BARRIERS TO THE USE OF MAGNESBARRIERS TO THE USE OF MAGNESBARRIERS TO THE USE OF MAGNESBARRIERS TO THE USE OF MAGNESIUM SULPHATE IUM SULPHATE IUM SULPHATE IUM SULPHATE

IN PAKISTANIN PAKISTANIN PAKISTANIN PAKISTAN---- A STUDY TO DEVELOP INFORMED A STUDY TO DEVELOP INFORMED A STUDY TO DEVELOP INFORMED A STUDY TO DEVELOP INFORMED

POLICYPOLICYPOLICYPOLICY

Submitted by:

Dr Assad Hafeez

Professor Shamsa Rizwan

Table of Contents

1. Background ------------------------------------------------------------------------ 1

2. Methodology ---------------------------------------------------------------------- 3

2.1 Data collection ------------------------------------------------------------------------------- 4

2.1.1 Government/Regulatory Level ------------------------------------------------------- 4

2.1.2 Pharmaceutical Supply System ------------------------------------------------------- 4

2.1.3 Health Professionals --------------------------------------------------------------------- 4

2.1.4 Health Facilities --------------------------------------------------------------------------- 5

2.2 Data analysis --------------------------------------------------------------------------------- 5

3. Findings ---------------------------------------------------------------------------- 6

3.1 Policy, Guidelines and Registration ----------------------------------------------------- 6

3.2 Procurement and Distribution ------------------------------------------------------------ 6

3.3 Cost and Consumption ---------------------------------------------------------------------- 7

3.4 Dosage Regimens and Route ------------------------------------------------------------- 8

3.5 Availability ------------------------------------------------------------------------------------ 9

3.6 Training --------------------------------------------------------------------------------------- 10

3.7 Awareness and Practices of Health Professionals --------------------------------- 11

4. Discussion ----------------------------------------------------------------------- 15

5. Recommendations ------------------------------------------------------------ 17

ANNEXURES: -----------------------------------------------------------------------------------------------18-24

ANNEXURE – I: TOOLS

ANNEXURE – II: PARTICIPANTS OF THE FOCUS GROUP DISCUSSIONS

ANNEXURE – III: LIST OF HEALTH FACILITIES SURVEYED FOR THE STUDY

REFRENCES

Acronyms

AIDS Acquired Immunodeficiency Syndrome

AJK Azad Jammu & Kashmir

ARI Acute Respiratory Infections

CMW Community Midwife

CPR Contraceptive Prevalence Rate

DoH Department of Health

DOTS Directly Observed Short Course Treatment

DPIU District Program Implementation Unit

EDO Executive District Officer

EMoC Emergency Obstetric Care

EPI Extended Programme on Immunization

ESS-EMCH Essential Surgical skills and Emergency Maternal and child Health

ESPs Essential Services Packages

FANA Federally Administered Northern Areas

FATA Federally Administered Tribal Areas

FLCFs First Level Care Facilities

FP Family Planning

FP & PHC Family Planning & Primary Health Care

FPIU Federal Program Implementation Unit

FPO Field Program Officer

GDP Gross Domestic Product

HDI Human Development Index

HIV Human immunodeficiency virus

HMIS Health Management Information System

ICT Islamabad Capital Territory

IMR Infant Mortality Rate

LHS Lady Health Supervisor

LHV Lady Health Visitor

LHWP Lady Health Workers Programme

LHWs Lady Health Workers

MgSO4 Magnesium sulfate

MS DMedical Store Depot

MCH Maternal and Child Health

MDG Millennium Development Goals

MNCH Maternal, Newborn and Child Health

MIS Management Information System

MMR Maternal Mortality Rate

MoH Ministry of Health

NGOs Non Governmental Organizations

NHF National Health Facility

PDHS Pakistan Demographic Household Survey

PIU Program Information Unit

PPIU Provincial Program Implementation Unit

PSDP Public Sector Development Programme

PSLM Pakistan Survey of Living Standards

RH Reproductive Health

SBA Skilled Birth Attendants

STI Sexually Transmitted Infections

TT Tetanus Toxiod

UK United Kingdom

UNFPA United Nation Fund for Population

UNICEF United Nation Children Fund

WHO World Health Organization

1

1. Background

Pre-eclampsia and eclampsia are grave complications of pregnancy and a significant reason

of maternal morbidity and mortality. The risk of dying from eclampsia is approximately

fourteen times higher in a developing country compared to a developed countryi .It is

estimated that 2000 women die of eclampsia and 8-10% women suffer from this condition

during their pregnancies in Pakistan. A report in Pakistan identifies pregnancy induced

hypertention and eclampsia as the second commonest cause of maternal mortality.

