De acordo com Valery, Pedro Paulo Trigo (Org) do Manual de Boas práticas para estocagem de medicamentos. – Brasília: Central de Medicamentos, 1989 a estocagem de medicamentos deve abranger os seguintes aspectos:Considerações Gerais Estocar e administrar um almoxarifado de medicamentos não é como estocar alimentos – apesar da importância das duas atividades para a saúde humana. O alimento estragado, na maioria das vezes, é facilmente identificável. No caso dos medicamentos a realidade é outra: se eles tem o seu estado normal alterado, tornam-se inativos ou nocivos à saúde e, o que é pior, são de difícil reconhecimento.Somente esse exemplo já serve para ilustrar a responsabilidade que representa o manuseio de medicamentos, que pode significar a diferença entre a saúde e a doença e, em casos extremos, entre a vida e a morte. Mesmo um breve tratamento incorreto pode torná-los ineficazes, o que traduz a importância do trabalho de todas as pessoas envolvidas em sua manipulação.
Definições:
Embalagem – Invólucro, recipiente ou qualquer forma de acondicionamento, removível ou não, destinado a cobrir, empacotar, envasar, proteger ou manter especificamente ou não os produtos.
Estocagem – Conservação racional e segura de medicamentos.
Inspeção de qualidade – Conjunto de medidas destinadas a garantir, a qualquer momento, durante o processo de recebimento, estocagem e distribuição, as características originais do produto.
Medicamento – É toda substância ou associação de substâncias utilizadas para modificar ou explorar sistemas fisiológicos ou estado patológico, para o benefício do receptor.
Partida ou lote – Quantidade de um medicamento ou produto que se produz em um ciclo de fabricação, cuja característica essencial é a homogeneidade.
Número do lote – Designação impressa no rótulo e na embalagem de medicamentos, que permita identificar a partida, série ou lote a que pertencem, para em caso de necessidades, localizar e rever todas as operações de fabricação e inspeção praticadas durante a produção.
Quarentena – Período de tempo, durante o qual os medicamentos são retidos com proibição de seu emprego.
Rótulo – Identificação impressa ou litografada, bem como dizeres pintados ou gravados a fogo, pressão, ou decalco, aplicada diretamente sobre recipiente, vasilhames, invólucros, envoltórios ou qualquer outro protetor de embalagem.
Normas de Boas Práticas de Estocagem de Medicamentos
1. Qualificação e responsabilidade do pessoal
1.1 - O pessoal envolvido na estocagem de medicamentos, tanto no seu manuseio, como no seu controle, deve possuir conhecimentos e experiência para o trabalho ao qual se propõe.
1.2 - A chefia do almoxarifado deve ser exercida por farmacêutico, por ser exigida perante a legislação específica tal responsabilidade pela guarda de medicamentos.
1.3 - O farmacêutico responsável deve receber de seus superiores todo o apoio necessário para um trabalho eficiente, como exigem as boas normas de estocagem de medicamentos. Tal apoio traduzir-se-á na autoridade e nos meios adequados que cada um deverá ter, na esfera de suas atividades, para exercer, efetiva e responsavelmente suas tarefas, recebendo os materiais e pessoal necessário.
2. Edifícios e instalações
2.1 - Qualquer edifício destinado a estocagem de medicamentos, deve ter área, construção e localização adequadas para facilitar sua manutenção, limpeza e operação, com espaço suficiente para estocagem racional dos medicamentos. Toda área alocada para estocagem deve destinar-se somente a esse propósito, além de oferecer condições de flexibilidade que permitam eventuais modificações futuras.
2.2 - Assim, devem ser consideradas como necessárias, as seguintes áreas:
2.2.1 - de recepção;
2.2.2 - de quarentena;
2.2.3 - de expedição;
2.2.4 - de estocagem;
2.2.4.1 - geral
2.2.4.2 - de medicamentos termolábeis
2.2.4.3 - de medicamentos controlados
2.2.4.4 - de imunobiológicos
2.2.5 - de administração
2.2.5.1 - de recebimento
2.2.5.2 - de distribuição
2.2.5.3 - geral
2.2.6 - instalações sanitárias
2.2.6.1 - para os funcionários da área de estocagem
2.2.6.2 - para os funcionários administrativos
2.3 - Os interiores dos almoxarifados devem apresentar superfícies lisas, sem rachaduras e sem desprendimento de pó, facilitando a limpeza e não permitindo a entrada de roedores, aves, insetos ou quaisquer outros animais.
