solomon islands - who.int · iii foreword the 2011 pharmaceutical country profile for solomon...

45
SOLOMON ISLANDS PHARMACEUTICAL COUNTRY PROFILE

Upload: hacong

Post on 22-Jan-2019

235 views

Category:

Documents


0 download

TRANSCRIPT

SOLOMON ISLANDS

PHARMACEUTICAL COUNTRY PROFILE

ii

Solomon Islands

Pharmaceutical Country Profile Published by Ministry of Health in collaboration with the World Health

Organization

June 2012

Any part of this document may be freely reviewed, quoted, reproduced, or translated in full or in part, provided that the source is acknowledged. It may not be sold, or

used in conjunction with commercial purposes or for profit.

Users of this Profile are encouraged to send any comments or queries to the following address:

The Director of National Pharmacy Services Division

Ministry of Health and Medical Services PO Box 349, Honiara

Email: [email protected]

This document was produced with the support of the WHO Representative Office in the South Pacific, and all reasonable precautions have been taken to verify the information contained

herein. The published material does not imply the expression of any opinion whatsoever on the part of the World Health Organization, and is being distributed without any warranty of any kind – either expressed or implied. The responsibility for interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising

from its use.

iii

Foreword

The 2011 Pharmaceutical Country Profile for Solomon Islands has been

produced by the Ministry of Health and Medical Services in collaboration with

the World Health Organization.

This document contains information on existing socio-economic and health-

related conditions, resources; as well as on regulatory structures, processes

and outcomes relating to the pharmaceutical sector in the Solomon Islands.

The compiled data comes from international sources (e.g. the World Health

Statistics), surveys conducted in the previous years and country level

information collected in 2011. Some more recent information is also included.

The sources of data for each piece of information are presented at the end of

this document.

On behalf of the Ministry of Health and Medical Services, Solomon Islands, I

wish to express my appreciation to all senior staff] from National Pharmacy

Services Division for their contributions to the process of data collection and

the development of this profile.

It is my hope that partners, researchers, policy-makers and all those who are

interested in the Solomon Islands Pharmaceutical Sector will find this profile

a useful tool to aid their activities.

Timmy Manea

National Pharmacy Services Division, Ministry of Health and Medical Services 28th June, 2012

Signature

iv

Table of content

Introduction ............................................................................................................ 1

Section 1 - Health and Demographic Data ........................................................ 2

Section 2 - Health Services ................................................................................ 6

Section 3 - Policy Issues .................................................................................. 12

Section 4 – Medicines Trade and Production ................................................. 14

Section 5 – Medicines Regulation ................................................................... 16

Section 6 - Medicines Financing ...................................................................... 25

Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector ................................................................................................................. 30

Section 8 - Selection and Rational Use of Medicines .................................... 34

Section 9 - Household Data/Access ............................................................ 3939

1

Introduction

This Pharmaceutical Country Profile provides data on existing socio-economic

and health-related conditions, resources, regulatory structures, processes and

outcomes relating to the pharmaceutical sector of the Solomon Islands. The

aim of this document is to compile all relevant, existing information on the

pharmaceutical sector and make it available to the public in a user-friendly

format. In 2010, the country profiles project was piloted in 13 countries

(http://www.who.int/medicines/areas/coordination/coordination_assessment/e

n/index.html). During 2011, the World Health Organization has supported all

WHO Member States to develop similar comprehensive pharmaceutical

country profiles.

The information is categorized in 9 sections, namely: (1) Health and

Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines Trade

and Production (5) Medicines Regulation, (6) Medicines Financing, (7)

Pharmaceutical procurement and distribution, (8) Selection and rational use,

and (9) Household data/access. The indicators have been divided into two

categories, namely "core" (most important) and "supplementary" (useful if

available). This narrative profile is based on data derived from both the core

and supplementary indicators. More recent information is also included. For

each piece of information, the year and source of the data are indicated; these

have been used to build the references at the end of the profile; and are also

indicated in the tables. If key national documents are available on-line, links

have been provided to the source documents so that users can easily access

these documents.

The selection of indicators for the profiles has involved all technical units

working in the Essential Medicines Department of the World Health

Organization (WHO), as well as experts from WHO Regional and Country

Offices, Harvard Medical School, Oswaldo Cruz Foundation (known as

Fiocruz), University of Utrecht, the Austrian Federal Institute for Health Care

and representatives from 13 pilot countries.

2

Data collection in all 193 Member States has been conducted using a user-

friendly electronic questionnaire that included a comprehensive instruction

manual and glossary. Countries were requested not to conduct any additional

surveys, but only to enter the results from previous surveys and to provide

centrally available information. To facilitate the work of national counterparts,

the questionnaires were pre-filled at WHO HQ using all publicly-available data

and before being sent out to each country by the WHO Regional Office. A

coordinator was nominated for each of the Member States. The coordinator

for Solomon Islands was Timmy Manea.

The completed questionnaires were then used to generate individual country

profiles. In order to do this in a structured and efficient manner, a text

template was developed. Experts from member states took part in the

development of the profile and, once the final document was ready, an officer

from the Ministry of Health certified the quality of the information and gave

formal permission to publish the profile on the WHO website.

This profile will be regularly updated by National Pharmacy Services Division.

Comments, suggestions or corrections may be sent to:

Timmy Manea

National Pharmacy Services Division , MHMS

PO Box 349

Honiara

Solomon Islands

Honiara Central Post Office

[email protected]

3

Section 1 - Health and Demographic Data

This section gives an overview of the demographics and health status of

Solomon Islands. 1.1 Demographics and Socioeconomic Indicators The total population of Solomon Islands in 2009 was 523,000 with an annual

population growth rate of 2.6%. The annual Gross Domestic Product (GDP)

growth rate is -2.20%. The GDP per capita was US$ 1,257.23 (at the current

exchange ratei).

Of the total population, 39% is under 15 years of age and 5% is over 60 years

of age. The urban population currently stands at 18% of the total population.

The fertility rate in Solomon Islands is 3.8 births per woman. The adult literacy

rate for the population over 15 years is 76.6% (Western Pacific Country

Health Information Profiles, WHO 2010).

1.2 Mortality and Causes of Death

The life expectancy at birth is 69 and 72 years for men and women

respectively. The infant mortality rate (i.e. children under 1 year) is 26/1,000

live births. For children under the age of 5, the mortality rate is 37 /1,000 live

birthsii. The maternal mortality rate is 146/100,000 live birthsiii (The Western

Pacific Country Health Information Profiles, 2010).

The top five diseases causing mortality are:

Disease

1 Cardiovascular diseases

2 Malaria

3 Neonatal causes

4 Neoplasm

5 Respiratory diseases (pneumonia as the leading causes)

i The current exchange rate for calculation is SBD 1 = USD 0.12350 on June 9th, 2011 (http://www.oanda.com/currency/converter/) ii Report on 2009 Population and Housing Census, Solomon Islands iii MDG Goals Progress Report for Solomon Islands, 2010

4

The top 10 diseases causing morbidity in the Solomon Islands [National

Health Strategic Plan, 2011-2015):

Disease DALY % of total DALY

1 Ishaemic Heart Disease 1185 5.9

2 Cerebro-Vascular Disease 1090 5.4

3 Unintentional Injuries 1055 5.3

4 Unipolar Depressive Disorders 900 4.5

5 Musculoskeletal Diseases 920 4.6

6 Maternal Conditions 872 4.3

7 Malignant Neoplasms 855 4.3

8 Malaria 776 3.9

9 Tuberculosis 688 3.4

10 Prematurity and Low Birth Weight 630 3.1

DALY: Disability-adjusted life year

The adult mortality rate for both sexes between 15 and 60 years is 145 /1,000

population, while the neonatal mortality rate is 15 /1,000 live births. The age-

standardised mortality rate by non-communicable diseases is 623 /100,000,

370 /100,000 by cardiovascular diseases and 78 /100,000 by cancer. The

mortality rate for HIV-related disease is 0 /100,000 and 18 /100,000 for

tuberculosis. The mortality rate for Malaria is 10.2 /100,000 (WHO Western

Pacific Region - 2010).

