Current Dispensing Mode

Categories in the UAE

&
Regulations of Medical
Prescription
 References

• Federal Law No. 14 of 1995 on the Countermeasures against

Narcotic Drugs and Psychotropic Substances
https://www.unodc.org/res/cld/document/are/federal-law-no-14-of-
1995_html/UAE-fedlaw_14-95.pdf

• Federal Law No. (8) of 2019 on Medical Products, the Profession of

Pharmacy and Pharmaceutical Facilities

• Ministerial Decree No. (888) for the year 2016 In respect of Rules
& Regulations for Prescribing and Dispensing of Narcotic,
Controlled and Semi Controlled Drugs
http://www.isahd.ae/content/docs/MOHAP%20Decree%20888-2016.pdf
 Classification Criteria For Medicinal Product

Current Classification Old Classification

1. Controlled Medicines 1. Controlled
2. Prescription Only Medicine (POM) 2. POM
3. Pharmacist Only Medicine (Ph-OM) 3. OTC
4. Over-The-Counter (OTC)
5. General Sale Supermarket
Medicine (OTC-G)
Medical Prescription
A written or electronic document issued by healthcare
professional a duly licensed to dispense according to the
executive decree of this Law, resolutions, orders and
instructions issued in this regard.

Forms of Medical Prescriptions:

- Controlled or Narcotic drugs
- General Medications
 Controlled and Semi-Controlled
medications in Pharmacy

Controlled Drug (CD) is a medicine that

having a significant potential for abuse,
addiction and/or could be diverted for illegal
use.
This group includes the medical and pharmaceuticals products that contain any of
the active ingredients listed in International Narcotics Control Board (INCB)
schedules Nos. (1, 2, 3, 4) contained within the convention of the United Nations
for psychotropic substances for the year 1971 and Schedules mentioned in the
Federal Law No. 14 of 1995 in respect of combating the Narcotic drugs and
Psychotropic substances and its amendments according to the afore mentioned
Cabinet Decree No. (38) Of 2015
Narcotic and Psychotropic Substances
Medical and therapeutic products and others
containing any of the active ingredients according
to Federal Law No. 14 of 1995, and its
amendments.

Semi-Controlled Substances
Substances or drugs not listed as narcotic or
psychotropic substances, however they must be
controlled inside the country, as its misuse may
lead to harm of public health.
 Controlled Medicines
1. Narcotic drugs (CD-Narcotics) Controlled
Example: Pethidine, Morphine, etc.
2. drugs (CD)
- Controlled A (CD A) Example: Lorazepam,
Diazepam, Misoprostol, etc.
- Controlled B (CD B) or Semi Controlled drugs
(SCD) Example: Somatropin, Citalopram,
Codeine, etc.
The law has categorized the narcotic and psychotropic
drugs into 9 schedules.
 Sample of
prescription for
controlled Drugs
 Narcotics
Medically: substances used to treat moderate
to severe pain.
• Example: Pethidine, Morphine
• Narcotic drugs can be prescribed, dispensed
and stored at:
– Hospitals: Used in-patient wards of
government and private hospitals.
– Governmental primary health care centers (for
emergency only)
Note: Narcotic Medications are not allowed to
stock/dispense at community pharmacies
Prescribing and dispensing of drugs in this group
shall be subject to the following regulation:
• An exception to the prescribing and dispensing of narcotic
medicines for use by patients outside the hospital is
limited to a maximum of 30 days for cancer patients,
treatment of severe pains and post major surgeries as per
specific dosage by the their treating physicians; specialists
or consultants according to their specialization.

• These drugs should be prescribed in specific Narcotic

Prescriptions supplied by MOHAP or local health
authorities and as per MOHAP’s approved rules and regulations
on consumption, distribution and dispensing of Narcotic Drugs.

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Prescribing and dispensing of drugs in this group
shall be subject to the following regulation:
• The pharmacist should NOT dispense the narcotic
prescription after three days from the prescription date.
• The pharmacist should record the prescription in the
specific narcotic registration book immediately and
keep the dispensed prescription after signing and
stamping it in the pharmacy for a minimum period of
five years.
• The hospital pharmacies shall provide the Ministry of
Health and Prevention (Drug Department) with a
quarterly report on the movement of these drugs
through their health authorities
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 Controlled Medicine (CD A)
The requirements for an out-patient
prescription written for a CD A. These include;
• Use a Controlled Drug Prescription form
• Written in permanent ink
• Name and address of the patient
• Amount of medicine and dose instructions
• Total amount to be written in words and figures
• The prescription must have been written not
more than 2 days earlier (as each controlled
prescription is only valid for 3 days).
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 Controlled Medicine (CD A)
• The dose must be within the manufacturers’ dose
range of the medicine
• No repeat can be issued without new prescription
• The minimum legal requirement for a medical
prescription in the UAE includes;
– Prescriber must have a valid UAE medical license
– Name and stamp of the prescriber must be clear
• The patient must provide a government issued
Photo-ID e.g. Passport, Emiratis ID, UAE Drivers
License, UAE Health Card, etc.
• Monthly transaction report to MOH 2
Duration of prescription allowed for CD A drugs

• General Practitioner 3 days in emergency

• Specialist 15 days

• Consultant 30 days

• Psychiatry; Specialist or Consultant 30 days

CD B (Semi Controlled drugs)
• CD B drugs do not require special prescription form
for prescribing it for in- or out-patients, therefore
these are prescribed using a normal medical
prescription.
• Example: Somatropin, Citalopram, some drugs
contain Codeine
• Duration of prescription allowed for
- General Practitioner 30 days- No refill
- Specialist 30 days + 30 days as refill
- Psychiatric: 30 days + 2 refills (total 90 days)
- Consultant 30 days + 2 refills (total 90 days)
 Dispensing controlled Drugs
• Controlled & Semi Controlled drugs (CD A & CD B) can
be stored and dispensed in all UAE pharmacies (private
and government).

• Any discrepancy, omission of information, or

uncertainty concerning a drug or its administration
shall be clarified with the physician by pharmacy staff
prior to dispensing.

• Prescriptions, if tampered or unauthorized correction

(abrasive, off-writing and over-writing) prescriptions
should not be dispensed.
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 Dispensing controlled Drugs
• Medicines are sold in quantity less than its original
pack must carry full medicine name, strength, batch
number and expiry date and the patient must receive
(free of charge) a copy of the original package insert
or patients leaflet from the pharmacy.

• Patient’s ID required for controlled drug prescriptions

include only valid passport, Emiratis ID, UAE driver’s
license or Labor card.

• If the patient is legally under-aged, the drugs should

be handed over to the legal guardian for proper use
of the drugs to ensure that they are not abused. 2
 Dispensing controlled drugs (CD B)
• The pharmacist shall hand over the original
prescription to the patient if it contains refills
after signing, stamping, adding the pharmacist
license number and the date of each dispensing.

• A copy of the prescription shall be retained in the

pharmacy.

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 Documentation - General Guide
• Hospital Pharmacies should have the following log books:
– Narcotics log book
– CD A log book
– CD B log book
• Community Pharmacies should have the following log books:
– CD A log book
– CD B log book
• Log books can be obtained from Drug Department at Ministry
of Health and Prevention (MoHaP).
• Monthly Report for controlled medicines
• All records (bills, prescription and log books) should be kept for
Five Years (5)
 Documentation
After dispensing:
• Up-date the log book with dispensed quantities and
remaining balance.
Reporting
• Monthly report must be sent at the first week of the
month to Ministry of Health
Expired (CD A & CD B) Drugs:
• Expired medicine of controlled drug must be isolated in
the locked cabinet and tagged as expired items.
• Responsible Pharmacist must inform the MOH inspector
to take action as well as deducting expired drugs and
quantities from the stock at the register book.
 E-Control Medicine Prescription
• The Drug Control section monitors and dispenses
controlled drugs through the Unified Controlled
Electronic Platform developed by UAE Ministry
of the Interior.
• The electronic system allows doctors and
pharmacists to register, prescribe and dispense
narcotics and controlled/semi controlled
medications, which facilitate tracking of
prescriptions issuance and dispensing.
 2. PRESCRIPTION ONLY MEDICINES (POM)
• Medicinal products to be supplied only on the
prescription of a licensed health care
professional, especially physician.
• Location of medicinal products should never
be accessed by customers directly.
Examples:
 Antibiotics
 Medicinal products used for direct treatment of
different serious chronic diseases such as
Cardiovascular, Endocrine diseases, etc.
 All Parenteral products
PRESCRIPTION ONLY MEDICINE (POM)
DISPENSING GENERAL GUIDE/ KEY REQUIREMENTS:

