NTA Level 6 • Semester 2 • PST06209

Establishment of Medicines and Medical

Entrepreneurship • Source Session/Topic 15

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Session 15: Establishment of Medicines and Medical

Supplies Outlets in Tanzania

Total Session Time: 120 minutes +1 hours of Tutorial

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define medicines and medical supplies outlets

• Outline medicines and medical supplies outlets in Tanzania

• Explain the procedures for establishing medicines and medical supplies outlets

• Describe criteria for Establishing a medicines and medical supplies outlet

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• LCD Projector and computer

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

10 minutes Definition of Medicines and Medical Supplies

Presentation

2 Outlets

Buzzing

20 minutes Presentation Types of Medicines and Medical Supplies

Outlets in Tanzania

30minutes Presentation Procedures for Establishing Medicines and

Brainstorming Medical Supplies Outlet

35 minutes Presentation Criteria for Establishing an Medicines and

brainstorming Medical Supplies Outlet

6 05 minutes Presentation Key Points

7 05 minutes Presentation Evaluation

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SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Medicines and Medical Supplies Outlets (20 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are medicines and medical supplies outlets?‖ ?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Medicines and medical supplies outlets means establishment that is engaged in

dispensing, delivery or distribution of drugs

o This is establishment can be:

 Any pharmacy

 Nursing home

 Shelter home

 Convalescent home

 Extended care facility

 drug abuse treatment center

 Penal institution

 hospital

 Family planning clinic

 Student health center

 Retail store

 Wholesaler

 manufacturer

 mail-order vendor or

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STEP 3: Types of Medicines and Medical Supplies Outlets in Tanzania

(10 Minutes)

• The common drugs and supplies outlets in Tanzania

o Community pharmacy

o Hospital pharmacy

o Whole sales

o Accredited drug dispensing outlet (ADDO)

STEP 4: Procedures for Establishing Medicines and Medical Supplies

Outlets (30 Minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are procedures for establishing medicine and medical supplies outlets?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Procedures for establishing an ADDO include the following area:

o Application to establish an ADDO

o Roles and responsibilities of various administrative levels

o Criteria for establishing ADDO

 Application to Establish an ADDO

 The application to establish an ADDO is done through the following

administrative levels:

• Village

• Ward

• Council

• Region

• Pharmacy Council

o An individual applying to establish an ADDO should do the following—

 Read and understand the Guideline for Establishing and Operating an ADDO.

 Copies of the guideline are available in the offices of Regional and Council

Pharmacists, Pharmacy Council Zonal Offices, and TFDA headquarters.

 Obtain the application form for permit to establish an ADDO

 Complete section A of the application form and then submit

 Pay the annual fee for the permit after receiving permission to operate an ADDO.

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• Roles of Various Administration Levels in Establishing ADDOs

o Application forms for establishing ADDOs have to pass through various

administrative levels whose members and their roles are as follows—

Village Level

At this level, the key responsible person is VEO/MEO who is supposed to:

• Provide application forms to the applicant

• Receive, review, and provide opinions related to the submitted application; this requires

filling in section B of the for

• Submit the completed form (sections A and B) to the WEO

Ward Level

The Ward Health Committee has the following members:

• WEO—chairperson

• Medical officer in-charge of the nearby health facility—secretary

• Ward health officer

• Ward extension officer dealing with livestock

• The Ward Health Committee is responsible for the following—

o To provide the application forms for establishing an ADDO

o To receive and go through completed application forms from VEO/MEO

o To interview applicants together with potential dispensers in accordance with

information in application form

o If conditions in the application form sections A and B have been satisfied, the

inspectors will inspect the premise for which the permit has been applied in

accordance with mapping and pre-inspection forms (Annex 2)

o To provide opinions on the submitted application to the committee by filling in

section C of the application form

o To submit completed application form together with results of the premise‘s

inspection to the CFDC secretary

Note: The applicant is advised to seek opinion from the Ward Health Committee on the

expected location of the ADDO before building/renovating the intended ADDO premise.

