IPP REVENUE HITS
Wednesday, July 31, 2013
FPGEE Exam Results
Scores from the April 12, 2013 FPGEE are now available.
Be prepared to log in with your EE number and your date of birth to access your score on NABP’s secure Web site.
FPGEE Exam Schedule
Scores from the April 12, 2013 FPGEE are now available.
Before you can schedule your examination with Pearson VUE, you must register to take the FPGEE with NABP. Within a few days of registering to test with NABP, you will be e-mailed your Authorization to Test (ATT) from Pearson VUE, NABP’s test vendor.
The ATT authorizes you to schedule an appointment to take the FPGEE at a Pearson VUE test site. Candidates have from July 15, 2013, to September 23, 2013, to schedule their exam. Scheduling is completed through the Pearson VUE Web site or by contacting Pearson VUE customer service at 888/709-2679. Detailed scheduling instructions will be provided in your ATT.
Before you can schedule your examination with Pearson VUE, you must register to take the FPGEE with NABP. Within a few days of registering to test with NABP, you will be e-mailed your Authorization to Test (ATT) from Pearson VUE, NABP’s test vendor.
The ATT authorizes you to schedule an appointment to take the FPGEE at a Pearson VUE test site. Candidates have from July 15, 2013, to September 23, 2013, to schedule their exam. Scheduling is completed through the Pearson VUE Web site or by contacting Pearson VUE customer service at 888/709-2679. Detailed scheduling instructions will be provided in your ATT.
Saturday, July 27, 2013
Why Pharmacists Do Not Dispense Prescription Order?
May
be you are thinking why some pharmacies do not dispense your
prescription orders yet you have a valid document. Do not worry so
much about it because there are reasons to correlate to your
situation. Some pharmacists are careful and following the regulation
so much that is why your prescription was not filled.
Usually
after the patient went to see a doctor, the doctor gives him a
prescription order to be filled by pharmacist for his treatment. The
patient goes to the pharmacy and buy the necessary drug/s there. But
before the drug will be dispensed, there are things that should be
considered most by pharmacists before dispensing the order. The
determination of the pharmacist shall be like these:
- The pharmacist or pharmacy technician reads and interprets the prescription order in the way the doctor wanted for the therapy. Thus, right interpretation of the drug should be done to give the right medicine. Sometimes the inscription of the doctor was hastened-like and cannot be understand by pharmacist, but because of his experience and expertise about drugs he can assess what drug is being ordered by the doctor. He can ask the patient about his ailment, transcribe the direction to the patient to correlate what drug is ordered, the dosage or dosage form and others. However, when the doctor's handwriting was not good and the details of the drug were incomplete or on the direction to the patient stated only “as directed”, the pharmacist shall not dispense the prescription order.
- The prescription order is not FDA approved, thus, the prescription will not be filled.
- The prescription order is a dangerous drug, whereas the ordinary prescription is not appropriate for it or the information about the doctor especially his S2 no. is not written or the prescription is not in triplicate copy.
- The age, weight and condition of the consumer is not appropriate to the written order. Example overweight given a under dose drug.
- The drug is out of stock, no stock, unavailable or not yet available.
- The drug prescribed is under drug recall or comprised status.
- The drug is not available in the country where you are staying and can be bought abroad.
- Drug condition and storage will be compromised when dispensed, especially when the home the patient is far and the drug needs to be in refrigerator or 2-8o C condition.
- Improper prescription order and lacking of the patient's information or doctor's information and signature.
- Laws and regulations interfere with the dispensing of drugs, especially those under FDDC Act and dangerous drugs.
- Pharmacist is not available for the meanwhile, so that no authorized personnel can fill the prescription.
Tuesday, July 23, 2013
Hiruscar
Hiruscar,
Another Innovative Scar Remover!
People are very conscious about their looks, especially on the way their skin has, so that when a scar or flaw appear they get easily frustrated and insecure. That is why most products today are made for skin problems. Thus, another scar remover has introduced to the market that will exactly complement the needs of the consumer.
People are very conscious about their looks, especially on the way their skin has, so that when a scar or flaw appear they get easily frustrated and insecure. That is why most products today are made for skin problems. Thus, another scar remover has introduced to the market that will exactly complement the needs of the consumer.
