DRUG - TEAM 2 6 August 2013 Philippine Association of Pharmacists - - PowerPoint PPT Presentation

Republic of the Philippines Department of Health Food and Drug Administration

DRUG - TEAM

Philippine College of Pharmaceutical Medicine Philippine Association of Pharmacists in the Veterinary Industry

125

regulations reviewed

Total

54 31 21

Administrative Orders Bureau Circulars Memorandum Circulars

2

PSD Memos

125

Total

4 3 2

FDA Circulars FDA Memorandum Circulars FDA Memorandum

5

Miscellaneous Regulations

regulations reviewed From 1968 up to 2013

35 12 11

Registration Licensing Clinicals

67

Guidelines/Instructions

REGULATIONS

DEALING

with

125

54 28 2

Updated For deletion Redundant

33

For revision/outdated

regulations reviewed

7

For further review

FOCUS

in

AO 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets

RECOMMENDATION

Definition of Manufacturer To align definition of a manufacturer with the ASEAN definition Specific licensing reqt for Vet manufacturer Chapter 1 2.1.1.3 - Valid Certificate of Registration of the Establishment’s Filipino Pharmacist from PRC To consider vet group 2.1.1.4 – Certificate of attendance to FDA Licensing seminar State validity of seminar attended Clarify accreditation vs. Certificate of Attendance 2.2.1.2 – Books required Add vet books like PNVDF, EP and PVET

AO 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets

RECOMMENDATION

3.1.1 Period of validity of Initial and Renewal; 5.2 Validity and Schedule of Fees Review with 2013-2014 Schedule of fees 4.3 Reapplication after Revocation Revision of the five years requirement is too long 5.2 Activities engaged by an establishment For review to allow vet to engage in veterinary drugs and products (cosmetics, food, etc)

AO 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets

RECOMMENDATION

Chapter 2 2.2.1.2 – Books required USP – delete Goodman and Gilman - review Prescription books – given more worth Poison books – delet Senior Citizen and Person with Disability Books – to be included Distribution record book for dangerous drugs 2.2.1.5, 2.2.2.4, 4.3.3 Physical presence of pharmacist when establishment is open To review with pending Pharmacy Law amendment 2.2.1.6.2, 4.2.2 – Filing of prescriptions, recording Review since most Rx are not left with pharmacist 2.2.1.6.3, 2.2.2.5.2 Dry seal

• r rubber stamp

Delete

AO 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets

RECOMMENDATION

2.2.2.1.1– Signboard To reflect only the name in the signboard 4.1 Temporary closure To review with pending Pharmacy Law amendment

REGULATION RECOMMENDATION

AO 54 s. 1999 Change of Manufacturers of Drug Products in Compliance with the CGMP Requirements To incorporate ACTD adoption BC 12 s. 2005 BFAD Quality Seal To consolidate with MC 15 s. 1992, Measures of Compliance with Good Manufacturing Practices MC 2 S. 1991 Clarification of "packing" and "repacking" in the definition of drug manufacturer Clarification to secure license to operate for packing and repacking activities only

REGULATION RECOMMENDATION

BFAD Reg 1 s. 1988 Amended general Regulation for the Licensing of Drug Establishment Should be updated to reflect changing regulatory environment (specify) MC 2 s. 1990 Compliance with AO 56 s. 1989 update sanctions and penalties for non- compliance to the law

AO 67 s. 1989 Revised Rules & Regulations

• n Registration of

Pharmaceutical Products

RECOMMENDATION

General To accomodate ACTD 2 General Standards Revise annotation re: new registration for new manufacturer; to follow ASEAN Variation 3.3 Pharmacological/therapeutic category this should not be based on PNDF if it is a new drug since most probably this is not yet included in the PNDF. Include provision for drugs not in PNDF 3.5 Branded/Generic Remove patent protection as this is not under FDA's jurisdiction. Update classification, as per current situation: Branded (innovator) Branded (Generics) Generic (generic)

