(TIPC) THERAPEUTIC INFORMATION & PHARMACOVIGILANCE CENTER · THERAPEUTIC INFORMATION AND PHARMACOVIGILANCE CENTER (TIPC) EVALUATION 2009 4 2. WHAT IS THE PROGRESS TOWARD ACHIEVING

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(TIPC) THERAPEUTIC INFORMATION & PHARMACOVIGILANCE CENTER

EVALUATION February-December 2009

Elena Moreno. Medicos del Mundo. (MdM).

DRAFT 1 23-November 2009

THERAPEUTIC INFORMATION AND PHARMACOVIGILANCE CENTER (TIPC) EVALUATION 2009

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TABLE OF CONTENTS

1. INTRODUCTION………………………………………………………………….……………...…..Page 3

2. WHAT IS THE PROGRESS TOWARD ACHIEVING THE MAIN GOALS?........................................................................................................................... Page 4

3. WILL THE GOALS BE ACHIEVED ACCORDING TO THE TIME-FRAME SPECIFIED IN THE PROGRAM IMPLEMENTATION (APRIL 2009-MAR 2010)?.......................................Page 5

4. DO PERSONNEL HAVE SUFFICIENT RESOURCES AND CAPACITY TO ACHIEVE THE GOALS?.........................................................................................................................................Page 5

5. HOW CAN THE DONNORS AND THE MINISTRY of HEALTH(MoHSS) CHANGE THE APPROACH TO FOCUS MORE ON ACHIEVING THE GOALS?.........................................Page 7

6. HOW SHOULD GOALS BE CHANGED? SHOULD ANY GOALS BE ADDED OR REMOVED? WHY?.............................................................................................................................................Page 7

7. ANY OTHER OBSERVATIONS /RECOMMENDATIONS..……………………………………....Page 8

8. ADVICE FOR FUTURE PROJECTS……………………………………………………………………….Page 10

ANNEX

ANNEX 1: TIPC PROGRAM IMPLEMENTATION PLAN APR09-MARCH 2010…………….Page 11

ANNEX 2: GRAPHS. Number of ADVERSE DRUG REACTIONS (ADR) …………………….….Page 17

ANNEX 3: GRAPHS. Number of QUERIES RECEIVED.....…………………………………………….Page 18

ANNEX 4: PHARMACIST’S SURVEY. PHARMACIST’S FORUM. JULY 2009. OTJIWARONGO…………………………………………………………………………………………..Page 19


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1. INTRODUCTION

THERAPEUTIC INFORMATION AND PHARMACOVIGILANCE CENTER

(TIPC) IS THE MINISTRY OF HEALTH AND SOCIAL SERVICES (MOHSS)

OFFICIAL CENTER FOR PROVISION OF UNBIASED THERAPEUTIC

INFORMATION AND PHARMACOVIGILANCE SERVICES TO HEALTH

CARE WORKERS AND THE GENERAL PUBLIC IN NAMIBIA.

Access to objective therapeutic information and existence of a functional pharmacovigilance system are important in promoting safe and rational use of medicines.

The center was officially launched in May, 2008, and is supported by 2 donnors:

-USAID, through Management Science for Health (MSH).

-AECID, through Medicos del Mundo, Spain. (MDM).

The purpose of this report is to evaluate the center during the period of the program implementation plan (April 2009-March 2010).

1Q(April-Jun 09)

2Q (July-Sept 09)

3Q (Oct-Dec 09)

4Q (Jan-March 2010). TIPC implementing Working Group(IGW) was created to evaluate ,follow up all TIPC activities, and for having a place to discuss the issues and challenges of the center. The members of this team are listed below: -Jennie Lates: Deputy Directors. Pharmaceutical Services (MoHSS) -Johannes Gaeseb: Chief pharmacist Pharmaceutical Control and Inspection (PC&I) (MoHSS) -Victor Sumbi: National Medicine Policy Co-ordination (NMPC).Pharmaceutical Services.(MoHSS) -Dr. Assegid Mengitsu. TIPC advisor -Mr.Joseph.K. Rushubiza. Windhoek Central Hospital. Chief Pharmacist. -Evans Sagwa. Senior Program Associate. Management Science for Health (MSH). Strengthening Pharmaceutical systems (SPS). -David Novak. Country coordinator. Médicos del Mundo. (MDM). -Elena Moreno. TIPC pharmacist. Volunteer. Medicos del Mundo. (MDM). (Feb 09/Dec 09)


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2. WHAT IS THE PROGRESS TOWARD ACHIEVING THE MAIN GOALS?

