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INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   1	
  
	
  
	
  
	
   	
  
T u l a n e 	
   U n i v e r s i t y 	
   S c h o o l 	
   o f 	
   P u b l i c 	
   H e a l t h 	
   a n d 	
   T r o p i c a l 	
   M e d i c i n e 	
  
Innovations	
  in	
  Access	
  to	
  Essential	
  
Medicines:	
  Focus	
  on	
  South	
  Africa	
  
Aimee	
  Edmondo	
  
MPH	
  Candidate	
  
Spring	
  
2014	
  
Public	
  Health	
  Analysis	
  Culminating	
  Experience	
  
	
  
Department:	
  Global	
  Health	
  Systems	
  and	
  Development	
  
Focus:	
  Program	
  Design	
  and	
  Implementation	
  
Advisor:	
  Nathan	
  Morrow	
  
List	
  of	
  Acronyms	
  
ANC	
  –	
  African	
  National	
  Congress	
  
ARV	
  –	
  Anti	
  Retro	
  Virals	
  
CHW	
  –	
  Community	
  Health	
  Worker	
  
DoH	
  –	
  Department	
  of	
  Health	
  
EDL	
  –	
  Essential	
  Drugs	
  List	
  
EDP	
  –	
  Essential	
  Drugs	
  Programme	
  
eHealth	
  –	
  Electronic	
  Health	
  Informatics	
  
EML	
  –	
  Essential	
  Medicines	
  List	
  
EMR	
  –	
  Electronic	
  Medical	
  Records	
  
FDC	
  –	
  Fixed	
  Dose	
  Combination	
  
HIS	
  –	
  Health	
  Information	
  System	
  
HIM	
  –	
  Health	
  Information	
  for	
  Management	
  
HIV	
  –	
  Human	
  Immunodeficiency	
  Virus	
  
HST	
  –	
  Health	
  Systems	
  Trust	
  
ICT	
  –	
  Information	
  and	
  Communications	
  Technology	
  
iDART	
  –	
  Intelligent	
  Dispensing	
  of	
  Anti-­‐Retroviral	
  Treatment	
  
KEMSA	
  –	
  Kenya	
  Medical	
  Supplies	
  Agency	
  
LMIC	
  –	
  Low	
  and	
  Middle-­‐Income	
  Countries	
  
LMIS	
  –	
  Logistics	
  Management	
  Information	
  System	
  
MatCH	
  –	
  Maternal	
  Adolescent	
  and	
  Child	
  Health	
  
mHealth	
  –	
  Mobile	
  health	
  technology	
  
MSF	
  –	
  Medecins	
  Sans	
  Frontieres	
  /	
  Doctors	
  Without	
  Borders	
  
MSH	
  –	
  Management	
  Sciences	
  for	
  Health	
  
NCD	
  –	
  Non-­‐Communicable	
  Disease	
  
NDP	
  –	
  National	
  Drug	
  Policy	
  
NDoH	
  –	
  National	
  Department	
  of	
  Health	
  
NGO	
  –	
  Non-­‐governmental	
  Organization	
  
PHC	
  –	
  Primary	
  Health	
  Care	
  
PTC	
  –	
  Pharmacy	
  and	
  Therapeutics	
  Committee	
  
RCT	
  –	
  Randomized	
  Controlled	
  Trial	
  
SMS	
  –	
  Short	
  Message	
  Service	
  
SSA	
  –	
  Sub	
  Saharan	
  Africa	
  
STG	
  –	
  Standard	
  Treatment	
  Guidelines	
  
TB	
  –	
  Tuberculosis	
  	
  
WHO	
  –	
  World	
  Health	
  Organization
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   1	
  
	
  
Abstract	
  
South	
  Africa	
  instituted	
  no	
  cost	
  public	
  healthcare	
  services	
  in	
  1994,	
  despite	
  this,	
  South	
  Africa	
  suffers	
  from	
  
a	
  quadruple	
  health	
  burden,	
  which	
  includes	
  communicable	
  disease,	
  non-­‐communicable	
  disease,	
  poor	
  
maternal	
  and	
  child	
  health,	
  and	
  injury	
  and	
  death	
  due	
  to	
  violence.	
  	
  Additionally,	
  South	
  Africa	
  is	
  home	
  to	
  
the	
  largest	
  populations	
  of	
  HIV	
  and	
  TB	
  infected	
  individuals	
  in	
  the	
  world.	
  	
  Satisfactory	
  health	
  outcomes	
  are	
  
dependent	
  upon	
  reliable	
  access	
  to	
  health	
  care	
  and	
  uninterrupted	
  supplies	
  of	
  essential	
  medicines.	
  	
  
Recently,	
  advocacy	
  organizations	
  have	
  reported	
  regular	
  stock	
  outs	
  of	
  essential	
  medicines,	
  and	
  reviews	
  
of	
  patient	
  experiences	
  in	
  the	
  public	
  healthcare	
  delivery	
  system	
  indicate	
  that	
  patients	
  are	
  required	
  to	
  
repeatedly	
  return	
  to	
  health	
  facilities	
  to	
  collect	
  medications.	
  	
  Consequently,	
  impoverished	
  patients	
  are	
  
often	
  demoralized	
  and	
  experience	
  catastrophic	
  out	
  of	
  pocket	
  expenses.	
  	
  In	
  this	
  analysis	
  mobile	
  
technology	
  is	
  explored	
  as	
  a	
  potential	
  intervention	
  to	
  empower	
  patients	
  and	
  simultaneously	
  improve	
  
access	
  to	
  essential	
  medicines	
  in	
  South	
  Africa.	
  
	
  
A	
  qualitative	
  review	
  of	
  literature	
  from	
  the	
  last	
  decade	
  was	
  conducted	
  to	
  explore	
  essential	
  drugs	
  access	
  
and	
  the	
  pharmaceutical	
  supply	
  chain	
  management	
  system	
  in	
  South	
  Africa.	
  	
  Additionally,	
  mobile	
  health	
  
technology	
  interventions	
  in	
  sub	
  Saharan	
  Africa	
  were	
  reviewed	
  for	
  their	
  feasibility	
  and	
  potential	
  to	
  
improve	
  supply	
  chains.	
  	
  Policy	
  documents	
  and	
  reports	
  from	
  advocacy	
  organizations	
  were	
  also	
  used	
  to	
  
inform	
  this	
  analysis.	
  
	
  
Over	
  20	
  documents	
  were	
  identified	
  for	
  this	
  public	
  health	
  analysis.	
  Findings	
  related	
  to	
  access	
  to	
  
medicines	
  and	
  care,	
  pharmaceutical	
  supply	
  chain	
  systems,	
  and	
  the	
  role	
  of	
  mobile	
  health	
  technology	
  
indicate	
  that	
  little	
  comprehensive	
  research	
  has	
  been	
  conducted	
  in	
  South	
  Africa	
  on	
  these	
  topics	
  and	
  the	
  
relationships	
  between	
  them.	
  	
  Furthermore,	
  few	
  peer-­‐reviewed	
  studies	
  have	
  explored	
  the	
  impact	
  of	
  
healthcare	
  access	
  barriers	
  and	
  essential	
  medicine	
  shortages	
  in	
  South	
  Africa	
  on	
  treatment	
  adherence	
  or	
  
overall	
  health	
  outcomes.	
  
	
  
Widespread	
  mobile	
  phone	
  use,	
  advanced	
  ICT	
  systems,	
  and	
  government-­‐initiated	
  health	
  technology	
  
policies	
  suggest	
  that	
  South	
  Africa	
  has	
  an	
  enabling	
  environment	
  to	
  facilitate	
  the	
  implementation	
  mHealth	
  
to	
  improve	
  essential	
  medicines	
  access.	
  	
  It	
  should	
  be	
  noted,	
  however,	
  that	
  limited	
  stewardship,	
  poor	
  
leadership,	
  resource	
  constraints,	
  and	
  an	
  ineffective	
  culture	
  of	
  service	
  delivery	
  will	
  need	
  to	
  be	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   2	
  
	
  
ameliorated	
  in	
  order	
  to	
  implement	
  beneficial	
  mHealth	
  innovations	
  to	
  improve	
  pharmaceutical	
  supply	
  
chain	
  management.	
  
Background	
  
WHO	
  and	
  the	
  Model	
  List	
  of	
  Essential	
  Medicines	
  
In	
  1975	
  global	
  concerns	
  about	
  the	
  availability	
  of	
  important	
  lifesaving	
  medicines	
  in	
  the	
  public	
  sector,	
  
particularly	
  in	
  developing	
  countries,	
  led	
  to	
  a	
  request	
  by	
  the	
  World	
  Health	
  Assembly	
  for	
  the	
  World	
  Health	
  
Organization	
  (WHO)	
  to	
  establish	
  a	
  model	
  list	
  of	
  essential	
  medicines.	
  	
  The	
  first	
  essential	
  medicines	
  list	
  
(EML)	
  was	
  released	
  in	
  1977.	
  	
  Challenges	
  to	
  the	
  EML	
  and	
  changing	
  patterns	
  of	
  health	
  and	
  evidenced-­‐
based	
  practices	
  have	
  led	
  to	
  several	
  revisions	
  of	
  this	
  list	
  (Laing	
  et	
  al.	
  2003).	
  	
  Today,	
  the	
  WHO	
  EML	
  is	
  in	
  its	
  
18th
	
  edition.	
  	
  Essential	
  medicines	
  are	
  defined	
  by	
  WHO	
  as:	
  
“Those	
  drugs	
  that	
  satisfy	
  the	
  priority	
  health	
  care	
  needs	
  of	
  the	
  of	
  the	
  population.	
  	
  They	
  are	
  
selected	
  with	
  due	
  regard	
  to	
  public	
  health	
  relevance,	
  evidence	
  on	
  efficacy	
  and	
  safety,	
  and	
  
comparative	
  cost-­‐effectiveness.	
  	
  Essential	
  medicines	
  are	
  intended	
  to	
  be	
  available	
  within	
  the	
  
context	
  of	
  functioning	
  health	
  systems	
  at	
  all	
  times	
  in	
  adequate	
  amounts,	
  appropriate	
  dosage	
  
forms,	
  with	
  assured	
  quality	
  and	
  adequate	
  information,	
  and	
  at	
  a	
  price	
  the	
  individual	
  and	
  
community	
  can	
  afford.	
  	
  The	
  implementation	
  of	
  the	
  concept	
  of	
  essential	
  medicines	
  is	
  intended	
  to	
  
be	
  flexible	
  and	
  adaptable	
  to	
  many	
  different	
  situations;	
  exactly	
  which	
  medicines	
  are	
  regarded	
  as	
  
essential	
  remains	
  a	
  national	
  responsibility	
  (2002).”	
  
	
  
Accordingly,	
  South	
  Africa	
  also	
  has	
  its	
  own	
  essential	
  drugs	
  list	
  (EDL)	
  and	
  associated	
  treatment	
  guidelines,	
  
though	
  the	
  evolution	
  of	
  this	
  list	
  has	
  been	
  fraught	
  with	
  controversy	
  and	
  heavily	
  influenced	
  by	
  a	
  host	
  of	
  
growing	
  epidemics	
  such	
  as	
  HIV	
  and	
  TB	
  (Laing	
  et	
  al.	
  2003).	
  
Primary	
  Health	
  Care	
  and	
  the	
  Essential	
  Drugs	
  List	
  in	
  South	
  Africa	
  
Following	
  democratic	
  transition	
  in	
  South	
  Africa	
  in	
  1994,	
  the	
  African	
  National	
  Congress	
  (ANC)	
  proposed	
  a	
  
plan	
  for	
  national	
  health	
  services	
  based	
  on	
  the	
  concept	
  of	
  primary	
  health	
  care	
  (PHC)	
  promoted	
  at	
  Alma	
  
Ata.	
  	
  Through	
  this	
  plan,	
  the	
  National	
  Department	
  of	
  Health	
  (NDoH)	
  sought	
  to	
  address	
  the	
  unequal	
  
distribution	
  of	
  health	
  services,	
  infrastructure,	
  monetary,	
  and	
  human	
  resources	
  resulting	
  from	
  Apartheid.	
  	
  
No	
  cost	
  PHC	
  became	
  available	
  to	
  the	
  public	
  though	
  a	
  district	
  health	
  system	
  following	
  the	
  construction	
  
and	
  upgrading	
  of	
  over	
  1,500	
  clinics	
  (Coovadia	
  et	
  al.	
  2009).	
  	
  In	
  1996	
  South	
  Africa	
  released	
  the	
  National	
  
Drug	
  Policy	
  (NDP),	
  which	
  outlined	
  changes	
  in	
  drug	
  management	
  and	
  detailed	
  a	
  host	
  of	
  legislative	
  and	
  
regulatory	
  priorities.	
  	
  One	
  of	
  these	
  priorities	
  involved	
  the	
  establishment	
  of	
  a	
  representative	
  committee	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   3	
  
	
  
to	
  produce	
  standard	
  treatment	
  guidelines	
  (STGs)	
  from	
  which	
  the	
  medicines	
  to	
  be	
  included	
  in	
  the	
  PHC	
  
EDL	
  would	
  be	
  extracted.	
  	
  The	
  first	
  editions	
  of	
  these	
  documents	
  were	
  released	
  in	
  April	
  of	
  1996	
  (Gray	
  &	
  
Suleman	
  2000,	
  Essack	
  et	
  al.	
  2011).	
  
	
  
Though	
  the	
  national	
  PHC	
  EDL	
  and	
  STGs	
  are	
  regularly	
  reviewed	
  and	
  updated,	
  limited	
  political	
  will,	
  patent	
  
policies,	
  and	
  inequitable	
  resources	
  mean	
  that	
  some	
  essential	
  drugs	
  are	
  less	
  accessible	
  than	
  others.	
  	
  HIV	
  
has	
  been	
  a	
  prominent	
  issue	
  in	
  the	
  EDL	
  process.	
  	
  Today	
  there	
  are	
  clear	
  STGs	
  for	
  HIV	
  and	
  TB	
  and	
  policy-­‐
based	
  strategic	
  plans	
  at	
  the	
  national	
  and	
  provincial	
  level	
  in	
  South	
  Africa,	
  but	
  at	
  one	
  time	
  anti-­‐retrovirals	
  
(ARVs)	
  were	
  considered	
  too	
  expensive	
  for	
  public	
  use.	
  	
  For	
  example,	
  in	
  the	
  1998	
  PHC	
  EDL	
  it	
  is	
  noted	
  that	
  
“these	
  medicines	
  are	
  very	
  costly	
  and	
  cannot	
  be	
  provided	
  on	
  a	
  mass	
  scale	
  by	
  the	
  public	
  health	
  services…	
  
they	
  may	
  only	
  be	
  provided	
  on	
  a	
  limited	
  and	
  selected	
  basis	
  or	
  for	
  academic	
  and	
  research	
  purposes	
  only”	
  
(Laing	
  et	
  al.	
  2003).	
  	
  Fortunately,	
  the	
  World	
  Health	
  Assembly	
  approved	
  a	
  Revised	
  Drug	
  Strategy	
  in	
  May	
  of	
  
1999,	
  which	
  allows	
  for	
  interpretation	
  of	
  the	
  World	
  Trade	
  Organization	
  (WTO)	
  TRIPS	
  agreement	
  based	
  on	
  
priority	
  global	
  health	
  concerns	
  (Hoen	
  et	
  al.	
  2011).	
  	
  This	
  has	
  greatly	
  reduced	
  the	
  cost	
  of	
  ARVs	
  and	
  allowed	
  
South	
  Africa	
  to	
  establish	
  a	
  national	
  ARV	
  program	
  in	
  2003	
  with	
  assistance	
  from	
  foreign	
  donors.	
  	
  With	
  
over	
  2.1	
  million	
  people	
  initiating	
  ARV	
  treatment	
  in	
  South	
  Africa	
  in	
  2012,	
  it	
  is	
  the	
  largest	
  program	
  of	
  its	
  
kind.	
  
Health	
  Service	
  Delivery	
  and	
  the	
  Health	
  Status	
  of	
  South	
  Africa	
  
Multiple	
  reviews	
  on	
  the	
  process	
  of	
  implementing	
  post-­‐Apartheid	
  national	
  health	
  services	
  in	
  South	
  Africa	
  
have	
  indicated	
  that	
  progress	
  is	
  slow,	
  uneven,	
  and	
  faces	
  multiple	
  difficulties.	
  	
  (Gray	
  &	
  Suleman	
  2000,	
  
Coovadia	
  et	
  al.	
  2009,	
  Levitt	
  N,	
  2011).	
  	
  Major	
  setbacks	
  in	
  implementation	
  have	
  included	
  confusion	
  about	
  
responsibilities	
  within	
  the	
  district	
  health	
  system.	
  	
  In	
  the	
  2004	
  National	
  Health	
  Act,	
  the	
  NDoH	
  is	
  identified	
  
as	
  the	
  sole	
  responsible	
  party	
  for	
  national	
  health	
  policy,	
  while	
  public	
  health	
  service	
  delivery	
  was	
  deemed	
  
a	
  provincial	
  responsibility.	
  	
