Pharmacy Awareness Campaign May 1

Licensing Process for Pharmacies and their

Professionals

Dr. Hana I. Badran

Sheryan Project Manager

Health Regulation Department

Todays Overview

1 Licensing Process for Professionals

2

3

List of DHA approved Professional Title

Licensing Process for Facility

5/2/2013 3

Application Process for

Professionals

1. For First time user: Visit our webpage:

http://eservices.dha.gov.ae/DHAWeb/Default.aspx

Create a Sheryan account on line (user name

and password)

5/2/2013 5

2. Fill New Professional License application and upload the required documents:

Latest Passport Size Photograph with white background

Valid passport copy Education certificate

Last 2 years experience PSV report from dataflow if available

MOH license (Valid or renewed receipt) or MOH

passing exam

Declaration Page

700 DHS

Notes

The DHA license expiry date will have the same expiry date of MOH license

DHA License can be renewed 3 month earlier to the expiry date, where a payment of 1010 DHS will need to

be done online via credit card.

Applicant can collect the license from HRD during working hours

This license will be valid only for the Emirate of Dubai

List of DHA approved

Professional Title

1. Pharmacist

2. Pharmacy Technician (equal to Pharmacy Assistant)

3. Pharmacy Trainee

4. Clinical Pharmacist

5/2/2013 11

Application Process for

Facilities

1. For First time user:

Visit our webpage http://eservices.dha.gov.ae/DHAWeb/Default.aspx

Create a Sheryan account online (user name

and password)

5/2/2013 13

2. Fill New Facility License application and upload the required documents:

1. Passport photocopy with residency visa for non-locals 2. UAE identity card (National ID) 3. Initial Approval: where you need to submit the

followings: Map Facility layout Blue print DED reservation name certificate MOH valid registration license 4. NO Payment of 1010 DHS, to email us [email protected] with your application reference number in order to do the needful

Notes

The DHA license expiry date will have the same expiry date of MOH license

DHA License can be renewed 3 month earlier to the expiry date, where a payment of 7510 DHS will need to be done

online via credit card.

Facility can collect the DHA license from HRD during working hours

May 1, 2013


Dubai Community Pharmacy Licensure &

Pharmaceutical PracticesGuide

Alia Hani Yousef ,Bs.c in Pharmacy

Objective

To provide awareness of the new pharmacy regulation in Dubai

To facilitate implementation

DHA Health Facility Regulations

Day Surgical Centre OutpatientHospital

Diagnostic Imaging Home HealthcareClinical Laboratory

Three Guidelines

Guidelines on Dental Infection Prevention

&Safety Health Record Guidelines

Health Facility Guidelines: Planning, Design, Construction and Commissioning

Community Pharmacy Regulation

Chapter One: Definitions & Procedures Administrative Procedures

Chapter Two: Requirements General Considerations

Community Pharmacy Requirements

Design Requirements

Requirements for 24 hours duty

Chapter Three: Pharmaceutical Practices Section one: Medication Management

Section Two: Records Management

Section Three: Good Pharmacy Practices

Dubai Community Pharmacy

LicensurePharmaceutical

PracticesGuide


Dubai Health Authority

Scope

This Guideline applies to every licensed pharmacy providing pharmaceutical

services and subject to licensure under the Dubai Health Authority establishment

law, including pharmacies private, semi-governmental, and free zone areas

Definition of Terms

Community Pharmacy - all those establishments that are privately owned and whose function is to serve societies need for both drug products and the pharmaceutical services

Controlled Drug -Class A - medicine that contains an active ingredient listed in schedules 7 and 8 of the UAE Federal law for 1995, or a medicine that has been assessed as having a significant potential for abuse and / or could be diverted for illegal use

Definition of Terms

Controlled Drug -Class B - medicine that is used for psychiatric conditions or a schedule 3 medicine that avoids narcotic control due to its formulation or any other medicine that requires stricter control than that of prescription

Medicine/medication/pharmaceutical drug - defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease

Narcotic - a medicine containing an active ingredient listed in Schedules 1 to 6 of UAE Federal law 14 for 1995





Design Requirements







PracticesGuide



Community Pharmacy RequirementsGeneral Considerations

Space Requirements

Hand Washing Area

Wall Finish & Flooring

Main area requirements (sales area, storage, dispensing, etc..)

