Pharmacy Premise Benchmark
To bring full benefit to the patients it is necessary to carry out the dispensing of medicines in a suitable pharmacy premise that is equipped with the essential apparatus, instruments, benches, and a computer system that operates on a suitable software program.
The legislations that regulate the dispensing and supply of poisons or any medicine that contains any scheduled poisons have definite requirement on the operation control or the outlay of the premise where such professional activities are being carried out. A special dispensing area, of adequate space, bench and proper lighting, should be available.
Physical Premise Specifications:
1.1 A medicine-dispensing premise shall have a professional appearance that inspires confidence in the nature of the healthcare that can be provided. The premise shall be clean, tidy, well lighted up, air-conditioned, with a distinct and clearly visible premise name and appropriate logo. A common logo for all the medicine-dispensing premises in Malaysia will be helpful for easy identification by the patients. Commercial promotion of whatsoever form shall not be permitted on the premise’s signboard.
1.2 The exterior of a medicine-dispensing premise needs to be appropriately painted and maintained at all times. The five-foot way or the way leading to the entrance of a premise shall be tiled; the interior floor of the premise shall also be tiled.
1.3 The interior layout of a medicine-dispensing premise shall exude a healthcare facility professional environment atmosphere, with appropriate signs, such as the words “prescription” or “counseling” that denotes the dispensing or patient medication counseling, respectively area, thereby giving the patients instant direction to the targeted area.
1.4 A minimum of 200 square feet of premise is required for the dispensing, counselling and storage of all the drugs; the actual size may be larger depending upon the volume of prescriptions dispensed and still allow a safe and efficient flow of work and effective communication and supervision. The dispensing area shall be distinctly partitioned from other departments, if any, in a larger set-up. The public and patients shall not have any unauthorized access to the area where the drugs are stored and where dispensing is being carried out.
1.5 The dispensing area shall have a clear bench-area of minimum (18x120) square inches for dry dispensing, and another wet dispensing area of (18x36) square inches with an adjacent or nearby basin and washing area. A refrigerator is required to store solely some drugs.
1.6 The shelves for storing the drugs shall be lockable, sufficient to keep all the drugs in an orderly manner, and positioned in such a way that allows easy retrieval of the required drug while exuding a professional image.
1.7 The air-conditioned premise, that is properly ventilated and well maintained, shall provide the patients and customers with a comfortable, clean and conducive environment to obtain their medication supply and receiving appropriate therapy counseling.
1.8 The name of a pharmacist who is on duty shall be displayed in a suitably designed signboard, with the professional certificate or annual practicing certificate displayed adjacent to or near to it, in a secure manner.
1.9 Display of the professional services (such as blood glucose, cholesterol, and blood pressure measurements, and pregnancy testing) shall be placed near to the pharmacist’s name signboard. A common signboard may also be used.
1.10 A designated area for patients’ medication counseling and a waiting place. The size of the area will depend on customer flow, the volume of dispensing and sales, the need to provide seats and the need to provide a quiet area where questions can be asked and advice given without the conversation being overheard.
1.11 All the scheduled poisons shall be stored in a container impervious to the poison and sufficiently stout to prevent leakage from the container arising from the ordinary course of handling. The poisons shall be kept in a room, cupboard or drawer under lock and key set apart solely for the keeping of poisons. (Refer to Poisons Regulations 1952 Regulations (5) and (6).
1.12 Psychotropic Substances are legally required to be stored in a room, cabinet, safe or receptacle that is so constructed and with reasonably sufficient security measures in order to prevent theft or diversion of the drugs stored therein. The storage place shall be locked and unlocked for the person authorized to possess such drugs. He only shall keep the key. He may lock and unlocked the storage place for the specific purposes related to his professional functions in the dispensing, supply and storage of such drugs. (Refer to Poisons (Psychotropic Substances) Regulations 1989 Regulation (24).
1.13 Although the legal storage requirements for Dangerous Drugs are the same as any other Group B Scheduled Poisons, less stringent that Psychotropic Substances, it is advisable to provide, at least, same strict security measures as the psychotropic substances.
1.14 Premise shall have a proper fire escape route and signboard. Occupational and safety health requirements need to be complied with. The working conditions should be so arranged as to protect the safety of the public and the people working on the premise.