Sustainability: On the program implementation plan (table attached at the end of this report) there is a column listing the perceived sustainability of all activities.

Knowledge and usage of the center: On July, 09 there was a pharmacist’ forum in Otjiwarongo.In that forum, TIPC distributed a survey to all the attendees (they were pharmacists from the 13 regions.)

The results of the survey were the following:

100% have heard about pharmacovigilance.

100% have heard about TIPC.

35% were trained in TIPC activities.

35% had used the center to ask any therapeutic information. 14% found the response to be very good, 43% good, 43% satisfactory, 0% poor.

A good feedback was that the reason of not asking was not known the mechanism to ask.

90% have never reported an ADR (Adverse Drug Reaction). 22% were not aware of the need to report.

75%/80% have available ADR and TI forms at their facilities.

90% have seen a bulletin of the Medicines Watch, although it was mentioned that at times it was received late and not every quarter.

80% have seen TIPC IEC materials and most consider that it is beneficial to create awareness, and they would like to continue receiving them.

65% believe that a good way to support the regions in order to improve the use of the center is by conducting trainings.

100% were interested in receiving ADR/Query monthly reports.

Limitations of the survey: We would say that this survey is representative because it was performed by pharmacists from all 13 regions, but we should also take in account that the center is used by doctors and nurses that did not attend the meeting. Moreover, the sample rate was relatively small in comparison with the total number of pharmacists in Namibia.

Therefore, we used this feedback to take actions, but we can not limit them, based only on this survey.

It was also agreed to repeat the survey every 6 months and trying to cover as much health-professional as possible.

Graphs of the survey are attached at the end of this report. ANNEX 4


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3. WILL THE GOALS BE ACHIEVED ACCORDING TO THE TIME-FRAME SPECIFIED IN THE PROGRAM IMPLEMENTATION (APRIL 2009-MAR 2010)?

On the program implementation plan (table attached at the end of this report ANNEX 2), it can be checked if the activities were or not achieved in the time-frame specified.

3.1 If the goals are not being achieved according to our time-frame, can we foresee and plan for a realistic time-frame.

It has been added a new column in the plan, indicating a new proposed time-frame to achieve the activities that have not been met yet.

4. DO PERSONNEL HAVE SUFFICIENT RESOURCES AND CAPACITY TO ACHIEVE THE GOALS?

Equipment / Resources:

There is a need to upgrade the TIPC computer in order to increase efficiency.

The internet connection is slow, meaning web based ADR database entry and internet research takes longer than necessary.

There is a need for a TIPC only LCD projector for workshops/sessions. Currently we are using one sometimes from MDM or MSH, but other times, we have to struggle with the hospital in order to secure one.

Facilities: Currently the 2 staff are not working in the same place (there is a distance of 5-10 minutes walking), therefore close collaboration is less efficient.

-TIPC advisor: located in the PC& I building.

-TIPC pharmacist: located in Windhoek Central Hospital. (Official TIPC office).

The purchase of a new building for the TIPC office has been established in the plan. This issue is a strong recommendation but is currently still under discussion (MDM/MoHSS/MSH).

Personnel:

Since February 2009 there are 2 staff involved full-time in TIPC activities.

-Dr. Assegid Mengitsu. TIPC advisor

-Elena Moreno. TIPC pharmacist.

The center has been waiting for a TIPC coordinator and for a TIPC librarian since January/09 but finally they are not linked to the center yet.

So during that period of time, Dr. Assegid and Elena Moreno have taken over their responsibilities.

It would be strongly recommended for 4 persons to work at the center.

