Ethics of Pharmacy PDF

3 Ethics of Pharmacy Code of Ethics ❖ This code states the principles, fundamental roles and responsibilities of pharmacists. The principles are: ❖ Pharmacists respect the relationship between the patient and pharmacist, and this occurs by:...

3 Ethics of Pharmacy Code of Ethics ❖ This code states the principles, fundamental roles and responsibilities of pharmacists. The principles are: ❖ Pharmacists respect the relationship between the patient and pharmacist, and this occurs by: ▪ Pharmacists must maintain knowledge. ▪ The pharmacist asks for consultation from colleagues. ❖ Pharmacists respect the autonomy and dignity of each patient. ▪ Autonomy: The pharmacist promotes the rights of self-determination by encouraging patients to participate in decisions about their health. ▪ Dignity: The pharmacist respects personal and cultural differences among patients. 22  Organizations ❖ Pharmacists must maintain and develop good pharmaceutical practices by working with national and international organizations. ✓ International organizations ❖ World Health Organization (W.H.O): It is responsible for health care all over the world. ❖ Food and Drug Administration (F.D.A.): It is responsible for the quality of food and drug in the U.S.A ❖ United Nations Division of Narcotic Drugs (UNND)) responsible for the regulations concerning the use and abuse of narcotic drugs. Role of international organizations ❖ Development of protocols & methodologies ❖ Development of materials & magazines ❖ Exchange of information & experiences ❖ Research for evaluations of medications 23 ✓ National organizations 1- Syndicate of pharmacist's ▪ Responsible for the profession of pharmacy and the welfare of pharmacists in Egypt. 2- Egyptian Pharmaceutical Society ▪ Its activities are educational: for continuing education. ▪ Issues a scientific Journal in pharmaceutical sciences. ▪ Hold conferences every two years for pharmacists. 3- Egyptian Society of Hospital Pharmacists ▪ Concerned with all aspects of hospital & clinical pharmacists. 4- National Pharmacopoeia Committee ▪ Responsible for reviewing & updating the Egyptian pharmacopoeia. 24  Information Resources in Pharmacy ❖ Types: Primary literature, Secondary literature & Special information ❖ Resources: library, internet 1- Primary literature ❖ Scientific journals in which research are published in the following manner: Abstract or Summary Introduction Description of the methodology used and results. Discussion of results List of references Examples of Scientific Journals ▪ Journal of Pharmaceutical Sciences ▪ International Journal of Pharmaceutics ▪ Pharmaceutical Research ▪ Journal of pharmacy & pharmacology ▪ Journal of Drug Development & Industrial Pharmacy 25 2- Secondary Literature A. Review Article. B. Textbooks: 26 3- Special Information's a. Pharmacopeias b. Formulary c. Drug Compendia A. Pharmacopoeias ❖ Pharmacopoeias are issued by governments or international agencies. ❖ The world's best-known national Pharmacopoeia: United States Pharmacopeias/National Formulary (USP/NF) 27  o The U.S.P. contains monographs on drugs & other substances. o NF contains monographs on excipients used in pharmaceutical preparations. British pharmacopoeia (B.P): Martindale, The Extra Pharmacopoeia: o It is not a true pharmacopeia but one of the preeminent drug information compendia. It contains information on drugs and medicines from around the world. B. Formularies ❖ They are a list of drugs approved for use by special hospitals or governments. ❖ FDA produces approved drug products with therapeutic equivalence evaluations, an annual publication that is popularly called the Orange Book. 28 C. Drug Compendia ❖ References contain information on the therapeutic use of drugs, dosage, contraindications, adverse effects, and pharmacokinetics of drugs. ❖ e.g. – ▪ Physician's Desk Reference (PDR) ▪ American Hospital Formulary Service (AHFS) ▪ Handbook of non-prescription products. 29  Pharmaceutical Dosage Form Good Dispensing Practice A) Proper labeling 1-Name of drug 2-Strength 3-Manufacturer name and address 4-Registry number 5- Manufacturing date 6-Expiry date 51 B) Proper Storage 1- Use amber glass bottles for light-sensitive drugs such as Acyclovir, Atenolol, Beperidil, and Claforan. 2- Use the refrigerator for heat-sensitive drugs such as Thorazine, Cognitin and Desipramine. 3- Use air-tight containers for oxygen-sensitive drugs such as Amiodarone, Bleomycin, and Cordaron. 4- Use adsorbents for hydrolysable drugs such as Acetaminophen, Amiodarone, Chlorpromazine, and Clonidine. Good Dispensing Environment ✓ Dispensing environments must be clean because most medicinal products are for internal use, making it important that they be hygienic and uncontaminated. ✓ The environment must also be organized so that dispensing can be performed accurately and efficiently. The dispensing environment includes: Staff Physical surroundings Shelving and storage areas Surfaces used during work 52  Equipment and packaging materials Good Dispensing Person The dispenser must be: Organized, Knowledgeable, Trained, Honest and Communicative Factors Affecting Drug Dosage Forms 1. Pharmacodynamics Factors Therapeutic objective Toxic effects Adverse effect 53  Therapeutic objective influences the design of the drug product, route of drug administration, dose, dosage regimen, and manufacturing process. Examples: An oral drug used in the treatment of an acute condition is generally formulated to achieve rapid release of the drug and to show rapid onset of action. If more rapid drug absorption is desired, an injectable drug formulation might be formulated. 2. Drug Factors Particle size Smaller particle size -- greater surface area -- higher dissolution rate – better absorption 54  pH profile ❖ The basic drug is more soluble in an acidic medium, forming a soluble salt. ❖ The acidic drug is more soluble in the intestine, forming a soluble salt at a more alkaline pH. ❖ Many drugs are stable between pH 4 and 8 Polymorphism ❖ Polymorph: presence of the drug in more than one crystalline form. ❖ Amorphous drug (non-crystalline form). 