Council Level

The CFDC has the following members—

• Executive director—chairperson

• Medical officer—secretary

• Pharmacist

• Trade officer

• Health officer

• Veterinary officer

• Agriculture officer

• Treasurer

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• Any other co-opted member whose expertise will be needed by the committee.

Note: The CFDC secretary is district medical officer supported by the district ist or district

livestock officer, depending on the objectives/issues of the meeting.

• The Council is responsible for the following:

o To provide ADDO applications and yearly renewal forms

o To receive the completed application forms for establishing ADDO and inspection

forms from ward level and make decision

o Using a team of approved ADDO inspectors, inspect all ADDOs that have submitted

application forms to the council

o To accept or reject ADDO applications on behalf of Pharmacy Council in accordance

with criteria of getting ADDO permit

o To submit reports on decisions relating to establishment and operation of ADDOs to

Pharmacy Council and a copy to the Region Food and Drug Committee (RFDC)

Note: Reports submitted from one administrative level to another must be accompanied by

the meeting minutes of respective committee.

Regional Level

The RFDC has the following members—

• Commissioner—chairperson

• Medical officer—secretary

• Pharmacist

• Health officer

• Agriculture officer

• Livestock officer

• Trade officer

• The committee is responsible for:

• Receiving a copy of decision made by the council on establishing and operation of

ADDOs

• Receiving and acting on appeals from council level

• Seeking further information on steps taken by the council committees with respect to

information it has received and take appropriate measures when necessary in

collaboration with Pharmacy Council

• Providing technical support to CFDC regarding the establishment and operation of

ADDO

Pharmacy Council

Pharmacy Council is the highest level in issuing the ADDO permit and is responsible in

effecting the following:

• To receive and review decisions of establishment of ADDO from CFDC

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• To make the final decision related to establishment of ADDO including accepting or

revoking decisions made by lower administrative levels for the benefit of the general

public

• To issue permits to those who have fulfilled the ADDO requirements

The procedure for establishing a community pharmacy and whole pharmacy

• Pay pre inspection fee to Pharmacy councils

• Pharmacy council will conduct pre inspection to assess:

o Location

 Must be 300 metre from another pharmacy

o Space

 More than 25 square meter for pharmacy

 More than 35 square metres for whole sale pharmacy

o Condition of the building

• At the end of inspection recommendation whether to continual or discontinue will be

provided by the Pharmacy council

o In case of Pharmacy council recommends to continual

 The applicants improve the promise

Improving the dispensing, storage, POM locker cabinet for psychotropic

 Applicant will call pharmacy council for inspection after improving the premises

 If pharmacy council is satisfied with improvement of the premises the permit to

open community pharmacy or whole pharmacy will be issued to applicant

• Applicant will apply to Tanzania Revenue Authority for tax clearance and seek licence to

operate from the municipal council

STEP 5: Criteria for Establishing a medicines and medical supplies outlets

(35 minutes)

To be accredited and get a permit, an ADDO and its staff should meet the following criteria.

• ADDO Dispenser

o The potential ADDO dispenser will have to attend and successfully complete special

training to dispense in an ADDO.

o To qualify for training, the potential dispenser must be one of the following—

 Pharmaceutical technician

 Pharmaceutical assistant

 Nursing officer

 Nurse midwife

 Clinical officer

 Clinical assistant

 Nursing assistant

 Any other person seen as capable after being advised by TFDA

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o For veterinary ADDOs, the potential dispenser should have the following

qualifications—

 Livestock officer

 Assistant livestock officer

 Any other person seen as capable after being advised by TFDA

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• ADDO Owner

An ADDO owner should meet the following criteria—

o Should be a Tanzania citizen 18 years old or above and of sound mental health

o Must have undergone a TFDA authorized training on Ethics and Regulations

Operating of ADDO

o Contract Agreement between the ADDO Owner and ADDO Dispenser

According to the Regulations of Operating ADDO, the owner and dispenser need to

enter into a contractual agreement to facilitate smooth running of the outlet, and

assume roles and responsibilities that benefit both parties.

The importance of the agreement is as follows—

 To help owner and dispenser to abide to their agreement related to the terms of

employment.

