UN Commission on Life-saving Commodities: Contraceptive Commodities (March 2012)

Publication date: 2012

        CONTRIBUTORS     Authors   Kabir  Ahmed,  UNFPA   Bidia  Deperthes,  UNFPA   Beth  Frederick,  Johns  Hopkins  Bloomberg  SPH   Suzanne  Ehlers,  PAPACT   Natalie  Kapp,  WHO   Cindy  Paladines,  Office  of  the  SGSE   Marie  Christine  Siemerink,  UAFC  Joint  Programme   John  Skibiak,  RH  Supplies  Coalition   Beth  Skorochod,  PSI   Markus  Steiner,  FHI360   John  Townsend,  The  Population  Council   Elizabeth  Westley,  ICEC         Acknowledgements   Christine  Ardal,  NORAD   Jennifer  Bergeson-­‐Lockwood,  USAID   Yves  Bergevin,  UNFPA   Alan  Bornbusch,  USAID   Campbell  Bright,  UNFPA   Blami  Dao,  JHPIEGO   Luc  de  Bernis,  UNFPA   Mario  Festin,  WHO   Susan  Guthridge-­‐Gould,  Consultant   Werner  Haug,  UNFPA   Katherine  Holland,  UNICEF   Jane  Hutchings,  PATH   Maggie  Kilbourne-­‐Brook,  PATH   Desmond  Koroma,  UNFPA   Benedict  Light,  UNFPA   Mike  Mbizvo,  WHO   Priya  Mehra,  EOSG   Amy  Meyers,  CHAI   Kirsten  Myhr,  NORAD   Kechi  Ogbuagu,  UNFPA   Nuriye  Ortayli,  UNFPA   Sharmila  Raj,  USAID   Sukanta  Sarker,  UNFPA   Kathleen  Schaffer,  ICEC   Ann  M.  Starrs,  Family  Care  International   Nguyen-­‐Toan  Tran,  IPPF   Amy  Tsui,  Johns  Hopkins  Bloomberg  SPH   Jagdish  Upadhyay,  UNFPA   Renee  Van  de  Weerdt,  UNICEF                               CONTENTS   A.   BACKGROUND  &  RATIONALE  .  1   B.   DATA  SYNTHESIS  .  4   1.   Contraceptive  implants  .  4   2.   Emergency  contraception  .  9   3.   The  female  condom  .  11   C.   RECOMMENDATIONS  FOR  FOCUS  BY  UN  COMMISSION  .  18   D.   CITED  WORKS  &  SUPPLEMENTARY  MATERIAL.  20                                             Cover  photo:  Fernanda  Manhique,  Maputo,  Mozambique     Credit:  Pedro  Sa  da  Bandeira  /  UNFPA           �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      1     A.  BACKGROUND  &  RATIONALE     Under   the   auspices   of   the   United  Nations   Secretary-­*HQHUDO¶V� (YHU\�:RPDQ� (YHU\�&KLOG� initiative,   the   Commission   on   Life-­Saving   Commodities   for   Women   and   Children   will   advocate  at  the  highest  levels  for  the  increased  availability,  affordability  and  accessibility  of   essential  but  underutilized  commodities  for  maternal  and  child  health.  When  the  creation  of   such  a  Commission  was  first  proposed  in  2011,  the  argument  was  made  that  positive  health   outcomes   in   reproductive,   maternal,   newborn   and   child   health   were   being   undermined   by   poor   access   to   a   limited   set   of   life-­saving   commodities   for   which   there   were   no   global   champions  or  institutionalized  sources  of  financial  and  technical  support.    This  emphasis  on   ³QHJOHFWHG� FRPPRGLWLHV´�� ZKLOH� ZLGHO\� DSSODXGHG�� GLG� FDXse   some   to   question   whether   contraceptive   commodities,   which   have   in   the   past   benefitted   from   initiatives   such   as   the   Reproductive  Health  Supplies  Coalition,  could  be  considered   neglected   in   the  same  way  as   other  curative  drugs  and  medicines.       The   prospect   that   contraceptive   commodities   might   be   excluded   from   review   by   the   Commission  alarmed  the  broader  reproductive  health  community.  Their  response  was  to  re-­ affirm   the   critical   role   of   family   planning   in   averting   maternal   and   newborn   deaths   and,   perhaps   even   more   importantly,   to   point   out   that   among   the   array   of   family   planning   methods,  certain  methods  were  indeed  neglected,  underutilized  and  orphaned.       In  October,  representatives  of  the  Commission  called  upon  the  Reproductive  Health  Supplies   Coalition   to   identify   one   contraceptive   commodity   that   most   closely   fit   the   criteria   of   ³RUSKDQHG´� DQG� WKDW� KHOG� RXW� WKH� JUHDWHVW� SURPLVH� IRU� LPSURYLQJ� reproductive   health   RXWFRPHV�� 7KH� &RDOLWLRQ¶V� ([HFXWLYH� &RPPLWWHH� UHVSRQGHG� E\� LGHQWLI\LQJ� WKUHH�� contraceptive  implants,  emergency  contraception  and  the  female  condom.       7KH� &RPPLVVLRQ¶V� subsequent   decision   to   include   family   planning   in   its   mandate   is   an   important  testament  to  the  need  to  build  on  the  progress  made  in  meeting  the  need  and  desire   for  contraception  over  the  last  four  decades.  In  selecting  these  three  overlooked  contraceptive   methods²contraceptive   implants,   emergency   contraception   and   the   female   condom²the   Commission   has   appropriately   focused   on   ensuring   access   to   methods   that   are   in   demand,   show  promise  for  increasing  public  health  benefits  (including  beyond  pregnancy  prevention),   and  have  received  inadequate  attention  from  the  public  and  private  sector.  Yet,  to  realize  the   full  public  health  benefits  of  increased  availability  of  overlooked  contraceptive  methods,  it  is   also  essential  to  ensure  access  for  all  to  a  full  range  of  methods  and  the  ability  of  women  to   choose  a  method  that  fits  within  their  own  fertility  goals  and  life  circumstances.       Sexually-­active  women  of  reproductive  age  in  developing  countries  experience  high  rates  of   unintended  pregnancy.  Nearly  90  percent  of   the  estimated  208  million  pregnancies   in  2008   occurred  in  the  developing  world,  according  to  the  Guttmacher  Institute.  Globally,  86  million     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      2     pregnancies  were  unintended;;  of  these,  41  million  ended  in  abortions  33  million  in  unplanned   birth  and  11  million   in  miscarriage.  Roughly  as  many  women  with  unintended  pregnancies   obtain   induced  abortions  as  give  birth   to  a  child   they  had  not  planned   for.   The  majority  of   these  induced  abortions  take  place  in  non-­medical  settings  under  unsafe  conditions.       When  women  and  couples  can  access  a  wide  range  of  contraceptive  methods,  they  are  more   likely  to  find  a  method  they  like  and  can  use  over  a  period  of  time,  to  switch  methods  when   life  circumstances  change,  and  to  meet  their  contraceptive  intentions.  Even  among  those  who   currently  use  contraception,  many  who  would  like  to  have  no  more  children  have  no  access  to   long-­acting  and  permanent  methods.  Similarly   those  who  are  at   risk  of  HIV/AIDS  or  other   sexually   transmitted   infections   (STIs)   too   often   do   not   have   access   to   the   means   for   prevention  of  both   infection  and  pregnancy.  Youth,  in  particular,  must  overcome  significant   barriers  to  access  contraception  that  meets  their  needs  and  vulnerability  to  unprotected  sex.       Among   investments   in  public  health,   those  made   to  ensure  access   to  contraceptive  supplies   and   services   are   proven   to   result   in   significant   improvements   in   the   health   of  women   and   children.1  The   603   million   women   who   currently   use   modern   contraception   in   developing   countries,   combined   with   the   215   million   women   with   an   unmet   need   for   modern   contraception,   attest   to   the   need   and   desire   for   contraceptive   services   and   related   commodities  overall.     The   choice   of   these   three   specific   contraceptive   commodities   reflected   two   principal   FRQVLGHUDWLRQV��7KH�ILUVW�ZDV�WKDW�DOO�WKUHH�KDG�ORQJ�EHHQ�FODVVLILHG�E\�WKH�&RDOLWLRQ¶V�&DXFXV� on  New  and  Underutilized  Methods  DV�EHLQJ�³XQGHUXWLOL]HG´���7KH�VHOHFWHG�WKUHH  were  among   10  WHFKQRORJLHV�WKDW��WR�XVH�WKH�FDXFXV¶�GHILQLWLRQ��ZHUH�³QRW�URXWLQHO\�DYDLODEOH�LQ�WKH�SXEOLF�� SULYDWH��RU�VRFLDO�PDUNHWLQJ�VHFWRUV������>QRU@�URXWLQHO\�SURFXUHG�E\�WKH�PDMRU�SURFXUHUV´��7KH\� DOVR�UHIOHFWHG�WKH�FULWHULD�VHW�IRUWK�LQ�WKH�&RPPLVVLRQ¶s  original  concept  paper.  All  three  were   inadequately  funded  by  existing  mechanisms.  In  the  case  of  implants  and  the  female  condom,   both  of  which  are  currently  witnessing  price  declines,  there  was  evidence  of  the  prospects  for   ³«� LQQRYDWLRQ� DQG� UDSLG� VFDOH   up   in   product   development   and  market   shaping´   (including   potential  for  price  reduction  and  improved  stability  of  supply).     The  second  reason  for  their  selection  was  that,  as  a  group,  the  three  serve  as  a  bellwether  for   identifying  opportunities  for  improving  access,  use  and  effectiveness  of  family  planning  and                                                                                                       1  Each   year,   the   current   level   of   modern   contraceptive   use   averts   188   million   unintended   pregnancies,   which   in   turn   results   in  112  million   fewer  abortions,  1.1  million   few  newborn  deaths  and  150,000   fewer   maternal   deaths.   If   unmet   need   for   modern   methods   were   fully   satisfied,   an   additional   53   million   unintended   pregnancies   would   be   averted   each   year,   resulting   in   22  million   fewer   unplanned   births,   25   million   fewer   induced  abortions  and  seven  million   fewer  miscarriages.    The   immediate  health  benefits  of   avertiQJ�WKHVH�XQLQWHQGHG�SUHJQDQFLHV�ZRXOG�EH�VXEVWDQWLDO��(DFK�\HDU��DQ�DGGLWLRQDO��������ZRPHQ¶V�OLYHV� would  be  saved  and  590,000  newborn  deaths  would  be  averted.  Guttmacher  Institute,  International  Planned   Parenthood   Federation,   Facts   on   Satisfying   the   Need   for   Contraception   in   Developing   Countries,   November  2010     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      3     for   meeting   Millennium   Development   Goal   5b²universal   access   to   reproductive   health.   Many  of  the  access  issues  that  clients  and  health  systems  face  when  seeking  to  provide  safe   protection   from   unwanted   pregnancy   or   infection   (e.g.   high   unit   cost,   political   opposition,   poor  supply  chains,  need  for  ancillary  equipment,  poor  training  of  providers)  are  indicative  of   barriers   faced   by   health   systems   in   providing   all   contraceptive   methods,   and   particularly   those  that  exist  outside  mainstream  donor  and  corporate  priorities.       