Manual of Practice DRUGS OBJECTIVE: To establish the general requirements of Practice to be observed in p harmaceutical care applied to the acquisition

, storage, preservation and dispens ation of industrial products in pharmacies and drugstores. DEFINITIONS: Dispensa tion: The act of providing guidance and consumer of drugs, medicines, pharmaceut ical and related to financial reward or not. Specialty Pharmaceuticals: product from the pharmaceutical industry registered with the Ministry of Health and avai lable on the market. Drugstore: establishment of dispensing and sale of drugs, m edicines, pharmaceutical and related supplies in their original packaging. Techn ical Manager: a qualified professional registered with the Regional Council of P harmacy, according to the law. Sanitation: A set of procedures designed to maint ain hygienic conditions. Product: substance or mixture of natural substances (mi nerals, animal and vegetable) or synthetic used for therapeutic, prophylactic or diagnostic purposes. Medicine: pharmaceutical product, technically obtained or prepared, with purpose: prophylactic, curative, palliative or diagnostic purpose s. Drug Reference: innovative product registered with the federal agency respons ible for health surveillance and marketed in the country, whose efficacy, safety and quality have been scientifically proven by the competent federal agency at the time of registration. Generic Drug: medicine similar to a reference product or innovative, it is intended to be interchangeable in this, usually produced af ter expiration or termination of patent protection or other exclusive rights, pr oven its effectiveness, safety and quality, and designated by the DCB or failing that by the DCI. Similar Drugs: one that contains the same or more active ingre dients, has the same concentration, dosage form, route of administration, dosage and therapeutic indication, prevention or diagnosis of the reference product re gistered with the federal agency responsible for health surveillance, which may differ only Page 1 of 12 Manual of Practice DRUGS characteristics related to size and shape of the produc t, shelf life, packaging, labeling, ingredient, and vehicles should be identifie d by its trade mark. Correlative: it's all substance, product, appliance or acce ssory, the use or application is connected to the defense and protection of indi vidual or collective health, hygiene and personal environments, or for diagnosti c and analytical. Storage / storage: A procedure that enables the orderly and ra tional stock of various categories of materials and products. Product Registrati on: private act of the competent organ of the Ministry of Health, designed to sh ow the right to manufacture the product, subject to a system of sanitary surveil lance. Batch number: name printed on the label of a medicinal product and subjec t to the system of health surveillance, identifying the batch or shipment to whi ch he belongs. Disposable product: any product of single use. Shelf life of prod uct: the deadline for use of a product. Packaging: wrapping, container or any fo rm of packaging, removable or not to cover, packaging, bottling, protect or main tain specific or not the products. Label: identification printed or lithographed , and words painted or engraved on fire, pressure, or modeled, applied directly on the container, containers, wrappers, wraps or other protective packaging. Pha rmaceutical Care: the compendium of attitudes, behaviors, commitments, from worr y, ethical values, functions, knowledge, responsibilities and skills of pharmaci sts in the provision of pharmacotherapy with the objective of achieving defined therapeutic outcomes in health and quality of life of patients. Recipe: written prescription drug, containing guidelines for use by the patient, performed by a legally qualified. Drill cutting: drilling and cutting tool at the same time. An tisepsis: use of substances capable of preventing the action of microorganisms b y destruction or inactivation. Page 2 of 12 Manual of Good Practices Correlate DRUGS: substance, product, device, or applica