55  Hygroscopicity Partition coefficient (k) ❖ (k = concentration of drug in organic phase/ concentration of drug in the aqueous phase) Excipient interaction ❖ Should be inert. ❖ Affect the dissolution properties of the drug. 56  Solubility ❖ Higher dissolution rate – better absorption 3. Drug product Factors Pharmacokinetics of drug ❖ (Absorption-Distribution-Metabolism-Elimination) Bioavailability consideration ❖ Rate: The amount or rate of drug absorption from the given dosage form. S.E. 57  ❖ Duration: how long does the drug present in the bloodstream Route of administration The desired dose of the drug ❖ Optimal dosage that gives desired effect with minimum side effects Dosing frequency ❖ Many potent drugs have cumulative action. ❖ If the frequency is too high, toxicity may occur even if the individual dose is safe, e.g., digoxin. ❖ In case of an overdose, the pharmacist should consult the physician. ❖ In certain cases, only the physician can know about the safety of the dose, e.g.: - A nervous person needs a higher dose of sedatives. - In severe pain, large doses of narcotics are used. 4. Patient Factors Acceptability & Compliance of drug product Cost 58 5. Manufacturing Factors Cost Availability of raw materials Stability QC 59  Routes of Administration ✓ A drug is defined as an agent intended for use in the diagnosis, treatment, cure, or prevention of disease in humans or other animals. ✓ After administration of a drug, a successful therapeutic response will be achieved if the drug reaches the suitable site of action or "receptor" site in sufficient concentration to exert its pharmacological action. ✓ A successful therapeutic response is achieved by the drug being absorbed into the body tissues from the site of administration. ✓ The choice of administration site depends on different factors, such as whether a local or systemic action is required or how quickly a response to the drug is needed. 60 1. The oral route: ❖ The oral route is used to obtain either systemic or local effects. ❖ The drug formulated in either solid or liquid form is absorbed from the gastrointestinal tract. ❖ It is the most used route for drug administration. Advantages of the oral route: ❖ It is the simplest route of administration. ❖ Self-administration of drugs can be carried out. ❖ It is the safest route of administration. Disadvantages of the oral route: ❖ The onset of action is relatively slow. ❖ Absorption from G.I.T. may be irregular. ❖ Certain drugs are destroyed by enzymes and other secretions found in G.I.T. 61  ❖ Slow gastric emptying drug inactivation by prolonged contact with gastric juices, especially in elderly peoples ❖ It is an unsuitable route for unconscious or vomiting patients. 2. The buccal route: ❖ A drug administered by the buccal route is formulated as a tablet. ❖ The high vascularity of the tongue and buccal cavity and the presence of saliva facilitate the dissolution of the drug, making this route highly effective. ❖ The tablets formulated for the buccal route give a quick onset of action. Advantages: ❖ Relatively quick onset of action ❖ Drugs are absorbed directly into the systemic circulation, avoiding the first-pass effect. ❖ Drugs can be administered to unconscious patients. ❖ Antiemetic drugs can be given by this route. 62 3. The sublingual route ❖ The sublingual route is used for sublingual absorption, where the area under the tongue is used. ❖ The sublingual route gives a very fast onset of action, but the duration is usually short. 4. The Rectal route 63  ❖ For administration by the Rectal route, drugs are formulated as liquids (enemas), solid dosage forms (suppositories), and semisolids (creams – ointments). ❖ The rectal route is used for both systemic and local effects. Advantages: ❖ It can be used when the oral route is unsuitable, e.g., vomiting, unconscious patient, elderly, or mentally disturbed patients. ❖ Useful when the drug causes G.I.T. irritation ❖ It can be used for local action. Disadvantage ❖ Absorption can be an irregular variable effect. ❖ It is less convenient than the oral route. ❖ Low patient acceptability 5. The Inhalation Route 64  ❖ In the Inhalation route, drugs are inhaled through the nose or mouth to produce either local or systemic effects. ❖ The inhalation route is used mainly to treat respiratory conditions; therefore, drugs here are delivered to the site of action lungs. ❖ Because of the large surface area, rapid drug absorption will be achieved. Advantages ❖ The drug dose required to produce a systemic effect is much smaller than for the oral route. ❖ Reduction in side effects 6. The Topical route: 65  ❖ This means that the skin is used as the site of administration. ❖ The Topical route is mainly used for local effects. ❖ The formulations used include ointments, Creams, pastes (semisolids), and lotions (liquids) The transdermal route gives systemic effects: absorbed into the systemic circulation, avoiding hepatic portal circulation. E.g., Glyceryl trinitrate in angina The topical route gives local effects applied to the skin, the cornea of the eye, the nasal, rectal, vaginal, or urethral mucosa. E.g., antiseptics, antifungal, anti-inflammatory. 7. Parenteral Route: ❖ Drugs may be administered into the circulation by IM, IV, Subcutaneous ❖ Used only when: ✓ Unconscious or vomiting patients ✓ Drugs cannot be given by oral route ✓ Rapid absorption in emergency 66 8. Intra nasal route: 67 68  Bioavailability ❖ Bioavailability is the fraction of the administered dose of the drug that reaches the systemic circulation. ❖ When a medication is administered intravenously, bioavailability is 100%; in other routes (such as orally), its bioavailability generally decreases. This is due to: ✓ incomplete absorption ✓ first-pass metabolism 69