise shall be supervised by Health Officer,
Environmental Officer, Policeman and Drug Inspector.
 Unfit medicines and cosmetic products shall be transported in a
closed motor vehicle to avoid pilferage.
 Supervisors shall wear protective gears
 Upon completion of the exercise, a Drug Disposal Form (Annex V)
shall be duly filled
 Drug Disposal Form shall be sent to TFDA headquarter offices.
 A certificate of destruction of unfit medicines and cosmetic products
(Annex VI) shall be prepared
 Particular care shall be taken while handling anti cancer drugs,
narcotic drugs and penicillins to avoid associated hazards.

3: Description of Model of Drug Disposal Form of Unfit Medicines

and Cosmetic Products
 Important information in the Disposal Form
 Name and address of the owner of the products destroyed
 Location/site where destruction exercise was conducted
 Date of the destruction exercise
 Methods of destruction used
 Total weight (Kg) and value(Tshs) of the products destroyed
 Name and signature of owner/in charge/representative of the
organization
 Names, title and signatures of Drug Inspector, other supervisor(s) and
witness of the disposal exercise.
Evaluation
 Who participates in the Destruction process of unfit medicines and
cosmetic products?
 What are procedures for Destruction of Unfit Medicines and
Cosmetic products
 What important information does Drug Disposal Form contain?
 What is the Certificate of Destruction of Unfit Medicines and
Cosmetic products