Title: LAWS GOVERNING THE USE OF NARCOTICS IN UGANDA: IMPORTATION, PROCUREMENT AND RECORD KEEPING
1LAWS GOVERNING THE USE OF NARCOTICS IN UGANDA
IMPORTATION, PROCUREMENT AND RECORD KEEPING
- By Dr.Jack G.M.Jagwe, FRCP (London), FRCP (Edin).
- MBch B(EA), Dip.H.A.(Honoris causa) ICMI
- Senior Advisor, National Policy/Drugs/Advocacy
- Hospice Africa, Uganda
- Visiting Physician, Mengo Hospital
2OPIOID THERAPY
- LAWS AND REGULATIONS
- International Laws and Treaties
- Opioids are regulated under
- The 1961 Single Convention on Narcotic Drugs as
amended by the 1972 Protocol
3PURPOSE OF THE TREATY
- To ensure the AVAILABILITY OF OPIOIDS for MEDICAL
USE AND SCIENTIFIC WORK AND AT THE SAME TIME - To prevent ABUSE and MISUSE-DIVERSION
- The International Narcotics Control Board (INCB),
Vienna, established in 1968 is a U.N. Agency - Independent and quasi-judicial body
4- To implement the UN Drug Conventions
- To ensure adequate supplies for medical and
scientific uses - To ensure absence of leakages to illicit drug
trafficking - To estimate opioid needs per nation
- To monitor international trade in narcotics
5The INCB, Vienna ensures
- Countries comply with the Single Convention
- Collects estimates of national Opioids needs
- Confirms National Estimates before a government
permits manufacture or import of Opioids - Quantity of Opioids manufactured or imported
should not exceed the governments official
estimate - Supplementary requests can be granted where
appropriate - Ensure mandatory accurate records of imports,
supplies, use and manufacture to be maintained
6National governments enact laws consistent with
the above treaty with regard to
- Production (cultivation of opium poppy)
- Manufacture (Opioids)
- Distribution/use
- Registration of all handlers/prescribers
- NOTE Drug Regulatory Authorities vary
- from country to country.
7- INCB being a U.N. Agency communicates through
Ministry of Health and the Ministry communicates
through the National Drug Regulatory Agency I.e
the National Drug Authority (NDA) - The National Drug Policy and Authority statute
No.13 of 1993 regulates the handling of drugs in
the country. - There are, in addition, Supplementary Statutory
Instruments No.7, 1993 and No.2, 1995 which help
NDA to carry out its responsibilities.
8Restricted or Class A Drugs
- Includes Opioids
- Morphine
- Pethidine
- Related Opioids
- Psychotropic drugs (a number of them)
- For these drugs records must be kept for 2
- years for purposes of inspection
9Loss of Class A drugs
-
- Loss of any Class A drug must be reported to
Chief Inspector of Drugs (NDA) within 7 days
10Expired, Rejected or Returned Class A drugs
- Unused drugs (class A) should be returned to the
prescriber/dispenser - if class A drugs expire or are rejected for any
reason, must be returned to the
pharmacy-in-charge, who should contact the drug
inspector - Expired drugs should be destroyed by the
pharmacy-in-charge, witnessed by the drug
inspector
11 DISPOSAL
- Destruction follows WHO guidelines (NDA)
- Details of the quantity destroyed and the reason
for destruction must be written in the class A
register
12Importation of class A drugs
- Manufacture/wholesale of class A drugs requires
an annual license. Currently NDA allows only - The National Medical Stores NMS (government)
- The Joint Medical Stores- JMS (NGO) to import
narcotics. - Private retail pharmacies and hospitals can
- access narcotics through the above
- agencies.
13IMPORTATIONThe importation procedures are
complex and detailed to prevent diversion of
narcotics to the illicit drug market.
14Storage
- Powdered morphine, finished products and all
narcotics must be stored according to N.D.P/A
statute /regulations, that is in a DDA Cupboard - immovable i.e fixed
- separate
- lockable
- restricted to public access
- under secure lock and key (double lock)
- NB DDA Cupboard of the old U.K. Dangerous Drugs
Act
15The key to a class A drug cupboard is held by a
responsible person. Pharmacist in charge -
pharmacy/hospital Dispenser in charge -
pharmacy/hospitalDoctor/Nursing officer
-Hospital /ward
16Transportation
- The Single Convention on Narcotics Drugs requires
that all enterprises and individuals involved in
the distribution system should be appropriately
licensed or authorised. - This is intended to prevent narcotics getting
into the hands of the illicit drug traffickers. - The government has in place an Anti-narcotic
Drug Squad of the Criminal Investigation
Department (CID) to ensure that narcotics are not
diverted.
17Prescription
- Previously only three categories of persons
were allowed by law, to prescribe/dispense
restricted and class A drugs - Registered Medical Practitioner
- Registered dentist
- Registered Veterinary Surgeon
- But now, with the advent of palliative care,
government allowed Specialised Palliative Care
Nurses/Clinical Officers to prescribe/dispense
drugs including narcotics for home care teams
(23rd April 2004 Statutory Instrument No. 13).
18Prescription Requirements
- 1. Usual requirements - e.g name, age, sex,
address etc - Total quantity of drug to be dispensed in words
and figures - stipulate the form of the drug e.g tablet, oral
solution, injection - specify the strength of the solution if
applicable e.g 5mg/5ml or 50mg/ml of oral
morphine
19LEGALITY
- Please note that, according to law, a
prescription form is a legal document which must
have all the details according to NDP/A statue. - Again note a prescription is valid for a period
not exceeding 14 days and the supply of a
narcotic must not exceed one month. - The prescription must be in duplicate.
20Penalties on infringement of the law
- Section 28, subsection 2, of NDP/A statute
states that Any person who is in possession of a
classified drug otherwise than in accordance with
provisions of this section commits an offence and
is liable to - I. A fine not-exceeding UShs 2 million
- ii. Imprisonment for a term not exceeding
two years - iii. or both a fine and imprisonment.
21- N.B The NDP/A statute is under review
- The pharmacists council is established.
- The guidelines for handling of class A Drugs
were published in 2001. They are due for review