PHARMACEUTICAL_LABELLING,_PACKAGING_AND_STORAGE (1).pptx

education on the dispensing practice

1. Pharmaceutical labelling, packaging and storage N. NDLOVU

2. PHARMACEUTICAL LABELLING Definition of terms Primary label – label upon the immediate container, i.e. container in direct contact with the product Secondary label – label on the outer pack immediate to the container holding the product Product information leaflet/Package insert (PI) – a leaflet accompanied with the medicinal product containing specific information for the healthcare professional

3. Definition of terms cont’d Patient information leaflet (PIL) – a leaflet accompanied with the medicinal product containing specific information in lay man’s language, for the patient Dispensing label – a label giving specific instructions to the patient and attached to the packaging of medicine at the point of dispensing

4. Labelling requirements The container of every medicine imported, manufactured, processed or packed locally or sold or exposed for sale shall have a label bearing the following information in English language.

5. The official or generic name of the medicinal product followed by its pharmaceutical form and strength - Where the product contains up to three active substances, the international non-proprietary name (INN) or any other commonly used official name such United States Approved Name (USAN) or British Approved Name (BAN) shall be included.

6. Cont’d For products containing more than three active substances, name descriptive of the true nature of the medicinal product shall be used. (E.g. Multivitamin Tablets)

7. The brand/proprietary name (if any) - The brand name should not be already registered for another product.

8. A statement of the active substance(s) showing quantitative particulars: (i) The quantity of each active ingredient, identified by its appropriate non-proprietary name, in each dosage unit of the medicinal product expressed in terms of weight, volume, capacity or units of activity; or (ii) where there is no dosage unit, the quantity of each active ingredient identified by its appropriate non-proprietary name, in the container of the medicinal product expressed in terms of weight, volume, capacity or units of activity or percentage by weight or volume of the total quantity

9. For active substances present as salts, they should be clearly indicated. E.g. each capsule contains Amoxicillin trihydrate equivalent to Amoxicillin 250mg

10. Pack size: the number of doses, weight, or volume contained in the pack Excipient(s) known to have undesirable effects and any other ingredients specified by the Authority. Particularly, presence of the following ingredients should be indicated: (i) Colorants(s) contained in the formulation of any medicinal product (ii) Sweeteners used as inactive ingredients (quantity in milligram per dosage unit) (iii) Alcohol content in oral liquids (as a percentage)

11. (iv) Presence of benzyl alcohol in parenteral preparations. (v) Preservatives contained in ophthalmic products. (as a percentage) (vi) Any added microbial preservatives in parenteral preparations. (as a percentage)

12. The dosage form The route of administration for injectable products Storage temperature and, other special storage precautions if any A special warning that the product must be stored out of reach of children. Specific instructions if the product needs to be reconstituted, diluted, or prepared by any other means prior to its use

13. Where applicable, the product is sterile. Where applicable, the product is free from bacterial endotoxins or that the product is apyrogenic . For injectable solutions, not to use if visible particles are present. Any other special warnings and precautions that may be necessary for the particular medicinal product

14. The date of manufacture in clear terms (month/year) The date of expiry in clear terms (month/year) The batch or lot number assigned by the manufacturer The period for which the medicine can be used after opening of the container or after reconstitution of the product, if applicable. Specific precautions related to disposal of unused quantities of the product, if applicable

15. The name of the manufacturer and address of the manufacturing site. -The name and address of the batch releaser shall be used, if different from the drug product manufacturer. -When the product owner is different to the manufacturer, the label shall indicate in the following manner: ‘manufactured by (name and address of actual manufacturer) for (name of product owner)’. - In addition, name and address of the packaging site(s) may be included [if different from the manufacturing/release site(s)

16. Exemptions for smaller labels Primary labels on smaller containers such as a blister strip, an ampoule or vial with a volume of 10 ml or less shall contain the following minimum information. the generic or common name the brand name (where applicable) the strength of the drug lot or Batch number the date of expiry and the name or logo of the manufacturer or the product owner