Hiruscar
is a scar remover product made by Medinova Switzerland. It is
available in a 5g and 20g tube. It is a product that specializes for
reduction of visibility of scar at which 93% average scar healed at
end of 12 weeks. It is quick absorbing, non-greasy and film-free
clear gel that helps to reduce scar visibility.
Hiruscar
contains 6 biomolecular substances that are clinically tested to
reduce visibility of scar. Mucopolysaccharide Polysulphate (MPS) and
Quercetin from Allium cepa including other four more elements work
together for reduction of excessive scar tissue forming.
Ingredients and their action
- Mucopolysaccharide Polysulphate (MPS) is an important ingredient of Hiruscar that helps to recover scar tissue by activating the production of hyaluronic acid, which makes the skin cell to be intact and to retain moisture. As result of its action better oxygenation of the the skin, softening the scar and nourishing your skin to produce healthy cell in the scar.
- Quercetin (Allium cepa) is an ingredient that impedes the production of excessive tissue. It also reduces the scar size, prevents redness, rashes and black marks.
- Allantoin known to retain moisture in the skin and promotes exfoliation of the skin to newer ones.
- Aloe vera is acted to promote wound healing and hinders the demaging of skin .
- Vitamin B3 (Niacin) is a vitamin that helps to lighten skin and reduces black marks.
- Vitamin E (Tocopherol) is a powerful antioxidant and moisturizer.
Scar to be treated
The
scar treatment may vary according to condition, size, severity, type
and age of the scars. The Hiruscar is used to treat scars or even
prevent them from appearing in various causes such as operation,
accident, burning, pimple inflammation, chicken pox and also
hypertrophic and keloidal scars.
Goal of the treatment
- Improves skin flawed with scars such as surgery marks by softening them.
- Lessens the black marks from inflamed pimple scars and bringing smoothness back to your skin.
- To prevent the onset of bulging red scars that usually appear after wounds have just healed.
Dosage and Administration
Hiruscar
is applied gently on closed wounds 2-3 times daily. For those who are
using make up and moisturizer, apply first the product before putting
them for better absorbance. Special cases of scars the following
should be known:
- For old scars that are thick and bulging, massage the affected area for 2-3 mins, 3-4 times a day and continue doing it for approximately 4-6 months.
- To prevent fresh wounds from leaving scars, once the wound has closed, apply Hiruscar continually for 4-8 weeks.
- For surgery and acne marks, 6-8 weeks of continual treatment is suggested.
- For burns from fires, exhaust pipes and hot water, 8 weeks of continual treatment is suggested.
Safety
Various
studies were conducted in conjunction with European institutions,
such as Dermscan (France) with over 250 subjects varying in age,
gender, skin type. Results show a 100% success rate in all cases.
Hiruscar is 100% hypoallergenic and safe for use on adults aged 18
years and above. It is 100% alcohol free.
Availability of the product (in the Philippines)
It
can be purchased in Mercury Drug, Watsons and South Star Drugstore.
5-gram tube costs P319.00, and the 20-grams tube is P852.00 (prices
may vary in different stores).
Conclusion:
It
can be compared to the two other leading scar removers in the market
such as contractubex and dermatix ultra, but which is the most
effective. For me I have seen the results of contractubex within 8
weeks wherein the scar lightened and less visible. I cannot testify
about the Hiruscar first but in the future I will blog again about
the action and result of the three.
Monday, July 22, 2013
Bioavailability and Bioequivalence
Because
pharmacists are professionals who are knowledgeable about drugs more,
it is ought that they should be expert in selecting of drug products
that can produce equivalent therapeutic effect and containing the
same amount of active drug whenever a substitution or change may
happen. There are terms that are highly needed to familiarize to be
able to facilitate decisions and right therapy for the patient. To
facilitate such decisions, guidelines have been developed by the U.S.
Food and Drug Administration. These guidelines and methods for
determining drug availability are discussed below.
Bioavailability.
Indicates
a measurement of the rate and extent (amount) of therapeutic active
drug that reaches the general circulation.1
It
can be also defined as both the relative amount of drug from an
administered dosage from which enters the systemic circulation and
the rate at which the drug appears in the blood stream.2
Bioequivalence requirement.
A
requirement imposed by the Food and Drug Administration for in vitro
and/or in vivo testing specified drug products which must be
satisfied as a condition of marketing.1,2
Bioequivalent drug products.
