Kilimanjaro Christian Medical Centre
PO Box 3010, Moshi, Tanzania,East Africa.

Phone Contact:
+255 27 2754377-2754383

Fax:
+255 27 2754381/2752038

Email:
kcmcadmin@kcmc.ac.tz

Annual Activity Report

Documenting Adverse Drug Reactions

Acknowledgement

First and foremost, I would like to thank all health care workers in KCMC who helped in one way or another to alert me and report on adverse drug reactions. Special thanks to the Pharmacy department and the Department of Internal Medicine. Without them, there would be no reports filled.

Furthermore, I would thank the administration of KCMC for the organization and tireless cooperation they provided me. Also to be thanked is the computer department for the Information technology solutions they offered us.

The office also commends the ministry of health acting through the Tanzania Food and Drug Authority for their guidance and support.

Dr. Kajiru Kilonzo

Coordinator, KCMC Drug Information Office

ACRONYMS

ACT     artemisinin-based combination therapy

ADR     adverse drug reaction

USAID  U.S. Agency for International development

TFDA   Tanzania Food and Drug Authority

ARVs   Anti retrovirals

Background

Globally, there has been an increase in development of new drugs; these have been a result of not only the emergence of new diseases but also resistance to old medication. In such an environment, continuous information dissemination and regulation of the new products on the market is essential to any health system. In most health care systems in the world this role has been taken by Drug Information Centres.

In Tanzania this concept was introduced in 1989 in Muhimbili medical Centre and later in 2002 it was broadened through Tanzania Food and Drug Authority to include Bugando, KCMC and Mbeya consultant hospitals. But the performance of these units has been below their capacity.

Functions of Drug Information Centres

The traditional responsibility areas of Drug Information Centres included;

• Answering Questions on Drugs
• Supporting the Pharmacy and Therapeutic Committee
• Preparing newsletters
• Education
• Research

As the patients become more knowledgeable, thanks to the information revolution, more emphasis is geared towards drug safety. In order to provide information on adverse drug reactions, pharmacovigilance as an essential tool has been adopted.

Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.

The history of pharmacovigilance goes back to 1965 during the 18th World Health Assembly, which drew attention to the problem of adverse drug reaction monitoring. After three more meetings the International Drug Monitoring Programme came into being in 1970. After 35 years the programme includes 78 countries as well as Tanzania.

Tanzania through the Tanzania Food and Drug Authority started pharmacovigilance in 2002 with three zonal centres. Whose function was basically to report adverse drug reactions from the zones.

Since the initiation the performance in Tanzania has been unsatisfactory. According to a recent evaluation of the programme, Tanzania is reporting 3 adverse drug reactions per every one million people per year. This is far below the recommended report rate of 400 ADR/1mil/year.

The current change in Malaria drugs and anti-retroviral medication has resurrected the need to monitor the adverse drug reaction hence the Drug information Centres.

Objectives included

• To provide general information on Drugs.
• To establish a pharmacovigilance culture.
  

Activities conducted/attended

TFDA Pharmacovigilance Training in Dar es Salaam July 2006

Together with all Zonal Drug Information coordinators, two KCMC staffs were trained in Pharmacovigilance for one week. And finally introduced to the WHO database for adverse drug reactions.

During this activity, KCMC was provided with a new Dell Pentium 4 Desktop computer together with an accompanying monitor.

Workshop in improving Pharmacovigilance in Tanzania, Bagamoyo July 2006

This workshop was organized by Management Sciences for Health, a Non-governmental Organization supported by U.S. Agency for International Development.

As a result of the Malaria policy change, especially with the introduction of artemisinin-based combination in pregnant women in Tanzania, a need to improve reporting of adverse drug reactions in this cohort was discussed during this meeting. The meeting was attended by representatives from Ghana, Mozambique, Switzerland, USA, Zanzibar, Mbeya, TFDA, Ifakara research institute and Bugando.

A proposal to improve both passive and active surveillance activities in the country was agreed on. Two districts, one each in Ruvuma and Morogoro regions were selected as pilots. Focus would be on the District health Management Team and improving Yellow card distribution.