Fig 1. Causes of death (n=128), Sukkur and Malir districts, 2005-2007

There is ample evidence to suggest that magnesium sulfate is the drug of choice for the

treatment and prevention of eclampsia and severe pre eclampsiaii iii

iv .Magnesium sulfate

has appeared on the World Health Organization's essential medicines list since 1996 and

since 2003, it has been included specifically for the treatment of severe pre-eclampsia and

eclampsiav.It is a low cost, highly effective drug and recent studies indicate that its use in

low income countries is more cost effective when compared to use in high income

countriesvi. However, studies show that this safe and effective medicine is still unavailable

and underutilized in many low and middle income countries vii

viii

.

2

If magnesium sulfate is used appropriately, 2000 maternal deaths could be prevented and

50,000 cases of eclampsia could be cured in a year in Pakistan, making a significant dent in

the overall mortality and morbidity figures. This would contribute positively to the national

efforts towards achieving Millennium Development Goals by 2015. The first step in

designing effective interventions to increase the use of MgSO4 is to identify barriers to use

and target the intervention accordinglyix.

If we consider the cost effectiveness of MgSO4 if only eclampsia were treated with

magnesium sulfate (and not preeclampsia) the use of magnesium sulfate would be an

extraordinarily cost effective intervention. Only two eclamptic women would need to be

treated to save one life because maternal deaths are almost halved with the use of

magnesium sulfate, whereas 36 women with signs of imminent eclampsia required

treatment to prevent one case of eclampsiax . Reasons for low usage in practice could have

a wide spectrum ranging from issues of production, pricing, availability, safety concerns,

attitudes of medical staff and other barriers. There is ample data from other developing

countries highlighting the issue of mgso4 use. A study in Mozambique and Zimbabwe, two

countries with high maternal mortality ratios, describes problems with the registration,

approval, acquisition, and distribution of magnesium sulphate, and hence its availability to

clinicians There is no published evidence from Pakistan that looks at the availability and

barriers in the use of magnesium sulphate. We aim to determine the barriers to the use of

magnesium sulphate and assess its availability in the public and private health facilities of

Pakistan with the ultimate goal of gathering context-specific evidence for formulation of

enabling policies at national and provincial level.

3

2. Methodology

We used a multipronged approach to assess the problem. A list of all the necessary

requirements for the rational use of the drug was formulated after literature search and

discussion (Fig 2). For each requirement listed, we identified the level in the health system

where the information could be gathered from.

Fig 2. Requirements for Rational MgSO4 use

The levels identified were

• Government/regulatory

• Pharmaceutical supply system

• Health facilities

• Health professionals.

We carried out quantitative and qualitative research and developed separate tools for the

health facility survey, in-depth interviews with pharmacists, government officials and key

Rational Use of

MgSO4

4

informants. Guidelines for the focus group discussion with the obstetricians and medical

officers were also developed. [Annex 1]

2.1 Data collection

Based on the requirements, we collected data for each level from all the four provinces of

Pakistan. Data collection took place between 20th

Nov and 31st

Dec 2010.

Different data collection approaches were used for different levels including in-depth, semi

structured qualitative interviews , informal discussions and quantitative questionnaires

covering the structure and process of policy for the management of eclampsia and pre-

eclampsia, factors affecting the implementation of policies ,individual's knowledge of

evidence , availability and use of Mg SO4.

Purposive sampling approach was used, based on the respondents' involvement in policy

making or procurement for magnesium sulphate for qualitative data and the type of facility.

The data collection procedure at different levels is given below.

2.1.1 Government/Regulatory Level

For government regulatory procedures desk review of available evidence from published

literature and national documents such as standard treatment guidelines, essential drug list,

other clinical guidelines and national policies was undertaken. Moreover in-depth interviews

with the Director General Health and MNCH program manager were carried out.

2.1.2 Pharmaceutical Supply System

Information about the procurement, supply and distribution of MgSO4 within the public

health system of Pakistan was obtained from Ministry of Health personnel responsible for

the procurement of medicines for the public sector, employees at the Central Medical Store

and pharmacy workers in the visited health facilities.