1.15 The premise’s entrance and doorways shall be wide enough to allow wheelchairs and pushchairs to enter.
1.16 A medicine-dispensing premise shall not permit any person to smoke inside it. It is against the law to smooth in an air-conditioned public place.
1.17 Location: A pharmacy shall not be located adjacent to certain types of business such as a car workshop or a wet fish market.
1.18 An acceptable method of pharmaceutical waste disposal is required. Waste materials should not be allowed to accumulate and should be collected in suitable, covered receptacles for removal to collection points. Care must be taken to segregate any special waste such as vaccines, nuclear active, or cytotoxic substances.
1.19 Regular pest control measures are necessary.
1.20 Insurance shall be required for fire and burglary, professional practice indemnity, and public liability.
Equipment and Facilities:
The following items will be necessary; other items may be added according to the requirement of the dispensary:
2.1 A computer installed with appropriate pharmacy software that will assist in inventory control, stocking ordering, drugs information, patient medication-leaflets, patient medication records, drug-drug interaction check, drug-food interaction check, and Internet access. A service contract will often include the provision of software upgrades when available.
2.2 A computer linked printer for the production of labels, patient-medication leaflets, and other printed materials. Or a means of mechanically printing, dispensing labels. Additional warning labels must be available, unless those warning are printed on the dispensing labels.
2.3 Capsules and tablets counting trays or a suitable means of counting capsules and tablets. And a range of graduated, liquid measuring cylinder or device.
2.4 Mortar and pestle, stirring rods and other appropriate equipment for extemporaneous preparations, where necessary.
2.5 A suitable weighing balance for some extemporaneous preparations, where necessary.
2.6 Tile or glass slabs, with spatula for the preparation or dilution of some creams or ointments, where required.
2.7 Medicine containers: A suitable range of different kinds of containers for internal and external preparations. Suitable plastic or glass containers for tablets or capsules. Appropriate sized ointment boxes to contain creams or ointments. Plastic or glass bottles, either amber or clear, either fluted or clear, for liquid preparations.
2.8 A suitable size refrigerator, equipped with a maximum and minimum thermometer, and temperature recording charts. Temperature shall be maintained between 2 to 8 degrees Celsius. The refrigerator shall be cleaned, defrosted and checked periodically to ensure efficient running. Unless there are adequate arrangements for separating various items to prevent cross contamination, this refrigerator shall be used only for pharmaceutical products.
2.9 The premise must be provided with a source of portable water. A sink, of durable material (such as Stainless steel) must be provided in the premise.
2.10 A cabinet or a storage place for all the documents and records, including Prescription Book, Prescription Register For Psychotropic Substances, Dangerous Drugs Register, Poisons Book, and Prescription sheets/slips.
Management by Pharmacist and Supporting Staff:
3.1 A registered pharmacist shall manage and control over a premise where medicines are dispensed.
3.2 All the medicine-dispensing personnel shall wear a professional uniform that has been agreed by the practitioners in Malaysia. The attire shall include a name-tag.
ESSENTIAL REFERENCE MATERIALS
The following Reference Books are recommended. An Internet access to these reference materials may be acceptable.
4.1 Martindale: The Extra Pharmacopoeia: The Complete Drug Reference, 34th or latest edition, by the Pharmaceutical Press.
4.2 BNF, 47th Edition or latest edition, by British Medical Association and Royal Pharmaceutical Society of Great Britain.
4.3 USP DI (Micromedex): Drug Information For Healthcare Professional Volume I (19th edition or latest edition), by United States Pharmacopoeia Convention Inc.
4.4 Dispensing For the Pharmaceutical Students, latest edition, by Cooper and Gunns, Pitman Medical.
4.5 The Pharmaceutical Handbook, latest edition, by the Pharmaceutical Press.
4.6 British Pharmacopoeia Codex, latest edition.
4.7 MIMS, latest edition, by MediMedia.
4.8 Malaysia Pharmacy Legislations, latest edition.
Any qualified health professional who desires to dispense any drug or medicine to any human being should only be permitted to carry out these professional activities within a registered Dispensing Premise that has met the above specifications.