  Within	
  the	
  national	
  pharmaceutical	
  program,	
  NDoH	
  is	
  responsible	
  for	
  the	
  
tender	
  process,	
  while	
  provincial	
  governments	
  are	
  responsible	
  for	
  ordering,	
  storage,	
  and	
  distribution	
  of	
  
medicines.	
  	
  Additional	
  national	
  health	
  care	
  challenges	
  include	
  skilled	
  human	
  resource	
  shortages,	
  
unequal	
  distribution	
  of	
  resources	
  –	
  with	
  very	
  few	
  at	
  the	
  rural	
  community	
  or	
  primary	
  level,	
  and	
  poor	
  
human	
  resource	
  management.	
  	
  Though	
  perhaps	
  more	
  damaging	
  has	
  been	
  a	
  historical	
  lack	
  of	
  
stewardship	
  and	
  leadership	
  within	
  the	
  health	
  system	
  at	
  a	
  national	
  level	
  (Coovadia	
  et	
  al.	
  2009).	
  
	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   4	
  
	
  
Though	
  South	
  Africa	
  is	
  considered	
  a	
  high-­‐middle	
  income	
  country,	
  its	
  health	
  outcomes	
  are	
  worse	
  than	
  
many	
  low-­‐income	
  countries.	
  	
  Currently	
  South	
  Africa	
  faces	
  a	
  quadruple	
  epidemic,	
  which	
  includes	
  
communicable	
  disease	
  (such	
  as	
  HIV	
  and	
  TB),	
  injury	
  and	
  death	
  due	
  to	
  violence,	
  diseases	
  of	
  poverty	
  (such	
  
as	
  poor	
  maternal	
  and	
  child	
  mortality	
  and	
  morbidity),	
  and	
  rising	
  non-­‐communicable	
  chronic	
  diseases	
  
related	
  to	
  diet	
  and	
  lifestyle.	
  	
  South	
  Africa	
  is	
  home	
  to	
  the	
  largest	
  number	
  of	
  HIV	
  infected	
  individuals	
  in	
  
the	
  world,	
  with	
  an	
  estimated	
  6.1	
  million	
  infected.	
  	
  Additionally,	
  over	
  60%	
  of	
  TB	
  patients	
  are	
  found	
  to	
  be	
  
co-­‐infected	
  with	
  HIV	
  (UNAIDS	
  2012).	
  	
  The	
  need	
  for	
  uninterrupted	
  supplies	
  of	
  essential	
  medicines,	
  
particularly	
  for	
  South	
  Africa’s	
  growing	
  burden	
  of	
  chronic	
  communicable	
  and	
  non-­‐communicable	
  disease,	
  
is	
  evident.	
  
Rationale	
  
South	
  Africa’s	
  overburdened	
  and	
  under-­‐resourced	
  public	
  healthcare	
  system	
  regularly	
  struggles	
  to	
  meet	
  
the	
  demands	
  of	
  the	
  public.	
  	
  In	
  addition,	
  poor	
  pharmaceutical	
  logistics	
  and	
  supply	
  chain	
  management	
  
impedes	
  the	
  ability	
  of	
  patients	
  to	
  adhere	
  to	
  treatment	
  regimes,	
  and	
  when	
  combined	
  with	
  poverty,	
  often	
  
deters	
  highly	
  vulnerable	
  households	
  from	
  engaging	
  in	
  health	
  seeking	
  behavior	
  (Goudge	
  et	
  al.	
  2009).	
  	
  
Regular	
  stock	
  outs	
  of	
  essential	
  medicines	
  at	
  the	
  facility	
  and	
  depot	
  level	
  put	
  patients	
  at	
  risk	
  of	
  developing	
  
poor	
  health	
  outcomes	
  and	
  increase	
  the	
  probability	
  of	
  drug	
  resistance.	
  	
  Moreover,	
  smaller	
  rural	
  clinics	
  
serving	
  traditionally	
  impoverished	
  areas	
  are	
  particularly	
  vulnerable	
  to	
  stock	
  outs	
  because	
  they	
  are	
  
downstream	
  recipients	
  of	
  medicines	
  from	
  larger	
  facilities	
  such	
  as	
  municipal	
  and	
  district	
  hospitals	
  (MSF	
  et	
  
al.	
  2013).	
  	
  Multiple	
  reviews	
  on	
  access	
  to	
  care	
  in	
  South	
  Africa	
  indicate	
  that	
  poverty,	
  poor	
  healthcare	
  
service	
  delivery,	
  and	
  a	
  lack	
  of	
  clear	
  information	
  from	
  providers	
  disempower	
  patients.	
  	
  In	
  order	
  to	
  
improve	
  the	
  disease	
  burden	
  in	
  South	
  Africa	
  these	
  reviews	
  indicate	
  that	
  novel	
  and	
  innovative	
  approaches	
  
to	
  improve	
  health	
  services	
  are	
  needed	
  (Goudge	
  et	
  al.	
  2009,	
  Coovadia	
  et	
  al.	
  2009,	
  Mayosi	
  et	
  al.	
  2009,	
  
Schneider	
  et	
  al.	
  2006).	
  
	
  
Mobile	
  health	
  technology	
  (mHealth)	
  is	
  a	
  growing	
  field.	
  	
  Innovative	
  uses	
  of	
  technology	
  have	
  improved	
  
information	
  flow,	
  allowed	
  for	
  timely	
  and	
  accurate	
  methods	
  of	
  data	
  collection,	
  and	
  have	
  connected	
  
consumers	
  with	
  providers.	
  	
  Recent	
  pilot	
  programs	
  have	
  looked	
  at	
  how	
  mobile	
  technology	
  can	
  increase	
  
access	
  to	
  medicines	
  by	
  improving	
  accountability	
  within	
  the	
  supply	
  chain	
  of	
  pharmaceuticals	
  (Barrington	
  
et	
  al.	
  2010).	
  	
  Given	
  that	
  there	
  are	
  29	
  million	
  mobile	
  phone	
  users	
  in	
  South	
  Africa,	
  a	
  noted	
  increase	
  from	
  
17%	
  to	
  76%	
  amongst	
  adults	
  in	
  the	
  past	
  decade,	
  it	
  would	
  be	
  advantageous	
  to	
  explore	
  the	
  ways	
  in	
  which	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   5	
  
	
  
mHealth	
  can	
  both	
  empower	
  patients	
  and	
  improve	
  access	
  to	
  medicines	
  in	
  low	
  resource	
  settings	
  in	
  South	
  
Africa	
  (KMPG	
  South	
  Africa	
  2013).	
  
Competencies	
  
The	
  competencies	
  to	
  be	
  developed	
  by	
  this	
  analysis	
  into	
  essential	
  medicines	
  access	
  in	
  South	
  Africa	
  are	
  as	
  
follows:	
  
Program	
  Design	
  and	
  Implementation	
  competencies:	
  
• Identify	
  program/project	
  goals,	
  objectives,	
  strategies,	
  activities	
  and	
  resource	
  requirements	
  for	
  
interventions	
  that	
  target	
  key	
  global	
  health	
  problems.	
  	
  
• Develop	
  management	
  systems	
  for	
  interventions	
  that	
  address	
  priority	
  global	
  health	
  problems.	
  
• Identify	
  information	
  requirements	
  for	
  design,	
  implementation,	
  and	
  evaluation	
  of	
  global	
  health	
  
programs.	
  
• Apply	
  design	
  and	
  implementation	
  principals	
  and	
  approaches	
  to	
  a	
  specific	
  program	
  area	
  within	
  
global	
  health.	
  
Topic-­‐specific	
  competencies:	
  
• Develop	
  an	
  understanding	
  of	
  the	
  supply	
  chain	
  management	
  system	
  for	
  essential	
  medicines	
  on	
  
the	
  national,	
  provincial,	
  and	
  district	
  level	
  in	
  South	
  Africa.	
  
• Conduct	
  a	
  landscape	
  analysis	
  of	
  the	
  current	
  health	
  issues	
  in	
  South	
  Africa	
  as	
  they	
  relate	
  to	
  
essential	
  medicines	
  access.	
  
• Review	
  the	
  existing	
  systemic	
  and	
  social	
  challenges	
  to	
  essential	
  medicine	
  access.	
  
• Research	
  and	
  compile	
  best	
  practices	
  regarding	
  the	
  use	
  of	
  mobile	
  technology	
  in	
  low-­‐resource	
  
setting	
  to	
  improve	
  health	
  outcomes	
  and	
  access	
  to	
  essential	
  medicines.	
  
Methodology	
  
Literature	
  in	
  this	
  analysis	
  was	
  located	
  utilizing	
  the	
  databases	
  PubMed	
  and	
  Google	
  Scholar.	
  	
  Peer	
  
reviewed	
  journal	
  articles	
  were	
  limited	
  to	
  the	
  past	
  decade	
  (2004	
  to	
  2014),	
  with	
  some	
  exceptions	
  such	
  as	
  
those	
  related	
  to	
  policies	
  implemented	
  prior	
  to	
  2004.	
  	
  Database	
  searches	
  included	
  the	
  following	
  terms	
  
and	
  phrases:	
  
• South	
  African	
  drug	
  policy	
  
• Pharmaceutical	
  supply	
  chain	
  management	
  in	
  South	
  Africa	
  
• Access	
  to	
  essential	
  medicines	
  in	
  South	
  Africa	
  
• Access	
  to	
  health	
  care	
  in	
  South	
  Africa	
  
• Medication	
  stock	
  outs	
  in	
  South	
  Africa	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   6	
  
	
  
• Mobile	
  technology	
  and	
  medicines	
  access	
  
• Mobile	
  health	
  in	
  South	
  Africa	
  
• Monitoring	
  distribution	
  of	
  essential	
  medicines	
  
• Health	
  impacts	
  of	
  medication	
  stock	
  outs	
  in	
  South	
  Africa	
  
Publications	
  regarding	
  essential	
  medicines	
  and	
  pharmaceutical	
  supply	
  chain	
  systems	
  from	
  multilateral	
  
institutions	
  such	
  as	
  the	
  World	
  Health	
  Organization	
  (WHO)	
  and	
  international	
  agencies	
  were	
  also	
  
considered	
  in	
  this	
  analysis.	
  	
  In	
  addition,	
  applicable	
  policy	
  briefs,	
  news	
  stories,	
  information	
  regarding	
  
mobile	
  health	
  technology	
  programs,	
  and	
  government	
  documents	
  were	
  accessed	
  via	
  the	
  online	
  websites	
  
of	
  the	
  South	
  African	
  National	
  Department	
  of	
  Health	
  (NDoH),	
  associated	
  press,	
  private	
  technology	
  
enterprises,	
  and	
  advocacy	
  organizations.	
  
Results	
  and	
  Discussion	
  
Findings	
  from	
  a	
  review	
  of	
  literature	
  related	
  to	
  access	
  to	
  medicines	
  and	
  care,	
  pharmaceutical	
  supply	
  
chain	
  systems,	
  and	
  the	
  role	
  of	
  mobile	
  health	
  technology	
  indicate	
  that	
  little	
  comprehensive	
  research	
  has	
  
been	
  conducted	
  in	
  South	
  Africa	
  on	
  these	
  topics	
  and	
  the	
  relationships	
  between	
  them.	
  	
  Furthermore,	
  few	
  
peer-­‐reviewed	
  studies	
  have	
  explored	
  the	
  impact	
  of	
  healthcare	
  access	
  barriers	
  and	
  essential	
  medicine	
  
shortages	
  in	
  South	
  Africa	
  on	
  treatment	
  adherence	
  or	
  overall	
  health	
  outcomes.	
  	
  Topics	
  that	
  repeatedly	
  
appeared	
  in	
  literature	
  searches	
  regarding	
  access	
  to	
  care	
  in	
  the	
  context	
  of	
  South	
  Africa	
  included	
  human	
  
resource	
  challenges	
  and	
  the	
  role	
  of	
  leadership	
  and	
  stewardship	
  in	
  health	
  systems	
  strengthening.	
  
	
  
Table	
  1:	
  Literature	
  sources	
  by	
  topic	
  
Document	
   Year	
   Location	
  
Source	
  
Type	
  
Access	
  
to	
  
Care	
  
Access	
  to	
  
Medicines	
  
Pharmaceutical	
  
Supply	
  Chain	
  
Mobile	
  
Health	
  
Technology	
  
Health	
  
Outcomes	
  
Aronovich	
  &	
  
Kinzett	
  
2001	
   Kenya	
   Report	
   	
   	
   X	
   	
   	
  
Barnighausen	
  
et	
  al	
  
2012	
   N/A	
  
Peer	
  
Reviewed	
  
Journal	
  
X	
   	
   	
   	
   	
  
Barrington	
  et	
  
al	
  
2010	
   Tanzania	
  
Peer	
  
Reviewed	
  
Journal	
  
	
   	
   X	
   X	
   X	
  
Demiris	
  et	
  al	
   2008	
   USA	
  
Peer	
  
Reviewed	
  
Journal	
  
	
   	
   	
   X	
   X	
  
Embrey	
  et	
  al	
   2009	
   Global	
  
Peer	
  
Reviwed	
  
Journal	
  
	
   	
   X	
   	
   	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   7	
  
	
  
Essack	
  et	
  al	
   2011	
  
South	
  
Africa	
  
Peer	
  
Reviewed	
  
Journal	
  
	
   	
   X	
   	
   	
  
Goudge	
  et	
  al	
   2009	
  
South	
  
Africa	
  
Peer	
  
Reviewed	
  
Journal	
  
X	
   	
   	
   	
   X	
  
Gray	
  &	
  
Suleman	
  
2000	
  
South	
  
Africa	
  
Report	
   	
   	
   X	
   	
   	
  
Harris	
  et	
  al.	
   2011	
  
South	
  
Africa	
  
Peer	
  
Reviewed	
  
Journal	
  
X	
   	
   	
   	
   	
  
Hozerzeil	
  
et	
  al.	
  
2013	
   Global	
  
Peer	
  
Reviewed	
  
Journal	
  
	
   X	
   	
   	
   	
  
Kaplan	
   2006	
   Global	
  
Peer	
  
Reviewed	
  
Journal	
  
	
   	
   	
   X	
   X	
  
Leon	
  et	
  al.	
   2012	
  
South	
  
Africa	
  
Peer	
  
Reviewed	
  
Journal	
  
	
   	
   	
   X	
   	
  
Levitt	
  et	
  al	
   2011	
  
South	
  
Africa	
  
Peer	
  
Reviewed	
  
Journal	
  
X	
   	
   	
   	
   X	
  
MSF	
  et	
  al	
   2013	
  
South	
  
Africa	
  
Report	
   	
   X	
   X	
   	
   X	
  
MSF	
  et	
  al.	
   2013	
  
South	
  
Africa	
  
Report	
   	
   X	
   X	
   	
   	
  
NDoH	
   2012	
  
South	
  
Africa	
  
Report	
   	
   	
   	
   X	
   	
  
NDoH	
   2011	
  
South	
  
Africa	
  
Report	
   X	
   X	
   	
   	
   	
  
Pharasi	
  &	
  
Miot	
  
2013	
  
South	
  
Africa	
  
Report	
   	
   	
   X	
   	
   	
  
Schneider	
  et	
  
al	
  
2006	
  
Souther
n	
  Africa	
  
Region	
  
Peer	
  
Reviewed	
  
Journal	
  
X	
   X	
   X	
   	
   	
  
Steyn	
  et	
  al.	
   2009	
  
South	
  
Africa	
  
Peer	
  
Reviewed	
  
Journal	
  
	
   X	
   X	
   	
   	
  
Access	
  to	
  Medicines	
  and	
  Health	
  Care	
  in	
  South	
  Africa	
  
An	
  initial	
  search	
  for	
  literature	
  related	
  to	
  access	
  to	
  medicines	
  in	
  South	
  Africa	
  yielded	
  few	
  results.	
  	
  
Therefore,	
  studies	
  related	
  to	
  public	
  sector	
  health	
  care	
  access	
  in	
  South	
  Africa	
  have	
  been	
  used	
  as	
  a	
  proxy	
  
for	
  essential	
  medicines	
  access.	
  	
  These	
  works	
  have	
  been	
  combined	
  with	
  reports	
  from	
  advocacy	
  
organizations	
  that	
  address	
  nationwide	
  pharmaceutical	
  stock	
  outs.	
  
	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   8	
  
	
  
Despite	
  the	
  great	
  strides	
  that	
  South	
  Africa	
  has	
  made	
  since	
  its	
  democratic	
  transition	
  from	
  Apartheid	
  in	
  
1994,	
  health	
  outcomes	
  remain	
  unsatisfactory.	
  	
  While	
  the	
  South	
  African	
  constitution	
  assures	
  state	
  
sponsored	
  PHC	
  for	
  all,	
  uneven	
  resource	
  allocation,	
  inadequate	
  infrastructure,	
  and	
  skilled	
  human	
  
resource	
  shortages	
  continue	
  to	
  plague	
  the	
  system.	
  	
  It	
  is	
  recognized	
  that	
  equitable	
  universal	
  health	
  care	
  
must	
  be	
  affordable,	
  available,	
  and	
  acceptable	
  to	
  recipients	
  of	
  services.	
  	
