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Valuable concise reference source on the UAE,
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Natural history of the UAE,
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Report by National US Arab Chamber of Commerce on the
UAE. Vol XV, No 3, June 2007. Includes analysis of UAE economy. |
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CONTROLLED DRUGS GUIDELINES
Guidelines for the Customs control at Airports. Seaports Post offices and
by road etc for the importation of medicines for personal use (PDF format)
List of restricted and controlled drugs (Excel document)
Ministry of Health Regulations for Controlled Drugs
MINISTRY OF HEALTH REGULATIONS FOR CONTROLLED DRUGS
CD (Narcotic)
No proposed changes to the overall process of outpatient control of CD (Narcotic). A special prescription is used and this could be made effective by requiring that the whole prescription should be written in words and figures instead of only the quantity.
Schedules 1-3 should be consistent with the lists of narcotic list in Federal Law number 14 and these MUST be updated to be in live with the current INCB list of narcotics under international control.
There is no practical different to the control of schedules 1-3 and for the purpose of defining the mode of dispensing they can be combined.
Any drug listed on the INCB list should be classified as Narcotic; however, internationally, some analgesic, cough suppressants and anti-diarrhoea preparation are controlled at a lower level as long as they are kept to a certain concentration. Provisions for this are already included in an earlier circular on the subject (90/1992) but could be updated.
Methylphenidate is one of the few 'narcotic' drugs available in the private sector. There is high demand but potential for abuse. We need to consider a system of formalizing the approval of Doctors and Pharmacies to prescribe and dispense Ritalin¨ in general practice.
Finally, there are no licensed forms of most Narcotic items e.g. morphine. Only four narcotics: methadone, methadone, methylphenidate, pentazocine and remifentanil are available in a UAE licensed form. This represents a serious lack of quality assurance and a 'fasttract' / abridged licensing system should be considered for established suppliers of Narcotics to the UAE.
Overview of the proposed CD (Narcotic) group
1. This is the highest level of control for a medicinal product. It includes those substances under international control (note 1) and listed by the INCB (note 2).
2. These drugs are subject to control of import, export, possession, supply and manufacturer. The approval of (license) of the MOH is required for all these activities.
3. CD (Narcotic) drugs can only be supplied from the pharmacies of Government hospitals (unless a special license has been issued).
4. There are detailed regulations covering the requisition, prescription, administration and destruction of CD (Narcotic) drugs in government hospitals. These should be extended to require words and figures to be used in the prescription and described in detail in the main regulations.
CD (A) Controlled Drugs of Abuse
These CDÕs are not narcotics but still carry a high risk of Abuse and dependency. They are currently referred to as 'RP' drugs because they can be supplied in response to a 'Registered Prescription'.
This category should apply to all medicines affected by the single convention on international control as Psychoactive drugs by the INCB but could include drugs for which the Minister had evidence that there is abuse that could be avoided through stronger control. See appendix for list of medicines
Overview of the proposed CD (A) group
1. This group will include those non-narcotic medicinal products containing substances under international control (note 3) and listed by the INCB (not 4).
2. These substances are often described as 'Psychotropic' drugs.
3. There are controls on the import and export, possession, supply and manufacture but these are not as strict as for CD (Narcotics).
4. Only the agent for the company and the UAE government (e.g. from foreign missions) can import these medicines. Personal imports are not allowed unless for less than three-month use for a UAE resident (not via the post) or non-residents with a supply to cover the duration of their visit visa and a doctor's letter
5. Only the agent can act as commercial distributor for CD (A) drugs. The can be supplied only in response to a signed requisition form the pharmacist. Non-agency wholesalers are not authorized to distribute these medicines.
6. Physician samples of CD (A) drugs are NOT allowed.
7. Storage of these medicines must be in the possession of a pharmacist.
8. Any UAE licensed doctor can prescribe a CD(A) drug if he uses the official MOH controlled drug prescription form (available from the private sector control section of the MOH)
9. The maximum supply on each prescription is currently one week by a non psychiatrist and one month by a psychiatrist (specialist or consultant). In view of the shortage of psychiatrists in the U.A.E this should be reviewed.
10. The pharmacist may only sell these in response to a valid prescription written by a UAE licensed physician on a MOH controlled drug prescription form.
11. The following records must be kept by the agent for 2 years or until the expiry date of the consignment, whichever is the shorter:
- The import permit and consignment note
- The signed from the pharmacy
- A copy of the delivery note to the pharmacy
12. The following records must be kept by the pharmacist for 2 years or the expiry date of the consignment, whichever is the shorter.
- The original prescription (for 2 years after dispensing, not date of writing), It must be filed according to the prescribing doctor and the week or dispensing.
- The invoice or delivery note (agent to pharmacy) must be kept for 2 years.
13. All records must be available on the premises (drug store, and pharmacies) for inspection by MOH inspector. Records can be destroyed only after approval by a MOH inspector. Destruction of records should follow good practice designed to preserve the confidentially of the doctor and patient.
14. Electronic records are acceptable only after validation and approval by the MOH.
See attached list of current and proposed CD(A) drugs.
CD (B) Controlled Drugs in the UAE
This category should apply to medicines that are NOT controlled by international conventional but for which there is concern the safe use based on the experience of the region. These medcines will have low or zero potential for abuse.
These are now controlled as schedule 5 drugs and usually have the Òcontrolled prescriptionÓ or ÒCPÓ mode of dispensing. This is slightly misleading because the prescription itself is not controlled; instead there are restrictions on who can prescribe the drug and the amount that can be prescribed.
Many of the schedule 5 drugs must be taken long-term to be effective, so the dispensing rules require unnecessary visits to the doctors. Alternatively, many doctors simple prescribe maximum or even excessive doses to provide the patient with a practical supply
Overview of the proposed CD(B) group
1. This group includes medicines that are NOT controlled by International Conventional because they have no evidence of addiction potential and a zero or very low potential for abuse. However, regional experience is that some extra level of control and monitoring is appropriate to discourage and detect attempts at abuse or illicit trade in these medicines.
2. Prescribed by any UAE licensed doctor using a standard prescription form
3. Maximum duration of supply should be one month per prescription by all licensed doctors.
4. May only be sold in response to a valid prescription written by a UAE licensed physician.
5. The following records must be kept by the agent or wholesaler for 2 years or until the expiry date of the consignment, whichever is the shorter:
- The import permit and consignment note
- A copy of the delivery note to the pharmacy
6. The following records must be kept by the pharmacist for 2 years or until the expiry date of the consignment, whichever is the shorter
- The original prescription (for 2 years after dispensing, not date of writing). It must be filed according to the prescribing doctor and the week of dispensing.
- The invoice or delivery note (agent to pharmacy).
7. All records must be available on the premises (drug stores, wholesalers and pharmacies) for inspection by MOH inspectors.
8. All records must be available on the premises (drug stores and pharmacies) for inspection by MOH inspectors. Record can be destroyed only after approval by an MOH inspector. Destruction or record should follow good practice designed to preserve the confidentiality of the doctor and patient.
NOTES
(1) In accordance with the single convention on Narcotic drugs of 1991 and the amending protocol of 25th March 1972.
(2) The INCB 'Yellow list' is published annually and is subject to frequent updates.The 42nd edition was published in December 2000.
(3) In accordance with the Convention on Psychotropic substances 1971
(4) The annex to the annual INCB statistical reports ('Green list') The 21st edition was published in December 2001.
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