DDB ADVISORY:Yellow Prescription Pads Now Available

The Department of Health announced that the Yellow Pad are now available for distribution. They also would like to inform all pharmacies, physicians, dentists and veterinarians that the ordinary prescription pad can be used in prescribing dangerous drug until June 30, 2012 or until DOH Special Prescription Form is ready.

The ordinary prescription form is valid only if  provided in three copies and with the details stated below. Original copy will be surrendered to the pharmacy, the duplicate is retained to the patient, and the third one is the prescribing physician's copy.

1. Date of Prescription
2. Name and Address of the Patient
3. Name, address and contact number of the prescribing physician, dentist, or veterinarian with the            following:

• The Professional Tax Receipt (PTR) Number
• S-2 License Number
• Professional regulation Commission (PRC) License Number

4. Brand nam or generic name of the dangerous drugs

5. Total number of units to be supplied in words followed by its equivalent in numerals enclosed in parenthesis

6. Specific direction for use

7. Signature of the physician

Source: DDB Advisory May 17, 2012


Disclaimer: 

The information  contained here are intended solely for the general information of the reader and NOT intended to replace the what is written in DDB Advisory May 17, 2012. The owner of this site disclaims any responsibility for the decisions you make based on this information. If you have any further questions, please visit DDB Advisory May 17, 2012.

Educational Credential Evaluators, Inc. (ECE) Requirements

What is ECE? Educational Credential Evaluators, Inc. validates the accuracy and authenticity of the certification requirements. ECE can be applied at the same time as the FPGEC. Candidates are required to submit the ECE application together with appropriate fees. All payments must be made in dollars by money order, checks, or major credit cards (Visa or Mastercard). If money order is issued outside US, it must contain  the printed name of US bank in which the local bank is affiliated. The general evaluation report costs $85. A candidate must request ECE to submit the report directly to FPGEC since FPGEC will not accept report from candidates.

Source:ECE  

What are the requirements for ECE?
You will need to submit two sets of the following to ECE at
Educational Credential Evaluators, Inc.
PO Box 514070
Milwaukee, WI 53203-3470

1. Pharmacy Education Documentation
2. Official Pharmacy School Transcripts
3. Official Proof of Degree

Please refer to FPGEC Certification Program - Application Bulletin page 18 for details of the requirements.

Source: FPGEC Certification Program - Application Bulletin
ECE Website


Disclaimer: 

The information  contained here are intended solely for the general information of the reader and NOT intended to replace the official guidelines/policy set by NABP-FPGEC. The owner of this site disclaims any responsibility for the decisions you make based on this information. If you have any further questions, please visit NABP.

FPGEC Certification Program - Application Procedures

The following are the procedures in applying for FPGEC Certification Program:

1. Request for  FPGEC Application Request Form. The NABP will send you the official application form 5 business days after request is received. The length of time for mailing may vary subjecting on your location.
2. Complete the FPGEC Application and return to NABP together with your payment, documentation, two photographs, and certified photocopy of valid ID. (REQUIREMENTS)
3. Complete an application with Educational Credential Evaluators (ECE) for assessment of your educational credentials. (Requirements for ECE)

• The FPGEC assesses every application along with all the documentation submitted while the ECE General Evaluation Report validates the accuracy and authenticity of the certification requirements. If the FPGEC and ECE find that your application meet the requirements, you will recieve a letter of acceptance to sit for the FPGEE. On the other hand, if your application does not meet the requirements, they will be inform you to correct the flaws. 
• The processing of your application commence on the date of receipt and the initial evaluation will be finished within six weeks. Additional assessment is necessary each time you resend any other supporting documents and that will take six more weeks. That is why, reading carefully of FPGEC Certification Program - Application Bulletin is important so as not to miss a thing.
• Once your application is approved, the letter of acceptance will inform you that you need to register for the upcoming Foreign Pharmacy Graduate Equivalency Examination (FPGEE).

After accomplishing the above steps, the next thing to do is to take the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) and Test of English as a Foreign Language (TOEFL) Internet-based Test (iBT).

Source: NABP

Disclaimer: 

The information  contained here are intended solely for the general information of the reader and NOT intended to replace the official guidelines/policy set by NABP-FPGEC. The owner of this site disclaims any responsibility for the decisions you make based on this information. If you have any further questions, please visit NABP.

Documentation and Fees for FPGEC Certification Program

Foreign Pharmacy Graduates who would like to undergo the FPGEC Certification Program must submit official documents and other supporting documents once your application is granted.

Requirements:

1. Official Transcript of Record (TOR)
2. Official Proof of Degree (Diploma)
3. Official Proof of Licensure and/or Registration (can be request at PRC)
4. Photo Identification -certified photocopy of a current ID (example: driver's license, PRC ID, or passport)
5. Certified photocopies of a. birth certificate b. marriage certificates, court orders approving a name change, or state-issued identification cards. 
6. Photographs (two identical, full-face, passport size, taken within three months of the date the application is mailed to NABP)

For further details about the requirements, please refer to page 18 of  FPGEC Certification Program - Application Bulletin

Fees:

Payments must be made to NABP in the form of certified check, cashier's check, or money order, payable in US funds through US bank.

• Initial application: $800 ( $200 for the evaluation of documentation and $600 for the FPGEE)
• Re-examination after failure: $600
• Re-application after withdrawal or file closure: $800

For further details about the fees, please refer to page 5 of  FPGEC Certification Program - Application Bulletin

Related Post:

National Association of Board of Pharmacy

FPGEC Certification Program (US)

Documentation and Fees for FPGEC Certification Program
FPGEC Application Procedures

Source: NABP

Disclaimer: 

The information  contained here are intended solely for the general information of the reader and NOT intended to replace the official guidelines/policy set by NABP-FPGEC. The owner of this site disclaims any responsibility for the decisions you make based on this information. If you have any further questions, please visit NABP.

FPGEC Certification Program (US)

Two examinations to pass before issuance FPGEC Certification:

1. Foreign Pharmacy Graduate Equivalency Examination (FPGEE)
2. Test of English as a Foreign Language (TOEFL) Internet-based Test (iBT)

Source: NABP

Foreign Pharmacy Graduate Examination  Committee (FPGEC) which operates under the support and protection of National Association of Boards of Pharmacy (NABP) is in charge of advising the foreign pharmacy graduate about the guidelines of the FPGEC Certification Program and the Foreign Pharmacy Graduate Equivalency Examination (FPGEE).

The FPGEC assesses the qualification of foreign pharmacy graduate based on all the requirements submitted. As foreign pharmacy graduate it is very important that you read carefully the FPGEC Certification Program - Application Bulletin to understand the whole process.

Before a foreign pharmacy graduate will be considered to sit for FPGEE, the following are the qualifications are needed:

1. Candidate must graduated from a recognized or accredited school of pharmacy of a foreign country or jurisdiction. 
2. Candidates who graduated prior to January 1, 2003 must have completed at least a four-year pharmacy curriculum at the time of graduation.Candidates who graduated after January 1, 2003 must have completed at least five-year pharmacy curriculum at the time of graduation.
3. Candidates must provide documentation that you are licensed and /or registered for the unrestricted practice of pharmacy in a foreign country or jurisdiction. (REQUIREMENTS)
4. Candidates must submit a completed application form, fees and supporting documentation in accordance with the procedures established by FPGEC.

Two examinations to pass before issuance FPGEC Certification:

1. Foreign Pharmacy Graduate Equivalency Examination (FPGEE)
2. Test of English as a Foreign Language (TOEFL) Internet-based Test (iBT)

Related Post:

National Association of Board of Pharmacy

FPGEC Certification Program (US)

Documentation and Fees for FPGEC Certification Program
FPGEC Certification Program - Application Procedures

APPLICATION REQUEST FORM

Source: NAB

Disclaimer: 

The information  contained here are intended solely for the general information of the reader and NOT intended to replace the official guidelines/policy set by NABP-FPGEC. The owner of this site disclaims any responsibility for the decisions you make based on this information. If you have any further questions, please visit NABP.

National Association of Boards of Pharmacy (US)

"The National Association of Board of Pharmacy is an impartial professional organization that supports the state boards of pharmacy in creating uniform regulations to protect public health." 

 Source: (NABP) 

National Board of Pharmacy (NABP) members are 50 States of America, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, Australia, 8 Canadian Provinces, and New Zealand. The association was built to protect the public health by creating and executing uniform standards such as assessment and accreditation programs.

NABP offers the FPGEC Certification program to assess qualification of foreign pharmacy graduate. it is pretty important that candidates provide accurate documents to justify their educational backgrounds and registration in their own country.