In   considering   improved   access   to   these   three   and   all   contraceptive   commodities,   the   Commission  is  urged  to  prioritize  the  following  recommendations  or  interventions:   x 3URYLVLRQ� RI� WKH� IXOO� UDQJH� RI� FRQWUDFHSWLYH�PHWKRGV� QHHGHG� WR�PHHW�ZRPHQ¶V� DQG� couples  need  for  short-­term,  long-­term  and  permanent  methods  of  contraception  and,   where  relevant,  for  prevention  of  STIs,  including  HIV;;   x Ensuring   equitable   access   to   contraceptive   commodities   for   all   who   are   at   risk   of   unwanted  pregnancy;;   x Streamlined   regulatory   processes   and   national-­level   responses   to   increase   opportunities  for  the  introduction  and  use  of  all  services  and  commodities  to  improve   maternal  and  child  health.         �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      4     B.  DATA  SYNTHESIS       1. Contraceptive  implants     Overview     Hormonal   implants   consist   of   small,   thin,   flexible   plastic   rods,   each   about   the   size   of   a   matchstick,   that   release  a  progestin  hormone   into   the  body.  They  are  safe,  highly  effective,   and  quickly   reversible   long-­acting   progestin-­only   contraceptives   that   require   little   attention   after   insertion.   Clients   are   satisfied   with   them   because   they   are   convenient   to   use,   long-­ lasting,  and  highly  effective.  Implants,  wKLFK�DUH�LQVHUWHG�XQGHU�WKH�VNLQ�RI�D�ZRPDQ¶V�XSSHU� arm,   prevent   pregnancy   for   an   extended   period   after   a   single   administration.   No   regular   action  by  the  user  and  no  routine  clinical  follow-­up  are  required.       Implants   are   available   from   three   main   manufacturers,   Bayer   Pharma   AG   (Germany),   Merck/MSD  Inc  (USA),  and  Shanghai  Dahua  Pharmaceuticals  Co.,  Ltd  (China)  with  a  cost   ranging  from  $8  to  $18.00  per  unit.2  The  most  common  types  include  Jadelle  (two  rods  each   containing   75   mg   of   levonorgestrel,   effective   for   five   years);;   Sino-­implant   (II),   which   is   currently  marketed  under  various  trade  names  including  Zarin,  Femplant  and  Trust  (two  rods   each   containing   75   mg   of   levonorgestrel,   effective   for   at   least   four   years);;   Implanon   and   Nexplanon   (both  with  one   rod  containing  68  mg  of  etonogestrel,   effective   for   three  years).   Nexplanon   is   radio-­opaque,   allowing  x-­ray   detection   if   the   rod   is   difficult   to   locate   due   to   deep  insertion,  and  also  has  an  improved  trocar.  Norplant  (six  rods  each  containing  36  mg  of   levonorgestrel,  effective  for  five  to  seven  years)  was  discontinued  in  2008.       Policy  ʹ  Guidelines,  protocols,  technical   Implants  are  included  in  the  WHO  Essential  Medicines  list  (2011)  and  specified  as  the  twoǦ rod   levonorgestrelǦreleasing   implant,   each  rod  containing  75  mg  of   levonorgestrel   (150  mg   total).    One  rod  implants  are  still  not  included  in  the  WHO  list.    In  addition,  service  delivery   policies   and   protocols,   are   in   place   in   many   countries   which   support   implant   provision,   including  both   two-­rod  and  one-­rod  presentations.  Given  the  different   implant  products   that   are  available  in  diverse  markets,  technical  requirements  for  competent  training  in  counseling,   insertion  and  removal  of  each  product  as  well  as  related  procurement  processes  is  required  to   ensure   that   these  commodities  are  provided  appropriately.     In   some  settings,  policies  allow   task-­shifting   which   permit   lower   cadres   of   health   care   providers   (i.e.   providers   other   than   doctors  such  as  nurses  or  midwives)  to  insert  and/or  remove  implants.  In  Ethiopia  since  2009,   Health  Extension  Workers   (HEWs)  have  offered   Implanon  at   the  community   level   through   the  Health  Extension  Program  with  nurses  or  midwives  trained  for  removal.3                                                                                                         2  All  amounts  are  in  US  dollars  (US$)     3  Under  this  scheme,  female  high  school  graduates  are  recruited  and  trained  for  one  year  (candidates  must   have  completed  grade  10  in   school,  need  to  be  from  the   local  community,  and  speak  the   local   language).     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      5       Regulatory:  Registration  and  distribution   Jadelle  is  prequalified  by  the  World  Health  Organization.  It  has  been  registered  in  more  than   47  counties  worldwide  with  review  underway  in  an  additional  10  countries.   It   is  distributed   commercially  by  Bayer  Pharma.  Sino-­implant  (II)  is  registered  in  19  countries  worldwide  and   is  under  active  regulatory  review  in  10  additional  countries.  In  addition  to  the  manufacturer's   name  for  the  product  (Sino-­implant  (II))  the  product  is  marketed  under  a  variety  of  names  by   different  distributors:  as  Zarin  by  Pharm  Access  Africa,  Ltd.,  as  TRUST  by  DKT  Ethiopia,   and  as  Femplant  by  Marie  Stopes  International.  Implanon  is  prequalified  by  the  World  Health   Organization  and  registered  in  approximately  80  countries.  It  is  distributed  commercially  by   Merck/MSD.     Financing  and  commodity  costs     High  commodity  costs  and  a  lack  of  supplies  at  the  country  level,  due  to  lack  of  procurement   or   distribution   networks  within   the   country,   contribute   to   unsatisfied   demand   for   implants.     Donors  and  governments  may  be  more  likely  to  purchase  large  quantities  of  short-­acting,  less   expensive  hormonal  methods   such  as   oral  contraceptives   (OCs)   instead  of  more  expensive,   longer-­acting  methods   such   as   implants.   However,   implants   are  more   cost-­effective   in   the   long  term  than  repeated  use  of  short-­acting  methods.       Significant  increases  in  procurement  of  contraceptive  implants  have  been  reported  worldwide   over   the   last   several   years.   Data   gathered   by   the   RH   Interchange   show   that   in   2005   approximately   132,000   implants   were   donated   in   sub-­Saharan   Africa.   By   2011,   donations   rose   to   more   than   2.5   million.   In   2011,   Merck/MSD   lowered   the   price   of   Implanon   to   $18/unit  in  developing  countries.  If  sales  volumes  of  4.5  million  units  or  more  are  reached  by   December  2012,   the  price  will  be  reduced  to  $16.50,   including  retroactive  price  reductions.   In   addition,   in   March   2012,   Bayer   Pharma   lowered   the   price   of   Jadelle   to   $18.00/unit   in   developing   countries.   Sino-­implant   (II)   costs   agencies   seeking   procurement   approximately   $8/unit.       For   Jadelle,  public-­sector  price  agreements  with  organizations   such  as   the  U.S.  Agency   for   International  Development  (USAID),  the  United  Nations  Population  Fund  (UNFPA),  PSI  and   others   have   been   established.     For   Sino-­implant   (II),   public-­sector   price   agreements   are   established   with   distribution   partners.   For   Implanon,   public-­sector   price   agreements   have   been  made  through  contracts  with  individual  ministries  of  health,  UNFPA,  USAID  and  non-­ governmental  organizations  (NGOs)  engaged  in  family  planning.                                                                                                                                                                                                                                                                                                         They  are  trained  as  HEWs  to  deliver  a  package  of  16  preventive  and  basic  curative  services  that  fall  under   four  main   components:   hygiene   and   environmental   sanitation;;   family   health   services;;   disease   prevention   and  control;;  and  health  education  and  communication.     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      6     Given  the  up-­front  cost  of  implants,  their  high  level  of  effectiveness  and  their  longer  duration   of   use,   both   public   and   private   sector   financing   strategies   are   used.     In   the   public   sector,   subsidies  are  provided  to  clients  who  are  unable  to  pay,  either  through  lower  prices  to  users   or  through  alternative  financing  arrangements  such  as  vouchers.    In  the  private  sector,  users   in  the  higher  wealth  segments  usually  pay  full  price  for  this  product,  or  modest  subsidies  are   provided  through  public-­private  partnerships  such  as  franchises  or  social  marketing  schemes.     Manufacturing  and  labeling   Currently   there   are   three   main   manufacturers   of   implants,   with   both   Bayer   Pharma   and   Merck   products   being   pre-­qualified   by   WHO;;   pre-­qualification   has   been   applied   for   by   Shanghai  Dahua  Pharmaceuticals  Co.,  Ltd.,   the  manufacturer  of  Sino-­implant   (II).   (See   the   overview   for   formulations   of   each   product).   Each   manufacturer   has   the   capacity   to   significantly   expand  production,   if   sufficient   demand  was   reflected   in   orders  and   financing   was  available  in  national  markets  or  through  donors.      Quality  assurance  efforts  are  integrated   ZLWKLQ� HDFK� PDQXIDFWXUHU¶V� SURGXFWLRn   plans   and   marketing   strategy.   All   products   are   shipped   pre-­packaged  with   appropriate   labels,   inserters,   and   instructions   for   providers   and   clients.   Given   the   size   of   the   global   market   for   implants,   the   know-­how   required   for   manufacturing   quality   implant   products   and   the   pricing   context.   There are two smaller manufacturers who are working in some of these same markets. A second Chinese PDQXIDFWXUHU� �/XGDQ�� LV� DOUHDG\�PDNLQJ� D� WZR� URG� LPSODQW� XVLQJ� WKH� VDPH� ³6LQR-LPSODQW´� technology and there is another manufacturer in Indonesia which is making Indoplant using a similar technology. Ludan is selling implants in China, while Indoplant has been registered in a few countries outside Indonesia as well.   Effectiveness   Implants  are  one  of  the  most  effective  contraceptive  methods.  