RA 5921-10918 Pt 2 Flashcards
Sec 18. Report of rating
Report within 3 working days after the last days of the examination
RA 5920 Sec. 20. Rating Required
General average of seventy-five percent
No ratings below fifty percent in more than 2 subjects
Fails to pass in three successive attempts; need to attend a pre-board review course from a duly accredited college of pharmacy
RA 10918, Sec. 17 Ratings
General average of seventy-five percent
No ratings below fifty percent in any subjects
Fails to pass in three successive attempts; need to attend a pre-board review course from a duly accredited college of pharmacy
A prescribed study program in an accredited school of pharmacy
Refresher Program
Process wherein a pharmacist provides consultative services and conducts prelimiary assessment of symptoms and refers the patient to a physician
Refererral
The record book maintained by pharmacists, listing the patients referred to different health facilities for durther diagnosis
Referral/Registry
Is affixing RPh after a registered pharmacist’s Name lawful?
Yes
Documents needed for Indication of Information
COR, PIC
Registry of Pharmacists is updated on what period interval
Once a year
Display of Certificate of Registration
Category B: Certified True Copy or Duplicate from PRC
Retail Drug outlets are licensed by what agency
FDA
Dispensing of Rx and POOM during emergency cases must be reported to the supervising pharmacist within
24 hours
Is it lawful for manufacturers to allow unlicensed outlets to dispense their manufactured drugs
No
Category A Pharmacist
Direct and Immediate Control and supervision (8 hours)
- Pharmaceutical establishments/outlets selling or otherwise making available to the consuming public prescription/ethical medicines, combination products classified as drugs according to the primary intended mode of action, pharmacist-only OTC medicine, whether owned by the government or by a private person or firm, whether sold at wholesale or retail;
- Establishments involved in the manufacture, importation, exportation, distribution, and sale of combination products (medical device and drugs) classified as drugs according to the primary intended mode of action;
- Departments/Divisions/Units of pharmaceutical laboratories, pharmaceutical manufacturing laboratories, or other establishments with processes involving the preparation, manufacture, assay, regulation, product research and development, quality control, repacking, importation, exportation, distribution, sale or transfer of pharmaceutical products in quantities greatly in excess of single therapeutic doses; and
- Government units, including local government, city, first to third class municipal health units, nongovernment organizations and/or associations involved in the procurement, distribution, dispensing and storage of pharmaceutical products;
Category B Pharmacist
Supervision and Oversight (4 outlets)
- Retail outlets selling household remedies and OTC drugs as differentiated from the pharmacist-only OTC medicines;
- Satellite institutional pharmacies providing medicines solely to employees of their respective companies or the employees’ qualified dependents, or both; or members of a duly registered organization or institution;
- Fourth, fifth and sixth class municipal health units involved in the procurement, distribution, dispensing, and storage of pharmaceutical products;
- Institutions providing telepharmacy services; and
- Nontraditional outlets of pharmaceutical products: Provided, That no prescription medicines and pharmacist-only OTC medicines are sold.
Sec. 39. Handling of Pharmaceutical Products by Persons Other Than a Pharmacist
Non-pharmacist pharmacy owners should undergo a comprehensive standardized training program
Sec. 40. Administration of Adult Vaccines
- Licensed and trained pharmacist
- Prescription: not more than seven (7) days old
- Monthly vaccination report and AEFI report to DOH regional offices using the prescribed form.
Art. 5, Sec 41. Accredited Professional Organization (APO) of Pharmacists
Integrated into one (1) national organization registered with the Securities and Exchange Commission (SEC) which shall be recognized by the Board and the PRC
Section 42. Membership to the Integrated and Accredited Professional Organization
- All registered pharmacists
- The PIC shall not be renewed if the requirements are not met including credit units for attendance to duly accredited CPD.
- All pharmacy support personnel must be registered as affiliate members
Section 43. Specialty Boards in Various Areas of Pharmacy Practice
Accreditation by the Board and the PRC.
Section 22. Practice Through Special/Temporary Permit (STP)
- being a consultant in foreign-funded or assisted projects of the government;
- being engaged or employed by a Filipino employer or establishment;
- providing free services in humanitarian missions: and
- being a visiting faculty member in any field or specialty in pharmacy
Conditions in securing STP
- The person is an internationally renowned pharmacist or expert in a field or specialty of pharmacy;
- The person is engaged in the provision of a professional service which is determined to be necessary due to lack of Filipino specialist or expert; and
- The person is required to work with a Filipino counterpart, a natural person who is a registered and licensed pharmacist.