tion whose use is linked to the defense and protection of individual or collecti ve health. Pharmaceutical Care: the set of actions and services to ensure compre hensive care, the promotion, protection and restoration of health in public or p rivate, performed by the pharmacist or under his supervision.€QUALIFICATION AND RESPONSIBILITY OF STAFF The admission of officials should be preceded by medic al examinations. Personnel involved with the drugs both in handling and in the ir control, should receive training so that knowledge and experience to the work to which it proposes. The Pharmacist in charge, if not the owner, needs to re ceive from his superiors all the assistance necessary for efficient work, as req uired by the practice of dispensing drugs. In the event of suspected or confir med illness the employee must be away from their activities complying with legis lation. All employees should be counseled about the personal hygiene and unifo rms must be clean and in good condition. PHYSICAL FACILITIES The pharmacy must be located, designed and built with an adequate infrastructure for the activiti es developed. Access to the drugstore to be independent so as not to allow com munication with home or elsewhere other than the establishment. The premises m ust have surfaces (floor, wall and ceiling) are smooth and impermeable, no crack s, resistant to sanitizers and easily washable. The environments must be prote cted against entry of insects and rodents. The conditions of ventilation and l ighting must be compatible with the activities. Page 3 of 12 Manual of Practice DRUGS The electrical installations must be well kept in goo d conditions of safety and usage. The toilet should be easily accessible, kept in a clean condition and have sink with running water. The local drugstore sh ould have to guard the belongings of employees. Must possess fire fighting equ ipment in adequate quantities, as specific legislation. RECEIPT OF GOODS Upon receipt, each supply must be examined as to their documents and physically inspe cted to ensure that the physical conditions are checked, label, type, manufactur ing date, expiration date and quantity. Check the invoice as to the name, quan tity, price, payment terms and that the shipment was made to order. The produc ers (manufacturer or laboratory) are required to inform on each unit produced, t he following items: • • • • • • • • • • • The name of the pharmaceutical product - the generic name and trade (see the legislation). Name and address of the man ufacturer with telephone service for customer care (SAC). Name of the technical, registration number and acronym of the Regional Council of Pharmacy of your sta te. Registration number in the Ministry of Health as published in the Official G azette. Date of manufacture. Expiration date, that period must be at least a yea r to a higher turnover of products. Lot number to which the unit belongs. Compos ition of pharmaceuticals. Weight, net volume or number of units if applicable. P urpose, use and application. Precautions, special care. If there is disagreement on one or more of the above items, do not receive the p roducts, doing the following: Page 4 of 12 Manual of Practice DRUGS • • Sign-handed the invoice and return it to the delive rer. Forward the invoice as directed by the company. STORAGE AND CONSERVATION OF MEDICINAL Space for the rational flow of people an d materials in order to minimize the risk of: • Breaks / contamination. The bo xes of medicines should not be placed directly on the floor. The thermolabile medicines must be stored immediately when they arrive at the pharmacy, and must be done to check the temperature of the refrigerator to see if it's ideal. It sh ould also be avoided to the maximum, the exposure of these products, any type of light, avoid direct exposure to soil and does not allow the freezing of these p roducts, they lose their pharmacological activities. The workplace must be kep t clean, free from dust and contamination, the garbage collected on the premises

must be disposed of through safe and sanitary systems, and deposited in special containers with lid and removed as quickly as possible, special attention shoul d be given the garbage room of injectables. The area or place of storage shoul d have sufficient capacity to ensure the orderly storage of various product cate gories. Have adequate security conditions for storage of flammable second tech nical standards, federal, state, municipal and Federal District. Have local or segregation system properly identified,€outside the area of dispensation for th e safekeeping of products that have proven irregularities or expiry date. Drug s abused or suspected of contamination should be removed from stocks traded, ide ntified and segregated into completely separate areas so as not to be sold by mi stake and not contaminate other goods. Check that the transport conditions wer e compatible with the storage conditions required for medications and products. The drugs and the products must be accompanied by their periods of validity, b atch number, number of registration at the Ministry of Health and Page 5 of 12 Manual of Practice DRUGS present with specified composition and packaging, leafl ets and labels intact. It is forbidden to place labels with new expiry dates a nd / or lot number on the validity and / or lot number in the original packaging and dispensing to the public of products and medications with expiration dates. All products and medicines with problems and / or irregularities should be re moved from the area of dispensing to the public and communicated to the Departme nt of Health Surveillance for the appropriate measures, especially those related to a precautionary ban and / or destruction. The drugs must be stored on shel ves in places that do not receive direct sunlight. Products with expiry date o r malfunctioning may segir two destinations: • Can be returned to the supplier ( manufacturer or laboratory), by invoice to return with the words "damaged goods or goods due", aiming at the goal of discarding . If no conditions for implement ing the above procedure, the pharmacist in charge must apply to the competent he alth authority, to receive guidance on the disposal of such. • SUPPLY / DISPENSATION The act of dispensing pharmaceuticals to the public, its operations must be properly recorded as a separate document and available to th e competent health authority. The sanitizing bleach, veterinary products, appl iances and accessories should be in a specific location separate from other prod ucts and medications. Check the dosage, route of administration and duration o f treatment, if necessary in case of doubt check with your doctor. Guiding the patient appropriate use of medication at the time of dispensing, work for ratio nal use of medication. Page December 6 Manual of Practice DRUGS Record sale of product, for statistical control of inventory and forecast cons umption. The program of computerization of the pharmacy business, you must pro vide the administrative sector of the pharmacy, recording the entire history of movement of the product dispensed. In the act of dispensing it is necessary to highlight some important aspects: • • • • • • • • • • Name of medicine establis hed medicinal product Dosing Directions for use Precautions Side effects Interac tions Storage Instructions Clarify the patient re-suspension lyophilized drugs, with use of boiled or filtered. Ensure that the patient has been cleared up prop erly and with respect. Build a system of information and educational material for research on medicin es if necessary. Warn the patient about self-medication and its consequences. Register in the book of injecting all prescriptions dispensed for this purpose

