Specifications Federal Decrees, Circular No. or International Standards (GPP,GSP,GDP) 1 A registered pharmacist must be present and assigned to the facility. 2 Pharmacist shifts and working hours are relevant to employed staff ratio, operational capacity and existing labor laws. As a 24 hr. pharmacy Labor laws, GAHS 1-05 staffing plan SS/PD/PHA. HAAD 24 hour’s pharmacy criteria. 3 Staff wear proper uniform, and have legible name badges (facility badges). HA-AD policy- Dress code - good practice guidelines for healthcare providers- PPR/HCP/P0031/08. circular no 1/2005 4 The facility must be clean and neat. GPP, GAHS 1X -07 pharmacy infection control and sterile technique PP/PD/PHA 5 Facility shall have a minimum area of 30 square meters to ensure safe and proper storage, dispensing and /or compounding of medicines MOH 72/1988 Article No. 19 HA-AD circular (4) 2007 1 JOPR/HSC/PA/2012/1.1 Requirements are not met S.N. Article No. in the pharmacy law of 1983 Requirements are met Outpatient registration Audit checklist Remarks Outpatient registration Audit checklist 6 The floor must not be below the public road level. MOH 72/1988 7 Facility must not be connected to, or have access to any other activity (Residence, Pharmacy, clinic, shop, etc.). It is permitted however for the pharmacy to be located inside a shopping mall. MOH 72/1988 The area where prescription only medicine, controlled drugs and refrigerator must only be accessible to authorized personnel. GPP, Guide to management of controlled drugs in private sector , 2007/Healthcare facilities manualAdditional requirements for controlled drugs(4)/HA-AD circular HPR/5/2006,circular no 32 for 2007 8 9 10 11 License Frames must be posted in a visible and accessible area (to be used for posting pharmacy license and licensed staff licenses). The Facility signboard is clean and legible. Facility name is printed visible in Arabic and English letters on a board fixed in an unobstructed view and the working hours (24hrs, for example) are displayed. The recommended ceiling height of the facility is ≥ 2.7 meters, but it shall never be below 2.5 meters. The ceiling must provide acceptable insulation to medications from Circular No. 1 for 2005 Article No. 24 HA-AD Circular No7/2006. MOH decree72/1988 HA-AD facility licensing requirements –Section 9 (NFA). HA-AD requirements. MOH 72/1988 2 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist 12 13 14 humidity, rain and heat. Floor shall be made of easily washable and fire resistant material; preferably be made of ceramic tiles The exterior walls of the facility must be built out of secured, solid, fireresistant, humidity-resistant and sealed walls; suitable to isolate the facility from illegal entry, heat, rain, and humidity. A certificate from a licensed consultant stating these qualities of the wall must be presented. Facility walls shall be painted with proper anti-bacterial paint with no sharp edges. A certificate from the contractor who carried out this work stating the quality of the paint must be presented. 15 Illumination is satisfactory and proportionate to the scope and range of activities /services provided. 16 Facility must be well ventilated with a proper air conditioning system capable of maintaining the inside temperature between 20°C- 23°C. GPP. MOH decree 72/1988 HA-AD facility licensing requirements –Section 9 (NFA). MOH decree 72/1988 GPP, GSP GPP, Environment, Health and Safety Management System for the Health Sector- Management and Administration Manual HAAD/HSED/ST/0000/HS_EHSMS, HCPDM ch 6 environment health and safety management GPP, Environment, Health and Safety Management System for the Health Sector- Management and Administration Manual HAAD/HSED/ST/0000/HS_EHSMS, 3 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist HCPDM ch 6 environment health and safety management. MOH 312/1989 17 There are distinct storage spaces for storage of Controlled Medicines. The cabinet must be; made of steel with internal hinges; securely fixed to the wall or floor; Not visible or accessible to the public; connected to the establishment’s security system. N.B: If controlled medications are not being handled by the facility, an official document/ letter must be provided to HAAD in order for the facility to be exempted from the above controlled medications storage requirements. Note: Narcotics for being dispensed through outpatient pharmacies is subject to having exceptional approval from HAAD. Circular No. 32 for 2007, Guide to management of controlled drugs in private sector, 2007/GAHS VII drug distribution services 02 Narcotic and controlled drug management, HCPDM chapter 4 medical products. Federal law articles no 75/ 72/1988. Federal Law 14/1995 4 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist 18 19 20 Humidity and internal temperature inside the facility must be monitored with digital thermo-hygrometers distributed uniformly all around the facility (depending on the structure and design) with a minimum of 3 units (1 unit per 