  The	
  public	
  health	
  care	
  system	
  in	
  
South	
  Africa	
  rarely	
  meets	
  these	
  requirements,	
  particularly	
  for	
  chronically	
  ill	
  patients	
  (Harris	
  et	
  al.	
  2011,	
  
Goudge	
  et	
  al.	
  2009).	
  
Affordability	
  
Affordability	
  is	
  a	
  key	
  component	
  of	
  accessible	
  health	
  care.	
  	
  While	
  PHC	
  services	
  are	
  offered	
  to	
  the	
  public	
  
at	
  no	
  cost,	
  there	
  are	
  often	
  catastrophic	
  out	
  of	
  pocket	
  expenses	
  that	
  affect	
  the	
  most	
  vulnerable	
  and	
  
impoverished	
  populations	
  in	
  South	
  Africa.	
  	
  Due	
  to	
  an	
  inequitable	
  distribution	
  of	
  infrastructure	
  and	
  
resources	
  many	
  individuals,	
  especially	
  those	
  in	
  rural	
  areas,	
  are	
  unable	
  to	
  access	
  care	
  due	
  to	
  public	
  
transport	
  costs.	
  	
  For	
  individuals	
  in	
  lower	
  wealth	
  quintiles	
  in	
  South	
  Africa,	
  transport	
  costs	
  and	
  distance	
  to	
  
PHC	
  clinics	
  are	
  likely	
  to	
  be	
  higher	
  than	
  those	
  for	
  individuals	
  in	
  the	
  uppermost	
  quintiles	
  -­‐	
  who	
  are	
  
generally	
  closer	
  to	
  secondary	
  and	
  tertiary	
  facilities	
  and	
  are	
  more	
  likely	
  to	
  utilize	
  private	
  modes	
  of	
  
transportation.	
  	
  With	
  high	
  rates	
  of	
  unemployment	
  (currently	
  24.5%	
  nationally),	
  many	
  households	
  in	
  
rural	
  areas	
  are	
  reliant	
  upon	
  government	
  funded	
  social	
  grants	
  as	
  a	
  sole	
  source	
  of	
  income.	
  	
  When	
  
transport	
  costs	
  are	
  combined	
  with	
  limited	
  availability	
  of	
  services	
  and	
  interrupted	
  drug	
  supplies,	
  these	
  
cost	
  burdens	
  can	
  account	
  for	
  6%	
  to	
  60%	
  of	
  household	
  expenditure	
  in	
  any	
  given	
  month	
  depending	
  on	
  the	
  
number	
  of	
  repeated	
  trips	
  to	
  obtain	
  medicines	
  and	
  care.	
  	
  Private	
  healthcare	
  services	
  are	
  also	
  frequently	
  
secondary	
  sources	
  of	
  out	
  of	
  pocket	
  expenses	
  for	
  vulnerable	
  groups	
  that	
  are	
  dissatisfied	
  with	
  publicly	
  
funded	
  PHC.	
  	
  In	
  South	
  Africa	
  private	
  healthcare	
  services	
  function	
  alongside	
  public	
  services,	
  delivering	
  
care	
  to	
  those	
  with	
  private	
  insurance	
  schemes	
  or	
  individuals	
  with	
  the	
  ability	
  to	
  pay.	
  	
  These	
  catastrophic	
  
costs	
  can	
  increase	
  household	
  vulnerabilities	
  and	
  food	
  insecurity	
  for	
  low-­‐income	
  families.	
  	
  For	
  individuals	
  
without	
  sufficient	
  financial	
  resources,	
  care	
  is	
  often	
  sought	
  intermittently,	
  despite	
  higher	
  rates	
  of	
  
infectious	
  and	
  non-­‐communicable	
  disease	
  (NCD)	
  within	
  these	
  lower	
  wealth	
  quintiles	
  (Harris	
  et	
  al.	
  2011,	
  
Goudge	
  et	
  al.	
  2009,	
  MSF	
  et	
  al.	
  2013).	
  	
  	
  
Availability	
  
Availability	
  of	
  healthcare	
  refers	
  to	
  the	
  quantity	
  of	
  fully	
  functioning	
  public	
  facilities,	
  goods,	
  and	
  services.	
  	
  
In	
  an	
  effort	
  to	
  bolster	
  PHC	
  services,	
  several	
  hundred	
  rural	
  primary	
  clinics	
  were	
  built	
  to	
  improve	
  access	
  
for	
  underserved	
  areas.	
  	
  Unfortunately,	
  these	
  rural	
  clinics	
  are	
  plagued	
  with	
  health	
  system	
  weaknesses	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   9	
  
	
  
and	
  frequently	
  lack	
  adequate	
  infrastructure	
  and	
  skilled	
  service	
  providers.	
  	
  In	
  South	
  Africa	
  the	
  number	
  of	
  
doctors,	
  pharmacists,	
  and	
  nurses	
  required	
  for	
  the	
  public	
  healthcare	
  system	
  to	
  function	
  outstrip	
  the	
  
number	
  of	
  available	
  professionals.	
  	
  Furthermore	
  many	
  of	
  the	
  national	
  human	
  resource	
  challenges	
  do	
  
not	
  reflect	
  the	
  disparities	
  within	
  South	
  Africa	
  –	
  many	
  of	
  these	
  healthcare	
  professionals	
  work	
  in	
  urban	
  
areas,	
  leave	
  the	
  government	
  system	
  to	
  provide	
  care	
  in	
  the	
  for-­‐profit	
  private	
  sector,	
  or	
  choose	
  to	
  practice	
  
outside	
  of	
  the	
  country.	
  	
  Over	
  85%	
  of	
  the	
  South	
  African	
  population	
  is	
  reliant	
  upon	
  public	
  services,	
  and	
  yet	
  
the	
  private	
  system	
  employs	
  70%	
  of	
  the	
  doctors	
  in	
  the	
  country.	
  	
  Similarly,	
  only	
  29%	
  of	
  registered	
  
pharmacists	
  work	
  in	
  the	
  public	
  sector.	
  	
  National	
  public	
  sector	
  vacancy	
  rates	
  for	
  doctors	
  and	
  nurses	
  are	
  
currently	
  56%	
  and	
  46%	
  respectively,	
  and	
  there	
  are	
  roughly	
  8	
  pharmacists	
  providing	
  services	
  per	
  100,000	
  
people	
  (George	
  et	
  al.	
  2009,	
  FIP	
  2012,	
  Gray	
  &	
  Suleman	
  2000,	
  Schneider	
  et	
  al.	
  2006).	
  
	
  
Few	
  studies	
  have	
  explored	
  healthcare	
  service	
  availability	
  from	
  a	
  beneficiary	
  perspective,	
  of	
  those	
  that	
  
have,	
  drug	
  stock	
  outs	
  were	
  frequently	
  noted	
  as	
  deterrents	
  to	
  care	
  (Schnieder	
  et	
  al.	
  2006,	
  Goudge	
  et	
  al.	
  
2009,	
  MSF	
  et	
  al.	
  2013).	
  	
  Two	
  of	
  the	
  national	
  core	
  standards	
  for	
  pharmaceutical	
  services	
  at	
  health	
  
facilities	
  in	
  South	
  Africa	
  ensure	
  that,	
  “medicines	
  and	
  medical	
  supplies	
  are	
  in	
  stock	
  and	
  their	
  delivery	
  is	
  
reliable,	
  and	
  that	
  stock	
  levels	
  and	
  storage	
  are	
  managed	
  appropriately”	
  (NDoH	
  2011).	
  	
  In	
  surveys	
  
performed	
  by	
  patient	
  advocacy	
  organizations,	
  it	
  was	
  found	
  that	
  21%	
  of	
  facilities	
  nationwide	
  had	
  
experienced	
  shortages	
  or	
  stock	
  outs	
  of	
  HIV	
  and	
  TB	
  medication,	
  with	
  some	
  rural	
  provinces	
  reporting	
  
stock	
  out	
  rates	
  of	
  over	
  50%.	
  	
  Vaccine	
  availability	
  was	
  surveyed	
  as	
  a	
  proxy	
  for	
  other	
  essential	
  medicines.	
  	
  
Nationally,	
  14.7%	
  of	
  facilities	
  had	
  experienced	
  shortages	
  and	
  stock	
  outs	
  of	
  vaccines.	
  	
  Again,	
  rural	
  
provinces	
  experienced	
  higher	
  vaccine	
  stock	
  out	
  rates	
  at	
  over	
  30%	
  (MSF	
  et	
  al.	
  2013).	
  	
  Similarly,	
  in	
  a	
  2011	
  
baseline	
  audit	
  of	
  national	
  health	
  care	
  facilities	
  77%	
  of	
  clinics,	
  70%	
  of	
  community	
  health	
  centers,	
  and	
  98%	
  
of	
  hospitals	
  did	
  not	
  have	
  EDL	
  tracer	
  medications	
  available	
  in	
  the	
  pharmacy	
  or	
  medication	
  storage	
  room	
  
(HST	
  et	
  al.	
  2012).	
  	
  Patients	
  utilizing	
  the	
  public	
  PHC	
  system	
  report	
  that	
  they	
  are	
  frequently	
  sent	
  home	
  
from	
  health	
  facilities	
  without	
  medication	
  or	
  told	
  to	
  return	
  at	
  a	
  later	
  date.	
  	
  Some	
  patients	
  who	
  are	
  reliant	
  
on	
  lifesaving	
  medications	
  resort	
  to	
  paying	
  out	
  of	
  pocket	
  for	
  essential	
  medicines	
  at	
  private	
  pharmacies.	
  	
  
For	
  chronic	
  patients	
  living	
  in	
  poverty,	
  availability	
  is	
  directly	
  related	
  to	
  affordability,	
  as	
  out	
  of	
  pocket	
  
expenses	
  for	
  repeated	
  attempts	
  to	
  obtain	
  medication	
  can	
  be	
  devastating	
  for	
  the	
  entire	
  household.	
  	
  
Furthermore,	
  a	
  lack	
  of	
  medication	
  and	
  supplies	
  is	
  demoralizing	
  for	
  health	
  workers	
  who	
  are	
  unable	
  to	
  
provide	
  necessary	
  services.	
  	
  Stock	
  outs	
  cause	
  relationships	
  between	
  patients	
  and	
  providers	
  to	
  become	
  
strained,	
  particularly	
  because	
  patients	
  consider	
  access	
  to	
  medication	
  as	
  an	
  indicator	
  of	
  the	
  overall	
  state	
  
of	
  the	
  public	
  health	
  system	
  (Steyn	
  et	
  al.	
  2009,	
  Goudge	
  et	
  al.	
  2009,	
  Levitt	
  et	
  al.	
  2011,	
  MSF	
  et	
  al.	
  2013).	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   10	
  
	
  
Acceptability	
  
Studies	
  indicate	
  that	
  anticipated	
  disrespect	
  and	
  ineffective	
  care	
  from	
  providers	
  counteracts	
  health-­‐
seeking	
  behavior	
  amongst	
  patients	
  accessing	
  public	
  services	
  in	
  South	
  Africa.	
  	
  Long	
  wait	
  times,	
  unsanitary	
  
facilities,	
  and	
  a	
  lack	
  of	
  privacy	
  and	
  confidentiality	
  were	
  also	
  reported	
  amongst	
  patients	
  expressing	
  
dissatisfaction	
  with	
  public	
  health	
  services.	
  	
  Productive	
  patient-­‐provider	
  relations	
  are	
  lacking	
  in	
  South	
  
Africa	
  largely	
  due	
  to	
  overburdened	
  health	
  care	
  professionals	
  resulting	
  from	
  human	
  resource	
  constraints.	
  	
  
However,	
  it	
  should	
  be	
  noted	
  that	
  differences	
  between	
  sociocultural	
  norms	
  amongst	
  providers	
  and	
  
patients	
  also	
  have	
  a	
  large	
  role	
  to	
  play	
  in	
  the	
  acceptability	
  of	
  services	
  and	
  the	
  belief	
  in	
  the	
  efficacy	
  of	
  
treatment	
  regimes	
  amongst	
  patients.	
  	
  A	
  lack	
  of	
  communication	
  and	
  understanding	
  can	
  also	
  negatively	
  
shape	
  the	
  patient-­‐provider	
  interaction.	
  	
  Without	
  clear	
  information	
  patients	
  feel	
  that	
  they	
  are	
  unable	
  to	
  
advocate	
  for	
  themselves	
  and	
  often	
  feel	
  disempowered.	
  	
  Such	
  feelings,	
  when	
  combined	
  with	
  medicine	
  
and	
  supply	
  shortages	
  can	
  potentially	
  ruin	
  the	
  trust	
  and	
  relationship	
  between	
  provider	
  and	
  patients	
  
(Schneider	
  et	
  al.	
  2006,	
  Goudge	
  et	
  al.	
  2009,	
  Harris	
  et	
  al.	
  2011,	
  MSF	
  et	
  al.	
  2013).	
  
Pharmaceutical	
  Supply	
  Chain	
  Management	
  in	
  South	
  Africa	
  
The	
  public	
  sector	
  drug	
  regulatory	
  system	
  in	
  South	
  Africa	
  is	
  founded	
  upon	
  the	
  National	
  Drug	
  Policy	
  of	
  
1996	
  (NDP).	
  	
  The	
  NDP	
  outlines	
  objectives	
  to	
  improve	
  the	
  availability	
  and	
  accessibility	
  of	
  essential	
  
medicines,	
  quality	
  assurance	
  measures,	
  and	
  rational	
  use	
  of	
  medicines.	
  	
  Initially,	
  the	
  primary	
  goals	
  of	
  the	
  
NDP	
  were	
  to	
  establish	
  an	
  Essential	
  Drugs	
  Programme	
  (EDP)	
  and	
  to	
  develop	
  an	
  Essential	
  Drugs	
  List	
  (EDL)	
  
and	
  Standard	
  Treatment	
  Guidelines	
  (STGs).	
  	
  Compiled	
  and	
  reviewed	
  regularly	
  by	
  experts	
  on	
  the	
  EDL	
  
committee,	
  these	
  documents	
  serve	
  as	
  the	
  foundation	
  of	
  essential	
  medicines	
  access	
  at	
  primary	
  care	
  and	
  
hospital	
  level	
  facilities.	
  
	
  
The	
  process	
  of	
  procurement	
  and	
  distribution	
  of	
  medicines	
  begins	
  at	
  the	
  hospital	
  level,	
  where	
  the	
  
Pharmacy	
  and	
  Therapeutics	
  Committee	
  (PTC)	
  at	
  each	
  hospital	
  submits	
  orders	
  and	
  expected	
  drug	
  needs	
  
to	
  the	
  NDoH.	
  	
  Hospital	
  demands	
  form	
  the	
  basis	
  of	
  the	
  medicine	
  quantities	
  requested	
  in	
  the	
  tender	
  
process.	
  	
  The	
  NDoH	
  then	
  manages	
  a	
  competitive	
  tender	
  process	
  with	
  pharmaceutical	
  suppliers.	
  	
  Once	
  
tenders	
  are	
  awarded,	
  suppliers	
  distribute	
  medicines	
  to	
  each	
  of	
  the	
  nine	
  provincial	
  government	
  
warehouse	
  depots.	
  	
  The	
  various	
  provincial	
  DoH	
  offices	
  manage	
  tenders	
  with	
  private	
  logistics	
  companies	
  
to	
  run	
  the	
  pharmaceutical	
  depots.	
  	
  In	
  most	
  provinces,	
  medicines	
  will	
  also	
  be	
  distributed	
  to	
  smaller	
  
district-­‐level	
  depots	
  and	
  hospitals,	
  from	
  which	
  small	
  rural	
  PHC	
  clinics	
  will	
  then	
  request	
  stock.	
  	
  These	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   11	
  
	
  
steps	
  can	
  be	
  visualized	
  within	
  the	
  pharmaceutical	
  management	
  framework	
  proposed	
  by	
  Management	
  
Sciences	
  for	
  Health	
  (MSH)	
  (Figure	
  1)	
  (Essack	
  et	
  al.	
  2011).	
  
	
  
Figure	
  1:	
  Pharmaceutical	
  Management	
  Framework	
  (Source:	
  MSH)	
  
Various	
  problems	
  at	
  every	
  level	
  of	
  the	
  supply	
  chain	
  compound	
  medicine	
  access	
  issues	
  for	
  patients	
  at	
  the	
  
rural	
  PHC	
  level.	
  	
  While	
  selection	
  is	
  based	
  on	
  the	
  South	
  African	
  EDL	
  and	
  STGs,	
  government	
  tenders	
  are	
  
often	
  issued	
  for	
  several	
  hundred	
  other	
  medicines	
  that	
  are	
  not	
  associated	
  with	
  the	
  EDL	
  (Gray	
  &	
  Suleman	
  
2000).	
  	
  It	
  is	
  not	
  clear	
  whether	
  this	
  inefficiency	
  is	
  due	
  to	
  oversight	
  or	
  a	
  need	
  to	
  evaluate	
  the	
  tender	
  
process.	
  	