In a general way, the main functions could be distributed as follows:


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ROLE TIPC activities

TIPC advisor Contribute to, coordinate and build the capacity of TIPC staff to publish the TIPC bulletin

Active surveillance

Contribute to development of TIPC’s training and advocacy materials

To create the link with HIV/TB/malaria/PHC programs

To be in contact with the Therapeutic Advisory Committee. Discuss drug ADR causalities and generate signals.

Design/ review pharmacovigilance tools and guidelines/indicators

Develop/ review internal SoPs

Develop systems and strategies for collecting, acknowledging, analysis, documentation, feedback and reporting of ADR reports

Provide technical assistance to the NMRC, PC & I and TIPC personnel in the management of medicine safety risks

Provide technical assistance for the design, improvement and maintenance of the TIPC website

TIPC coordinator/ pharmacist

(2 staff)

To promote the center in all the regions

Training/short TIPC sessions in all the regions

To follow up with TIPC focal person in each region

Proactive therapeutic Information (tools, letters, flowcharts, drug interaction, generic name/brand names..)

Train interns/Pharmacist Assistants in PV.

Design a plan, in collaboration with the chief pharmacist of WCH, for interns to encourage and involve them in TIPC activities.

Receive/answer queries

Update query database.

Acknowledge receipt of ADRs(attaching articles or data that support the reported case)

Entering ADRs in vigiflow

Review reports and statistics on TIPC activities for guidance

Run reports from VIgiflow to generate signals.

Poisoning issues.

Strengthen network of specialists

PV indicators

TIPC librarian To maintain good updates of the journals

To receive table of contents of all the journals.

Identify articles for proactive information

Provide articles to answer queries

Create database with Pharmaceutical Companies contacts

Keep updated distribution list of the reporters.

Currently, since we are only 2 staffs there are some of the mentioned activities that are not being done, or we are not devoting adequate time.

Burden of the most relevant tasks:

-There are 60 ADR reports pending to be entered in VIGIFLOW database.


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- A network of specialists is still not consolidated.

-Not providing as much proactive information to Health professionals as expected/ as wished.

-PV indicators/ Monitoring safety guidelines/SOPS are still pending to be finished and approved.

5. HOW CAN THE DONORS AND THE MINISTRY of HEALTH(MoHSS) CHANGE THE APPROACH TO FOCUS MORE ON ACHIEVING THE GOALS?

On the program implementation plan (table attached at the end of this report ANNEX 1) it has been added a column indicating the recommendations to accomplish each activity.

6. HOW SHOULD GOALS BE CHANGED? SHOULD ANY GOALS BE ADDED OR REMOVED? WHY?

Under the objective of: Strengthening Regional TIPC activities there is an activity of training Community Health Workers (CHW) in pharmacovigilance.

Since the CHWs are a pool of health professionals that are in daily contact with the HIV and TB patients, and therefore with high possibilities to identify side effects of the ARV and TB medicines; TIPC members though/considered that training them in how to report ADRs and pharmacovigilance aspects, the center would increase the number of ADR reports received.

However, after having done trainings in 2 Regions (Erongo and Kunene), the center has only received 1 ADR report from the CHW.

Follow up calls have been done, and a data collection tool was created to find out why might be the reason of not reporting.

Basically, they are not reporting because they alleged to be overwhelmed. In addition, some of them forgot to do it, or they were not asking proactively about side effects to the patients, so there were no complains and therefore nothing to report.

Since there is a need to create awareness of the center among all health professionals, and train people in how, when and what to report; It would be recommended to train first doctors and nurses in pharmacovigilance activities before going ahead with this kind of target; Once the others have been trained then the CHWs can also be trained in how to identify ADRs and then they will be able to easily transfer the patient, who is experiencing a side effect, to the nurse/doctor to evaluate it and fill the ADR form. There will be a connection between CHW-patient-nurse-doctor and all of them will know what they have to do.


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7. ANY OTHER OBSERVATIONS /RECOMMENDATIONS

A. UNDER-REPORTING / CREATE AWARENESS of the center

Under reporting is a common phenomenon in all countries. Under-reporting may delay signal detection and cause underestimation of the size of the problem. However, in signal detection not only the quantity but also the relevance of case reports and quality of data are important.