What is FPGEC?
What is FPGEC Certification Program?
What are the qualifications for FPGEC Certification?
What are the documentation requirements for FPGEC Certification?
Where can I apply for FPGEC Certification Program?
What are the two examinations to take and pass before issuance of FPGEC Certification?
How much is the application fee?
Does the application fee includes the FPGEE?
What is FPGEE?
What is ECE?

Source: NABP

Disclaimer: 

The information  contained here are intended solely for the general information of the reader and NOT intended to replace the official guidelines/policy set by NABP-FPGEC. The owner of this site disclaims any responsibility for the decisions you make based on this information. If you have any further questions, please visit NABP.

Medicines fo Motion Sickness

The following are the medicines for Motion Sickness

Prescription Drugs (Rx)

1. Brand Name: Stugeron 25 mg ( Janssen)

    Generic Name: Cinnarizine

    Dosage Form: Tablet

    Dosage: 

    - for adult: 1 tablet  

    - for children:1/2 tablet 

    *All doses to be taken 1/2 hour before travelling every 6 hour.

2. Brand Name: Cinamin 25 mg ( INTERHEALTHcare)

    Generic Name: Cinnarizine

    Dosage Form: Tablet

    Dosage:

    -for adult:  1 tablet 

    *To be taken 1/2 hour before travelling and 6 hourly thereafter.

3. Brand Name: Dizzinon 25 mg (JustRight Pharma)

    Generic Name: Cinnarizine

    Dosage Form: Tablet

    Dosage: 

    - for adult: 1 tablet 2 hour before start of journey and 1/2 tablet every 8 hour

    -for children 5 to 12 years old: 1/2 tablet 2 hour before start of journey and 7.5 mg every 8 hour

4. Brand Name: Niziran 50 mg (Crisdy-na)
    Generic Name: Cinnarizine
    Dosage Form: Capsule
    Dosage: 
    - for adult: 1 capsule three times a day. 
5. Brand Name: Vertisin 25 mg ( Littman)
    Generic Name: Cinnarizine
    Dosage Form: tablet
    Dosage: 
    - for adult: 1 to 3 tablet three times a day. 

Non-Prescription Drugs (Non-Rx)

1. Brand Name: Bonamine 12.5 mg, 25mg (Johnson & Johnson)

    Generic Name: Meclizine HCl

    Dosage Form: Chewable Tablet

    Dosage: 

    -for adult and children 11-12 years old: 25mg-50mg 

    -for children 5 to 10 years old: 12.5 mg 

    *All doses to be taken 1 hour before travel for 24-hour protection

2. Brand Name: Dizitab 25 mg ( United Lab)

    Generic Name: Meclizine HCl

    Dosage Form: Chewable Tablet

    Dosage: 

    - for adult and children 12 years old: 1 to 2 tablet 

    - for children 6 to 12 years old: 1/2 tablet 
3. Brand Name: Nodiz 12.5 mg and 25 mg (Pascual)
    Generic Name: Meclizine HCl
    Dosage Form: tablet
    Dosage: 
    -for adult and children 11-12 years old: 25mg-50mg 

    -for children 5 to 10 years old: 12.5 mg 

    *All doses to be taken 1 hour before travel for 24-hour protection
4. Brand Name: Postadoxine 25 mg (UCB)
    Generic Name: Meclizine HCl
    Dosage Form: tablet
    Dosage: 
    - for adult: 25-50 mg 
    - for children 5 to 10 years old: 12.5 mg to 25 mg
    * All doses to be taken 1 hour before the anticipated motion. May be repeated every 24 hour for the duration of journey.

Source: MIMS Philippines

_________________________________________________________

Disclaimer: 

The information and reference materials contained here are intended solely for the general information of the reader and NOT intended to replace the advice of a doctor. The owner of this site disclaims any responsibility for the decisions you make based on this information. If you have any health-related questions, persistent health condition or before taking any medication, please consult your health care provider.

Motion Sickness

If you ever feel sick because of rough airplane, train, bus, boat ride then you know how uncomfortable having motion sickness.

