RA 5921-10918 Pt 2 Flashcards

1
Q

Sec 18. Report of rating

A

Report within 3 working days after the last days of the examination

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2
Q

RA 5920 Sec. 20. Rating Required

A

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

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3
Q

RA 10918, Sec. 17 Ratings

A

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

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4
Q

A prescribed study program in an accredited school of pharmacy

A

Refresher Program

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5
Q

Process wherein a pharmacist provides consultative services and conducts prelimiary assessment of symptoms and refers the patient to a physician

A

Refererral

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6
Q

The record book maintained by pharmacists, listing the patients referred to different health facilities for durther diagnosis

A

Referral/Registry

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7
Q

Is affixing RPh after a registered pharmacist’s Name lawful?

A

Yes

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8
Q

Documents needed for Indication of Information

A

COR, PIC

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9
Q

Registry of Pharmacists is updated on what period interval

A

Once a year

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10
Q

Display of Certificate of Registration

A

Category B: Certified True Copy or Duplicate from PRC

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11
Q

Retail Drug outlets are licensed by what agency

A

FDA

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12
Q

Dispensing of Rx and POOM during emergency cases must be reported to the supervising pharmacist within

A

24 hours

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13
Q

Is it lawful for manufacturers to allow unlicensed outlets to dispense their manufactured drugs

A

No

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14
Q

Category A Pharmacist

A

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;
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15
Q

Category B Pharmacist

A

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.
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16
Q

Sec. 39. Handling of Pharmaceutical Products by Persons Other Than a Pharmacist

A

Non-pharmacist pharmacy owners should undergo a comprehensive standardized training program

17
Q

Sec. 40. Administration of Adult Vaccines

A
  • 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.
18
Q

Art. 5, Sec 41. Accredited Professional Organization (APO) of Pharmacists

A

Integrated into one (1) national organization registered with the Securities and Exchange Commission (SEC) which shall be recognized by the Board and the PRC

19
Q

Section 42. Membership to the Integrated and Accredited Professional Organization

A
  • 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
20
Q

Section 43. Specialty Boards in Various Areas of Pharmacy Practice

A

Accreditation by the Board and the PRC.

21
Q

Section 22. Practice Through Special/Temporary Permit (STP)

A
  1. being a consultant in foreign-funded or assisted projects of the government;
  2. being engaged or employed by a Filipino employer or establishment;
  3. providing free services in humanitarian missions: and
  4. being a visiting faculty member in any field or specialty in pharmacy
22
Q

Conditions in securing STP

A
  • 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.
23
Q

Omitted provisions in Pharmacy law (not included in RA 10918)

A

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**
**

23
Q

Omitted provisions in Pharmacy law (not included in RA 10918)

A

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**
**

24
Sec. 35. Provisions relative to dispensing of less violent poisons
Classified by FDA Is Rx required? Sold w/o Rx Record: Poison Record Book
25
Sec. 36. Receptacle for poisonous drugs
Kept in securely lock when not in use
26
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
27
28
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
29
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
30
RA 10918 Art. VII Sec. 45 Penal Provisions Violations
1. Display of COR where the RPh is not employed or ghost pharmacists 2. Dispensing ethical Drugs by a non-pharmacist 3. Compounding and dispensing not accordance with standards 4. Practicing Pharmacy practice with expired or suspensed license 5. Dispensing of prescription and pharmacist-only OTC pharmaceutical products 6. Compounding and dispensing not in accordance with current Good Manufacturing Practice, Good Laboratory Practice and Philippine Practice Standards 7. Selling of prescription and pharmacist-only OTC drugs to unlicensed pharmaceutical outlets 8. Substituting prescription drugs which are not generically equivalent 9. Forcing, coercing, or intimidating a duly registered and licensed pharmacist to compound or dispense 10. Preparing and compounding of pharmaceutical products in quantities greatly in excess 11. Noncompliance with the labeling requirements for dispensed medicines by a pharmaceutical outlet; 12. Manufacturing and selling under fraudulent name or address 13. Adulterating and misbranding 14. Manufacturing and selling of unsafe, substandard and counterfeit pharmaceutical products; 15. Operating an unlicensed pharmaceutical outlet 16. Operating a Category A establishment without a registered pharmacist 17. Operating a Category B establishment without the licensed pharmacist 18. Practicing pharmacy with an expired, suspended or revoked license 19. Filling and refilling of prescription and pharmacist-only OTC pharmaceutical products w/o rph 20. Dispensing prescription drugs and pharmacist-only OTC drugs by rural health units w/o rph
31
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
32
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
33
34
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
35
PD 1363 PD 1926
Approved by: F. Marcos PD 1363: May 2, 1978 PD 1926: May 30, 1984
36
EO 174
Approved by: C. Aquino May 22, 1987
37
CMO #3 s. 2005
Approved by: CHED 2005