Drug Store Registration Audit Checklist

Transcription

1 S.N. Specifications Article No. in the pharmacy law of 1983 Federal Decrees, Circular No. or International Standards (GPP,GSP,GDP) Requirements are met Requirements are not met Remarks 1 A registered pharmacist must be present and assigned to the facility. Article No. 19 HA-AD circular (4) Pharmacist shifts and working hours are relevant to employed staff ratio, operational capacity and existing labor laws. Labor laws, GAHS 1-05 staffing plan SS/PD/PHA 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/ The facility must be clean and neat. GPP, GAHS 1X -07 pharmacy infection control and sterile technique PP/PD/PHA 5 Offices must be separated from the storage area. GSP. MOH 312/ JSOR/HSC/PA/2012/1.1

2 6 Storage area should be well secured, with accessibility to only authorized personnel. 6- Article No. 23 GSP. MOH 312/ Facility shall have a minimum storage area of 30 square meters to ensure safe and proper receiving, storage, dispensing/ dispatching, and delivery of pharmaceuticals. GSP. MOH72/ The floor must not be below the public road level. MOH 72/ Facility must not be connected to, or have access to any other activity (Residence, Pharmacy, clinic, shop, etc.). MOH 72/ License Frames must be posted in a visible and accessible area (to be used for posting pharmacy license and licensed staff licenses). Circular No. 1 for 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 are displayed. Article No. 24 HA-AD Circular No7/2006. MOH 72/ JSOR/HSC/PA/2012/1.1

3 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 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, fire-resistant, 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. HA-AD facility licensing requirements Section 9 (NFA) HA-AD requirements. MOH72/1988. GPP. MOH decree 72/1988 HA-AD facility licensing requirements Section 9 (NFA). MOH decree 72/1988. GPP, GSP 3 JSOR/HSC/PA/2012/1.1

4 Illumination is satisfactory and proportionate to the scope and range of activities /services provided. Facility must be well ventilated with a proper air conditioning system capable of maintaining the inside temperature between 20 C- 23 C. There are distinct storage spaces one dedicated for Narcotics and other for storage of Controlled Medicines inside a secure cabinet/ vault meeting HAAD requirement. It is preferable to have the safes/ cabinets kept inside a dedicated and secure room meeting the below requirements: a- The room must be lockable (when not occupied) and have walls, ceiling and floor that cannot GPP, Environment, Health and Safety Management System for the Health Sector- Management and Administration Manual - HAAD/HSED/ST/0000/HS_EHS MS, 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_EHS MS, HCPDM ch 6 environment health and safety management. MOH 312/1989 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/ JSOR/HSC/PA/2012/1.1

5 be easily broken. b- The room for storing controlled /Narcotics should not be accessible to unauthorized persons. When it is not in the direct line/ site of the supervising pharmacist, there should be an alarm that indicates when door has been opened. c- 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 /Narcotic 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. 5 JSOR/HSC/PA/2012/1.1

6 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. There is a dedicated staff rest room. A special isolated and secured quarantine area should be available for storing all recalled, damaged, expired, and banned products, with explicit labeling. There should be a separate secured place to store medical samples (if any). Controlled medical samples, if available, must be placed inside the GPP, Circular No. 4 for Circular No7/2006 GPP GSP. GPP GSP. MOH 312/ JSOR/HSC/PA/2012/1.1

7 controlled medicine cabinet with a special register for it 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. A water closet should be available in the facility with its drainage, directly connected to the municipality drainage system as per municipality regulations. First aid kit must be available in the facility and shall include all necessary updated items. Pharmacy has a computer system with internet access Pharmacy has a dedicated fax machine and a fax line. GPP. MOH 72/1988 HA-AD facility licensing requirements Section 9 (NFA). MOH 312/1989 GPP, HA-AD Standard for Minimum Preparedness for common medical emergencies in the ambulatory care settings Circular No.1/2005 Circular No.1/ Facility must have a direct telephone line Circular No.1/ The facility has a dedicated GPP3.8./MOH, HA-AD circular 7 JSOR/HSC/PA/2012/1.1

8 pharmaceutical refrigerator/cold room (in good working condition) for the storage of temperature sensitive pharmaceutical products. If storing vaccines, a dedicated refrigerator/ cold room must be installed that meet the requirements of HAAD policy and international standards. 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. A minimum distance of 90cm must be maintained between shelves/ racks to facilitate smooth and uninterrupted movement of staff and / or forklifts Facility must have adequate number of waste containers with lid. 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 GSP. MOH 72/1988 GSP HA-AD policy on Medical waste management in Healthcare facilities PPR/HCP/P0002/07 8 JSOR/HSC/PA/2012/1.1

9 Red and black fire extinguishers must be distributed all around the facility, or a sparkling fire system must be installed. Facility must maintain an upto-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. The facility has a valid contract or other alternative arrangements for pest and rodents control (copy is acceptable). Facility must have HAAD approved Medical Transportation Unit(s). Copy of 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. HA-AD requirement for Renewal of healthcare facility license accessible online GPP 3.15, HAAD infection control facility audit check list GSP/GDP. HAAD MTU Standard circular 9 JSOR/HSC/PA/2012/1.1

10 HA-AD approval letter is kept. 39 Maintain box file for keeping copies of facility and staff licenses along with their renewals. Alternatively, electronic storage arrangements could be utilized. GPP, HAAD Circular 1/2005. Ministerial decree No.1470 year JSOR/HSC/PA/2012/1.1