Midterm Examination-April 29,2013

LAWS AND REGULATIONS IN THE PHARMACY RA 3720- FOOD, DRUG, COSMETIC, AND DEVICE ACT An act to ensure the safety and purity of foods, drugs, and cosmetics being made available to the public by creating the food and drug administration which shall administer and enforce the laws pertaining thereto RA 6675- GENERICS ACT OF 1988 An act to promote, require, and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names Sec. 2 -To emphasize the scientific basis in the use of drug -To promote drug safety by minimizing duplication in medication -To encourage use of drugs with generic names through a rational system of procurement and distribution RA 5921- PHARMACY LAW An act regulating the practice of pharmacy and settings standards of pharmaceutical education in the Philippines and of other purposes Sec. 1 Objectives - Standardization and regulation of pharmaceutical education - Examination for registration of graduates of school of pharmacy - Supervision, control and regulation of the practice of pharmacy in the Philippines RA 8203- SPECIAL LAW ON COUNTERFEIT DRUGS An act on prohibiting counterfeit drugs, providing penalties for violations and appropriating funds therefor Sec. 3 Definition of Terms Counterfeit Drugs- medicinal products with the correct ingredients but not in the amounts as provided, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, drug which is deliberately and fraudulently mislabeled with respect to identity or fake packaging RA 9165- COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002 Sec. 2 MDMA- methylenedioxymethamphetamine/ecstasy PMA- paramethoxyamphetamine TMA- trimethoxyamphetamine LSD- lysergic acid diethylamine GHB- gamma hydroxybutyrate RA 9502- UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF 2008 An act providing for cheaper and quality medicines, amending for the purpose RA 8293, RA 6675, and RA 5921; and for other purposes RA 9994- EXPANDED SENIOR CITIZENS ACT OF 2010 An act granting additional benefits and privileges to senior citizens, further amending RA 7432, as amended, otherwise known as an act to maximize the contribution of senior citizens to nation building, grant benefits and special privileges and for other purposes RA 9711- FOOD AND DRUG ADMINISTRATION ACT OF 2009 An act strengthening and rationalizing the regulatory activity/capacity of BFAD by establishing adequate testing laboratories and field offices, upgrading its equipment, augmenting its human resource complement, giving authority to retain its income, renaming it FDA, amending certain sections of RA 3720, as amended, and appropriating funds thereof

RA 9257- EXPANDED SENIOR CITIZENS ACT OF 2003 An act granting additional benefits and privileges to senior citizens amending for the purpose of RA 7432, otherwise known as an act to maximize the contribution of senior citizens to nation building, grant benefits and special privileges and for other purposes PD 881- HOUSEHOLD HAZARDOUS ACT Empowering the secretary of Health to regulate the labeling, sale, and distribution of hazardous substances EO 51- NATIONAL CODE OF MARKETING OF BREASTMILK SUBSTITUTES, BREASTMILK SUPPLEMENTS AND OTHER RELATED PRODUCTS Adopting a national code of marketing of breastmilk substitutes, supplements, and related products, penalizing violations thereof, and for other purposes Sec. 2 Aim of the Code -Contribution to the provision of safe and adequate nutrition for infants by protection and promotion of breastfeeding and by ensuring the proper use of breastmilk substitutes and supplements when they are necessary MC 17 s. 1989- MONITORING OF DRUGSTORE PHARMACISTS OFFICE HOURS Pharmacists required compensation- not more than 1 drugstore, only by Rph MC 15 s. 1990- EXEMPTION FROM THE REQUIREMENT PROVIDING ONE PHARMACIST FOR EACH LICENSED ACTIVITY Certificate of registration by PRC MC 5 s. 1991- THE DESIGNATION AND REGISTRATION OF AN OFFICIAL LIASON OFFICER MC 3 s. 1994- DRUGSTORE PERSONNEL DEVELOPMENT PROGRAM Enhancing the competence and improving services of pharmacy salesclerks at the point of sale

