LAWS GOVERNING THE USE OF NARCOTICS IN UGANDA: IMPORTATION, PROCUREMENT AND RECORD KEEPING

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LAWS 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

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OPIOID 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

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PURPOSE 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

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• 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

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The 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

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National 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.

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• 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.

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Restricted 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

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Loss of Class A drugs

• Loss of any Class A drug must be reported to
  Chief Inspector of Drugs (NDA) within 7 days

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Expired, 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

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DISPOSAL

• Destruction follows WHO guidelines (NDA)
• Details of the quantity destroyed and the reason
  for destruction must be written in the class A
  register

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Importation 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.

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IMPORTATIONThe importation procedures are
complex and detailed to prevent diversion of
narcotics to the illicit drug market.
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Storage

• 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

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The 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

• SAFETY

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Transportation

• 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.

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Prescription

• 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).

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Prescription 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

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LEGALITY

• 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.

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Penalties 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.

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• 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