• No dispensing of a prescription only medicine

(POM) without a prescription from licensed
healthcare professional in the UAE.
• Any discrepancy, omission of information, or
uncertainty concerning a drug or its
administration shall be clarified with the physician
by pharmacy staff prior to dispensing.
• Do not dispense if in doubt.

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PRESCRIPTION ONLY MEDICINE (POM)
DISPENSING GENERAL GUIDE/ KEY REQUIREMENTS:
• All medicines must be sold as original packs.
• If part packs are required then they must carry the
medicine name, batch number and expiry date and
the patient must receive (free of charge) a copy of
the original package insert or patient leaflet from
the pharmacy.
• Prescription medicines can only be sold in
accordance with a prescription written by a UAE
licensed doctor within the last 6 months.
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PRESCRIPTION ONLY MEDICINE (POM)
DISPENSING GENERAL GUIDE/ KEY REQUIREMENTS:
• At the time of dispensing, a pharmacist is responsible for the
addition of the following to the original prescription:
– On the back side of the prescription, signature, identification
code of the dispensing pharmacist and stamp.
– Quantity dispensed, if different from the quantity prescribed.
– Date of dispensing, if different from the date of issuance.
– Brand name or manufacturer of the drug product actually
dispensed, if the drug was prescribed by generic name or if a
drug product other than the one prescribed was dispensed.
– Any changes done by the physician to the prescription after
telephone clarification of the order by a pharmacist.
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 ISSUE WITH PRESCRIPTION
If the pharmacist-in-charge discovers a mistake or
omission in the medical prescription or becomes
doubtful about some of its particulars, he/she must
discreetly contact the physician who issued the
prescription for clarification. he/she should return the
prescription to the physician if he/she does not
accept the latter’s clarifications, in which case the
physician shall underline the point of disagreement in
the prescription and sign it.

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 NON PRESCRIPTION MEDICINES

The medicinal products that don’t fall within any of the

previous criteria may be designated as one of the non-
prescription dispensing modes

• Pharmacist Only Medicine (Ph-OM)

• OTC- Pharmacy Medicine (OTC-P)
• OTC -General Sale Supermarket Medicine (OTC-G)
PHARMACIST ONLY MEDICINE (PH-OM)
• Medicinal products may be dispensed without a
prescription from another licensed healthcare
professional but only after the patient receives a
relevant counseling from a licensed pharmacist in
a pharmacy.
• Examples: Omeprazole 10mg, Ranitidine 150mg,
Econazole (topical) 1%, Silver sulfadiazine 1%, Ibuprofen
(tab) 400mg, Nicotine (patch), Oxymetazoline (nasal)

• Location of medicinal products should not be

accessed by customers directly.
 OTC - PHARMACY MEDICINE (OTC-P)

• Medicinal products may be supplied without a

prescription and sold only in a pharmacy

• May be stored at a location that allows direct

access for customers.

Examples: Ranitidine75mg, Ibuprofen (tab) 200mg,

Ibuprofen (topical) 5%, Loratadine, Bromhexine
 GENERAL SALE SUPERMARKET MEDICINE
(OTC-G)

• Medicinal products may be sold on retail basis

from outlets other than pharmacies with
controlled storage conditions while wholesale
distribution.
• Should be made through licensed medicinal store
only.

Examples: Paracetamol 500mg, Benzyl benzoate (topical),

Nicotine (gum) 4mg
 OTHER PRODUCTS
• Natural Source
– Herbal
– Homeopathy
– Dietary Supplements
– Herbal teas
• Antiseptics & Disinfectants
• Medicated Cosmetics
• Miscellaneous; baby milk, baby product, etc.

All products should be registered in the MOH