5

Further information:

Solomon  Islands  is  in  a  phase  of  epidemiological  transition.  Having  to  deal  with  both  the  control   of   infectious   diseases   and   an   increasing   incidence   of   non-­‐communicable  diseases,   with   very   limited   resources,   poses   a   major   challenge   for   the   Government.  With  the  dissipation  of  ethnic  conflict  during  1999-­‐2003  and  with  support  in  2004  from  the   Global   Fund   to   Fight   AIDS,   Tuberculosis   and   Malaria   (the   Global   Fund),   the  Australian  Agency  for  International  Development  (AusAID),  the  World  Bank  and  Rotary  International,   progress   has   been   made   in   malaria   control.   The   malaria   burden,  measured  by  annual  parasite  incidence  (API)  has  been  declining  steadily  over  the  years.  From  an  API  of  167  per  1000  population  in  2002,  data  from  2009  show  an  API  of  74.8  per  1000  population,  better  than  the  targeted  API  of  90  per  1000  population.  

The   tuberculosis   prevalence   rate  was   70   per   100   000   for   2009,  with   a   93%   cure   rate  through  directly  observed  treatment,  short-­‐course  (DOTS)  therapy  in  2008  cohort  cases.  With  the  recent  approval  of  the  Global  Fund  submission,  the  national  TB  programme  is  set  to  make  further  rapid  improvements  in  TB  prevention  and  control.  

There  was  no  major  disease  outbreak  in  2008/2009.  However,  the  worldwide  threats  of  influenza   A(HINI)   and   HIV-­‐related   disease   have   resulted   in   the   development   of   new  policies   and   strategies   to   strengthen   and   revitalize   disease   prevention,   control   and  surveillance,  as  well  as  preparedness  for  action.  

Although  infectious  diseases  are  still  the  major  causes  of  morbidity  and  mortality,  there  is   some   evidence   that   non-­‐communicable   diseases   like   cancer   (cervical   and   breast  cancers   are   reported   to   be   the   most   common,   followed   by   lung   cancer),   diabetes  mellitus,  hypertension,  tobacco-­‐related  diseases  and  mental  illness  are  increasing.  

The  National  Pharmacy  Services  Division  Five-­‐Year  Strategic  Plan  (2011-­‐2015),  highlights  key  priority  areas  of  i)  Essential  Medicines  Policy  and  Management;  ii)  Procurement;  iii)  Provincial  Strengthening  and;  iv)  Rational  Use  of  Medicines.  

In   particular,   Rational   Use   of   Medicines   initiatives,   led   primarily   by   the   Medicines  Information   Centre,   form   the   forefront   of   pharmacy   division’s   response   to   the  epidemiological  transition  and  these  are  highlighted  in  the  Five-­‐Year  document.

Key recommendations:

The  National  Pharmacy  Services  Division  is  addressing  the  epidemiological  transition  in  provisions   within   their   Five-­‐Year   Strategic   Plan   (2011-­‐2015),   which   highlights   key  priority   areas   of   i)   Essential   Medicines   Policy   and   Management;   ii)   Procurement;   iii)  Provincial  Strengthening  and;  iv)  Rational  Use  of  Medicines.  

In  particular,  the  pharmacy  division’s  Rational  Use  of  Medicines  initiatives,  led  primarily  by   the  Medicines   Information   Centre,   and   initiatives   to   maintain   reliable   supplies   of  appropriate   medicines   should   be   vigorously   continued   in   the   response   to   the  epidemiological  situation.  

6

Section 2 - Health Services This section provides information regarding health expenditures and human

resources for health in the Solomon Islands. The contribution of the public and

private sector to overall health expenditure is shown and the specific

information on pharmaceutical expenditure is also presented. Data on human

resources for health and for the pharmaceutical sector is provided as well.

2.1 Health Expenditures

The National Health Accounts (2009) showed that in Solomon Islands, the

total health expenditure (THE) in 2009 was 304 million Solomon Islands

Dollars (SBD) (US$ 37.72 million). The total health expenditure was 5.74% of

the Gross Domestic Product (GDP), equivalent to SBD 581.26 (US$ 72.12)

per capita.

The general governmentiv health expenditure (GGHE) in 2009, as reflected in

the National Health Accounts (NHA) was SBD 285.00 million (US$ 35.36

million). That is, 93.75% of the THE, with a total public health expenditure of

SBD 544.93 (US$ 67.61) per capita. Private health expenditure covers the

remaining 6.25% of the THE. The GGHE represents 16.80% of the total

government budget.

Of the total population, 100% is covered by a public health service, public

health insurance or social insurance, or other sickness funds and 0% is

covered by a private health insurancev.

According to NHA (2009), total pharmaceutical expenditure (TPE) in Solomon

Islands is US$ 2,250,000 which is equivalent to US$ 4.30 per capita. The total

pharmaceutical expenditure accounts for 0.34% of the GDP and makes up

5.97% of the THE (Figure 1). Public expenditure on pharmaceuticals

represents 100% of the total expenditure on pharmaceuticals.

iv According to the NHA definition, by "government expenditure" it is meant all expenditure from public sources, like central government, local government, public insurance funds and parastatal companies. v However, some private companies provide healthcare for their employees

7

Figure 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health Expenditure. The THE in 2009 was 304 million Solomon Islands Dollars (US$ 37.72 million)

[National Health Accounts, 2009; Ministry of Health and Medical Services]

Social security expenditure makes up 0.0% of government expenditure on

health.

Out-of-pocket expenditure (OOP) as % of private health expenditure is 67.4%.

Premiums for private prepaid health plans are 0.0% of total private health

expenditure.

2.2 Health Personnel and Infrastructure

The health workforce is described in the table below. There are 14 (0.27

/10,000) licensed pharmacists, of which 8 (0.15 /10,000) work in the public

sector. There are 46 (0.88 /10,000) pharmaceutical technicians and assistants

(in all sectors). The pharmacy technicians and assistants are pharmacy

officers, who have undergone a two-year in-country certificate course. They

generally undertake basic functions of dispensing and supply in hospitals and

provincially, whilst several hold senior positions within the National Pharmacy

Services Division, MHMS. There are approximately six times as many

pharmacy officers as pharmacists in the public sector.

There are 89 (1.70 /10,000) physicians and 694 (13.27 /10,000) nursing and

midwifery personnel in Solomon Islands. The ratio of doctors to pharmacists is

6.4 and the ratio of doctors to nurses and midwifery personnel is 0.13.

94%

6%

TPE Other

8

Table 1: Human resources for health in Solomon Islands

Human Resource Licensed pharmacists (all sectors) 14 (0.27 /10,000)

Pharmacists in the public sector 8

Pharmacy technicians and assistants (all sectors) 46 (0.88 /10,000)

Physicians (all sectors) 89 (1.70 /10,000)

Nursing and midwifery personnel (all sectors) 694 (13.27 /10,000)

Figure 2: Distribution of Pharmacy Personnel, Solomon Islands, 2011

In Solomon Islands, there is a Strategic Plan for Pharmaceutical Human

Resource Development in place.

The health infrastructure is described in Table 2 below. There are 11 hospitals

and 732 hospital beds (14 /10,000) in Solomon Islands. There are 310

primary health care units and centres and nine licensed private pharmacies.

Table 2: Health Infrastructure

Infrastructure Hospitals 11

Hospital beds 732 (14 /10,000)1

Primary health care units and centres 310

Private licensed pharmacies 9

23%

77%

Pharmaceutical technicians and assistants Pharmacists

9

The annual starting salary for a newly registered pharmacist in the public

sector is SBD 52,000. The total number of pharmacists who graduated (as a

first degree) in the past two years is six. The Pharmacy Officer Course is run

by the National Training Unit, National Pharmacy Services Division. The

curriculum is regularly reviewed (see box: Further information and key

findings). There are no university-level pharmacy schools in the country.

