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Drug Control anD aCCess to ControlleD MeDiCines: a global view
aCCess to ControlleD MeDiCines anD the un Drug ConventionsThe 1961 Single Convention on Narcotic Drugs obliges states to make “adequate provision… to ensure the availability of narcotic drugs” which continue to be “indispensable for the relief of pain and suffering.” The international Narcotics Control board (iNCb) has stated that the Single Convention “establishes a dual drug control obligation: to ensure adequate availability of narcotic drugs for medical and scientific purposes, while at the same time preventing the illicit production of, and trafficking in and use of such drugs.” Yet, the President of the iNCb observed in July 2009 that access to controlled medicines is “virtually non-existent in over 150 countries.” ensuring the availability of essential medicines like morphine, methadone and buprenorphine is a core obligation of governments under the right to the highest attainable standard of health. Drug control regulations that restrict the adequate availability of these medications violate that right. Denial of strong opioids to patients in severe pain can also constitute cruel, inhuman or degrading treatment.
regulatory barriers to MeDiCal aCCess to ControlleD Drugsaccess to controlled medicines must be regulated to prevent their misuse. The 1961 Single Convention establishes three basic requirements for such regulations:
Controlled medicines may be dispensed only pursuant •to a prescription;a license must be required to manufacture, trade or •distribute them, and appropriate records must be kept.• 1
Yet, many countries have enacted regulations that go well beyond what is required by the Single Convention and that impede availability of controlled medications. iNCb has repeatedly called on countries to review their drug control regulations to assess whether they unnecessarily impede access to controlled medicines.2
PresCriPtion ProCeDuresSPeCial PreSCriPTioN formS•many countries, like Turkey, require use of a special prescription for controlled medicines. wHo has observed that special multiple-copy prescription requirements “typically reduce prescribing of covered drugs by 50 percent or more.” The requirement to use special prescription forms can be particularly burdensome if doctors have to apply to receive the
forms, as in morocco and germany, or have to pay for them, as in the Philippines, Denmark, albania and estonia. Problems accessing enough special prescription forms have been reported in Turkey, el Salvador and Ukraine.
PreSCriPTioN limiTaTioNS•many countries, like morocco, limit the number of days a prescription for controlled medicines can cover. wHo recommends “decisions concerning…the amount of the prescription and the duration of therapy are best made by medical professionals on the basis of the individual need of the patient, not by regulation.”3 extreme time limits include Ukraine (1 day), belarus (3 days), greece, lithuania and russia (5 days). in many other countries, an opioid prescription may be valid for as many as 90 days or there is no limitation at all.4
rigHT To PreSCribe limiTeD To CerTaiN SPeCialiSTS•like montenegro, some countries limit the right to prescribe opioids to doctors practicing in certain specialties, commonly oncology, pain management or anesthesiology. Such restrictions significantly limit patients’ access to opioid medicines. The wHo recommends that “physicians, nurses and pharmacists should be legally empowered to prescribe, dispense and administer opioids to patients in accordance with local needs.”5 Countries with similar restrictions include, among others, egypt and Ukraine.6
liCensing requireMentsSPeCial liCeNSeS for DoCTorS•in many countries, like greece, doctors need a special license or registration to prescribe controlled medicines. while in some countries the process for obtaining a license is simple, in others obtaining it requires considerable paperwork or even invasive screening of the doctor. for example, the Philippines requires doctors applying for a license to submit to blood tests. as a result of excessively complex licensing procedures in some countries, including morocco and the Philippines, very few doctors obtain them.7
liCeNSeS for PHarmaCieS, HoSPiTalS aND •HoSPiCeS The UN drug conventions require that states create a system to license healthcare institutions that handle opioid medications. Some countries arbitrarily exclude certain healthcare facilities from eligibility for a license
*Except where otherwise noted, all information is from Human Rights Watch interviews or correspondence with healthcare professionals in the countries mentioned. These examples are illustrative of regulations that promote or impede access to controlled medicines and do not fully reflect the regulatory environment in the countries mentioned. These examples are not intended to suggest that practices in the countries mentioned are better or worse than those in countries not mentioned. Non-regulatory barriers also contribute to the unavailability of controlled medicines, particularly inadequate training for healthcare workers in their use. additional sources of information on reverse: Jordan: Jan Stjernswärd et al., “Jordan Palliative Care initiative: a wHo Demonstration Project”, Journal of Pain and Symptom management, vol. 33 no. 5, may 2007, 631; rwanda: international Narcotics Control board, Narcotic Drugs: estimated world requirements for 2009 – Statistics for 2007, e/f/S.09.Xi.02 (New York: United Nations, 2009), p. 241; K. m. foley, “Pain Syndromes in Patients with Cancer,” in K. m. foley, J. J. bonica and v. ventafridda, eds., advances in Pain research and Therapy, (New York: raven Press, 1979), 981_994; UNaiDS, “rwanda: Country Situation”, July 2008, http://data.unaids.org/pub/factSheet/2008/sa08_rwa_en.pdf (accessed february 9, 2010); Singapore: Central Narcotics bureau, annual bulletin, 2007.