AO 67 s. 1989 Revised Rules & Regulations

• n Registration of

Pharmaceutical Products

RECOMMENDATION

3.6 Annotation agreement between FDA and PDEA should be revisited 3.6.4 Drugs requiring strict precaution in prescribing and dispensing Update List B drugs 4.3 Evaluation by testing of submitted sample Testing of physical attributes against Certificate of Analysis 4,5 Action on Registration Application deficiency letters (NODs, reapplication) must be included as an action on registration 4.5.4 MR Validity revise to include current practice for MR products FDA Circular No. 2013-004 (validity of 5 years maximum with no extension for MR registration) 4.7 Grounds for limited Approval revise to include current practice for MR products FDA Circular No. 2013-004 (risk management plan instead of PMS Protocol)

AO 67 s. 1989 Revised Rules & Regulations

• n Registration of

Pharmaceutical Products

RECOMMENDATION

5 Renewal to align with current regulation on renewal i.e. Automatic renewal, regular renewal Schedule of Fees update fees ANNEX 1 General Requirements align with ACTR ANNEX 1, General Requirements ,5 Number of Label number of labeling materials required must be aligned with checklist ANNEX 1, Specific Requirement, 2 New Drug revise to include current practice for MR products FDA Circular No. 2013-004 Annex 1, Add'l Reqt 3 Branded Drug, 5 Investigational Drug, 6 New Drug delete these parts; not current practice Annex 1, Add'l Reqt 4 Imported Finished Product change to include CPP and Export Certificate/Free Sale (if product is not marketed in country of origin)

REGULATION RECOMMENDATION

BC 05 s. 1997 Revised Checklist of Requirements and the 1997 Guidelines for the Registration

• f Pharmaceutical Products

To accomodate ACTD To provide separate checklist for Vet Products To adopt ACTD glossary and reclassify existing terms vis a vis (i.e. NDA vs NCE) AO 2006-0021 Supplemental Guidelines to AO 67 s.1987: Revised Rules & Regulations on Reg. of Pharmac'l Products & BC 5 s.1997 in evaluating NDA To incorporate FDA Circular 2013-004 – PMS To provide separate checklist for Vet Products AO 2005-0031 Guidelines & Procedures for the Issuance of the PCPR & the Listing of Identical Drug Products based on the Identity

• f Manufacturer & Pharmac'l

Formulation To address labeling concerns for LTO To provide separate checklist for Vet Products

BC 12 s. 1991 Clarification of New Registration when there is a Change of Manufacturer To delete in alignment with ACTD MC 16 s. 1991 Conditional Registration for Improvement of Immediate Container of Packaging of Registered Drug Products To incorporate ASEAN Variation Guideline AO 4 s. 1992 Policy & Requirements for Availing of Compassionate Special Permit (CSP) for Restricted Use of Unregistered Drug & Device To provide implementation details (i.e., manner of importation) Consider one time issuance for total therapy regimen BC 4 s. 1995 Period within which an Initial Conditional Registration shall be Processed and Issued Delete following latest issuance of schedule of fees

AO 55 s. 1988 Requirements for labeling materials of pharmaceutical products

RECOMMENDATION

2.1 Minimum mandatory information to allow the option of putting "see package insert for full prescribing information" or "see package insert for indication, contraindication, precaution and warning" 2.4 Label of the primary container outside of the PDP there should be a provision for small labels i.e. ampules or vials on what minimum mandatory information should be seen 4 Biological Products there should be more detailed labeling requirements for biologicals

AO 55 s. 1988 Requirements for labeling materials of pharmaceutical products

RECOMMENDATION

9 Small Containers revisit minimum mandatory requirements stated in 9.2; amount of info vs size of labels and weigh risk-benefit of making the important info readable than overcrowding the small label Consider other means for indicating important drug information on immediate container label 11 Exemption put a clear guideline on criteria for exemption and align with FDA circular 2013-012 RE: Validity of GLE for Pharma Products

FOR CONSOLIDATION

AO 85 s. 1990 Requirements for labeling materials

• f certain categories of products

containing two or more active ingredients BC 5 s. 2005 Black box warning for all anti- depressant drugs AO 99 s. 1990 Requirements for labeling materials

• f categories of pharmaceutical

products containing four or more active ingredients outside the coverage of AO 85 s 1990 PSD Memo 2-2005 Black box warning for all erythromycin products AO 23C s. 2000 Policies & Guidelines on OTC Drug Products BC No. 3 s. 2003 Mandatory printing of boxed warning

• n all phenylpropanolamine (PPA)

containing products (OTC and Rx)

BO 67-B s. 1996 Requiring the inclusion of warning statement for products containing sodium metabisulfite and other derivatives of this sodium salt PSD Memo 06-2005 Standard indication and black-box warning for all COX-2 inhibitors MC 6 s. 1991 Implementation details of AO 99 s. 1990 BC No. 18 s. 2005 New advisory on labelling selective cycloxygenase-2 (COX-2) inhibitors and non-steroidal anti-inflammatory drugs (NSAID) FDA Circular No. 2011-002 Application for Revisions/Updates in the Package Insert, Patient Leaflet Information, Prescribing Information, Core Data Sheet and Basic Succinct Statement BC No. 8, s. 2005 (selective COX-2 inhibitors) AO 61 s. 1968 General regulations for the enforcement of the food, drug & cosmetic act (C-3 Misbranding- Drugs & Devices) BC No. 11 s. 2005 Revised labelling of selective COX-2 inhibitor drugs and NSAIDS

Bam Aquino and C. Villar expressed interest Cong Datu & Gloria Arroyo, Cong Defensor Draft reviewed in June 2013 Already submitted to PRC legal office for their comment

"Pharmacy Assistants" are persons who assist pharmacists in compounding and dispensing of medicines in community, hospital, industrial settings and in other activities, such as, but not limited to medical missions, under the supervision of the pharmacist and as described in Section 41 of this Act. Pharmacy aides/clerks are those who assist in other aspects of pharmacy operation.

• SEC. 41. -Handling of Drugs by Persons Other than a Pharmacist, - For the

purpose of this section, persons handling drugs other than the pharmacist are: professional medical ,representatives, pharmacy assistants, pharmacy aides/clerks, and other persons who assist pharmacists in dispensing medicines or any other person performing functions involving the handling of drugs and drug products, It is preferred that these positions are occupied by those who finished pharmacy degree, not necessarily licensed as pharmacists and who have undergone the prescribed training from a Commission-accredited provider. No person, except pharmacy graduates, shall be allowed to render such services without undergoing comprehensive standardized training programs approved and accredited by the Board, A reasonable fee shall be assessed by the accreditation board for the examination and accreditation.

"Non-traditional outlets" ~ other retail outlets licensed by FDA other than drugstores and pharmacies where drugs are made available in conjunction with the provisions of R.A.9502. "Online pharmacy" refers to any activity of taking orders for medicines

• nline or thru the internet

" "Pharmaceutical marketing" means any activity undertaken, organized or sponsored by a drug establishment which is directed at promoting the prescription, recommendation, supply, administration or consumption of its pharmaceutical product(s) through direct personal contact and all media, including the internet; "Telepharmacy" is the provision of pharmacy services utilizing electronic information and communication technology under the supervision of a pharmacist;

• SEC. 23. Non payment of the Registration Fees. –

The Board shall suspend a registered pharmacist from the practice of his/her profession for non-payment of the PRC registration fees for more than three (3) consecutive years from its last or previous year of

• payment. The resumption of his/her practice shall take place only upon

payment of delinquency fees plus surcharges and interest and in accordance with the rules of the Commission. The ruling of the three- year period may be interrupted upon written notice about the discontinuance of his/her practice and surrender of his/her certificate of registration with professional identification card to the Board and/or the Commission.

• SEC. 20. Affixing R.Ph. after a Registered Pharmacist's Name - Only

pharmacists who are duly registered and licensed by the Board and the Commission has the light to affix the title, "Registered Pharmacist" or "R.Ph." after his/her name.