17. Product Information Leaflet / Package Insert (PI) This should contain the following information Generic or official name of the drug product, the dosage form, and the strength. Net content of the active substance(s). -When an active substance is present as a salt, this should be clearly indicated. Brand or proprietary name, if any. Product Description - a description of the relevant physical and chemical characteristics of the drug product and a description of the appearance of the product ( colour , markings etc.) should be given

18. For products to be reconstituted before use, the appearance before reconstitution should be stated. - If a diluent/ solvent is accompanied with product, a physical description of diluent/solvent should be stated. If applicable, information on pH and osmolarity should be provided

19. For tablets designed with a score line, information on the purpose of the score-line should be given, e.g. ‘the score line only serves to facilitate breaking for ease of swallowing and does not divide the tablet into equal half-doses’, or ‘the tablet can be divided into equal halves.

20. Excipients contained in the product, of which the knowledge of presence is important for the safe and effective use of the medicinal product. (e.g. preservatives, colourants , antioxidants etc.)

21. Pharmacodynamics/Pharmacokinetics – information to be mentioned in this section include: Mechanism of action of each drug substance Pharmacokinetic properties of each drug substance Clinical trial information relating to clinical efficacy and safety; and Relevant pharmacogenetic information from clinical studies with data showing a difference in benefit or risk to a particular genotype or phenotype

22. Indication and usage – the therapeutic indication(s) of the product Dosage and administration – the information required include, as appropriate: A concise summary of the recommended dosage regimen (e.g., starting dose, dose range, titration regimens, route of administration) Critical differences among population subsets Information on dose adjustments in special populations, e.g. elderly, children, renal insufficiency, hepatic insufficiency and other concomitant diseases and therapies

23. -Maximum recommended/tolerated daily dose and the maximum dose for an entire course of therapy; Monitoring requirements: advices relevant for dosage adjustment from monitoring of clinical symptoms and signs and/or laboratory investigations, when appropriate. Other pertinent information, such as relationship to meals and compatibility with other drugs and fluids

24. Method/Route of Administration only standard abbreviations should be used. Contraindications - situations where patients should never or generally not be treated with the medicine. Warnings and Precautions - circumstances where caution is required to ensure the safe and efficacious use of the product. Mention if appropriate, possible effects on the ability to drive vehicles or operate machinery

25. Interactions - forms of interactions with other medicines and other forms of interaction (e.g. with alcohol, food varieties) with clinical significance. Use during Pregnancy/Lactation Adverse Effects/Undesirable Effects - a description of the adverse reactions under normal use of the medicine and, if necessary, action to be taken by the patient.

26. Overdose and Treatment – - symptoms, signs and recommended treatment of overdose or accidental poisoning. Method of preparation – if applicable, the complete method of reconstitution or dilution should be stated.

27. Storage Conditions Shelf Life -The information on in-use shelf-life after dilution or reconstitution or first opening should be provided (if applicable) Available pack size(s) The name and address of the manufacturer, batch releaser or product owner. The date on which the leaflet was last revised

28. Patient Information Leaflet The patient information leaflet shall contain the following particulars: Name of the medicine (generic and brand if applicable), dosage form, strength, net content of active ingredient(s), details of certain excipients such as preservatives and colourants and a description of the appearance of the product

29. Any specific age groups for which the medicine is intended to, if applicable What is this medicine used for How much and how often should the medicine be taken, and how long the course of treatment will last? Any other specific directions about how to use the medicine Symptoms of serious or frequent possible adverse effects/undesirable effects and what to do if such effect is experienced When this medicine should not be used? What other medicines or food should be avoided while taking this medicine

30. What should be done, if a dose is missed? Any risks to the mother and the fetus or the infant from the use of the medicine during pregnancy or breast-feeding. Information for any other special groups of patients, if applicable Any other precautions that should be taken while taking this medicine Signs and symptoms of overdose and what to do if more than the recommended dose has been taken How should the medicine be stored?