Regarding active surveillance, TFDA should strengthen coordination with active surveillance research projects throughout the country. These include research and clinical trials from hospitals, research centres and universities.

Agreed was that ADR reporting should be the responsibility of both health professionals and the general public.

KCMC Clinical conference presentation

In collaboration with the Pharmacy department a major sensitization event was organized. Introduction and importance of the concept was presented. And who, how and when should the yellow cards be used was elaborated.

In this presentation a major concern was that the data collected should be for KCMC consumption first before it is shared. Although the system is designed in such a way there is instantaneous sharing of information to the whole network, Tanzania and internationally.

Setting up the Pharmacovigilance office

The designated office was handed over to the clinical department from the pharmacy on the 30th of august 2006. Left behind was the old Compaq computer which was not working and furniture consisting of a chair and desk.

In close collaboration with the administration, a printer and UPS voltage stabilizer was bought. These together with the new donated Dell desktop computer were installed with the help of the computer department. This is now working albeit without internet connection.

 The printing unit was and continues to be very instrumental in printing Yellow cards. A printing plate was developed for the yellow card, hence this A4 sheet is always available like other request forms.

Development of a sensitization tool March 2007

A leaflet delineating the importance of the Yellow card and how to fill one was developed and distributed. Instructions on the filling of yellow cards were distributed in the Out patient clinics and the medical nursing stations.

KCMC Day 2007

In collaboration with the Pharmacy department, information on drugs and adverse drug reaction reporting was conducted. All 30 Leaflets produced were taken by spectators. The general impression of the visitors was positive to the presentation.

Visit from the Head of Pharmacovigilance in TFDA

Mr Henry Irunde and Mrs Masanja visited us with an aim to supervise the progress of pharmacovigilance at KCMC.

Visit from the Head of IT in TFDA July 2007

 Mr Simba from TFDA came and supplied us with a brand new scanner. Discussed was the unavailability of internet in the office and possibility of broadband connection from TTCL. He concluded that TFDA was ready to support the office with such a connection as Bugando has such connection.

Presentation of Lipodystrophy June 2007

Noted was the appearance of fat accumulation in patients taking ARVs. A presentation in collaboration with the department of Internal Medicine was conducted in the Wednesday Clinical Conference.

 A positive response from the department of medicine was observed. Statements like “The numbers reported are small, from now on we are going to fill in as many ADRs as possible” started appearing.

Data entry and analysing the Adverse drug reaction.

 The major activities of the office consisted of data entry. Data was primarily entered in a KCMC ADR database. Then these were re-entered in the WHO database to be assessed by the TFDA pharmacovigilance unit.

 Summary of the Adverse Reactions Reported

 Sensitization

A total of 105 cases of adverse side effects were reported between may 2006 and August 2007 at KCMC.

 Graph 1. Number of ADRs reported monthly at KCMC.

After the Pharmacovigilance presentation at the clinical conference in July 2006, we saw an increased reporting which lasted for about 7 months before decreased reporting occurred. This might demonstrate the need for repeated sensitization presentations in the future. Another presentation was made in June 2007, and this together with the addition a new pharmacist at KCMC, the ADRs have started to increase again.

Which departments are reporting?

 Internal medicine reported most of the ADRs 85%, followed by Pharmacy 13%, causality 2% and lastly surgery 1%. The departments of Paediatrics, Dermatology and Obstetrics did not report any ADRs.

Who are reporting?

 Mostly done by the coordinator but the following should be encouraged (in order of contributions).

• 1.     Riffat Hanza, Pharmacist
• 2.     Dr Kitange, resident internal medicine
• 3.     Dr Chaula, resident internal medicine
• 4.     Dr Nyimbi, resident internal medicine
• 5.     Dr Neema, resident internal medicine
• 6.     Dr Sarah, resident internal medicine

Although the level of sensitization, the culture of pharmacovigilance is not at its maximum capacity, all life threatening reactions or deaths from non pregnant adults thought to be caused by drugs were reported. And this should be considered as an improvement.

Adverse Reactions

The top three reactions reported were

• 1.     Lipodystrophy           23 cases
• 2.     Peripheral neuropathy   13
• 3.     Skin rash                   11

Among others nausea and vomiting, headache, Erythema multiforme minor, angioedema, lactic acidosis, convulsion, wheezing and fractures were reported.

