THE ESSENCE OF Pharmaceutical and medical commodity research. Classification and coding of goods

1. THE ESSENCE OF Pharmaceutical and medical commodity research. Classification and coding of goods

2. Pharmaceutical and medical commodity research is profiling discipline which aims at training employees of the pharmacy to perform professional merchandising functions related to providing medical institutions and public with pharmaceutical goods and medical equipment, training of pharmacist skills of work with tools, instruments and medical equipment.

3. Pharmaceutical and medical commodity research studies: • - Consumer properties of pharmaceutical and medical goods; • - Range; • - Classification; • - Coding • - Commodity transactions of goods in a chemist's network; • - Influence on the quality of goods; • - Organization of storage and so on.

4. Principles of Commodity science • 1. Safety - a principle that is impermissible in the absence of risk associated with the possibility of applying product (service process) damage to life, health and property. • 2. Efficiency - a principle that determine achievement optimum results in the production, storage, and consumption of goods. • 3. Compatibility - the principle that determined suitability of goods (processes, services) for common use. • 4. Interchangeability - a principle which determined suitability of a product (process service) is used instead of other goods (process service) to perform the same functions. • 5. Systematization - a principle which is to establish a sequence of homogeneous, mutually related products (processes and services).

5. In economics and accounting, a good is a product that can be used to satisfy some desire or need. More narrowly but commonly, a good is a tangible physical product that can be contrasted with a service which is intangible.

6. “Pharmaceutical product” means any substance, or mixture of substances, for use in human beings or animals, for: • a) the diagnosis, treatment, mitigation or prevention of a disease or its symptom; • b) the diagnosis, treatment, mitigation of any abnormal physical or physiological state or its symptom; • c) altering, modifying, correcting or restoring any organic function.

7. Classification (from Lat. Classic - level, group) - the distribution of various objects (objects and phenomena) into classes, groups, and other units based on common attributes. The first attempts were scientific classification done by M. J. Kitarry in the "public course of commodity”, and then by other scientists.

8. There are categories of classification: • - Higher; • - Average; • - Lower. • Higher classification category indicates the terms, "unit" or "class", "division". • Medium-category "group", "subgroup", "type". • Lower-category "subspecies".

9. Classification of Pharmaceutical Products 1. Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included. • Glands and other organs, dried, whether or not powdered • Extracts of glands or other organs or of their secretions • Other

10. Classification of Pharmaceutical Products 2. Human Blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeast) and similar products. • Antisera and other blood fractions and modified immunological • products, whether or not obtained by means of biotechnological processes • Vaccines for human medicine • Vaccines for veterinary medicine • Others

11. Classification of Pharmaceutical Products 4. Medicaments (excluding goods of heading) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. • Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives • Containing other antibiotics • Containing hormones or other products of heading not containing antibiotics: Containing insulin Other • Containing alkaloids or derivatives thereof but not containing • hormones or other products of heading or antibiotics • Other

12. Classification of Pharmaceutical Products 5. Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packing for retail sale for medical, surgical, dental or veterinary purposes. • Adhesive dressings and other articles having an adhesive layer • Wadding and gauze, neither impregnated nor covered with pharmaceutical substances • Other

13. Classification of Pharmaceutical Products 6. Pharmaceutical goods including sterile surgical and dental goods, blood-grouping reagents, opacifying preparations, x-ray diagnostic reagent, dental cements and other dental filings, bone cement, first-aid boxes and kits, contraceptive preparations based on hormones or spermicides. 7. Sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure; sterile laminaria tents; sterile absorbable surgical or dental haemostatics • Blood-grouping reagents • Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient • Dental cements and other dental fillings; bone reconstruction cements • First-aid boxes and kits • Chemical contraceptive preparations based on hormones or spermicides

14. Certain products are exempted from registration under the Pharmacy and Poisons Ordinance. These are: • Proprietary Chinese medicines or Chinese herbal medicines as defined in the Chinese Medicine Ordinance. (Note: Proprietary Chinese medicines are still required to be registered under the Chinese Medicine Ordinance, and an import/export licence is still required for their import/export.); and • Medical devices. A medical device is defined as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar, alone or in combination, for human beings for one or more of the specific purpose

15. Examples of medical device are: • bone cements (including bone cements containing an antibiotic) • catheters (including heparin-coated catheters) • contact lens care products • drug eluting stents • haemodialysis concentrates • intra-uterine devices for contraceptive use • surgical dressings • surgical sutures

16. The Anatomical Therapeutic Chemical (ATC) Classification System is used for the classification of drugs. It is controlled by the WHO Collaborating Centre for Drug Statistics Methodology (WHOCC), and was first published in 1976

17. The classification system divides drugs into different groups according to the organ or system on which they act and/or their therapeutic and chemical characteristics. Each bottom-level ATC code stands for a pharmaceutically used substance in a single indication (or use). This means that one drug can have more than one code: acetylsalicylic acid (aspirin), for example, has A01AD05 as a drug for local oral treatment, B01AC06 as a platelet inhibitor, and N02BA01 as an analgesic and antipyretic. On the other hand, several different brands share the same code if they have the same active substance and indications.

