Pharmacy Awareness Campaign May 1
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Transcript of Pharmacy Awareness Campaign May 1
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Licensing Process for Pharmacies and their
Professionals
Dr. Hana I. Badran
Sheryan Project Manager
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Health Regulation Department
Todays Overview
1 Licensing Process for Professionals
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3
List of DHA approved Professional Title
Licensing Process for Facility
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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)
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http://eservices.dha.gov.ae/DHAWeb/Default.aspx
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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
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Declaration Page
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700 DHS
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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
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List of DHA approved
Professional Title
1. Pharmacist
2. Pharmacy Technician (equal to Pharmacy Assistant)
3. Pharmacy Trainee
4. Clinical Pharmacist
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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)
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http://eservices.dha.gov.ae/DHAWeb/Default.aspx
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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
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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
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May 1, 2013
Health Regulation Department
Dubai Community Pharmacy Licensure &
Pharmaceutical PracticesGuide
Alia Hani Yousef ,Bs.c in Pharmacy
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Objective
To provide awareness of the new pharmacy regulation in Dubai
To facilitate implementation
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DHA Health Facility Regulations
Day Surgical Centre OutpatientHospital
Diagnostic Imaging Home HealthcareClinical Laboratory
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Three Guidelines
Guidelines on Dental Infection Prevention
&Safety Health Record Guidelines
Health Facility Guidelines: Planning, Design, Construction and Commissioning
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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
Health Regulation Department
Dubai Health Authority
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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
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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
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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
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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
Health Regulation Department
Dubai Health Authority
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Community Pharmacy RequirementsGeneral Considerations
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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
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Medication Preparation Area
Power Supply
First Aid Kit
DHA Pharmacy license
Fire extinguishers
Ref
Community Pharmacy Requirements Design Requirements
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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
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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
Health Regulation Department
Dubai Health Authority
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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
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Storing Medications and Pharmaceutical Products
Exposure to sun light POM display and advertisingStorage conditions
PHARMACEUTICAL PRACTICES Section One: Medication Management
Precautions
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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
PHARMACEUTICAL PRACTICES Section One: Medication Management
Purchasing and Dispensing
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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
PHARMACEUTICAL PRACTICES Section One: Medication Management
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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)
PHARMACEUTICAL PRACTICES Section One: Medication Management
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Alterations in Prescription
PHARMACEUTICAL PRACTICES Section One: Medication Management
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!!!
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PHARMACEUTICAL PRACTICES Section One: Medication Management
Errors in Prescription
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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
PHARMACEUTICAL PRACTICES Section One: Medication Management
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PHARMACEUTICAL PRACTICES Section One: Medication Management
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
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PHARMACEUTICAL PRACTICES Section One: Medication Management
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
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PHARMACEUTICAL PRACTICES Section One: Medication Management
CDA(Group-A)Registration log book
CAB (Group-B)Registration log book
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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
PHARMACEUTICAL PRACTICES Section One: Medication Management
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PHARMACEUTICAL PRACTICES Section One: Medication Management
Special Requirements CDA Outpatient Prescription Federal Law No.4 (1983)
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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
PHARMACEUTICAL PRACTICES Section One: Medication Management
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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
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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
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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
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Registers Records and Reports
Daily Temperature Record (12 months) Records of controlled drug registers
CDA CDB numbered and stamped by MOH
Invoices
PHARMACEUTICAL PRACTICES Section Two: Record Management
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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
PHARMACEUTICAL PRACTICES Section Two: Record Management
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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
PHARMACEUTICAL PRACTICES Section Two: Record Management
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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
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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
PHARMACEUTICAL PRACTICES Section three : Good Pharmacy Practices
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Waste ManagementWaste Management
Disposal of wastes in accordance with UAE laws and regulation
Disposal via approved companies must be recorded
PHARMACEUTICAL PRACTICES Section three : Good Pharmacy Practices
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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 -
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.Healthcare ProfessionalsRegistration & Licensing
Ms. Khawla Al MansooriHealth Regulation Department
Dubai Health Authority
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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.
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Renewal of Professional License
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Continuous Professional Development (CPD)
CPD requirements Category
30 hoursDoctors and Dentists
15 hoursNursing
15 hoursPharmacists
10 hoursAllied Health
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General Rules for Inspection
Alia Hani Sharif, BS.c in Pharmacy
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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
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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
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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
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Definition
Inspection CommitteeA group of qualified professional working
together to review and evaluate the services of the facility and compliance to DHA Standards
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Scope All Health Care Facilities Located in
DubaiHospitalsDay care surgery centersSpecialty clinics PolyclinicsGeneral clinics Physiotherapy centersDiagnostic centers Optical shopsPharmacies
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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
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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
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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
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General Rules
Planned InspectionsInitial Final
Unannounced InspectionRandom Inspection
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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
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General Rules
Licensure surveyors authoritiesUse of digital cameras when deemed
necessaryRequest the reproduction of any relevant
document
Field Inspection Report Form
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Thank you.
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.Executive Council Resolution No. (32) Regulating
Practice of Medical Professions in Dubai
Dr Layla Al-Marzouqi Health Regulation Department
Dubai Health Authority
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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
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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
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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
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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.
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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
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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
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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
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Penalties for Ethical & Technical Violations
Warning Fine 2,000- 10,000 dirhams HCP Fine 5,000- 25,000dirhams - HCF
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Grievance written grievance to be submitted within 30 days Will be referred to grievance committee decision shall be final
10
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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
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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
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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 -