10

Further information and key findings:

The   centrepiece   of   Pharmacy   Training   in   Solomon   Islands   is   the   Pharmacy   Officer  Certificate  course,  which  has  been  running  since  the  1990s  and  most  recently  updated  in  2008.   This  most   recent   update   has  modernised   the   programme,  making   all   resources  available  electronically.  The  course  combines   twice-­‐weekly   tutorials,   rotations   through  all  areas  of  public  and  private  sector  pharmacy,  provincial  experiential  placements  and  ongoing  multi-­‐faceted  assessments.   It   is   two  years   in   length  and  now  entirely   run  and  managed  by  local  pharmacists,  who  have  received  training  and  support  from  Australian  volunteers  (through  Australian  Volunteers  International).  

Graduates   are   eligible   to  work   in   public   pharmacy   facilities   and   carry   out  most   of   the  functions  of  qualified  pharmacists  in  remote  areas  without  pharmacists  available.  

In  2009-­‐2010,  10  candidates  completed  the  course.  In  2012,  a  new  course  commenced  with   13   public   candidates   and   six   students   also   participating   from   the   private   sector,  which  is  an  exciting  initiative.  

The  National  Pharmacy  Training  Unit  also   runs  a  12  month   intern  course   for   returning  Pharmacy   Graduates,   which   had   six   participants   in   2012,   and   a   basic   continuing  education  program   for  all   staff,   consisting  of   four  annual  quizzes  which  are   sent   to  all  facilities.   This   Continuing   Education   program,   called   Expansion,   is   slated   for  strengthening  in  the  next  two  to  three  years.  

Solomon   Islands’   health   care   system   is   organized  on   a   five   tier   system   that   shapes   its  formal  health   services.   The  National  Referral  Hospital   is   the  only   tertiary   institution   in  the   country.   There   are   eleven   provincial   hospitals   and   316   other   health   facilities   in  Solomon  Islands  that  are  overseen  by  the  Ministry  of  Health  and  Medical  Services.  Four  of  the  eleven  provincial  hospitals  are  operated  by  churches  and  report  to  MHMS  ,  who  provide  resources  and  oversight.    

Primary   Health   Care   is   delivered   through   a   system   comprised   of   provincial   hospitals,  Area  Health  Centres   (AHC),  Rural  Health  Clinics   (RHC),  Urban  Health  Clinics   (UHC),  and  Nurse   Aid   Posts   (NAP).   Doctors   are   available   at   eleven   health   facilities   in   Solomon  Islands:  the  National  Referral  Hospital   in  Honiara  along  with  seven  public  hospitals  and  three   church   operated   hospitals   in   the   provinces.   There   is   not   a   doctor   resident   in  Renbel  province.    

Registered  nurses  and  nurse  aides  are  the  front  line  clinical  personnel  in  health  centers,  clinics  and  aid  posts.  AHCs  have  four  to  five  staff  (Registered  Nurses  or  Nurse  Aids,  and  malaria   microscopists)   and   provide   the   highest   clinic   level   of   primary   health   care,  including   outpatient   and  basic   inpatient   care.   There   are   30  AHCs,   four  UHCs,   and   five  Sub-­‐UHCs  in  the  country.  Four  of  the  UHCs  function  as  AHCs.  RHCs  have  up  to  two  staff  and  are  smaller  than  AHCs,  but  provide  similar  services.  There  are  109  RHCs  in  Solomon  Islands.    

Nurse  Aid  Posts  are  small  clinics  staffed  by  one  Nurse  Aide  who  is  typically  a  member  of  the   community.   Nurse   Aides   provide   first   aid,   basic   primary   health   care   activities,  emergency   birthing   and   observation   of   sick   patients   before   they   are   referred   to   a  higher-­‐level  facility.  There  are  177  NAPs  in  Solomon  Islands.  (reference:  Solomon  Islands  Global  AIDS  Response  Progress  Report  2012)    

11

Key recommendations:

Existing  policy  documents  and  recommendations  relating  to  this  section  are  in  place  for  the  next  years.      

It  is  recommended  that  implementation  of  the  Pharmacy  Sector  Strategic  Plan  2011  –  2015  is  continued,  especially  in  regards  to:    

• Strengthening  the  Pharmacy  Human  Resource  base  throughout  the  sector  • Upgrading  training  and  CE  activities  as  needed  • Developing  a  suitable  career  structure  to  retain  staff  in  the  public  sector  • Exploring   the   issue   of   partnerships   with   other   organizations;   and   technical  

cooperation   for   exchange   programs   involving   qualified   personnel   from   other  countries  whose  services  can  be  utilised   for  a  period  of   time  to  address  unmet  training  and  service  delivery  needs.

12

Section 3 - Policy Issues

This section addresses the main characteristics of the pharmaceutical policy

in Solomon Islands. The many components of a national pharmaceutical

policy are taken from the WHO publication “How to develop and implement a

national drug policy” (http://apps.who.int/medicinedocs/en/d/Js2283e/).

Information about the capacity for manufacturing medicines and the legal

provisions governing patents is also provided.

3.1 Policy Framework

In Solomon Islands, a National Health Policy (NHP) exists and it was released

in 2011. An associated National Health Policy implementation plan (written in

2011) also exists. An official National Medicines Policy (NMP) document

exists in the Solomon Islands, as detailed in Table 3. It was updated in 2009.

However, a draft of an additional updated version also exists currently. A NMP

implementation plan does not exist, but a Five-Year Strategic Plan for

Pharmacy is available. NMP implementation is regularly monitored/assessed

by the National Pharmacy Services Division and national pharmaceutical

legislation is currently under review, with WHO support.

Table 3: The NMP covers10

Aspect of policy Covered

Selection of essential medicines Yes

Medicines financing Yes

Medicines pricing Yes

Medicines Procurement Yes

Medicines Distribution Yes

Medicines Regulation Yes

Pharmacovigilance Yes

Rational use of medicines Yes

Human Resource Development Yes

Research No

Monitoring and evaluation Yes

Traditional Medicine No

13

A policy relating to clinical laboratories is in development. There are official

written guidelines on medicines donations.

A policy is not in place to manage and sanction conflict of interest issues in

pharmaceutical affairs. There is a formal code of conduct for public officials. A

whistle-blowing mechanism that allows individuals to raise concerns about

wrongdoing occurring in the pharmaceutical sector of Solomon Islands does

not exist.

Further information and key findings:

The  overall  goal  of  the  NMP  is:  

The  development  within  the  available  financial  and  human  resources,  of  the  potential  that  medicines  have  to  contribute  to  community  health  within  all  sectors  in  the  Solomon  Islands:  the  public,  private,  non-­‐government  and  church  sectors.  

The  four  main  aims  of  the  NMP  are:  

1. To  ensure  the  ready  and  reliable  availability  of  good  quality,  acceptably  safe,  and  proven  effective  and  affordable  essential  medicines.  

2. To  rationalise  use  of  these  essential  medicines  through  the  provision  of  improved  medicine  utilisation  information  and  trained  health  professionals,  and  through  education  of  the  public  in  appropriate  medicine  use  and  storage  with  the  aim  of  rationalising  medicine  supply  management,  prescribing  and  dispensing,  and  improving  patient  compliance.  

3. To  inform  the  National  Health  Plan  on  issues  related  to  maintenance  of  safe  and  reliable  treatment  with  essential  medical  supplies.    

4. To inform the development of a strategic plan that will set priorities for actions in the short – medium – and long – term.  

Key recommendations:

It  is  recommended  that  National  Pharmacy  Services  Division  Five-­‐Year  Strategic  Plan  (2011-­‐2015)  aimed  at  implementing  components  of  the  NMP  continues  to  be  prioritised  and  implemented.  

Activities   should   be   undertaken   according   to   the   plan   and   indicators   of   their  achievement   should   be   monitored   to   assess   implementation   and   modified   if  necessary.

