Ambekar 24 aug - opioid policy and legal issues

24 August, 2014, Ludhiana

• Is it working ?

International Drug

regulatory framework

• Implications for mental health professionals

The Indian Scene

» About 1 in 20 persons between the ages of 15 and 64 uses an illicit drug at least once a year ˃ Large majority of them use CANNABIS

» Fewer than 1 in 160 are “problem drug users”

» Overall value of the illicit drug market: about $320 billion (0.9 % of global GDP)

AlcoholTobacco

Illicit Drugs

35%

25%

2.50%

Global Prevalence of 'past month' use

» Today’s ‘narcotics’ have had a long history of use throughout the world

» Plants have been major source of drugs: ˃ Opioids

˃ Cannabis

˃ Cocaine

» Drugs have been used as medicines, for recreation and as part of social / cultural rituals

19th Century: Indian Opium exports to China

1909: Shanghai Opium Commission

1912: Hague Convention

UN Conventions: 1961, 1971, 1988

International Drug treaties

Opiates Cocaine Cannabis

12.9 13.4

147.4

17.35 17

160

Number of users in millions 1998 2008

"Sadly, the illicit

manufacture and

illicit consumption

of drugs occur

everywhere.”

Yury Fedotov, Executive Director, UNODC, 2012

Pettus, 2014

“Evil” reflects influence of missionaries in early prohibition policy”

» The stated intention behind the establishment of the global drug prohibition regime was to protect the world from the dangers of drugs.

» At different points in history, drug production, use and supply have all been presented as threats to security:

˃ human,

˃ national or

˃ international security.

“Menace” “Social evil”

“Existential threat”

Creation of a criminal black

market

Policy displacement

Geographical displacement

Substance displacement

Marginalization of drug users from social mainstream

UNODC 2008

Decrease

from 14.1 % in

2001 to

10.6 % in 2006

http://www.globalcommissionondrugs.org/

“The war on drugs has failed”

» Drug policies must be based on scientific evidence human rights and public health principles ..

» …legal regulation of drugs …

» …evidence-based prevention ... treatment and care for drug dependence..

Supply reduction

• Department of Revenue, Ministry of Finance

• Narcotics Control Bureau, Ministry of Home

• Central Bureau of Narcotics, Ministry of Finance

Demand reduction

• Prevention and Rehabilitation: Ministry of Social Justice and Empowerment NGOs

• Medical Treatment: DDAP, Ministry of Health and Family Welfare Govt. Hospitals

Harm reduction (IDU)

• National AIDS Control Organisation (NACO), MoH&FW NGOs and Govt. Hospitals

Major ‘players’

Additionally, ‘Alternate approaches’: AA, spiritual / religious groups etc.

Availability of treatment services in India

» 124 in number

» Established by the Union MOHFW (DDAP division)

» Attached with district hospitals and medical colleges (Department of Psychiatry)

Only a few get recurring grant from the central government

Rest, dependent on the state governments

Drug dependence treatment is often seen as a low priority area by the local state governments

At some places, buildings meant for De-addiction centers are being used for other purposes!

» ‘Minimum standards of care’ exist

» No structured, regular system for M & E

˃ DAMS for new patients

» Capacity Building: Through institutions located regionally

» Supported by the MSJE

» About 450 in number

» Get funding from the ministry ˃ Mainly residential (in-patient) treatment

˃ Stand alone services – not a part of general health care

» Recent revision of guidelines / scheme

» Functioning status?

» Capacity Building – through RRTCs

» Number: unknown

» Qualifications of service providers: unknown ˃ ranges from MD Psychiatry to no professional

qualification (just an experience of having gone through the treatment)

» Whether follow some standards / norms: unknown

» Highly variable status for evaluation / functioning

Gaps in service demand and service provision » Conservative

estimate of number of Alcohol / drug dependent individuals

= 1 crore (10000000)

» Conservative estimate of number of Alcohol / drug dependent individuals

= 1 crore (10000000)

» Liberal estimates of Number of beds available for drug treatment

NGO sector 400 X 15 6000

Government sector 100 X 10 1000

Private sector --- 5000

Total 12000

Assuming minimum duration of acute-phase treatment = 1 month

144000

10000000

144000

Gaps in service demand and service provision

10000000 versus

Gaps in service demand and service provision

144000

Clearly, reliance only on the existing number of services and the in-patient, ‘de-addiction’ model is not enough!