  In	
  a	
  review	
  of	
  tenders	
  for	
  antibiotics	
  from	
  2007	
  to	
  2011	
  it	
  was	
  discovered	
  that	
  hospital	
  PTC	
  
requests	
  for	
  antibiotics	
  have	
  seen	
  little	
  change,	
  despite	
  expected	
  increases	
  (Essack	
  et	
  al.	
  2011).	
  	
  
Recently,	
  there	
  have	
  been	
  instances	
  in	
  which	
  pharmaceutical	
  suppliers	
  have	
  been	
  unable	
  to	
  deliver	
  on	
  
tenders	
  that	
  have	
  been	
  offered	
  to	
  them.	
  	
  In	
  early	
  2013,	
  several	
  thousand	
  clinics	
  reported	
  shortages	
  of	
  
the	
  newly	
  introduced	
  fixed	
  dose	
  combination	
  (FDC)	
  ARVs	
  because	
  the	
  sole	
  supplier	
  could	
  not	
  produce	
  
enough	
  of	
  the	
  FDC	
  pills	
  according	
  to	
  the	
  scheduled	
  contract.	
  	
  In	
  2012,	
  the	
  Limpopo	
  provincial	
  
pharmaceutical	
  depot	
  was	
  placed	
  under	
  administration	
  and	
  the	
  private	
  logistics	
  company	
  contract	
  was	
  
cancelled	
  when	
  it	
  was	
  discovered	
  that	
  millions	
  of	
  Rand	
  in	
  expired	
  medication	
  were	
  destroyed	
  because	
  
they	
  were	
  not	
  distributed	
  to	
  facilities.	
  	
  Also	
  in	
  2012,	
  staff	
  at	
  a	
  district	
  pharmaceutical	
  depot	
  in	
  the	
  
Eastern	
  Cape	
  staged	
  a	
  month	
  long	
  strike	
  followed	
  by	
  DoH	
  suspensions	
  for	
  75%	
  of	
  the	
  staff.	
  	
  A	
  mere	
  10	
  
working	
  staff	
  members	
  remained	
  to	
  provide	
  services	
  to	
  300	
  medical	
  facilities	
  that	
  provide	
  ARVs	
  to	
  over	
  
100,000	
  patients.	
  	
  Three	
  months	
  following	
  the	
  strike	
  over	
  53%	
  of	
  facilities	
  served	
  by	
  the	
  depot	
  reported	
  
experiencing	
  TB	
  and	
  ARV	
  stock	
  outs	
  (MSF	
  et	
  al.	
  2013).	
  	
  At	
  the	
  distribution	
  level,	
  communication	
  issues	
  
between	
  the	
  provincial	
  and	
  district	
  depots	
  and	
  facilities	
  have	
  resulted	
  in	
  drugs	
  not	
  ordered	
  on	
  time	
  or	
  
not	
  ordered	
  at	
  all.	
  	
  These	
  delays	
  are	
  particularly	
  difficult	
  for	
  remote	
  PHC	
  facilities,	
  where	
  supply	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   12	
  
	
  
deliveries	
  occur	
  on	
  a	
  monthly	
  basis.	
  	
  Despite	
  the	
  use	
  of	
  human	
  resources	
  task	
  shifting	
  and	
  sharing	
  in	
  the	
  
public	
  healthcare	
  sector,	
  these	
  stock	
  issues	
  are	
  made	
  more	
  difficult	
  by	
  a	
  lack	
  of	
  skilled	
  health	
  
professionals	
  such	
  as	
  pharmacists.	
  
	
  
It	
  is	
  clear	
  that	
  national	
  and	
  provincial	
  pharmaceutical	
  supply	
  chain	
  management	
  is	
  fragmented.	
  	
  There	
  
are	
  no	
  clear,	
  cohesive,	
  or	
  systematic	
  national	
  standards	
  or	
  procedures	
  for	
  stock	
  monitoring	
  and	
  
reporting.	
  	
  Many	
  medicine	
  shortages	
  and	
  stock-­‐outs	
  are	
  underreported,	
  which	
  only	
  exacerbates	
  access	
  
issues,	
  puts	
  patients	
  at	
  risk	
  for	
  poor	
  health	
  outcomes,	
  and	
  inadvertently	
  leads	
  to	
  increased	
  drug	
  
resistance	
  and	
  communicable	
  infections.	
  
Mobile	
  Technologies	
  and	
  Health	
  
Globally,	
  pervasive	
  interest	
  in	
  information	
  and	
  communications	
  technologies	
  (ICT)	
  in	
  health	
  and	
  
development	
  has	
  grown	
  considerably.	
  	
  Enthusiasm	
  for	
  mHealth	
  is	
  based	
  upon	
  the	
  ability	
  to	
  rapidly	
  
collect,	
  store,	
  and	
  collate	
  information	
  in	
  a	
  short	
  amount	
  of	
  time	
  from	
  remote	
  locations.	
  	
  The	
  widespread	
  
use	
  of	
  basic	
  mobile	
  phones,	
  and	
  the	
  limited	
  level	
  of	
  skill	
  or	
  literacy	
  required	
  to	
  use	
  them,	
  suggest	
  that	
  
they	
  are	
  convenient	
  mediums	
  for	
  data	
  collection	
  or	
  limited	
  information	
  transfer	
  amongst	
  diverse	
  
populations	
  in	
  low	
  resource	
  settings	
  (Kaplan	
  2006,	
  Leon	
  et	
  al.	
  2012).	
  	
  Furthermore,	
  the	
  role	
  of	
  mHealth	
  
as	
  a	
  means	
  to	
  engender	
  a	
  transition	
  from	
  the	
  role	
  of	
  patients	
  as	
  passive	
  recipients	
  of	
  health	
  care	
  
services	
  to	
  active	
  participants	
  suggests	
  an	
  opportunity	
  for	
  empowerment	
  (Demiris	
  et	
  al.	
  2008).	
  
	
  
Despite	
  broad	
  based	
  policy	
  and	
  debate	
  regarding	
  ICT	
  for	
  health	
  and	
  development,	
  many	
  innovative	
  uses	
  
of	
  mHealth	
  have	
  been	
  confined	
  to	
  small	
  pilot	
  programs	
  and	
  studies	
  conducted	
  within	
  the	
  non-­‐profit	
  
sector.	
  	
  Due	
  to	
  the	
  small	
  scale	
  of	
  these	
  studies	
  and	
  their	
  diverse	
  approaches	
  to	
  the	
  use	
  of	
  mHealth,	
  it	
  is	
  
difficult	
  to	
  generalize	
  about	
  the	
  efficacy,	
  value,	
  and	
  impact	
  of	
  scaled	
  mHealth.	
  	
  With	
  the	
  exception	
  of	
  
small	
  mHealth	
  treatment	
  adherence	
  programs	
  for	
  HIV	
  and	
  TB,	
  there	
  is	
  scant	
  literature	
  on	
  the	
  use	
  of	
  
mHealth	
  to	
  improve	
  health	
  outcomes	
  for	
  chronic	
  communicable	
  and	
  non-­‐communicable	
  diseases	
  in	
  low	
  
and	
  middle-­‐income	
  countries	
  (LMIC).	
  	
  Notwithstanding	
  the	
  success	
  of	
  several	
  pilot	
  projects,	
  few	
  studies	
  
have	
  researched	
  the	
  use	
  of	
  mobile	
  technology	
  to	
  improve	
  pharmaceutical	
  stock	
  levels	
  on	
  a	
  large	
  scale.	
  	
  
While	
  there	
  are	
  small	
  advocacy	
  projects	
  run	
  by	
  local	
  and	
  international	
  civil	
  society	
  organizations	
  that	
  
encourage	
  patient	
  reporting	
  of	
  stock	
  outs,	
  there	
  are	
  no	
  systems	
  of	
  accountability	
  that	
  allow	
  for	
  
bidirectional	
  communication	
  between	
  patients	
  and	
  providers	
  to	
  manage	
  pharmaceutical	
  stock	
  (Kaplan	
  
2006,	
  Barringson	
  et	
  al.	
  2010,	
  Leon	
  et	
  al.	
  2012).	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   13	
  
	
  
	
  
There	
  is	
  great	
  potential	
  for	
  the	
  implementation	
  of	
  mHealth	
  technology	
  in	
  South	
  Africa	
  for	
  the	
  following	
  
reasons:	
  (1)	
  At	
  76%	
  saturation,	
  mobile	
  phone	
  use	
  in	
  South	
  Africa	
  is	
  prevalent	
  in	
  both	
  rural	
  and	
  urban	
  
settings.	
  (2)	
  In	
  comparison	
  to	
  other	
  LMICs,	
  the	
  ICT	
  industry	
  is	
  relatively	
  well	
  developed	
  and	
  there	
  are	
  
diverse	
  mobile	
  network	
  providers.	
  (3)	
  Lastly,	
  there	
  is	
  an	
  enabling	
  policy	
  environment	
  for	
  implementing	
  
mHealth	
  (Leon	
  et	
  al.	
  2012).	
  	
  In	
  2012	
  the	
  National	
  Department	
  of	
  Health	
  released	
  the	
  eHealth	
  Strategy	
  
for	
  South	
  Africa.	
  	
  This	
  document	
  provides	
  a	
  review	
  of	
  policies	
  and	
  a	
  strategic	
  approach	
  for	
  the	
  use	
  of	
  
electronic	
  health	
  informatics	
  in	
  South	
  Africa’s	
  public	
  healthcare	
  system.	
  	
  Within	
  this	
  report,	
  a	
  situational	
  
analysis	
  of	
  South	
  Africa’s	
  capacity	
  for	
  eHealth	
  is	
  provided.	
  	
  The	
  report	
  also	
  defines	
  the	
  ways	
  in	
  which	
  
eHealth	
  interventions	
  can	
  contribute	
  to	
  the	
  strategic	
  objectives	
  of	
  the	
  NDoH.	
  	
  Suggested	
  interventions	
  
include	
  a	
  drug	
  supply	
  and	
  logistics	
  support	
  system,	
  an	
  electronic	
  medical	
  records	
  (EMR)	
  and	
  pharmacy	
  
system	
  interface,	
  an	
  SMS	
  patient	
  reminder	
  system	
  for	
  appointments	
  and	
  medicines,	
  and	
  a	
  
communication	
  mechanism	
  for	
  community	
  health	
  workers	
  (CHWs).	
  
	
  
In	
  a	
  review	
  of	
  mHealth	
  in	
  South	
  Africa,	
  Leon	
  et	
  al.	
  is	
  critical	
  of	
  inherent	
  health	
  system	
  challenges	
  that	
  
create	
  barriers	
  to	
  successful	
  implementation	
  of	
  mHealth	
  interventions.	
  	
  These	
  challenges	
  include	
  the	
  
need	
  for	
  leadership	
  and	
  stewardship,	
  the	
  current	
  culture	
  of	
  healthcare	
  service	
  delivery,	
  requisite	
  
systems	
  of	
  sustainable	
  funding,	
  and	
  the	
  ability	
  to	
  integrate	
  mHealth	
  interventions	
  with	
  existing	
  health	
  
information	
  systems	
  (HIS)	
  (Figure	
  2).	
  	
  	
  
	
  
Figure	
  2:	
  Health	
  systems	
  framework	
  for	
  making	
  decisions	
  about	
  mHealth	
  (Source:	
  Leon	
  et	
  al.)	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   14	
  
	
  
In	
  the	
  context	
  of	
  mHealth	
  for	
  community-­‐based	
  health	
  services,	
  Leon	
  et	
  al.	
  has	
  the	
  following	
  points	
  to	
  
make	
  about	
  each	
  health	
  system	
  dimension:	
  
• Stewardship	
  –	
  The	
  majority	
  of	
  mHealth	
  interventions	
  conducted	
  in	
  South	
  Africa	
  have	
  been	
  
initiated	
  by	
  non-­‐governmental	
  organizations	
  (NGOs).	
  	
  Accordingly,	
  they	
  were	
  conducted	
  on	
  a	
  
small	
  scale	
  and	
  did	
  not	
  involve	
  the	
  larger	
  public	
  health	
  system,	
  nor	
  did	
  they	
  require	
  policy	
  
support	
  from	
  the	
  government.	
  	
  Although	
  the	
  NDoH	
  has	
  released	
  an	
  eHealth	
  strategy,	
  there	
  
remains	
  a	
  lack	
  of	
  high-­‐level	
  political	
  and	
  financial	
  support	
  from	
  the	
  government	
  for	
  
implementation	
  of	
  mHealth.	
  	
  Stewardship	
  also	
  requires	
  a	
  commitment	
  to	
  establishing	
  public-­‐
private	
  partnerships,	
  securing	
  funding,	
  and	
  the	
  identification	
  of	
  best	
  practices	
  for	
  mHealth	
  
interventions.	
  
• Organizational	
  –	
  Although	
  the	
  goal	
  of	
  mHealth	
  is	
  to	
  improve	
  the	
  efficiency	
  of	
  health	
  systems,	
  
the	
  introduction	
  of	
  mHealth	
  interventions	
  present	
  new	
  management	
  challenges.	
  	
  Poor	
  health	
  
outcomes	
  in	
  South	
  Africa	
  are	
  largely	
  attributed	
  to	
  organizational	
  weaknesses,	
  such	
  as	
  a	
  lack	
  of	
  
management	
  and	
  accountability	
  resulting	
  in	
  inadequate	
  service	
  delivery.	
  	
  Furthermore,	
  
healthcare	
  professionals	
  at	
  the	
  district	
  and	
  provincial	
  levels	
  have	
  demonstrated	
  difficulties	
  
utilizing	
  existing	
  health	
  information	
  for	
  management	
  (HIM).	
  
• Technological	
  –	
  Implementing	
  new	
  large-­‐scale	
  mHealth	
  programs	
  require	
  user-­‐friendly	
  
platforms	
  for	
  diverse	
  stakeholder	
  populations.	
  	
  Stakeholders	
  at	
  all	
  levels	
  must	
  also	
  believe	
  in	
  the	
  
usefulness	
  of	
  the	
  technology	
  and	
  the	
  data	
  it	
  produces.	
  	
  It	
  is	
  important	
  that	
  a	
  new	
  intervention	
  
have	
  the	
  ability	
  to	
  seamlessly	
  integrate	
  into	
  existing	
  HIS.	
  	
  This	
  is	
  a	
  difficult	
  obstacle	
  to	
  overcome	
  
in	
  South	
  Africa,	
  where	
  patient	
  management	
  systems	
  are	
  different	
  for	
  each	
  provincial	
  DoH	
  
(Figure	
  3).	
  
	
  
Figure	
  3:	
  Patient	
  Management	
  Systems	
  by	
  Province	
  (Source:	
  NDoH)	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   15	
  
	
  
	
  
• Financial	
  –	
  As	
  noted	
  previously,	
  most	
  mHealth	
  interventions	
  in	
  South	
  Africa	
  have	
  been	
  small-­‐
scale	
  pilot	
  projects	
  initiated	
  by	
  NGOs	
  with	
  independent	
  funders.	
  	
  Establishing	
  long-­‐term	
  funding	
  
for	
  large	
  scale	
  mHealth	
  will	
  be	
  problematic	
  in	
  a	
  system	
  that	
  already	
  exhibits	
  inadequate	
  
stewardship.	
  
Pharmaceutical	
  Supply	
  Chain	
  Management	
  mHealth	
  Innovations	
  in	
  Sub	
  Saharan	
  Africa	
  
SMS	
  for	
  Life	
  
‘SMS	
  for	
  Life’	
  is	
  a	
  pilot	
  study	
  that	
  was	
  conducted	
  in	
  Tanzania	
  for	
  21	
  weeks	
  in	
  2009	
  and	
  2010.	
  	
  The	
  
mHealth	
  intervention	
  focused	
  on	
  improving	
  stock	
  of	
  anti-­‐malarial	
  medication	
  at	
  the	
  health	
  facility	
  level	
  
utilizing	
  SMS	
  messages	
  and	
  electronic	
  mapping.	
  	
  Stock	
  counts	
  were	
  conducted	
  at	
  each	
  facility	
  on	
  a	
  
weekly	
  basis	
  and	
  then	
  reported	
  via	
  SMS	
  messages.	
  	
  District	
  management	
  teams	
  were	
  able	
  to	
  view	
  stock	
  
levels	
  through	
  a	
  web-­‐based	
  reporting	
  tool	
  that	
  assimilated	
  data	
  from	
  SMS	
  messages	
  at	
  each	
  facility	
  
(Figure	
  4).	
  	
  	
  
	
  
Figure	
  4:	
  Schematic	
  of	
  SMS	
  system	
  in	
  'SMS	
  for	
  Life'	
  pilot	
  (Source:	
  Barrington	
  et	
  al.)	
  
Weekly	
  stock	
  visibility	
  allowed	
  district	
  medical	
  officers	
  to	
  redistribute	
  anti-­‐malarial	
  medications	
  between	
  
facilities,	
  thereby	
  reducing	
  the	
  risk	
  of	
  stock	
  outs.	
  	
  The	
  ‘SMS	
  for	
  Life’	
  pilot	
  involved	
  129	
  health	
  facilities	
  in	
  
three	
  districts.	
  	