1 Single Convention on Narcotic Drugs, 1961, adopted
march 30, 1961, 520 U.N.T.S. 151, entered into force December 13, 1964, preamble.
2 international Narcotics Control board, “availability of opiates
for medical Needs: report of the international Narcotics Control board for 1995,” http://www.incb.org/pdf/e/ar/1995/suppl1en.pdf (accessed february 10, 2010), p. 1.
3 UN economic and Social Council, “Statement
by Professor Sevil atasoy, President of the international Narcotics Control board,” July 30, 2009, http://www.incb.org/documents/President_statements_09/2009_eCoSoC_Substantive_Session_published.pdf (accessed february 10, 2010), p. 2.
4 UN Committee on economic, Social
and Cultural rights, “Substantive issues arising in the implementation of the international Covenant on economic, Social and Cultural rights,” general Comment No. 14, The right to the Highest attainable Standard of Health, e/C.12/2000/4 (2000), http://www.unhchr.ch/tbs/doc.nsf/(symbol)/e.C.12.2000.4.en (accessed february 9, 2010), para. 43. 5
Human rights Council, report of the Special rapporteur on Torture and other Cruel, inhuman or Degrading Treatment or Punishment, manfred Nowak, “Promotion and Protection of all Human rights, Civil Political, economic, Social and Cultural rights, including the right to Development,” a/HrC/10/44, January 14, 2009, para. 72.
6 international
Narcotics Control board, report of the international Narcotics Control board for 2008, e.09.Xi.1 (New York: United Nations, 2009), p. 118. 7 wHo, Cancer pain relief: with a guide to opioid availability, 2nd ed.,
(geneva: wHo, 1996). 8
N.i. Cherney et.al, “formulary availability and regulatory barriers to accessibility of opioids for cancer pain in europe: a report from the eSmo/eaPC opioid Policy initiative”, annals of oncology, forthcoming, february 2010.
9 evan anderson et al., “Closing the gap:
Case Studies of opioid access reform in China, india, romania & vietnam” (Centers for law and Public Health: a Collaborative at the Johns Hopkins and georgetown Universities, 2008).
10 wHo, UNoDC, UNaiDS,
Position Paper: Substitution maintenance therapy in the management of opioid dependence and Hiv/aiDS prevention, (geneva: world Health organization, 2004).
11 Catherine Cook and Natalya Kanaef, global State
of Harm reduction 2008: mapping the response to drug-related Hiv and Hepatitis C epidemics (london: international Harm reduction association, 2008).
12 Daniela mosoiu, et al., “romania: Changing the regulatory
environment,” Journal of Pain and Symptom management, vol. 33 no. 5, may 2007, 610.
13 international Narcotics Control board, report of
the international Narcotics Control board for 2004, e.05.Xi.3 (New York: United Nations, 2005), para. 196.
or have unnecessarily burdensome licensing procedures that deter pharmacies and medical institutions from stocking controlled medicines, and divert healthcare workers’ time from providing medical care.
The licensing system in most of india’s states, where healthcare providers must obtain five different licenses from several government agencies, is a prime example. To its credit, the indian government has recommended partial reform to improve patient access to morphine. Today, 14 states have adopted a new, simple system for morphine that involves obtaining one license from one government agency. in China, hospitals are categorized according to their size, and only larger hospitals are authorized to handle opioids. as a result, people living outside of large cities have to travel much further to obtain opioid medicines than they would if they were available in all hospitals.
surveillanCe of Patients anD health Care ProviDers
PaTieNT SUrveillaNCe •Prescription tracking systems have a legitimate role in preventing diversion of controlled medications but some countries have instituted much more invasive surveillance of patients. in georgia, for example, patients are required to visit police stations to fill their opioid prescriptions. intrusive surveillance deters legitimate use of controlled medicines and may violate privacy rights.