2.4 - A iluminação, a ventilação e a umidade devem ser controladas, para evitar efeitos prejudiciais sobre os medicamentos estocados.
2.5 - O espaço ao redor dos almoxarifados deve ser urbanizado, a fim de impedir a formação de pó, permitir fácil acesso e manobra dos caminhões.
2.6 - Para se determinar a adequação das áreas, devem ser tidas em conta as seguintes condições:
2.6.1 - Compatibilidade das operações de estocagem e manipulação a serem conduzidas nos diferentes locais.
2.6.2 - Espaço suficiente para o fluxo racional de pessoal e materiais, visando reduzir ao mínimo o risco de:
2.6.2.1 - mistura de diferentes medicamentos
2.6.2.2 - mistura de lotes diferentes de um mesmo medicamento.
3. Lixo
3.1 - O lixo coletado nas dependências do almoxarifado e em suas proximidades, deve ser eliminado através de sistemas seguros e higiênicos.
4. Lavatórios e instalações sanitárias
4.1 - Devem existir lavatórios e instalações sanitárias em condições de higiene perfeitas e separadas para uso do pessoal administrativo e para o pessoal da área de estocagem.
5. Higiene
5.1 - Todas as áreas circundantes ou adjacentes ao almoxarifado, bem como seu interior, devem ser mantidos limpos, sem acúmulo ou formação de pó.
6. Alimentação
6.1 - As refeições devem ser preparadas e ingeridas somente nos locais especialmente designados para tal, fora das áreas de estocagem e de escritório.
7. Uniformes
7.1 - Nas áreas de trabalho, os funcionários deverão usar uniformes condizentes com o tipo de trabalho a executar.
8. Higiene pessoal
8.1 - Devem existir instalações sanitárias, bem como chuveiros em número suficiente, para uso dos funcionários da área de estocagem, localizados nas proximidades dos locais de trabalho.
9. Limpeza dos locais
9.1 - Os locais de trabalho e de estocagem devem ser mantidos limpos e isentos de pó e contaminação.
9.2 - O lixo deverá ser depositado em recipientes especiais, com tampa e deverão ser esvaziados e limpos, fora das áreas de estocagem.
10. Equipamentos
10.1 - Todos os equipamentos usados no manuseio de medicamentos, devem ser apropriados para o uso a que se destinam.
11. Segurança
11.1 - Medidas apropriadas devem ser tomadas para a segurança dos almoxarifados, tanto para os medicamentos quanto para o pessoal que ali trabalha.
11.2 - Medidas rigorosas devem ser praticadas para a prevenção e combate a incêndios.
11.2.1 - É indispensável a instalação adequada de equipamento contra incêndio.
11.2.2 - O pessoal deve sofrer treinamento periódico no combate a incêndio.
11.2.3 - Aconselha-se a existência de uma CIPA (Comissão Interna para Prevenção de Acidentes) permanente.
12. Recebimento de medicamentos
Devem existir instruções por escrito, descrevendo com detalhes o recebimento, a identificação e o manuseio dos medicamentos. Elas devem indicar adequadamente os métodos de estocagem e definir os procedimentos burocráticos para com as outras áreas de organização.
12.1 - No ato do recebimento, cada entrada deve ser examinada quanto a sua documentação e fisicamente inspecionada para se verificar suas condições, rotulagem, tipo e quantidade.
12.2 - Se for o caso de recebimento de um produto com mais de um lote de fabricação, ele deve ser subdividido em quantos lotes forem necessários e estocados dessa forma.
12.3 - Os lotes que forem submetidos a amostragem ou os julgados passíveis de análise, devem ser conservados em quarentena até decisão do Controle de Qualidade.
13. Estocagem. Considerações gerais
13.1 - Toda e qualquer área destinada à estocagem de medicamentos deve ter condições que permitam preservar suas condições de uso.
13.2 - Nenhum medicamento poderá ser estocado antes de ser oficialmente recebido e nem liberado para entrega sem a devida permissão, também oficial.
13.3 - Os estoques devem ser inventariados periodicamente e qualquer discrepância devidamente esclarecida.
13.4 - Os estoques devem ser inspecionados com freqüência para verificar-se qualquer degradação visível, especialmente se os medicamentos ainda estiverem sob garantia de seus prazos de validade.
13.5 - Medicamentos com prazos de validade vencidos, devem ser baixados do estoque e destruídos, com registro justificado por escrito pelo farmacêutico responsável, obedecendo ao disposto na legislação vigente.
