Physical-chemical analyses for medical devices used in
aid of administration of pharmaceutical products R.A. 10918: Philippine Pharmacy Act 7. Administration of vaccines as approved by the FDA - “An act regulating and modernizing the practice of pharmacy in 8. Conduct or undertake scientific research in all aspects the Philippines repealing for the purpose R.A. 5921 (Pharmacy involving pharmaceutical products and health care Law).” 9. Provide other services where pharmaceutical knowledge is required Legal Control Article 1, Section 3 Requirements for the Opening and Operation of 1. Standardization and regulation of pharmacy education; Pharmaceutical Outlet or Establishment (Article 4, Section 2. Administration of licensure examination, registration, 38) and licensing of pharmacists; § In accordance with the rules and regulations prescribed 3. Supervision control, and regulation of the practice of by Phil. FDA pharmacy in the Philippines; § Application is signed by a Filipino registered 4. Development and enhancement of professional pharmacist competence of pharmacists through continuing professional development, research, and other related Administration of Adult Vaccines (Article 4, Section 40) activities; § Trained pharmacist shall administer adult vaccines 5. Integration of the pharmacy profession § Doctor’s prescription (n.m.t 7 days) is required for the vaccination Board of Pharmacy § Submit a monthly vaccination report and Adverse Event § Chairman + 2 members Following Immunization (AEFI) to DOH § Supervised by the Professional Regulation Commission (PRC) Definition of Terms (Article 1, Section 5) § Functions: • Brand Name. Proprietary name given by the o Examine applicants for the practice of manufacturer to distinguish its products from Pharmacy competitors o Issue certificates of registration of pharmacists • Generic Name. Scientifically and internationally o Reprimand any pharmacist or suspend or recognized name of the active ingredients revoke his certificate of registration • Medicines. Drugs in their appropriate dosage forms, o Promulgate rules and regulation as necessary with assured quality, safety and efficacy for humans and o Regulate and monitor the practice of pharmacy animals in the Philippines • Dispensing. Sum of processes performed by a pharmacist, from reading, validating, validating & Practice of Pharmacy (Article 1, Section 4) compounding prescriptions, preparing, packaging, 1. Prepare, compound or manufacture, preserve, store, labeling, record keeping, dose calculations, and distribute, procure, sell, or dispense, or both, any counseling or giving information in relation to sale or pharmaceutical product or its raw material transfer of pharmaceutical products, with or without 2. Render services such as: prescription. a. Clinical pharmacy b. Drug information • Cosmetics. Substance or preparation intended to be c. Regulatory placed in contact with external parts of the body or with d. Pharmaceutical marketing teeth and the mucous membrane of the oral cavity e. Medication management • Household Remedies. Any preparation containing Whenever the expertise and technical knowledge of the pharmaceutical substances of common or ordinary use pharmacist is required to relieve common physical ailments; may be dispensed 3. Engage in teaching scientific, technical, or professional without medical prescription in original packaging pharmacy courses in a school or college of pharmacy • Biopharmaceuticals. Pharmaceutical products that are 4. Dispense pharmaceutical products in situations where used for therapeutic or for in vivo diagnostic purposes supervision of dispensing pharmaceutical products is (i.e. vaccines, sera, and drug derived from life forms required using biotechnology) 5. Chemical, biological or microbiological analyses and • Institutional Pharmacies. Pharmacies of institutions, assay of pharmaceutical products, food/dietary organizations and/or corporations that provide a range supplements, health supplements, and cosmetics of pharmaceutical services, given exclusively to the employee or their qualified dependents • Medical Device. Instrument, apparatus, implement, • Drug Products. Finished product form that machine, etc. intended by the manufacturer to be used contains the active ingredients, generally but not alone, or in combination, for human beings necessarily associated with inactive ingredients • Adulterated/Deteriorated Pharmaceuticals, • Drug Outlets. Drugstores, pharmacies, and other Proprietary Medicine or Pharmaceutical Specialties. business establishments that sell drugs Any drug, preparation or mixture of drugs, mixed under • Complimentary List. List of alternative drugs a trade name and intended for the cure, mitigation, or used when there is no response to the core essential prevention of disease drugs or when there is a hypersensitivity reaction to • Counterfeit Pharmaceutical Products. the core drug or core drug cannot be given Pharmaceutical products with do not contain the • Core List. List of drugs that meet the health care amount as claimed; with wrong ingredients; without needs of the majority of the population active ingredients; or with insufficient quantity of active Generic terminologies are used by (Sec. 6): ingredients 1. All government agencies and their personnel during • Food/Dietary Supplements. Processed food products the entire medication use process intended to supplement the diet that contains one or 2. All medical, dental, and veterinary practitioners in more of the dietary ingredients (i.e. vitamins, minerals, prescribing herbs, amino acids, dietary substances) 3. Any organization or company involved in • Health Supplements. Products that are used to manufacture, importation, repacking, marketing maintain, enhance, and improve health function of the and/or distribution of drugs and medicine human body and contains herbal fatty acids, enzymes, 4. Drug outlets, including drugstores, hospital, and probiotics, and other bioactive substances. non-hospital pharmacies and non-traditional outlets such as supermarkets and stores R.A. 6675: Generics Act of 1988 - “An act to promote, require, and ensure that the production of Ethical Control an adequate supply, distribution, use and acceptance of drugs and Ethics medicines identified by their generic name.” § Philosophical science dealing with the morality of Statement of Policy (Sec. 2) human act § Promote, encourage, and require the use of generic § Deals with right conduct directed towards the formation terminology of the individual § Ensure adequate supply of drugs with generic names at Special Ethics the lowest possible cost and free to indigent patients § Deals with application of the general principles or § Encourage the extensive use of drugs with generic name morality to the particular actions of man as individuals through a rational system of procurement and and as a member of society distribution § Emphasize the scientific basis for the use of drugs Professional Ethics § Promote drug safety by minimizing duplication in § The less the public know about the quality and medicine techniques of a human activity, the greater is the Definition of Terms (Sec. 3) opportunity of transgressing the standards of equity and • Brand Name. Proprietary name given by the charity by those who have the know-how manufacturer to distinguish its products from § For self-government of its members competitors • Generic Name. Identification of drugs by their Objectives of Professional Code of Ethics scientifically and internationally recognized active 1. To define professional privileges, behavior and ingredients or their official generic name as responsibilities towards the members of the same determined by the FDA and DOH. profession and towards the members of the community in general • Generic Drug. Drugs not covered by patent 2. To promote professional quality, professional conduct protection and are labeled solely by international and a moral method of procedure non-proprietary or generic name 3. To defend private professions from undue interference • Active Ingredient. Chemical component by the government or other private agencies responsible for claimed therapeutic effect of the 4. To preserve the dignity of the profession and the product confidence of the public • Chemical Name. Description of the chemical 5. To defend clients from unscrupulous professionals structure of the drug and serves as the complete 6. To fix certain standards of compensation for services or identification of a compound work o Fees should commensurate with the Ethics of Pharmacy services rendered and with the § Primary consideration = SERVICE professional training § Dedicated to preservation, promotion, and protection of § Pharmacist-Patient-Prescriber relationship the nation’s health o Promote a close relationship with § Economic gain is important, legal compliance is patients compulsory and social prestige is desirable - Personal contact in receiving and o Material gain is necessary but could remain a delivering Rx secondary motive - Attend and supervise sales of o We cannot legislate morality OTC and other supplies o Service and not material gain is the true - Provide professional advice and measure of success counsel § Serves as guidelines for pharmacists in their relationship o Strengthen pharmacist-prescriber with professional relationship 1. The public - Invite him to pharmacy 2. Other members of the health profession - Keep him informed of unusual 3. Fellow pharmacists patient problems, reactions, and progress The Public - Provide updates on medications § Drugs of good quality - Participates in inter-professional o Reputation and integrity of the meetings manufacturer should be considered o Consult references like USP/NF Other Members of the Health Profession (Inter- § Conformity to laws professional Relations) o Explain the pertinent legal § Drug consultant requirements, the purpose of those o Drug experts = most knowledgeable requirements, and the proper person regrading drugs procedure to follow § Diagnosing and Prescribing § Confidential information o Pharmacist are not qualified to o Only when patient’s welfare is at diagnose and treat diseases stake may such a secrecy may be o Auto-therapy (self-medication) disclosed Advantages disadvantages § Physical facilities Relieve the overloaded Treats only symptoms and not o Appropriate environmental medical profession the cause condition for storage, quality of Human instinct to self- Misuse and abuse of drug professional service, professional medicate therapy appearance of pharmacy staff, Home remedies are highly Misinterpretation of printed displays, and general décor effective and are now strictly directions & precautions o Should describe complete dedication regulated to advancing public health through Self-medication can be Delays treatment professional practice psychologically useful § Civic responsibilities o Be an example of responsible § Compounding and dispensing prescription citizenship o Pharmacists are responsible for the - Informed and enlightened voter, accuracy, quality, and safety of the supporter of constructive efforts prescribed medication for public welfare, firm upholder § Clandestine arrangements of duty constituted authority, o Exploitation of patients by certain participate in community arrangements of the pharmacist with program on public health other members of the healthcare § Renumeration team should never be done o The value of life itself represents the o Conflict of interest actual worth of their services § Interpersonal Relationship o Requires combined and cooperative efforts of a team o Opportunities for a successful inter- professional relationship 1. In-service visits between practitioners 2. Co-sponsored seminars and other professional meetings 3. Participation in inter- professional and public health activities 4. Formal and informal correspondence related to problems and plans of mutual interest 5. Social and community intercourse
Fellow Pharmacists (Intra-professional Relations)
§ Self-improvement o Regular reading is the key to keeping current with the practice o Pharmaceutical research is valuable tool of self-improvement § Recruitment o Pharmacists should attract and encourage promising, responsible and superior student of good character to pursue pharmacy programs § Instruction o Every pharmacist is a teacher by precept and example § Professional Organization o Pharmaceutical problems need group effort § Unethical Practices o Prevention and elimination of unethical practices o To function effectively, a profession should police itself § Intra-professional relations o Selfish interest should be subordinated to public interest o Service should always be the primary objective of every pharmacist