In  three  years  of  Implanon  use,   less  than  one  pregnancy  per  100  users  can  be  expected.  For  Jadelle,  the  cumulative  pregnancy   rate   at   the   end   of   five   years   is   1.1   per   100   users.   For   Sino-­implant   (II),   the   cumulative   pregnancy   rate   at   the   end   of   four   years   is   0.9-­1.06   percent.   These   efficacy   rates   are   comparable   to   those   of   other   long-­acting   and   permanent   methods,   including   the   IUD   and   female   and  male   sterilization.   The   contraceptive   effect   of   implants   ends   immediately   after   removal  and  fertility  returns  rapidly.  In  general,  long-­acting  methods,  including  implants,  are   more   effective   in   practice   than   shorter   acting   methods,   including   oral   contraceptives   and   injectables,  because  compliance  and  continuation   rates  are  higher  with  methods   that  do  not   require  regular  action  by  the  user.     Safety   Implants   are   safe   for   use   by  most  women,   including   lactating  mothers,  women   living  with   HIV,  women  who  smoke  cigarettes,  women  over  the  age  of  35,  women  who  have  just  had  an   abortion,   women  with   diabetes,  women   at   risk   for   cardiovascular   disease   (including   those   with  high  blood  pressure),  and  adolescents.  Women  on  antiretroviral  therapy  should  discuss   the  use  of   implants  with   their  doctor  as   the  possibility  of  an   interaction  exists  which  might   lead  to  somewhat  reduced  implant  effectiveness.  Implants  can  be  initiated  immediately  after     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      7     childbirth  if  a  woman  is  not  breastfeeding,  and  six  weeks  postpartum  if  a  woman  is  partially   or   fully   breastfeeding.   Studies   have   shown   that   use   of   implants   has   no   impact   on   breastfeeding  or  the  healthy  development  of  breastfed  babies.  Compared  to  nonusers,  users  of   implants   could   have   reduced   risk   of   ectopic   pregnancies   and   pelvic   inflammatory   disease   (PID).   In   some   women,   implants   might   help   alleviate   iron-­deficiency   anemia   through   reduced  menstrual  bleeding.  Implanon  might  also  help  with  dysmenorrhea  and  can  help  treat   symptomatic  endometriosis.     Insertion  and  removal     Complications  during  insertion  and  removal  of  implants  are  rare.    Implants  can  be  inserted  at   any  time  during  the  menstrual  cycle  if  the  provider  can  be  reasonably  certain  that  the  woman   is  not  pregnant.  Implants  are  effective  immediately  if  inserted  within  the  first  seven  days  after   monthly  bleeding  begins  (five  days  for  Implanon  and  Nexplanon).  If  a  woman  has  implants   inserted  after  the  seventh  day  (fifth  day  for  Implanon  and  Nexplanon),  she  must  use  a  backup   contraceptive   method   for   the   next   seven   days   after   insertion.   In   studies   of   experienced   providers,   insertion   required   an   average   of   one   to   five   minutes,   and   removal   took   three   minutes  to  fifteen  minutes,  with  faster  times  associated  with  implants  with  fewer  rods.       Traditionally,   reusable   stainless   steel   trocars   have   been   used   to   insert   implants.   However,   these  require  sterilization  between  uses,  and  sterilization  equipment  is  not  always  available  in   low-­resource  settings.    Both  Sino-­implant  (II)  and  Jadelle  are  now  available  with  a  disposable   trocar   (the   one-­rod   Implanon   has   always   been  provided   in   a   pre-­loaded  disposable   trocar).   Disposable  trocars  may  make  implant  insertion  more  feasible  in  developing  countries,  enable   a  more   decentralized   provision  of   the  method,   and   reduce   the   risk   that   improperly   cleaned   equipment  could  lead  to  transmission.       It  is  crucial  that  policymakers,  donors  and  service  delivery  groups  work  together  to  guarantee   that   women   have   access   to   reliable,   affordable   implant   removal   services.   This   includes   providing   information   about   removal   services   at   the   time   of   insertion;;   ensuring   adequate   training   of   providers   and   sufficient   commodities   to   support   same-­day   removals   when   requested;;   and   establishing   adequate   referral   systems   especially   for   women   who   receive   implants  through  mobile  services  or  community-­based  programmes.     Side  effects     The   majority   of   implant   users   experience   menstrual   disturbances,   although   the   menstrual   changes  are   typically  not  as  severe  as   those  experienced  by  DMPA  users.  Disturbances  can   include   heavy   and   prolonged   menses,   light   intermenstrual   bleeding,   oligomenorrhea   and   amenorrhea.  Such  disturbances  are  the  overwhelming  reason  that  women  stop  using  implants,   followed  by  minor  medical  side  effects  and  the  desire   to  have   children.  Tolerance   is  lowest   for  prolonged  bleeding  (more  than  seven  days),  an  excessive  amount  of  blood,  and  frequent   and   irregular   episodes   of   bleeding.  Older  women   and  more   educated  women   tend   to   have   lower  rates  of  removal  due  to  side  effects.    In  addition  to  menstrual  disturbances,  side  effects   that   can   be   attributed   to   implant   use   include   weight   gain,   vaginitis,   acne,   breast   pain,     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      8     headache,   abdominal   pain,   ovarian   cysts   and   mood   changes.   In   contrast   to   injectable   contraceptives,  the  hormone  does  not  remain  in  the  body  after  discontinuation,  so  side  effects   should  resolve  quickly  after  removal.       Supply  chain  management   Stock-­outs   of   contraceptive   commodities   and   other   needed   equipment,   instruments,   and   supplies   for   family  planning  provision  are  commonly   reported   in   service  programmes.  The   unavailability   of   either   the   method   or   other   needed   instruments   and   supplies   means   that   implants  services  are  also  unavailable.  Thus,  attention  to  logistics  is  critical,  and  must  include   instruments,  expendable  medical  supplies  as  well  as  the  contraceptive  implant  itself.    A  table   indicating  which   instruments  and  supplies  are  needed  for  both   insertion  and  removal  of   the   hormonal   implants   currently   available   can   be   found   at   http://www.k4health.org/toolkits/   implants/logistics/instruments.    One  challenge  for  supply-­chain  management  is  that  implants   are  often  combined  in  information  systems  and  on  procurement  lists  leading  to  challenges  in   supply  management.     Demand  for  prescription  and  availability  of  services/products   %HFDXVH� RI� LPSODQWV¶� HIIHFWLYHQHVV� DQG� ease   of   use,   they   are   popular   and   in   demand  when   available   in   family   planning   programmes.  However,   the   upfront   commodity   cost   can   be   a   barrier   to   both   procurement   and   client   access   especially   in   resource-­constrained   settings.   Still,   because   they   are   long   acting   �L�H�� WKUHH� WR� ILYH� \HDUV��� DUH� LQGHSHQGHQW� RI� XVHU¶V� compliance,  and  do  not  require  frequent  resupply,  implants  are  more  reliable  and  more  cost-­ effective  compared  to  other  shorter-­acting  contraceptive  methods.     Although  use  of  implants,  as  a  percent  of  the  method  mix,  remains  low  worldwide,  demand   often  exceeds  supply.  In  many  settings  where  there  are  not  enough  supplies  to  meet  demand,   potential   implant   users   go   on  waiting   lists  or  choose  another  method.    While   total   demand   therefore   is   unknown,   significant   increases   in   procurement   of   contraceptive   implants   have   been  reported  worldwide  over  the  last  four  years.       Demand  by  consumers  and  accessibility     Despite  a  high  incidence  of  adverse  menstrual  events,  overall   levels  of  user  satisfaction  are   high.   Furthermore,   implants   have   higher   continuation   rates   than   most   other   reversible   methods.  According  to  a  recent  Cochrane  review,  implants  have  continuation  rates  as  high  as   82  percent  after  two  years.    8VHUV¶�DWWLWXGHV�DERXW�VLGH�HIIHFWV�DUH�VWURQJO\�LQIOXHQFHG�E\�WKH� quality   of   information   and   counseling   provided.   Evidence   indicates   that   thorough   pre-­ insertion   counseling   can   help  women   accept   side   effects   and,   as   a   result,   can   reduce   their   early   discontinuation   of   the   method.   Providers   should   address   not   only   menstrual   disturbances  but  also  the  possibility  of  infection  at  the  insertion  site,  the  fact  that  implants  do   not   protect   against   HIV   or   other   STIs,   the   availability   of   removal   services,   and   other   contraceptive  options.         �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      9     Although   increased   use   of   implants   could   substantially   reduce   the   numbers   of   unintended   pregnancies,   abortions,   and   maternal   deaths,   worldwide   use   of   implants   is   low.   Among   married  women  between   the  ages  of  15  and  49  around   the  globe,  53  percent  use  a  modern   method   of   contraception   but   less   than   one   percent   use   implants.    A   study   of  HIV-­positive   pregnant  women   in  Rwanda   found   that  when  access   to   long-­acting   reversible  contraceptive   methods   was   provided,   a   substantial   number   of   women   chose   to   initiate   use   of   hormonal   implants,  but  not  IUDs.  This  suggests  a  need  for  improved  access  to  implants  for  postpartum   family   planning   and   for   HIV-­positive   women.   Several   studies   have   investigated   the   effectiveness   and   acceptability   of   the   implant   as   a  method   of   contraception   for   adolescent   mothers  after  pregnancy.       Guidance   for   effective   implant   introduction   and   scale-­up   is   available   for   providers   and   managers.   An   online   toolkit   on   contraceptive   implants   provides   up-­to-­date   and   accurate   information  on  training,  guidance  on  best  practices,  and  resources  and  tools  to  help  improve   access  to  and  quality  of  services:  http://www.k4health.org/toolkits/implants.     