SUrveillaNCe aND legal SaNCTioN of HealTHCare •worKerS Healthcare institutions that handle controlled substances are required to keep records so that the authorities can monitor their use. However, some countries have created invasive systems of control that may deter or stigmatize prescribing of controlled medicines or violate privacy rights. for example, in Ukraine, staff who handle opioids are subject to blood tests, and empty morphine ampoules must be collected and counted.
Proven treatMent illegalUNoDC, UNaiDS and wHo agree that opioid substitution therapy (oST) using methadone or buprenorphine is one of the most effective treatments for opioid dependence, and critical to Hiv prevention and facilitating antiretroviral therapy among people who inject drugs.8 Yet, methadone
for oST is illegal in russia, malaysia, the Philippines and Sri lanka; use of buprenorphine for oST is illegal in burma; and both are illegal in bangladesh, bhutan, Cambodia, Japan and Singapore. in many other countries, including Pakistan, Kazakhstan, egypt, argentina and brazil, large numbers of people inject opioids, but no oST is available.9
innovative regulation ProMoting safe aCCess to ControlleD MeDiCinesComPreHeNSive regUlaTorY reformSeveral countries, including vietnam, Colombia and romania, have undertaken comprehensive reviews of their drug control regulations, as recommended by the iNCb, to ensure that they do not unnecessarily impede access to controlled medicines. as a result, all three countries increased the amount of time that oral morphine can be prescribed for using one prescription to 30 days, from previous limits between 3 and 10 days. romania also changed its regulations to ensure that all doctors could prescribe opioids and that all patients in pain could receive them, regardless of their underlying disease.10 vietnam expanded the types of health facilities that are authorized to prescribe and dispense opioids, and mandated that district hospitals stock opioid medicines if no pharmacy in a district does.
NUrSe PreSCribiNgUganda, the United Kingdom and most states in the United States allow nurses to prescribe controlled medicines in certain circumstances. in some cases, pharmacists, clinical officers or physician’s assistants may also be licensed to prescribe controlled medicines. for example, in 2008 vietnam amended its law to allow assistant doctors to prescribe morphine when no doctor is available.11 Nurse prescribing has the most potential to improve access to controlled medicines in resource-limited settings where there are not enough doctors. The iNCb has commended Uganda for its efforts to increase access to controlled medicines.12
emergeNCY PreSCribiNglithuania and the United Kingdom allow pharmacists and nurses to prescribe controlled medicines when a patient is in severe pain and no doctor is available. They also allow doctors to authorize an emergency prescription by telephone or fax, as do many other european countries.13
Photo: Palliative care nurses and volunteers check up on a 67-year-old woman, who is paralyzed and taking morphine for pain in south Kerala. © 2009 Brent Foster
syr
ia o
ut-p
atie
nts
mus
t vi
sit t
he
min
istr
y of
Hea
lth
to o
bta
in m
orp
hin
eo
ut-p
atie
nts
can
only
re
ceiv
e or
al m
orph
ine
afte
r obt
aini
ng p
erm
issi
on
from
the
min
istr
y of
H
ealt
h in
Dam
ascu
s. T
his
unne
cess
arily
com
plic
ates
ac
cess
to th
ese
esse
ntia
l m
edic
atio
ns, e
spec
ially
fo
r tho
se w
ho li
ve o
utsi
de
the
capi
tal c
ity.
tan
zan
ia m
orp
hin
e no
t av
aila
ble
in p
harm
acie
sif
a h
osp
ital
wan
ts to
of
fer o
ral m
orp
hin
e to
it
s pa
tien
ts, a
qua
lified
p
harm
acis
t has
to c
olle
ct
it fr
om th
e ca
pit
al c
ity,
a
trip
that
can
take
up
to
thre
e da
ys.
as
a re
sult
, ve
ry fe
w h
osp
ital
s ha
ve
oral
mor
ph
ine,
leav
ing
mos
t pat
ient
s w
ith
sev
ere
pain
to s
uffe
r.