Omitted provisions in Pharmacy law (not included in RA 10918)
Sec. 34. Provisions relative to dispensing of violent poisons
Arsenical preparations, phosphorus; corrosive sublimate; atropine, strychnine, or any of their salts, hycocyanic acid or any of its salts; oil of bitter almonds containing hydrocyanic acid or prassic acid; oil of mirbane (Nitro-benzene); and such other poisonous substances which may from time to time be classified under this category by the Food and Drug Administration
Is prescription required? Yes
Posion Record Book shall be kept for: 5 years after last entry
Label: red label with** “POISON” & skull and bones**
Do not sell if** <18 years or mentally deranged**
**
Omitted provisions in Pharmacy law (not included in RA 10918)
Sec. 34. Provisions relative to dispensing of violent poisons
Arsenical preparations, phosphorus; corrosive sublimate; atropine, strychnine, or any of their salts, hycocyanic acid or any of its salts; oil of bitter almonds containing hydrocyanic acid or prassic acid; oil of mirbane (Nitro-benzene); and such other poisonous substances which may from time to time be classified under this category by the Food and Drug Administration
Is prescription required? Yes
Posion Record Book shall be kept for: 5 years after last entry
Label: red label with** “POISON” & skull and bones**
Do not sell if** <18 years or mentally deranged**
**
Sec. 35. Provisions relative to dispensing of less violent poisons
Classified by FDA
Is Rx required? Sold w/o Rx
Record: Poison Record Book
Sec. 36. Receptacle for poisonous drugs
Kept in securely lock when not in use
Section 37. Provisions relative to dispensing of abolifecients or anti-conceptional substances and devices
Provoke abortion or preventing conception (FDA Classified)
Is Rx required? Yes
Record Book: Separate record book for abortive or anticonceptional substance
RA 5921 Sec. 40
Penal Provisions
Fine of NLT 1000 but NMT 4000
or
imprisonment of NLT 6 months and 1 day but NMT 4 years
RA 10918 Art. VII Sec. 45
Penal Provisions
Fine of NLT 250,000 but NMT 500,000
imprisonment of NLT 1 year and 1 day, but NMT 6 years
or both
RA 10918 Art. VII Sec. 45
Penal Provisions Violations
- Display of COR where the RPh is not employed or ghost pharmacists
- Dispensing ethical Drugs by a non-pharmacist
- Compounding and dispensing not accordance with standards
- Practicing Pharmacy practice with expired or suspensed license
- Dispensing of prescription and pharmacist-only OTC pharmaceutical products
- Compounding and dispensing not in accordance with current Good Manufacturing Practice, Good Laboratory Practice and Philippine Practice Standards
- Selling of prescription and pharmacist-only OTC drugs to unlicensed pharmaceutical outlets
- Substituting prescription drugs which are not generically equivalent
- Forcing, coercing, or intimidating a duly registered and licensed pharmacist to compound or dispense
- Preparing and compounding of pharmaceutical products in quantities greatly in excess
- Noncompliance with the labeling requirements for dispensed medicines by a pharmaceutical outlet;
- Manufacturing and selling under fraudulent name or address
- Adulterating and misbranding
- Manufacturing and selling of unsafe, substandard and counterfeit pharmaceutical products;
- Operating an unlicensed pharmaceutical outlet
- Operating a Category A establishment without a registered pharmacist
- Operating a Category B establishment without the licensed pharmacist
- Practicing pharmacy with an expired, suspended or revoked license
- Filling and refilling of prescription and pharmacist-only OTC pharmaceutical products w/o rph
- Dispensing prescription drugs and pharmacist-only OTC drugs by rural health units w/o rph
RA 10918 Art. VII Sec. 46
Other penalties
Fine of NLT 100,000 but NMT 200,000
imprisonment of NLT 30 days, but NMT 1 year
or both
RA 10918 Art. VII Sec. 46
Violations
- Affixing of the title “RPh”
- Practicing without a valid COR, PIC or STP;
- Non-indication of a pharmacist of his/her COR
- Refusal to display the COR of the pharmacist in a prominent place
- Noncompliance on the filling of prescription
- Noncompliance on the requirements for partially-filled prescription
- Selling of physician’s samples
- Distribution of antimicrobials, including anti-TB drugs as physician’s samples;
- Removal, erasure and alteration of mark or label of physician’s sample
- Use of cipher, codes, or secret keys or unusual names or terms in prescriptions
- Rendering dispensing-related services by non-pharmacists without undergoing the training
- Filling of prescriptions where codes are used
- Employment of personnel without the required training and certification
- Dispensing pharmaceutical products in medical missions without the supervision
- Refusal of a non-pharmacist owner to undergo training and certification and CPD, training
- Noncompliance with
a. labeling requirements for dispensed medicines
b. requirements on the keeping of record books by a pharmaceutical outlet
c. required training and certification
Amendmens of RA 5921
PD 1363
18a - Citizenship
25 - Sale of med, pharm drugs and devices
39 - Req. for opening a drug store
PD 1926
18d - 5 to 4 years
EO 174
29 - Resp. for OPEs
40 - Penal provision
42C
CMO #3 s. 2005
18c - Internship program hourse
PD 1363
PD 1926
Approved by: F. Marcos
PD 1363: May 2, 1978
PD 1926: May 30, 1984
EO 174
Approved by: C. Aquino
May 22, 1987
CMO #3 s. 2005
Approved by: CHED
2005