2. Emergency  contraception       Overview   This   description   refers   to   the   main   method   of   emergency   contraception   (EC)   currently   available  around   the  world,   the   levonorgestrel-­alone  dedicated  product.  While   several  other   compounds  ±  as  well  as  IUDs  ±  can  be  used  as  emergency  contraception,  the  LNG  product  is   the   only   one   that   is   widely   available   in   developing   countries.   The   levonorgestrel-­alone   emergency   contraceptive   pill   (ECP)   is   optimally   taken   in   one   dose   of   1.5  mg,   as   soon   as   possible  after  sexual  activity.  A  product  containing  two  tablets  of  0.75  mgs  each,  labeled  to   be  taken  12  hours  apart,  is  widely  available.     A  survey  of  40  developing  countries  conducted  by  JSI/DELIVER  found  that  ECP  was  most   often   offered   in   the   commercial   sector   (81   percent   of   countries)   followed   by   NGOs   at   58   percent  and  the  public  sector  at  54  percent.  Thus,  EC  occupies  a  somewhat  different  market   position  than  many  other  contraceptive  methods   that  require   the   involvement  of  a  clinician;;   WKHUH�DUH�EHQHILWV�DQG�GLVDGYDQWDJHV�WR�(&¶V�VWUHQJWK�LQ�WKH�SULYDWH�VHFWRU�     $�PDMRU�UHVWULFWLRQ�RQ�ZRPHQ¶V�XVH�RI�(&�LV�WKHLU�YHU\�ORZ�UDWHV�RI�DZDUHQHVV�RI�(&�LQ�PRVW� developing  countries  as  captured   in  DHS  surveys.  Because  EC   is  generally  accessed  at   the   pharmacy  level  women  must  know  about  it  in  order  to  seek  it  out.  In  this  regard,  EC  differs   significantly  in  the  commodity  and  supply  chain  issues  from  the  other  two  methods  described   here.   It   offers   important   lessons   for   other   more   user-­initiated   reproductive   health   technologies,  such  as  misoprostol  at  the  community  level  to  prevent  post-­partum  hemorrhage.       This   method   is   of   particular   importance   for   all   those   who   have   a   limited   access   to   contraceptives,  adolescents  in  particular.           �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      10     Policy  issues  related  to  emergency  contraception     Emergency  contraception   is  well-­supported  by  policies  at   the  global   level.   It   is   included  as   SDUW�RI�WKH�:RUOG�+HDOWK�2UJDQL]DWLRQ¶V�Model  List  of  Essential  Medicines  and  is  included  in   norms,   protocols   and   guidelines   issued   by   global   organizations   such   as   the   International   Federation   of   Gynecology   and   Obstetrics   (FIGO).   An   EC   product   is   registered   in   most   developing  and  developed  countries;;  where  a  product  is  not  registered  it  is  generally  because   of  conservative  policies  and  a  conflating  of  EC  with  abortion  (this  is  the  case  in  Costa  Rica,   Honduras  and  the  Philippines).     EC   is   safe   and   appropriate   for   dispensing   without   a   prescription   by   a   pharmacist   or   drug   seller.  Currently,  it  is  registered  as  a  non-­prescription  product  in  over  50  countries,  including   many   lower   income   countries.   Additionally,   it   is   available   directly   from   pharmacists   informally  even  in  many  developing  countries  where  it  is  registered  as  a  prescription  product.       In   some   countries,   EC   faces   opposition   due   to   confusion   with   abortion,   and   general   opposition  to  family  planning  methods.  Legal  restrictions  on  sale  or  use  are  rare  but  do  exist   in   a   few   countries.   More   commonly,   restrictions   on   access   are   due   to   unnecessary   prescription  requirements  or  lack  of  provision  in  the  public  sector.     Regulation   There  are  currently  over  60  manufacturers  of  EC.  Of  these  only  two  have  received  stringent   regulatory  approval  from  the  U.S.  Food  and  Drug  Administration  (USFDA)  or  the  European   Medicines   Agency   (EMA);;   they   are   products   manufactured   by   Gedeon   Richter   and   HRA   Pharma.  One  product  has  received  WHO  Prequalification   �*HGHRQ�5LFKWHU¶V���7KH�RSWLPXP� formulation   of   the   drug   (the   one-­pill   product)   is   patented   and   the   two-­pill   non-­patented   product   is  more  widely  available   to  women   in  developing  countries.  Because  EC   is  widely   used   in   the   developed   world   (Europe   and   USA)   it   is   subject   to   extensive   post-­marketing   surveillance  and  has  been  found  to  be  safe.     Financing   EC  has  found  its  niche  in  the  commercial  sector.  Globally,  the  majority  of  EC  that  is  used  is   purchased  by  women  for  their  own  use  in  the  commercial  sector;;  this  is  true  in  the  developed   and   developing   countries   alike.   Donor   support   is   required   for   this   method   specifically   to   promote  equitable  access  for  poor  women  who  seek  services  from  the  public  sector,  for  post-­ rape   care   (usually   provided   in   public   hospitals)   and   for   crisis   and   post-­conflict   settings.   Donor  support  is  needed  for  programming,  including  training  providers  and  making  women   more  aware  of  EC.    Because  women  generally  pay  for  EC  out  of  pocket,  attention  should  be   paid  to  affordability  and  comparative  cost  of  EC  compared  to  other  family  planning  methods.       Monitoring  and  evaluation   Increasingly  EC  is  being  tracked  in  DHS  surveys  and  country-­level  monitoring  systems.  This   should  be  encouraged  and  strengthened.       �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      11     Manufacturing:  Package,  dose,  formulation,  instructions   Currently   the   package,   dose   and   instructions   are   adequate   but   not   optimum   due   to   patent   issues.  The  ideal  EC  package  is  a  single  pill  formation  which  is  currently  under  patent  in  both   developed   countries   and   member   states   of   the   African   Regional   Intellectual   Property   Organization.   There   are   instances   of  developing   countries   selling   a  generic   version   of   the   single-­pill  formulation,  but  the  majority  of  the  product  sold  outside  of  Europe  and  the  US  is  a   two-­pill  formulation.  The  benefits  of  the  single  pill  formulation  are  ease-­of-­use;;  there  are  no   safety  or  effectiveness  issues  associated  with  the  two-­pill  formulation.   Supply  chain  management   EC,   like  other  new  and  underutilized  commodities,   can  prove  challenging   for   supply  chain   management.  Forecasting  in  particular  is  difficult  with  little  historical  data.  Since  EC  is  still   little  known  by  health  care  providers,  there  have  been  examples  of  countries   (such  as  Kenya   and   Uganda)   that   have   purchased   EC   for   their   public   sector   services   only   to   see   it   underutilized   as   providers   did   not   order   it   for   their   clinics.   Programming   must   always   accompany  supply.     Demand  by  consumers  and  accessibility   Because   many   consumers   prefer   to   access   EC   from   the   commercial   and   social   marketing   sectors,   they   need   to   learn   about   it   outside   of   clinic   services.  Media,   social   marketing   and   other  demand  generating  strategies  are  all  very  important.       3. The  female  condom     Overview   While   a   range   of   contraceptives   protect   against   unintended   pregnancies,   only   condoms² male   and   female²provide   dual   protection   by   stopping   HIV   transmission   and   preventing   unintended  pregnancies.      Male  and  female  condoms,  when  used  consistently  and  correctly,   are   highly   effective   at   preventing   sexually   transmitted   infections   (STIs),   including   HIV.   Indeed,   male   and   female   condoms   are   central   to   efforts   to   halt   the   spread   of   HIV   as   recognized  at   the   International  Conference  on  Population  and  Development   in  1994  as  well   as   by   the   UNGASS   Political   Declaration   on   HIV/AIDS,   adopted   unanimously   by   United   Nations  Member   States   on   2   June   2006   and   10   June   2011   respectively.   In   particular,   the   female   condom   is   currently   the   only   technology   that   gives   women   and   adolescent   girls   greater  control  over  protecting  themselves  from  HIV,  other  STIs  and  unintended  pregnancy.   The  product,  however,  has  not  yet  achieved  its  full  potential  due   to   inadequate  promotional   activities,  insufficient  supply  and  comparatively  higher  cost  than  male  condoms   (there  is  no   fixed  price,  but  the  average  price  is  about  $0.57  for  a  female  condom  versus  $0.03  for  a  male   latex  condom).         The  total  need  for  family  planning  condoms  in  low-­  and  middle-­income  countries  in  2015  is   estimated   at   almost   5   billion   pieces,   according   to   a   report   by   the   Reproductive   Health     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      12     Supplies   Coalition   report   that   estimates   condom   requirements   separately   (those   used   primarily   for   family   planning   and   those   used   primarily   for   prevention   of   HIV   and   other   sexually  transmitted  infections).  The  total  for  both  purposes  would  be  nearly  18  billion  pieces   in   2015.   Large   countries   such   as   Brazil,   China,   India   and   South   Africa,   however,   do   not   depend  on  donors  for  their  condom  supply,  For  this  reason,  the  requirement  for  donor  support   is  much  less:  approximately  4.4  billion  pieces  in  2015  of  which  2.4  billion  are  for  STI/HIV   prevention   and  2   billion   are   for   family   planning.   (Reproductive  Health  Supplies  Coalition,   2009)     Policy  ʹ  Guidelines,  protocols,  technical   Condoms, both male and female, are currently the only available and most effective technology to prevent HIV and other sexually transmitted infections, as well as unintended pregnancies, among sexually active people. They are inexpensive, cost-effective, do not need a prescription, have no side effects4, and can be used by every sexually active person in need of a barrier method. An  estimated  10  billion  condoms  are  needed  every  year  to  cover  all  risky  sex  acts.  