14

Section 4 – Medicines Trade and Production 4.1 Intellectual Property Laws and Medicines

Solomon Islands is a member of the World Trade Organization. Legal

provisions granting patents to manufacturers exist. These cover

pharmaceuticals, laboratory supplies, medical supplies and medical

equipment.

Intellectual Property Rights are managed and enforced by the Ministry of

Police and Justice.

National legislation has not been modified to implement the Trade-Related

Aspects of Intellectual Property Rights (TRIPS) Agreement and does not

contain TRIPS-specific flexibilities and safeguards. Solomon Islands is eligible

for the transitional period to 2016.

There are no legal provisions for data exclusivity for pharmaceuticals, patent

term extension or linkage between patent status and marketing authorization.

The country is not engaged in capacity-strengthening initiatives to manage

and apply Intellectual Property Rights in order to contribute to innovation and

promote public health.

4.2 Manufacturing

There are no licensed pharmaceutical manufacturers in Solomon Islands.

Manufacturing capabilities are presented in Table 4 below. Table 4: Solomon Islands manufacturing capabilities

Manufacturing capabilities

Research and Development for discovering new active substances No

Production of pharmaceutical starting materials (APIs) No

The production of formulations from pharmaceutical starting material No

The repackaging of finished dosage forms Yes

15

Further information and key findings:

Very   little  work  has  been  done  addressing  TRIPS  compliance;   this   is   likely   to  be  a  major  issue  in  the  coming  three  years.  It   is  not  expected  to  impact  heavily  on  the  Solomon   Islands   in   the   medium-­‐term   however,   as   few   innovator   drugs   are  currently  on  the  Essential  Medicines  List.  

There  are  no  plans  to  stimulate  local  production  or  manufacture,  as  the  market  is  small,  there  is  a  lack  of  capacity  and  funding  capital  to  commence  operations,  it  is  difficult  to  maintain  proper  manufacturing  conditions  in  this  environment  and  the  Solomon  Islands  is  poorly  situated  for  the  export  market.

Key recommendations:

It   is   recommended   that   Trade-­‐Related   Aspects   of   Intellectual   Property   Rights  (TRIPS)   compliant,   health   sensitive   Laws   be   developed   to   enable   access   to  affordable  medicines  that  are  needed  to  address  the  health  problems  of  Solomon  Islands.    

§ The  Government   should   take   advantage   of   all   the   flexibilities   and   safeguards  within   the   TRIPS  Agreement   for   the  promotion  of   public   health   and   ensuring  access  to  pharmaceuticals.    

§ The  implications  of    international  trade  and  other  treaties  should  be  studied  so  as   to   safeguard   the   national   interest   concerning   public   health   and   ensure  access   to   pharmaceuticals.   In   particular,   any   potential   Free   Trade  Agreement  will  be  examined  in  detail  to  ensure  that  flexibilities  available  under  the  TRIPS  agreement  are  not  affected.      

§ The   Ministry   of   Health   and   Medical   Services   should   collaborate   with   the  Ministries   of   Trade   and   Commerce,   Foreign   Affairs   and   External   Trade,   and  other  relevant  agencies  in  the  area  of  Intellectual  Property  Rights  in  developing  a  legal  framework  that  enhances  access  to  essential  medicines  including  grant  of   compulsory   licensing  and  parallel   importation  and  Government  Use.  Public  health   and   access   to   pharmaceuticals   must   remain   in   the   forefront   while  undertaking  and  signing  any  bilateral  or  international  treaties  or  agreements.

16

Section 5 – Medicines Regulation

This section details the pharmaceutical regulatory framework, resources,

governing institutions and practices in Solomon Islands.

5.1 Regulatory Framework

In Solomon Islands, there are legal provisions establishing the powers and

responsibilities of the Regulatory Affairs Unit (RAU). The RAU is a part of the

National Pharmacy Services Divisions, Ministry of Health and Medical

Services with a number of functions outlined in Table 5. The RAU does not

have its own websitevi.

Table 5: Functions of the national RAU

Function Marketing authorisation / registration No

Inspection Yes

Import control Yes

Licensing Yes

Market control Yes

Quality control Yes

Medicines advertising and promotion Yes

Clinical trials control Yes

Pharmacovigilance Yes

Other: Control safety of products in complementary medicines and agrochemicals.

Yes

As of May 31st 2011, there were two permanent staff members working for the

RAU. The RAU does not receive external technical assistance to support its

activities. However, WHO has provided technical support for review of

legislation and for strengthening human resource capacity in the National

Pharmacy Services Division. The RAU is not involved in

harmonization/collaboration initiatives. An assessment of the medicines

regulatory system has not been conducted in the last five years. Funding for

the RAU is provided through the regular government budget, as well as vi Regulatory Affairs should be a profession which has developed from the desire of the Government (MoH) to protect public health in safety and efficacy of medicines.

17

through additional sources. The RAU is primarily funded through the Ministry

of Health and Medical Services and its officers are public servants. Minor

revenues derived from regulatory activities (such as registration fees for

pharmacy professionals and registration of premises) are kept within the RAU

but constitute only a fractional basis of funding. This body does not utilize a

computerized information management system to store and retrieve

information on processes that include registrations, inspection etc.

5.2 Marketing Authorization (Registration)

In Solomon Islands, there are no legal provisions requiring marketing

authorization (registration) for all pharmaceutical products on the market.

Criteria for assessing applications for marketing authorization of

pharmaceutical products do not exist. There are no pharmaceutical products

registered in Solomon Islands. There is a need to support the RAU with

regard to product registration. No registration system currently exists. (See

Box: Further Information and Key Findings at the end of this section for the

current status of pharmacy-related Legislation.)

In the public sector, only those items contained on the Essential Medicines

List are approved for import and supply; the EML is overseen by the National

Drugs and Therapeutics Committee. In the private sector, there is no form of

registration at all; pharmacies are bound by legislation on scheduling of

medicines (and require import permits) but this legislation is out-dated, many

items are not listed on schedules at all and the entire legislation system is

currently under review, with WHO support. It is anticipated that new legislation

and scheduling will go to parliament in 2013.

5.3 Regulatory Inspection

In Solomon Islands, legal provisions exist allowing for appointment of

government pharmaceutical inspectors. Legal provisions permitting inspectors

to inspect premises where pharmaceutical activities are performed exist; such

inspections are required by law and are a pre-requisite for the licensing of

public and private facilities. Where inspections are legal requirements, these

18

are not the same for public and private facilities. Inspections are carried out

on a number of entities, outlined in Table 6.

Table 6: Local entities inspected for compliance

Entity Inspection Frequencyvii

Local manufacturers No N/A

Private wholesalers Yes Annual

Retail distributors Yes Annual

Public pharmacies and stores Yes Annual

Pharmacies and dispensing points of health facilities

Yes Annual

N/A: not applicable

5.4 Import Control

Legal provisions requiring authorization to import medicines exist. Laws that

allow the sampling of imported products for testing exist. Legal provisions

requiring importation of medicines through authorized ports of entry also exist.

Regulations or laws to allow for inspection of imported pharmaceutical

products at authorized ports of entry exist.

5.5 Licensing

In Solomon Islands, legal provisions requiring manufacturers to be licensed

exist. Legal provisions requiring manufacturers (both domestic and

international) to comply with Good Manufacturing Practices (GMP) also exist.

Good Manufacturing Practices are not published by the government.

Legal provisions requiring importers, wholesalers and distributors to be

licensed exist. Legal provisions requiring wholesalers and distributors to

comply with Good Distribution Practices (GDP) exist.

vii Annual inspections for all facilities unless urgent issues arise

19

Table 7: Legal provisions pertaining to licensing

Entity requiring licensing Importers Yes

Wholesalers Yes

Distributors Yes

Good Distribution Practices are not published by the government but GDP is

covered in the National Medicines Policy and included in the training

curriculum for Pharmacy Officers.

Legal provisions requiring pharmacists to be registered exist. Legal provisions

exist requiring private, but not public, pharmacies to be licensed. National

Good Pharmacy Practice Guidelines are published by the government. By law,

a list of all licensed pharmaceutical facilities is required to be published.

