Tiêu đề 11. PATIENT INFORMATION LEAFLETS.pdf ✅

PHARMD GURU Page 1 INTRODUCTION: Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal product's properties and the conditions attached to its use. It contains everything you need to know about your medicine. For example:  what the medicine is intended for  how you should use the medicine  when you should not use the medicine  when caution is advised  which adverse events are possible  which ingredients the medicine contains GUIDELINES BEFORE YOU START TAKING THE MEDICINE:  Read the entire leaflet carefully.  Keep this leaflet. You may need to read it again.  If you have any further questions, ask your health care provider.  This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.  If any of the side effects becomes serious or if you notice any side effects not listed in this leaflet. Please tell your health care prodder. CONTENT: 1) IDENTIFICATION OF THE MEDICINE: The name of the medicine, the active substance(s), the pharmaceutical form and the strength of the product should be stated. 2) THERAPEUTIC INDICATIONS:  The conditions for which the medicine is authorized must be listed.  The section should include any benefit information considered appropriate. PATIENT INFORMATION LEAFLETS
PHARMD GURU Page 2 3) INFORMATION NECESSARY BEFORE TAKING THE MEDICINE: Situations where the medicine should not be used, any precautions, warnings, interactions with other medicines or foods, information for special group of patients (pregnant or nursing mothers) and any effects the medicine may have on the patient's ability to drive. 4) DOSAGE:  How to take or use the medicine, including both the route and method of administration.  How often it should be given.  How long the course of treatment will last. 5) DESCRIPTION OF SIDE EFFECTS: All the effects which may occur under normal use of the medicine and what action the patient should take if any of these occur. They should be listed by seriousness and then by frequency 6) ADDITIONAL INFORMATION: This covers information on excipient detail, a description of the product, registered pack sizes, storage conditions, name and address of the manufacturer. LAYOUT AND DESIGN GUIDELINES:  Appropriate Layout and Design of a leaflet improves the patient's acceptance. Many guidelines were published to show model information leaflets.  In 1990, Kitching recommended the following guidelines for content and layout to prepare a patient information leaflet with good acceptance by reader.  Line in a PIL should be 50-89 mm long.  There should be a 2.5mm separation between two lines.  Unjustified lines are easier to read.  Serif type of letter face is easy to read.  Letter type should be of at least 12 points.  Indenting the first line of a paragraph increases reading speed.  Titles all in capitals are harder to read than lower cases.  Italics impair comprehension.  Points should be positive rather than negative.
PHARMD GURU Page 3  Headings should stand out in a different type or extra space.  Arabic numerals (1,2) are easier than roman (I, II etc).  Numbers are easier as numerals - ‘9' is easier than ‘nine'.  Highlighting by color or boxing is not helpful.  Pictures are helpful for complex maneuvers (E.g., Inserting suppositories or eye drops) but others may distract.  Basara and Juergens scored leaflets for print size, graphics, color printing, amount of white space and paper quality.  Baker Able also developed useful guidelines for the layout and design of leaflet similar to Kitching.  Baker Able also stressed on length of line (50- 80mm) separation between lines, (>2.8mm) unjustification of lines, Serif type face, type size (>12 point) indenting of first line, lower case titles, words in italics, (0-3 words) positive advice, standard headings, numbers in Arabic, boxed tent (0-1 Box).  Apart from these specifications, Baker Able added three more important criteria in the design of leaflet. They are:  Number of colors used, (4 Colors)  Amount of white space (% of page area. Ex: Cm2 , >40%) and  Paper quality (>90 gsm).  Baker Able Leaflet Design (BALD) criteria is used commonly to assess the layout and design of various patient package inserts (PPI). ADVISORY LABELS: 1. MEDICATION SPECIFIC LABELS:  Usage Instructions: Clear instructions on how to use the medication.  Dosage: Exact dosage information.  Warnings: Specific warnings about usage or interactions. 2. EMERGENCY CONTACT LABELS:  Emergency Instructions: What to do in case of a severe reaction.  Contact Numbers: For immediate medical help or support.
PHARMD GURU Page 4 3. STORAGE AND DISPOSAL LABELS:  Storage Conditions: Temperature, light, and moisture requirements.  Disposal Instructions: Safe disposal methods for unused or expired medication. Example of Consumer Medicine Information (CMI) leaflet: