TEMA 12 Pharmaceutical Products PDF

# TEMA 12 - SISTEMAS DE ALMACENAJE Y CONDICIONES DE CONSERVACIÓN DE PRODUCTOS FARMACÉUTICOS Y PARAFARMACÉUTICOS SEGÚN SUS CARACTERÍSTICAS. CÓDIGOS FARMACÉUTICOS IDENTIFICATIVOS DE LOS PRODUCTOS FARMACÉUTICOS Y PARAFARMACÉUTICOS. ORDENACIÓN DE LOS PRODUCTOS. GESTIÓN DE EXISTENCIAS. CONTROL DE CADUCID...

# TEMA 12 - SISTEMAS DE ALMACENAJE Y CONDICIONES DE CONSERVACIÓN DE PRODUCTOS FARMACÉUTICOS Y PARAFARMACÉUTICOS SEGÚN SUS CARACTERÍSTICAS. CÓDIGOS FARMACÉUTICOS IDENTIFICATIVOS DE LOS PRODUCTOS FARMACÉUTICOS Y PARAFARMACÉUTICOS. ORDENACIÓN DE LOS PRODUCTOS. GESTIÓN DE EXISTENCIAS. CONTROL DE CADUCIDADES. PROCEDIMIENTO DE DEVOLUCIÓN DE PRODUCTOS CADUCADOS CONFORME A LA NORMATIVA. RETIRADA DE PRODUCTOS POR ALERTA SANITARIA. ELIMINACIÓN DE LOS PRODUCTOS SEGÚN EL SISTEMA INTEGRAL ESTABLECIDO. APLICACIONES INFORMÁTICAS DE GESTIÓN Y CONTROL DE ALMACÉN. ## 1. CÓDIGOS FARMACÉUTICOS. IDENTIFICACIÓN DE LOS PRODUCTOS DE FARMACIA. - **1.1. CÓDIGO NACIONAL.** - **1.2. CÓDIGO DE BARRAS.** - **1.3. CÓDIGO INTERNO.** - **1.4. SISTEMA DE AUTENTICACIÓN DE MEDICAMENTOS.** ## 2. CRITERIOS DE ORDENACIÓN DE PRODUCTOS EN LA OFICINA DE FARMACIA Y SISTEMAS DE ALMACENAJE. ## 3. CONTROLES ADICIONALES EN EL ALMACÉN DE FARMACIA. ## 4. PROCEDIMIENTO DE DEVOLUCIÓN DE MEDICAMENTOS CADUCADOS. ## 5. RETIRAR PRODUCTOS POR ALERTA SANITARIA. ## 6. GESTIÓN DE EXISTENCIAS; CONCEPTOS BÁSICOS. ## 7. ELIMINACIÓN DE LOS PRODUCTOS SEGÚN EL SISTEMA INTEGRAL ESTABLECIDO. ## 8. APLICACIONES INFORMÁTICAS DE GESTIÓN Y CONTROL DE ALMACÉN. ## 1. CÓDIGOS FARMACÉUTICOS. IDENTIFICACIÓN DE LOS PRODUCTOS DE FARMACIA. ### 1.1. CÓDIGO NACIONAL. The national code (CN) is an identification code for pharmaceutical products consisting of seven digits and a dot. These digits are ordered so that there are always six digits first, then the dot and finally a control digit. It is a system that serves to identify commercial services, as each of them corresponds to a code. The Ministry of Health assigns the national code to each product through different institutions depending on the type of product: - **CGCOF:** responsible for assigning the national code to over-the-counter products. The assignment of this code does not imply exclusivity of sale, guarantee of quality of the products or health endorsement. - **AEMPS:** assigns codes to drugs when they are authorized and registered. - **DGFPS:** is the agency responsible for assigning the national code to dietetic products and effects and accessories. In addition, the national code that each product has assigned has a meaning, as depending on the digits it carries, it can be identified if it concerns one type of product or another, in general, although there may be an exception: - **Over-the-counter products and non-financed products** start with 1, 2 or 3, i.e., 150,000-399,999. - **Effects and accessories** start with 4, i.e., 400,000-510,000. - **Veterinary drugs** start with 5, i.e., 510,000-599,999. - **Human use drugs (including EC)** start with 6, 7, 8 or 9, i.e., 600,0000-999.999 Regardless of the product in question, the national code must appear on the product packaging. ### 1.2. CÓDIGO DE BARRAS. The barcode is a combination of lines and numbers printed that we can find, among others, in the packaging of pharmaceutical products to facilitate their identification by an optical reader that transmits the data to the computer program. In the case of pharmaceutical products, the barcode includes the national code and follows the EAN 13 (European Article Number of 13 digits) coding. ### 1.3. CÓDIGO INTERNO. Some products do not have a national code assigned. In these cases, pharmacy offices and pharmaceutical warehouses must assign an internal code of their own with which they can be identified. To add a product without a national code, the following steps must be followed: 1. Request a free code from the software program for this item. 2. Create the file as for any other product. 3. Link the assigned code with the internal code of each supplier. To do this, you must search in each warehouse with which the pharmacy works the code that it has assigned to the product. In this way, when the pharmacy needs to make a request to the warehouse, it launches the item with the assigned code, and the software program, depending on the warehouse to which it is going to be sent, will translate it and send it with the corresponding supplier code. ### 1.4. SISTEMA DE AUTENTICACIÓN DE MEDICAMENTOS. As a result of this new legal framework, all manufacturers and holders of marketing authorization, whether they are innovative laboratories, generics or parallel importers, will have to incorporate two types of security devices on all medicinal product packages subject to verification. The first device is a two-dimensional code in Datamatrix format that identifies the package individually. The second is an anti-tampering device that will allow you to check if the packaging has been tampered with. Manufacturers and holders of marketing authorization will introduce these unique identifiers, for all packages subject to verification that are going to be marketed in the European Union and the European Economic Area, in a central database, the European Medicines Verification System (EMVS), also known as the "European Platform". This platform will connect with national systems, ensuring interoperability between them. The codes of the serialized drugs will be downloaded in the market of destination, for example, in Spain they will be transferred to SEVeM, the Spanish Medicines Verification System. ## 2. CRITERIOS DE ORDENACIÓN DE PRODUCTOS EN LA OFICINA DE FARMACIA Y SISTEMAS DE ALMACENAJE. The pharmacy office works with a large amount of products, so it is essential that a meticulous order exists in the warehouse. All personnel working in the pharmacy must know the criteria followed for the ordering of products, with a twofold objective: - **Easy and quick location of products:** This way, customer service will be of higher quality, since there will be no delay in finding the product to be dispensed and more time can be spent on pharmaceutical advice. - **Minimizing the risk of error:** If you are meticulous in the ordering, risks can be avoided that lead to errors, for example, dosages, brand or number of units per package. Pharmacies have different warehouse systems. They combine open, fixed and mobile shelves with drawers of different heights. When placing products, these general rules applicable to all pharmacies must be taken into account: - **Expiration date** - **The products that have a higher sales volume are usually placed on open shelves closer to the dispensing area to speed up the process.** -Products that are bought in large volumes, either because of their high turnover or because of seasonality** , will be placed in the replenishment warehouse until they are needed, which will be placed in the dispensing warehouse. - **Daily sales products, but that do not have a high turnover, will be located in drawers or similar inside the dispensing warehouse.** - **Closed drawers must indicate, on the outside, the products they contain; to do this, usually the initials of the first product and those of the last one are placed in each drawer.** - **Bulky and heavy products must be placed in areas of easy access that do not hinder their placement or selection, but that do not obstruct the passage.** - **You must consider the storage conditions of each product so that they do not break and preserve their integral characteristics.** - **There must be a well-differentiated area for immobilized items (expired, withdrawn, defective...) to prevent them from being dispensed by error.** - **Veterinary products will also have their own place.** The ordering of products within the pharmaceutical warehouse can be done following different criteria, so each pharmacy must define them so that the staff working in it knows them and facilitates work. These criteria can be summarized in the following table: | Category | Characteristics | Advantages | Disadvantages | |-------------|-------------|-------------|-------------| | **Alphabetical Order** | Products are ordered alphabetically based on their commercial name. | Easy to remember and understand, so it is easy to use. | The storage space is not optimized because all types of packages are mixed. | | **Pharmaceutical Form** | All products are categorized by their pharmaceutical form, i.e., the warehouse is divided into areas for each pharmaceutical form. | The storage space is optimized by using the available resources well. The size of the packaging of products with the same pharmaceutical form are usually very similar. | It requires a more extensive and thorough knowledge of the pharmaceutical forms from the staff. | | **Pharmacological Activity** | Products are organized by their pharmacological activity, i.e., by the therapeutic indication for which they are used. | It facilitates dispensing based on pharmaceutical indications. | It requires extensive pharmaceutical knowledge from the personnel working in the pharmacy. The space is not optimized because there are many different types of packaging. | | **Supplier Order** | All products are organized by supplier. | It is mainly used for over-the-counter products. It is very effective visually as it is well organized. | The most visual products can be found easier. | | **Expiration Date** | Products are organized by expiration date. | No disadvantages reported. | | Usually, a mixture of criteria is used in pharmacies for the ordering of the products and, thus, to comply with the basic principles of space optimization of the storage and streamline the replenishment and dispensing process of products, minimizing the time spent searching for items and the risk of errors. Of all of them, the most used is the alphabetical ordering system by pharmaceutical form, not strictly or rigorously, and, within this, in alphabetical order. ## 6. GESTIÓN DE EXISTENCIAS; CONCEPTOS BÁSICOS. Pharmacy offices follow specific ordering criteria to achieve efficient warehouse management.  ## 7. ELIMINACIÓN DE LOS PRODUCTOS SEGÚN EL SISTEMA INTEGRAL ESTABLECIDO. The increase in health centers and the use of scientific techniques is increasingly sophisticated, so the management of these centers produces a significant amount of health waste. The management of these waste deserves special attention because they present a health risk. This management must begin in the healthcare production center with a minimization of waste and with a proper separation by categories or groups, following a convenient packaging, safe transportation by the healthcare production center, and the provision of warehouses for the different waste. Finally, an external manager will be in charge of proper collection, transportation, treatment and elimination of these health wastes. It is important to keep in mind that the management of health waste mainly affects three areas: - **Public health**, as a poor internal management of the center can affect patients and the public, and an improper external management can affect the general population. - **The environment**, when treatment and elimination are not effective, causing pollution. - **Workers**, both those who work within the healthcare production center and those who work in the external management of the waste. The importance that the proper management of this waste has means that each Autonomous Community develops legislation on this matter, emphasizing both internal and external center management, since general regulations do not specify anything about it. From a legal point of view, the national level has the current Law 10/1998, of April 21, on waste. Chapter IV of Law 10/1998 on specific rules for the production and management of hazardous waste sets out certain obligations for the producer and the manager, as well as safety, registration and emergency measures. However, it does not specify anything about management in healthcare centers, nor does the legislation prior to this law. Because Autonomous Communities (CAA) must prepare Autonomous Waste Plans (article 4), most of them have (previous and subsequent to the Waste Act) regulations that specify the measures to adopt within the healthcare production center, as well as the obligations of the manager that collects, treats and eliminates health waste. Law 22/2011 on waste and contaminated soils establishes the legal regime for the production and management of waste, as well as providing for measures to prevent its generation and to avoid or reduce the adverse impacts on human health and the environment associated with its generation and management. In the Galician Autonomous Decree, it is important to apply Decree 10/2008, of November 3, on Galician waste. According to its article 3, this law applies to all types of waste that originate and are managed in the territorial scope of the Autonomous Community, without health waste being included among the exclusions mentioned in that provision. **Decree 38/2015, of February 16, on Galician Healthcare Waste (DOG of April 1, 2015)**. Its scope of application covers all activities of production or management of healthcare waste, both public and private, that occur within the Autonomous Community and, as a novelty, includes the waste collected in classes IIa and III that occur in beauty centers, tattoos, micropigmentation and piercings, and in funeral parlors, as well as those waste that are attributed the nature of healthcare waste by legal or regulatory provision. The following are excluded from the scope of application of this decree: - **Radioactive waste** (Decree 102/2014 for responsible management of spent nuclear fuel and radioactive waste). - **Human cadavers and remains** (Decree 151/2014, on Galician mortuary health). - **Animal carcasses and animal by-products**. A new classification of WASTE is made, depending on its hazard and the risk associated with the health activity: **1) NON-HAZARDOUS HEALTH WASTE** a) **Class 1: Domestic waste**. Waste generated in healthcare centers similar to those produced in homes. b) **Class II: Non-domestic waste**. Waste generated in healthcare centers different from those produced in homes. i) **Class IIa: Specific waste of the healthcare class:** waste generated in healthcare centers, different from waste produced in homes, such as a result of the healthcare activity itself. ii) **Class llb: Non-specific waste of the healthcare activity:** waste different from waste produced in homes, but which is not the result of the healthcare activity itself. **2) HAZARDOUS HEALTH WASTE** a) **Class III: Biocontaminated healthcare waste:** waste that requires separate management both inside and outside healthcare centers, in all stages of its management. The following are included in this class: - **Waste from healthcare activities of patients affected by pathologies related to Annex I.** - **Waste of culture or reserve of infectious agents and materials in contact with them, including the high-efficiency filters of laminar flow hoods.** - **Waste of vaccines with live or attenuated agents.** - **Waste from laboratory animals, carcasses and anatomical remains of animals infected or inoculated with infectious agents responsible for infections related to Annex I.** - **Waste from cytotoxic and cytostatic drugs and all materials used in their preparation and contact with them (not including those in class III and IV).** b) **Class IV: Cytotoxic and cytostatic waste and all materials used in their preparation and contact with them (not included in class III and IV).** c) **Class V: Other hazardous waste (those not included in classes III and IV).** **ANNEX I** **Waste of infectious diseases that require special requirements to prevent infections.** 1) Any waste from materials, objects or substances that have been in contact with patients affected by the following infectious diseases: **Viral hemorrhagic fevers**, such as: - **Congo-Crimean Hemorrhagic Fever.** - **Lassa Fever.** - **Marburg.** - **Ebola.** - **Argentinian Hemorrhagic Fever (Junín).** - **Bolivian Hemorrhagic Fever (Machupo).** **Arthropod-borne encephalitis complex transmitted by arthropod vectors (arboviruses)**: Absettarow, Hanzalova, Hypr, Kumlinge, Kiasanur ForestDisease, Omsk hemorrhagic fever, Russian Spring-Summer encephalitis. - **Monkey B Virus (Herpes virus simiae)**. - **Rabies.** - **Anthrax (Bacillus anthracis)**. - **Glanders.** - **Melioidosis**. - **Diphtheria**. - **Tularemia.** - **Smallpox (eradicated)**. - **Creutzfeldt-Jakob and other diseases caused by prions**. 2) Waste contaminated with feces of patients affected by the following infections: - **Typhoid Fever.** - **Paratyphoid Fever.** - **Cholera.** - **Dysentery.** 3) Waste contaminated with respiratory secretions from patients with the following infections: - **Tuberculosis.** - **Q Fever.** 4) Dialysis filters from machines reserved for patients carrying the following blood-borne infections: - **Hepatitis B.** - **Hepatitis C.** - **Human immunodeficiency virus (HIV).** 5) Waste from analysis or experimental microbiological activities contaminated with infectious agents or derived biological products, such as: - **Cultures of infectious agents and waste materials in contact with them: Petri dishes, blood cultures, liquid extracts, broths, contaminated instruments, etc.** - **Infectious agent reserves.** - **Live or attenuated vaccines, except stained materials of single use.** 6) Waste from carcasses, body parts and other anatomical remains of experimental animals inoculated with the infectious agents responsible for infections mentioned in points 1, 2, 3 and 4, as well as waste from bedding of such animals. The collection of healthcare waste within the healthcare centers that generate them must meet separation, hygiene, harmlessness and economics criteria, and comply with the current regulations for preventing occupational hazards. A separate collection system will be implemented for healthcare waste, in accordance with the classification established in the types of waste. Separation, identification and packaging of the waste generated must be rigorously carried out at the source. Containers and their closures will be designed and made in such a way as to prevent any loss of content and will be made of materials that are not susceptible to being attacked by the content or to form dangerous combinations with them. They must also be solid and robust to respond safely to the necessary manipulations and must be maintained in good condition, free from structural defects and without leaks. Waste collected in bags will be transported and stored in containers that, when not for single use, willكون constructed of rigid structure and that will allow easy cleaning and disinfection. The containers must be completely closed before transport and must never be dragged or handled in a way that affects their integrity. Carts or containers used in the transport of containers will be exclusive for this purpose and, if they are not disposable, will allow easy cleaning and disinfection, will be corrosion-resistant, and will not have sharp or pointed elements, designed in such a way as to prevent the containers from falling on workers; they will be inspected and replaced if they show any defects. The health waste, properly separated and packaged, may be stored in places specifically designated for this purpose. It is forbidden to store the waste in any other place that is not the authorized area for this purpose and to store the bags in the open air. Transportation of waste within healthcare centers must meet criteria of speed, hygiene, harmlessness and safety, avoiding or minimizing actions or manipulations that might pose any risk to workers involved in its collection and transportation, workers, users, and the public. Domestic waste will be separated selectively and in accordance with the current legislation on waste and according to waste plans that are applicable and municipal regulations. **Management of Class II waste**: Non-domestic waste will be collected in containers or packages that facilitate their handling and, under conditions that prevent risks to human health and the environment. The plastic bags intended for the collection and storage of waste must be opaque, impermeable and strong enough to safely hold the type of waste for which they were designed. Management of sharp and pointed waste of Class IIa will be carried out in the same way as that of Class III healthcare waste. **Management of Class III and IV waste**: These waste will be collected into containers suitable for the type of waste and the place of production, which must meet the following characteristics: a) **Rigid and freely supported.** b) **Opaque, impermeable and resistant to humidity.** c) **Resistant to perforation. ** d) **Equipped with a hermetic seal.