2.1.3 Health Professionals

Members from the Society of Gynaecologists and Obstetricians (SOGP) were interviewed,

and focus group discussions were carried out with Gynaecologists from all provinces as well

as women medical officers most likely to be managing patients with pre-eclampsia and

eclampsia[Annex 2].

5

2.1.4 Health Facilities

An observational exercise was undertaken at each sampled health facility to ascertain if the

facility had the necessary supplies and equipment to administer MgSO4 injection and

monitor a patient receiving MgSO4 treatment of severe pre-eclampsia or eclampsia. This

was to assess not only if MgSO4 was available on the day of the visit, but also if the facility

had sufficient quantity of MgSO4 to give the recommended treatment regimen to one

patient. Moreover which route of administration was preferred in the facility? The presence

of guidelines/ protocols in the facility was also observed.

Sample selection of health facilities

A total of fifteen health facilities including teaching hospitals, District Head Quarter (DHQ),

tehsil head quarter (THQ), Rural health centers (RHC) and private hospitals were surveyed

[Annex3]. The pharmacy and the Obstetric departments were visited for data collection.

2.2 Data analysis

All interviews were audio recorded and transcribed. Categories emerging from the data

were identified and a coding frame developed. Quantitative data was analyzed using SPSS

version 15.

6

3. Findings

The barriers to the use of magnesium sulfate were assessed at various levels and the

findings are summarized below.

3.1 Policy, Guidelines and Registration

Magnesium sulphate injection is Registered for use in Pakistan and is listed as the first line

treatment for eclampsia in the key policy documents - the national Essential Medicines List

NEML (2007), Pakistan National Formulary (2005) and the MNCH EmONC training manual

(2005). In Pakistan Mg SO4 is registered for the treatment of both severe pre-eclampsia and

eclampsia and not for other convulsions. However, no national guidelines are available for

its use. Mg SO4 is not a part of the Pakistan Best Practices Policy (Karachi seminar

declaration, 2008). Only one Pakistan based multinational pharmaceutical company (Zafa) is

manufacturing the medicine. The dosage regimens recommended in the EmNOC are

different from the regimen recommended by the Oxford Group. There is no mention of the

intramuscular only regimen in any of the policy documents.

3.2 Procurement and Distribution

National procurement of medicines is carried out by the Ministry of Health and is based on

the national Essential Medicines List. There is no separate budget allocated for medicines to

the provinces and procurement of medicines is directly through provinces with whom the

NEML is shared. The Provincial Medical Store Depot (MSD) manages the acquisition, storage

and distribution of medicines for the province and is the main supplier of medicines to

public sector hospital pharmacies and district health offices (DHO). Private hospitals acquire

medicines from the open market. Central and specialized hospitals, such as the Pakistan

Institute of medical sciences (Teaching Hospital), are also given a grant by the ministry of

health for the independent procurement of emergency medicines and medical supplies. The

procurement of MgSO4 was mostly depended upon the demand by the health departments.

Indicating an independent procurement of emergency medicines and is therefore

dependent on facility policies rather than national procurement policies.

7

3.3 Cost and Production

Magnesium sulfate is a low cost drug and too inexpensive for being an incentive for the

pharmaceutical companies. Low price may also be a counter-incentive for facilities

especially when facilities have some freedom in independent procurement of drugs. The

market for the drug is small and the drug is not widely used for other conditions thereby

lacking the economy of scope. The average price is Rs 3.5 per ampoule. However in Quetta,

Baluchistan the all year availability is an issue and MgSO4 is being sold at a price of Rs 75 in

the open market implying out-of-pocket expenditure that may not be affordable by some

patients.

The consumption data from the ministry displays an overall usage of MGSO4 (public and

private) for any indication in Pakistan. There is a rising trend in the utilization for 10ml

injections over the years, however the usage data observed (0.06% of the pregnant women

received magnesium sulfate in 2009) does not even cover a 24h administration for

eclampsia alone. Women who actually need treatment for eclampsia are estimated to be 8-

10% whereas the combined eclampsia and severe pre eclampsia incidence is much higher.

So more than 10 times higher consumption is desirable.

Figure 2.Production Data of Mg so4 (2002-2009)

10 ML0

200,000

400,000

600,000

800,000

2002 2004 2006 2008

10 ML

2 ML

required

Production

8

3.4 Dosage Regimens and Route

There are two main recommended dosage regimens, both starting with an intravenous

bolus followed by intramuscular or intravenous maintenance regimen ( Fig 3). RCOG

Guideline No. 10(A) recommends the i/v route.