Bioequivalent
drug products are pharmaceutical equivalents that have similar
bioavailability (ie, are not significantly different with respect to
rate and extent of absorption) when given in the same more dose and
studied under similar experimental conditions. Some drugs may be
considered bioequivalent that are equal in the extent of absorption
but not in the rate of absorption; this is possible if the difference
in the rate of absorption is considered clinically insignificant, is
not essential for the attainment of effective body drug
concentrations on chronic use, and is reflected in the proposed
labeling. For example, aspirin and acetaminophen are well-absorbed
drugs, and small differences in the rate of absorption are of very
little clinical consequence.1
Bioequivalence
of drug product is achieved if its extent and rate of absorption are
not statistically significantly different from those of the standard
when administered at the same molar dose.2
Brand name.
Trade
name of the drug. This name is privately owned by the manufacturer or
distributor and is used to distinguish the specific drug product from
competitors' products1 (eg, Tempra, Biogesic).
Chemical name.
Name
used by the organic chemist to indicate the chemical structure of the
drug (eg, N-acetyl-p-aminophenol).1
Chemical
equivalents are pharmaceutical equivalents.
Drug product.
The
finished dosage form (eg, tablet or capsule) that contains the active
drug ingredient, generally but not necessarily in association with
inactive ingredients.1
A
Drug Product of Dosage Form is the gross pharmaceutical form
containing the active ingredient(s) [drug(s)] and vehicle substances
necessary in formulating a medicament of desired dosage, desired
volume and desired application form, ready for administration.2
Drug product selection.
The
process of choosing or selecting the drug product in a specified
dosage form.1
Equivalence.
Relation
in terms of bioavailability, therapeutic response, or a set of
established standards of one drug product to another.1
Generic name.
The
established, nonproprietory or common name of the active drug in a
drug product1 (eg, Mefenamic Acid).
Generic substitution.
The
process of dispensing a different brand or unbranded drug product in
place of the prescribed drug product. The substituted drug product
contains the same active ingredient or therapeutic moiety as the same
salt or ester in the same dosage form but is made by a different
manufacturer. For example, a prescription of Motrin brand of
ibuprofen might be dispensed by the pharmacist as Rufen brand of
ibuprofen if generic substitution is permitted and desired by the
physician.1
Pharmaceutical alternatives.
Drug
products that contain the same therapeutic moiety but as different
salts, esters, or complexes. For example, tetracycline phosphate or
tetracycline hydrochloride equivalent to 250mg tetracycline base are
considered pharmaceutic alternatives. Different dosage forms and
strength within a product line by a single manufacturer are
pharmaceutic alternatives (eg, an extended-release dosage form and a
standard immediate-release dosage form of the same active
ingredient).1
Drug
products that contain the identical therapeutic moiety, or its
precursor, but not necessarily in the same amount, or dosage form or
as the same salt or ester.1
Pharmaceutical Equivalents.
Drug
products that contain the same active drug ingredient (same salt,
ester, or chemical form) and are identical in strength or
concentration, dosage form, and rout of administration (eg, diazepam,
5mg oral tablets). Pharmaceutical equivalent drug products must meet
the identical standards (strength, quality, purity, and identity),
but may differ in such characteristics as color, flavor, shape,
scoring configuration, packaging, preservatives, expirationg time,
and (within certain limits) labeling.1
Drug
products that contain identical amounts of identical active drug
ingredient, i.e., the same salt or ester of the same therapeutic
moiety, in identical dosage forms, but not necessarily containing the
same inactive ingredients.2
Pharmaceutical substitution.
The
process of dispensing a pharmaceutical alternative for the prescribed
drug product. For example, ampicillin suspension us dispensed in
place of ampicillin capsules, or tetracycline hydrochloride is
dispensed in place of tetracycline phosphate. Pharmaceutical
substitution generally requires the physician's approval.1
Therapeutic alternatives.
Drug
products containing different active ingredients that are indicated
for the same therapeutic or clinical objectives. Active ingredients
in therapeutic alternatives are from the same pharmacologic class and
are expected to have the same therapeutic effect when administered to
patients for such condition of use. For example, ibuprofen is given
instead of aspirin.1
Therapeutic equivalents.
Therapeutic
equivalents are drug products that contain the same therapeutically
active drug that should give the same therapeutic effect and have
equal potential for adverse effects under conditions set forth in the
labels of these drugs products. Therapeutic drug products may differ
in certain characteristics, such as color, scoring, flavor,
configuration, packaging, preservatives, and expiration date.