Sometimes healthcare professionals fear that the acknowledgement of adverse reactions may reflect negatively on their competence or put them at risk of litigation. Some are reluctant to report adverse reactions because of doubts regarding the causal role of the drug. Under-reporting is both a technical and a psychological issue. Clarity of criteria for reporting, simple procedures and good motivational practice are all influential in addressing the problem.

Another main reason for under-reporting that we are identifying is that Health professionals do know about the center, or they have ever heard about TIPC but the do not what exactly to do.

Therefore if we want to increase the ADR reporting and the number of queries received, we should focus in creating awareness of the center.

Some suggestion could be the following:

Short sessions in TIPC functions and Pharmacovigilance.

We have seen that the short sessions at hospitals are very effective.

They consist in creating a link or having a focal person per district and per hospital: could be the regional pharmacist, the PMO, the matron, chief pharmacist..

Then you have an appointment with the nurses, doctors of every specialty, and pharmacists at the same time or separated. But the important thing is trying to go in working hours, only 1 hour session and in their working place to avoid transportation, accommodation, and days off.

For example after doing these kinds of visits in Erongo region (covering Hospitals and clinics from 2districts) we increased the number of ADRs received by 3 times.

It would be strongly recommended to train all the main facilities in all regions and districts in that way.

Checking availability of ADR and IT forms and IEC materials

We have got the feedback from the regions that IEC materials are good to create awareness. (banners, stickers, posters, pen, lab coats)

One of the recommendations would be to continue sending materials and always send them with acknowledge receipt to be able to follow up them.

Ask frequently to our TIPC focal person about the availability, and use of them.


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B. STIMULATING REPORTING

After creating the awareness of the center, the center should be focused on motivating reporters.

When the center receives a report we have to acknowledge the receipt by fax or by phone.

It has been well demonstrated that if you give them feedback about the case that they are reporting (eg providing them results of studies of anemia and AZT.), or comments, or give proactive information on the suspected medicine; they keep on sending reports even more frequently.

Moreover, the center should keep reporters informed on the actual status of the reporting by all the regions. One way currently used, is sending ADR/Query monthly reports by email.

But It would be recommended also sending the monthly report by fax to all the hospitals to reach as much people as possible.

C. PROACTIVE INFORMATION

Sharing with the health professionals every article, document or safety alert of medicines that we find and can be result in interest of them. Doing this, they will be confident with the center and they will start asking more information.

Creating tools charts or whatever thing that can help health professionals in the management of the medicines: Drug interactions charts, list of trade/generic name, health promotion advertisements.

D. CAPACITY BUILDING

To ensure sustainability of the center, there is need of capacity building on Pharmacovigilance to the pharmacist interns.

In collaboration with the chief pharmacist, we have been creating some TIPC assignments, to have them involved in the center. After that, we will already have pharmacists trained in how to report when they are working in other hospitals/districts/regions.

Currently we are working with one intern in 2 researches to have her familiarize with the reference materials for providing information:

-Identify the best SSRI and TCA in terms of safety, efficacy and cost-effectiveness. Then, establish a comparison between the best SSRI and the best TCA.

-Identify which kind of heparin is most recommended in different type of conditions.

(Low weight heparin and unfraccionated heparin)

8. ADVICE FOR FUTURE PROJECTS

HOW TO START A PHARMACOVIGILANCE CENTRE The location of a pharmacovigilance centre depends on the organization and development


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of the healthcare system in the country. Whatever the location of the centre, pharmcovigilance should be closely linked to drug regulation and Governmental support needed for national co-ordination and communication.

1.1 Basic steps in setting up a Pharmacovigilance Centre 1. Make contacts with the health authorities and with local, regional or national institutions and groups, working in clinical medicine, pharmacology and toxicology outlining the importance of the project and its purposes. Still need to elaborate on topics such as a desk review of existing policies, relevant stakeholders and structures, not to mention strategic planning and the integration of such a centre within existing structures from the onset. It required substantial, constant and consistent advocacy to get this centre rolling, accepted and owned by MoHSS -David 2. Design a reporting form and start collecting data by distributing to hospital departments, family practitioners, etc. 3. Produce printed material to inform health professionals about definitions, aims and methods of the pharmacovigilance system. 4. Create the centre by acquiring staff, accommodation, phone, computer, database management capability, bibliography etc. 5. Train pharmacovigilance staff in: · Data collection and verification · Interpretation and coding of adverse reaction descriptions · Coding of drugs · Case causality assessment · Signal detection · Risk management. 6. Establish a database (administrative system for the storage and retrieval of data) 7. Organize meetings in hospitals, academia and professional associations, explaining the principles and demands of pharmacovigilance and the importance of reporting. 8. Promote the importance of reporting adverse drug reactions through medical journals, other professional publications, and communications activities. 9. Maintain contact with international institutions working in pharmcovigilance.(eg. Upsala Monitoring Center)