  At	
  the	
  beginning	
  of	
  the	
  program	
  78%	
  of	
  facilities	
  experienced	
  stock	
  outs	
  of	
  one	
  or	
  more	
  
anti-­‐malarial	
  medication,	
  and	
  at	
  the	
  end	
  of	
  week	
  21	
  only	
  26%	
  of	
  facilities	
  reported	
  stock	
  outs.	
  	
  Stock	
  
reporting	
  via	
  SMS	
  remained	
  high	
  at	
  over	
  93%	
  for	
  the	
  duration	
  of	
  the	
  pilot,	
  though	
  this	
  was	
  likely	
  due	
  to	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   16	
  
	
  
mobile	
  credit	
  incentives.	
  	
  ‘SMS	
  for	
  Life’	
  was	
  a	
  public-­‐private	
  partnership	
  between	
  the	
  Ministry	
  of	
  Health	
  
and	
  Social	
  Welfare’s	
  National	
  Malaria	
  Control	
  Programme,	
  the	
  Roll	
  Back	
  Malaria	
  Partnership,	
  Novartis	
  
Pharma	
  AG,	
  Vodafone,	
  and	
  IBM.	
  	
  Barrington	
  et	
  al.	
  credit	
  government	
  commitment,	
  adequate	
  mobile	
  
telephone	
  coverage,	
  the	
  use	
  of	
  personal	
  phones,	
  airtime	
  credit	
  incentives,	
  effective	
  training	
  sessions,	
  
and	
  adequate	
  health	
  facility	
  storerooms	
  as	
  project	
  implementation	
  success	
  factors	
  (2010).	
  	
  The	
  ‘SMS	
  for	
  
Life’	
  model	
  has	
  expanded	
  to	
  include	
  other	
  medicines	
  and	
  is	
  currently	
  being	
  piloted	
  in	
  other	
  SSA	
  
countries.	
  
KEMSA	
  
In	
  2001	
  the	
  Kenyan	
  government	
  decided	
  to	
  create	
  a	
  parastatal	
  agency	
  to	
  procure,	
  store,	
  manage,	
  and	
  
distribute	
  medical	
  supplies	
  to	
  public	
  health	
  facilities	
  using	
  private	
  sector	
  logistics	
  and	
  management	
  
techniques	
  (Aronovich	
  &	
  Kinzett	
  2001).	
  	
  This	
  agency	
  is	
  known	
  as	
  the	
  Kenyan	
  Medical	
  Supplies	
  Agency	
  
(KEMSA),	
  and	
  in	
  2013	
  it	
  became	
  a	
  state	
  corporation	
  under	
  the	
  KEMSA	
  Act	
  of	
  2013.	
  	
  A	
  decentralization	
  of	
  
health	
  services	
  funding	
  and	
  operations	
  to	
  the	
  county	
  level	
  was	
  one	
  of	
  the	
  rationalizations	
  in	
  establishing	
  
KEMSA.	
  	
  Under	
  the	
  new	
  system	
  KEMSA	
  is	
  responsible	
  for	
  procuring	
  supplies	
  with	
  its	
  own	
  funds,	
  ordering	
  
from	
  KEMSA	
  is	
  then	
  completed	
  by	
  counties	
  according	
  to	
  their	
  needs.	
  	
  County	
  governments	
  pay	
  KEMSA	
  
for	
  the	
  supplies	
  and	
  are	
  accountable	
  for	
  the	
  cost	
  of	
  distribution.	
  	
  KEMSA	
  replenishes	
  stock	
  through	
  
profits	
  from	
  sales	
  to	
  counties.	
  	
  KEMSA	
  start	
  up	
  costs	
  were	
  sponsored	
  by	
  the	
  World	
  Bank’s	
  Health	
  Sector	
  
Support	
  Project.	
  	
  Also	
  in	
  2013,	
  KEMSA	
  announced	
  the	
  launch	
  of	
  KEMSA	
  E-­‐Mobile,	
  a	
  partnership	
  between	
  
the	
  Center	
  for	
  Disease	
  Control	
  Foundation,	
  mHealth	
  Kenya,	
  Safaricom,	
  Fintech,	
  Dazzle,	
  and	
  SafeMark.	
  	
  
KEMSA	
  E-­‐Mobile	
  is	
  a	
  series	
  of	
  applications	
  and	
  platforms	
  that	
  allow	
  public	
  health	
  facilities	
  and	
  Kenyan	
  
Citizens	
  to	
  interact	
  with	
  KEMSA’s	
  logistic	
  management	
  information	
  system.	
  	
  At	
  the	
  health	
  facility	
  level,	
  
consumption	
  can	
  be	
  reported	
  and	
  supplies	
  can	
  be	
  ordered	
  via	
  mobile	
  phone,	
  this	
  facility	
  level	
  
information	
  is	
  then	
  made	
  available	
  to	
  county	
  health	
  management	
  teams.	
  	
  For	
  Kenyan	
  Citizens,	
  KEMSA’s	
  
E-­‐Mobile	
  program	
  provides	
  a	
  level	
  of	
  transparency	
  and	
  integrity,	
  allowing	
  them	
  to	
  anonymously	
  report	
  
suspicious	
  or	
  inappropriate	
  supply	
  issues	
  at	
  health	
  facilities	
  and	
  to	
  inquire	
  about	
  drug	
  availability	
  at	
  their	
  
closest	
  facility	
  via	
  mobile	
  phone.	
  	
  A	
  comprehensive	
  review	
  of	
  KEMSA’s	
  E-­‐Mobile	
  initiative	
  has	
  not	
  been	
  
released	
  due	
  to	
  the	
  recent	
  introduction	
  of	
  the	
  program.	
  
iDART	
  by	
  Cell	
  Life	
  
Intelligent	
  dispensing	
  for	
  antiretroviral	
  treatment	
  (iDART)	
  is	
  a	
  software	
  program	
  developed	
  by	
  Cell	
  Life	
  in	
  
collaboration	
  with	
  the	
  Desmond	
  Tutu	
  HIV	
  Foundation,	
  Cape	
  Peninsula	
  University	
  of	
  Technology,	
  and	
  the	
  
University	
  of	
  Cape	
  Town	
  to	
  improve	
  the	
  dispensing	
  of	
  ARVs	
  and	
  treatment	
  adherence	
  within	
  the	
  public	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   17	
  
	
  
health	
  care	
  sector	
  in	
  South	
  Africa.	
  	
  The	
  system	
  is	
  intended	
  to	
  allow	
  pharmacists	
  to	
  readily	
  and	
  accurately	
  
dispense	
  ARVs,	
  manage	
  EDL	
  stock	
  levels,	
  and	
  generate	
  reports	
  for	
  a	
  growing	
  number	
  of	
  HIV	
  patients.	
  	
  
iDART	
  requires	
  either	
  direct	
  dispensing	
  of	
  ARVs	
  or	
  pre-­‐packaged	
  remote	
  dispensing	
  with	
  unique	
  
barcodes	
  that,	
  when	
  scanned,	
  collect	
  patient	
  information.	
  	
  The	
  iDART	
  system	
  is	
  compatible	
  with	
  DoH	
  
monitoring	
  and	
  evaluation	
  mechanisms,	
  thereby	
  allowing	
  for	
  improved	
  reporting	
  for	
  the	
  government	
  
and	
  international	
  donors.	
  	
  In	
  2010	
  the	
  Canadian	
  International	
  Development	
  Agency,	
  in	
  collaboration	
  
with	
  Maternal	
  Adolescent	
  and	
  Child	
  Health	
  (MatCH)	
  at	
  the	
  University	
  of	
  the	
  Witwatersrand,	
  designed	
  a	
  
randomized	
  controlled	
  trial	
  to	
  evaluate	
  the	
  introduction	
  of	
  an	
  SMS	
  component	
  to	
  iDART	
  to	
  reduce	
  
treatment	
  interruption	
  and	
  increase	
  adherence	
  amongst	
  new	
  ART	
  patients.	
  	
  Four	
  sites	
  were	
  chosen	
  for	
  
the	
  RCT,	
  which	
  was	
  completed	
  in	
  late	
  2013.	
  	
  To	
  date	
  results	
  of	
  this	
  study	
  have	
  not	
  been	
  published.	
  
Limitations	
  
This	
  analysis	
  was	
  limited	
  by	
  relatively	
  scant	
  literature	
  on	
  the	
  role	
  of	
  mHealth	
  to	
  improve	
  supply	
  chain	
  
management	
  of	
  essential	
  medicines	
  in	
  low	
  resource	
  settings.	
  	
  Furthermore,	
  the	
  existing	
  literature	
  
generally	
  features	
  small	
  scale	
  mHealth	
  interventions	
  initiated	
  by	
  NGOs	
  with	
  fixed	
  funding	
  and	
  project	
  
time	
  scales.	
  	
  There	
  were	
  difficulties	
  finding	
  comprehensive	
  information	
  on	
  the	
  process	
  of	
  
pharmaceutical	
  supply	
  chain	
  management	
  in	
  South	
  Africa	
  because	
  national	
  LIMS	
  are	
  fragmented	
  by	
  the	
  
decentralization	
  of	
  public	
  healthcare	
  services	
  to	
  the	
  provincial	
  level	
  and	
  the	
  privatization	
  of	
  
pharmaceutical	
  distribution.	
  	
  Lastly,	
  very	
  few	
  studies	
  have	
  investigated	
  patient	
  perspectives	
  on	
  access	
  to	
  
medicines	
  and	
  healthcare	
  in	
  South	
  Africa,	
  or	
  the	
  potential	
  to	
  integrate	
  bi-­‐directional	
  mHealth	
  
communication	
  systems	
  with	
  patients	
  to	
  improve	
  supply	
  chain	
  management	
  and	
  access.	
  
Conclusions	
  and	
  Recommendations	
  
Despite	
  spending	
  more	
  money	
  on	
  healthcare	
  than	
  other	
  LMICs,	
  South	
  Africa	
  has	
  unacceptably	
  poor	
  
health	
  outcomes.	
  	
  Additionally,	
  South	
  Africa	
  is	
  also	
  home	
  to	
  the	
  largest	
  populations	
  of	
  individuals	
  
affected	
  by	
  HIV	
  and	
  TB	
  -­‐	
  considerable	
  constituents	
  of	
  the	
  quadruple	
  disease	
  burden,	
  of	
  which	
  the	
  other	
  
three	
  are	
  NCD,	
  poor	
  maternal	
  and	
  child	
  health,	
  and	
  violence.	
  	
  Human,	
  financial,	
  and	
  physical	
  resources	
  
remain	
  inequitably	
  distributed	
  within	
  the	
  South	
  African	
  health	
  system	
  in	
  spite	
  of	
  the	
  gains	
  that	
  have	
  
been	
  made	
  in	
  the	
  public	
  healthcare	
  sector	
  following	
  democratic	
  transition	
  in	
  1994.	
  	
  Rural	
  and	
  
impoverished	
  populations	
  within	
  South	
  Africa	
  consequently	
  bear	
  the	
  brunt	
  of	
  these	
  inequities.	
  
	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   18	
  
	
  
With	
  over	
  2.1	
  million	
  individuals	
  initiating	
  treatment,	
  South	
  Africa	
  operates	
  the	
  largest	
  ARV	
  program	
  in	
  
the	
  world.	
  	
  However,	
  tracking	
  treatment	
  compliance	
  and	
  loss	
  to	
  follow	
  up	
  remains	
  an	
  obstacle.	
  	
  South	
  
Africa	
  is	
  also	
  the	
  epitome	
  of	
  a	
  country	
  in	
  transition	
  and	
  chronic	
  NCD	
  is	
  on	
  the	
  rise.	
  	
  The	
  disease	
  burden	
  
in	
  South	
  Africa	
  necessitates	
  a	
  regular	
  and	
  reliable	
  supply	
  of	
  essential	
  drugs	
  for	
  chronic	
  illnesses.	
  	
  	
  
	
  
Impoverished	
  patients	
  are	
  constrained	
  to	
  utilizing	
  PHC	
  clinics	
  with	
  few	
  resources.	
  	
  In	
  reviews	
  of	
  the	
  
South	
  African	
  PHC	
  system	
  patients	
  report	
  poor	
  service	
  delivery	
  and	
  regular	
  shortages	
  of	
  medications.	
  	
  
Patients	
  are	
  often	
  told	
  to	
  return	
  to	
  facilities	
  at	
  a	
  later	
  date	
  to	
  collect	
  out	
  of	
  stock	
  medications.	
  	
  Patients	
  
within	
  the	
  public	
  healthcare	
  sector	
  generally	
  choose	
  facilities	
  based	
  on	
  distance	
  in	
  order	
  to	
  reduce	
  the	
  
economic	
  impact	
  of	
  transport	
  costs,	
  however,	
  repeated	
  attempts	
  to	
  obtain	
  medication	
  can	
  result	
  in	
  
catastrophic	
  costs	
  for	
  the	
  entire	
  household.	
  	
  Inadequate	
  access	
  to	
  medicines	
  may	
  lead	
  to	
  treatment	
  non	
  
adherence,	
  potential	
  development	
  of	
  resistant	
  strains	
  of	
  TB,	
  HIV	
  reinfection,	
  and	
  poor	
  health	
  outcomes	
  
overall	
  –	
  though	
  there	
  are	
  no	
  known	
  studies	
  to	
  confirm	
  this	
  relationship.	
  	
  The	
  economic	
  impact	
  of	
  these	
  
consequences	
  are	
  also	
  unknown.	
  
	
  
Pharmaceutical	
  supply	
  chain	
  management	
  within	
  South	
  Africa	
  is	
  controlled	
  at	
  the	
  provincial	
  level,	
  with	
  
NDoH	
  heading	
  the	
  tender	
  process	
  for	
  obtaining	
  supplies	
  and	
  medicines.	
  	
  The	
  quasi-­‐provincial	
  
implementation	
  of	
  drug	
  delivery	
  and	
  public	
  health	
  services	
  creates	
  a	
  difficult	
  environment	
  with	
  which	
  to	
  
streamline	
  HIM	
  and	
  data	
  collection	
  for	
  improved	
  decision-­‐making.	
  	
  Multiple	
  advocacy	
  organizations	
  
have	
  documented	
  essential	
  drug	
  stock	
  outs	
  resulting	
  from	
  the	
  inefficiencies	
  of	
  supply	
  chain	
  
management	
  in	
  the	
  public	
  sector.	
  
	
  
MHealth	
  has	
  the	
  potential	
  to	
  empower	
  South	
  African	
  patients	
  by	
  connecting	
  them	
  with	
  necessary	
  
information,	
  such	
  as	
  facility-­‐based	
  drug	
  availability.	
  	
  Additionally,	
  bidirectional	
  communication	
  
transforms	
  the	
  traditional	
  patient	
  role	
  from	
  passive	
  recipient	
  to	
  active	
  participant	
  in	
  the	
  health	
  care	
  
system.	
  	
  Initiating	
  large-­‐scale	
  participatory	
  mHealth	
  in	
  South	
  Africa	
  to	
  improve	
  the	
  pharmaceutical	
  
supply	
  chain	
  will	
  require	
  leadership	
  and	
  stewardship	
  at	
  all	
  levels.	
  	
  Previous	
  mHealth	
  pilot	
  projects	
  have	
  
demonstrated	
  the	
  importance	
  of	
  public-­‐private	
  partnerships.	
  	
  A	
  scaled	
  mHealth	
  innovation	
  will	
  require	
  
sustainable	
  funding,	
  the	
  identification	
  of	
  stakeholders,	
  and	
  the	
  involvement	
  of	
  multilateral	
  agencies,	
  
civil	
  society	
  organizations,	
  academia,	
  the	
  private	
  ICT	
  industry,	
  and	
  the	
  South	
  African	
  government.	
  	
  It	
  
would	
  be	
  advantageous	
  for	
  the	
  South	
  African	
  Government	
  to	
  build	
  on	
  the	
  successes	
  of	
  existing	
  
pharmaceutical	
  supply	
  chain	
  management	
  mHealth	
  programs	
  in	
  SSA.	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   19	
  
	
  
	
  
Widespread	
  mobile	
  phone	
  use,	
  an	
  advanced	
  ICT	
  network,	
  and	
  an	
  enabling	
  policy	
  environment	
  suggest	
  
that	
  the	
  potential	
  to	
  implement	
  mHealth	
  in	
  South	
  Africa	
  to	
  improve	
  supply	
  chain	
  management	
  is	
  great.	
  	
  
However,	
  it	
  should	
  be	
  noted	
  that	
  introducing	
  mHealth	
  will	
  likely	
  create	
  additional	
  management	
  
responsibilities.	
  	
  In	
  South	
  Africa	
  there	
  are	
  skilled	
  human	
  resource	
  shortages	
  in	
  the	
  healthcare	
  sector	
  and	
  
an	
  unfavorable	
  culture	
  of	
  service	
  delivery.	
  	
  Until	
  such	
  resource	
  constraints	
  can	
  be	
  ameliorated,	
  it	
  is	
  
unlikely	
  that	
  introducing	
  innovative	
  approaches	
  will	
  produce	
  beneficial	
  results.	
   	
