Philippine Pharmacy Laws & Ethics (PDF)

LAWS & ETHICS\ AFFECTING PHARMACY Legal Control -The practice of pharmacy is **regulated** by the\ law of the country. To practice pharmacy, a\ pharmacist must be a **registered\ pharmacist (RPh)** in that country. -Administration of **pharmacy laws** and the\ granting of **registration** to prac...

LAWS & ETHICS\ AFFECTING PHARMACY Legal Control -The practice of pharmacy is **regulated** by the\ law of the country. To practice pharmacy, a\ pharmacist must be a **registered\ pharmacist (RPh)** in that country. -Administration of **pharmacy laws** and the\ granting of **registration** to practice pharmacy\ are authorities vested in the ***[Board of\ Pharmacy.]*** The following laws govern the practice of pharmacy profession and relative to drugs in the Philippines.\ **R.A. No. 10918** - The Pharmacy Act\ **R.A. No. 3720** - The Food, Drug and Cosmetics Act\ **R. A. No. 9165** - The Dangerous Drug Act of 2002\ **R.A. No. 6675** - The Generics Law of 1988\ **R.A. No. 8203-** The Special Law on Counterfeit Drugs\ **R.A. No. 9994**- The Senior Citizen Act\ **R.A. No. 7394**- The Consumer Act of the Philippines **R.A 10918** This act provides for and shall govern:\ 1) The standardization and regulation of pharmaceutical education. (**council of pharmaceutical education)**\ 2) The examination for registration of graduate of schools of pharmacy; and (**board of pharmacy**)\ 3) The supervision, control, and regulation of the practice of pharmacy in the Philippines. (**board of pharmacy)** The Board of Pharmacy shall be composed of 3 members appointed by the President of the Republic.\ **Qualifications:\ **1) Natural born citizen of the Philippines\ 2) Duly registered pharmacist and has been in the practice of pharmacy for at least 10 years\ 3) A member of good standing of bonafide national\ pharmaceutical association in the Philippines\ 4) A foreigner residing in the Philippines for 5 years\ 5) Not a member of any college of Pharmacy **Provisions affecting pharmacy practice** **Indicating of Information** -The pharmacist shall be required to indicate the serial numbers, the date of expiry of the pharmacist's PIC and APO Certificate of Membership on all pertinent documents signed by him/her. **Display of Certificate of Registration**\ Display the COR in a prominent and conspicuous place.\ -- **Category A (**establishments that *require* direct\ *[supervision of RPh]*)- *original copy*\ **-- Category B-** (outlets where *[the supervision]* and oversight of a *[duly registered and licensed pharmacist]* is *required)*-duplicate copy **Dispensing/Sale and Compounding of\ Pharmaceutical Products**\ It should be done by a registered\ Pharmacist in an establishment with a valid\ **License to Operate** given by the FDA\ Phil.\ In emergency cases, dispensing of Rx and\ Pharmacist-only OTC can be done by non-\ pharmacist. **NO LTO (Licensed to Operate)**\ Dispensing or allowing the dispensing or offering for sale of prescription drugs or pharmaceutical products (manufacturer and distributor) in a place [not licensed by the FDA] as a pharmaceutical outlet is **punishable by law.** -**Partial filling of prescription** less than\ the total quantity indicated in the\ prescription shall be allowed,\ -**Pharmacist dispensing** the last quantity completing the prescription to keep the prescription according to proper prescription recording guidelines.\ -**Fully filled prescription**- pharmacist will keep the prescription **Dispensing & Recording of Prescription\ **All prescription [drugs must be dispensed] only by **the Pharmacist**.\ All prescriptions must be recorded in **a record book.\ Logbooks:**\ 1) Prescription record book---kept in the drug store for 2 years\ 2) Dangerous drug book- kept for 2 years\ 3) Poisonous substances record book---5 years\ 4) Referral logbook- kept for 2 years **Administration of adult vaccines** as approved by the FDA, provided that the pharmacist shall\ undergo trainings for safe administration.\ (RA10918) **"GHOST PHARMACIST"**\ Allowing the display of one\'s COR in a pharmaceutical establishment where the *[pharmacist is not employed and practicing.]*\ is an **act punishable by the law.** Handling of Dangerous Drugs:\ -**Yellow prescription** is needed\ (Triplicate copy)\ -Physician must have a **s-license** (issued\ DDB) **PROTECTION OF PHARMACISTS\ ** **Forcing, coercing, or intimidating** a duly registered and licensed pharmacist to compound or dispense medical and pharmaceutical products in violation of the provisions of RA 10918. **HISTORY OF FDA PHIL.** **Francisco Duque Sr.- -**created a subcommittee on Food and Drugs in the year 1961-62 **June 22, 1963\ Republic Act No. 3720\ **-was passed into law\ \--known as the "Food, Drug and Cosmetic Act". On December 2, 1982, **Executive Order No. 851\ **by Section 4, under the Minister of **Health Hon.\ Jesus M. Azurin**, The FDA was abolished and\ created the BFAD.\ **Ms. Catalina C. Sanchez** was appointed the first\ Director of the BFAD on Feb. 20, 1984 and took\ her oath on Feb. 28, 1984. In 1987, R.A. 3720 was amended by *[Executive Order 175]* to the new title **"Foods, Drugs, and Devices and Cosmetics Act"**\ 2009: BFAD renamed **as FDA**\ (FDA Act of 2009)  The manufacture, importation, exportation, sale, offering for sale, distribution or transfer of any food, drug, device or cosmetic that is **adulterated or misbranded is prohibited** **Refusal to permit entry or inspection** or to allow samples to be collected by the Food & Drug Administration or other appropriate government agency.  **MISBRANDED DRUGS AND DEVICES** 1\) If its labeling is **false or misleading**\ 2) If in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer or distributor; (2) an accurate statement of the quantity of the contents in terms of weight/ measure\ 3) If any work or statement required by or under authority appear on the label or labeling is not **prominently placed with such\ conspicuousness** **RA 6675** It is 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.  **Purposes:** 1\) To promote, encourage, and require **the use of generic terminology** in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs;\ 2) To **ensure the adequate supply of drugs with generic names** at the ***lowest possible cost*** of endeavor to make them available for free to indigent patients;\ 3) To encourage **the extensive use of drugs with generic names** through a rational system of procurement and distribution; 4\) To **emphasize the scientific basis for the use of drugs** so that health professionals may become more aware and cognizant of their therapeutic effectiveness; and\ 5) To **promote drug safety** by minimizing duplication in medications and/or of drugs with potentially adverse drug\ interactions. **GENERIC NAME**- - simpler term for scientifically recognized AI of the drug\ -**Using GN**\ reduce the cost of treatment by reducing the promotions and advertising cost associated with branded products. **WHO SHALL USE GENERIC\ TERMINOLOGY?** -All **government health agencies** and their personnel as well as other government agencies\ -All **medical, dental and veterinary practitioners,** including private practitioners, shall write prescriptions using the generic name. The brand name may be included if so desired.\ -**Any organization or company** involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product -Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores, shall inform any buyer about any and all other drug products having the same generic name, together with their corresponding prices so that the buyer may adequately exercise, his option\ **PRESCRIPTION** -Is a medication order written by a **physician, dentist** or other license medical practitioner and given to the patient for presentation to the pharmacist.\ -It contains specific medication and dosage to be administered to a particular patient**.** **Prescriber's Information\ **- the name of the prescriber, his specialty, clinic address, contact number and office hours.\ **Patient's Information\ **- full name of the patient, address, age, sex, weight, body surface area (if pediatric) **Date**\ - prescription are dated at the time they are written.\ **Superscription or Rx Symbol**\ -Consist of the heading where the Rx symbol is found.\ **Subscription\ **- the dispensing direction to the pharmacist. **Transcription**\ Direction to the patient on how to take or use the medication. **Transcription or Signa**\ Must contain the following:\ 1. Route of administration\ 2. Number of dosage unit per dose.\ 3. Frequency of dosing\ 4. Duration of dosing\ 5. Use of the drug (optional) **Inscription**\ - medication prescribed\ Must contain the following:\ 1. Non-proprietary name (Generic Name)\ 2. Proprietary name (Brand name)\ 3. Dosage form\ 4. Strength\ 5. Quantity **Refill information**\ - if not indicated, it is generally assumed that no refills needed.\ **Prescriber's Signature**\ - contains complete name and signature of the prescriber who wrote the prescription order.\ (includes: PRC number, PTR and TIN) **VIOLATIVE PRESCRIPTION** Generic name is not written\ Generic name is illegible but\ brand name is legible\ Both are written but with word**\ "NO SUBSTITUTION"** **ERRONEOUS PRESCRIPTION** Brand name precedes generic name\ Generic is in parenthesis\ Brand is not in parenthesis **IMPOSSIBLE PRESCRIPTION** Only generic is written but not legible\ Generic name does not match with brand name\ Both written -- both illegible\ Drug is not registered with DOH **CODE OF ETHICS** **Professional Ethics** are used only to denote the set of ethical principles perceived only by the professionals themselves to be appropriate for their professional behavior.\ **IMPORTANCE\ **-A Code of Ethics makes the decision-making process more\ efficient\ - Individual professionals may occasionally need guidelines for\ directing their professional behavior.\ - Professional ethics establish a pattern of behavior which clients\ come to expect of members of the profession. **Declaration of Principles:\ -- Provide efficient service** in compounding and filling of prescriptions and the dispensing of drugs, chemicals, and medicines**\ -- Special knowledge, skill, and integrity** are demanded on the part of those engaged in Pharmacy **--** Pharmacists should pursue **a prescribed course of stud**y and **should pass a professional examination.\ --** Qualified pharmacists have a full recognition of their responsibility **for the preservation of public health** **--** The pharmacist should therefore ever bear in mind that he **is more than a merchant**. (We are not "glorified merchant" we are an integral part of the health care team giving drug information to the public.) **DUTIES OF PHARMACISTS** **TOWARDS THE:\ **1. PUBLIC\ 2. PHYSICIAN\ 3. COLLEAGUES\ 4. INTERNS/ PHARMACY ASSISTANTS