I do not know how they come up with this costly seminars? Was their any consultation from the pharmacy organizations, pharmacists, and pharmacy industry? How about those newly passers that are looking for jobs and needing seminars, provided, they had previous expenses from their board review and exam, also with their graduation, and immediately a very expensive training will appear in their sight? How would those newly pharmacists response on these high cost seminars and training, if almost drugstores and owners are only mediocre in income and status? FDA must be considerate that not every drug establishment and pharmacist can afford to enroll to their very costly seminars and trainings. Maybe those big pharmaceutical companies and chained drugstores can afford them.
IPP REVENUE HITS
Thursday, February 28, 2013
FDA Seminar and Training for 2013
You will be surprised again if you see these seminars and trainings and how much they cost and worth. The seminars and trainings were scheduled already, also how many participants and days of trainings were already stated.
I do not know how they come up with this costly seminars? Was their any consultation from the pharmacy organizations, pharmacists, and pharmacy industry? How about those newly passers that are looking for jobs and needing seminars, provided, they had previous expenses from their board review and exam, also with their graduation, and immediately a very expensive training will appear in their sight? How would those newly pharmacists response on these high cost seminars and training, if almost drugstores and owners are only mediocre in income and status? FDA must be considerate that not every drug establishment and pharmacist can afford to enroll to their very costly seminars and trainings. Maybe those big pharmaceutical companies and chained drugstores can afford them.
I do not know how they come up with this costly seminars? Was their any consultation from the pharmacy organizations, pharmacists, and pharmacy industry? How about those newly passers that are looking for jobs and needing seminars, provided, they had previous expenses from their board review and exam, also with their graduation, and immediately a very expensive training will appear in their sight? How would those newly pharmacists response on these high cost seminars and training, if almost drugstores and owners are only mediocre in income and status? FDA must be considerate that not every drug establishment and pharmacist can afford to enroll to their very costly seminars and trainings. Maybe those big pharmaceutical companies and chained drugstores can afford them.
US-FDA Attempts: Americans Can Obtain Drugs Without Prescription
Did you know that US-FDA attempts to take off prescription and allows Americans to obtain some drugs for hypertension, asthma, diabetes, and others without prescription.
It is being processed and contemplated by US-FDA that obtaining drugs can be done without prescription to cut off the expenses of patients going to visiting and consulting high-ceiling paying doctors. And help them to save more in their pocket and insurance. The ethical medicines can be made available as OTC drugs do, and pharmacists involvement and responsibility will be greatly needed.
If you want to read the whole article you can read as this site: http://www.washingtontimes.com/news/2012/apr/29/fda-may-let-patients-buy-drugs-without-prescriptio/?page=all#.T6VD4p02-uw.facebook
It is being processed and contemplated by US-FDA that obtaining drugs can be done without prescription to cut off the expenses of patients going to visiting and consulting high-ceiling paying doctors. And help them to save more in their pocket and insurance. The ethical medicines can be made available as OTC drugs do, and pharmacists involvement and responsibility will be greatly needed.
If you want to read the whole article you can read as this site: http://www.washingtontimes.com/news/2012/apr/29/fda-may-let-patients-buy-drugs-without-prescriptio/?page=all#.T6VD4p02-uw.facebook
My Pharmacy Practice
Hello there! Before you read my article I would just introduce a little of me. I am a pharmacist by profession and about four years in practicing my chosen career. I am a pharmacist in one of the community drugstores in MetroManila, which is near hospital. I do a lot of work everyday. My work includes maintaining the quality of stocks, storage, administrative work, liaison and etc. My function also encompasses the dispensing or filling customers' prescription/s, procuring and receiving deliveries, engaging with salesmen and few detailmen, pricing and many more. It is my task also to keep the pharmacy in good status within the policy and regulation that FDA and PDEA are imposing.
I do some counseling and interrogation with some patient but always that concept of being pharmacist is elusive within my practice. But still I tried to talk and advice patient sometimes, whenever their is a need of it or a reason to talk about him/her that matter.
The pharmacy setting as we think in the Philippines is not the ideal setting to practice. As we perceived long ago that becoming a pharmacist in our country means you are going to be a vendor in a pharmacy or drug establishment. But wait our profession is not in that thing at all. Filipinos are idealistic, we are very presumptuous that other countries' pharmacy practice are better than us. But come to think with this, any place you go, the feeling is the same, the conditions or predicaments are parallel, the day to day work does not far from the actual.
I have just read blogs of the pharmacists in the USA about their seething and bold talk of their practice with regards to community pharmacy condition. Their experience with American customers, who are very pampered with their insurance, convenience and filling of prescriptions. If your read their blogs they are being pest, always moody and sometimes want to killing their patient by filling them with wrong drug instead of the right one. You can sense their feeling of engaging with customers who are very rude, indecent and very demanding that make them angry, exhausted and unkind.
We thought that everything that involved in pharmacy profession in the US is very perfect as if their is no flaw, and because we idolized their being so perfect, we are dreaming that we would be like that. But wait did you know that even pharmacists their are always in bad situation and exhausted and complaining about indecency of their patients or their day is ruined by filling patient's prescription?
I show you some ideal thing we admired most from them, but the fact that the same thing happens to us also.
1.USA Setting: The patient would call the pharmacy to tell if his prescriptions are already sent to them by his doctor and be ready to pick up sooner. But afterwards the pharmacist filled the prescriptions and notifies the patient about his bill and the patient sees the cost is expensive, he gonna change his mine and request the pharmacy to transfer his prescriptions to a bigger chained drugstore in the USA. After filling and long time of working for that, the patient has no consideration of appreciating the work of pharmacist to get the filled prescription and prepared drugs for him. That would cause bad effects to the pharmacist.
Philippine Setting: After reviewing the patient's prescription and noting all the prices and calculated the whole cost of the prescription, the patient would change his mine and not to buy anymore because he just into canvassing to where he can buy less expensive drugs. That would be a bad day to have and make the pharmacist or salesclerk to be moody at all.
2. USA Setting: Some patients and customers are demanding and feel they are VIP. They get irate when their prescription is not filled within 5 minutes or less.
Ph Setting: Patient gets irate whenever his prescription filling is very long even he stands there just less than a minute yet.
3.USA Setting: Patient who says his prescription filling is expensive, however, almost all expenses are covered by his insurance.
Ph Setting: Even we never collect payments from insurance, in our setting, the patients are given the least price of medicines and still they are complaining about the price.
If you want to know about more strange and very ridiculous experiences of pharmacists in the US, please read some blogs that can relate to your situation and practice.
Conclusion:
I know that pharmacy setting in the Philippines is not as strict as in the USA with prescription, policy and reputation, I can say we are still lucky to have such practice like this in the Philippines. The reason I said that are the following:
1. Almost all customers are very pleasing, well-mannered and easily to convince. They do not ask many things anymore and believe what you are validly saying to them.
2. No insurances to take, no receiving of prescription through fax, phone or email because it is not yet well implemented and no vivid regulation regarding those and especially no drive thrus.
3. Pharmacy is not being manned by pharmacist alone but along with salesclerks and pharmacy assistants.
4. The basis of payment is cash or card.
5. Easily to end up transaction.
6. Prescription strictness is not absolute and many customers buy ethical drugs as OTC drugs do.
7. Pharmacist may not be present at business hours (depends on the policy of drugstore, but it is against the law to operate without pharmacist)
While the best things in the US is that:
1. No prescription, no filling!
2. Patient-doctor-and-pharmacist relationship is open and active.
3. Strictly implemented, No pharmacist no operation. Especially on lunch time, pharmacies close for 30 minutes to 1 hour, so patients are complaining whenever they needed their drugs to fill or refill.
4. Pharmacists are actively involving in patient counseling, dispensing and monitoring patient's record.
4. Pharmacists are actively involving in patient counseling, dispensing and monitoring patient's record.
5. Pharmacists are highly respected and considered as their first choice to consult about drugs.
6. Pharmacies rapport is harmonious and help each other wherever the patient chooses to fill his prescription.
7. Pharmacist are the ones who prepare the prescription and also imprint the label needed in filling.
Tuesday, February 26, 2013
SUMMARY OF ADMINITRATIVE ORDER NO. 56 SERIES OF 1989
Title: REVISED REGULATIONS FOR THE LICENSING OF DRUG
ESTABLISHMENTS AND OUTLETS
Types of Drug Establishments:
- Drug Manufacturer – any establishment engaged in operations involved in the production of drug, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, ornamenting, and labeling with the end in view of storage, distribution, or sale of the product.
- Drug Trader – any establishment which is registered owner of the drug product, procures the raw materials and packing components, and provides the production monographs, quality control standards and procedures, but sub-contract the manufacturer of such product to a licensed manufacturer. It may engage in distribution and/or marketing of its products.
- Drug Distributor/Exporter – any drug establishment that exports raw materials, active ingredients and/or finished products to another country.
- Drug Distributor/Wholesaler – any drug establishment that procures raw materials, active ingredients and/or finished products from local establishments in wholesale basis.