Therapeutic equivalent drug products must be (1) safe and effective,
(2) pharmaceutical equivalents, (3) bioequivalent, (4) adequately
labeled, and (5) manufactured in compliance with current good
manufacturing practices.1
Therapeutic substitution.
The
process of dispensing a therapeutic alternative in place of the
prescribed drug product. For example, amoxicillin is dispensed for
ampicillin.1
Importance of Bioavailability Studies
In
the Philippines there are a lot of generic drug products that are
being marketed without bioequivalency studies, clinical studies and
bioavailability studies. It is not that FDA granted these drug
products to be marketed and overlooked these important studies, but
actually it is the company's responsibility to perform such tests and
studies extensively. FDA is only to approved what has been shown to
them and perform also its function before approving these drug
products.
Thus
when a drug company is introducing a new branded drug or generic
drug, the drug should have done (1) clinical studies that are useful
in determining the safety and efficacy of the drug product; (2)
bioavailability studies which are useful in defining the drug product
in terms of its effect on the pharmacokinetics of the drug; whereas
(3) bioequivalency studies are useful in comparing the
bioavailability of a drug from various drug products. Once the drug
products are demonstrated to be bioequivalent, then the efficacy of
these drug products is assumed to be similar.
Because
most of generic drug products in the Philippines do not have these
studies it is concluded that most of them are ineffective and not
safe.
1Shargel,
L and Yu, A.B.C. 1994. Applied Biopharmaceutics and
Pharmacokinetics, 2nd ed., Appleton & Lange,
Norwalk, CT, p193-195
2Ritschel,
W.A. 1992. Handbook of
Basic Pharmacokinetics, 4th ed., Drug Intelligence
Publications, Inc, Hamilton, IL, p 2-12
Wednesday, July 17, 2013
Schools Of Pharmacy in the Philippines
In
this time, pharmacists are highly in-demand, because of lacking of
professional manpower whom are expected to fill up the vacancy in all
pharmaceutical establishment position. Pharmacists are definitely
needed to start a pharmaceutical business, to continue to operate as
pharmaceutical business and to intercede for company linkage to FDA,
as liaison officer. Henceforth, the students are encouraged and
pursued to take this course.
School
is a second learning home of a person who is aspiring for more depth
knowledge and skills. It is where the basics and the fundamental
knowledge are being broadened and deepened. Moreover, because of the
high demand for pharmacists, students who are taking Pharmacy Degree
should choose a better school to attend at. School has a big role to
mold and hone the students' skills and knowledge in line with their
respective courses.
Choosing a school of pharmacy should be considered the following criteria:
- Percentage of students that made to pass the licensure exam, and the school's ranking from the previous and current Pharmacist Licensure Exams.
- Status of accreditation from various organizations or accrediting bodies, such as PACOP.
- Faculty of the school and their proficiency about the subject matter.
- The facilities of the school, experience and the expertise for pharmacy course.
- Conveyance of learning process and strategies on how would student to learn and succeed.
Based
on the latest Pharmacist Licensure Exam June 2013, SAINT LOUIS UNIVERSITY topped the schools with
50 or more examinees and with at least 80% passing percentage, having
a 98.39% passing percentage at which 122 out of 124 have passed;
Secondly is the OUR LADY OF FATIMA UNIVERSITY – VALENZUELA having a
91.04% passing percentage at which 122 out of 134 passed; and thirdly
is the UNIVERSITY OF SANTO TOMAS gathering a percentage score of
80.27% having 293 out of 365 who have passed.
Below is the list of Schools of Pharmacy in the Philippines*
ADAMSON
UNIVERSITY
ANGELES
UNIVERSITY FOUNDATION
CEBU
DOCTORS UNIVERSITY
CENTRAL
ILOCANDIA COLLEGE OF SCIENCE & TECHNOLOGY
CENTRAL
LUZON DOCTOR'S HOSPITAL EDUCATIONAL INSTITUTION
CENTRO
ESCOLAR UNIVERSITY – MAKATI
CENTRO
ESCOLAR UNIVERSITY – MALOLOS
CENTRO
ESCOLAR UNIVERSITY – MANILA
EMILIO
AGUINALDO COLLEGE – MANILA
LYCEUM
NORTHWESTERN – DAGUPAN CITY
MANILA
CENTRAL UNIVERSITY – CALOOCAN CITY
MARIANO
MARCOS STATE UNIVERSITY – BATAC
MEDINA
COLLEGE – OZAMIS CITY
MINDANAO
MEDICAL FOUNDATION COLLEGE
NATIONAL
UNIVERSITY – MANILA
NEGROS
ORIENTAL STATE UNIVERSITY (CVPC) – DUMAGUETE
NUEVA
ECIJA COLLEGES
OUR
LADY OF FATIMA UNIVERSITY – ANTIPOLO CITY
OUR
LADY OF FATIMA UNIVERSITY – QUEZON CITY
OUR
LADY OF FATIMA UNIVERSITY – VALENZUELA
PANPACIFIC
UNIVERSITY NORTH PHILIPPINES
PHILIPPINE
WOMEN'S UNIVERSITY – MANILA
PINES
CITY COLLEGE
SAINT
JUDE COLLEGE – MANILA
SAINT
LOUIS UNIVERSITY
SAINT
PAUL UNIVERSITY – TUGUEGARAO
SAN
PEDRO COLLEGE – DAVAO CITY
SOUTHWESTERN
UNIVERSITY
SOUTHWESTERN
UNIVERSITY – COLLEGE OF MEDICINE
ST.
SCHOLASTICA'S COLLEGE – TACLOBAN
UNIVERSIDAD
DE ZAMBOANGA
UNIVERSITY
OF BOHOL
UNIVERSITY
OF LA SALETTE – SANTIAGO
UNIVERSITY
OF LUZON
UNIVERSITY
OF PERPETUAL HELP – RIZAL-CALAMBA CAMPUS
UNIVERSITY
OF PERPETUAL HELP SYSTEM DALTA-LAS PINAS
UNIVERSITY
OF PERPETUAL HELP SYSTEM-LAGUNA
UNIVERSITY
OF SAN AGUSTIN
UNIVERSITY
OF SAN CARLOS
UNIVERSITY
OF SANTO TOMAS
UNIVERSITY
OF SOUTHERN PHILIPPINES
UNIVERSITY
OF THE IMMACULATE – CONCEPTION-DAVAO
UNIVERSITY
OF THE PHILIPPINES – MANILA
UNIVERSITY
OF THE VISAYAS – CEBU CITY
URDANETA
CITY UNIVERSITY
VIRGEN
MILAGROSA UNIVERSITY FOUNDATION
WORLD
CITI COLLEGES, QUEZON CITY(QUEZON CITY M.C.C)
However,
in the end the student shall be the one who can tell his fate. School
is only to guide and instill knowledge, but it is in the student's
hand, how much he learned and absorbed the knowledge that conveyed to
him, that will make him to pass the board exam and make his school
proud to him.
*Based
on the lists that currently issued by the PRC, Pharmacist Licensure
Exam June 2103.
Saturday, July 13, 2013
Pharmaceutical Incompatibility: Acacia
- Alcohol or alcoholic precipitate acacia in the form of a viscid mass, when the alcohol amounts to more than about 50 percent of the total volume. Solution is effected by dilution with water.
- The mucilage is gelatinized by ferric chloride solution and tincture, ferric sulfate, ferric subsulfate and iron and ammonium acetate solutions, but not by ferric citro-chloride tincture or the scale salts of iron. This gelatination is prevented by alkali acetates, cintrates and tartrates and by dilution with water, glycerin or syrup.
- Concentrated solutions of borax and lead acetate solution also gelatinized acacia, but is retarded by adding syrup or glycerin.
- Acacia contains calcium and therefore possess the incompatibilities of this iron.
- Acacia contains a peroxidase which act as an oxidizing agent and produces colored derivatives of aminopyrine, antipyrine, cresol, guaiacol, phenol, tannin, thymol, vanillin and other substances. Heating the solution of acacia for a few minutes at 100oC destroys the peroxidase and the color reactions are avoided.
- Sulfuric acid converts acacia into arabic and then metarabic acid and precipitate calcium sulfate.
Illustration of
Acacia Incompatibilities and their Criticisms
No. 1
Rx
Tincutre guiaici
/
aa ............................... 1 fluidram
Muc. Acaciae /
M. S. Teaspoonful
every three hours.