REQUIREMENTS *policy: RA 5921 Pharmacy Law Sec. 24 Prerequisite of Practice -holder of valid certificate of registration, 21 yrs. Old, pass PRC exam Sec. 39 Opening and Operation -no form, not signed by registered pharmacist Sec. 27 Pharmacists Required Compensations -under supervision of Rph -no Rph have more than I supervision of pharmacy outlet Sec. 28 Display of Certificate -License -open space in drugstore -no pharmacist is allowed to use if not an employee *penalty Imprisonment of 6 mos.- not more than 6 years A. GENERAL *Issuance of LTO 1. Proof of Registration (Mayors permit)-Security and Exchange Commission 2. Standard Petition Form 3. Certificate of Attendance 4. Tentative Listing of Products 5. Affidavit of Undertaking- agreement 6. Valid Certificate of Registration

B. SPECIFIC 1. Premise -area of 15 sqm -ventilated -water -ref, equipments 2. Reference Books -Remington -USP-NF -Goodman and Gilman -Ph. Law Manual -MIMS/PIMS *Laws: RA 5921, 6675, 720, 6425/9165, 8203, 9711, 9994 3. Record Books -Prescription Books 2yrs -Poison Book 5yrs -Senior Citizens Book 2yrs -Dangerous Drug Books 2yrs 4. Apparatus -mortar and pestle -beaker -graduated cylinder -weighing scale -paper tab 5. Rph 6. Additional Requirements -invoices -dry seal -red (external) and white (internal) labels -file for prescription SANCTIONS: 1. Temporary Closure of Drugstore -absence of pharmacist (3 consecutive times) 2. Suspension of LTO *30-60 days under discretion of court -not issuing an invoice -failure to file and record prescription drugs -refusal to allow entry *partially fill- attach *fully fill- record all .3. Revocation of LTO -operation without pharmacist (lack) -no file of dangerous drugs *Regulated: Sleeping Pills, antibiotic, Valium, Diazepam, Barbiturates, Tranquilizers (prescribe physicians license, S2 license) *Prohibited: Cocaine, Heroin, Opium, Codeine, Morphine, LSD, etc.(prescribe 3x: white(patient), yellow(RpH), pink (PDEA)) -selling mutilated, adulterated, and misbranded drugs (under unsanitary conditions, selling physicians samples) -failure to take necessary remedial measures prescribed by an FDA personnel TYPES OF OUTLETS 1. dispensaries/drugstores 2. retail outlet- nontraditional/nonprescription RESPONSIBILITIES OF A PHARMACIST 1. Patient Safety with Drugs

2. Patient Education in relation with Drugs 3. Patient Care FIELDS 1. Hospital 2. Community 3. Industrial 4. Clinical OTC PRODUCTS AND COMMON AILMENTS *Community Pharmacy: Drugs (OTC and RX) *Strength: baby (6 mos.-2 yrs), infant (0-6 mos.) OTC: -cough and colds -UTI -sore throat -rashes -pain -headache -fever -HTN -insomnia -rhinitis -allergy -hyperacidity -constipation -diarrhea -sore eyes -dysmenorrhea A. Fever- paracetamol 1. How many days? 2. What are the other complaints? 3. What are other medications that are taken? 4. Who will take the medication? (age, preferred dosage form) e.g. drop=100 mg/ml (1 mL q4h) syrup=120 mg/mL, 250 mg/mL (0.8 mL q4h) *dose: in label of the box, PI (package insert) 5. When to take the medication? (Pt Counseling) *How often? *Until when- until fever is lost 1st time: 6-8 hrs (severity of complaint) *HA 1 tab q6h 6h- analgesic 4h- fever Stop if cough/cold is gone (3x for 3d) B. Headache 1. Which part of the head is aching? *stress, hunger, hot temp, fever- temporal *history of accident? have tumor? Existing ailment?- parietal (not give a pain reliever, see doctor- if complain pharmacist) *same with temporal- frontal (F+T= analgesic/pain reliever *have HTN? Not aware that he is hypertensive? Take maintenance drug? When did you take maintenance drug? Did you drink today? = If hypertensive, temporal(pain), taken med: when HA started? If after meal, ask the meal? C. Cough and Colds (same of fever)