Fig 3 Standard MgSO4 regimens

The Oxford groups of experts have recommended an intramuscular regimen of 10g

intramuscular loading dose followed by 5gm intramuscular every 4 hours. This is to safely

provide the drug in a variety of care settings by paramedical and medical personnel and for

wider use. The intramuscular regimen was shown to be effective in Ghana and Bangladeshxi.

Only one of the facilities was using the intramuscular only regimen, where the obstetrician

had been trained in essential Surgical skills and Emergency Maternal and child health (ESS-

EMCH) training.

The findings from the facilities and the focus group discussions with the obstetricians

highlight the variation in the dosage quantities and regimens used at various settings. Some

hospitals reported using intramuscular regimen, later followed by intravenous infusion

which was opposite to the recommendations. A few of the facilities were using only the 5 g

bolus, followed by no maintenance dose whatsoever. The others were using as small as 500

mg dosage intramuscularly, which would be ineffective in preventing fits. Very few of the

9

facility were using the i/v regimen because of lack of staff and equipment as reported in the

interviews as well as observed by the researchers.

3.5 Availability

The availability of Mg SO4 in the private and public pharmacies was assessed in all the four

provinces. The medicine was available in the pharmacies of larger cities, and the teaching

hospitals whereas it was not attainable in majority of other settings.

The pharmacies at the Teaching Hospitals had MgSO4 in stock, procured from a local

wholesaler/ vender using the grant provided by the MoH. The procurement was a result of

demand from the obstetricians working at the hospitals. The teaching hospital pharmacies

had the NEML with them at the time of survey. During focus group discussions, some of the

teaching staff raised the concern about continuous and persistent availability of MgSO4.

Since most of the eclampsia patients were referred to tertiary care, most of the non-

teaching hospitals lacked the demand, hence the availability. At some places patient’s

relatives were asked to bring the medicine from private pharmacies. The medicine is neither

easily available nor is availability throughout the year guaranteed in the Baluchistan and

Sindh province. However as it is acquired for teaching/ army hospitals through the MSD,

they had the stocks available at the time of visit. There was a shortage of the medicine in

the open market at some places and was being sold at a higher price compromising the

availability of the drug to the poor.

The private hospital pharmacies surveyed did not have the medicine as they only procured if

there was a demand and the demand was not great in private sector.

The availability of the 24 hour dosage in the labour wards was also assessed. All the teaching

hospitals had the medicine available in sufficient quantities but in THQ and some DHQs it

was either not available or was not in sufficient quantity (fig. 3). The availability of necessary

adjunct treatment and supplies was deficient even in some teaching hospitals. The antidote

calcium gluconate and local anesthetic 2% xylocain for i/m regimen was not available in

many settings. The infusion pumps for i/v infusions were not available in any setting. There

were no written protocols for use in majority of the facilities. In contrast to guidelines,

diazepam ampoules were on the emergency trays at some sites indicating that diazepam is

still used in an emergency.

10

Private facilities did not have the drug available in the obstetric wards or labour rooms for

use. The overall availability in the lower level health settings and in the private hospitals

reflects the lack of demand by the clinicians, stressing upon the need of raised awareness.

3.6 Training

None of the pharmacists had any formal training in the use or dosage preparation of Mg

SO4 and the obstetric department themselves prepared the medicine. There was also a lack

of clinical pharmacies even in some of the teaching hospitals.

Many of the staff dispensing the treatment admitted to not attaining any formal training in

the use of MgSO4; only on job experience was reported. Though the training of doctors was

perceived to be sufficient in the teaching hospitals, we observed contradictory practices.

Some of the teaching hospitals were using diazepam and MgSO4 together for admitted

eclampsia patients, which are against the standard treatment guidelines and can be

dangerous. Some of the staff working in the non-teaching settings had EmNOC trainings by

MNCH program which increased their awareness about the use of MgSO4.

The lower level hospitals where some maternal care intervention had been implemented

were better equipped and were using MgSO4 injections for eclampsia (e.g., Muridke THQ).

The training and intervention was found to be extremely facilitative factor for the use of MG

SO4 even in the non-teaching facilities

0%

20%

40%

60%

80%

100%

120%

Teaching non teaching

Fig.3 Availability, Training , Use and Protocol for MgSO4

Availability Training Use Protocols available

11

Most of the doctors found the dosage preparation to be the biggest barrier to the use of the

medicine as they have to recall, calculate and prepare the dosage themselves.