. APPLICATION OF INJECTABLES For the delivery of application services to injecti on drug store should have: Local separately, and equipped for proper implement ation of injectables with independent access so as not to serve as a passage to other areas. Facilities in hygienic and sanitary and in good repair. Profess ionals legally qualified to perform the procedures. Page 7 of 12 Manual of Practice DRUGS Conditions for the disposal of skin-piercing properly aimed to avoid risks of accidents and contamination, as well as from other wast e resulting from the application of injectables. The drugs should be administe red only by prescription from a qualified professional. In the application of injectable drugs can not be certain of the quality of the product to be administ ered and if the product have differentiated characteristics as color, odor, turb idity, or foreign body inside the product, it should not be administered, and th e professional services notify the Health Surveillance.€GENERIC DRUGS It is the duty of pharmacists responsible for technical drugstores: Clarify the user abo ut the existence of generic drugs, replacing, if necessary, the drug prescribed solely by the corresponding generic drug, unless specifically requested in his o wn handwriting recorded in the document by the prescribing professional . Indi cate on the back of the substitution of prescription, citing the generic drug ma nufacturing industry and, affixing a stamp bearing his name and registration num ber in the CRF, place and date by signing the declaration. In the act of dispe nsing explain in detail the patient about the use of the product, providing all necessary guidance to its rational use. To inform the patient and the prescrib er to the existence or not of generic drugs, differentiating them from similar. FOOD The pharmacist can dispense the following food categories: I. Foods for spe cial purposes, regulated by specific legislation in force, as specified below: a . Foods for restricted diets with nutrients; Page 8 of 12 Manual of Practice DRUGS Foods with carbohydrate restriction (dietary sweetene rs and without sugar). foods with restricted fat diets. Food for protein-res tricted diets (phenylketonuria). foods diet with sodium restriction. b. Food f or controlled nutrient intake: Food for weight control. Feeds for practi cing physical activities. Food diets for enteral nutrition. Food dietary intake of sugars controlled. c. Food for population groups Foods for infants, breast milk substitutes (modi fied powder milk / whole milk powder) Food supplements for pregnant and lactat ing women. Food elderly. d. Other specific foods: Vitamin supple ments and / or minerals. Artificial salt. Foods rich in fiber. Functional foods. Mel and derivatives. Aromatic teas. RECONSTRUCTIONIST lyophilized intestinal fl ora. The pharmacist can not allow the dispensing in pharmacies and drugstores of the following foods: 1. Conventional foods and beverages in general "in nature" and / or industrialized. 2. Diet sodas. 3. Pasteurized milk, sterilized, and other d airy products in liquid form. 4. Foods for special purposes not included in the Law of Health Surveillance. 5. Modified conventional foods as low, low level, hi gh content, power, or low, light, rich or high, souce. Page 9 of 12 Manual of Practice DRUGS Must observe the following procedures regarding the custody and dispensing of fo od provided by law: 1. Food must be registered with the competent ministry. 2. M ust be separated from other products and medicines. 3. The products must meet th

e labeling of specific legislation. 4. Must be pre-packaged units being prohibit ed its fractionation. 5. Consumers should be counseled about the differences, in dications and risks of using these foods. The correlates RELATED sold in drugsto res are: Dietetic products: sweeteners in the form of powder and liquid. Hos pital and Medical Articles: disposable collector of feces and urine, breast prot ector, suspenders scrotal, shower gynecological products for pregnancy test, the rmometers, water bags, etc.. Products for personal hygiene: internal and exter nal sanitary napkins, toothpaste, soap, talcum powder, toothbrush, etc.. Perfu mery: shampoos, nail polishes, conditioners, hair dyes, etc.. Miscellaneous pr oducts: disposable diapers for adults and children, baby wipes, rubber gloves, c omb hair, nail and cuticle pliers, nail clippers, among others. The OTC products OTC products do not have their prices fixed, ie not set a maximum value for con sumers. The rate undergoes a change of drugstore to drugstore. These products do not rely on prescription drugs and their sale is permitted in hotels, bars, res taurants, etc ... Home December 10 Manual of Practice drugs some examples: Swabs Cotton Absorbent Pads Ba nd-Aids Bandages Gauze Merthiolate Condoms Antipyretics Analgesics A ntacids COMMUNICATION IN THE SERVICE There are many types of patients / customers. When communicating search: Use a clear and objective language. Ask your name and try to call him by name. Ask questions only clear and objective.€Know listen carefully and show confidence and interest in avoiding carelessness or inattent ion. Never interrupt your speech. Maintain a friendly smile and sincere care for and be honest. It is necessary to maintain a healthy appearance and clean liness body, if possible use of lab coats or aprons. WELL IS NEEDED TO MEET Home December 11 Manual of Practice DRUGS Develop your personal ability. Knowing well the com pany and the work to be developed. Remain calm in any situation, even if the c lient is uncontrolled. Listening is indispensable for anyone who serves the pu blic, because look, keep up the weights and needs of partners are important requ irements to identify the type of customer and serve them the most convenient way possible. Home December 12