31. Information on in-use shelf-life after dilution, reconstitution, or first opening, if applicable General advices e.g. ‘keep away from children’, as decided by the Authority The name and address of the manufacturing site The name and address of the marketing authorization holder

32. Dispensing Labels When a prescription medicine or an over the counter medicine is dispensed to the patient, a dispensing label giving specific instructions on its usage shall be fixed to the packaging of the medicine. If the dispensing label is fixed to the original commercial pack, it should not obscure important information on the original label. When a medicine has to be prepared or taken out of the original pack, the dispensing label shall be fixed on an envelope or on a suitable container used for packaging the medicine.

33. The following particulars shall be included on the dispensing label. Name of the patient Name of the medicine (generic and brand) The dose, frequency of administration Other specific directions for use, if any (e.g. before or after meals) Quantity of the medicine dispensed The name/address of the pharmacy, hospital or clinic Name and signature of the pharmacist, the medical practitioner or the dentist Medicines for external application should be labelled : “ FOR EXTERNAL USE ONLY”

34. Pharmaceutical packaging Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification , information, convenience ,compliance , integrity and stability of the product

35. Purposes for packaging Product Identification :- Packaging greatly helps in identification of products. Product Protection :- Packaging protects the contents of a product from spoilage, breakage, leakage, etc. Facilitating the use of product :- Packaging should be convenience to open, handle and use for the consumers. Product Promotion :- Packaging is also used for promotional and attracting the attention of the people while purchasing.

36. Types of packaging Primary packaging - is the material that first envelops the product and holds it. -This usually is the smallest unit of distribution or use. Ex. Aerosol spray can, blister packs, bottle Secondary packaging - Is outside the primary packaging perhaps used to group primary package together. Ex. Boxes, cartons

37. Types of packaging cont’d Tertiary packaging- is used to bulk handling and shipping. Ex. Barrel, container, edge protector

38. Packaging materials used for pharmaceutical products Glass Plastics Rubbers Paper/card boards Metals

39. THE CHOICE OF PACKAGING MATERIAL WILL DEPEND UPON: The degree of protection required Compatibility with the dosage form Customer convenience e.g. size, weight of dosage form Filling method Sterilization method to be employed and cost

40. Glass Glass has been widely used as a drug packaging material Advantages The y are transparent. They have good protection power. They can be easily labelled . Economical Variety of sizes Disadvantages Glass is fragile so easily broken. Release alkali to aqueous preparation

41. Plastics Plastics may be defined as any group of substances, of natural or synthetic origins, consisting chiefly of polymers of high molecular weight that can be molded into a shape or form by heat and pressure. Advantages Less weight than glass , flexible Variety of sizes and shapes Essentially chemically inert, strong, rigid Safety use, high quality, various designs Extremely resistant to breakage Disadvantages Absorption permeable to moisture

42. Metals Metals are used for construction of containers. The metals commonly used for this purpose are aluminium ,tin plated steel, stainless steel, tin and lead Advantages They are impermeable to light, moisture and gases. They are made into rigid unbreakable containers by impact extrusion. They are light in weight compared to glass containers. Labels can printed directly on to their surface. Disadvantages They are expensive. They react with certain chemicals

43. Rubber Rubber is used mainly for the construction of closure meant for vials, transfusion fluid bottles, dropping bottles and as washers in many other types of product. Advantages Water absorption is very low. They are relatively cheaper compared to other synthetic rubbers. Disadvantages Slow decomposition takes place above 130 ▫ C. Oil and solvent resistance is not very good.

44. Tamper resistant packaging Tamper resistant packaging is one having an indicator to entry in which, if missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. FDA approves the following configurations as tamper resistant packaging Film wrappers Blister package Strip package Bubble pack Shrink seals, and bands Oil Paper plastic pouches Bottle seals Tape seals Breakable caps Aerosol containers

45. Film wraper Film wrapping has been used extensively over the years for products requiring package integrity or environmental protection.