3.7 Awareness and Practices of Health Professionals

There are certain clinical requirements for the use of magnesium sulfate, which include the

availability of infusion pumps for I/v use, dosage preparation, availability of the antidote

calcium gluconate and understanding the contra-indication to use especially alongside

diazepam. Magnesium levels are not required routinely for its use. This clearly demonstrates

that NEML and clinical guidelines only cannot solve the problem but that procedures need

to be in place at facility level, staff trained and equipment available.

Against the backdrop that most of the doctors and midwives were trained in the use of

diazepam, or 'lytic' cocktail as anticonvulsants for pre-eclampsia and eclampsia, majority of

the health professionals were aware of the usefulness of Mg SO4 as the first line treatment

for eclampsia, many had no knowledge of its use in severe pre eclampsia. One of the tertiary

care hospitals where MgSO4 was being used for severe pre-eclampsia, had been part of the

international MAGPIE trial. In addition to the reduced morbidity and mortality in severe pre-

eclampsia, obstetrician expressed that it also helped in prolonging the pregnancy duration,

leading to better fetal outcome. Most of the facilities using MgSO4 were not doing

magnesium levels.

Due to less numbers of the eclampsia patients entertained in some of the smaller level of

facilities, there is lack of recent knowledge and experience which is another potential barrier

to effective administration of MgSO4 and would highlight the need for frequent refresher

courses and other educational reminders, to ensure appropriate diagnosis and treatment.

There was a” Fear” of using Mg SO4 among the health professionals. The staff in many of

the THQs and BHUs immediately referred the convulsing patients without any emergency

management as they felt inadequate. There were no referral guidelines available for

use.The relatives would sometimes take the woman directly to a tertiary care even if was far

off, leading to repeated convulsions and higher morbidity and mortality when they do reach

the tertiary care setting.

12

The obstetricians felt that trained staff for dosage

preparation and monitoring of the toxicity is a

necessary pre- requisite for Mg SO4 use and hence

none of the obstetricians were using it in private

settings. The injection was mostly prepared by the

doctors and in some cases by the nurses in the

institutions. There was a misconception that this

drug can only be used in advanced settings with

intensive care availability. When asked whether primary health care should be using Mg

SO4, majority agreed to the benefit to women but stressed the need for proper training and

availability of pre- dosage calculated packs. There are concerns of magnesium sulfate

toxicity especially among the older generation of physicians.

Table I. Summarizes the barriers and identifies actions needed

Table1. Barriers to the use of MgSO4, Recommendations and follow-up in Pakistan

Barriers Identified Recommendations Follow up Indicators

Policy

• No clear national

treatment guidelines

for MgSO4 use in

eclampsia / severe

pre-eclampsia

• Not included in the

Best Practices

• Pre/eclampsia

specifically, not a

priority on public

health agendas

• Preparation of Standard

national treatment

guidelines for MgSO4 use

• Develop Pakistan specific

standards of care based

on WHO guidelines &

area best practices for

MgSO4.

• Raise awareness of the

disease,

Show the “burden of the

disease

• Available

Standard national

treatment

guidelines for

MgSO4 use

• Included in the

Best practices

• Meetigs and

seminars

conducted

Supply, procurement and

distribution

• Interrupted supply in

some provinces

• Ensure uninterrupted

supplies

• Availability in the

facilities all year

“ I lost one patient because the i/v

infusion was turned fast by a

relative, So I will never use it as it

is not safe without monitoring”

( An obstetrician at a DHQ)

