ORIENTATION TEAM Lecture 4 /Clinical2020CU Clinical Pharmacy Cairo University 2014/2015 1 Continue chapter 6.... *How to Calculation Child's Dose ? -In Relation to the normal adult dose according to child's: 1- Child age 2- Body weight 3- Body Surface area * Based on age : - Fried's rule : *For infant younger than 2 years ( <2 ) *Infant can tolerate the usual adult dose when he reaches the age of 150 months ( 12.5 years ) # Rule : Infant's dose = (Age in months \ 150 )x adult dose - Young's Rule : *for children 2 years and older ( 2 or more) #rule : Child's dose =]age in years \ (Age in years +12 )[x Adult dose *Based on Body weight : Clark's rule : -IN Kilograms : Child's dose = ]weight in Kg \ 70 [x Adult dose -IN Pounds : Child's dose = ]weight in lb \150 [x adult dose *Based on Body surface Area ( BSA): - Child's dose = ]BSA in m^2 /1.7 [x adult dose *Remember the 10 steps of Handling the prescription from the last lecture: 1. Receiving the prescription 2. Reading and checking the prescription 3. Numbering and dating the prescription 4. Preparing the prescription 5. Packing the prepared prescription 6. Labeling the packed prescription 7. Rechecking the prescription 8. Delivering the prescription 2 9. Recording and filling the prescription 10. Pricing the prescription 3] NUMBERING AND DATING THE PRESCRIPTION -Each received prescription must be Given: * A Number ( why?) To identify the dispensed Drug * Date : when the prescription was dispensed WHY ? >> to detect the delay in receiving the treatment for narcotic prescription 4] PREPARING THE PRESCRIPTION For prescriptions containing prefabricated drugs: 1-Check the product's name * on Label & *on prescription 2- Notice the expiration date 3- Notice the appearance of the dispensed products : a- any sign of poor manufacture b- deterioration c-defect FOR Prescriptions that need pharmaceutical compounding: >> Before compounding : 1- Check Drug –Drug Incompitability 2- Check the required mathematical calculations 3- the proper order of mixing to be used 4- the need for special technique of compounding 5- the need for special adjuvant >> While Compounding : 1- All required ingredients ( including additives ) are collected in certain location on the compounding counter 2- Each weighed (4 solids ) or Measured ( for Liquids ) ingredients is transferred to another place >> After Compounding : Used chemicals are returned back on the shelves 3 The labels are checked 3 times : first : when the containers are removed from the shelves second : Ingredients are weighed or measured third : the containers are returned back on the shelves Technique ensures : 1- no error 2- No missed or double added ingredient 5] PACKAGING THE PRESCRIPTION (this applies for prescriptions that need pharmaceutical compounding ) *Choice of the container: -Packaging a pharmaceutical compounding presc. requires proper selection of the container and the closure . ** Ideal container : ( Light –Water gain –Water loss ) 1- protect from the physical and mechanical hazards 2-Protect from the effect of atmosphere 3-protect from water gain & loss 4- protect from loss of volatile materials 5- protect from light 6- Have pharmaceutically elegant appearance 7- easy labeled 8- convenient for the patient >> Container Selection should be based on : -the Type of Drug = Drug form -the Quantity intended to be dispensed -the method ( route ) of administration **selected container must be suitable for the packed product this includes : -Shape -size -Mouth opening -Color -Composition 4 The Types of Drug Product liquid solid DF DF semi- Molded Parenteral Aerosol solid DF DF DF DF 1]Liquid Drug product Use Oral Low Viscosity Packging (Container ) Prescription bottles High viscosity Oral Drop Wide mouth bottle Dropper bottle Ophthalmic (eye) Nasal dropper Bottle Otic ( Ear) Dropper bottle External (Topical) Ripped bottle Applicator bottle 5 2]Solid Drug product : *Tablets (powder *Capsules Small No. *Round vials large No. *wide mouth bottles *#blister pack ( best package ) Why?? preserve stability Of tabs *wide mouth bottles *In slide box In lid box In hinged *Shifter top containers Bulk powder * Powders divided dose packers *External(topical) زى بودرة التلك 3]Semisolids Drug product هى المواد اللى محتاجة تكون فيها **مميزات الحاجات الصلبة –انها تكون بتفضل ثابتة مكانها على الجلد مثال **مميزات السوائل انها