5.6 Market Control and Quality Control

In Solomon Islands, whilst legal provisions for controlling the pharmaceutical

market exist, quality control testing has not taken place for several years. A

Medicine Quality Control Laboratory does not exist and the MRA does not

contract quality testing services elsewhere. Medicines are visually inspected

in the public sector for a number of reasons, summarised in Table 8.

Table 8: Reason for medicines testing

Medicines tested: For quality monitoring in the public sectorviii Yes

For quality monitoring in the private sectorix No

When there are complaints or problem reports Yes

For product registration No

For public procurement prequalification Yes

For public program products prior to acceptance and/or distribution Yes

viii Routine sampling in pharmacy stores and health facilities ix Routine sampling in retail outlets

20

Samples are not collected by government inspectors for undertaking post-

marketing surveillance testing. The results of quality testing are not publicly

available.

5.7 Medicines Advertising and Promotion

In Solomon Islands, legal provisions to control the promotion and/or

advertising of prescription medicines exist. The Regulatory Affairs Unit is

responsible for regulating promotion and/or advertising of medicines. Legal

provisions prohibit direct advertising of prescription medicines to the public.

Pre-approval for medicines advertisements and promotional materials is not

required. Guidelines and Regulations for advertising and promotion of non-

prescription medicines do not exist. There is a national code of conduct

concerning advertising and promotion of medicines by marketing authorization

holders. The code of conduct applies to both domestic and multinational

manufacturers, for which adherence is voluntary. The code does not contain a

formal process for complaints and sanctions. A list of the complaints and

sanctions for the last two years is not publicly available.

5.8 Clinical Trials

In Solomon Islands, legal provisions requiring authorization for conducting

clinical trials do exist. Approval of clinical trials is undertaken by the National

Ethics Committee within the Ministry of Health and Medical Services.

Clinical trials are required to be entered into an international/national/regional

registry, by law.

Legal provisions do not exist for GMP compliance of investigational products.

Sponsor investigators are not legally required to comply with Good Clinical

Practices (GCP). National GCP regulations are not published by the

Government. Legal provisions do not permit the inspection of facilities where

clinical trials are performed.

21

5.9 Controlled Medicines

Solomon Islands is a signatory to a number of international conventions,

detailed in Table 9.

Table 9: International Conventions to which Solomon Islands is a signatory

Convention Signatory

Single Convention on Narcotic Drugs, 1961 Yes

1972 Protocol amending the Single Convention on Narcotic Drugs, 1961 Yes

Convention on Psychotropic Substances 1971 No

United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988

No

Laws for the control of narcotic and psychotropic substances and precursors

exist.

The legal provisions and regulations for the control of narcotic and

psychotropic substances, and precursors have been reviewed by a WHO

International Expert or Partner Organization to assess the balance between

the prevention of abuse and access for medical need. Figures from pharmacy

records regarding the annual consumption of certain controlled substances in

the country and information provided by the International Narcotic Control

Board are outlined in Table 9S below. Table 9S: Annual consumption of selected controlled substances in Solomon Islands

Controlled substance Annual consumption (mg/capita)

Morphine 0.480000

Fentanyl 7.679217

Pethidine 1.826

Oxycodone 0

Hydrocodone 0

Phenobarbital 0

Methadone 3.909

22

5.10 Pharmacovigilance

In Solomon Islands, there are no legal provisions in the Drugs and Poisons

Act that provide for pharmacovigilance activities as part of the MRA mandate. Legal provisions requiring the Marketing Authorization holder to continuously

monitor the safety of their products and report to the MRA do not exist. Laws

regarding the monitoring of Adverse Drug Reactions (ADRs) do not exist in

Solomon Islands. A national pharmacovigilance centre linked to the MRA

exists. The Pharmacovigilance Centre has one staff member, who is also

responsible for the Medicines Information Centre. The Centre has not

published an analysis report in the previous two years and it does not publish

a regular ADR bulletin; it undertakes only fledgling pharmacovigilance and will

require strengthening in the next two to three years.

An official standardized form for reporting ADRs is used in Solomon Islands.

Feedback is not provided to reporters. Information pertaining to ADRs is not

stored in a national ADR database.

There is no national ADR or pharmacovigilance advisory committee able to

provide technical assistance or causality assessment, risk assessment, risk

management, case investigation and, where necessary, crisis management

including crisis communication in Solomon Islands. A clear communication

strategy for routine communication and crises communication does not exist.

ADRs are monitored in some public health programs (for example

tuberculosis, HIV-related disease, malaria). A number of steps are being

considered in order to enhance the pharmacovigilance system. For example,

funding exists for a consultant to review the pharmacovigilance mechanisms

in the country with a view to establishing a database for at least some drugs

(e.g. anti-malarial drugs). A standardised form is already in place but this

requires promotion and staff are not currently available to undertake this.

Medication errors (MEs) are not reported. A risk management plan is not

presented as part of the product dossier submitted for Marketing Authorization.

23

In the last two years there has not been a regulatory decision based on local

pharmacovigilance. There are no training courses in pharmacovigilance.

Further information and key findings:

With  WHO   support,   pharmaceutical   legislation  was   reviewed   in   Solomon   Islands.  The   Pharmacy   Practitioners’   Act   and   Pharmacy   &   Poisons   Act   were   re-­‐drafted,  along  with  subsidiary  regulations  to  be  reviewed  by  the  Pharmacy  Board  following  a  period  of  stakeholder  consultations.  After  presentation  to  the  Attorney  General’s  office,  presentation  to  parliament  is  expected  in  2013.  

Very   little  work  has  been  done  addressing  TRIPS  compliance;   this   is   likely   to  be  a  major   issue   in   the   coming   three   years.   It   is   not   expected   to   impact   heavily   on  Solomon   Islands   in   the   medium-­‐term   however,   as   few   innovator   drugs   are  currently  on  the  Essential  Medicines  List.  

There  are  no  plans  to  stimulate  local  production  or  manufacture,  as  the  market  is  small,  there  is  a  lack  of  capacity  and  funding  capital  to  commence  operations,  it  is  difficult   to   maintain   proper   manufacturing   conditions   in   this   environment   and  Solomon  Islands  is  poorly  situated  for  the  export  market.  

24

Key recommendations:

TRIPS  

It   is   recommended   that   Trade-­‐Related   Aspects   of   Intellectual   Property   Rights  (TRIPS)   compliant,   health   sensitive   laws   be   developed   to   enable   access   to  affordable  medicines  that  are  needed  to  address  the  health  problems  of  Solomon  Islands.    

§ The  Government  should  take  advantage  of  all  the  flexibilities  and  safeguards  within  the  TRIPS  Agreement  for  the  promotion  of  public  health  and  ensuring  access  to  pharmaceuticals.    

§ The  implications  of  international  trade  and  other  treaties  should  be  studied  so  as   to   safeguard   the   national   interest   concerning   public   health   and   ensure  access  to  pharmaceuticals.  In  particular,  any  potential  Free  Trade  Agreement  will  be  examined  in  detail  to  ensure  that  flexibilities  available  under  the  TRIPS  agreement  are  not  affected.      

§ The   Ministry   of   Health   and   Medical   Services   should   collaborate   with   the  Ministries   of   Trade   and   Commerce,   Foreign   Affairs   and   External   Trade,   and  other   relevant   agencies   in   the   area   of   Intellectual   Property   Rights   in  developing   a   legal   framework   that   enhances   access   to   essential   medicines  including   grant   of   compulsory   licensing   and   parallel   importation   and  Government  Use.  Public  health  and  access  to  pharmaceuticals  must  remain  in  the   forefront   while   undertaking   and   signing   any   bilateral   or   international  treaties  or  agreements.