In  2010,   2.8   billion   male   condoms   and   18   million   female   condoms   were   provided   by   the   donor   community,  mostly  to  sub-­Saharan  Africa.  Though  the  number  of  condoms  distributed  by  the   private  sector   is  not  known,   this  market   is  almost  nonexistent   in   sub-­Saharan  Africa,  where   commodity  support,   including  male  and  female  condoms,   is  heavily  dependent  on  donation   from  development  partners.     One  female  condom  was  distributed  for  every  13  women  of  reproductive  age  in  sub-­Saharan   Africa  in  2010.  Nine  male  condoms  were  available  for  every  adult  male  of  reproductive  age   in  sub-­Saharan  Africa.  These  results  were  confirmed  by  a  USAID  review  of  16  sub-­Saharan   countries  in  2010,  which  noted  large  variations  the  availability  of  male  and  female  condoms:5       The   review   identified   large   variations   in   condom  availability²ranging   from   nearly   30  male  condoms  per  man  per  year  in  Zimbabwe  to  only  1.1  male  condoms  per  man   SHU�\HDU�LQ�&{WH�G¶,YRLUH²among  the  14  countries  for  which  data  were  available.  The   median  average  availability  of  male  condoms  was  9.65  condoms  per  man  per  year.   While  no  standard  guidance  exists  on  the  appropriate  number  of  condoms  needed  per   man  per  year  to  protect  against  HIV  infection,  less  than  10  condoms  per  man  per  year   appears  at  face  value  to  be  insufficient  given  the  number  of  sex  acts  that  are  likely  to   take  place  in  one  year.  Female  condom  availability  was  significantly  lower  than  male   condom  availability  in  all  countries.  With  the  exception  of  Zimbabwe,  less  than  one                                                                                                       4  People  with  an  allergy  or  intolerance  for  latex  should  refrain  from  using  latex  male  or  female  condoms.   5  The   review   focused   on   16   countries   in   sub-­6DKDUDQ�$IULFD��%RWVZDQD��&{WH� G¶,YRLUH��(WKLRSLD�   Kenya,   Lesotho,  Malawi,  Mozambique,  Namibia,  Nigeria,  Rwanda,  South  Africa,   Swaziland,  Tanzania,  Uganda,   Zambia,  and  Zimbabwe.     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      13     female  condom  per  woman  per  year  was  available.  With  the  exception  of  Zimbabwe,   less  than  one  female  condom  was  available  per  woman  aged  15-­64  in  all  14  countries   and  the  average  availability  of  female  condoms  was  148  times  lower  than  that  of  male   condoms.         Despite  years  of  advocacy  with  parliamentarians  and  other  stakeholders,  the  vast  majority  of   low-­   and  middle-­income   countries   do   not  have   a   budget   line   for  male   and   female   condom   acquisition.   If   condoms   are  mentioned   in   policies,   female   condoms   are   rarely   included,   or   only  for  high  risk  groups  and  not  as  a  family  planning  commodity.     Though  new  HIV  prevention  strategies  and  policies  at  the  global  level  have  integrated  female   condoms  as  a  vital  commodity  for  protection6,  this  is  still  not  the  case  in  many  countries.  The   female  condom  is  not  included  in  the  2010  WHO  Model  List  of  Essential  Medicines,  making   it  difficult  for  countries  to  enter  it  in  their  national  essential  list  of  commodities.     A  number  of  new  female  condom  (FC)  products  are  available  in  limited  distribution  in  some   countries   or   are   in   the   development   process.   The   Cupid   FC,   made   in   India   has   a   limited   global  distribution.  The  Phoenurse  FC  is  available  in  China,  with  approval  from  the  Chinese   State   Food   and   Drug   Administration   (SFDA)   and   European   CE   marking   (Conformité   Européene).  The  ,QQRYD�4XDOLW\�6�$�6�³&RQGRQ�)HPHQLQR´�)&6�3DQW\�&RQGRP�LV�DYDLODEOH� in   Colombia,   with   (XURSHDQ� &(� PDUNLQJ�� 7KH� :RPDQ¶V� &RQGRP� LV� DYDLODEOH� LQ� OLPLWHd   distribution   channels   in   China,   including   online,   and   has   Chinese   SFDA   approval   and   European   CE   marking.   All   of   these   female   condoms   are   currently   under   review   by   the   WHO/RHR  Female  Condom  Technical  Review  Committee  to  determine  their  suitability  for   public-­sector  purchase.  The  Origami  FC  made  of  silicone  is  still  being  developed  and  plans   to  test  the  device  for  its  reusability  potential  will  be  a  part  of  future  testing.       Regulation   The   most   widely   distributed   female   condoms   are   FC2,   produced   by   the   Female   Health   Company.  Today,  FC2   is   the   only   female   condom   to  have   completed   the   technical   review   process  by  the  WHO,  which  found  it  acceptable  for  bulk  procurement  by  all  United  Nations   agencies  in  2007,  followed  by  USFDA  approval  in  2009.       As  noted  above,  other  female  condoms  (e.g.  Cupid  FC  in  India,  the  Natural  Sensations  Panty   Condom   in  ColoPELD��DQG�:RPHQ¶V�&RQGRP� LQ�&KLQD��KDYH� UHFHLYHG� WKH�&(�PDUNLQJ� IRU� sale  in  Europe  and  are  in  limited  global  distribution.  The  Phoenurse  FC  is  available  in  China.     These  new  condoms  are  currently  under  review  by  the  WHO/UNFPA  Technical  Committee   to  determine  their  suitability  for  public-­sector  purchase.                                                                                                               6  Among  others  UNFPA,  UNAIDS,  PEPFAR,  USAID,  DFID     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      14     Financing  ʹ  Traditional,  innovative   The   vast   majority   of   female   condoms   are   procured   and   donated   by   the   international   community   to   low  and  middle   income  countries.   In  2010,  more   than  90  percent  of  supplies   went  to  sub-­Saharan  Africa,  and  most  of  the  remaining  went  to  Asia.       In   terms   of   trends   in   donor   expenditures   for   female   condoms,   there  was   an   increase   from   2007   to   2008   of   about   $2  million   and   then   a   sharp   rise   in   2009,   doubling   support   by   all   donors   for   the   procurement   of   female   condoms   from   $14  million   to   $29  million.   In   2010,   GRQRUV¶�VXSSRUW�IRU�WKH�SURFXUHPHQW�RI�IHPDOH�FRndoms  significantly  decreased  to  about  $12   million.  A  relatively  small  number  of  countries  use  domestic  funds  to  buy  female  condoms,   including  Botswana,  Brazil,  India  and  South  Africa.       Female   condoms   remain   very   expensive   to   procure.   It  was   expected   that   the   new  material   used  to  produce  FC2  would  result  in  a  significant  reduction  of  the  price.  Though  the  price  did   drop  by  25  percent,   the  average  FC2  unit  cost   is  still   $0.57  which   is  almost  20   times  more   costly   than  male   condoms   ($0.03).  Given   the   fact   the   female   condom   is  more   complex   to   produce  than  the  male  equivalent  and  that  more  materials  are  used,  the  cost  will  never  be  as   low  as  the  male  condom.  However,  female  condom  experts  expect  a  drop  in  the  procurement   price   to  at   least   $0.35  per  unit.  A  combination  of   increased  demand,   increased  competition   (because   of  more  WHO  prequalified   female  condom  models   from  different  manufacturers)   and  pooled  procurement  could  result  in  even  lower  prices.       Female  condom  programming  requires  at   least   four   to  five   times   the  product  cost   to  ensure   that   service   providers   are   adequately   trained   and   that   educational   materials   including   demonstration   models   are  made   available   to   women   and   couples.   This   is   particularly   true   when   first   introducing   the   female  condom   in  an  area.  As   the   results  of   the   female  condom   programme  in  Zimbabwe  show,  female  condom  programme  costs  do  decrease  over  the  years   as  more  people  acquire  knowledge  on  the  female  condom  and  its  use.       Unlike  male  condom  distribution,  there  is  currently  no  private  sector  involvement  in  the  sale   of  female  condoms  at   the  country   level,  with   the  exception  of  small  enterprises  distributing   condoms  through  social  marketing.     Monitoring  and  evaluation,  and  information  systems   The  female  condom  is  not  integrated  into  any  monitoring  and  evaluation  system  at  the  global   nor,   for  most   countries,   at   the   national   level.   This  makes   it   difficult   to  measure   its   added   value  as  an  HIV  prevention  option  or  an  effective  contraceptive.    Special  studies  to  assess  the   impact   of   the   female   condom   on   STI/HIV   prevention,   cost-­effectiveness   studies   or   efficacy/effectiveness  studies,  have   received   limited   funding   in   the  past  decades.    The  only   research   data   that   exists   on   female   condoms   are   related   to   the   original   or   first   generation   female   condom   (FC1).   The   PATH   :RPDQ¶V� &RQGRP   is   currently   being   assessed   as   a   contraceptive  method.       �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      15     Manufacturing:  Package,  dose,  formulation,  instructions   The  first  female  condom  (FC1)  was  introduced  on  the  market  by  the  Female  Health  Company   in  1992.  This  female  condom,  made  of  polyurethane,  has  been  replaced  by  a  new  version,  the   FC2.  This  condom   is  nearly   identical   to   its  predecessor  but   is  made  of  synthetic  nitrile  and   considerably   less   expensive   to   manufacture.   After   technical   consultation   with   WHO   in   January   2006   to   review   the   new   female   condoms  dossier,   experts   concluded   that  FC2  was   compatible   with   FC1   and   recommended   it   for   UNFPA   procurement   for   public   sector   programmes.  Production  of  the  FC1  has  since  ceased.     More  manufacturers  are  currently  in  the  process  of  either  developing  a  female  condom  or  are   having   their   model   assessed   by   WHO   for   prequalification.   A   thorough   but   quick   prequalification  procedure  would  mean  a  big  step  towards  more  choice  and  variety  and  more   competition  and  therefore  lower  prices  on  the  international  female  condom  market.  