Requirements for Drug Outlets:
A. Premises
- A signboard in front of the place of the business bearing registered name of the drugstore
- A well-ventilated area not less than 15 sq m in floor area with concrete tile or wooden flooring
- A place suitable for compounding prescription and for washing and sterilizing bottles (compulsory only for hospital pharmacy)
- A suitable and proper place for the adequate storage of drugs and biological products as specified on the label
- A suitable cabinet for keeping poisons and/or dangerous drugstores
- An adequate water supply
B. References/Documents
- Philippine National Drug Formulary (when available)
- USP/NF (latest edition)
- RA 3720, RA 6675, RA 5921
- Remington's Pharmaceutical Sciences (latest edition)
- Goodman and Gilman: Pharmacological Basis of Therapeutics (latest edition)
C. Record Books duly registered with BFAD
- Prescription Book
- Dangerous Drug Book
- Exempt Preparation Book
- Poisons Book
- Record Book for Selected Non-prescription Drugs
D. A full-time validity registered pharmacist
physically present while drugstore is open for business
E. Others
- Invoices indicating the lot number or batch number of the manufacturer's stock
- File of prescription filled, consecutively numbered
- Dry seal or rubber containing the name and address of the drug outlet
- Red and white labels indicating the name and address of drugstore
Monday, February 25, 2013
THE SUMMARY OF REPUBLIC ACT NO. 3720
Republic Act No. 3720 “Foods,
Drugs, Devices and Cosmetics Act” as
amended by E.O. 175
Title: AN ACT TO ENSURE THE SAFETY
AND PURITY OF FOODS AND COSMETICS, AND THE PURITY, SAFETY, EFFICACY
AND QUALITY OF DRUGS AND DEVICES BEING MADE AVAILABLE TO THE PUBLIC,
VESTING THE BUREAU OF FOOD AND DRUGS WITH AUTHORITY TO ADMINISTER AND
ENFORCE THE LAWS PERTAINING THRETO, AND FOR OTHER PURPOSES.
Objectives:
a. Establish standards and quality
measures for foods, drugs, and devices and cosmetics.
b. Adopt measures to ensure pure and
safe supply of foods and cosmetics, and pure, safe, efficacious and
good quality drugs and devices in the country.
c. Adopt measures to ensure the
rational use of drugs and decives, such as, but not limited to,
banning, recalling or withdrawing from the market drugs and devices
which are not registered, unsafe, inefficacious or of doubtful
therapeutic value, the adoption of an National Drug Formulary, and
the use of generic names in the labeling of drugs.
d. Strengthen the Bureau of Food and Drug
FDA Functions:
a. To administer and supervise the implementation of
this Act and of rules and regulation issued pursuant to the same.
b. To provide for the collection of samples of food,
drug and cosmetic.
c. To analyze and inspect food, drug and cosmetic in
connection with the implementation of this Act.
d. To establish analytical data to serve as basis
for the preparation of food, drug and cosmetic standards, and
recommend standards of identity, purity, quality and fill of
container.
e. To issue certificate of compliance with technical
requirements to serve as bases for the issuance of license and
spot-check for compliance with regulations regarding operation of
food, drug and cosmetics manufacturers and establishments.
f. To levy, assess and collect fees for inspection,
analysis and testing of products and materials submitting in
compliance with the provisions of this Act.
g. To certify batches of antibiotics and antibiotic
preparations
FDA Divisions:
- Inspection and Licensing Division
- Laboratory Division
Adulterated Drugs or Devices:
- If it consists in whole or part of any filthy, or decomposed substances
- It has been manufactured, prepared or held under unsanitary conditions
- It is composed of any poisonous or deleterious substances
- It contains any color other than a permissible one
- It purports to be an official drug and its strength differs from, or its safely, efficacy, quality or purity falls below the standards set forth
- It has been mixed or packed or substituted so as to reduce safety, efficacy, quality, strength or purity
- Methods, facilities or controls used do not conform to current good manufacturing practices
Misbranded Drugs and Devices:
- Labeling is false or misleading
- It did not contain (a) the name and place of business of the manufacturer, importer, packer, or distributor, and (b) an accurate statement of the quantity of contents in terms of weight, measure or numerical count.
- If any word or information required is not prominently placed with conspicuousness
- If it is for use of man and contains any quantity of narcotic or hypnotic substances
- It is not designated solely by a name recognized in an official compedium
- Unless its labeling bears (a) adequate directions for use, and (b) such adequate warnings against use
- It purports to be the drug the name of which recognized in an official compendium
- It has been found to be a drug liable to deterioration unless its label bears a statement of precautions
- Its container is so made, formed of filled as to be misleading
- It is an imitation of another drug
- It is offered for sale under the name of another drug
- It is dangerous to health when use in dosage recommended or suggested in the labeling
- If it purports to be, or is represented as a drug composed wholly or partly
THE SUMMARY OF REPUBLIC ACT NO. 5921
Republic Act No. 5921 “The
Pharmacy Law” as amended by
E.O. 174
Title: AN ACT REGULATING THE
PRACTICE OF PHARMACY AND SETTING STANDARDS OF PHARMACEUTICAL
EDUCATION IN THE PHILIPPINES AND FOR OTHER PURPOSES
Objectives: To govern: the
standardization and regulation of pharmaceutical education; the
examination for registration of graduates of schools of pharmacy; and
the supervision, control and regulation of the practice of pharmacy
in the Philippines.