Cabinets (POM, Controlled Drugs, Expired Meds, etc)

Communication Devices

Air Conditioning

lighting

Community Pharmacy Requirements Design Requirements

Medication Preparation Area

Power Supply

First Aid Kit

DHA Pharmacy license

Fire extinguishers

Ref

Community Pharmacy Requirements Design Requirements

Duty permission and ValidityDuty permission and Validity

24 hours operating pharmacy not allowed to close / unless permission cancel

24 hours operating pharmacy not allowed to close / unless permission cancel

pharmacy access pharmacy access

pharmacy display board pharmacy display board

licensed pharmacist availability licensed pharmacist availability

medications availability medications availability

Community Pharmacy Requirements 24 Hour Duty Pharmacies





Design Requirements







PracticesGuide



Storing Medications andPharmaceutical Products

Medicines Vaccines Pharmaceutical products

Storage

Room temperature between 15-30 c Relatively cool area between 8-15c Cold place temperature around 8c Refrigerator temperature between 2-8 c

Pharmacy Temperature monitoring

PHARMACEUTICAL PRACTICES Section One: Medication Management

Storing Medications and Pharmaceutical Products

Exposure to sun light POM display and advertisingStorage conditions


Precautions

Licensed Agents or MOH

Registered Distributors

Official Purchase Invoice (batch/lot no. of each item,

expiry)

Dispensing expired

medication !

Smuggled and Illegal Products

Free Sample Medications

Selling Price & Discounts


Purchasing and Dispensing

Purchasing and Dispensing

Trading of Medical Products

Directing customers to buy

other than prescribed

Changing or modifying

pharmaceutical preparation

Selling medication in original packs or part packs Medicine name,

batch number/lot number

Expiry date Leaflet

Stickers and Labels


Prescription Only Medications (POM)

Prescription

Availability Validity Legible Contents (hand written or electronically printed)

Name, Age, weight, &

contact numberGeneric or Trade

name

Pharmaceutical preparation

form, dosage, route of

administration, duration & instruction

Licensed Healthcare

Professional (Name, stamp,

signature & date)


Alterations in Prescription


Permission from Patient & Doctor

Change product with similar

active ingredient

Document in writing

Signature of Pharmacist

Doctors cannot be contacted

Doctors refuse to change medication

Pharmacist is not permitted to dispense

medication!!!


Errors in Prescription

Controlled DrugsFederal Law No. 4 for 1983

Controlled Prescription Psychotropic Substances

Duration of Prescription (CDA & CDB) General Practitioner - 3days Specialist - 2 weeks Consultant - 4 weeks Psychiatry Specialist or Consultant - 4 weeks



Condition for Dispensing (CDA) Medication

Prescription exceeds specified period

MOH Controlled Drug Prescription form

Validity - 3 days from the date of issuance

copy of patients UAE identity card/passport

Stamp and signature


Condition for Dispensing (CDA) Medication

record in special register book (DHA,

MOH)

re-dispensing

Dispensing medications

exceeding approved doses

licensed physician issuing narcotic or

psychotropic substances for

himself

Storage

Return of damaged stock


CDA(Group-A)Registration log book

CAB (Group-B)Registration log book

Special Requirements CDA Outpatient Prescription Federal Law No.4 (1983)

serial number patient's full name, age and address (given name, surname, middle

name) permanent ink generic & trade name of medicine date of issuance, signature and stamp of the prescribing physician dosage & strength of active ingredient (figures & letters) route of

administration, duration and instructions of use Duration of supply



Special Requirements CDA Outpatient Prescription Federal Law No.4 (1983)

Controlled Drugs

Management of expired controlled drugs separated from the active stock labelled removed as soon as possible may be returned or destroyed as per the Narcotics

and Controlled Drugs Guide Record in the controlled drug register


Documents & Records

Dedicated area

UAE Pharmacy Professional law Pharmacist Professional Code of Conduct Guidelines and minimum standards for Good Pharmacy

Practice (GPP) in UAE Pharmacies issued by MOH DHA and MOH circulars and relevant documents Forms reporting adverse reactions used by

Pharmacological vigilance program

PHARMACEUTICAL PRACTICES Section Two: Record Management

Documents & Records List of registered medication in UAE approved price list issued by MOH amendments List of controlled drugs and classifications and

amendments pharmacy license DHA and DED staff valid DHA licenses (including trainees) Staff list Continuous Professional Development (CPD)