13

• Only available in 10

ml and 2 ml form

• Ensure registration

requirements for pre-

filled dosage

• Pre filled dosage

available

Training

• Lack of training of

midwives, nurses

and doctors

• No referral

guidelines available

• Regular training and

refreshers

• Simplified protocols and

short one day trainings

• Referral guidelines

prepared

• On job trainings

conducted at all

levels

• Simplified

protocols

available

• Referral

guidelines

available

Health Professionals/ Use

• Reluctance to adopt

new practice and

Lack of awareness

• Difficult dosage

preparation

• Need for intensive

monitoring

• Lack of a champion

• Fear of Use

• On the job training

• Discourage other

treatment use by raised

awareness via workshops

• Award hospitals using

MgSO4

• Engagement of leading

professionals

• Acquire prefilled standard

dose

• Explain basic monitoring

enough

• Identify & reward local

champions- Senior

obstetricians need to be

brought on board as they

seem to have

misconceptions about the

medicines but will play

important role in training

• Other treatment

e.g diazepam not

in use in facilities

• Facility

certifications for

appreciation

• Professional

group formed for

Mg SO4 use

• Prefilled dosage

preparation

available

• Being used in

lower levels of

facility

• Political leader

involved

• Workshops,

newspaper

reporting on

14

younger generations and

supervising midwives

• Effective communication

strategy

safety

Facility

• Lack of developed

protocols

• Difficulty in using iv

regimen for non-

teaching facility

• Absence of antidotes

and other adjuncts

• simple protocols should

be in place

• i/m only regimen should

be enforced

• Create a standard

treatment box for

containing antidotes and

lignocaine etc.

• Protocols

developed

• I/M only regimen

being used in

primary care use

• Standard

treatment box

available

Tracers

30% increase in the production of mgso4

Availability in 70% of the sampled non- teaching public and private health facilities

Availability in 70 % of public pharmacies and 50% of the private pharmacies sampled

70% of the primary and secondary care staff trained in the use of i/m mgso4

15

4. Discussion

Before undertaking any intervention to improve the management of eclampsia and severe

eclampsia a thorough understanding of the local situation is needed .Our study is the first of

its kind where we tried to assess the barriers to the use of MgSO4 both in public and private

settings of Pakistan using a mixed method approach. The qualitative discussions with the

health professionals have added depth to the understanding of the barriers. The sample

includes data from rural, urban, public and private sector hospitals in each province which

adds generalizability to the results. The barriers identified included the lack of clinical

guidelines from the Ministry of Health on the use of magnesium sulphate, lack of a clinical

champion, clinicians' ease with previous use of other drugs to manage eclampsia, difficult

dosage calculation and constraints on equipment, human resources and their training.

The teaching hospitals were getting the maximum load of eclampsia and severe pre

eclampsia patients, some getting as many as 2-3 per week. The tertiary care facility staff

feels that the patients referred to them are not given any emergency treatment at the first

level of care, hence the need to include referral guidelines as an important component of

national guidelines. The data from the clinical records and the anecdotes from staff

suggested that cases of pre-eclampsia and eclampsia were infrequent at small hospitals and

most of them were either referred or given alternative treatment for convulsions e.g.,

Diazepam as they were used to this treatment. Discrepancy between private and public

facilities, in the availability of treatment with magnesium sulfate is another issue to be

resolved.

This study highlights the importance of translating evidence base into policy and action for

meaningful outcome. There is a need to proliferate the use of this life saving medicine

outside the tertiary care settings to reduce mortality, as a very significant portion of the

maternal deaths from eclampsia reported from many developing countries are among

women who had multiple seizures outside the hospital and those without prenatal carexii

*.

In Pakistan majority of women do not have access to services where preeclampsia could

likely be diagnosed or have contact with professionals who could administer magnesium

sulfate. There is a shortage of human resource for health, an insufficient number of qualified

clinicians to monitor the use of magnesium sulfate or even to prescribe the drug in

peripheral hospitals but training the available resource can reduce adverse maternal

16

outcomes. The misconception that intensive hospital care is involved with providing Mg SO4

was a barrier and should be dispelled.

The small sample size may be a limitation of the study, but gives us a quick review of the

situation in different provinces. A large portion of the sample was the teaching hospitals

which give an optimistic view and does not reflect the current situation in smaller settings.

The diagnostic criteria for severe preeclampsia and eclampsia as well as the available

equipment for the diagnosis were not assessed.

The implication from the study is that MgSO4 is still not in widespread use. The public and

private sector hospitals and stake holders like the general practitioners and midwives need

the information, training and encouragement. It is important to disseminate these findings

to policy makers, program managers, obstetricians, and even journalists.

The cost effectiveness of the medicine should be assessed in light of its low cost, expenses

on the diagnosis of severe pre-eclampsia and eclampsia, monitoring costs, hospital stay

costs and death and long term morbidity prevention costs. Scaling up its use in Pakistan, by

addressing the barriers will significantly advance the safe motherhood agenda and thereby

add to our accomplishing the millennium development goals.