Regulatory  Affairs  

There   is   a   need   to   support   the   Regulatory   Affairs   Unit   with   regard   to   product  registration.   Regulatory   Affairs   should   strengthened   to   protect   public   health   in  safety   and   efficacy   of   medicines.   The   MRA   should   be   strengthened   to   cover  licensing  and  control  of  importation  and  monitoring  of  medicines  throughout  the  system,  including  public,  private,  non-­‐government  and  faith  based  organisations,  to   ensure   adherence   to   quality   standards   and   specifications.     It   should   include  capacity  for   investigation  within  different  phases  of   importation,  quality  control,  distribution  and  use  of  medicines.  

Pharmacovigilance  and  medication  errors  

A  pharmacovigilance  system  with  ADR  monitoring  capacity  should  be  developed  as   a   priority,   possibly   within   a   strengthened   Medicines   Information   Unit   with  strong  links  with  the  National  Drugs  and  Therapeutics  Committee.    A  system  for  reporting  and  dealing  with  medication  errors  should  be  included.  

 

25

Section 6 - Medicines Financing

In this section, information is provided on the medicines financing mechanism

in Solomon Islands, including the medicines coverage through public and

private health insurance, use of user charges for medicines and the existence

of public programmes providing free medicines. Policies and regulations

affecting the pricing and availability of medicines (e.g. price control and taxes)

are also discussed.

6.1 Medicines Coverage and Exemptions

In Solomon Islands, concessions are made for certain groups to receive

medicines free of charge (see Table 10). Furthermore, the public health

system or social health insurance schemes provide medicines free of charge

for particular conditions (see Table 11).

Table 10: Population groups provided with medicines free of charge

Patient group Covered Patients who cannot afford them Yes

Children under 5 Yes

Pregnant women Yes

Elderly persons Yes

Table 11: Medications provided publicly, at no cost

Conditions Covered All conditions treated by medicines in the EML Yes

Any non-communicable diseases Yes

Malaria Yes

Tuberculosis Yes

Sexually transmitted diseases Yes

HIV-related disease Yes

Expanded Program on Immunization (EPI) vaccines for children Yes

26

A public health service provides coverage for medicines that are on the

Essential Medicines List (EML) for inpatients and outpatients. Furthermore, all

patients (except foreign nationals) receive all medicines free of charge;

foreign nationals are provided free medical services and drugs in emergency

situations, under an informal system. Only medicines on the EML are

available within the public sector.

Private health insurance schemes do not provide medicines coverage. Some

private companies do provide healthcare to their employees but they do so at

their own expense and generally within the restrictions of the EML.

6.2 Patients Fees and Co-payments

Co-payments or fee requirements for consultations are levied at the point of

service delivery. However, there are no co-payments or fee requirements

imposed for medicines. Whilst there is officially no co-payment system, many

clinics will request a 'donation' or contribution for medical consultations or

medicines. Most often, these contributions go towards infrastructure or local

medical transport costs. However, there is no evidence to suggest they are

being used for staff wages or payments.

6.3 Pricing Regulation for the Private Sectorx

In Solomon Islands, there are no legal or regulatory provisions affecting

pricing of medicines.

The government does not run an active national medicines price monitoring

system for retail prices. Regulations do not exist mandating that retail

medicine price information should be publicly accessible.

x This section does not include information pertaining to the non-profit voluntary sector

27

6.4 Prices, Availability and Affordability of Key Medicines

There has not been a WHO/HAI pricing survey conducted in the Solomon

Islands and there would be limited benefit in doing so; the private sector is

very small and heavily concentrated in the capital, Honiara.

6.5 Price Components and Affordability

In the past five years, there has not been a survey on medicine price

components conducted in Solomon Islands.

6.6 Duties and Taxes on Pharmaceuticals (Market)

Solomon Islands does not impose duties on imported active pharmaceutical

ingredients (APIs) in the public sector and duties on imported finished

products are also not imposed.

28

Further information and key findings:

Currently,   the   Australian   Agency   for   International   Development   (AusAID)   funds  roughly   90%   of   the   entire   drugs   budget   for   the   public   sector   and   pressure   will  continue   to  be  applied   to   reduce   this  donor  burden.  Given   likely   increases   in   the  national  drug  budget,  due  to  the  continuing  health  transition  increasing  the  burden  on   non-­‐communicable   diseases   and   increasing   public   expectations,   medicines  financing  is  likely  to  become  increasingly  difficult  in  the  next  five  years.  

It   is  difficult  to  properly  assess   improvements  in  coverage  over  the  last  ten  years,  given  a  paucity  of  evidence  but  anecdotal  reports  suggest  that  medicines  coverage  has  markedly  improved  in  the  last  five  years.  Improvements  have  been  particularly  strong  at  the  national  level.  

Several  disease  areas  continue  to  suffer  from  chronic  under-­‐funding;  these  include  but  are  not  limited  to  mental  health,  oncology  and  palliative  care.  The  availability  of  commodities  and  expertise  in  these  programs  is  sadly  lacking.  

There  is  no  political  will  to  introduce  co-­‐payments  for  medicines  and  little  evidence  to  support  this  policy,  in  a  society  that  is  still  primarily  subsistence  based.  Roughly  80%   of   the   population   live   in   rural   areas,   largely   outside   the   cash   economy   and  international  evidence  suggests   that  even  minor  payment  schemes  would   reduce  access   for   the  most   vulnerable   populations.   It   is   extremely   unlikely   that   any   co-­‐payment  system  for  medicines   in   the  public   sector  will  be   introduced   in   the  next  five  years.  

Informal  payments  are  still  requested  by  some  clinics   in  rural  areas;  usually  these  are   to  support  community-­‐based  projects   to   improve   local  health   facilities.  There  has   been   no   study   assessing   the   impact   of   these   informal   payments   but   it   is  unlikely  they  have  reduced  access  to  medicines  for  any  group.  

The   largest  barrier  to  access  remains  geographic   factors;  by   far,   the  greatest  cost  for   accessing   healthcare   is   transport   to   the   nearest   health   facility.   There   is   no  clearly  defined  strategy  for  addressing  this  within  the  pharmacy  division.  

There   has   been   no   formal   study   of   the   affordability   of   medicines   in   the   private  sector  but  given   the   relatively   small   size  of   the  market,   this   is  not  a  priority.  The  private   market   is   estimated   to   represent   between   5   and   10%   of   the   overall  pharmaceuticals  market   in   the  country,   though   there  has  been  no  assessment  of  the  market.  

29

Key recommendations:

The   Ministry   of   Health   and   Medical   Services   should   effectively   advocate   for  budgetary  allocations  from  the  Solomon  Islands  Government  and  donor  partners,  including  vertical  programs,  which  should   increasingly   look  to   incorporate  parallel  funding  systems  into  an  integrated  national  pharmacy  budget.  

Transport   and   distribution   costs   must   be   included   in   the   national   pharmacy  budget. An   improved   system   of   record   keeping   linked   to   appropriate   quantification   of  medicines  needs  at  all  health   facility   levels,   in   line  with   the  National  Pharmacy  5  Year  Strategic  Plan,  would  provide  information  concerning  coverage  with  essential  medicines.  

30

Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector

This section provides a short overview on the procurement and distribution of

pharmaceuticals in the public sector of Solomon Islands.

7.1 Public Sector Procurement

The public sector procurement is centralized under the responsibility of

National Medical Store (NMS), which is a part of the National Pharmacy

Service Division, MHMS. Pharmaceuticals and medical supplies procured by

National Medical Store are distributed through its Provincial Medical Stores to

primary healthcare facilities.

Tender documents can be obtained from the mSupply data base system used

for procurement. The mSupply system generates reports on all awards and

they are publicly available. Hard copies can be obtained from the NMS.

Procurement is based on the prequalification of suppliers. Prequalification is

performed through the World Bank Prequalification exercise; selection of bids

is based on prior performance, quality assurance, lead times and price

according to the National Medical Stores Procurement Plan and Tender

Guidelines.

There is a written policy for public sector procurement. This policy was

approved in 2010. Legal provisions that give priority to locally produced goods

in public procurement do not exist, as there is no local pharmaceutical

manufacturer. The National Medical Stores Procurement Plan and Tender

Guidelines were approved in 2012.