PHARMACEUTICAL PRACTICESSection Two: Record Management

Contact dataContact data

Contact Numbers

Pharmaceutical Vigilance Committee in MOH (MOH website www.moh.gov.ae)

Poison Information Centres in the UAE http://www.haad.ae/haaddeps/pdic/tabid/194/default.aspx

Directory of all health facilities contact details

PHARMACEUTICAL PRACTICESSection Two: Record Management

Registers Records and Reports

Daily Temperature Record (12 months) Records of controlled drug registers

CDA CDB numbered and stamped by MOH

Invoices


Registers Records and ReportsRegisters Records and Reports

Commercial transactions

Controlled Drugs prescriptions (5 years) (CDA and CDB)

Reports of Controlled Drugs (CDA and CDB)

Prescriptions of medication preparation

Violations and fines - pharmacy & staff


Scientific References

British National Formulary (BNF) British Pharmacopoeia (BP) United States Pharmacopeia (USP) European Pharmacopoeia (Ph. Eur.) Martindale: The Complete Drug Reference Goodman and Gilman: The Pharmacological Basis of Therapeutics A book for clinical pharmacy or clinical pharmacology


Legal and Ethical frameworkLegal and Ethical framework

Abide with UAE Pharmacy federal laws, related legislations and circulars

Comply with Pharmacists Professional Code of Conduct by MOH

Pharmacy staff is not allowed to offend or criticize any healthcare professional

Continuing professional development Up to date knowledge and skills

PHARMACEUTICAL PRACTICES Section three : Good Pharmacy Practices

Personnel

Valid DHA license; Training permission Availability during duty hours Scope of Practice Technicians & Trainees under supervision Professional Staff Uniform and ID card Confidentiality First Aid Activities not allowed Annual leave not exceeding 60 days Substitute Pharmacist Pre-approved by HRD


Waste ManagementWaste Management

Disposal of wastes in accordance with UAE laws and regulation

Disposal via approved companies must be recorded


Medication Management ClassificationofMedicationsinUAE

Federal law 14 (1995) Schedules

MOH assigned Mode of Dispensing Abbreviation

Older UAE descriptions

1-6 (Narcotics) Controlled Drug - Narcotic Narcotic Narcotics

7-6 (Psychotropics) Controlled Drug - Class A CDA Registered Prescription (RP)

Not scheduled accordingto Federal Law 14 (1995)

Controlled Drug - Class B CDB Semi-Controlled, prescription (CP)

Prescription Only Medicine POM

Prescription Drug (P)

Over the Counter OTC -

General Sale List GSL -

.Healthcare ProfessionalsRegistration & Licensing

Ms. Khawla Al MansooriHealth Regulation Department


Licensing Titles

2

Title Qualifications Experience

Clinical Pharmacist (New)

Route 1:BSc or Doctor of Pharmacy (Pharm. D) degree from an accredited college of pharmacyORPost baccalaureate Pharm. D degree or MSc Clinical PharmacyANDCurrent National License

Minimum of one year experience as a clinical pharmacist with clinical responsibilities providing Pharmaceutical care

Pharmacist

Bachelor degree in Pharmacy from an accredited college of pharmacy recognized in home country ANDActive License/Registration to practice pharmacy

Minimum of two years experience as Pharmacist.

Pharmacy Technician

Graduate of an accredited diploma in Pharmacy program (minimum of two 2 years course duration) recognized in home country.

Minimum of two years experience as Pharmacy Technician.

Renewal of Professional License

3

Continuous Professional Development (CPD)

CPD requirements Category

30 hoursDoctors and Dentists

15 hoursNursing

15 hoursPharmacists

10 hoursAllied Health

General Rules for Inspection

Alia Hani Sharif, BS.c in Pharmacy

Objectives To promote awareness on the general rules of

Quality Assurance Section, Facility Monitoring Unit Inspections

Specifically, emphasize the scope of inspectionaccentuate the purpose of inspectionhighlight expectations from Licensure Surveyors

Definition

Inspectionis the onsite survey of health facility including all

aspects of the facility (physical structure, Medical, Engineering, nursing etc)

Initial Inspectionis an inspection conducted in order to review and

compare the architectural floor-plan submitted and Health facility Guidelines of a new applicant

Definition Final Inspection

is an on-site inspection by surveyors and/or relevant others to determine compliance with the DHA regulatory standards of a new applicant for licensure