17

5. Recommendations

The desired use of magnesium sulfate in Pakistan would need ownership, commitment and

a dedicated group of professionals. This has to be a priority in the policy recommendations

and in public health arena. Awareness raising, guidelines preparation for easy use, trainings,

inclusion in the best practices, introduction of the I/M only regimen for lower level of health

facilities, uninterrupted supply and availability of pre filled dosage preparation will be a few

steps towards achieving the goal. Separate MgSO4 guidelines should be developed and

Ministry of Health should take a lead in implementation. Guidelines should be displayed at

the health facilities. Orientation sessions should be organized. Dissemination workshops

should be organized at district level. There should be multiple suppliers from

pharmaceutical industry. MgSO4 Kits should be locally prepared with instructions in local

language. Moreover injections should be ready to use with no preparation required. Those

who are practicing should be the role models and the facilities using the medicines should

be offered some kind of certification and reward. Clear guidelines should exit for safe

referral of patients after receiving emergency treatment.

There is a need for advocacy for the use of magnesium sulfate. Involvement of professional

and civil society, identifying a champion, political participation and policy briefs are the way

forward in this direction.

18

Annex I

Tools

Tool 1. Barriers to the Use of Magnessium Sulphate In Pakistan-

Hospital Survey Form

Name of the Hospital

Type of facility Urban

Teaching

DHQ

THQ

Rural

THQ

Name of union Council

Name of District

Province

Date of Interview

Key Respondent

Information about Mg So4

I. How many patients with Eclampsia and severe Pre eclampsia were seen in the last one

year in this hospital?

None

1-10

11-20

21-30

30

II. How many deliveries took place in the last one year?

III. What is your first choice for management of fits in Eclampsia?

Mg So4

Diazepam

Refferal

Others ( specify)

IV. What is your first choice for management of severe pre- Eclampsia?

Mg So4

Diazepam

Refferal

Others ( specify)

V. What Dosage do you use?

VI. Who provides the injecton?

Hospital pharmacy

Patients bring it

others

VII. Who prepares the injection?

Doctor

nurse

others

VIII. What route do you prefer?

I/M only

19

I/V only

I/V followed by I/M

others

IX. Do you have infusion chambers for I/v infusion?

yes

No

X. Do you have a written protocol for its use?

yes

No

XI. Why do you prefer the medicine that you use as a first choice?

Easy Availability

better results

Safety

others

XII. Did the person dispensing receive any training for the use of MgSo4

Yes

No

XIII. Do you have an admitted patient with Eclampsia?

Yes

No

XIV. If yes What treatment is she receiving ( see The file)

Observe these

XV. Sufficient quantity of MgSO4 to provide 24h treatment?( 10ml in IV/IM regimen requires

10 ampoules, IV regimen requires 6 ampoules.2ml ampoule of 50% solution for IV/IM 44

ampoules

and IV 28 ampoules)

Yes

No

XVI. Calcium gluconate (1g, 10ml of 10% solution)

Yes

No

XVII. 2% Lignocaine (1ml ampoules)

Yes

No

XVIII. Sterile syringes (10ml or 20ml)

Yes

No

XIX. What are your views about mg so4 use?

20

Tool 2: Barriers to the use of MgSO4 in Pakistan In depth Interview with

Pharmacists

Name--------------------------------------------------

Designation------------------------------------------

Location----------------------------------------------

Date--------------------------------------------------

Interviewer/Facilitator

No. Question Probe Response

1 Is magnesium sulfate injection

available in your pharmacy?

( check the stock) If not why?

Yes/ No

1. lack of demand

2. no profit

3. low cost

4. registration

2 Who demands for the drug? 1. In the essential drug list

2. Obstetricians

3. Private hospitals

4. Public hospitals

3 Do you have a formulation with

pre prepared dosage?

1. Why not

2. Do you prepare it?

4 From where do you acquire Mg

So4?

1. Central pharmacy

2. Other source

5 Have you

received in-service training

regarding use of

MgSO4 injection for treatment

of preeclampsia/

eclampsia

1. Yes

2. No

6 What is the price of one

injection of magnesium sulfate

in Rupees?

7

8

Is the Essential drug list

available with you?

Are the guidelines for Mgso4

use available?

1. Yes

2. No

1. yes

2. No

21

Tool 3: In depth Interview with Key informants

Name--------------------------------------------------

Designation------------------------------------------

Location----------------------------------------------

Date--------------------------------------------------

Interviewer/Facilitator

No. Question Probe Response

1 How do you think MgSO4 use

in eclampsia and severe pre

eclampsia can help women?