13.6 - A estocagem, quer em estantes, armários, prateleiras ou estrados, devem permitir a fácil visualização para a perfeita identificação dos medicamentos, quanto ao nome do produto, seu número de lote e seu prazo de validade.
13.7 - A estocagem nunca deve ser efetuada diretamente em contacto direta com o solo e nem em lugar que receba luz solar direta.
13.8 - As áreas para estocagem devem ser livres de pó, lixo, roedores, aves, insetos e quaisquer animais.
13.9 - Para facilitar a limpeza e a circulação de pessoas, os medicamentos devem ser estocados à distância mínima de 1 (um) metro das paredes.
13.10 - A movimentação de pessoas, escadas e veículos internos nas áreas de estocagem devem ser cuidadosos para evitar avarias e comprometimento e/ou perda de medicamentos.
13.11 - Embalagens parcialmente utilizadas devem ser fechadas novamente, para prevenir
perdas e/ou contaminações, indicando a eventual quantidade faltante no lado externo da embalagem.
perdas e/ou contaminações, indicando a eventual quantidade faltante no lado externo da embalagem.
13.12 - A liberação de medicamentos para entrega deve obedecer a ordem cronológica de seus lotes de fabricação, ou seja, expedição dos lotes mais antigos antes dos mais novos.
13.13 - A presença de pessoas estranhas aos almoxarifados deve ser terminantemente proibida nas áreas de estocagem.
14. Estocagem de medicamentos
Para os medicamentos que não podem sofrer variações excessivas de temperatura, além das recomendações do item 13, devem ser observadas as seguintes:
14.1 - O local de estocagem deve manter uma temperatura constante,ao redor de 20ºC ( 2º).
14.2 - As medições de temperatura devem ser efetuadas de maneira constante e seguras, com registros escritos.
14.3 - Deverão existir sistemas de alerta que possibilite detectar defeitos no equipamento de ar condicionado para pronta reparação.
15. Estocagem de medicamentos imunobiológicos (Vacinas e Soros)
Esses produtos, para manterem suas efetividades de uso, requerem condições ótimas de estocagem, especialmente no que se refere a temperatura. Assim, sem prejuízo das recomendações do item 13, mais as seguintes, devem ser observadas.
15.1 - O manuseio de medicamentos imunobiológicos deve ter prioridade em relação aos demais, bem como sua liberação para entrega.
15.2 - Deve ser evitada, ao máximo, a exposição desses produtos a qualquer tipo de luz.
15.3 - As áreas de estocagem devem ser em equipamento frigorífico, constituído de refrigeradores, “freezers” e câmaras frias.
15.3.1 - Refrigerador é o equipamento que permite temperaturas entre 4ºC e 8ºC.15.3.2 - “Freezer” é o equipamento que permite temperaturas não superiores a -10ºC.
15.3.3 - Câmara fria é o equipamento que permite temperaturas entre 8ºC e 15ºC.
15.3.4 - Os equipamentos frigoríficos devem ser controlados diariamente por:
15.3.4.1 - Termógrafos, nas câmaras frias.
15.3.4.2 - Termômetros de máxima e mínima em refrigeradores e “freezers”.
15.4 - As medições de temperatura efetuadas devem ser registradas diariamente pelo responsável pelo almoxarifado e, qualquer anormalidade, corrigida no mais breve espaço de tempo.
15.5 - A distribuição dos produtos dentro dos equipamentos frigoríficos deve permitir a livre circulação do ar frio entre as diversas embalagens contidas nos mesmos.
15.5.1 - No caso das câmaras frias é aconselhável a existência de ante-câmaras para evitar a perda desnecessária de frio, quando da abertura das portas dessas câmaras.
15.6 - As entradas e retiradas de produtos de qualquer equipamento frigorífico devem ser programadas antecipadamente, visando diminuir, ao máximo, as variações internas de temperatura.
15.7 - Os equipamentos frigoríficos devem estar permanentemente em funcionamento, ligados a rede elétrica local e sempre que possível, possuindo uma rede alternativa de energia (gerador) para atender eventuais faltas de energia no sistema.
15.8 - Cada equipamento do sistema frigorífico deve ter ligação exclusiva para evitar sobrecarga de energia elétrica e facilitar seu controle de uso.
15.9 - Tanto os refrigeradores como os “freezers”, devem ser aproveitados também para a produção de gelo, a ser utilizado na remessa dos produtos e para segurança do próprio equipamento e dos produtos que ele contém, numa eventual falha do seu sistema interno de resfriamento.