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ANNEX 1 TIPC PROGRAM IMPLEMENTATION PLAN APR09-MARCH 2010

OBJECTIVE

ACTIVITIES OUTCOME

INDICATORS

TIME FRAME

Realistic time-Frame

RESPONSIBLE PERSON(S)

ACHIEVEMENTS Constraints Way to achieve Sustainability.

2009-2010: 1Q (April-Jun 09); 2Q (July-Sept 09); 3Q (Oct-Dec 09); 4Q (Jan-March 2010).

2010-2011: 1Q (April-Jun 10); 2Q (July-Sept 10); 3Q (Oct-Dec 10); 4Q (Jan-March 2011).

S

tren

gth

en

T

IPC

serv

ice

s

1. Revision of Pharmacovigilance(PV) and Therapeutic Information forms (TI)

Revised PV and TI form

Availability of revised forms

1st Q & 2nd Q 2009-2010

4th Q 2009-2010

TIPC Advisor

Partially met. TI form not revised/ PV form created but pending to be revised and approved.

TI does not need to be updated/ PV form is included in the National Guideline for Medicine Safety, which is a big document; so until the whole document is not approved the form will not be approved and launched.

Incorporated obtained comments so far, finalized and send to approval.

It could be sustainable. Once guidelines and forms are approved the guidelines should be update as needed by TIPC IGW members.

2. Develop National Guidelines for Medicine Safety Surveillance

National Guidelines for Medicine Safety Surveillance

Availability of ADR monitoring GL

1st Q & 2nd Q 2009-2010

4th Q 2009-2010

TIPC Advisor

Partially met. Draft of the guidelines prepared, but is pending to be revised and approved.

Feedback from IGW has not been got as expected.

Incorporated obtained comments so far, finalized and send to approval.

It could be sustainable. Once guidelines and forms are approved the guidelines should be update as needed by TIPC IGW members.

3. Prepare SOP for TI and PV services

SOPs SOPs available

1st Q & 2nd Q 2009-2010

4th Q 2009-2010

TIPC Advisor/ TIPC coordinator

Partially met. . Draft of the SOPs for PV and TI prepared, but is pending to be revised and approved.

Workload of TIPC coordinator/advisor entering ADRs into Vigiflow. On the other hand TIPC SOPs will be approved together with the other PC&I SOPs; so if there is a delay in the others, that can be a constraint for the TIPC ones.

There is a need of more staff. Closely follow up with PC&I.

It could be sustainable. Once SOPs are done and approved the guidelines should be update as needed by TIPC advisor/coordinator.

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4. Prepare TIPC toll free call centre

Toll free call centre

Availability of toll free call centre

1st Q & 2nd Q 2009-2010

3Q 2010-2011

TIPC advisor

NOT MET YET. -Building construction and toll free center are correlated. -Man power to answer the calls -Cost to MoHSS

Follow up with donors on info structure and call center.

I do not see the sustainability of this activity if it is managed exclusively by TIPC as there are too many factors, internal and external, in making it function – specifically in regard to logistics and maintenance. The cost also seems prohibitive to outsource this activity. Perhaps we can look at attaching it to an existing service? Please look into this.

5. Renovation and construction of future TIPC office and library

Availability of TIPC office and library

Relocation of TIPC office and library

1st - 4th Q2009-2010

4th Q2009-2010

TIPC Advisor

Negotiations in final stages

- Suitable location near hospital - Initial running costs - Future maintenance

- MoHSS to confirm/secure sustainability factors for building - MoHSS with MdM and MSH to choose appropriate site - MSH to renovate building in order to make it suitable for said purpose

Once MoHSS includes running costs within its budget the sustainability of this activity is guaranteed.