1. productive/ nonproductive? with/ without phlegm? 2. how many days e.g. 5d caused by bacteria (antibiotic-go to doctor) *nonproductive: -activity: smoke? Allergic? If allergic, no antitussive If more than 3d, give antitussive 1/2d: antihistamine -not all can induce sleep *Induce Sleep: chlorpheniramine, hydroxyzine, diphenhydramine *Not Induce Sleep: cetirizine, loratadine *non drowse/drowse D. Rashes 1. do you have history of any allergy? Anti-allergy: itchiness 2. What you eat/ drink? E. Diarrhea 1. how many times you have bowel movement? 2. type of stool? *bloody: water replacement, ORS, pedialyte (not Gatorade) 220mL/ 1 glass of water after bowel movt, 24h @ ref *antidiarrheal- Loperamide (stomach ache) If 10x- water replacement If 2d- water replacement, go to doctor *fever+diarrhea= ok to give q4h *Loperamide- 2 tab; after 6h- 1 tab *diarrhea+maintaining drug= check PI (contraindications) F.Dysmenorrhea 1. age *first aid q8h, can stop G. Hyperacidity 1. how many days? -before giving laxative, give fiber diet (pineapple, papaya) *Laxative: Bisacodyl Dulcolax, Lactulose H. Sore Throat 1. how many days? *gargle with salt and water 3xd before and after meals -w/ bactericidal effect, lozenge sugar free I. UTI 1. symptoms? -urinalysis, doctor J. Insomnia 1. ask factors why patient cannot sleep? (emotional, work, stress, change in temp) - drink milk, dont exercise, dont eat too much, change body clock

PHARMACIST-PATIENT INTERACTION/ COUNSELING 1. determine patients condition, symptoms 2. allow to assist patient in assistance of drugs/give info 3. establish ph-pt relationship -trust and confidence -more questions

*Communication Skills: verbal, nonverbal (smile, eye to eye contact, body language, gesture, listening STEPS: 1. greet and introduce yourself with a smile 2. determine patients wants and needs 3. explain how you can help 4. provide comfort 5. proceed to questioning for assessment 6. referral 7.patient counseling -to avoid untoward effect of med -to ensure full compliance *PATIENT COUNSELING: 1. establish goal of treatment e.g. paracetamol 1d 3-4h (overdose/kidney toxicity) *6 ATC*500 mg=3000mg 2. help patient for product selection -recommend but therapeutically equivalent 3. provide information of product -stomach discomfort, N&V( cough) , drowsiness (colds) 4. test for understanding 5. summarize important concerns 6. close counseling PARTS OF A PACKAGE INSERT (PI) 1. Generic Name 2. Brand/Product Name 3. Indication 4. Pharmacology 5. Pharmacokinetics- LADMER (liberation, absorption, distribution, metabolism, excretion, response) 6. Formulation 7. Description 8. Drug Interactions 9. Contraindications 10. Warning & Precautions 11. Adverse Effect 12. Dosage &Method or Route of Administration 13. Overdosage 14. Strong Condition 15. Caution & Availability

PHARMACEUTICAL DOSAGE FORMS -enabling to deliver to patient A. LIQUIDS(solutions) -Solutions: aqueous, non-aqueous, sweet & viscid -Emulsions -Suspensions *Water: vehicle -nontoxic, non-irritant, tasteless, cheap, abundant, inert 1. Oral Solutions- gargle, mouthwash *Advantages: -available for absorption -flexible dosing -for any route

