Patient Package Insert and PPL CMT.pptx

PPI & PPL CMT.pptx

1. Community Pharmacy & Management Chapter - Patient Counselling By Mr. Dheeraj D.Chechare Lecturer PRES’s College of Pharmacy (D & B.Pharm )

2. DEFINITION Patient Package insert is a small document which is provided with package of medication and is approved by the administrative licensing authority it is also called as prescription drug label or prescribing information. it mainly delivered the information of safe and effective use of the medications.

3. Importance and benefits of PPIs Patient package inserts similar to patient information leaflets and it address issues that are precise to particular drugs. It contain FDA approved information and help patients to use the medication safely and effectively. It also help the patients to avoid serious adverse effects. Patient also get aware about way of dosage form administration.

4. Sections of the PPI The USFDA's new prescribing information format follows "physician labeling rule" format The old one was "non-physician labeling rule" format. In India, package insert is governed by the 'D&C Act 1940 and Rules 1945 under Section 6 of Schedule D (II) of the Rules 1945 with the Section 6.2 and Section 6.3. The PPIs varies from country to country keeping main focus on important information for physicians, other healthcare providers and patients. In general, PPI lists following information in it.

5. 1) Description: It includes the proprietary name (if any), nonproprietary name, dosage form , qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information of medication. 2 ) Clinical Pharmacology: This section provides information on working mechanism of medication in the body including, how it is absorbed and eliminated, and its likely effects at various concentrations. It may also contain findings of various clinical trials and/or explanations of the medication's effect on various populations, for example. children and women . 3 ) Indications and Usage: It includes uses for which the drug has been approved, for example, asthma hypertension, diabetes. Doctors legally can and often do prescribe for purposes not listed in this section, called medicines off-label uses

6. 4) Contraindications: It lists conditions in which the medication should not be used. for example, in patients with other medical conditions such as kidney dysfunctioning , allergies, morbidities, etc . 5 ) Warnings: It emphasizes on possible serious side effects that may occur and is usually presented in a box called boxed warning. 6) Precautions: This section gives information and guidelines for safe use of medication including potential physical impairments and drug interactions; for example "Take this medication on empty stomach" or "Too much insulin can cause low blood sugar"

7. 7 ) Adverse Reactions: This section lists all side effects observed in all studies of the drug in specific populations . 8 ) Nonclinical Toxicology: It provides information about carcinogenesis, mutagenesis, impairment of fertility, animal toxicology and/or pharmacology. 9 ) Drug Abuse and Dependence: It provides information regarding whether prolonged use of the medication can cause physical dependence, if applicable . 10 ) Overdosage : It gives the results of an overdose and provides recommended action in such cases.  

8. 11) Dosage and Administration: It specifies recommended dosage(s), may list more than one for different conditions or different patients, for example, lower dosages for children. (12) Dosage Form and Strength: It gives information about the dosage form, strength, unit in which the dosage form is ordinarily available and National Drug Code (NDC). (13) Storage and Handling: This section presents handling guidelines and special storage conditions, for example, "Keep container well closed" or "Store between 20 and 25°C" or "Store below 8°C.

9. 14) Name and Address of Manufacturer: Corresponding details. 15) Name and Address of Marketing Authorization Holder: Corresponding details. 16) Date of Revision of Package Insert: It provides a date on which contents are revised. 17) References: This section lists various print and digital resources such regulatory agencies websites, journals, compendia, etc., used to assemble information presented in PPI.

10. Required PPI Voluntary PPI It is mandatory and must be provided with medication package. It is not mandatory but manufacturer may provide it. The content and format is covered by regulations. The content and format not covered regulations. Manufactures are required to provide to dispensers and dispensers are provide to dispensers and dispensers are required to provide with each prescription while dispensed. Manufactures are not required to provide to dispensers and dispensers are not required to provide with each prescription while dispensed. E.g . oral contraceptives, estrogen ,  phenytoin , ampicillin , etc. require PPI E.g. when manufacture thinks it necessary then PPI may be provide with his products.

11. Patient Information Leaflet (PIL) Patient information leaflets (PILs) are leaflets containing specific information about medical conditions, doses, side effects that packed with medicines to give the user information about the product. PIL is the European version of the Package insert. The PIL is written by the manufacturing pharmaceutical company. All licensed medicines need to carry such a leaflet. But to minimize the cost, manufacturers avoid inserting a PIL.

12. Patient information leaflets contain following information : 1) Which active pharmaceutical ingredients the medicine contains? 2) Which adverse effects are possible? 3) When and what caution is advised? 4) When you should not use the medicine? 5) How you should use the medicine? 6) What the medicine is intended for?

13. Uses of patient information leaflets 1) PIL gives and a chance to patient to participate in their own care. 2 ) Patient can take informed decision if required by understanding diagnosis, treatment or prediction with more clarity. 3 ) Patient gain more knowledge if pharmacist and physician don't have sufficient time for counselling. 4 ) It educate the patients with increasing their satisfaction with their treatment. 5 ) Patient awareness of the benefits and side effects of their prescribed medication increase much more after reading the leaflets. 6 ) Through Patient information leaflets patient can aware about how to used a erosol and even about dosage form as suppositories and ways of insertion of suppositories .

14. Content of Patient information leaflets 1 ) Identification of medicines : The name, the active substance (s), the pharmaceutical dosage form, strength of the product should be mentioned on leaflets. 2 ) Therapeutic indications : The condition for which medication prescribed should be listed. 3 ) Information required before administration : Conditions in which the medicine should not be used. It also contain information about any precautions, warnings, interactions with other medicines or foods, information for special groups of patients specially for pregnant or nursing mothers, and also any effects or precautions the patient should take while driving .

15. 4) Detailed discussion of side effects : It gives detailed discussion about normal use of medicines and what action is necessary if any side effect persists. 5) Additional information : 1ges information about excipients, description of product, package size. storage condition with name and address of manufactures.