** e) **Composition that guarantees that its destruction minimises or eliminates emissions. ** Containers and containers used in the storage and intracenter transport will be labeled according to the general waste regulations. They will be labeled with biorisk or cytotoxic pictograms, or both, and with their associated texts. Sharp and cutting waste will be stored in specific containers and will be provided with safety devices that prevent them from being opened.  **Management of Class V waste**: The packaging, labeling and separation of this waste will be done according to the current legislation for this type of waste and, specifically, according to Law 22/2011, of July 28, on waste and contaminated soils, and Law 10/2008, of November 3, on Galician waste. ## 8. APLICACIONES INFORMÁTICAS DE GESTIÓN Y CONTROL DE ALMACÉN. Today, most sectors of professional activity make use of basic computer applications, which often are: - **Word Processor:** This application allows us to write a text, give it a certain appearance or format, add images and graphs, make tables, etc. In addition, it incorporates spell checkers and other utilities. It is widely used to write reports, manuals, letters, etc. Some examples include Word from the Windows Office suite, or the free LibreOffice (currently used by the SERGAS, Spain's Galician National Health Service). - **Spreadsheet:** This application facilitates mathematical calculations. It usually works on a basis of "cells" in which we write concepts and numbers. Then, mathematical formulas involving various cells can be used. An example is the Excel software in the Office suite. - **Database:** This program allows you to store and retrieve data in an organized way. Working with a database sometimes involves structuring the database itself. In other words, to organize a series of files or records in which data from one or more variables can be compiled. For example, Access software from Windows. A related concept is that of relational database manager, which is that program that is able to take data from various files and link them through a common field. This software can be useful for health centers, especially regarding patient medical records, since each center has its own specific software. But if they can use these basic programs and common to other professional areas, for different tasks, such as reports, medical recommendations, etc., this can be helpful. - **Inventory:**  You should establish clear storage rules to reduce costs, prevent losses and waste due to theft, obsolescence, breakage, damage to the product or the package, etc., and to clearly establish where each product is located, to have easy access to each element, to physically control inventories and strive to ensure that products maintain their full quality for the maximum time possible, through proper control of: - **Temperature:** pay attention to symbols on the packaging and temperature conditions, which indicate the storage conditions - **Humidity:** which affects the stability of the medications - **Minimum exposure to sunlight or daylight:** (it can accelerate the process of degradation of the medications; attention to PHOTOSENSIBLE drugs) - **Complete absence of insects.** You should also avoid the following deficiencies: **1. Deterioration:** damage due to deterioration is usually proportional to the volume of stocks and to the time of the products’ stay, i.e., they are greater the higher the number of items or the longer the storage time. **2. Obsolescence:** the risk of obsolescence of the products leads to smaller purchases and smaller inventories. Many innovations have little or no advantage over older products, but rather, are due to marketing factors, which makes for a double impact on inventories: the old product expires and thus becomes obsolete, while the new one runs out frequently. **3. Expiration:** especially medications have an expiration date, that is, only returning them is an alternate option if the expiration date of the product is later. Statistically, around 5% of products in inventory expire and this waste increases the average cost of those supplied. **4. Theft:** its magnitude depends on the controls and the motivation of both warehouse and hospital staff in general. **5. Accidents:** giving special treatment to heavy, hazardous or highly polluting items. When controlling stocks, the goal should always be to maximize the benefits to the patient while minimizing the total cost of inventories. ## E. MÉTODOS DE VALORACIÓN DE EXISTENCIAS. As companies, pharmacies seek to make a profit, although it is neither the only nor the main goal. Therefore, it is essential to know the value of the products in stock to know how the economy of the pharmacy is going. To determine whether the pharmacy is making a profit or, on the contrary, whether it is losing, the value of the costs must be subtracted from the value of the sales. To carry out this valuation of stocks, the purchase price of the item in stock must be considered, not the selling price. Although doing the valuation of stocks using the purchase price rules is not easy, it is not such a difficult task, as the prices of pharmaceutical products are in constant flux.