-no need to shake: uniformly distributed -facilitate swallowing *Disadvantages: -diff. to mask unpleasant taste -bulky, diff to transport & prone to breakages -technical accuracy is needed to measure the dose on administration -some drugs are poorly soluble -measuring device is needed for administration a. Aqueous- no alcohol 1. water- chemically: hydrogen monoxide H2O; clear, colorless, odorless, and tasteless (Adjuvant, base, vehicle, corrective) 2. dil. Acid- aqueous soln of acids of a suitable strength for internal administration(10%) 3. solutions- 1/more substances dissolved in water 4. douches- used to clean body cavities (antiseptics) 5. enemas- evacuation enema; used to evacuate bowel(before pre-operation) 6. gargles- treating pharynx and naso-pharynx by forcing air from lung through the gargle which is held in throat (antibacterial) 7. washes- colored, pleasantly flavored, slightly acidic 8. juices- expressed, strainedfrom fresh fruits 9. ophthalmic Solutions- in eyes (eye wash/ eye drops) 10. otic soln- ears (sharp) 11. nasal soln- administeredto nasal passages in drops or spray 12. aromatic water- medicated water; clear saturated soln of volatile oils/ aromatic/volatile substance (flavored perfumed vehicle) 13. aqueous acid- additive, concentrated % by weight b. Sweet and Viscid Soln 1. syrup- of sugar and water 2. honey- thick liquid preparation containing honey as base 3. mucilage- thick, viscous, viscid, adhesive, liquid prepared by dispersing gum in water 4. jelly- same as gum, jelly-like, semisolid c. Non- Aqueous 1. spirit- alcoholic/hydrochloric soln of volatile substances 2. elixir- sweetened, alcoholic/hydroalcoholic cleared, flavored soln with/without med. Agents, oral use 3. dental liniments- applied to the gum for local stimulant and anesthetic effect 4. collodion- pyroxyllin with ether and alcohol 5. glycerites- mixture of various subs with not less than 50% glycerin 6. liniment- soln of subs in oil/ alcoholic soln of soap/ emulsion 7. toothache drops-temporary relief of toothache 8. oleovitamins-vitamin in oil (use of soluble vitamins- A&D) 9. spray- aqueous/oily soln of med. agent 10. inhalation- inhaled by patient 2. Emulsion *dispersed phase, dispersing medium, emulsifying agent - contain globules of those particles equal/greater than of largest colloidal part. 3. Suspension a. suspension- in susp./powder form by addition of liquid b. mixture- contain suspended insoluble solid substances for internal use c. magma and milk- sufficient suspended insoluble subs, usually inorganic to make viscous d. gel- gelatinous e. lotion- emollient, anti-itch B. EXTRACTS -soln of active constituent of a crude drug obtained by maceration /percolation (tincture, fluidextracts, extracts) 1. tincture- alcoholic/hydroalcoholic prepared from vegetable materials/chemical substances 2. fluidextract- use alcohol as solvent( 1mL-1g of active constituent)

3. extract- concentrated preparation of vegetable or animal drug by removal of active constituent with suitable menstruum, evaporation of solvent, and adjustment of residual masses or powders C. PARENTERAL PREPARATIONS -sterile inj/prep intended to beadministered by inj under/ through one /more layer of skin/mucous membrane -in ampul/vial 5/10ml 1. Solutions ready for injection (insulin) 2. Dry soluble product ready to be combined with a solvent just prior to use (antibiotic-sterile water) 3. Suspension ready for inj 4. Dry insoluble product combined with a vehicle 5. Emulsion D. IV ADMIXTURES -added to IV solutions 1. IV fluids- sterile/large volume of sol (NaCl soln, D5LR) 2. IV admixture- aseptic technique 3. Total Parenteral Nutrition- calories, nitrogen, nutrients (laminar flowhole, comnpounding area) E. OPHTHALMIC PREPARATIONS 1. Soln sterile to be instilled into eyes(isotonic) 2. Suspensions 3. Ointment- bedtime instilliators 4. Lens care products -wetting soln: furnish hydrophilic coating -cleaning soln: remove contaminated lipid, proteins -disinfection soln: isotonic -soaking soln: hydrate hard lens - artificial tears: revert hard lens F. MEDICATION APPLICATIONS -topical 1. ointment- semisolid 2. cataplasm- poultice 3. paste- stiff to the point of dryness 4. powders for ext. use- dusting(starch, talc, zinc stearate) 5. dressing- ex. Application 6. creams- viscous liq/semisolid emulsion 7. plasters- hard material to adhere skin 8. suppository- rectal, vaginal, urethral G. POWDERS 1. powder preparations- mixture -oral powder ORS -dentrifices -douche powder -dusting - insufflations: insufflators - triturations 1:10 conc H. ORAL DOSAGE FORMS 1. Tablets- with or without diluents and prepared either by compression and molding 2. Capsule- encloased in hard or soft container or form of gelatin 3. Pills- small, round , solid dosage form 4. Troches- lozenge, pastilles, discoid shape (antibacterial/pain reliever) 5. Cachet- rel. to caps. Made of flour and water 6. Pellets- 3.2 nm by 8nm(compression)