Photo Courtesy of marcello from potenza, italy

Motion sickness is a condition in which some parts of the body detect motion while the other parts do not sense it at all. The inner ear, eyes, and other parts of the body sense that there's motion while the body itself is in static position only. When such conflicts arise on the brain, motion sickness occurs. Example of this is when you are riding a train, you see movement outside your window moves while you are sitting inside the train. That sends the conflicting message to the brain causing you feel the following symptoms:

1. Nausea
2. Vomiting
3. Headache
4. Cold Sweats
5. Malaise

Motion sickness is usual to children over 2 years but become common with age, women, and elderly people. Taking prescription or nonprescription medicines can prevent or reduce symptoms. Symptoms are hard to stop when they start. 

Treatment: 

Drugs last for certain time in the body and this may mean taking another dose may be necessary. That is why considering the length of journey and the time of departure in preventing the onset of travel sickness. Most of these medicines are best taken before you travel to give them the chance to become fully active before voyage begins.

Non-Prescription Drug (Non-Rx)
   Generic Name: Meclizine HCl

1. Bonamine 12.5 mg & 25 mg 
2. Dizitab 25 mg
3. Nodiz 12.5 mg & 25 mg 
4. Postadoxine 25 mg 

Prescription Drug (Rx)

   Generic Name: Cinnarizine

1. Stugeron 25 mg 
2. Cinnamin 25 mg 
3. Dizzinon 25 mg
4. Niziran 50mg
5. Vertisin 25 mg

_________________________________________________________

Disclaimer: 

The information and reference materials contained here are intended solely for the general information of the reader and NOT intended to replace the advice of a doctor. The owner of this site disclaims any responsibility for the decisions you make based on this information. If you have any health-related questions, persistent health condition or before taking any medication, please consult your health care provider.

Unregistered Slimming Products

Numerous unregistered slimming products are now ordered for recall from the market and ban for distribution by FDA Philippines. Results of laboratory tests conducted by FDA showed that they contain one or combination of Amphetamine (dangerous drug), Sibutramine (withdrawn in the market) and/or steroids (prescription drug). These components made them unsafe or dangerous for human consumption.  

All drugstores and other establishments are alerted that importing, selling or distribution of identified slimming products are violations of Republic Act 9711 or Food and Drug Administration Act of 2009. Therefore, if caught doing so will be penalized accordingly. 

List of UNREGISTERED SLIMMING PRODUCTS

Source:

FDA CIRCULAR No. 2012-003  

Guidelines on Product Registration with FDA

A company with a valid License to Operate from FDA must register their products with FDA as well. Evaluating the safety, efficacy and quality of the product is important prior to issuance of Certificate of Product Registration (CPR). After the company secured the CPR, the product is now ready for marketing, distribution and selling.

What are the requirements for product registration with FDA? Each product has its own checklist. Please click below, the name of the product to be registered to see the checklist of requirements for registration.

Pharmaceutical Products for Human Use

Food Supplement

Medical Devices

Locally Manufactured Food Products

Imported Food and Food Products

Virgin Coconut Oil (VCO)

In Vitro Diagnostic Reagents

Biological and Vaccines

Herbal Medicines

Traditionally Used Herbal Medicines

Pharmaceutical Products for Veterinary Use

Household Hazardous Substances

In every application for registration, a duly notarized Letterof Application must be attached along with other requirements in the checklist.

Procedure for Product Registration with FDA

1. Submit the application and all the requirements at Public Assistance Information & Compliance Section (PAICS Room 101) for assessment of documents.
2. Accounting and billing (Room 114) for order of payment.
3. Payment and Issuance of Official Receipt at the cashier (Room 112)
4. Present the OR, Assessment Slip and Dossier at PAICS for issuance of Routing Slip No. (RSN)
5. Product services Division (Ground Floor, Annex Bldg.) will evaluate the technical documents and labeling materials submitted prior to preparation of endorsement for Certificate of Product Registration (CPR) or Letter or Denial (LOD) or Notice of Deficiency (NOD).
6. Upon endorsement for CPR, the director (Room 218) signs the CPR and will be forwarded to Releasing Section (Room 100).

Please note the schedule for application of FDA Product registration.

• Mondays – Processed Food
• Tuesdays and Wednesdays – Drugs, Medical Devices, Diagnostic Reagents, Drug Testing Kit, Biological and Vaccines, Herbal and Traditionally Used Medicines
• Thursdays – Cosmetic, Household Hazardous Substances 

Product registration process from submission of requirements varies depending on type of product: for Pharmaceutical 8 months to 1 year, for Food 30- 90 days, for Cosmetics 2 weeks to 1 month and for other products, ask the officer at the PAICS.