Dr
ug
Co
ntr
ol
an
D a
CCes
s to
Co
ntr
oll
eD
MeD
iCin
es:
Sele
CTeD
eX
am
PleS
ro
Ma
nia
com
pre
hen
sive
re
gula
tory
refo
rmN
ew d
rug
regu
lati
ons
enac
ted
in 2
006
sign
ifica
ntly
imp
rove
d ac
cess
ibili
ty o
f con
trol
led
med
icat
ions
, aut
hor
izin
g al
l doc
tors
to p
resc
rib
e op
ioid
s an
d a
llow
ing
pati
ents
in s
ever
e pa
in to
re
ceiv
e op
ioid
s re
gard
less
of
the
und
erly
ing
dis
ease
.
lith
ua
nia
em
erge
ncy
pre
scri
bin
gN
urse
s an
d ph
arm
acis
ts
may
pre
scri
be o
pioi
ds in
em
erge
ncie
s, m
eani
ng
pati
ents
no
long
er h
ave
to
suff
er a
goni
zing
pai
n if
no
doct
or is
ava
ilabl
e.
ru
ss
ia e
ffec
tive
tr
eatm
ent i
llega
lo
pio
id s
ubst
itut
ion
ther
apy
wit
h m
etha
don
e or
bup
reno
rph
ine
is
illeg
al, l
eavi
ng h
und
reds
of
thou
sand
s of
rus
sian
s w
ith
out e
ffec
tive
tr
eatm
ent f
or d
rug
dep
end
ence
and
at h
igh
risk
of H
iv in
fect
ion.
inD
ia m
ultip
le li
cens
es
requ
ired
to p
rocu
re o
pioi
dsin
man
y st
ates
, hos
pit
als
req
uire
as
man
y as
five
di
ffere
nt li
cens
es to
pro
cure
an
d s
tock
mor
ph
ine
and
the
pro
cure
men
t pro
cess
ca
n ta
ke m
onth
s. a
s a
resu
lt, m
any
hos
pit
als
sim
ply
do
not s
tock
the
med
icat
ion,
ab
and
onin
g co
untl
ess
pati
ents
to
excr
ucia
ting
pai
n.
Ch
ina
man
y h
osp
ital
s ar
e b
arre
d
from
pre
scri
bin
g op
ioid
so
nly
hos
pit
als
wit
h a
ce
rtai
n ra
nk, w
hic
h is
b
ased
on
thei
r siz
e, a
re
auth
oriz
ed to
pre
scri
be
opio
id m
edic
atio
ns. a
s a
resu
lt, h
osp
ital
s in
man
y ci
ties
and
tow
ns c
anno
t d
isp
ense
op
ioid
s an
d p
eopl
e m
ay h
ave
to tr
avel
lo
ng d
ista
nces
in o
rder
to
be
able
to o
bta
in th
em.
Mex
iCo
few
hos
pit
als
and
pha
rmac
ies
stoc
k m
orp
hin
em
exic
o Ci
ty h
as a
po
pula
tion
of 1
8 m
illio
n pe
ople
, yet
onl
y ni
ne o
f its
ho
spita
ls o
r pha
rmac
ies
stoc
k m
orph
ine,
ap
pare
ntly
bec
ause
of
burd
enso
me
regu
lato
ry
requ
irem
ents
. Th
is
mak
es p
ain
trea
tmen
t in
acce
ssib
le to
mos
t of
the
city
’s in
habi
tant
s.
uk
ra
ine
unn
eces
sari
ly
com
plex
pre
scri
pti
on
pro
ced
ures
Th
ree
doc
tors
mus
t si
gn e
ach
mor
ph
ine
pre
scri
pti
on.
This
cu
mb
erso
me
pro
cess
m
akes
man
y d
octo
rs
relu
ctan
t to
pre
scri
be
the
med
icat
ion.
geo
rg
ia p
atie
nt
surv
eilla
nce
mor
ph
ine
is d
isp
ense
d to
ou
t-p
atie
nts
from
sp
ecia
l ph
arm
acie
s in
dis
tric
t p
olic
e-st
atio
ns, s
tigm
atiz
ing
its
legi
tim
ate
med
ical
us
e an
d c
omp
rom
isin
g p
atie
nts’
pri
vacy
.
gr
eeCe
per
mit
s re
qui
red
for d
octo
rs a
nd p
atie
nts
Doc
tors
nee
d a
sp
ecia
l p
erm
it to
pre
scri
be
opio
id
med
icin
es a
nd p
atie
nts
need
one
to re
ceiv
e th
em.
bot
h re
qui
rem
ents
det
er
the
legi
tim
ate
med
ical
us
e of
op
ioid
s.