15.10 - Todo o pessoal do almoxarifado, especialmente os ligados a estocagem de medicamentos imunobiológicos, deve estar familiarizado com as técnicas de estocagem desses produtos, para poder atender qualquer situação de emergência, conseqüente a um eventual corte de energia elétrica ou defeito no sistema de refrigeração.
15.11 - Todos os equipamentos, geladeiras, “freezers” e câmaras frias, devem possuir um sistema de alarme confiável, que indique prontamente qualquer tipo de anormalidade em seu funcionamento.
16. Estocagem de medicamentos de uso controlado
Dada às características desses medicamentos, sua área de estocagem deve ser considerada de segurança máxima.
16.1 - Independentemente das recomendações contidas nos itens 13, 14 e 15, onde elas couberem, esses medicamentos precisam estar em área isolada das demais, somente podendo ter acesso a ela o pessoal autorizado pelo farmacêutico responsável do almoxarifado.
16.2 - Os registros de entrada e de saída desses medicamentos, devem ser feitos de acordo com a legislação sanitária específica, sem prejuízo daquelas que foram determinadas pela própria administração do almoxarifado.
17. Distribuição
17. Distribuição
17.1 - Deve existir um sistema de distribuição que permita a fácil identificação do seu destino. Para tanto, os registros de distribuição devem conter a identificação do produto, seu número de lote, nome e endereço do destinatário, data e quantidade enviada e o número da nota fiscal, ou do documento de despacho.
http://farmaciabrasileira.blogspot.com/2009/06/prc-wilken-memorial-de-titulos-e.html
According to Valery, Pedro Paulo Trigo (Org) Manual of Good Practice for the storage of medicines. - Brasilia: Central Drug Administration, 1989 stockpiling of drugs should include the following: General Considerations Store and manage a warehouse of drugs is not as stock food - despite the importance of both activities to human health. The spoiled food, in most cases, is easily identifiable. If the drugs reality is different: if they have changed their normal state, become inactive or harmful to health and, worse still, are difficult reconhecimento.Somente this example already serves to illustrate the responsibility that represents the handling of medicines, which can mean the difference between health and disease and, in extreme cases, between life and death. Even a brief incorrect treatment can make them ineffective, which reflects the importance of the work of all persons involved in handling them.
Definitions:
Packaging - housing, container or any form of packaging, removable or not to cover, pack, bottle, protect or maintain the products specifically or not.
Storage - Conservation rational and safe medication.
Quality Inspection - Set of measures to ensure, at any time during the process of receiving, warehousing and distribution, the original characteristics of the product.
Medicine - is any substance or combination of substances used to modify or explore physiological systems or pathological state, for the benefit of the receiver.
Match or plot - Amount of a drug or product that is produced in a manufacturing cycle, whose main characteristic is its homogeneity.
Lot number - Name printed on the label and packaging of drugs, identifying the match, series or plot to which they belong, where the need for, locate and review all manufacturing and inspection operations carried out during production.
Quarantine - The time during which the drugs are retained with prohibition of their employment.
Label - printed or lithographed Identification and sayings painted or burned with fire, pressure, or transfer it, applied directly on container, containers, packs, wraps or other protective packaging.
Standards of Practice for Storage of Medicines
1. Qualification and responsibility of staff
1.1 - Personnel involved in the storage of medicines, both in his handling, as in their control, should have knowledge and experience to the job for which it proposes.
1.2 - The head of the warehouse must be exercised by a pharmacist, to be required before the specific legislation that responsibility for the safekeeping of medicines.
1.3 - The responsible pharmacist must receive from his superiors all the support necessary for efficient work, as required under the rules of good storage of medicines. Such support will translate the authority and the appropriate means everyone should have in the sphere of its activities, to exercise their duties responsibly and effectively, getting the materials and personnel.
2. Buildings and Facilities
2.1 - Any building for storage of drugs, must have an area, construction and location to facilitate maintenance, cleaning and operation, with enough space for rational drug storage. The entire area allocated for storage should be designed only for that purpose, and provide conditions for flexibility to accommodate possible future changes.
2.2 - should therefore be considered as necessary, the following areas:
2.2.1 - reception;
2.2.2 - quarantine;
2.2.3 - dispatch;
2.2.4 - storage;
2.2.4.1 - General
2.2.4.2 - drugs thermolabile
2.2.4.3 - controlled drugs
2.2.4.4 - immunobiological
2.2.5 - Administration
2.2.5.1 - Receive
2.2.5.2 - Distribution
2.2.5.3 - General
2.2.6 - toilets
2.2.6.1 - for employees in the storage
2.2.6.2 - for clerks
2.3 - The interiors of the warehouses must provide a smooth surface without cracks and without shedding of dust, making cleaning easy and not allowing the entry of rodents, birds, insects or other animals.