  
INNOVATIONS	
  IN	
  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
   20	
  
	
  
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INNOVATIONS	
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  ACCESS	
  TO	
  ESSENTIAL	
  MEDICINES:	
  FOCUS	
  ON	
  SOUTH	
  AFRICA	
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Kaplan	
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in-­‐south-­‐africa/	
  
	
  
Laing	
  B,	
  Waning	
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  Gray	
  A,	
  Ford	
  N,	
  ‘T	
  Hoen,	
  Ellen.	
  25	
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  the	
  WHO	
  essential	
  medicines	
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progress	
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  challenges.	
  Lancet.	
  2003;	
  361:1723-­‐29.	
  
	
  
Leon	
  N,	
  Schneider	
  H,	
  Daviaud	
  E.	
  Applying	
  a	
  framework	
  for	
  assessing	
  the	
  health	
  system	
  challenges	
  to	
  
scaling	
  up	
  mHealth	
  in	
  South	
  Africa.	
  BMC	
  Medical	
  Informatics	
  and	
  Decision	
  Making.	
  2012.	
  12:123.	
  
	
  
Levitt	
  NS,	
  Steyn	
  K,	
  Dave	
  J,	
  Bradshaw,	
  D.	
  Chronic	
  non	
  communicable	
  diseases	
  and	
  HIV/AIDS	
  on	
  a	
  collision	
  
course:	
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INNOVATIONS	
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  Health	
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drugs	
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Steyn	
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Scaling	
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USAID	
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Considerations	
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Edmondo Aimee PHA Final Spring 2014