 To provide modalities on how to resign or be terminated from work when

necessary without causing unnecessary inconvenience to either of the parties

• Location for Establishing an ADDO

o ADDOs are to be located in the following areas:

 Rural areas and small towns where the availability of medicines is problematic

 In peripheral areas of big towns or cities where the availability of medicines is

erratic

 In the small town with a population of about 3,000 to 5,000, the ADDO must be

established at a distance not less than 300 meters in each direction from the

nearest ADDO. In rural areas the distance should not be less than 200 meters from

the nearest ADDO and not less than 500 meters from a pharmacy. (Distance is not

taken into consideration for veterinary ADDOs.)

 ADDOs should not be located in or close by an area where there are open sewage

systems, dumping sites, or industries using toxic chemicals.

 ADDO Building (Premises)

• Should be a permanent, well-built structure

• Should have a sturdy, leak-proof roof and ceiling

• Should have a solid floor which can be easily cleaned

• Should have sturdy walls painted white which can be easily cleaned

• Should have two front doors—a strong outer door for security and an inner

glass door that should be kept closed to protect against dust, insects, and

rodents

• Should have at least two rooms; one for dispensing and the other for storage

• The dispensing room should be the following size: 3.04 meters long (10 feet)

by 2.74 meters wide (9 feet) and 2.43 meters in height (8 feet).

• The dispensing room should be arranged to allow customers to get into the

room—dispensing through windows in strictly prohibited.

• Should have a hand-washing facility in the dispensing room.

• The medicine storage room should be of adequate size and have shelves or

pallets.

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• Every room must have a sturdy window covered with mosquito gauze which

allows adequate ventilation and, where possible, the room should have a fan or

air conditioner (temperatures should not exceed 30°C).

• There should not be egress to other rooms that are not part of ADDO, such as

bedroom or living room.

• Should have a sign prohibiting smoking of any kind while inside the ADDO

(NO SMOKING)

• Should have a glass counter and display case and a movable section of counter

to allow access to shop

• Should have sign with an ADDO logo as shown below (to get the sign, the

owner should liaise with CFDC)

• Criteria for establishing a pharmacy or a whole sale pharmacy

o Must be pharmacist or to have superintendent who is a pharmacist

 If the pharmacist is government employee, there must be pharmaceutical

technician will be dispensing on consultation to pharmacist when need arise

STEP 6: Key Points (5 Minutes

• Medicines and medical supplies outlets

Medicines and medical supplies outlets means establishment that is engaged in

dispensing, delivery or distribution of drugs

• The common drugs and supplies outlets in Tanzania

o Community pharmacy

o Hospital pharmacy

o Whole sales

o ADDO

• Procedures for establishing an ADDO include the following area:

o Application to establish an ADDO

o Roles and responsibilities of various administrative levels

o Criteria for establishing ADDO

STEP 7: Evaluation (5 Minutes)

• What is medicines and medical supplies outlets

• List medicines and medical supplies outlets in Tanzania

• What are the procedures for establishing medicines and medical supplies outlets?

• List criteria for establishing a medicines and medical supplies outlets addo

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References

Buskirk, R. H (1994). The Entrepreneurs Handbook: Premier Entrepreneur Programs, Inc.

Denver, Co.

Charantimath, P. M (2006) Entrepreneurship Development Small Business Enterprises:

Delhi, India: Pearson Education,

Hisrich, R.D., Peters, M.P., & Shepherd, D.A. (2005). Entrepreneurship. (6th Ed.) Boston:

McGraw-Hill.

Kuratko, D.F., & Hodgetts, R.M. (2007). Entrepreneurship: Theory, Process & Practice. (7th

Ed.) USA: Thomson

Roy, R. (2011, 2008). Entrepreneurship. 2nd Ed. Oxford: Oxford University Press.

Stokes, D. & Wilson, N. (2002). Small Business Management and Entrepreneurship. (5th

Ed.) London: High Holborn House.

Zimmerer, T. W. & Scarborough N. M. (2008) Essentials of Entrepreneurship and Small

Business Management. (5th Ed) New Jersey: Pearson Education International

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