2.4 - lighting, ventilation and humidity should be controlled to avoid adverse effects on the drugs stocked.
2.5 - The area around the warehouses should be urban, to prevent dust formation, to allow easy access and maneuvering of trucks.
2.6 - To determine the suitability of the areas should be taken into account the following conditions:
2.6.1 - Compatibility of storage and handling operations to be conducted in various locations.
2.6.2 - Enough space for the rational flow of personnel and materials in order to minimize the risk of:
2.6.2.1 - a combination of different drugs
2.6.2.2 - mixing of different batches of the same drug.
3. Garbage
3.1 - The garbage collected from the warehouse premises and its vicinity, should be disposed of through safe and sanitary systems.
4. Sinks and toilets
4.1 - There shall be lavatories and toilets in perfect hygienic conditions and separated for use by administrative staff and staff in the storage room.
5. Hygiene
5.1 - All areas surrounding or adjacent to the warehouse, and inside, must be kept clean with no buildup or dust.
6. Food
6.1 - Meals should be prepared and eaten only in places specifically designated for such outside storage areas and office.
7. Uniforms
7.1 - In working areas, employees must wear uniforms that match with the type of work to perform.
8. Personal hygiene
8.1 - There should be toilets and showers in sufficient numbers for use by employees of the storage area, located near the workplace.
9. Clean sites
9.1 - The places of work and storage areas must be kept clean and free from dust and contamination.
9.2 - The trash must be deposited in special containers with lid and must be emptied and cleaned out the storage areas.
10. Equipment
10.1 - All equipment used when handling medicines must be suitable for use as intended.
11. Security
11.1 - Appropriate measures should be taken to the security of warehouses, both for drugs and for the people who work there.
11.2 - Strict measures should be practiced for the prevention and firefighting.
11.2.1 - It is essential to install adequate fire fighting equipment.
11.2.2 - Personnel should undergo periodic training in fire fighting.
11.2.3 - It is advised that there is a CIPA (Internal Commission for Accident Prevention) permanent.
12. Receipt of medicines
There shall be written instructions, describing in detail the receipt, identification and handling of medicines. They must properly indicate the methods of storage and set the bureaucratic procedures for the other areas of the organization.
12.1 - Upon receipt, each entry must be examined as to their documents and physically inspected to verify their condition, labeling, type and quantity.
12.2 - If they are receiving a product with more than one manufacturing lot, it must be subdivided into as many batches as necessary and stored that way.
12.3 - The lots that are sampled or judged suitable for analysis must be kept in quarantine until the decision of Quality Control.
13. Storage. General considerations
13.1 - Any area used for storage of medicines must be able to safeguard its condition.
13.2 - No medication can be stored before it is officially received and not released for sale without permission, also official.
13.3 - Inventories should be inventoried periodically and any discrepancies duly informed.
13.4 - Inventories should be inspected frequently to check up any noticeable degradation, especially if the drugs are still under guarantee of their validity periods.
13.5 - Drugs with a validity period expired, must be downloaded from stock and destroyed, with the record justified in writing by the pharmacist in charge, according to the provisions of law.
13.6 - The storage, either on shelves, cupboards, shelves or pallets must allow easy viewing for the perfect identification of drugs, as the name of the product, its lot number and its expiration date.
13.7 - The storage should never be performed directly in direct contact with the ground and not in place that receives direct sunlight.
13.8 - Areas for storage should be free of dust, garbage, rodents, birds, insects and all animals.
13.9 - To facilitate cleaning and movement of people, medicines must be stored at a minimum distance of 1 (one) meter from the walls.
13.10 - The movement of people, vehicles and stairs built in storage areas must be careful to avoid damage and impairment and / or loss of drugs.
13.11 - partially used packages must be closed again to prevent losses and / or contamination, indicating the possible amount missing on the outside of the package.
13:12 - The release of drugs for delivery should follow the chronological order of their production batches, ie, dispatch the lots before the oldest of the youngest.
13.13 - The presence of strangers to warehouses must be strictly prohibited in storage areas.
14. Storage of thermolabile medicines
For drugs that can not suffer extremes of temperature, in addition to the recommendations in item 13 should be observed the following:
14.1 - The storage site shall maintain a constant temperature around 20 degrees C (2nd).
14.2 - The temperature measurements must be made consistently and secure, with written records.