I. AEROSOLS -oral/topical -therapeutically dissolved in a propellant/in a m. of solvent/propellant -asthma, HA, dermatological J. RADIOPHARMACEUTICALS -IV,SubQ -radioistopes used in diagnostics procedures K. BIOLOGICAL PRODUCTS 1. for active immunity: vaccine, toxoid 2. for passive immunity: a. Human Immune Sera -IgG, hyperimmune serum b. Animal immune serum -antitoxin -antiviral serum: w/ spec. viral vaccine -antivenin: neutralize the venom

1. interpretation of prescription contents and parts 2. processing, recording, and filling of rx 3. drug label & label of dispensed drug PARTS OF A PRESCRIPTION 1. Prescribers info: name, address, tel.no. 2. Patients info: name, age, gender, weight, height 3. Date 4. Superscription: Rx must prepare 5. Medication/Inscription: active ingredient, quantity, potency, board 6. Subscription: to pharmacists, for dilution 7. Transcription: signa, to patient(instructions) 8. Prescribers Signature: license no, s2 dtr: dangerous drugs

WRONG PRESCRIPTION 1. erroneous -generic is in parenthesis -more than 1 drug 2. violative -generic name not legibly written -no substitution (mindering generic dispensing) 3. impossible -brand name doesnt correspond to generic name -both are not written legibly

CHECKING OF PRESCRIPTION FOR CORRECTNESS 1. evaluate the prescription 2. inform the patient of other available brand with price *branded-generic(bioequivalence test-prove efficacy; CPR-certificate of product registration) 3. dispense and patient counseling OTC 1. no need of prescription 2. inform of other brands with prices 3.dispense and patient counseling Sec. 30 of RA 5921 Filling of Prescription Rx shall be filled or refilled by a registered pharmacist. In case of interns, they assist to the rph and to compounding. In case of fully filled rx, file eventually recorded in the rx book.

Sec.32 of RA 5921 Recording of Rx Require the Prescription Book All fully/partially filled shall be recorded in Rx book that will be file consecutively and must be opened by authorities by the time drugstore is open to public. 2 yrs from last entry *fully filled=all(get Rx) *partially filled -date of filling -signature -quantity and balance -name of drugstore and pharmacist

PARTS OF A PRESCRIPTION BOOK -date -#Rx -Prescriber -Rx -Quantity -Lot/Batch No. -Instructions -Remarks(fully/partially filled)

LABEL DRUGS AND LABEL OF DISPENSED DRUGS -display of written in immediate matter -all info are attached *Labeling Purposes: -Identification of Contents and Parts -Ensure a clear and concise information about the medication in a safe and appropriated way Legal and Prop. Requirements Sec. 1 of RA 5921Label of Dispensed Medicine -Upon every box, package, or bottle of a medicines sold or dispensed by a pharmacist based on a prescription; they shall be pasted, imprinted, a label bearing of name of prescription drug with date of Rx and directions for use. -Every Rx prepared by a pharmacist if they obtain any quantity of a drug which is habitforming/derivative of such drug; shall have a label attached to the container.Warning: May be habit-forming -If the preparation is for external use, bear a label imprinted in black ink, label of ingredient FOR EXTERNAL USE written on bottom part of the label. * Vit. E- Tocopherol * Vit. D- Cholecalciferol *RT- mEq ons *ROH- %age