This  will   facilitate  more  and  better  access  for  men  and  women  who  want  to  use  them  and  who  would   highly  benefit  from  the  female  condom.       An  important  aspect  of  programming  is  the  marketing  of  the  condom,  as  was  the  case  for  the   male  condom  when  it  was  introduced  to  new  markets.    To  make  it  an  attractive  and  appealing   product,  presentation  and  marketing  needs  to  be  taken  into  account.       Acceptability  of  the  female  condom   Women   may   be   able   to   negotiate   use   of   the   female   condom   more   easily   than   the   male   condom,  giving  them  potentially  more  power   to  protect   themselves   in  a  sexual  relationship.   But   the   female   condom   must   be   acceptable   to   both   men   and   women   in   order   to   be   used   consistently   and   correctly,   thus   providing   effective   protection   against   sexually   transmitted   infections  and  pregnancy.     Studies   conducted   in  more   than   40   countries   in  Africa,  Asia,   Europe,   Latin  America     and   North  America   have   found   good   initial   acceptability   of   the   device   by   people  with   varying   sexual  histories,  ages,  social  situations  and  economic  status.  Acceptance  rates  in  these  studies   varied  widely,  from  37  percent  to  96  percent  of  study  participants.1  More  research  is  needed   to   confirm  whether   initial   acceptors   continue   female   condom   use   over   time.  Research   and   programme  experience  suggest  several  conclusions:     x Counseling  helps  overcome  women's  initial  difficulties  in  using  the  device;;     x Directing  promotion  campaigns  to  men  and  providing  women  with  negotiation  skills   are  important  to  overcome  men's  resistance  to  use;;  and     x Over   time,  use   tends   to  become  concentrated  among  a   subset  of  women  or  couples   with  high  motivation  to  use  it.       Supply  chain  management   Poor  distribution  systems  significantly  restrict  male  and  female  condom  accessibility.  When   donors   ship   large   numbers   of   condoms   to   a   country,   they   are   not   always   distributed   in   an   effective   and   efficient   manner,   contributing   to   their   decreased   accessibility   for   end-­users.     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      16     Problems  with  distribution  systems  may  be  due   to  a   lack  of   transport  capacity   (particularly   availability  of  vehicles)  and  poor   infrastructure   such  as   roads  and  bridges,  which  can  make   distribution   to   rural  and   remote  areas  difficult.  UNFPA  estimates   that   in  Mozambique  only   25  percent  of  condoms  provided  by  USAID  and  UNFPA  reached  end-­users  in  2008,  and  that   85   percent   of   the   available   50  million   public   sector   condoms   sat   in   central  warehouses   in   June   2009.   This   was   largely   a   result   of   limitations   in   space   available   in   vehicles   due   to   increased  distribution  of  HIV  essential  drugs  and  treatment  commodities.         Demand  for  prescription  and  availability  of  services/products   The   female   condom   does   not   require   a   prescription   but   is   based   on   user-­awareness   of   the   method  and  its  benefits.    It  is  often  distributed  free  of  charge  or  at  a  very  subsidized  price  by   NGOs,  community-­based  organization  or  public  sector  organizations.  It  is  a  coital  dependent   method,   which   necessitates   some   training   for   proper   insertion.   The   female   condom   is   a   visible  internal  device,  effective  and  recommended  for  penile-­vaginal  intercourse.  The  female   condom  also  has  been  reported  for  use  for  penile-­anal  intercourse  but  research  on  this  topic  is   YHU\�OLPLWHG���,Q�HLWKHU�FDVH��LW�LQYROYHV�WKH�WZR�SDUWQHUV¶�FROODERUDWLRQ�IRU�XVH��     Demand  by  consumers  and  accessibility   The   female   condom   is   a   powerful   dual   protection   tool   that   has   been  much   neglected.   The   female  condom  is  barely  available  to  women  and  couples  to  protect  themselves  when  needed.     As  discussed  above,  acceptability  of  the  female  condom,  once  consumers  are  educated  about   the  product  and  its  usage,  is  not  the  issue.  It  is  the  accessibility,  availability  and  affordability   of   the   female   condom   that   hampers   the   demand   and   uptake.   When   governments   do   not   include  female  condom  in  their  prevention  programmes,  when  there  is  little  variety  of  choice   like   with   the   male   condom,   the   female   condom   remains   an   unknown   answer   to   the   often   posed   question   of   family   planning.   Men   and   women   need   to   be   able   to   make   the   choice   whether   they   want   to   use   a   male   or   female   condom   when   they   are   looking   for   a   dual   protection  method.  Currently  that  choice  is  rarely  an  option.     Barriers  to  the  accessibility  and  availability  of  female  condoms  limit  demand  and  uptake:   x There  is  no  budget  line  in  most  national  programmes  for  FC  procurement;;   x Limited  funds  are  allocated  to  programming  including  human  resources  for  education   and   promotion,   job   aids,   demonstration   models,   raising   awareness   campaigns   and   more.  Without  proper  and  adequate  training  and  demonstration,  men  and  women  who   want  to  use  the  female  condom  for  the  first  time  can  experience  difficulties  inserting   the   tool   correctly   and  may   feel   intimidated   or   discouraged.  With   practice,   insertion   becomes  easy;;   x Global  public  sector  distribution  of  female  condoms  was  about  35  million  in  2010  (50   million   in   2009)   for   all   sexually   active   women   at   risk   of   HIV   and   unintended   pregnancy  and  whose  partner  is  reluctant  to  use  a  male  condom.  That  translates  to  1   female  condom  available  for  13  women  in  sub-­Saharan  Africa,  most  hit  by  the  HIV   epidemic;;  and     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      17     x The   female   condom   is   absent   from   the   contraceptive   mix   of   family   planning   products.     Areas  of  need  and  potential  impact,  with  country  examples   Effective  female  condom  interventions  can  increase  the  proportion  of  protected  sex  acts  and   decrease   STI   prevalence.   The   contribution   of   the   female   condom   to   overall   increased   protection   and   decreased   prevalence   of   STIs   depends   on   who   uses   it,   how   correctly   and   consistently  it  is  used,  and  whether  it  is  a  substitute  for  the  male  condom.  The  female  condom   is  also  likely  to  reach  women  in  relationships  in  which  other  barrier  methods  have  not  been   used,  and  to  help  empower  women  in  negotiating  safe  sex.       Several  studies  show  that  providing  the  female  condom  as  part  of  a  comprehensive  preven-­ tion   strategy   results   in   increased   levels   of   protection.7  Protected   sex   among  women   in   the   United  States  and  Brazil  doubled  after  they  received  female  condoms  and  counseling  on  their   correct  use.    In  Madagascar,  protected  sex  increased  by  10  percent  among  sex  workers  due  to   their  use  of  the  female  condom.  Studies  in  other  countries,  including  Kenya,  Nigeria,  South   Africa,  the  United  States,  Zambia  and  Zimbabwe  found  that  encouraging  use  of  either  male   or   female   condoms   contributed   to   increases   in   the   proportion   of   protected   sex   acts.  When   both   types  of  condoms  are  available,   consistent  condom  users  often  alternate  use  of   female   and  male  condoms.  These  studies  provide  important  evidence  that  the  female  condom  is  not   just  a  substitute  for  the  male  condom,  but  is  complementary  and  contributes  to  increased  use   of  both  types  of  condoms.                                                                                                                     7  Vijakumar   G,   Mabude   Z,   Smit   J,   Beskinska   M,   Lurie   M.   A   review   of   female   condom   effectiveness;;   patterns  of  use  and  impact  on  protected  sex  acts  and  STI  incidence,  Int  J  STD  AIDS  2006.     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      18     C. RECOMMENDATIONS  FOR  FOCUS  BY                                         UN  COMMISSION       Contraceptive  implants   Contraceptive   implants   offer   a   safe   and   effective   means   of   contraception   to   those   women   who  seek  a  long-­acting  contraceptive  product  that   is  private  in  use  and  can  be  used  for  both   spacing  and  limiting  births  for  women  of  reproductive  age.         We   therefore   call   on   the   United   Nations   Commission   on   Life-­Saving   Commodities   for   Women  and  Children  to  advocate  to  governments  and  the  donor  community  to  expand  their   support  to:   x Further   expand   innovative   financing   strategies   for   subsidizing   the   cost   of   procurement  and  provision  of  implant  services  as  well  as  the  cost  to  users.  (Market   Shaping)   x Support  efforts  by  health  systems  to  adopt  policies  and  guidelines  for  the  provision   of   implant   services,   both   insertion   and   removal,   by   a   range  of   qualified   providers,   which   may   include   physicians,   nurses   and   other   paramedical   personnel   where   competency  is  assured.  (Regulatory  Environment)   x Ensure   access   to   safe   removal   of   implants   for   all   women   either   at   the   time   the   product  loses  efficacy  according  to  the  label  or  whenever  the  women  would  like  to   have  it  removed  for  any  reason.  (Regulatory  Environment)   x Improve   record   keeping   on   both   users   and   supplies   of   implants   to   ensure   timely   access   to   removal,   as   well   as   reporting   on   the   specific   product   used   for   better   forecasting  of  the  need  for  implants  and  related  supplies.  (Regulatory  Environment)   x Review  medical  eligibility  criteria   for  women   to  use   implants,  eliminating  medical   barriers  to  their  use  due  to  age,  parity  or  exposure  to  the  risk  of  HIV  acquisition  or   transmission.  (Regulatory  Environment)     Emergency  contraception   Emergency  contraception  is  a  unique  family  planning  method  that   is  woman-­controlled  and   can  be  used  as  needed  to  substantially  lower  the  risk  of  pregnancy  from  an  individual  act  of   coitus.  It  can  safely  be  provided  in  pharmacy  settings  without  clinical  supervision,  so  it   is  a   good  fit  for  the  commercial  and  social  marketing  sectors.     We   therefore   call   on   the   UN   Commission   to   advocate   to   governments   and   the   donor   community  to  expand  their  support  to:   x Support   and   strengthen   quality   assurance  mechanisms   at   the   country,   regional   and   global  levels,  includinJ�:+2¶V�3UHTXDOLILFDWLRQ�ZRUN.  (Regulatory  Environment)     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      19     x Support  the  capacity  of  the  pharmacy  and  drug-­selling  sectors  to  provide  high  quality   family  planning  products  and  advice.  (Regulatory  Environment)   x Ensure   that   supplies   are   coupled   with   programmatic   support   (e.g.   training   of   providers,  strengthening  of  clinic  systems  in  all  cases  to  ensure  that  commodities  that   are  purchased  are  pulled  through  the  system  and  delivered  at  service  delivery  points.   (Market  Shaping)   x Support  evidence-­based  advocacy  to   incrHDVH�ZRPHQ¶V�DZDUHQHVV�RI�D�IXOO� UDQJH�RI� contraceptive   options   and   reduce   provider   and   systemic   barriers   to   access   to   all   contraceptive  methods.  (Best  Practices,  Innovation)     Female  condom   The   male   and   female   condoms   are   the   only   technology   currently   available   that   enables   women  to  protect  themselves  against  unintended  pregnancies  and  sexual  transmitted  diseases.     When  men  are   reluctant   to  use  a  male  condom,  women  and  girls  are   left  with  only   female   condom  as  a  choice.    Access  to  the  female  condom  will  empower  them  by  giving  them  more   control  over  their  own  bodies  and  reproductive  health.  It  offers  a  life-­saving  alternative  when   male  condoms  are  not  used  and  helps  reduce  unprotected  sexual  activity.       We   therefore   call   on   the   UN   Commission   to   advocate   to   governments   and   the   donor   community  to  expand  their  support  to:     x Create   an   enabling   environment   among   policy  makers   and   providers   so   that   users   will   be  made   aware   of   their   risk,   feel   free   to  demand   and  access  male   and   female   condoms  and  have  the  knowledge  to  use   them  correctly  and  consistently.   (Demand   Generation)   x Augment   their   funding   for   essential   commodities,   including   male   and   female   condoms  for  HIV  prevention  and  as  a  dual  protection  method.      (Market  Shaping  or   Innovation  Strategies  for  Demand  Generation)   x Allocate   funds   for   integrated   programming,   including   capacity-­strengthening   for   service   provision,   global   awareness   campaigns   on   the   role   of   condoms,   demand-­ creation  to  stimulate  and  sustain  their  use,  and  monitoring  and  evaluation  systems  to   improve  programme  delivery  and  measure  the  effectiveness  and  impact  of  condom   use.  (Strategies  to  Increase  Demand,  Innovation  for  Scaling  Up)   x Allocate   financial   resources   to   female   condom   research   and   development.  Having   only   one   female   condom   manufacturer   whose   product   is   approved   by  WHO   and   FDA  is  too  risky.  In  case  that  company  ceases  production,  women  and  couples  will   be  left  with  no  alternative  to  female  condoms  in  the  fight  of  sexually  transmission  of   HIV  and  dual  protection.  (Regulation)           �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      20     D. CITED  WORKS  &  SUPPLEMENTARY  MATERIAL     Contraceptive  implants   A  peer-­reviewed   synthesis   of   existing   information   on   contraceptive   implants   can   be   found   here:  http://www.path.org/publications/files/RHSC_implants_br.pdf     1. Adams  K,  Beal  MW.  Implanon:  a  review  of  the  literature  with  recommendations  for   clinical  management.  J  Midwifery  Womens  Health.  2009;;54(2):142-­9.  (abstract)   2. Arribas-­Mir  L,  Rueda-­Lozano  D,  Agrela-­Cardona  M,  et  al.  Insertion  and  3-­year   follow-­up  experience  of  372  etonogestrel  subdermal  contraceptive  implants  by   family  physicians  in  Granada,  Spain.  Contraception.  2009;;80(5):457-­62.  (abstract)   3. Ba  MG,  Moreau  JC,  Sokal  D,  et  al.  A  5-­year  clinical  evaluation  of  Norplant®   implants  in  Senegal.  Contraception  1999;;59(6):377-­81.  (abstract)   4. Bachmann  G,  Korner  P.  Bleeding  patterns  associated  with  non-­oral  hormonal   contraceptives:  a  review  of  the  literature.  Contraception.  2009;;79(4):247-­58.   (abstract)     5. Blumenthal  PD,  Gemzell-­Danielsson  K,  and  Marintcheva-­Petrova  M.  Tolerability   and  clinical  safety  of  Implanon.  Eur  J  Contracept  Reprod  Health  Care   2008;;13(S1):29-­36.  (abstract)   6. Brache  V,  Blumenthal  PC,  Alvarez  F,  et  al.  Timing  of  onset  of  contraceptive   effectiveness  in  Norplant®  implant  users  II:  Effect  on  the  ovarian  function  in  the  first   cycle  of  use.  Contraception  1999;;59(4):245-­51.  (abstract)   7. Carson-­DeWitt  R.  Contraceptive  Implants:  Safe,  Effective,  Long-­Acting,  Reversible.   Global  Health  Technical  Briefs.  Family  Health  International,  2007.  (full  text)   8. Contraceptive  Implants  Fact  Sheet.  Reproductive  Health  Supplies  Coalition.  (full   text)     9. Coukell  AJ,  Balfour  JA.  Levonorgestrel  subdermal  implants.  Review  of  contraceptive   efficacy  and  acceptability.  Drugs  1998;;55(6):861-­887.  (abstract)   10. Croxatto  HB.  Progestin  implants.  Steroids  2000;;65(10-­11):681-­685.  (abstract)   11. Diab  KM,  Zaki  MM.  Contraception  in  diabetic  women:  comparative  metabolic  study   of  norplant,  depot  medroxyprogesterone  acetate,  low  dose  oral  contraceptive  pill  and   CuT380A.  J  Obstet  Gynaecol  Res  2000;;26(1):17-­26.  (abstract)   12. Dhont  N,  Ndayisaba  GF,  Peltier  CA,  Nzabonimpa  A,  Temmerman  M,  van  de  Wijgert   J.  Improved  access  increases  postpartum  uptake  of  contraceptive  implants  among   HIV-­positive  women  in  Rwanda.  Eur  J  Contracept  Reprod  Health  Care.   2009;;14(6):420-­5.    (abstract)     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      21     13. Dorflinger  LJ.  Metabolic  effects  of  implantable  steroid  contraceptives  for  women.   Contraception  2002;;65(1):47-­62.  (abstract)   14. Faúndes  A,  Alvarez  F,  Brache  V,  et  al.  Endometrial  thickness  and  oestradiol   concentration  in  women  with  bleeding  complaints  during  use  of  Norplant  implants.   Hum  Reprod  1998;;13(1):188-­191.  (abstract)   15. Fischer  MA.  Implanon:  a  new  contraceptive  implant.  J  Obstet  Gynecol  Neonatal   Nurs.  2008  May-­Jun;;37(3):361-­8.  (abstract)   16. Fraser  IS,  Tiitinen  A,  Affandi  B,  et  al.  Norplant  consensus  statement  and  background   review.  Contraception  1998;;57(1):1-­9.  (abstract)   17. French  RS,  Cowan  FM.  Contraception  for  Adolescents.  Best  Pract  Res  Clin  Obstet   Gynaecol.  2009;;23(2):233-­47.  (abstract)   18. Grimes,  DA.  Forgettable  contraception.  Contraception  2009;;80(6):497-­9.  (abstract)   19. Guazzelli  CA,  de  Queiroz  FT,  Barbieri  M,  Torloni  MR,  de  Araujo  FF.  Etonogestrel   implant  in  postpartum  adolescents:  bleeding  pattern,  efficacy  and  discontinuation   rate.  Contraception.  2010  Sep;;82(3):256-­9.   20. Guazzelli  CA,  de  Queiroz  FT,  Barbieri  M,  Torloni  MR,  de  Araujo  FF.  Etonogestrel   implant  in  adolescents:  evaluation  of  clinical  aspects.  Contraception.  2011   Apr;;83(4):336-­9.   21. Hannaford  P.  Postmarketing  surveillance  study  of  Norplant  in  developing  countries.   Lancet  2001;;357(9271):1815.  (excerpt)   22. Hardee  K,  Barkat-­e-­Khuda,  Kamal  GM,  et  al.  Contraceptive  implant  users  and  their   access  to  removal  services  in  Bangladesh.  Intl  Family  Planning  Perspectives.  1994;;   20(20):59-­65.  (full  article)   23. Hohmann  H.  Examining  the  efficacy,  safety,  and  patient  acceptability  of  the   etonogestrel  implantable  contraceptive.  Patient  Prefer  Adherence.  2009  Nov  3;;3:205-­ 11.  (abstract)   24. Hohmann  H,  Creinin  MD.  The  contraceptive  implant.  Clin  Obstet  Gynecol.  2007   Dec;;50(4):907-­17.  (abstract)   25. Hubacher  D,  Dorflinger  L.    Avoiding  controversy  in  international  provision  of   subdermal  contraceptive  implants.    Contraception.  2012²in  press  [January  2012:   Epub  ahead  of  print)   26. Hubacher  D,  Kimani  J,  Steiner  M,  et  al.  Contraceptive  implants  in  Kenya:  current   status  and  future  prospects.  Contraception  2007;;75(6):468-­473.  (abstract)   27. Hubacher  D,  López  L,  Steiner  MJ,  et  al.  Menstrual  pattern  changes  from  LNG   implants  and  DMPA:  systematic  review  and  evidence-­based  summary  measures  to   help  clinicians  and  clients  manage  choice  and  expectations.  Contraception   2008;;78(2):172.  (abstract)       �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      22     28. Hubacher  D,  Mavranezouli  I,  McGinn  E.  Unintended  pregnancy  in  sub-­Saharan   Africa:  magnitude  of  the  problem  and  potential  role  of  contraceptive  implants  to   alleviate  it.  Contraception  2008;;78(1):73-­8.  (abstract)   29. Isley  MM,  Edelman  A.  Contraceptive  implants:  an  overview  and  update.  Obstet   Gynecol  Clin  North  Am  2007;;34(1):73-­90.  (abstract)   30. Lakhi  N,  Govind  A.  Implanon  failure  in  patients  on  antiretroviral  medication:  the   importance  of  disclosure.  J  Fam  Plann  Reprod  Health  Care.  2010  Jul;;36(3):181-­2.   31. Levine  JP,  Sinofsky  FE,  Christ  MF.  Assessment  of  Implanon  insertion  and  removal.   Contraception.  2008;;78(5):409-­17.  (abstract)   32. Lewis  LN,  Doherty  DA,  Hickey  M,  Skinner  SR.  Implanon  as  a  contraceptive  choice   for  teenage  mothers:  a  comparison  of  contraceptive  choices,  acceptability  and  repeat   pregnancy.  Contraception.  2010  May;;81(5):421-­6.   