18. 1 Classification • 1.1 First level • 1.2 Second level • 1.3 Third level • 1.4 Fourth level • 1.5 Fifth level

19. The first level of the code indicates the anatomical main group and consists of one letter. There are 14 main groups: • A Alimentary tract and metabolism • B Blood and blood forming organs • C Cardiovascular system • D Dermatologicals • G Genito-urinary system and sex hormones • H Systemic hormonal preparations, excluding sex hormones and insulins • J Antiinfectives for systemic use • L Antineoplastic and immunomodulating agents • M Musculo-skeletal system • N Nervous system • P Antiparasitic products, insecticides and repellents • R Respiratory system • S Sensory organs • V Various

20. Second level The second level of the code indicates the therapeutic main group and consists of two digits. Example: C03 Diuretics • Third level The third level of the code indicates the therapeutic/pharmacological subgroup and consists of one letter. Example: C03C High-ceiling diuretics • Fourth level The fourth level of the code indicates the chemical/therapeutic/pharmacological subgroup and consists of one letter. Example: C03CA Sulfonamides • Fifth level The fifth level of the code indicates the chemical substance and consists of two digits. Example: C03CA01 Furosemide

21. Bar Codes Bar codes are used worldwide in supply chain management to identify specific products. A bar code consists of a string of numbers, letters, or special characters, with a series of black and white parallel lines and spaces or mosaics in a checkerboard or honeycomb pattern, representing the numbers, letters, or special characters in a machine-readable form.

22. A “checksum” digit is added at the end of the bar code’s data string, calculated from the other characters in the data string. This extra digit is a technical way of preventing misinterpretation by the scanner (caused by, for instance, a mangled label) which might otherwise result in an error.

23. Bar codes are read by scanners, which may be stationary (like those at store checkout counters) or portable (hand-held wands or pens). Scanners typically transmit the data for one item at a time, but also available are portable battery-operated “batch” scanners, which can store data in memory for later transfer to a host computer, and portable wireless scanners, which can transfer batch data in real time.

24. Bar codes encompass three basic elements: content of the bar code, data format, and symbology. • •Content refers to the information encoded in the bar code. In the context of medications, examples of content include the drug name, manufacturer, drug strength and form, expiry date, lot number, and package size and type. • •Data format refers to the order in which the data elements representing each content item are arranged. To use a written-language analogy, data format is comparable to sentence structure, where the words are equivalent to the data elements. • •Symbology refers to the number and width of the printed bars and intervening spaces that make up the machine-readable identifier. To use another written-language analogy, the symbology describes the “font” in which the machine-readable code is written. The type and number of characters encoded and the amount of space available for the bar code are some of the factors that determine which type of symbology is most appropriate for a given bar code application.

25. There are currently two established standards for data format in health care, one managed by GS1 (an amalgamation of the former Uniform Code Council [UCC] and EAN International) and the other by the Health Information Business Communications Council (HIBCC).

26. Three common symbologies are linear barcodes, two-dimensional matrix bar codes, and composite symbologies. • Linear bar codes consist of a series of tall printed bars of various widths • Two-dimensional (2-D) matrix symbologies (e.g., Data Matrix) consist of matrices of printed squares or dots, spiralling outward from the centre of the symbol. • Emerging composite symbologies use a combination of linear and 2-D symbols to encode significant amounts of data in addition to product identification. • Reduced space symbology (RSS) is a relatively new type of linear symbology, developed to store more data in a much smaller area.RSS symbols can be printed on small labels applied to curved surfaces, such as vials, ampoules, and blister packs.

27. Example of RSS-14 stacked omnidirectional bar code20

28. There are currently two leading not-for-profit standards-setting organizations in the health care arena: GS1 and HIBCC. GS1 is headquartered in Brussels, with member countries around the world. HIBCC is based in the United States, with affiliates in Australia, France, and the United Kingdom. In addition, a European Health Industry Business Communications Council is based in The Hague, Netherlands.

29. There are many similarities and differences between the GS1 and HIBCC systems. Similarities include the following: • • Both assign unique identifiers to the manufacturer or packager, allowing the manufacturer to assign its own product identifier (using criteria determined by the particular system). • • Both provide the same basic information (identification of the manufacturer/labeller, the product, and the packaging level)through their data structures. • • Both offer methods for encoding secondary data, such as lot number, batch number, and expiry date (usually encoded in a separate bar code but occasionally merged with the primary data into one long bar code).