LABEL OF PRESCRIPTION DRUGS (REQUIREMENTS) 1. Rx symbol- prominently display on principal display panel of the label (contrasting color of the Rx symbol not be less than 50% of the short dimension of rectangle label) -amp. Rx in outer label 2. Name of Product -generic name and brand name -if product needs dilution shall be the pharmaceutical form to be used as part of label (final form) e.g. EES granules for suspension or syrup e.g. Macrol IV -Z inj.: ready for injection -Y inj.: product need to be diluted

3. Pharmacologic Category: therapeutic action 4. Formulation -in metric system -list and amount of active ingredient/dosage unit *API: active pharmaceutical ingredient 5. Indication -Tartrazine: indicate/precaution of allergic rxn 6. Dosage and Mode of Administration -amount of drug with frequent dosing and site of administration/delivery 7. Warning, Contraindication and Precaution 8. PI: Package Insert/Drug Literature 9. Name/address of Manufacturer/distributor/Packer 10. Lot/Batch Number (packing) 11. Expiration Date -retain its pharmacological effect, efficacy -Ind. Approved clinical tests -warning information abt the occurrence of serious effect - side effect associated with the use of drug -pre. instruct specific care in case of reconstitute reconstituted must be specified based on storage condition 12. Registration Number: assigned number to upon submission for registration 13. Net Content: total quantity of dosage form 14. Storage Condition: humidity; ensure stability

LABEL OF DISPENSED DRUG 1. Name of Drugstore 2. Address of Drugstore 3. Name of Patient 4. Name of Physician 5. Date dispensed 6. Name of prescribed drug 7. Dosage or Strength 8. Quantity of drug dispensed 9. Directions for use 10. Name of Registered pharmacist 11. Expiration Date

PROPER STORAGE AND HANDLING OF PHARMACEUTICAL PRODUCTS 1. Store pharmaceutical product /drug according to storage condition specified in the label. - cool place: 8-15 Centigrade-ref; 2-8 Centigrade-biological ref; 20-25 Centigrade- aircon (vaccines) - protect from light 2. When no storage condition is specified, it is understood that the product must be free from excessive temperature, moisture and freezing. 3. Hazardous chemicals must be stored separately in locked cabinet that is properly labeled. 4. In handling hazardous chemicals, always observe safety measures like wearing of gloves, use of mask, etc. 5. In repacking drug products, the ff packaging must be used: a. vials: small plastic, glass container, plastic envelope for tablet and capsule b. paper, plastic bags c. small boxes d. prescription bottles 6. Dont dispense drug products if the ff physical signs are present. Physical signs present degradation of product. -presence of precipitate/solidification of liquid rug -change in color/formation of color -liquification/of softening of solid (tab, cap,syr-withstand compression) -rancidity of ointment and medicated applications

DRUG PROCUREMENT AND INVENTORY CONTROL - Hospital Ph: therapeutic committee; limited -Community Ph: any; can be consumed; depend on purchaser 1. Know the most legible supplier/ distributors. -registered -check: Company Registration(license to open-update); Product List (Lot/Batch #, Expiration Date: if registered) 2. Limit your suppliers/short listing. -to monitor -limit to most important/legible suppliers 3. Refer your purchases with your faltas. 4. Buy products with longer expiration dates. -fast moving -need replenished 5. Return to suppliers non-moving and near expiry drugs. -2-3 months before expiration date

INVENTORY CONTROL -First in, First out -quarterly

Diphenhydramine- Benadryl Rx 25 mg, 50 mg; OTC syr 125 mg/5 mL * Pharmacologic action: Diphenhydramine *Therapeutic action: relieve nasal congestion, antihistamine, drowsiness