1. prevent maternal

mortality

2. prevent morbidity

2 Why in your opinion is it not

widely available in Pakistan?

1. registration

2. acquisition

3. approval

4. policy

5. lack of demand

3 What factors affect the

implementation of policy

regarding Mg so4 in primary

health care?

4 Can you suggest the structure

and process of policy making

for the management of

eclampsia and pre-eclampsia?

5 Is it included as first line

therapy for eclampsia in the

essential drug list?

6 What level of health facility is

MgSO4 approved for?

7 What other drugs are licensed

and indicated for pre-

eclampsia and eclampsia?

8 Are there any guidelines

available from the ministry for

its use?

22

Tool 4: FGD with Obstetricians/ WMO

Location---------------------------------------------

Place ------------------------------------------

Note taker------------------------------------------

Date--------------------------------------------------

Interviewer/Facilitator -----------------------------

No. Question Probe Response

1 What do you know about the use

of magnesium sulfate for

eclampsia and severe pre

eclamppsia?

2 Do you have any written

protocols for its use in the

hospitals where you work?

What are the protocols?

3 What is your experience about

this medicine?

1. Are there any

benefits/ side effects?

2. Is it widely available?

4 Do you think primary health care

facilities should have this

medicine available to them?

1. 1 .why / why not

2. what route

5 What is your preference about

the dosage and route?

1. I/M

2. I/V

3. Combined

4. Explore reasons for

particular option

6 What are the main challenges

that you face for its use in the

private sector?

7 What would you suggest should

be done to increase its use by the

doctors?

23

Annex 2

Participants of the Focus Group discussions

S.No Name Designation Hospital 1 Lt Col Ambreen Anwer Classified Gynaecologist CMH Quetta

2 Prof Shaista Muhammad

Din

Professor Liaquat University of Medical & Health

Sciences Jamshoro

3 Prof Dr Zahida Perveen Professor Ayub Medical College Abbottabad

4 Dr Sajida Yousaf Associate Prof Liaquat University of Medical & Health

Sciences Jamshoro

5 Dr Asifa Ghazi Associate Prof Dow University of Health sciences,

Karachi

6 Dr Farzana Kazmi Associate Prof DHQ Teaching Hospital/ RHC & Allied

Hospital,Faisalabad

7 Brig Nadra Professor retired

8 Prof Aisha Malik Professor LGH / PGMI Lahore

9 Dr Maruim Professor Fatima Jinah,Lahore

10 Dr Uzma Ass professor Lady Wallingdon, Lahore

11 Prof Sadiqa Jafri Professor Head of NMCHC, sindh

12 Prof Razia Khorejo Professor JPMC Karachi

13 Dr Farhat Perveen Malik Assistant Professor/Obs

Gynae

MCH Centre Islamabad

14 Dr Asma Kamal Consultant Gynaecologist Maroof International Hospital Islamabad

15 Dr Irum Aziz Associate Professor Fauji foundation hospital Rawalpindi

16 Dr Naabia Tariq Head of Department Shifa International Hospital, Islamabad

24

Annex 3

List of health Facilities surveyed for the study

S.No Name of facility Type of Facility/ service

Baluchistan

1 Sandeman Provicial Hospital Quetta Teaching hospital

2 Akram Hospital Quetta Private, Comprehensive EmONC

3 CMH Quetta Teaching hospital

Khaibar Pakhtun khawah

4 Khyber Teaching Hospital Peshawar Teaching Hospital

5 THQ Dargai, Malakand Agency Comprehensive EmONC

Punjab

6 Pakistan Institute of Medical Sciences,

Islamabad

Teaching Hospital

7 THQ hospital Muredke, sheikhupura Comprehensive EmONC

8 CDA DHQ hospital, Islamabad Comprehensive EmONC

9 THQ kahuta, Rawalpindi Comprehensive EmONC

10 THQ Nankana Basic EmOnC

11 Ali Hospital, Islamabad Private, Comprehensive EmONC

Sindh

12 Jinnah Postgraduate Medical Institute, Karachi Teaching Hospital

13 Sheikh Zayed hospital,Mir Pur Sakro Comprehensive EmONC

14 THQ Umerkot Basic EmONC

15 Gharo Rural Health Centre Mirpur sakro Basic EmONC

25

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