46. Blister package Blister package provides excellent environmental protection, and efficacious appearance. It also provides user functionality in terms of convenience and resistance and tamper resistance

47. Strip package A strip package is a form of unit dose packaging that is commonly used for the packaging of tablets and capsule A strip package is formed by feeding two webs of a heat sealable flexible through heated crimping roller . Different packaging materials used are paper/polyethylene/foil/PVC.

48. Closures- Bottle seals A bottle may be made tamper resistant by bonding and inner seal to the rim of the bottle in such a way that the product can only be attained by destroying the seal . Tape seals It involves the application of glued or pressure sensitive tape or label around or over the closure of the package which is to be destroyed to obtain the product. The paper used must often be a high density light weight paper with poor tear strength

49. Breakable caps Breakable closures come in many different designs. The roll-on cap design of aluminum shell used for carbonated beverages. T h e bottom portion of the cap is rolled around the bottle neck finish. T h e lower portion of the cap blank is usually perforated to breaks away when the cap is unscrewed. The bottom portion of the closure has a tear away strip

50. Unit dose packaging This is the packaging of individual doses of medicine in containers which preserve the identity and integrity from the point of packaging to the point of administration The ordered amount of medicine will be in a dosage form ready for administration to a particular patient, by the prescribed route of administration at the prescribed time and properly labelled with the name, strength and expiration of the product

51. Original pack dispensing Discuss with the class and differentiate from unit dose packaging

52. Storage of pharmaceuticals Routine storeroom management tasks DAILY/ WEEKLY Monitor storage conditions Record temperatures for cold chain medicines Clean bins, shelves and cupboards if necessary Ensure adequate ventilation and cooling Ensure that products are protected from direct sunlight Monitor product quality Update stock records and maintain files Separate expired stocks and move to secure area

53. Monthly Update stockcard Conduct physical inventory or cycle count Inspect the storage structure for damage, including the walls, floors, roof, windows and doors

54. Quartely Conduct physical inventory or cycle count and update stock keeping records Use established procedures to disposed of expired or damaged products Visually inspect fire extinguishers to ensure that pressures are maintained and extinguishers are ready for use Complete and submit requisition forms Store products according to correct procedures, rearrange commodities to facilitate the first expiry, first out (FEFO) policy

55. Every 6 months Inspect trees near the medical store and cut down or trim any trees with weak branches Prepare schedule for detecting insects and rodents

56. Storeroom arrangement and storage If using pellets, stack cartons on pellets: At least 10cm off the floor At least 30cm away from the walls and other stacks Not more than 2.5m high

57. Cont’d For other products Place liquid products on the lower shelves or on bottom of stacks Store all products in a manner that facilitates FEFO policy for stock management. Always place products that will expire first in front Separate damaged or expired products from usable stock without delay Arrange cartoons so that arrows point up and identification labels, expiry dates and manufacturing dates should be visible

58. Special storage conditions Narcotic drugs Eg morphine, opium preparations, codein Should be stored in a lockable cupboard

59. Monitoring product quality Products of different types show damage in different ways. Indicators used to indicate damage are as follows

60. All products Broken or ripped packaging (vials, bottles, boxes etc ) Liquids Discolouration Cloudiness Broken seal on bottle Cracks in ampoule, bottle or vial Moisture in packaging

61. Injectables Liquid does not return to suspension after shaking Latex products Dry Brittle cracked

62. Foil packs Perforation in packaging Capsules Discolouration Stickiness Crushed

63. Tablets Discolouration Crumbed pills Stickiness Unusual smell Tubes Sticky tubes Leaky contents Perforations or holes in the tube

64. Store frozen: products such as vaccines need to be transported within a cold chain at –degrees celcius some products are heat sensitive but must not be frozen They should be stored at 2 to 8 degrees celcius Keep cool : store between 8 to 15 degrees celcius Store at room temperature : store at 15 to 25 degrees celcius Store at ambient temperature : store at surrounding temperature