14.3 - There should be warning systems that allows to detect defects in air conditioning equipment for immediate repair.
15. Stocking of immunobiological drugs (vaccines and sera)
These products, to maintain their effectiveness in use, require optimum conditions of storage, especially as regards the temperature. Thus, notwithstanding the recommendations of item 13, plus the following should be observed.
15.1 - Handling of immunobiological drugs should take precedence over the other, as well as its release for delivery.
15.2 - should be avoided as much as possible the exposure of these products to any type of light.
15.3 - Storage areas should be in refrigerating equipment, consisting of refrigerators, freezers and cold rooms.
15.3.1 - Refrigerator is the equipment that allows temperatures between 4 º C and 8 C.15.3.2 - "Freezer" is equipment that allows temperature of -10 º C.
15.3.3 - Cold Storage is the equipment that allows temperatures between 8 º C and 15 º C.
15.3.4 - The refrigeration equipment must be checked daily for:
15.3.4.1 - Thermography, in the cold.
15.3.4.2 - maximum and minimum thermometers in refrigerators and freezers.
15.4 - Temperature measurements made should be recorded daily by the data warehouse, and any abnormalities corrected in the shortest time.
15.5 - Distribution of the products within the refrigeration equipment should allow the free circulation of cold air between the various packages contained therein.
15.5.1 - In case of cold storage is desirable to have ante-chambers to avoid unnecessary loss of cold at the opening of the doors of these chambers.
15.6 - entries and withdrawals of products from any refrigeration equipment must be scheduled in advance in order to decrease the maximum of the internal variations in temperature.
15.7 - The refrigeration equipment shall be permanently in operation, connected to local grid and whenever possible, having a network of alternative energy (generator) to meet any shortage of energy in the system.
15.8 - Each equipment of the refrigeration system should be linked solely to avoid overloading the power and ease of use control.
15.9 - much like refrigerators freezers, should be used also for production of ice to be used in the delivery of products and for the safety of the equipment and products it contains, in a possible failure of its internal system cooling .
15.10 - All staff of the warehouse, particularly those related to storage of immunobiological drugs, should be familiar with techniques for storage of those products to meet any emergency situation, resulting in a possible power cut or fault in the cooling system .
15.11 - All equipment, refrigerators, freezers and cold rooms, must have a reliable alarm system, which readily indicate any abnormality in their functioning.
16. Storage of controlled drugs
Given the characteristics of these products, their storage area should be considered maximum security.
16.1 - Regardless of the recommendations contained in items 13, 14 and 15, where they fit, these medications need to be isolated from others in the area and may only have access to her personnel authorized by the pharmacist in charge of the warehouse.
16.2 - The input and output of these drugs should be made according to the specific health legislation, without prejudice to those which were determined by the administration itself almoxarifado.1
7. Distribution
17.1 - There should be a distribution system that permits easy identification of your destination. For this, the distribution records shall include the name of the product, its lot number, name and address of the recipient, date and quantity shipped and invoice number, order or document.
http://farmaciabrasileira.blogspot.com/2009/06/prc-wilken-memorial-de-titulos-e.html
According to Valery, Pedro Paulo Trigo (Org) Manual of Good Practice for the storage of medicines. - Brasilia: Central Drug Administration, 1989 stockpiling of drugs should include the following: General Considerations Store and manage a warehouse of drugs is not as stock food - despite the importance of both activities to human health. The spoiled food, in most cases, is easily identifiable. If the drugs reality is different: if they have changed their normal state, become inactive or harmful to health and, worse still, are difficult reconhecimento.Somente this example already serves to illustrate the responsibility that represents the handling of medicines, which can mean the difference between health and disease and, in extreme cases, between life and death. Even a brief incorrect treatment can make them ineffective, which reflects the importance of the work of all persons involved in handling them.
Definitions:
Packaging - housing, container or any form of packaging, removable or not to cover, pack, bottle, protect or maintain the products specifically or not.
Storage - Conservation rational and safe medication.
Quality Inspection - Set of measures to ensure, at any time during the process of receiving, warehousing and distribution, the original characteristics of the product.
Medicine - is any substance or combination of substances used to modify or explore physiological systems or pathological state, for the benefit of the receiver.
Match or plot - Amount of a drug or product that is produced in a manufacturing cycle, whose main characteristic is its homogeneity.
Lot number - Name printed on the label and packaging of drugs, identifying the match, series or plot to which they belong, where the need for, locate and review all manufacturing and inspection operations carried out during production.
Quarantine - The time during which the drugs are retained with prohibition of their employment.