6. Development of database for Therapeutic enquires

To have records of the queries received

Therapeutics information data base available.

1st Q & 2nd Q2009-2010

NA TIPC advisor

MET.TIPC Database created.

Already achieved.

To keep updated the data base.

Ongoing basis.

Ongoing basis.

TIPC coordinator

Partially met. No all queries have been entered.

-Lack of time to keep it updated. -There is no enough space in the answer section, so still you need to add a word doc.

-There is a need of more staff. -Convert in pdf and combine files to have only 1 document

Keeping at least 2 positions in TIPC It could be sustainable

7. Development of NMRC/ TIPC web site

Health professionals updated in TIPC functions/activities

TIPC web page available and updated

1st Q & 2nd Q2009-2010

Ongoing basis.

TIPC Advisor

MET. TIPC web page created

It should contain more information. -Time constraints -Difficulties in getting information from other divisions. -Consultants are working on the design.

There is a need of more staff.

Sustainable. Training has been given for web site management.

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8. Constitute an advisory committee (Clinical committee)

Expert Advisory Committee constituted to evaluate causalities of ADRs.

Functional EAC

1st Q & 2nd Q2009-2010

1st Q 2010-2011

TIPC coordinator/ TIPC advisor/ Mainly PC&I

NOT MET. Council has started very recently.

-Follow up with NMRC about the existence of the Clinical Committee -Submit through NMRC ADR cases that requires discussion and assessment. -Training of council members in PV activities.

Keep motivated and updated in PV issues to members of council.

9. Create virtual network

Functional network of specialists

Network of four major medical speciality areas

1st Q & 2nd Q2009-2010

1st Q 2010-2011

TIPC coordinator/TIPC advisor

Partially met .TB, HIV program and PHC have been contacted and the link was created. I-TECH clinical mentors have been also contacted. And dermatologist and nutritionist from outside were also consulted.

Specialists are very busy and overwhelmed.

To strength the link and the collaboration with them, having often meeting, transmitting the importance of PV and acquiring a commitment from their side, identifying a focal PV person.

Sustainable if we get involved specialists working in the Ministry. Find out until when I-TECH will be in Namibia.

10. Prepare data tool for PV indicators

To measure PV system in Nambia

Data tool finished and approved

4Q2009-2010

1st Q 2010-2011

TIPC advisor/TIPC Coordinator

Ongoing. Workload. No enough time to work more on this activity

There is a need of more staff.

There must be enough personnel to request the stakeholders to fill in the data tool, and follow up and asses the results.

Str

en

gth

en

reg

ion

al

TIP

C

acti

vit

ies

11. Regional training on TI & PV with collaboration of the focal person regional

Increased the awareness of TIPC

Training of 4 regions conducted.

Along the year

4Q2009-2010

TIPC Coordinator/TIPC advisor

Partially met. Erongo, Kunene and Khomas regions have been trained.

Money and personnel available to travel to the regions.

Plan budget to travel and establish

a priority for the regions. Short

sessions/face to face visit to the

hospitals.

Money for the first trainings/contacts should be received by donors, after that refresh calls/letters could be enough and sustainable.

Increased the number of ADRs received.

Number of ADRs increased from the baseline. How many were expected?

Along the year

Depends on the number of ADRs expected.

TIPC Coordinator

231 ADRs received(up to Nov09)

No awareness of the center. Health professional overwhelmed. They consider the reporting as an extra work

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12. Regional training to the community health workers(CHW)

Increased the awareness of TIPC

Training of 2 regions conducted.

2rd Q & 3th Q2009-2010

Depends on how many regions were planned

TIPC coordinator/ TIPC advisor

MET. Training was conducted in 2 regions (Kunene & Erongo)

CHW were worried about their

supervisors facilitating or

hindering the implementation

of the knowledge and skills

they have acquired. They

commented that it would be

better if the supervisors have

been trained in ADRs before to

make easier the reporting.

Problems may be experienced

if they give the forms to the

supervisor to fax to TIPC and

they have not been trained

yet.