Random Inspection is an unannounced onsite visit to an established and

licensed health facility in order to identify compliance to DHA standards

Definition

Inspection CommitteeA group of qualified professional working

together to review and evaluate the services of the facility and compliance to DHA Standards

Scope All Health Care Facilities Located in

DubaiHospitalsDay care surgery centersSpecialty clinics PolyclinicsGeneral clinics Physiotherapy centersDiagnostic centers Optical shopsPharmacies

General Rules

Purpose of InspectionInspection makes an important contribution to

the improvement of delivering health services provides assurance to the public on the safety of

services in the Emirate of Dubai

General Rules

DHA Authorized SurveyorsQAS-FMU Licensure Surveyors are given the

right to conduct various inspections

through Delegation of Authority by the Director General of Dubai Health Authority and the Ministry of Justice

Legal Seizer Bailiffs

General Rules

The Inspection TeamMinimum of two licensure surveyorsCommittee consisting of multi-sector

specialist

Frequency of Inspection minimum of two inspections per yearsurveyors shall decide upon the time interval

between visits

General Rules

Planned InspectionsInitial Final

Unannounced InspectionRandom Inspection

General Rules Expectations

Surveyors approach shall be one of Transparency High degree of professionalism

Surveyors shall make objective judgmentsSurveyors shall provide constructive

recommendations after inspection process

General Rules

Licensure surveyors authoritiesUse of digital cameras when deemed

necessaryRequest the reproduction of any relevant

document

Field Inspection Report Form

Thank you.

.Executive Council Resolution No. (32) Regulating

Practice of Medical Professions in Dubai

Dr Layla Al-Marzouqi Health Regulation Department


28 articles--Summary

Practising healthcare profession Medical Practice Committee & its function Process of Application for License Penalties for Ethical & Technical Violations

&Administrative Violations Law Enforcement Officers Penalties Appeal Reinstatement of License to Practise a Profession Accrual of Fees and Fines

Medical Practice Committee

Develop / review Rules & Conditions for licensing Professionals /

Healthcare Facilities standards for equivalence of academic &

professional medical qualifications Consider license applications of Professionals/

Healthcare Facilities

Medical Practice Committee

Set exemption standards from initial assessment required for granting licenses

Impose appropriate penalties on violating Professionals / Healthcare Facilities

Perform any other duties assigned by Director General

Fees for Healthcare Facilities Licenses Fees for License of Professionals Penalties for Administrative Violations

Suspended/revoked HCP may not work, even in

administrative positions, in HCF without prior approval from HRD.

Fines

Practicing without license Opening facility without getting final approval Being uncooperative with Law Enforcement

Officers Not submitting required date to DHA within time

limit Not issuing sick leave electronically Not issuing medical report to patient For technical and ethical violation

6

Administrative Measures for Violating Legislation

close section or whole HCF for a period not > 6 M at a time

suspend the HCP for 12 M revoke License of HCP/HCF Investigation :

temporary partial or complete closure/ suspension of HCF/HCP for a period not >3 M

Extension of the closure for the same period. Violation constitutes a criminal refereed to judicial

body

Ethical & Technical violations

Running unnecessary medical tests for patients to make financial profits

Treatment of a patient without prior consent, except in emergency

Determining treatment by a Professional without conducting clinical examination of the patient.

Infection control measures Use of unauthorised or illegal means to treat

patients

8

Penalties for Ethical & Technical Violations

Warning Fine 2,000- 10,000 dirhams HCP Fine 5,000- 25,000dirhams - HCF

Grievance written grievance to be submitted within 30 days Will be referred to grievance committee decision shall be final

10

Reinstatement of License to Practise a Profession

HCF/HCP can apply for reinstatement of License after 2 years

Committee shall decide on the application according

Law Enforcement Officers

Function prove acts committed in violation of this

resolution have access to inspect HCF audit Professionals issue violation reports seek assistance from government entities

concerned, including police officers

Thank you

Dr. Hana Badran - Sheryan Procedure for PharmacyAlai Yousef - Pharmacy RegulationsKhawla Al Mansoori - Professional Pharmacist RequirementsMicrosoft PowerPoint - Alia Yousef - General Rules for Inspection [Compatibility Mode]Dr. Layla Al Marzouqi - Executive Council Resolution No 32 9 -