بتسيل على مسافة طويلة او بتوصل الماكن كتييرة )(دا شرح الدكتور Creams *ointments jars Ointments- jells tubes or* collapsible 4]Molded drug form suppositories' Vaginal suppositories hinged lid boxes or slide boxes hinged lid boxes 5]parenteral Drug Form (single use) ampoules-vials (multiple use) vials 6 *Color of the container: - pharmaceutical containers may be : -colorless - Amber –colored --Amber colored containers are useful for Light sensitive products to provide maximum protection against photochemical deterioration Composition of the container : -pharmaceutical containers are mainly made of : -Glass -plastic Advantages : Disadvantages : Glass containers Plastic Containers : -Chemically Inert -relatively Cheap -Easy to be cleaned and sterilized Light in weight -Heavy in weight -Easily Broken Not easily broken - Easily Shaped -May permeate their contents to atmosphere -May permeate Moisture ( leads to hydrolysis of sensitive drugs ) -Oxygen >> lead to oxidation -Not easily sterilized choice of closure: to strict moisture entrance Childproof closures or safety closures Childproof closures reduces the probability for accidental children poisoning or suffocation due to ingestion of medications 7 6] LABELING THE PRESCRIPTION: (USUALLY (ONLY) 4 the prescriptions that need pharmaceutical compounding) >> The label must be Aesthetic - Must be Tidy -Clean - Written in a clear and easy way for the patient to read *Labels : 1- Main Label 2-Auxillary Label *Main Label : >> the label must be Professional-appearing -Must include : -Pharmacy information -Prescriber's Name -Patient's Name -Date of dispensing -Number of the prescription ( WHY? ) 4 identification - Directions of use **example for the main label: Ibn Sina Pharmacy 23 E;-Nasr St. , Dokki tel No. :34455478 Prescriber's name : Dr. Abo el-leil. El-Masry Patient Name : Maha Abd El-Gabar Dispensing Date :18-8-09 Rx No. : 325 The Oral Solution One Teaspoonful three times daily **Color of the Main Label : White label internal use Red label External use 8 *Auxiliary Label : >>For Any Additional Directions : 1- Directions for handling the prescription 2- Proper Conditions of the preparations 3- Important Warnings and precautions 4- Directions for proper use of the preparation ---- Refill Status : 1- State the added Adjuvant 2- State the coloring agents 3- State the flavoring Agents >> To facilitate Refilling >> to facilitate the preparation of the same product again with the same properties **EX: (proper USE of the drug ) Shake well before use (Important Warnings ) Keep in Refrigerator Keep Out of reach of Children May cause Drowsiness Not to be taken by Mouth For external use only ( for proper Use of Preparation ) To be Swallowed with 200 mL Water Dissolve under the tongue To be swallowed as a whole Not to be chewed 9 7] RECHECKING THE PRESCRIPTIONS Every Prescription Should be Rechecked for -The ingredients -Their amounts -The Details of the Label 8] DELIVERING THE PRESCRIPTIONS >>-Pharmacists should Personally present the dispensed Medication to : - Patient or – his care-giver >To Facilitate Patients' counseling >> Items that the Pharmacist Must discuss with the patient or his care giver 1- Information on the drug ( its use & therapeutic effect ) 2-the dosage form 3- The Route of administration 4- Any special directions for use 5- Drug interactions with Food or other Drugs 6- Contra-indications of the Drug 7- Expected Allergic or sensitivity Reactions 8- Proper Storage Conditions 9- What to do if a Dose or more were missed (v. Important ) 9] RECORDING & FILING THE PRESCRIPTION **(FILING مشFILLING ) يعنى احطه فى ملف >> A record of the dispensed prescription : -In a Hard Copy files -on the computer this facilitates the storage and the rapid recall for the information on the dispensed prescription 10] PRICING THE PRESCRIPTION : >> the Charge Applied to a prescription should cover the costs of - the ingredients - Labels & Containers -the Time of the pharmacist & Other personnel involved -reasonable margin of profit 10 * Monitoring the patients Compliance : >>Patients Compliance means : The Adherence of the patient with a the Schedule of the prescribed medications >> The responsibility of the Physician &the pharmacist >> the Direct relation between the pharmacist & patient enables the pharmacist to : - discuss the way to take the prescribed medication s >> Examples of the patient Compliance Problems 1- Patient may Delay the initiation of the therapy 2- The Patient may discontinue the Drug therapy 3- the patient may reduce the dose of the prescribed drug 4- the patient may increase the dose of the prescribed drug 5- the patient may alter the dose &\ or the dose regimen of the prescribed drug 6- the patient may not adhere to the dose regimen ** to increase the patients' compliance >> Some manufacturers designed special drug packs ( containers ) ex : Contraceptive pills (*packed in blisters with the monthly medication cycle printed on it ) Monitoring the drug product : QUALITY *when a defect A REPORT Adverse drug *Reactions discovered , the pharmacist should record: -written by the pharmacist -sent to regulatory agencies -contains : 1- product's name 2-DF , strength , size 3-Manufacture date 4-expiring date & signature 11 Adverse Drug Reactions = side effects -THE PRODUCT should be removed from the market. - If it wasn't completely pure , it occurs when the pharmacist observes serious reactions [He must report the ministry of health ] . N.B: -THE quality the product should comply with the standard of (CGMP) [Current Good Manufacture Practice] -The protocol to establish standards for quality of : raw materials pharmaceutical products pharmaceutical processes The End of chapter 6.. :) Chapter 7 -Roles and responsibilities of the pharmacy..... >> THE PHARMACY : -Drug -Product -Patient DRUG 1]industry-centered responsibilities PRODUCT 2]quality drug supplier resp. PATIENT 1]Industry-centered resp. : 1. Apply hi-tech pharmaceutical techniques 2. Ensure efficacy , safety of new products (post-marketing surveillance ) 3. Clinical trials 4. Ensure quality of drug products (quality control - CGMP ) 5. Improve the drug products : -efficacy , safety , cost BY: -New manufacturing techniques -New dosage form -proper additives 6. Generating resources for research 7. Providing expert , experienced human resources 8. Collaborate to avail innovative ideas 9. Provide institutes with the latest know-how 12 2] quality drug supplier resp. : 1. Ensure that drug product is of good quality 2. Ensure that drug product is from a reputable source 3. Ensure proper storage conditions for raw materials and drug products . Patient-oriented resp. of pharmacists : -Patient requires (health care team ) >> physician - nurse - pharmacist -In pharmacy profession , the pharmacist has : Drug oriented >> roles and resp. Patient oriented >> roles and resp. *THE PHARMACIST : -Discusses medication related issues with other members of the team -Advises patients about their treatment WHY ?? >> large number of drugs >> complex new therapeutics >> poor patients adherence to the prescription **Pharmaceutical care :-WHO , FIP PHARMACISTS have an important role to play in health care , which is much more than just selling medicines (the concept of seven stars pharmacist ) . EIGHT - STARES PHARMACIST Care giver : -Pharmacist provides caring services in the following fields : clinical field , analytical field , technological field , regulatory field 13 Communicator : health care team patient 1- provide drug information 1-obtained detailed health 2- take full patient history history 3- work in harmony 2-diagnose some cases 3-decide about self medication or physician consultancy 4- provide information about the diseases and medications Decision maker Life-long learner Teacher Manager leader Research: -pharmacist should : 1- promote self medication (rational use of drug ) 2- promote healthy lifestyle (self care ) -good hygiene , healthy diet , regular exercise Main objectives of national drug policy 1- Make essential drug available 2- Ensure drug safety , efficacy , quality 3- promote rational use of drug 4- Ensure the availability of essential drugs 5- Ensure research development 14 6- Observe professional ethics 7- Support adverse reactions reporting *Code of pharmacy ethics: -Pharmacy profession is practiced under the control of : 1- pharmacy law 2- National restrictions (national drug policy) 3- code of drug ethics *THIS CODE : 1-States publicly the principles of pharmacist resp. 2- Was established . supported by pharmacists 3- Includes moral obligations to guide pharmacists in their relation with patients , health professional society . .......القسم فى الكتاااااب ORIENTATION TEAM.. GOOD LUCK.. 15