Prescription Drug Development & Regulation PDF

PREPARED BY: Reysan S. Cosas What is a Prescripti on @Itrepresents a summary of da i gnoss i, prognosis, and treatment of patient’s illness. Prescripti on @An order for medication written by a physician, dentist or other licensed medical practitioner...

PREPARED BY: Reysan S. Cosas What is a Prescripti on @Itrepresents a summary of da i gnoss i, prognosis, and treatment of patient’s illness. Prescripti on @An order for medication written by a physician, dentist or other licensed medical practitioner and given to the patient for presentation to the pharmacist Legal Concepts of Prescription Doctrine of Informed Consent The patient must be aware of the procedures to perform, other alternatives, pro and cons of procedure, adverse reactions and benefits they will receive before patients will make informed decision Doctrine of Respondeat Superior or “Letr eanswer” the t s am The superior is responsible for actionsd etm o tcm by i subordinates. Minors and Incompetent in Medical decsoin making Minors and incompetent are required the n o m fired consent of a What are the Parts of a Prescriber’s Information  It usually contains the name of the physician or dentist, his specialty, clinic address, contact number and clinic hours Patient’s Information  It contains pertinent information about the patient such as the name, address, sex, age and weight and sometimes BSA Dat e  Prescriptions are datedat the m ite they are written and also when they are received and filled in the pharmacy. Superscription  The Rx symbol is a Latin verb “recipe” meaning “take thou” or “you take”  Historians believed that this symbol originated from the sign of Jupiter employed by ancients in requesting aid for healing Inscription The medication prescribed Itis the body or principal part of the prescription order Subscription  Dispensing directions to the pharmacist  It contains directions to the pharmacist for preparing and labeling the prescription  It usuallycontainsthe q y u tan it of the medication to be dispensed Transcription  Directions for the patients  It is also known as “signature” or “sg i na” meaning “mark thou” or “let it be labeled”  The instructions are usually written using abbreviated forms of English or Latin terms Refill Information  **If refill information is not supp e ild, it is generally assumed that no refills are authorized Prescriber’s Signature and License Numbers  It contains the signature of the pe rsc b rier as well as the doctor’s license number to practice his profession, PTR number, and sometimes S2 number 11 4 1 /5 Summary of Classification of Medication based on Nonprescription drugs  Are pharmaceutical products or drug preparations that can be dispensed even without the written order of a validly registered licensed physician, dentist or veterinarian, for the use of consumers for the prevention or symptomatic relief of minor or self- limiting ailments Nonprescription drugs Simpler and safer drugs may bed etek m ra for sale without a prescription Prescription drugs  Are pharmaceutical products or drug preparations that are to be dispensed only upon written order of a validly registered physician, dentist or veterinarian for the management or treatment of a condition or disease. Prescription drugs Are drugs that are deemed to require oc m e xp l directions regarding their use They can be purchased onlyhtw i a prescriber’s direction (the prescription) Dangerous drugs  Are pharmaceutical products referring to either prohibited or regulated drugs which require a special prescription form usually obtained from the Dangerous Drugs Board. Dangerous drugs Are drugs that are considered to have ca g n sfi iti potential for illicit use (due to addiction liability and other reasons) Ranking based on their perceived social danger Schedule I – banned from prescription or anh y g ti other than research use Schedule II – includestrongly g nitcid a drugs that nevertheless have important medical uses Schedule III to Schedule V – drugs that are progressively less addicting Comparison of the 3 drugs in terms of prescription requirement DRUG OTC Rx DRUG Dangerous drug Prescription requre id none Ordinary Yellow prescription prescription Number of copies none One RPh, MD, & patient Ways of identifying No Rx sign With Rx sign land anolabel i t id da With Rx sign land anolabel i t id da requiring prescription requiring prescription and List A Recording required No Prescription book Dangerous drug book Filing of prescrp i to in No 2 years 1 year Note: for poison drug – the prescription should be kept for 5 years and recorded in poison book. 28