Mo
nte
neg
ro
man
y sp
ecia
lists
can
not
pre
scri
be
opio
ids
onc
olog
ists
may
pre
scri
be
opio
id m
edic
ines
but
m
any
othe
r spe
cial
ists
ca
nnot
, sev
erel
y lim
itin
g
acce
ss to
opi
oid
med
icin
es
for p
atie
nts
with
pai
n fr
om
caus
es o
ther
than
can
cer.
Colo
Mb
ia i
ncre
ase
in ti
me
limit
for o
pio
id
pre
scri
pti
ons
in 2
00
6, n
ew re
gula
tion
s in
crea
sed
the
leng
th
of ti
me
for w
hic
h o
ral
mor
ph
ine
can
be
pre
scri
bed
usi
ng o
ne
pre
scri
pti
on fr
om 1
0 to
3
0 d
ays.
Jor
Da
n r
efor
ms
to a
llow
al
l doc
tors
to p
resc
rib
e op
ioid
sS
ince
20
04
, all
doc
tors
ca
n p
resc
rib
e m
orp
hin
e.
Prev
ious
ly, o
nly
onco
logi
sts
coul
d, m
akin
g tr
eatm
ent
inac
cess
ible
to p
eopl
e w
ith
sev
ere
pain
from
ca
uses
oth
er th
an c
ance
r.
viet
na
M a
ll d
istr
icts
m
ust h
ave
stro
ng o
pio
ids
Sin
ce 2
008,
regu
lati
ons
requ
ire
dist
rict
hos
pita
ls
to s
tock
opi
oid
med
icin
es
if no
pha
rmac
y in
a
dist
rict
doe
s, c
onsi
dera
bly
impr
ovin
g ac
cess
ibili
ty.
sin
ga
Por
e e
ffec
tive
tr
eatm
ent i
llega
lb
upre
norp
hin
e is
a
ban
ned
sub
stan
ce,
leav
ing
thou
sand
s of
p
eopl
e w
ith
out e
ffec
tive
tr
eatm
ent f
or d
rug
dep
end
ence
and
at h
igh
risk
of H
iv in
fect
ion.
Mo
ro
CCo
pre
scri
pti
on
limit
atio
nsPa
tien
ts c
an o
nly
get
one
wee
k’s
supp
ly
of m
orp
hin
e p
er
pre
scri
pti
on, m
eani
ng
that
they
mus
t pic
k up
a
new
pre
scri
pti
on e
very
w
eek.
for
pat
ient
s w
ho
are
term
inal
ly il
l or l
ive
far
from
thei
r doc
tor t
his
is
very
dif
ficul
t.
tur
key
sp
ecia
l op
ioid
p
resc
rip
tion
form
sPr
escr
ipti
ons
for s
tron
g op
ioid
s m
ust b
e m
ade
on
a sp
ecia
l pre
scrip
tion
form
. Pr
ocur
ing
thes
e fo
rms
is
tim
e-co
nsum
ing;
man
y d
octo
rs d
o no
t kee
p a
su
pply
of t
hem
and
are
not
ab
le to
pre
scri
be
opio
ids
to p
atie
nts
in p
ain.
exa
MPl
es o
f g
oo
D r
egu
lati
on
exa
MPl
es o
f Po
or
reg
ula
tio
n
ug
an
Da
nur
se p
resc
ribin
gS
ince
20
04
, sp
ecia
lly
trai
ned
nur
ses
and
clin
ical
offi
cers
are
au
thor
ized
to p
resc
rib
e m
orp
hin
e, s
igni
fican
tly
incr
easi
ng it
s ac
cess
ibili
ty
in a
cou
ntry
wit
h a
sev
ere
shor
tage
of d
octo
rs.
rw
an
Da
alm
ost n
o op
ioid
s av
aila
ble
UN
dru
g co
nven
tions
re
quire
sta
tes
to e
nsur
e ad
equa
te ‘a
vaila
bilit
y of
na
rcot
ic d
rugs
for [
med
ical
] pu
rpos
es.’
Yet,
bet
wee
n 20
03 a
nd 2
007,
rw
anda
used
an
amou
nt o
f m
orph
ine
suffi
cien
t to
trea
t onl
y 33
0 of
the
mor
e th
an 4
0,00
0 pa
tient
s w
ho d
ied
of c
ance
r dur
ing
that
per
iod,
80
perc
ent o
f w
hom
are
like
ly to
hav
e su
ffere
d si
gnifi
cant
pai
n.