Most reactions were expected ADRs. There were two unexpected ADRs cases which were suspected to be caused by ALU. Both were causing cardiovascular symptoms. One case resulted into worsened heart failure. Whether these are only occurring by chance it is not known.

Drugs

Triomune 40/30

ARVs feature out as the most reported drug. Triomune 40/30 have specifically been implicated.

From the data we collected, with a certain amount of firmness, it can be said ARVs do not cause death. Four patients died, only two deaths were thought to be as a result of ARVs. ARVs improve survival in patients with HIV/AIDS.

Artemether Lumefantrine

From our reported ADRs, 4 cases were reported suspected to have been caused by ALU. Two had cardiovascular symptoms, one convulsions and one case of skin blistering.

Although a proper review is needed, one can assume that ALU dose not deserve the public scare it is getting.

But it is important to note that, the departments of paediatrics and obstetrics have not reported any ADRs. And these special populations are the ones not usually included in clinical trials. So it remains unclear how much toxicity ALU is causing in these special population in KCMC.

Other Drugs

ACE inhibitors causing an benign irritating cough and a dangerous angioedema (2 cases). Atenolol causing awareness of heart beats.

Severity

Most reactions reported were considered severe reactions as the following table 1 shows.

Table 1. Severity of Adverse reactions.

Permanent disability was mostly caused by ART. These represent disfigurement due to lipid redistribution, Lipodystrophy. This is regarded as a form of the Metabolic syndrome X. And indeed, Diabetes was also included as an adverse effect of these ARVs, in particular Triomune 40 which is a combination of Stavudine, Lamivudine and Nevirapine.

Those who died included one case of severe Toxic Epidermal Necrolysis due to penicillin, worsening heart failure after ALU and two cases of presumed Lactic acidosis in patients on Triomune 40.

Recommendations

• 1.     New strategies to build a pharmacovigilance culture in KCMC are needed, some included
• a.  Printing out certificates of appreciation for top reporters.
• b.  Pharmacovigilance boxes. Boxes to drop off filled yellow cards in the clinics/?corridors would serve both to remind health care workers and improve collection of the forms.

• 2.     More coordinators should be assigned this sensitization task. Being a part of internal medicine made it easier for the coordinator to sensitize this department. As dermatology, paediatrics and obstetrics are currently not reporting, suggested is including clinicians from these departments in the pharmacovigilance team.

• 3.     A pharmacist should be part of the Pharmacovigilance team. As there is now a new Pharmacist who has shown interest, it is high time to include her in the coordination.

• 4.     Pharmacovigilance office
• a.  Connectivity. Internet connection has been unavailable for the past 6 months due to financial barriers. We are more than 6 months late in reporting these data to the TFDA database.
•                                                         i.      TFDA is ready to sponsor a broadband connection from TTCL. Pending is a permanent office.
• b.  Accesibility. As this is volunteer work, it is not done during working hours. But after hours the office is close, making the whole exercise difficult.
• c.  Visibility. The office is hidden, an office which is not so hidden would help the cause.

Sources of Materials

1. Amerson. Drug Information Centres. Drug Information Journal 1989 20 (2) 173-8.
2. WHO. The Safety of Medicine in Public Health Programmes. WHO Library Cataloguing-in-Publication Data 2006.
3. Caduff-Janosa, P. Assessment of the current Pharmacovigilance system in Tanzania. Proceeding from a consultative meeting to discuss ADR of Artesimin Combination Therapy in pregnant women in Tanzania. Bagamoyo July 2006.

Contact personel:

Dr Siya Temu ( siyatemu@hotmail.com)

Department of Paediatrics

Kilimanjaro Christian Medical CentreP. O. Box 3010 Moshi, Kilimanjaro+255756203107

Dr Kajiru Kilonzo ( kajiru@yahoo.com)

Department of Internal MedicineKilimanjaro Christian Medical Centre P. O. Box 3010 Moshi, Kilimanjaro+255756337067

Sr Ghikas

Department of Internal MedicineKilimanjaro Christian Medical CentreP. O. Box 3010Moshi, Kilimanjaro

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