Do our laws and policies facilitate treatment of opioid dependence ?

» Principle of regulatory framework:

“Balance between:

curbing misuse

and

ensuring access for medical and scientific purpose”

» Principle of regulatory framework:

“Balance between:

curbing misuse

and

ensuring access for medical and scientific purpose”

» Drug Use a criminal act

» Provision for treatment in lieu of jail term for Drug Users ˃ Onus on accused to prove that s/he is a

drug user; not a trafficker !

» Three amendments: 1988, 2001, 2014

» 1988 amendment ˃ Stringent punishment for harboring offenders and

financing illicit traffic including death

˃ Forfeiture of property derived from/ used in illicit traffic

» 2001 amendment ˃ Punishment based on quantity found

˃ Further strengthened powers to trace and seize illegally acquired properties

2014 amendment

» ‘Essential Narcotic Drugs’ for medical use

» Subject to central rules; state licenses not needed

» Government to recognize and approve treatment centres to regulate illegal / unethical practices

» Punishment for users & traffickers increased!

» 28 July 2014: National Workshop on drafting NDPS rules

» All stakeholders welcomed the proposals: ˃ A uniform national set of regulations (as opposed to

state-specific rules)

˃ Recognition that easy access and availability of medications as important as stringent regulations

˃ ENDs – indicated for both – Pain relief and treatment of Opioid Dependence

» National Narcotic Drugs and Psychotropic Substances (NDPS) Policy (2012)

˃ Talks about a combination of supply, demand and “Harm Reduction” approaches

˃ Harm reduction – reluctantly endorsed; Only for IDUs

»National Drug and Alcohol Demand Reduction Policy (DRAFT) ˃ (Was) Being Developed by the MSJE

˃? Draft under the process of review and refinement

˃No clear stand on evidence-based pharmacological treatment of opioid addiction

Methadone

Buprenorphine

Buprenorphine+naloxone

Morphine

Tramadol

Non Opioids (Clonidine; Naltrexone etc.)

Methadone

Buprenorphine

Buprenorphine+naloxone

Morphine

Tramadol

1961 convention

1971 convention

1971 convention

1961 convention

Not under control*

International Control

Methadone

Buprenorphine

Buprenorphine+naloxone

Morphine

(Essential) Narcotic

Psychotropic

Psychotropic

(Essential) Narcotic

Indian Law

Methadone

Buprenorphine

Buprenorphine+naloxone

Morphine

?

Schedule H1

Schedule H1

Schedule K

Indian Scheduling and regulations

“The preparation shall be supplied only to the designated de-addiction centres set up by the Govt. of India funded by the Ministry of Health and Ministry of Social Justice and Empowerment and Hospitals with De-addiction facilities and a list of the centres to whom the supply of the drug is made should be made to this Directorate periodically indicating the quantities supplied to each centre.”

» The Punjab chaos spreads to other parts of the country. Some over-zealous official proposes to totally ban Buprenorphine

» Methadone and Morphine get listed as ENDs (and become available easily, even with prescription). Buprenorphine remains tightly regulated.

» Buprenorphine becomes de-regulated and starts being available in the pharmacy shops. Soon, it becomes OTC (like practically everything else) and we see a fresh epidemic.

» The ideal scenario

» Buprenorphine or Methadone are not available in pharmacies.

» They are available only through licensed and accredited facilities:

˃ Drug Treatment centres / Clinics (Govt. / NGO / Private)

˃ Prescribed by specifically trained doctors

˃ Records are maintained; M & E framework exists

» Methadone and plain Buprenorphine available only as DOTS

» Buprenorphine + Naloxone available as ‘take-home’ option (with standard procedures, and an upper limit)

Conceptual basis for a ‘rational drug policy’

» Prevention

» Supply reduction

» Treatment and harm reduction

» Criminal sanctions and decriminalisation

» Control of the legal market through prescription drug regimes

Drug policy and the public good, Babor et al, 2010

Is there something we can do?

» Ensuring only evidence-based practice

» Advocacy

˃Realizing that our role goes much beyond the service provision

˃Making our presence felt as professional bodies

˃Generating the discourse on policy reforms

˃Pressurizing our governments to take right stand in the International forums

Acknowledgement:

Dr. Sathya Prakash Senior Resident,

AIIMS, New Delhi