10 m2) with separate log sheets for each unit. .Readings per each unit must be logged on a separate sheet at least twice daily. Records of such are maintained. A documented procedure on how to handle temperature excursions must also be maintained. Designated cabinet or adequate arrangements for the storage and dispensing of 'High-Alert Medications’ are in place and conform to the requirements of Institute for Safe Medication Practices (ISMP). Facility must contain a special cabinet labeled “Expired Items, Not for Sale" or any other arrangement for physical isolation of all expired items from the valid stock. GPP, Circular No. 4 for 2007. Circular No7/2006 GSP. ISMP Article No. 31 GSP 5 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist 21 Facility shall have a public source of water drained to a rust-resistant sink with provision for hot and cold water. The sink must be surrounded with ceramic tiles, and drained to public sanitation network. GPP. MOH72/1988 22 First aid kit must be available in the facility and shall include all necessary updated items. GPP, HA-AD Standard for ‘Minimum Preparedness for common medical emergencies in the ambulatory care settings’ 23 24 25 Pharmacy has a computer system with internet access Pharmacy has a dedicated fax machine and a fax line. Facility must have a direct telephone line Circular No.1/2005 Circular No.1/2005 Circular No.1/2005 26 The facility has a dedicated pharmaceutical refrigerator (in good working condition) for the storage of temperature sensitive pharmaceutical products. If storing vaccines, a dedicated refrigerator must be installed that meet the requirements of HAAD policy. GSP. GPP3.8./MOH, HA-AD circular 4/2007, Standard for Safe Vaccine Handling and Cold Chain maintenance in the Emirate of Abu Dhabi-HAAD/VHCC/SD/0.9, GAHS V-01 drug procurement and storage (2), GAHS 1X -07 pharmacy infection control and sterile technique 27 Facility shall maintain a patient counseling area, designed to ensure an acceptable degree of privacy (facilitating confidential communication with customers). GPP 6 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist 28 29 30 31 32 Facility must have sufficient number of rust-free shelves and cabinets for storing medicines and other consumables. Euro pallets could be used for temporal separation of medications from direct contact with the floor. Facility must have at least two covered waste containers. One shall be located in the pharmacy professional service area while the other is kept in the customer waiting area Compounding medicine (if done) must adopt Good Compounding Practices for sterile and non-sterile items in reference with (GCP) manual and USP 797guidlines. If not willing to perform compounding, a letter must be submitted to HAAD in this regard. If a facility is utilizing the services of an internal Drug Information Center (DIC), a designated area shall be maintained with proper policy and procedures. If a facility is pre-packing/re-packing, designated area and equipment shall be maintained to fit the purpose. Records of maintenance, register of pre-packing/re-packing and labeling GSP. MOH72/1988 GPP, HA-AD policy on Medical waste management in Healthcare facilities PPR/HCP/P0002/07 GCP. BP. USP. GPP, GAHS SS/PD/PHA V11 -03 Extemporaneous Compounding of Pharmaceuticals. MOH 72/1988 GPP GCP. BP. USP. GAHS V11 03-007 labeling standards 7 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist system must be maintained. 33 34 35 36 37 If a facility is using a unit-dose system of dispensing/ distribution, proper policy and procedures concerning all aspects of operation must be available and implemented Red and black fire extinguishers must be distributed all around the facility, or a sparkling fire system must be installed. Facility must maintain an up-to-date copy of pertinent laws/regulations on the pharmacy practice issued by MOH or HAAD. Electronic copies or accessibility thereto is acceptable Facility shall maintain at least one valid scientific pharmaceutical reference that covers each area of practice. Maintain a valid contract or adequate arrangement for waste-management and disposal. GAHSV11-03-001 repackaging of oral and liquids in single use units and unit dose single units GSP GPP, Circular No. 1 for 2005 Circular No. 1 for 2005 HA-AD policy on Medical waste management in Healthcare facilities PPR/HCP/P0002/07. HAAD requirement for “Renewal of healthcare facility license’ accessible online www.haad.ae 8 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist 38 39 The facility has a valid contract or other alternative arrangements for pest and rodents control (copy is acceptable). Maintain box file for keeping copies of facility and staff licenses along with their renewals. Alternatively, electronic storage arrangements could be utilized. GPP 3.15, HAAD infection control facility audit check list GPP, HAAD Circular 1/2005. Ministerial decree No.1470 year 1986 9 JOPR/HSC/PA/2012/1.1
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