Label - printed or lithographed Identification and sayings painted or burned with fire, pressure, or transfer it, applied directly on container, containers, packs, wraps or other protective packaging.
Standards of Practice for Storage of Medicines
1. Qualification and responsibility of staff
1.1 - Personnel involved in the storage of medicines, both in his handling, as in their control, should have knowledge and experience to the job for which it proposes.
1.2 - The head of the warehouse must be exercised by a pharmacist, to be required before the specific legislation that responsibility for the safekeeping of medicines.
1.3 - The responsible pharmacist must receive from his superiors all the support necessary for efficient work, as required under the rules of good storage of medicines. Such support will translate the authority and the appropriate means everyone should have in the sphere of its activities, to exercise their duties responsibly and effectively, getting the materials and personnel.
2. Buildings and Facilities
2.1 - Any building for storage of drugs, must have an area, construction and location to facilitate maintenance, cleaning and operation, with enough space for rational drug storage. The entire area allocated for storage should be designed only for that purpose, and provide conditions for flexibility to accommodate possible future changes.
2.2 - should therefore be considered as necessary, the following areas:
2.2.1 - reception;
2.2.2 - quarantine;
2.2.3 - dispatch;
2.2.4 - storage;
2.2.4.1 - General
2.2.4.2 - drugs thermolabile
2.2.4.3 - controlled drugs
2.2.4.4 - immunobiological
2.2.5 - Administration
2.2.5.1 - Receive
2.2.5.2 - Distribution
2.2.5.3 - General
2.2.6 - toilets
2.2.6.1 - for employees in the storage
2.2.6.2 - for clerks
2.3 - The interiors of the warehouses must provide a smooth surface without cracks and without shedding of dust, making cleaning easy and not allowing the entry of rodents, birds, insects or other animals.
2.4 - lighting, ventilation and humidity should be controlled to avoid adverse effects on the drugs stocked.
2.5 - The area around the warehouses should be urban, to prevent dust formation, to allow easy access and maneuvering of trucks.
2.6 - To determine the suitability of the areas should be taken into account the following conditions:
2.6.1 - Compatibility of storage and handling operations to be conducted in various locations.
2.6.2 - Enough space for the rational flow of personnel and materials in order to minimize the risk of:
2.6.2.1 - a combination of different drugs
2.6.2.2 - mixing of different batches of the same drug.
3. Garbage
3.1 - The garbage collected from the warehouse premises and its vicinity, should be disposed of through safe and sanitary systems.
4. Sinks and toilets
4.1 - There shall be lavatories and toilets in perfect hygienic conditions and separated for use by administrative staff and staff in the storage room.
5. Hygiene
5.1 - All areas surrounding or adjacent to the warehouse, and inside, must be kept clean with no buildup or dust.
6. Food
6.1 - Meals should be prepared and eaten only in places specifically designated for such outside storage areas and office.
7. Uniforms
7.1 - In working areas, employees must wear uniforms that match with the type of work to perform.
8. Personal hygiene
8.1 - There should be toilets and showers in sufficient numbers for use by employees of the storage area, located near the workplace.
9. Clean sites
9.1 - The places of work and storage areas must be kept clean and free from dust and contamination.
9.2 - The trash must be deposited in special containers with lid and must be emptied and cleaned out the storage areas.
10. Equipment
10.1 - All equipment used when handling medicines must be suitable for use as intended.
11. Security
11.1 - Appropriate measures should be taken to the security of warehouses, both for drugs and for the people who work there.
11.2 - Strict measures should be practiced for the prevention and firefighting.
11.2.1 - It is essential to install adequate fire fighting equipment.
11.2.2 - Personnel should undergo periodic training in fire fighting.
11.2.3 - It is advised that there is a CIPA (Internal Commission for Accident Prevention) permanent.
12. Receipt of medicines
There shall be written instructions, describing in detail the receipt, identification and handling of medicines. They must properly indicate the methods of storage and set the bureaucratic procedures for the other areas of the organization.
12.1 - Upon receipt, each entry must be examined as to their documents and physically inspected to verify their condition, labeling, type and quantity.
12.2 - If they are receiving a product with more than one manufacturing lot, it must be subdivided into as many batches as necessary and stored that way.
12.3 - The lots that are sampled or judged suitable for analysis must be kept in quarantine until the decision of Quality Control.
13. Storage. General considerations
13.1 - Any area used for storage of medicines must be able to safeguard its condition.
13.2 - No medication can be stored before it is officially received and not released for sale without permission, also official.
13.3 - Inventories should be inventoried periodically and any discrepancies duly informed.