• SEC. 29. Indication of Numbers: Certificate of Registration, Professional

Tax Receipt , ad Accredited Integrated National Organization (AIPO)

• membership. - The pharmacist shall be required to indicate on any

document he/she signs, uses or issues in connection with the practice of pharmacy the following information: (a) his/her registration number and date of issuance, (b) the expiration dale of his/her professional identification card, (c) the Professional Tax Receipt (PTR) Number and date of issuance, and (d) the certificate of AIPO membership (annual/lifetime) number and the

• fficial receipt of payment, number and date.

Concerns from the Industry was raised

• SEC. 30. Registry of Pharmacists. –

The Board shall prepare and maintain a registry of the names, residences and/or office addresses of all registered pharmacists which shall be updated annually in cooperation with the Accredited Integrated Professional Organization (AIPO), indicating therein the status of the certificate of registration, professional identification card and Accredited Integrated Professional Organization (AIPO) membership, whether valid or inactive due to death, or other reasons, delinquent, suspended or with revoked certificate of registration. The said registry of pharmacists shall be conspicuously posted within the premises of the Commission and the information therein made available to the public upon inquiry or request.

• SEC. 31. Display of Certificate of Registration. -It shall be the duly of

every pharmacist engaged in the practice of pharmacy either on his/her

• wn account or under the employ of another to display his/her original

certificate of registration in a prominent and conspicuous place in a retail drug outlet or drug establishment which he operates or in which he/she is employed in his/her professional capacity as

• pharmacist. No pharmacist shall, with his/her knowledge, allow

his/her certificate of registration to be displayed in such establishment when he/she is notactually employed or operating therein in his/her professional capacity. A photocopy of the registration certificate duly certified by the Board shall be displayed in Category B establishments as described in Section 33 of this Act.

• SEC. 33. Pharmacist Requirement and Compensation. -

Category A. Establishments where the direct and immediate control, supervision and responsibility of a registered and licensed pharmacist is required at all times when open for business include:

• 1. Every drug establishment/outlet selling prescription drugs and

medicines, ethical products, pharmacists-only over-the- counter drugs and medicines and medicated cosmetics whether owned by the government or a private person or firm, whether sold at wholesale or retail

• 2. Each operation of pharmaceutical laboratories, pharmaceutical

manufacturing laboratories or other establishments with processes involving the preparation, manufacture, quality control, repacking, importation, exportation, distribution, sale or transfer of pharmaceutical products and medicated cosmetics in quantities greatly in excess of single therapeutic doses

• SEC. 33. Pharmacist Requirement and Compensation. –

Category B. Establishments where supervision and oversight of a registered and licensed pharmacist is required pursuant to the provision of pertinent laws include:

• 1. Retail outlets selling over-the-counter drugs only
• 2. Establishments involved in the manufacture, importation,

exportation, distribution and sale of medical devices

• 3. Institutional pharmacies providing medicines to employees

and their relatives

• 4. Government agencies including local government units, city

and municipal health units, and, private establishments involved in the procurement, distribution, dispensing and storage of drugs and medicines

• 5. Institutions providing telepharmacy services
• 6. Other non-traditional outlets of drugs and medicines provided no

prescription or ethical products are sold

• SEC. 33. Pharmacist Requirement and Compensation. –

A pharmacist working in a Category A establishment may be allowed to simultaneously work or render pharmacy services in not more than two Category B establishments, provided that the Category B establishments are within a ten (l0) kilometer radius from the Category B

• SEC. 33. Pharmacist Requirement and Compensation. –

Pharmacists in government service shall receive a starting salary equivalent to Salary Grade 15 as provided in R.A. 6758 (Compensation and Position Classification Act of 1989) and its amendments. Pharmacists in the private sector shall receive an entry-level salary in peso equivalent of at least 35% above the prevailing minimum wage.

• SEC. 43. Membership in the Accredited Integrated Professional

Organization of Pharmacists. – All registered pharmacists and pharmacy assistants must be members of the AIPO and must maintain membership throughout the duration of the practice of the profession. Professional identification card shall not be renewed if the requirements for membership with AIPO are not met including credit units for attendance at duly accredited continuing professional development (CPD) education activities.