A Pharmaceutical Tender Board (PTB) performs selection and awards. The

awards are then sent to the Medical Tender Board (MTB) which is the contact

for the Central Tender Board. These two boards approve awards for specific

pharmaceutical supplies or rubber stamp them, because the technicalities

associated with pharmaceutical procurement are performed by the PTB. The

31

PTB is separate but includes a person from the MTB for transparency

requirements.

A process exists to ensure the quality of products that are publicly procured.

Explicit criteria and procedures for prequalification of suppliers exist and a list

of prequalified suppliers and products is publicly available.

In accordance with Solomon Islands Government Financial Instructions, all

major tenders are required to be approved by the Central Tender Board,

within the Ministry of Finance & Treasury.

The tender methods employed in public sector procurement include

international competitive restricted tenders and direct purchasing; Standing

Offer Arrangements for all products are established following each annual

tender, reducing the requirement for non-competitive direct purchasing or

onerous Request-for-Quotations needing to be separately issued. All

purchasing is now done using prequalified suppliers.

7.2 Public Sector Distribution

The National Pharmacy Service Division, MHMS has a Central Medical Store

(called “National Medical Store”) at the national level. There are 14 public

warehouses (Second Level Medical Stores or Provincial Medical Stores) in

the secondary tier of the public sector distribution. There are no national

guidelines on Good Distribution Practices (GDP) but there are National

Pharmacy Standards defining the role, function and infrastructure

requirements of Second Level Medical Stores. A licensing authority that

issues GDP licenses does not exist so a list of GDP certified warehouses or

distributors does not exist in the public sector.

A number of processes are in place at the CMS as detailed in Table 12.

32

Table 12: Processes employed by the Central Medical Store

Process

Forecasting of order quantities Yes

Requisition/Stock orders Yes

Preparation of picking/packing slips Yes

Reports of stock on hand Yes

Reports of outstanding order lines Yes

Expiry dates management Yes

Batch tracking Yes

Reports of products out of stock Yes

Routine procedures to track the expiry dates of medicines at the CMS exist.

The Public CMS is not GDP certified by a licensing authority or ISO certified.

The second tier public warehouses are also not GDP certified by a licensing

authority or ISO certified.

7.3 Private Sector Distribution

Legal provisions for licensing private wholesalers and distributors exist.

However, GDP certified wholesalers or distributors do not exist in the private

sector.

33

Further information and key findings:

The  National  Essential  Medicines  List  is  overseen  by  the  National  Drugs  &  Therapeutics  Committee,  although  under  its  current  mandate,  this  is  an  advisory  body  only;  all  decisions  can  technically  be  over-­‐ruled  by  the  Ministry  of  Health  Executive  (though  this  power  has  never  been  exercised).  

National  Medical  Stores  is  then  charged  with  procuring  and  distributing  all  essential  medicines  through  the  public  sector.  It  does  this  through  prequalified  suppliers;  the  prequalification  criteria  has  recently  been  re-­‐drafted,  using  the  WHO  Prequalification  questionnaire  templates.  

Three   major   documents   have   been   developed   in   recent   years   to   improve  procurement  and  distribution  systems:  

1. SI  National  Pharmacy  Standards:  These  standards,  believed  to  be  amongst  the  first   of   their   kind   in   the   developing   setting,   establish   uniform   criteria   for   all  provincial  Second  Level  Medical  Stores  across  11  functional  areas,  including  HR,  Infrastructure,   Stock   Management,   Dispensing   etc.   Each   facility   is   assessed  annually  by  senior  staff  within  Pharmacy  Division.  

2. Standard   Operating   Procedures   for   National   Medical   Stores:   The   NMS   SOPs  establish  all  processes  within  the  NMS  facility,  across  core  and  supplementary  activities   such   as   Goods   Receipt,   Dispatch,   Inventory   Management,   Waste  Disposal  etc.  

3. National   Procurement   Plan   and   Annual   Tender   Guidelines:   This   combined  document  sets  out  the  framework  by  which  procurement  is  undertaken  by  the  National  Pharmacy  Services  Division  and  also  establishes  a  step-­‐by-­‐step  plan  on  how   to   undertake   an   annual   tender,   from   budgeting   and   planning,   through  quantification,  bid  evaluation  etc.  

At  the  primary  healthcare  level,  stock-­‐outs  of  critical  items  are  still  common.  Plans  are  currently  in  place  to  further  strengthen  provincial  distribution  through  the  development  and  implementation  of  a  national  distribution  plan  and  the  modernising  of  distribution  systems,  using  increasing  IT  functionality.  The  Division  is  working  with  software  partner  Sustainable  Solutions  to  implement  these  improvements.  

Key recommendations:

In   addition   to   training   and   application   of   the   National   Pharmacy   Standards,   the  SOPs   for  National  Medical  Stores  and   the  National  Procurement  Plan  and  Annual  Tender   Guidelines   efforts   should   be   focussed   on   the   primary   level   where   stock-­‐outs  are  still  common.      

Introduction  of  SOPs  and  standard  Order  Forms  relevant  for  the  stock  appropriate  for   each   particular   health   service   should   be   introduced   to   maintain   reliable  supplies   of   essential   medicines   and   avoid   stock-­‐outs.     Training   associated   with  adherence   to   STGs   and   maintenance   of   records   of   use   should   be   linked   to  appropriate   quantification   of  medicines   needs   at   all   health   facility   levels,   in   line  with  the  National  Pharmacy  5  Year  Strategic  Plan.  

34

Section 8 - Selection and Rational Use of Medicines

This section outlines the structures and policies governing the selection of

essential medicines and promotion of rational medicines use in Solomon

Islands.

8.1 National Structures

A National Essential Medicines List (EML) exists in Solomon Islands. The

EML was lastly updated in 2010 and is publicly available. There are currently

475 medicines on the EML. Selection of medicines for the EML is overseen by

the National Drugs and Therapeutics Committee through a written process. A

mechanism aligning the EML with the Standard Treatment Guidelines is in

place.

National Standard Treatment Guidelines (STGs) for most common illnesses

are produced and endorsed by the Ministry of Health and Medical Services in

Solomon Islands. These were last updated in 2011. Specific STGs cover

primary care (updated in 2011) and paediatric conditions (updated in 2009).

Of the public health facilities, 100% have a copy of the EML and 100% have a

copy of the STGs.

There is a public or independently funded national Medicines Information

Centre (MIC) providing information on medicines to prescribers, dispensers

and consumers. Public education campaigns on rational medicine use topics

have been conducted in the last two years. A survey on rational use of

medicines has not been conducted in the previous two years. There is a

national programme and committee, involving government, civil society and

professional bodies, to monitor and promote rational use of medicines.  

The MIC printed and launched the 2013 update of the Solomon Islands

Essential Medicines List. They have also developed and are rolling out a

package of interventions to improve the availability and usage of priority

medicines for mothers and children. Interventions include research on zinc

sulphate and ORS for child diarrhoea. In 2012 a comprehensive pilot study

35

was undertaken in one province to ascertain the availability of zinc sulphate in

health facilities, staff knowledge of the rationale for its use and correct use of

zinc sulphate with ORS for diarrhoea. It was demonstrated that it is possible

to increase the availability and comprehension of zinc sulphate for use in

children with diarrhoea, with a series of low-cost, contextually appropriate

interventions. This pilot study will now be rolled out across all provinces;

further work may also focus on all 30 WHO Priority Medicines for Mothers &

Children. This work is likely to be reproducible in similar settings across the

Pacific but more methodological rigour is needed in larger studies. The report

of the study is available from the Pharmacy Services Division.

Other activities carried out by the unit are: two-way radio programs with

nurses in rural areas, printing of special bulletins and Pharmacy Newsletters

that contain information on various drugs, targeting irrational use of medicines

and focus on changes in treatment such as the use of artemesinin compound

treatment for malaria and other current areas of concern.

A written National Strategy for Containing Antimicrobial Resistance does not

exist.