  • 1. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   1           T u l a n e   U n i v e r s i t y   S c h o o l   o f   P u b l i c   H e a l t h   a n d   T r o p i c a l   M e d i c i n e   Innovations  in  Access  to  Essential   Medicines:  Focus  on  South  Africa   Aimee  Edmondo   MPH  Candidate   Spring   2014   Public  Health  Analysis  Culminating  Experience     Department:  Global  Health  Systems  and  Development   Focus:  Program  Design  and  Implementation   Advisor:  Nathan  Morrow  
  • 2. List  of  Acronyms   ANC  –  African  National  Congress   ARV  –  Anti  Retro  Virals   CHW  –  Community  Health  Worker   DoH  –  Department  of  Health   EDL  –  Essential  Drugs  List   EDP  –  Essential  Drugs  Programme   eHealth  –  Electronic  Health  Informatics   EML  –  Essential  Medicines  List   EMR  –  Electronic  Medical  Records   FDC  –  Fixed  Dose  Combination   HIS  –  Health  Information  System   HIM  –  Health  Information  for  Management   HIV  –  Human  Immunodeficiency  Virus   HST  –  Health  Systems  Trust   ICT  –  Information  and  Communications  Technology   iDART  –  Intelligent  Dispensing  of  Anti-­‐Retroviral  Treatment   KEMSA  –  Kenya  Medical  Supplies  Agency   LMIC  –  Low  and  Middle-­‐Income  Countries   LMIS  –  Logistics  Management  Information  System   MatCH  –  Maternal  Adolescent  and  Child  Health   mHealth  –  Mobile  health  technology   MSF  –  Medecins  Sans  Frontieres  /  Doctors  Without  Borders   MSH  –  Management  Sciences  for  Health   NCD  –  Non-­‐Communicable  Disease   NDP  –  National  Drug  Policy   NDoH  –  National  Department  of  Health   NGO  –  Non-­‐governmental  Organization   PHC  –  Primary  Health  Care   PTC  –  Pharmacy  and  Therapeutics  Committee   RCT  –  Randomized  Controlled  Trial   SMS  –  Short  Message  Service   SSA  –  Sub  Saharan  Africa   STG  –  Standard  Treatment  Guidelines   TB  –  Tuberculosis     WHO  –  World  Health  Organization
  • 3. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   1     Abstract   South  Africa  instituted  no  cost  public  healthcare  services  in  1994,  despite  this,  South  Africa  suffers  from   a  quadruple  health  burden,  which  includes  communicable  disease,  non-­‐communicable  disease,  poor   maternal  and  child  health,  and  injury  and  death  due  to  violence.    Additionally,  South  Africa  is  home  to   the  largest  populations  of  HIV  and  TB  infected  individuals  in  the  world.    Satisfactory  health  outcomes  are   dependent  upon  reliable  access  to  health  care  and  uninterrupted  supplies  of  essential  medicines.     Recently,  advocacy  organizations  have  reported  regular  stock  outs  of  essential  medicines,  and  reviews   of  patient  experiences  in  the  public  healthcare  delivery  system  indicate  that  patients  are  required  to   repeatedly  return  to  health  facilities  to  collect  medications.    Consequently,  impoverished  patients  are   often  demoralized  and  experience  catastrophic  out  of  pocket  expenses.    In  this  analysis  mobile   technology  is  explored  as  a  potential  intervention  to  empower  patients  and  simultaneously  improve   access  to  essential  medicines  in  South  Africa.     A  qualitative  review  of  literature  from  the  last  decade  was  conducted  to  explore  essential  drugs  access   and  the  pharmaceutical  supply  chain  management  system  in  South  Africa.    Additionally,  mobile  health   technology  interventions  in  sub  Saharan  Africa  were  reviewed  for  their  feasibility  and  potential  to   improve  supply  chains.    Policy  documents  and  reports  from  advocacy  organizations  were  also  used  to   inform  this  analysis.     Over  20  documents  were  identified  for  this  public  health  analysis.  Findings  related  to  access  to   medicines  and  care,  pharmaceutical  supply  chain  systems,  and  the  role  of  mobile  health  technology   indicate  that  little  comprehensive  research  has  been  conducted  in  South  Africa  on  these  topics  and  the   relationships  between  them.    Furthermore,  few  peer-­‐reviewed  studies  have  explored  the  impact  of   healthcare  access  barriers  and  essential  medicine  shortages  in  South  Africa  on  treatment  adherence  or   overall  health  outcomes.     Widespread  mobile  phone  use,  advanced  ICT  systems,  and  government-­‐initiated  health  technology   policies  suggest  that  South  Africa  has  an  enabling  environment  to  facilitate  the  implementation  mHealth   to  improve  essential  medicines  access.    It  should  be  noted,  however,  that  limited  stewardship,  poor   leadership,  resource  constraints,  and  an  ineffective  culture  of  service  delivery  will  need  to  be  
  • 4. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   2     ameliorated  in  order  to  implement  beneficial  mHealth  innovations  to  improve  pharmaceutical  supply   chain  management.   Background   WHO  and  the  Model  List  of  Essential  Medicines   In  1975  global  concerns  about  the  availability  of  important  lifesaving  medicines  in  the  public  sector,   particularly  in  developing  countries,  led  to  a  request  by  the  World  Health  Assembly  for  the  World  Health   Organization  (WHO)  to  establish  a  model  list  of  essential  medicines.    The  first  essential  medicines  list   (EML)  was  released  in  1977.    Challenges  to  the  EML  and  changing  patterns  of  health  and  evidenced-­‐ based  practices  have  led  to  several  revisions  of  this  list  (Laing  et  al.  2003).    Today,  the  WHO  EML  is  in  its   18th  edition.    Essential  medicines  are  defined  by  WHO  as:   “Those  drugs  that  satisfy  the  priority  health  care  needs  of  the  of  the  population.    They  are   selected  with  due  regard  to  public  health  relevance,  evidence  on  efficacy  and  safety,  and   comparative  cost-­‐effectiveness.    Essential  medicines  are  intended  to  be  available  within  the   context  of  functioning  health  systems  at  all  times  in  adequate  amounts,  appropriate  dosage   forms,  with  assured  quality  and  adequate  information,  and  at  a  price  the  individual  and   community  can  afford.    The  implementation  of  the  concept  of  essential  medicines  is  intended  to   be  flexible  and  adaptable  to  many  different  situations;  exactly  which  medicines  are  regarded  as   essential  remains  a  national  responsibility  (2002).”     Accordingly,  South  Africa  also  has  its  own  essential  drugs  list  (EDL)  and  associated  treatment  guidelines,   though  the  evolution  of  this  list  has  been  fraught  with  controversy  and  heavily  influenced  by  a  host  of   growing  epidemics  such  as  HIV  and  TB  (Laing  et  al.  2003).   Primary  Health  Care  and  the  Essential  Drugs  List  in  South  Africa   Following  democratic  transition  in  South  Africa  in  1994,  the  African  National  Congress  (ANC)  proposed  a   plan  for  national  health  services  based  on  the  concept  of  primary  health  care  (PHC)  promoted  at  Alma   Ata.    Through  this  plan,  the  National  Department  of  Health  (NDoH)  sought  to  address  the  unequal   distribution  of  health  services,  infrastructure,  monetary,  and  human  resources  resulting  from  Apartheid.     No  cost  PHC  became  available  to  the  public  though  a  district  health  system  following  the  construction   and  upgrading  of  over  1,500  clinics  (Coovadia  et  al.  2009).    In  1996  South  Africa  released  the  National   Drug  Policy  (NDP),  which  outlined  changes  in  drug  management  and  detailed  a  host  of  legislative  and   regulatory  priorities.    One  of  these  priorities  involved  the  establishment  of  a  representative  committee  
  • 5. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   3     to  produce  standard  treatment  guidelines  (STGs)  from  which  the  medicines  to  be  included  in  the  PHC   EDL  would  be  extracted.    The  first  editions  of  these  documents  were  released  in  April  of  1996  (Gray  &   Suleman  2000,  Essack  et  al.  2011).     Though  the  national  PHC  EDL  and  STGs  are  regularly  reviewed  and  updated,  limited  political  will,  patent   policies,  and  inequitable  resources  mean  that  some  essential  drugs  are  less  accessible  than  others.    HIV   has  been  a  prominent  issue  in  the  EDL  process.    Today  there  are  clear  STGs  for  HIV  and  TB  and  policy-­‐ based  strategic  plans  at  the  national  and  provincial  level  in  South  Africa,  but  at  one  time  anti-­‐retrovirals   (ARVs)  were  considered  too  expensive  for  public  use.    For  example,  in  the  1998  PHC  EDL  it  is  noted  that   “these  medicines  are  very  costly  and  cannot  be  provided  on  a  mass  scale  by  the  public  health  services…   they  may  only  be  provided  on  a  limited  and  selected  basis  or  for  academic  and  research  purposes  only”   (Laing  et  al.  2003).    Fortunately,  the  World  Health  Assembly  approved  a  Revised  Drug  Strategy  in  May  of   1999,  which  allows  for  interpretation  of  the  World  Trade  Organization  (WTO)  TRIPS  agreement  based  on   priority  global  health  concerns  (Hoen  et  al.  2011).    This  has  greatly  reduced  the  cost  of  ARVs  and  allowed   South  Africa  to  establish  a  national  ARV  program  in  2003  with  assistance  from  foreign  donors.    With   over  2.1  million  people  initiating  ARV  treatment  in  South  Africa  in  2012,  it  is  the  largest  program  of  its   kind.   Health  Service  Delivery  and  the  Health  Status  of  South  Africa   Multiple  reviews  on  the  process  of  implementing  post-­‐Apartheid  national  health  services  in  South  Africa   have  indicated  that  progress  is  slow,  uneven,  and  faces  multiple  difficulties.    (Gray  &  Suleman  2000,   Coovadia  et  al.  2009,  Levitt  N,  2011).    Major  setbacks  in  implementation  have  included  confusion  about   responsibilities  within  the  district  health  system.    In  the  2004  National  Health  Act,  the  NDoH  is  identified   as  the  sole  responsible  party  for  national  health  policy,  while  public  health  service  delivery  was  deemed   a  provincial  responsibility.    Within  the  national  pharmaceutical  program,  NDoH  is  responsible  for  the   tender  process,  while  provincial  governments  are  responsible  for  ordering,  storage,  and  distribution  of   medicines.    Additional  national  health  care  challenges  include  skilled  human  resource  shortages,   unequal  distribution  of  resources  –  with  very  few  at  the  rural  community  or  primary  level,  and  poor   human  resource  management.    Though  perhaps  more  damaging  has  been  a  historical  lack  of   stewardship  and  leadership  within  the  health  system  at  a  national  level  (Coovadia  et  al.  2009).    
  • 6. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   4     Though  South  Africa  is  considered  a  high-­‐middle  income  country,  its  health  outcomes  are  worse  than   many  low-­‐income  countries.    Currently  South  Africa  faces  a  quadruple  epidemic,  which  includes   communicable  disease  (such  as  HIV  and  TB),  injury  and  death  due  to  violence,  diseases  of  poverty  (such   as  poor  maternal  and  child  mortality  and  morbidity),  and  rising  non-­‐communicable  chronic  diseases   related  to  diet  and  lifestyle.    South  Africa  is  home  to  the  largest  number  of  HIV  infected  individuals  in   the  world,  with  an  estimated  6.1  million  infected.    Additionally,  over  60%  of  TB  patients  are  found  to  be   co-­‐infected  with  HIV  (UNAIDS  2012).    The  need  for  uninterrupted  supplies  of  essential  medicines,   particularly  for  South  Africa’s  growing  burden  of  chronic  communicable  and  non-­‐communicable  disease,   is  evident.   Rationale   South  Africa’s  overburdened  and  under-­‐resourced  public  healthcare  system  regularly  struggles  to  meet   the  demands  of  the  public.    In  addition,  poor  pharmaceutical  logistics  and  supply  chain  management   impedes  the  ability  of  patients  to  adhere  to  treatment  regimes,  and  when  combined  with  poverty,  often   deters  highly  vulnerable  households  from  engaging  in  health  seeking  behavior  (Goudge  et  al.  2009).     Regular  stock  outs  of  essential  medicines  at  the  facility  and  depot  level  put  patients  at  risk  of  developing   poor  health  outcomes  and  increase  the  probability  of  drug  resistance.    Moreover,  smaller  rural  clinics   serving  traditionally  impoverished  areas  are  particularly  vulnerable  to  stock  outs  because  they  are   downstream  recipients  of  medicines  from  larger  facilities  such  as  municipal  and  district  hospitals  (MSF  et   al.  2013).    Multiple  reviews  on  access  to  care  in  South  Africa  indicate  that  poverty,  poor  healthcare   service  delivery,  and  a  lack  of  clear  information  from  providers  disempower  patients.    In  order  to   improve  the  disease  burden  in  South  Africa  these  reviews  indicate  that  novel  and  innovative  approaches   to  improve  health  services  are  needed  (Goudge  et  al.  2009,  Coovadia  et  al.  2009,  Mayosi  et  al.  2009,   Schneider  et  al.  2006).     Mobile  health  technology  (mHealth)  is  a  growing  field.    Innovative  uses  of  technology  have  improved   information  flow,  allowed  for  timely  and  accurate  methods  of  data  collection,  and  have  connected   consumers  with  providers.    Recent  pilot  programs  have  looked  at  how  mobile  technology  can  increase   access  to  medicines  by  improving  accountability  within  the  supply  chain  of  pharmaceuticals  (Barrington   et  al.  2010).    Given  that  there  are  29  million  mobile  phone  users  in  South  Africa,  a  noted  increase  from   17%  to  76%  amongst  adults  in  the  past  decade,  it  would  be  advantageous  to  explore  the  ways  in  which  
  • 7. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   5     mHealth  can  both  empower  patients  and  improve  access  to  medicines  in  low  resource  settings  in  South   Africa  (KMPG  South  Africa  2013).   Competencies   The  competencies  to  be  developed  by  this  analysis  into  essential  medicines  access  in  South  Africa  are  as   follows:   Program  Design  and  Implementation  competencies:   • Identify  program/project  goals,  objectives,  strategies,  activities  and  resource  requirements  for   interventions  that  target  key  global  health  problems.     • Develop  management  systems  for  interventions  that  address  priority  global  health  problems.   • Identify  information  requirements  for  design,  implementation,  and  evaluation  of  global  health   programs.   • Apply  design  and  implementation  principals  and  approaches  to  a  specific  program  area  within   global  health.   Topic-­‐specific  competencies:   • Develop  an  understanding  of  the  supply  chain  management  system  for  essential  medicines  on   the  national,  provincial,  and  district  level  in  South  Africa.   • Conduct  a  landscape  analysis  of  the  current  health  issues  in  South  Africa  as  they  relate  to   essential  medicines  access.   • Review  the  existing  systemic  and  social  challenges  to  essential  medicine  access.   • Research  and  compile  best  practices  regarding  the  use  of  mobile  technology  in  low-­‐resource   setting  to  improve  health  outcomes  and  access  to  essential  medicines.   Methodology   Literature  in  this  analysis  was  located  utilizing  the  databases  PubMed  and  Google  Scholar.    Peer   reviewed  journal  articles  were  limited  to  the  past  decade  (2004  to  2014),  with  some  exceptions  such  as   those  related  to  policies  implemented  prior  to  2004.    Database  searches  included  the  following  terms   and  phrases:   • South  African  drug  policy   • Pharmaceutical  supply  chain  management  in  South  Africa   • Access  to  essential  medicines  in  South  Africa   • Access  to  health  care  in  South  Africa   • Medication  stock  outs  in  South  Africa  
  • 8. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   6     • Mobile  technology  and  medicines  access   • Mobile  health  in  South  Africa   • Monitoring  distribution  of  essential  medicines   • Health  impacts  of  medication  stock  outs  in  South  Africa   Publications  regarding  essential  medicines  and  pharmaceutical  supply  chain  systems  from  multilateral   institutions  such  as  the  World  Health  Organization  (WHO)  and  international  agencies  were  also   considered  in  this  analysis.    In  addition,  applicable  policy  briefs,  news  stories,  information  regarding   mobile  health  technology  programs,  and  government  documents  were  accessed  via  the  online  websites   of  the  South  African  National  Department  of  Health  (NDoH),  associated  press,  private  technology   enterprises,  and  advocacy  organizations.   Results  and  Discussion   Findings  from  a  review  of  literature  related  to  access  to  medicines  and  care,  pharmaceutical  supply   chain  systems,  and  the  role  of  mobile  health  technology  indicate  that  little  comprehensive  research  has   been  conducted  in  South  Africa  on  these  topics  and  the  relationships  between  them.    Furthermore,  few   peer-­‐reviewed  studies  have  explored  the  impact  of  healthcare  access  barriers  and  essential  medicine   shortages  in  South  Africa  on  treatment  adherence  or  overall  health  outcomes.    Topics  that  repeatedly   appeared  in  literature  searches  regarding  access  to  care  in  the  context  of  South  Africa  included  human   resource  challenges  and  the  role  of  leadership  and  stewardship  in  health  systems  strengthening.     Table  1:  Literature  sources  by  topic   Document   Year   Location   Source   Type   Access   to   Care   Access  to   Medicines   Pharmaceutical   Supply  Chain   Mobile   Health   Technology   Health   Outcomes   Aronovich  &   Kinzett   2001   Kenya   Report       X       Barnighausen   et  al   2012   N/A   Peer   Reviewed   Journal   X           Barrington  et   al   2010   Tanzania   Peer   Reviewed   Journal       X   X   X   Demiris  et  al   2008   USA   Peer   Reviewed   Journal         X   X   Embrey  et  al   2009   Global   Peer   Reviwed   Journal       X      
  • 9. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   7     Essack  et  al   2011   South   Africa   Peer   Reviewed   Journal       X       Goudge  et  al   2009   South   Africa   Peer   Reviewed   Journal   X         X   Gray  &   Suleman   2000   South   Africa   Report       X       Harris  et  al.   2011   South   Africa   Peer   Reviewed   Journal   X           Hozerzeil   et  al.   2013   Global   Peer   Reviewed   Journal     X         Kaplan   2006   Global   Peer   Reviewed   Journal         X   X   Leon  et  al.   2012   South   Africa   Peer   Reviewed   Journal         X     Levitt  et  al   2011   South   Africa   Peer   Reviewed   Journal   X         X   MSF  et  al   2013   South   Africa   Report     X   X     X   MSF  et  al.   2013   South   Africa   Report     X   X       NDoH   2012   South   Africa   Report         X     NDoH   2011   South   Africa   Report   X   X         Pharasi  &   Miot   2013   South   Africa   Report       X       Schneider  et   al   2006   Souther n  Africa   Region   Peer   Reviewed   Journal   X   X   X       Steyn  et  al.   2009   South   Africa   Peer   Reviewed   Journal     X   X       Access  to  Medicines  and  Health  Care  in  South  Africa   An  initial  search  for  literature  related  to  access  to  medicines  in  South  Africa  yielded  few  results.     Therefore,  studies  related  to  public  sector  health  care  access  in  South  Africa  have  been  used  as  a  proxy   for  essential  medicines  access.    These  works  have  been  combined  with  reports  from  advocacy   organizations  that  address  nationwide  pharmaceutical  stock  outs.    
  • 10. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   8     Despite  the  great  strides  that  South  Africa  has  made  since  its  democratic  transition  from  Apartheid  in   1994,  health  outcomes  remain  unsatisfactory.    While  the  South  African  constitution  assures  state   sponsored  PHC  for  all,  uneven  resource  allocation,  inadequate  infrastructure,  and  skilled  human   resource  shortages  continue  to  plague  the  system.    It  is  recognized  that  equitable  universal  health  care   must  be  affordable,  available,  and  acceptable  to  recipients  of  services.    The  public  health  care  system  in   South  Africa  rarely  meets  these  requirements,  particularly  for  chronically  ill  patients  (Harris  et  al.  2011,   Goudge  et  al.  2009).   Affordability   Affordability  is  a  key  component  of  accessible  health  care.    While  PHC  services  are  offered  to  the  public   at  no  cost,  there  are  often  catastrophic  out  of  pocket  expenses  that  affect  the  most  vulnerable  and   impoverished  populations  in  South  Africa.    Due  to  an  inequitable  distribution  of  infrastructure  and   resources  many  individuals,  especially  those  in  rural  areas,  are  unable  to  access  care  due  to  public   transport  costs.    For  individuals  in  lower  wealth  quintiles  in  South  Africa,  transport  costs  and  distance  to   PHC  clinics  are  likely  to  be  higher  than  those  for  individuals  in  the  uppermost  quintiles  -­‐  who  are   generally  closer  to  secondary  and  tertiary  facilities  and  are  more  likely  to  utilize  private  modes  of   transportation.    With  high  rates  of  unemployment  (currently  24.5%  nationally),  many  households  in   rural  areas  are  reliant  upon  government  funded  social  grants  as  a  sole  source  of  income.    When   transport  costs  are  combined  with  limited  availability  of  services  and  interrupted  drug  supplies,  these   cost  burdens  can  account  for  6%  to  60%  of  household  expenditure  in  any  given  month  depending  on  the   number  of  repeated  trips  to  obtain  medicines  and  care.    Private  healthcare  services  are  also  frequently   secondary  sources  of  out  of  pocket  expenses  for  vulnerable  groups  that  are  dissatisfied  with  publicly   funded  PHC.    In  South  Africa  private  healthcare  services  function  alongside  public  services,  delivering   care  to  those  with  private  insurance  schemes  or  individuals  with  the  ability  to  pay.    These  catastrophic   costs  can  increase  household  vulnerabilities  and  food  insecurity  for  low-­‐income  families.    For  individuals   without  sufficient  financial  resources,  care  is  often  sought  intermittently,  despite  higher  rates  of   infectious  and  non-­‐communicable  disease  (NCD)  within  these  lower  wealth  quintiles  (Harris  et  al.  2011,   Goudge  et  al.  2009,  MSF  et  al.  2013).       Availability   Availability  of  healthcare  refers  to  the  quantity  of  fully  functioning  public  facilities,  goods,  and  services.     In  an  effort  to  bolster  PHC  services,  several  hundred  rural  primary  clinics  were  built  to  improve  access   for  underserved  areas.    Unfortunately,  these  rural  clinics  are  plagued  with  health  system  weaknesses  
  • 11. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   9     and  frequently  lack  adequate  infrastructure  and  skilled  service  providers.    In  South  Africa  the  number  of   doctors,  pharmacists,  and  nurses  required  for  the  public  healthcare  system  to  function  outstrip  the   number  of  available  professionals.    Furthermore  many  of  the  national  human  resource  challenges  do   not  reflect  the  disparities  within  South  Africa  –  many  of  these  healthcare  professionals  work  in  urban   areas,  leave  the  government  system  to  provide  care  in  the  for-­‐profit  private  sector,  or  choose  to  practice   outside  of  the  country.    Over  85%  of  the  South  African  population  is  reliant  upon  public  services,  and  yet   the  private  system  employs  70%  of  the  doctors  in  the  country.    Similarly,  only  29%  of  registered   pharmacists  work  in  the  public  sector.    National  public  sector  vacancy  rates  for  doctors  and  nurses  are   currently  56%  and  46%  respectively,  and  there  are  roughly  8  pharmacists  providing  services  per  100,000   people  (George  et  al.  2009,  FIP  2012,  Gray  &  Suleman  2000,  Schneider  et  al.  2006).     Few  studies  have  explored  healthcare  service  availability  from  a  beneficiary  perspective,  of  those  that   have,  drug  stock  outs  were  frequently  noted  as  deterrents  to  care  (Schnieder  et  al.  2006,  Goudge  et  al.   2009,  MSF  et  al.  2013).    Two  of  the  national  core  standards  for  pharmaceutical  services  at  health   facilities  in  South  Africa  ensure  that,  “medicines  and  medical  supplies  are  in  stock  and  their  delivery  is   reliable,  and  that  stock  levels  and  storage  are  managed  appropriately”  (NDoH  2011).    In  surveys   performed  by  patient  advocacy  organizations,  it  was  found  that  21%  of  facilities  nationwide  had   experienced  shortages  or  stock  outs  of  HIV  and  TB  medication,  with  some  rural  provinces  reporting   stock  out  rates  of  over  50%.    Vaccine  availability  was  surveyed  as  a  proxy  for  other  essential  medicines.     Nationally,  14.7%  of  facilities  had  experienced  shortages  and  stock  outs  of  vaccines.    Again,  rural   provinces  experienced  higher  vaccine  stock  out  rates  at  over  30%  (MSF  et  al.  2013).    Similarly,  in  a  2011   baseline  audit  of  national  health  care  facilities  77%  of  clinics,  70%  of  community  health  centers,  and  98%   of  hospitals  did  not  have  EDL  tracer  medications  available  in  the  pharmacy  or  medication  storage  room   (HST  et  al.  2012).    Patients  utilizing  the  public  PHC  system  report  that  they  are  frequently  sent  home   from  health  facilities  without  medication  or  told  to  return  at  a  later  date.    Some  patients  who  are  reliant   on  lifesaving  medications  resort  to  paying  out  of  pocket  for  essential  medicines  at  private  pharmacies.     For  chronic  patients  living  in  poverty,  availability  is  directly  related  to  affordability,  as  out  of  pocket   expenses  for  repeated  attempts  to  obtain  medication  can  be  devastating  for  the  entire  household.     Furthermore,  a  lack  of  medication  and  supplies  is  demoralizing  for  health  workers  who  are  unable  to   provide  necessary  services.    Stock  outs  cause  relationships  between  patients  and  providers  to  become   strained,  particularly  because  patients  consider  access  to  medication  as  an  indicator  of  the  overall  state   of  the  public  health  system  (Steyn  et  al.  2009,  Goudge  et  al.  2009,  Levitt  et  al.  2011,  MSF  et  al.  2013).  