30. Code 39 Barcode This Symbology is also known as ANSI/AIM Code 39, ANSI/AIM Code 39, Uniform Symbology Specification Code 39, USS Code 39, USS 39, Code 3/9, Code 3 of 9, USD-3, LOGMARS, Alpha39, Code 39 Extended, and Code 39 Full ASCII. Code 39, the first alpha-numeric symbology to be developed, is still widely used-especially in non-retail environments. It is suitable for encoding general purpose alphanumeric data. It is the standard barcode used by the United States Department of Defense, and is also used by the Health Industry Bar Code Council (HIBCC).

31. Interlevead 2 of 5 Barcode This Symbology is also known as ANSI/AIM ITF 25, ANSI/AIM I-2/5, Uniform Symbology Specification ITF, USS ITF 2/5, ITF, I-2/5, 2 of 5 Interleaved, 2/5 Interleaved. Interleaved 2 of 5 is a higher-density numeric symbology based upon the Industrial 2 of 5 symbology. It is suitable for encoding general purpose all-numeric data and is used primarily in the distribution and warehouse industry.

32. Code 128 Barcode This Symbology is also known as ANSI/AIM 128, ANSI/AIM Code 128, USS Code 128, Uniform Symbology Specification Code 128, Code 128 Code Set A, Code 128 Code Set B, Code 128 Code Set C, Code 128A, Code 128B, Code 128C. Code 128 is a linear bar code symbology capable of encoding the full 128-character ASCII character set and extended character sets. This Symbology includes a checksum digit for verification, and the barcode may also be verified character-by-character verifying the parity of each data byte. It has been widely implemented in many applications where a relatively large amount of data must be encoded in a relatively small amount of space.

33. EAN 8 Barcode This Symbology is also known as European Article Number 8, EAN-8 Supplement 5/Five-digit Add-On, EAN-8 Supplement 2/Two-digit Add-On, EAN-8+5, EAN-8+2, EAN8, EAN8+5, UPC-8, GTIN-8, GS1-8, EAN/UCC-8. EAN-8 is the EAN equivalent of UPC-E in the sense that it provides a "short" barcode for small packages. The primary purpose of the EAN-8 code is to use as little space as possible. EAN-8 is encoded using the three EAN-13 character sets and also has a check digit that is calculated in the same way as EAN-13. The data digits in an EAN-8 symbol identify a particular product and manufacturer. Since a limited number of EAN-8 codes are available in each country, they are issued only for products with insufficient space for a normal EAN-13 symbol. For example, a 2-digit country code permits a total of only 100,000 item numbers.

34. EAN 13 Barcode This Symbology is also known as European Article Number 13, EAN-13 Supplement 5/Five-digit Add-On, EAN-13 Supplement 2/Two-digit Add-On, EAN-13+5, EAN-13+2, EAN13, EAN13+5, EAN13+2, UPC-13, GTIN-13, GS1-13, EAN/UCC-13. EAN-13, based upon the UPC-A standard, was implemented by the International Article Numbering Association (EAN) in Europe. EAN-13 is a superset of UPC-A. This means that any software or hardware capable of reading an EAN-13 symbol will automatically be able to read an UPC-A symbol. The only difference between EAN-13 and UPC-A is that the number system code in UPC-A is a single digit from 0 through 9 whereas an EAN-13 number system code consists of two digits ranging from 00 through 99, which is essentially a country code.

35. EAN 14 (ITF 14) Barcode  This Symbology is also known as UPC Shipping Container Symbol ITF-14, ITF14, Case Code, UPC Case Code, EAN/UCC-14, EAN-14, UCC-14, DUN-14 and GTIN-14. The ITF-14 or UPC Shipping Container Symbol is used to mark cartons, cases, or pallets that contain products which have a UPC or EAN product identification number. The short-hand name for the symbol is "ITF-14", and 14 digits (the length of the container symbol).

36. EAN 128 Barcode This Symbology is also known as EAN-128, UCC-128, USS-128, GS1-128, UCC.EAN-128 and GTIN-128. The UCC/EAN-128 Symbology is a subset of the more general Code 128 Symbology. By agreement among AIM, Inc., EAN International and the UCC, use of the Function 1 Character (FNC1) in Code 128 Symbols in the first symbol character position following the Start Character has been reserved exclusively for the EAN.UCC System. UCC/EAN-128 was developed to provide a worldwide format and standard for exchanging common data between companies. While other barcodes simply encode data with no respect for what the data represents, UCC/EAN-128 encodes data and encodes what that data represents.

37. Example of an HIBCC Data Matrix bar code for a unit-dose package