The Solomon Islands’ EML includes formulations specifically for children.

Criteria for the selection of medicines in the EML are explicitly documented. A

formal committee for the selection of products on the EML exists. Conflict of

interest declarations are not required from members of the national EML

committee. A national medicines formulary does not exist.

A funded national inter-sectoral task force to coordinate the promotion of the

appropriate use of antimicrobials and prevention of the spread of infection

does not exist. A national reference laboratory or other institution does not

have responsibility for coordinating epidemiological surveillance of

antimicrobial resistance.

36

8.2 Prescribing

Legal provisions exist to govern the licensing and prescribing practices of

prescribers. Furthermore, legal provisions restricting dispensing by

prescribers exist. Prescribers in the private sector dispense medicines.

There is a National Drugs and Therapeutics Committee (NDTC), as mandated

by the Ministry of Health and Medical Services that oversees the development

and revision of the Essential Medicines List and all Standard Treatment

Guidelines. Provincial Hospitals do not have separate DTCs; the NDTC is

based at the only referral hospital in the country.

Mandatory continuing education that includes rational use of medicines is

required for doctors and nurses, but not for paramedical staff.

Prescribing by INN is obligatory in the public sector, but not in the private

sector. Of the medicines prescribed in the outpatient public health care

facilities, 100% are on the national EML.

A professional association code of conduct which governs the professional

behaviour of doctors exists. Similarly, a professional association code of

conduct governing the professional behaviour of nurses also exists.

8.3 Dispensing

Legal provisions in Solomon Islands to govern dispensing practices of

pharmacy personnel exist. The basic pharmacist training curriculum includes

a spectrum of components as outlined in Table 13.

37

Table 13: Core aspects of the pharmacist training curriculum

Curriculum Covered

The concept of EML Yes

Use of STGs Yes

Drug information Yes

Clinical pharmacology Yes

Medicines supply management Yes

Mandatory continuing education that includes rational use of medicines is

required for pharmacists.

Substitution of generic equivalents at the point of dispensing is allowed in

public and private sector facilities. Sometimes, antibiotics are often sold over-

the-counter without a prescription.

A professional association code of conduct which governs the professional

behaviour of pharmacists exists. Nurses are allowed to prescribe a number of

prescription-only medicines at the primary care level in the public sector, in

accordance with the Essential Medicines List, which categorises each drug

against different levels of use (from Nurse to Specialist Doctors). However,

pharmacists and all other paramedics do not.

Further information and key findings:

It   is   believed   that   the   results   of   the   zinc   sulphate   study   indicated   that   low-­‐cost  interventions,   which   incorporate   patient   education   simultaneously   with   staff  education   and   supply   chain   mechanism   improvements   are   more   effective   and  considerably  less  expensive  than  staff  workshops,  which  are  often  used  by  vertical  programs  and  external  agencies.  

Standard   Treatment   Guidelines   (STGs)   are   regularly   updated.   They   are   being  advocated   and   distributed   to   promote   rational   use   of   medicines   in   all   health  facilities.     There   is   good   understanding   about   the   role   of   STGs   throughout   the  public     health   sector   and   all   medicines   recommended   in   STGs   are   available   and  supplied  free  of  charge  by  the  Ministry  of  Health  and  Medical  Services.

STGs   are   developed   with   technical   and   financial   assistance   from   Therapeutic  Guidelines  Limited,  Australia,  and  WHO.  

38

Key recommendations:

Activities  defined  in  the  Pharmaceutical  Service  Division  5  Year  Strategic  Plan  2011  –  2015  will   address  outstanding   issues  associated  with   rational  use  of  medicines.    These   activities   should   be   supported   so   they   can   be   undertaken   in   a   timely  manner.  Among  others,  activities  are  defined  to  strengthen:  

• The  roles  of  the  Drugs  and  Therapeutics  committee  • The  maintenance  of  an  updated  EML  • Training  for  rational  use  of  medicines;  prescribing  and  dispensing  • Patient  compliance  and  self-­‐medication  • Adverse  medicines  reaction  reporting  and  response  • Medicines  Information  

Each  edition  of  Standard  Treatment  Guidelines  should  be  updated  every  5  years  to  maintain  currency.  

39

Section 9 - Household Data/Access In the past 5 years, no household surveys have been undertaken to assess

the access to medicines.

40

List of key reference documents: International Narcotics Control Board (INCB) (1982). Website: http://www.incb.org/

MDG Goals Progress Report for Solomon Islands, 2010. Available from the Ministry of Health and Medical Services

Ministry of Health, Unpublished data (2010).

Ministry of Police and Justice, Registrar-General's Office, P.O. Box G 15 Honiara, Guadalcanal, Solomon Islands

National Good Pharmacy Practice Guidelines. Available from Pharmacy Services division.

National Health Accounts (NHA) Country Information, “Solomon Islands - National Expenditure on Health (Solomon Dollar) 2009”. Available online: http://www.who.int/nha/country/slb/en/

National Malaria Treatment Guidelines (2009). Available from Pharmacy Services Division.

National Pharmacy Division, “Solomon Islands Essential Medicines List 2010”, Ministry of Health and Medical Services. Available online: http://www.who.int/selection_medicines/country_lists/slb_eml_2010.pdf

National Pharmacy Services Division Complete Five Year Strategic Plan 2011-2015. Available from the National Pharmacy Services Division. .

National Procurement Plan and Annual Tender Guidelines. Available from the National Pharmacy Services Division

Regulatory Affairs, National Pharmacy Division, PO Box 349, Honiara, Solomon Islands

SI National Pharmacy Standards. Available from the National Pharmacy Services Division

SI National Pharmacy Officer Training Curriculum. Available from the Pharmacy Services Division.

Solomon Islands Essential Medicines List, 2010. Available online http://apps.who.int/medicinedocs/documents/s19524en/s19524en.pdf

Solomon Islands Government, “National Health Strategic Plan 2011-2015”, The Ministry of Health & Medical Services, March 2011. Available online: http://www.wpro.who.int/health_services/solomon_islands_nationalhealthplan.pdf

Solomon Islands Guidelines for Donations of Medicines. Available from the Pharmacy Services Division.

Solomon Islands National Medicines Policy. Available from Pharmacy Services Division.

Standard Operating Procedures for National Medical Stores. Available from the National Pharmacy Services Division

Standard Treatment Manual for Adults (2011). Available from Pharmacy Services Division.

Standard Treatment Manual for Children, 3rd Edition, 2009. Available online http://apps.who.int/medicinedocs/documents/s17086e/s17086e.pdf

WHO Solomon Islands Country Profile. Available online http://www.who.int/countries/slb/en/

41

World Bank data (2009). Website: http://data.worldbank.org/

World Health Organization (WHO) (2007), “WHO Level I survey”, Geneva

World Health Organization (WHO) (2009), “World Health Statistics 2009”, WHO Press, Geneva. Available online: http://www.who.int/whosis/whostat/2009/en/index.html.

World Health Organization (WHO) (2010), “World Health Statistics 2010”, WHO Press, Geneva. Available online: http://www.who.int/whosis/whostat/2010/en/index.html.

World Health Organization (WHO) (2011), “World Health Statistics 2011”, WHO Press, Geneva. Available online: http://www.who.int/whosis/whostat/2011/en/index.html

World Health Organization (WHO) Western Pacific Region (2010), “Achieving the Health-Related MDGs in the Western Pacific Region”, Progress Report 2010, WHO Press, Geneva. Available online: http://www.wpro.who.int/health_information_evidence/documents/MDG_Progress_2010_11.pdf

World Health Organization (WHO) Western Pacific Region (2010), “Country Health Information Profiles (CHIPS)”, 2010 Revision, WHO Press, Geneva. Available online: http://www.wpro.who.int/publications/CHIPS2010.pdf

World Health Organization, Western Pacific Region (2010), Consultant's report on National Laboratory Policy and Plan.

World Trade Organization (1996). Available online: http://www.wto.org/english/thewto_e/countries_e/solomon_islands_e.htm