Composition of Council of
Pharmaceutical Education:
- Secretary of Education (Chairman)
- Undersecretary of Health Services
- FDA Director
- Chairman of the Board of Pharmacy
- UP College of Pharmacy Dean
- Dean of the College of Pharmacy ( representing duly accredited private schools of pharmacy)
- Representative (bona fide national pharmaceutical organization in the Philippines)
Selection of representative from all
deans of accredited colleges or schools of pharmacy or universities
is by agreement among themselves to promulgate their policy of
selection of one among them to represent the council. It is also the
same with the bona fide pharmaceutical organization to select their
representative in the council.
Board of Pharmacy: Composed
of Chairman and 2 members with three-year terminally
Qualification of Board Members:
a. A natural-born Filipino citizen
b. A duly registered pharmacist and
practicing pharmacy for at least ten years
c. Of good moral character and of
recognized standing in the profession
d. At the time of appointment, not a
faculty of any school offering courses in pharmacy or college of
pharmacy
e. Member of a national pharmacy organization of the
Philippines
Candidacy for Board Examination:
- Filipino Citizen
- Of good moral character
- Must have completed internship requirements
- Graduate with degree in pharmacy
Ratings Required:
A general average of at least 75%; No ratings below 50% in more than
two subjects; and failure to pass the board exam in three consecutive
attempts needs to enroll and undergo a pre-board review course from a
duly accredited college of pharmacy.
Practice of Pharmacy:
- Prepare or manufacture, analyzed, assay, preserve, store, distribute or sell any medicine, drug chemicals, cosmetics, pharmaceuticals, devices of contrivances used in pursuance thereof;
- Render pharmaceutical service in any office or drug and cosmetic establishment where scientific, technological or professional knowledge of pharmacy is applied;
- Engage in teaching scientific, technological or professional pharmacy subject in a college of pharmacy; or
- Conduct or undertake scientific pharmaceutical research for biological and bacteriological testings and examinations.
Prerequisites for the Practice of
Pharmacy:
- Is at least 21 years of age;
- Passed the Board Exams
- Holder of valid certificate of registration
Sunday, February 24, 2013
Erroneous, Violative and Impossible Prescriptions
Erroneous Prescriptions (Click Here for Samples)
Erroneous prescriptions shall be filed. Such prescription shall also be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH office for appropriate action.
Violative Prescriptions (Click Here for Samples)
Violative prescriptions shall not be filed. They are kept and reported by the pharmacist of drug outlet or any other interested party to the nearest DOH office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
Impossible Prescriptions (Click Here for Samples)
Impossible prescription shall not be filed. They shall be and reported by the pharmacist of drug outlet or any other interested party to the nearest DOH office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
Note: In all cases enumerated in violative and impossible prescriptions, the local DOH office shall be responsible for giving written notice to the erring doctor concerned and for transmitting through channels the report of violation/error to the Professional Regulation Commission (PRC) or to the fiscal's office for appropriate action.
- Where the brand name precedes the generic name
- Where the generic name is the one in parenthesis
- Where the brand name is not in parentheses
- Where more than one drug product is prescribed on one prescription form.
Erroneous prescriptions shall be filed. Such prescription shall also be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH office for appropriate action.
Violative Prescriptions (Click Here for Samples)
- Where generic name is not written
- Where the generic name is not legible and a brand name which is legible is written
- When the brand name is indicated and instructions added (such as the phrase " no substitution") which tend to obstruct, hinder or prevent proper generic dispensing.
Violative prescriptions shall not be filed. They are kept and reported by the pharmacist of drug outlet or any other interested party to the nearest DOH office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
Impossible Prescriptions (Click Here for Samples)
- When only the generic name is written but it is not legible.
- When the generic name does not correspond to the brand name
- When both the generic name and the brand name are not legible
- When the drug product prescribed is not registered with FDA
Impossible prescription shall not be filed. They shall be and reported by the pharmacist of drug outlet or any other interested party to the nearest DOH office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
Note: In all cases enumerated in violative and impossible prescriptions, the local DOH office shall be responsible for giving written notice to the erring doctor concerned and for transmitting through channels the report of violation/error to the Professional Regulation Commission (PRC) or to the fiscal's office for appropriate action.
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