13.4 - Inventories should be inspected frequently to check up any noticeable degradation, especially if the drugs are still under guarantee of their validity periods.
13.5 - Drugs with a validity period expired, must be downloaded from stock and destroyed, with the record justified in writing by the pharmacist in charge, according to the provisions of law.
13.6 - The storage, either on shelves, cupboards, shelves or pallets must allow easy viewing for the perfect identification of drugs, as the name of the product, its lot number and its expiration date.
13.7 - The storage should never be performed directly in direct contact with the ground and not in place that receives direct sunlight.
13.8 - Areas for storage should be free of dust, garbage, rodents, birds, insects and all animals.
13.9 - To facilitate cleaning and movement of people, medicines must be stored at a minimum distance of 1 (one) meter from the walls.
13.10 - The movement of people, vehicles and stairs built in storage areas must be careful to avoid damage and impairment and / or loss of drugs.
13.11 - partially used packages must be closed again to prevent losses and / or contamination, indicating the possible amount missing on the outside of the package.
13:12 - The release of drugs for delivery should follow the chronological order of their production batches, ie, dispatch the lots before the oldest of the youngest.
13.13 - The presence of strangers to warehouses must be strictly prohibited in storage areas.
14. Storage of thermolabile medicines
For drugs that can not suffer extremes of temperature, in addition to the recommendations in item 13 should be observed the following:
14.1 - The storage site shall maintain a constant temperature around 20 degrees C (2nd).
14.2 - The temperature measurements must be made consistently and secure, with written records.
14.3 - There should be warning systems that allows to detect defects in air conditioning equipment for immediate repair.
15. Stocking of immunobiological drugs (vaccines and sera)
These products, to maintain their effectiveness in use, require optimum conditions of storage, especially as regards the temperature. Thus, notwithstanding the recommendations of item 13, plus the following should be observed.
15.1 - Handling of immunobiological drugs should take precedence over the other, as well as its release for delivery.
15.2 - should be avoided as much as possible the exposure of these products to any type of light.
15.3 - Storage areas should be in refrigerating equipment, consisting of refrigerators, freezers and cold rooms.
15.3.1 - Refrigerator is the equipment that allows temperatures between 4 º C and 8 C.15.3.2 - "Freezer" is equipment that allows temperature of -10 º C.
15.3.3 - Cold Storage is the equipment that allows temperatures between 8 º C and 15 º C.
15.3.4 - The refrigeration equipment must be checked daily for:
15.3.4.1 - Thermography, in the cold.
15.3.4.2 - maximum and minimum thermometers in refrigerators and freezers.
15.4 - Temperature measurements made should be recorded daily by the data warehouse, and any abnormalities corrected in the shortest time.
15.5 - Distribution of the products within the refrigeration equipment should allow the free circulation of cold air between the various packages contained therein.
15.5.1 - In case of cold storage is desirable to have ante-chambers to avoid unnecessary loss of cold at the opening of the doors of these chambers.
15.6 - entries and withdrawals of products from any refrigeration equipment must be scheduled in advance in order to decrease the maximum of the internal variations in temperature.
15.7 - The refrigeration equipment shall be permanently in operation, connected to local grid and whenever possible, having a network of alternative energy (generator) to meet any shortage of energy in the system.
15.8 - Each equipment of the refrigeration system should be linked solely to avoid overloading the power and ease of use control.
15.9 - much like refrigerators freezers, should be used also for production of ice to be used in the delivery of products and for the safety of the equipment and products it contains, in a possible failure of its internal system cooling .
15.10 - All staff of the warehouse, particularly those related to storage of immunobiological drugs, should be familiar with techniques for storage of those products to meet any emergency situation, resulting in a possible power cut or fault in the cooling system .
15.11 - All equipment, refrigerators, freezers and cold rooms, must have a reliable alarm system, which readily indicate any abnormality in their functioning.
16. Storage of controlled drugs
Given the characteristics of these products, their storage area should be considered maximum security.
16.1 - Regardless of the recommendations contained in items 13, 14 and 15, where they fit, these medications need to be isolated from others in the area and may only have access to her personnel authorized by the pharmacist in charge of the warehouse.
16.2 - The input and output of these drugs should be made according to the specific health legislation, without prejudice to those which were determined by the administration itself almoxarifado.1
7. Distribution
17.1 - There should be a distribution system that permits easy identification of your destination. For this, the distribution records shall include the name of the product, its lot number, name and address of the recipient, date and quantity shipped and invoice number, order or document.
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