33. Lipetz  C,  Phillips  C,  Fleming  C.  Actual  cost  of  providing  long-­acting  reversible   contraception:  a  study  of  Implanon  cost.  J  Fam  Plann  Reprod  Health  Care.   2009;;35(2):75-­9.  (abstract)   34. Mansour  D.  Nexplanon:  What  Implanon  did  next.  J  Fam  Plann  Reprod  Health  Care.   2010  Oct;;36(4):187-­9.   35. Mansour  D,  Inki  P,  Gemzell-­Danielsson  K.  Efficacy  of  contraceptive  methods:  a   review  of  the  literature.  Eur  J  Contracept  Reprod  Health  Care.  2010  Feb;;15(1):4-­16.   (abstract)   36. Mavranezouli  I.  Health  economics  of  contraception.  Best  Pract  Res  Clin  Obstet   Gynaecol.  2009  Apr;;23(2):187-­98.  (abstract)   37. McCarty  EJ,  Keane  H,  Quinn  K,  Quah  S.  Implanon(R)  failure  in  an  HIV-­positive   woman  on  antiretroviral  therapy  resulting  in  two  ectopic  pregnancies.  Int  J  STD   AIDS.  2011  Jul;;22(7):413-­4.   38. Merki-­Feld  GS,  Imthurn  B,  Seifert  B.  Effects  of  the  progestagen-­only  contraceptive   implant  Implanon  on  cardiovascular  risk  factors.  Clin  Endocrinol.  2008;;68:355-­60.   (abstract)   39. Mutihir  JT,  Daru  PH.  Implanon  sub-­dermal  implants:  a  10-­month  review  of   acceptability  in  Jos,  North-­Central  Nigeria.  Niger  J  Clin  Pract.  2008;;11(4):320-­3.   (abstract)   40. Pathfinder  and  JSI.  Scaling  Up  Community-­Based  Distribution  of  Implanon:  The   ,QWHJUDWHG�)DPLO\�+HDOWK�3URJUDP¶V�ExperienceTraining  Health  Extension  Workers   (full  text)   41. Power  J,  French  R,  and  Cowan  F.  Subdermal  Implantable  Contraceptives  Versus   Other  Forms  of  Reversible  Contraceptives  or  Other  Implants  As  Effective  Methods  of   Preventing  Pregnancy  (Review).  Cochrane  Database  of  Systematic  Reviews   2007;;3(3):1-­31.  (abstract)     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      23     42. Ramchandran  D,  Upadhyay  UD.  Implants:  The  Next  Generation.  Population  Reports.   Series  K:  Injectables  and  Implants  2007:7;;1-­19.  (full  text)   43. Rehan  N,  Inayatullah  A,  Chaudhary  I.  Norplant®:  reasons  for  discontinuation  and   side-­effects.  Eur  J  Contracept  Reprod  Health  Care  2000;;5(2):113-­118.  (abstract)   44. RHInterchange.  Accessed  January  2012.   http://rhi.rhsupplies.org/rhi/index.do?locale=en_US   45. Rivera  R,  Rountree  W.  Characteristics  of  menstrual  problems  associated  with   Norplant  discontinuation:  results  of  a  multinational  study.  Contraception   2003;;67(5):373-­7.  (abstract)   46. Rowlands  S,  Sujan  MA,  Cooke  M.  A  risk  management  approach  to  the  design  of   contraceptive  implants.  J  Fam  Plann  Reprod  Health  Care.  2010  Oct;;36(4):191-­5.   47. Ruddick  C.  Long-­acting  reversible  contraception:  reducing  unintended  pregnancies.   Community  Pract.  2009;;82(9):24-­7.  (abstract)   48. Sarfati  J,  de  Vernejoul  MC.  Impact  of  combined  and  progestogen-­only  contraceptives   on  bone  mineral  density.  Joint  Bone  Spine.  2009;;76(2):134-­8.  (abstract)   49. Sivin  I.  Risks  and  benefits,  advantages  and  disadvantages  of  levonorgestrel-­releasing   contraceptive  implants.  Drug  Saf  2003;;26(5):303-­335.  (abstract)   50. Sivin  I,  Campodonico  I,  Kiriwat  O,  et  al.  The  performance  of  levonorgestrel  rod  and   Norplant®  contraceptive  implants:  a  5  year  randomized  study.  Hum  Reprod   1998;;13(12):3371-­3378.  (abstract)   51. Steiner  MJ,  Boler  T,  Obhai  G,  et  al.  Assessment  of  a  disposable  trocar  for  insertion  of   contraceptive  implants.  Contraception.  2010  Feb;;81(2):140-­2.  (abstract)   52. Steiner  MJ,  Lopez  LM,  Grimes  DA,  Cheng  L,  Shelton  J,  Trussell  J,  et  al.  Sino-­ implant  (II)-­-­a  levonorgestrel-­releasing  two-­rod  implant:  systematic  review  of  the   randomized  controlled  trials.  Contraception.  2010  Mar;;81(3):197-­201.  (abstract)   53. Stringer  EM,  Giganti  M,  Carter  RJ,  et  al.  Hormonal  contraception  and  HIV  disease   progression:  a  multicountry  cohort  analysis  of  the  MTCT-­Plus  Initiative.  AIDS.  2009   Nov;;23  Suppl  1:S69-­77.  (abstract)   54. Thamkhantho  M,  Jivasak-­Apimas  S,  Angsuwathana  S,  et  al.  One-­year  assessment  of   women  receiving  sub-­dermal  contraceptive  implant  at  Siriraj  Family  Planning  Clinic.   J  Med  Assoc  Thai.  2008;;91(6):775-­80.  (abstract)   55. Tolley  E,  Nare  C.  Access  to  Norplant  removal:  an  issue  of  informed  choice.  Afr  J   Reprod  Health  2001;;5(1):90-­9.  (abstract)   56. Tuladhar  J,  Donaldson  PJ,  Noble  J.  The  Introduction  and  Use  of  Norplant  registered   Implants  in  Indonesia.  Studies  in  Family  Planning.  1998;;  29(3):  291-­299  (full   article).       �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      24     57. Tumlinson  K,  Steiner  MJ,  Rademacher  KH,  Olawo  A,  Solomon  M,  Bratt  J.  The   promise  of  affordable  implants:  is  cost  recovery  possible  in  Kenya?  Contraception.   2011;;  83(1):  88-­93.   58. World  Health  Organization.  Prequalification  Programme.  http://apps.who.int/prequal/   59. World  Health  Organization.  Medical  eligibility  criteria  for  contraceptive  use.   Geneva:  WHO,  2009  (full  text)   60. World  Health  Organization.  Selected  Practice  Recommendations  for  Contraceptive   Use.  Geneva:  WHO,  2004  (full  text)   Emergency  contraception   For  general  information  on  EC,  two  websites  are  recommended:  The  Emergency   Contraception  Website,  maintained  by  Princeton  University:  http://ec.princeton.edu/   The  International  Consortium  for  Emergency  Contraception:   http://www.emergencycontraception.org/     1. Cheng L, Gülmezoglu AM, Piaggio G, Ezcurra E, Van Look PF. Interventions for emergency contraception. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD001324. Review. 2. International Federation of Obstetrics and Gynecology and International Consortium for Emergency Contraception. Mechanism of Action: How to Levonorgestrel-alone Emergency Contraceptive Pills (LNG ECPs) Prevent Pregnancy? March 2011. 3. Khan S, Mishra V, Arnold F, Abderrahim N. Contraceptive trends in developing countries [CHS comparative reports 16]. Calverton: Macro International;. 2007. Available from: http://www.measuredhs.com/pubs/pdf/CR16/CR16.pdf[accessed 9 March 2010]. 4. Moreau C, Bouyer J, Goulard H, Bajos N. The remaining barriers to the use of emergency contraception: perception of pregnancy risk by women undergoing induced abortions. Contraception 2005; 71: 202-7 doi:10.1016/j.contraception.2004.09.004 pmid: 15722071. 5. World Health Organization. Medical eligibility criteria for contraceptive use. Geneva: WHO, 2009. 6. World Health Organization. Selected Practice Recommendations for Contraceptive Use. Geneva: WHO, 2004. 7. World Health Organization, International Consortium for Emergency Contraception, International Federation of Obstetrics and Gynecology, and International Planned Parenthood Federation. Fact sheet on the safety of levonorgestrel-alone emergency contraceptive pills (LNG ECPs). WHO, 2010.     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      25     The  female  condom   A  peer-­reviewed   synthesis   of   existing   information   on   female   condoms   can   be   found   here:   http://www.path.org/publications/files/RHSC_fem_condom_br.pdf       1. Female  condom-­  A  powerful  tool  for  protection.  UNFPA,  PATH.  (under  review)   2. Female  condom-­  Baltimore  Meeting.  PATH,  USAID,  UNFPA.  2006   3. Female  Condom  Technical  Review  Committee  Report.  FC2.  WHO.    2007   4. Policy  brief.  Global  Fund  Financing  of  condoms  and  contraceptive  security.  JSI   Delivery,  USAID.  2008.   http://deliver.jsi.com/dlvr_content/resources/allpubs/logisticsbriefs/GlobFundFinaCo ndCS.pdf   5. Position  paper  on  condoms.  UNFPA,  WHO,  UNAIDS.  2009   http://www.unaids.org/en/Resources/PressCentre/Featurestories/2009/March/200903 19preventionposition/   6. Female  Initiated  HIV  Prevention  Methods.  UNFPA  and  Partners.    2010   7. Comprehensive  Condom  Programming.    A  guide  for  resource  mobilization  and   country  programming.  UNFPA  2010   8. Comprehensive  Condom  Programming.  Towards  a  unified  approach.  UNFPA  2010   9. Condom  Gap  Report.  USAID  2010   10. HIV  prevention  gains  momentum:  successes  in  programming  female  condoms.   UNFPA  2011   11. UNFPA  Issues  Briefs:  Comprehensive  Condom  Programming.  Revised  2011   12. Female  condom  technical  review  committee  report.  Review  of  submissions  by   manufacturers  to  initiate  the  prequalification  process  for  bulk  procurements.  WHO,   UNFPA,  FHI360.  2011   13. Female  condom  technical  review  committee  report.  Scientific  and  technical   requirement  to  formulate  a  female  condom  generic  specification  and  prequalification   scheme.  WHO,  UNFPA,  FHI360.  2011   14. Female  Condom  Research  Briefs  Series.  No.  4.    Female  Condom  Acceptability  and   Sustained  Use.  FHI  360   http://www.fhi360.org/en/RH/Pubs/Briefs/FemCondom/acceptability.htm   15. IS  THERE A CONDOM GAP IN 2010? A Review of Condom Availability, Accessibility, and Acceptability in Sub-Saharan Africa. USAID. 2010   16. 6\VWHPDWLF�UHYLHZ�RI�FRQWUDFHSWLYH�PHGLFLQHV��³'RHV�FKRLFH�PDNH�D� GLIIHUHQFH"´ Reproductive Health and Research Unit (RHRU). 2006     �ŽŶƚƌĂĐĞƉƚŝǀĞ��ŽŵŵŽĚŝƚŝĞƐ�ĨŽƌ�tŽŵĞŶ͛Ɛ�,ĞĂůƚŚ      26     17. Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for :RPHQ¶V�+HDOWK CHANGE. 2011. http://www.genderhealth.org/files/uploads/pepfar_watch/publications/unfinishedimpe rative.pdf   18. Smarter Programming of the Female Condom: Increasing Its Impact on HIV Prevention in the Developing World. FSG 2008. http://www.fsg.org/Portals/0/Uploads/Documents/PDF/Female_Condom_Impact.pdf ?cpgn=WP%20DL%20-%20Female%20Condom%20Impact   19. Female condom technology: new products and regulatory issues. Mags Beksinskaa, Jenni Smit, Carol Joanis, Margaret Usher-Patel, William Potter. Contraception. Volume 83, Issue 4, Pages 316-321   20. Three  new  female  condoms:  Which  do  South-­African  women  prefer?  Carol  Joanisa,   Mags  Beksinska,  Catherine  Hart,  Katie  Tweedy,  Jabu  Linda,  Jenni  Smit.   Contraception.  Volume  83,  Issue  3,  Pages  248-­254   21. A review of female-condom effectiveness: patterns of use and impact on protected sex acts and STI incidence Gowri Vijayakumar, Zonke Mabude, Jenni Smit, Mags Beksinska, Mark Lurie. International Journal of STD & AIDS 2006; 17: 652±659      

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