  • 12. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   10     Acceptability   Studies  indicate  that  anticipated  disrespect  and  ineffective  care  from  providers  counteracts  health-­‐ seeking  behavior  amongst  patients  accessing  public  services  in  South  Africa.    Long  wait  times,  unsanitary   facilities,  and  a  lack  of  privacy  and  confidentiality  were  also  reported  amongst  patients  expressing   dissatisfaction  with  public  health  services.    Productive  patient-­‐provider  relations  are  lacking  in  South   Africa  largely  due  to  overburdened  health  care  professionals  resulting  from  human  resource  constraints.     However,  it  should  be  noted  that  differences  between  sociocultural  norms  amongst  providers  and   patients  also  have  a  large  role  to  play  in  the  acceptability  of  services  and  the  belief  in  the  efficacy  of   treatment  regimes  amongst  patients.    A  lack  of  communication  and  understanding  can  also  negatively   shape  the  patient-­‐provider  interaction.    Without  clear  information  patients  feel  that  they  are  unable  to   advocate  for  themselves  and  often  feel  disempowered.    Such  feelings,  when  combined  with  medicine   and  supply  shortages  can  potentially  ruin  the  trust  and  relationship  between  provider  and  patients   (Schneider  et  al.  2006,  Goudge  et  al.  2009,  Harris  et  al.  2011,  MSF  et  al.  2013).   Pharmaceutical  Supply  Chain  Management  in  South  Africa   The  public  sector  drug  regulatory  system  in  South  Africa  is  founded  upon  the  National  Drug  Policy  of   1996  (NDP).    The  NDP  outlines  objectives  to  improve  the  availability  and  accessibility  of  essential   medicines,  quality  assurance  measures,  and  rational  use  of  medicines.    Initially,  the  primary  goals  of  the   NDP  were  to  establish  an  Essential  Drugs  Programme  (EDP)  and  to  develop  an  Essential  Drugs  List  (EDL)   and  Standard  Treatment  Guidelines  (STGs).    Compiled  and  reviewed  regularly  by  experts  on  the  EDL   committee,  these  documents  serve  as  the  foundation  of  essential  medicines  access  at  primary  care  and   hospital  level  facilities.     The  process  of  procurement  and  distribution  of  medicines  begins  at  the  hospital  level,  where  the   Pharmacy  and  Therapeutics  Committee  (PTC)  at  each  hospital  submits  orders  and  expected  drug  needs   to  the  NDoH.    Hospital  demands  form  the  basis  of  the  medicine  quantities  requested  in  the  tender   process.    The  NDoH  then  manages  a  competitive  tender  process  with  pharmaceutical  suppliers.    Once   tenders  are  awarded,  suppliers  distribute  medicines  to  each  of  the  nine  provincial  government   warehouse  depots.    The  various  provincial  DoH  offices  manage  tenders  with  private  logistics  companies   to  run  the  pharmaceutical  depots.    In  most  provinces,  medicines  will  also  be  distributed  to  smaller   district-­‐level  depots  and  hospitals,  from  which  small  rural  PHC  clinics  will  then  request  stock.    These  
  • 13. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   11     steps  can  be  visualized  within  the  pharmaceutical  management  framework  proposed  by  Management   Sciences  for  Health  (MSH)  (Figure  1)  (Essack  et  al.  2011).     Figure  1:  Pharmaceutical  Management  Framework  (Source:  MSH)   Various  problems  at  every  level  of  the  supply  chain  compound  medicine  access  issues  for  patients  at  the   rural  PHC  level.    While  selection  is  based  on  the  South  African  EDL  and  STGs,  government  tenders  are   often  issued  for  several  hundred  other  medicines  that  are  not  associated  with  the  EDL  (Gray  &  Suleman   2000).    It  is  not  clear  whether  this  inefficiency  is  due  to  oversight  or  a  need  to  evaluate  the  tender   process.    In  a  review  of  tenders  for  antibiotics  from  2007  to  2011  it  was  discovered  that  hospital  PTC   requests  for  antibiotics  have  seen  little  change,  despite  expected  increases  (Essack  et  al.  2011).     Recently,  there  have  been  instances  in  which  pharmaceutical  suppliers  have  been  unable  to  deliver  on   tenders  that  have  been  offered  to  them.    In  early  2013,  several  thousand  clinics  reported  shortages  of   the  newly  introduced  fixed  dose  combination  (FDC)  ARVs  because  the  sole  supplier  could  not  produce   enough  of  the  FDC  pills  according  to  the  scheduled  contract.    In  2012,  the  Limpopo  provincial   pharmaceutical  depot  was  placed  under  administration  and  the  private  logistics  company  contract  was   cancelled  when  it  was  discovered  that  millions  of  Rand  in  expired  medication  were  destroyed  because   they  were  not  distributed  to  facilities.    Also  in  2012,  staff  at  a  district  pharmaceutical  depot  in  the   Eastern  Cape  staged  a  month  long  strike  followed  by  DoH  suspensions  for  75%  of  the  staff.    A  mere  10   working  staff  members  remained  to  provide  services  to  300  medical  facilities  that  provide  ARVs  to  over   100,000  patients.    Three  months  following  the  strike  over  53%  of  facilities  served  by  the  depot  reported   experiencing  TB  and  ARV  stock  outs  (MSF  et  al.  2013).    At  the  distribution  level,  communication  issues   between  the  provincial  and  district  depots  and  facilities  have  resulted  in  drugs  not  ordered  on  time  or   not  ordered  at  all.    These  delays  are  particularly  difficult  for  remote  PHC  facilities,  where  supply  
  • 14. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   12     deliveries  occur  on  a  monthly  basis.    Despite  the  use  of  human  resources  task  shifting  and  sharing  in  the   public  healthcare  sector,  these  stock  issues  are  made  more  difficult  by  a  lack  of  skilled  health   professionals  such  as  pharmacists.     It  is  clear  that  national  and  provincial  pharmaceutical  supply  chain  management  is  fragmented.    There   are  no  clear,  cohesive,  or  systematic  national  standards  or  procedures  for  stock  monitoring  and   reporting.    Many  medicine  shortages  and  stock-­‐outs  are  underreported,  which  only  exacerbates  access   issues,  puts  patients  at  risk  for  poor  health  outcomes,  and  inadvertently  leads  to  increased  drug   resistance  and  communicable  infections.   Mobile  Technologies  and  Health   Globally,  pervasive  interest  in  information  and  communications  technologies  (ICT)  in  health  and   development  has  grown  considerably.    Enthusiasm  for  mHealth  is  based  upon  the  ability  to  rapidly   collect,  store,  and  collate  information  in  a  short  amount  of  time  from  remote  locations.    The  widespread   use  of  basic  mobile  phones,  and  the  limited  level  of  skill  or  literacy  required  to  use  them,  suggest  that   they  are  convenient  mediums  for  data  collection  or  limited  information  transfer  amongst  diverse   populations  in  low  resource  settings  (Kaplan  2006,  Leon  et  al.  2012).    Furthermore,  the  role  of  mHealth   as  a  means  to  engender  a  transition  from  the  role  of  patients  as  passive  recipients  of  health  care   services  to  active  participants  suggests  an  opportunity  for  empowerment  (Demiris  et  al.  2008).     Despite  broad  based  policy  and  debate  regarding  ICT  for  health  and  development,  many  innovative  uses   of  mHealth  have  been  confined  to  small  pilot  programs  and  studies  conducted  within  the  non-­‐profit   sector.    Due  to  the  small  scale  of  these  studies  and  their  diverse  approaches  to  the  use  of  mHealth,  it  is   difficult  to  generalize  about  the  efficacy,  value,  and  impact  of  scaled  mHealth.    With  the  exception  of   small  mHealth  treatment  adherence  programs  for  HIV  and  TB,  there  is  scant  literature  on  the  use  of   mHealth  to  improve  health  outcomes  for  chronic  communicable  and  non-­‐communicable  diseases  in  low   and  middle-­‐income  countries  (LMIC).    Notwithstanding  the  success  of  several  pilot  projects,  few  studies   have  researched  the  use  of  mobile  technology  to  improve  pharmaceutical  stock  levels  on  a  large  scale.     While  there  are  small  advocacy  projects  run  by  local  and  international  civil  society  organizations  that   encourage  patient  reporting  of  stock  outs,  there  are  no  systems  of  accountability  that  allow  for   bidirectional  communication  between  patients  and  providers  to  manage  pharmaceutical  stock  (Kaplan   2006,  Barringson  et  al.  2010,  Leon  et  al.  2012).  
  • 15. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   13       There  is  great  potential  for  the  implementation  of  mHealth  technology  in  South  Africa  for  the  following   reasons:  (1)  At  76%  saturation,  mobile  phone  use  in  South  Africa  is  prevalent  in  both  rural  and  urban   settings.  (2)  In  comparison  to  other  LMICs,  the  ICT  industry  is  relatively  well  developed  and  there  are   diverse  mobile  network  providers.  (3)  Lastly,  there  is  an  enabling  policy  environment  for  implementing   mHealth  (Leon  et  al.  2012).    In  2012  the  National  Department  of  Health  released  the  eHealth  Strategy   for  South  Africa.    This  document  provides  a  review  of  policies  and  a  strategic  approach  for  the  use  of   electronic  health  informatics  in  South  Africa’s  public  healthcare  system.    Within  this  report,  a  situational   analysis  of  South  Africa’s  capacity  for  eHealth  is  provided.    The  report  also  defines  the  ways  in  which   eHealth  interventions  can  contribute  to  the  strategic  objectives  of  the  NDoH.    Suggested  interventions   include  a  drug  supply  and  logistics  support  system,  an  electronic  medical  records  (EMR)  and  pharmacy   system  interface,  an  SMS  patient  reminder  system  for  appointments  and  medicines,  and  a   communication  mechanism  for  community  health  workers  (CHWs).     In  a  review  of  mHealth  in  South  Africa,  Leon  et  al.  is  critical  of  inherent  health  system  challenges  that   create  barriers  to  successful  implementation  of  mHealth  interventions.    These  challenges  include  the   need  for  leadership  and  stewardship,  the  current  culture  of  healthcare  service  delivery,  requisite   systems  of  sustainable  funding,  and  the  ability  to  integrate  mHealth  interventions  with  existing  health   information  systems  (HIS)  (Figure  2).         Figure  2:  Health  systems  framework  for  making  decisions  about  mHealth  (Source:  Leon  et  al.)  
  • 16. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   14     In  the  context  of  mHealth  for  community-­‐based  health  services,  Leon  et  al.  has  the  following  points  to   make  about  each  health  system  dimension:   • Stewardship  –  The  majority  of  mHealth  interventions  conducted  in  South  Africa  have  been   initiated  by  non-­‐governmental  organizations  (NGOs).    Accordingly,  they  were  conducted  on  a   small  scale  and  did  not  involve  the  larger  public  health  system,  nor  did  they  require  policy   support  from  the  government.    Although  the  NDoH  has  released  an  eHealth  strategy,  there   remains  a  lack  of  high-­‐level  political  and  financial  support  from  the  government  for   implementation  of  mHealth.    Stewardship  also  requires  a  commitment  to  establishing  public-­‐ private  partnerships,  securing  funding,  and  the  identification  of  best  practices  for  mHealth   interventions.   • Organizational  –  Although  the  goal  of  mHealth  is  to  improve  the  efficiency  of  health  systems,   the  introduction  of  mHealth  interventions  present  new  management  challenges.    Poor  health   outcomes  in  South  Africa  are  largely  attributed  to  organizational  weaknesses,  such  as  a  lack  of   management  and  accountability  resulting  in  inadequate  service  delivery.    Furthermore,   healthcare  professionals  at  the  district  and  provincial  levels  have  demonstrated  difficulties   utilizing  existing  health  information  for  management  (HIM).   • Technological  –  Implementing  new  large-­‐scale  mHealth  programs  require  user-­‐friendly   platforms  for  diverse  stakeholder  populations.    Stakeholders  at  all  levels  must  also  believe  in  the   usefulness  of  the  technology  and  the  data  it  produces.    It  is  important  that  a  new  intervention   have  the  ability  to  seamlessly  integrate  into  existing  HIS.    This  is  a  difficult  obstacle  to  overcome   in  South  Africa,  where  patient  management  systems  are  different  for  each  provincial  DoH   (Figure  3).     Figure  3:  Patient  Management  Systems  by  Province  (Source:  NDoH)  
  • 17. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   15       • Financial  –  As  noted  previously,  most  mHealth  interventions  in  South  Africa  have  been  small-­‐ scale  pilot  projects  initiated  by  NGOs  with  independent  funders.    Establishing  long-­‐term  funding   for  large  scale  mHealth  will  be  problematic  in  a  system  that  already  exhibits  inadequate   stewardship.   Pharmaceutical  Supply  Chain  Management  mHealth  Innovations  in  Sub  Saharan  Africa   SMS  for  Life   ‘SMS  for  Life’  is  a  pilot  study  that  was  conducted  in  Tanzania  for  21  weeks  in  2009  and  2010.    The   mHealth  intervention  focused  on  improving  stock  of  anti-­‐malarial  medication  at  the  health  facility  level   utilizing  SMS  messages  and  electronic  mapping.    Stock  counts  were  conducted  at  each  facility  on  a   weekly  basis  and  then  reported  via  SMS  messages.    District  management  teams  were  able  to  view  stock   levels  through  a  web-­‐based  reporting  tool  that  assimilated  data  from  SMS  messages  at  each  facility   (Figure  4).         Figure  4:  Schematic  of  SMS  system  in  'SMS  for  Life'  pilot  (Source:  Barrington  et  al.)   Weekly  stock  visibility  allowed  district  medical  officers  to  redistribute  anti-­‐malarial  medications  between   facilities,  thereby  reducing  the  risk  of  stock  outs.    The  ‘SMS  for  Life’  pilot  involved  129  health  facilities  in   three  districts.    At  the  beginning  of  the  program  78%  of  facilities  experienced  stock  outs  of  one  or  more   anti-­‐malarial  medication,  and  at  the  end  of  week  21  only  26%  of  facilities  reported  stock  outs.    Stock   reporting  via  SMS  remained  high  at  over  93%  for  the  duration  of  the  pilot,  though  this  was  likely  due  to  
  • 18. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   16     mobile  credit  incentives.    ‘SMS  for  Life’  was  a  public-­‐private  partnership  between  the  Ministry  of  Health   and  Social  Welfare’s  National  Malaria  Control  Programme,  the  Roll  Back  Malaria  Partnership,  Novartis   Pharma  AG,  Vodafone,  and  IBM.    Barrington  et  al.  credit  government  commitment,  adequate  mobile   telephone  coverage,  the  use  of  personal  phones,  airtime  credit  incentives,  effective  training  sessions,   and  adequate  health  facility  storerooms  as  project  implementation  success  factors  (2010).    The  ‘SMS  for   Life’  model  has  expanded  to  include  other  medicines  and  is  currently  being  piloted  in  other  SSA   countries.   KEMSA   In  2001  the  Kenyan  government  decided  to  create  a  parastatal  agency  to  procure,  store,  manage,  and   distribute  medical  supplies  to  public  health  facilities  using  private  sector  logistics  and  management   techniques  (Aronovich  &  Kinzett  2001).    This  agency  is  known  as  the  Kenyan  Medical  Supplies  Agency   (KEMSA),  and  in  2013  it  became  a  state  corporation  under  the  KEMSA  Act  of  2013.    A  decentralization  of   health  services  funding  and  operations  to  the  county  level  was  one  of  the  rationalizations  in  establishing   KEMSA.    Under  the  new  system  KEMSA  is  responsible  for  procuring  supplies  with  its  own  funds,  ordering   from  KEMSA  is  then  completed  by  counties  according  to  their  needs.    County  governments  pay  KEMSA   for  the  supplies  and  are  accountable  for  the  cost  of  distribution.    KEMSA  replenishes  stock  through   profits  from  sales  to  counties.    KEMSA  start  up  costs  were  sponsored  by  the  World  Bank’s  Health  Sector   Support  Project.    Also  in  2013,  KEMSA  announced  the  launch  of  KEMSA  E-­‐Mobile,  a  partnership  between   the  Center  for  Disease  Control  Foundation,  mHealth  Kenya,  Safaricom,  Fintech,  Dazzle,  and  SafeMark.     KEMSA  E-­‐Mobile  is  a  series  of  applications  and  platforms  that  allow  public  health  facilities  and  Kenyan   Citizens  to  interact  with  KEMSA’s  logistic  management  information  system.    At  the  health  facility  level,   consumption  can  be  reported  and  supplies  can  be  ordered  via  mobile  phone,  this  facility  level   information  is  then  made  available  to  county  health  management  teams.    For  Kenyan  Citizens,  KEMSA’s   E-­‐Mobile  program  provides  a  level  of  transparency  and  integrity,  allowing  them  to  anonymously  report   suspicious  or  inappropriate  supply  issues  at  health  facilities  and  to  inquire  about  drug  availability  at  their   closest  facility  via  mobile  phone.    A  comprehensive  review  of  KEMSA’s  E-­‐Mobile  initiative  has  not  been   released  due  to  the  recent  introduction  of  the  program.   iDART  by  Cell  Life   Intelligent  dispensing  for  antiretroviral  treatment  (iDART)  is  a  software  program  developed  by  Cell  Life  in   collaboration  with  the  Desmond  Tutu  HIV  Foundation,  Cape  Peninsula  University  of  Technology,  and  the   University  of  Cape  Town  to  improve  the  dispensing  of  ARVs  and  treatment  adherence  within  the  public  
  • 19. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   17     health  care  sector  in  South  Africa.    The  system  is  intended  to  allow  pharmacists  to  readily  and  accurately   dispense  ARVs,  manage  EDL  stock  levels,  and  generate  reports  for  a  growing  number  of  HIV  patients.     iDART  requires  either  direct  dispensing  of  ARVs  or  pre-­‐packaged  remote  dispensing  with  unique   barcodes  that,  when  scanned,  collect  patient  information.    The  iDART  system  is  compatible  with  DoH   monitoring  and  evaluation  mechanisms,  thereby  allowing  for  improved  reporting  for  the  government   and  international  donors.    In  2010  the  Canadian  International  Development  Agency,  in  collaboration   with  Maternal  Adolescent  and  Child  Health  (MatCH)  at  the  University  of  the  Witwatersrand,  designed  a   randomized  controlled  trial  to  evaluate  the  introduction  of  an  SMS  component  to  iDART  to  reduce   treatment  interruption  and  increase  adherence  amongst  new  ART  patients.    Four  sites  were  chosen  for   the  RCT,  which  was  completed  in  late  2013.    To  date  results  of  this  study  have  not  been  published.   Limitations   This  analysis  was  limited  by  relatively  scant  literature  on  the  role  of  mHealth  to  improve  supply  chain   management  of  essential  medicines  in  low  resource  settings.    Furthermore,  the  existing  literature   generally  features  small  scale  mHealth  interventions  initiated  by  NGOs  with  fixed  funding  and  project   time  scales.    There  were  difficulties  finding  comprehensive  information  on  the  process  of   pharmaceutical  supply  chain  management  in  South  Africa  because  national  LIMS  are  fragmented  by  the   decentralization  of  public  healthcare  services  to  the  provincial  level  and  the  privatization  of   pharmaceutical  distribution.    Lastly,  very  few  studies  have  investigated  patient  perspectives  on  access  to   medicines  and  healthcare  in  South  Africa,  or  the  potential  to  integrate  bi-­‐directional  mHealth   communication  systems  with  patients  to  improve  supply  chain  management  and  access.   Conclusions  and  Recommendations   Despite  spending  more  money  on  healthcare  than  other  LMICs,  South  Africa  has  unacceptably  poor   health  outcomes.    Additionally,  South  Africa  is  also  home  to  the  largest  populations  of  individuals   affected  by  HIV  and  TB  -­‐  considerable  constituents  of  the  quadruple  disease  burden,  of  which  the  other   three  are  NCD,  poor  maternal  and  child  health,  and  violence.    Human,  financial,  and  physical  resources   remain  inequitably  distributed  within  the  South  African  health  system  in  spite  of  the  gains  that  have   been  made  in  the  public  healthcare  sector  following  democratic  transition  in  1994.    Rural  and   impoverished  populations  within  South  Africa  consequently  bear  the  brunt  of  these  inequities.    
  • 20. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   18     With  over  2.1  million  individuals  initiating  treatment,  South  Africa  operates  the  largest  ARV  program  in   the  world.    However,  tracking  treatment  compliance  and  loss  to  follow  up  remains  an  obstacle.    South   Africa  is  also  the  epitome  of  a  country  in  transition  and  chronic  NCD  is  on  the  rise.    The  disease  burden   in  South  Africa  necessitates  a  regular  and  reliable  supply  of  essential  drugs  for  chronic  illnesses.         Impoverished  patients  are  constrained  to  utilizing  PHC  clinics  with  few  resources.    In  reviews  of  the   South  African  PHC  system  patients  report  poor  service  delivery  and  regular  shortages  of  medications.     Patients  are  often  told  to  return  to  facilities  at  a  later  date  to  collect  out  of  stock  medications.    Patients   within  the  public  healthcare  sector  generally  choose  facilities  based  on  distance  in  order  to  reduce  the   economic  impact  of  transport  costs,  however,  repeated  attempts  to  obtain  medication  can  result  in   catastrophic  costs  for  the  entire  household.    Inadequate  access  to  medicines  may  lead  to  treatment  non   adherence,  potential  development  of  resistant  strains  of  TB,  HIV  reinfection,  and  poor  health  outcomes   overall  –  though  there  are  no  known  studies  to  confirm  this  relationship.    The  economic  impact  of  these   consequences  are  also  unknown.     Pharmaceutical  supply  chain  management  within  South  Africa  is  controlled  at  the  provincial  level,  with   NDoH  heading  the  tender  process  for  obtaining  supplies  and  medicines.    The  quasi-­‐provincial   implementation  of  drug  delivery  and  public  health  services  creates  a  difficult  environment  with  which  to   streamline  HIM  and  data  collection  for  improved  decision-­‐making.    Multiple  advocacy  organizations   have  documented  essential  drug  stock  outs  resulting  from  the  inefficiencies  of  supply  chain   management  in  the  public  sector.     MHealth  has  the  potential  to  empower  South  African  patients  by  connecting  them  with  necessary   information,  such  as  facility-­‐based  drug  availability.    Additionally,  bidirectional  communication   transforms  the  traditional  patient  role  from  passive  recipient  to  active  participant  in  the  health  care   system.    Initiating  large-­‐scale  participatory  mHealth  in  South  Africa  to  improve  the  pharmaceutical   supply  chain  will  require  leadership  and  stewardship  at  all  levels.    Previous  mHealth  pilot  projects  have   demonstrated  the  importance  of  public-­‐private  partnerships.    A  scaled  mHealth  innovation  will  require   sustainable  funding,  the  identification  of  stakeholders,  and  the  involvement  of  multilateral  agencies,   civil  society  organizations,  academia,  the  private  ICT  industry,  and  the  South  African  government.    It   would  be  advantageous  for  the  South  African  Government  to  build  on  the  successes  of  existing   pharmaceutical  supply  chain  management  mHealth  programs  in  SSA.  
  • 21. INNOVATIONS  IN  ACCESS  TO  ESSENTIAL  MEDICINES:  FOCUS  ON  SOUTH  AFRICA   19       Widespread  mobile  phone  use,  an  advanced  ICT  network,  and  an  enabling  policy  environment  suggest   that  the  potential  to  implement  mHealth  in  South  Africa  to  improve  supply  chain  management  is  great.     However,  it  should  be  noted  that  introducing  mHealth  will  likely  create  additional  management   responsibilities.    In  South  Africa  there  are  skilled  human  resource  shortages  in  the  healthcare  sector  and   an  unfavorable  culture  of  service  delivery.    Until  such  resource  constraints  can  be  ameliorated,  it  is   unlikely  that  introducing  innovative  approaches  will  produce  beneficial  results.    
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