In the future,

consider to invite

also the

supervisors.

- request the

regional

pharmacist to write

a letter informing

supervisors about

the training.

Each participant

should endeavor to

give a feedback to

his/her supervisor

as soon as they

return to their

district.

There is a need of money to organize the training: accommodation, transports, and meals. I would train first: doctors, nurses, and pharmacists..

Increased the number of ADR and queries received from CHW

Along the year

Depend on how many ADRs were expected

Not met. Number of ADRs has not been increased. Only 1 ADR received from Kunene

13. National Baseline Survey on regional TI &PV activities

To identify the needs and the TIPC awareness from all the regions.

National Baseline Survey conducted

3rd Q & 4th Q2009-2010

NA TIPC Coordinator

MET. Survey was done at Pharmacy Forum in July.

Survey was not completely representative because in the forum only pharmacists attended.

Every 6 month (by phone, fax, email) Create time, to send, encourage people and follow up the results. Try to cover nurses and doctors too.

Sustainable.

Pro

vid

e T

I

Se

rvic

es t

o

hea

lth

care

pro

fes

sio

na

ls

14. Answering therapeutics enquiries, documentation, analysis of therapeutics information required to include in Medicines watch

Knowledge and better use of the medicines improved.

Number of queries answered and analyzed. 200 are expected for the first year of operation.

Ongoing along the year

Depends on the number of queries expected.

TIPC Coordinator /

103 queries received up to November 09

Not all the health professional know the center. So that's could be a reason of under using. There is still a need to strength the network of specialist to be ready for any type of query.

Strength network of specialist. And promote the center around the regions.

Only sustainable if MOHSS take over of the subscriptions of Micromedex, and journals.

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15. Identify topics to be covered in the Medicines watch, communicate with possible contributors, collect articles & edit articles, publish and distribute to health care workers

Quarterly Bulletin

Timely publication of the quarterly bulletin (deadline met within the first 10 days of every 3-monthly )

Quarterly Now is pending until new contract is done.

TIPC advisor/TIPC Coordinator

MET.(volume 1 issue 4 was distributed in July09)

Difficulties on ensuring proper dissemination.

Distribution list created. Acknowledge receipts attached to the shipments. Control the acknowledge receipts received. Follow up with those that do not receive the issue.

Contract with the designers has finished. MSH is working in make a new contract but trying to ensure sustainability.(If some from TIPC personnel have to be in charged of the design, there must be more staff)

Mo

nit

or

sa

fety

of

med

icin

es

16. Collection of ADRs reports, causality assessment and analysis of case reports, entering of ADR reports into the VigiFlow,ackowledge received, and motivate the health professional to continue reporting

Signals detected, measures taken

Number of ADR reports committed to Vigibase (100% of the total received) and assessed.



TIPC coordinator/ TIPC advisor???

Partially met -60 ADRs pending to be entered in vigiflow. -Signal detected: Anemia/AZT. Draft of prospective study written.

The challenge is lack of time, slow speed internet connection, poor quality of the reports.

-Improve internet connections. -There is a need of more staff.

It could be sustainable, with at least 3 TIPC positions, and with an stable Clinical Committee to do the causality assessment.

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ANNEX 2: ADVERSE DRUG REACTIONS (ADR) RECEIVED

ANNEX 3: QUERIES RECEIVED

17

1 2

209

1 4 619

2

26

13

103

0

20

40

60

80

100

120

Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 TOTAL

NUMBER OF QUERIES RECEIVED in 2009BY MONTHS UP TO NOVEMBER 09

04

06 4

66

4 2 16

3 1 0 2 1 10

10

20

30

40

50

60

70

NUMBER OF QUERIES BY REGION in 2009up to November/09

ANNEX 4: PHARMACIST’S SURVEY. PHARMACIST’S FORUM. JULY 2009. OTJIWARONGO

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Documents

(TIPC) THERAPEUTIC INFORMATION & PHARMACOVIGILANCE CENTER · THERAPEUTIC INFORMATION AND PHARMACOVIGILANCE CENTER (TIPC) EVALUATION 2009 4 2. WHAT IS THE PROGRESS TOWARD ACHIEVING