Criticisms: The
alcohol of the tincture throws the acacia out of solution and the
water of the mucilage precipitate the resin from the tincture so that
a white precipitate ultimately forms in the bottom of the bottle. A
fresh tincture of guaiac with mucilage of acacia gives a blue color
but and old tincture gives a brown-red color. With the consent of the
physician the prescription may be filled by using glycerin and water
instead of mucilage. Or honey in place of the mucilage keeps the
resinous matter better suspended than glycerin.
No. 2
Rx
Liquoris ferri
dialysati ...................... iv foz
Syrupi
................................................i fluidram
Mucilainis
acaciae .............................iv fluidrams
M.
Criticisms:
Ferric salts gelatinized mucilage of acacia, and if the solution of
dialyzed iron is added directly to the mucilage a solid mass results,
which dissolves slowly in the syrup. By diluting the solution of iron
with syrup, and then adding this slowly to the mucilage with constant
stirring, a thick homogenous liquid may be obtained.
No. 3
Rx
Liq. Plumbi
subacat ...............................foz ss
Muc. Acaciae
.........................................i fluidram
Aq. ditil., q.s.
ad. ...................................iv fluidrams
M. Ft. lotio
Criticisms: When
solution of lead subacetate is added to mucilage of acacia, a solid
gelatinous mass is formed. In this prescription if both are diluted
with water and mixed with constant stirring the acacia is
precipitated in small masses. Neutral lead acetate solution does not
gelatinize mucilage of acacia. The addition of a few drops of acetic
acid may also prevent the precipitation of the acacia.
No. 4
Rx
Sodii boratis
....................................ii oz
Pulv. Acaciae
...................................i oz
Syrupi
..............................................fluidram ss
Aq. menthae pip
..............................iii fluidrams
M. S. A.
Sig. A tsp q 3
hours.
Criticisms: There
could be a physical incompatibility between acacia and borax but this
is prevented by the syrup. This is properly dispensed by dissolving
the borax in the aq. mentha. pip. and acacia in the syrup then mix
the two solutions.
General Consideration of Incompatible Prescriptions
Generally, it can
be said that the question of compounding and dispensing an
incompatible prescription, is entirely dependent upon good judgment.
Every pharmacist
should know an explosive prescription at sight, should know those
which should not be combined under any circumstances (such as
glycerin and nitric acid), and those which can be mixed if proper
precautions are taken (like iodine and oil of turpentine). Explosive
prescriptions are a menace to the Compounder rather than to the
customer, hence, self-preservation requires a complete knowledge of
such dangerous prescriptions.
In other forms of
incompatibility the pharmacist is confronted with two important
questions:
- Is the prescription safe to dispense?
- How can it be least objectionably compounded?
There are
frequently cases of intentional incompatibilities cases where the
doctor really desires an unsightly mixture, because of its
therapeutic value. We all know that the official chalk mixture is of
value because of the insoluble calcium carbonate it contains, another
is the prescription calling for zinc sulfate and lead acetate, which
must be dispensed with precipitated lead sulfate, since the
therapeutic value or its healing property is dependent largely upon
it.
On the other hand
prescription in which potent medicines are produced in insoluble
form, like prescriptions where powerful alkaoids are precipitated,
should be viewed with suspicion by the compounder, and while it is
often an exceedingly delicate matter to approach the physician on the
subject, it is usually best to let the doctor know, either at the
time, or later of the possibility of danger. No pharmacist of act or
good sense of course will bluntly announce to the customer that he
will not compound such a prescription, but will always consult the
physician. In all cases where precipitation or possible precipitation
of potent drugs will take place the container should be provided with
a “shake well” label.
There are some
prescriptions of this kind, however, which must not be dispensed,
such as the mixing of chloral hydrate and alkali, which will result
to evolution of much chloroform or cases where dangerous or poisonous
substances are produced.
In case the
physician is to be approached about dangerous incompatibilities or
doses, always approach him armed with accepted authorities like
dispensatories, pharmacopoeias or Scovilles Art of Compounding.
In a general way
it might be stated that when the two substances likely to react are
diluted as much as possible before mixing, the chances of
incompatibility are minimized.
Another important
question in compounding is “When is the pharmacist justified in
Changing a prescription? The Answer is that a change is justified
only when such change improves the prescription without altering the
therapeutic value or action of the preparation, as in the following
cases:
- An aromatic water, when used to dissolve a salt like potassium bromide, has some of its oil separate, and a cloudly mixture results. If the salt is dissolve in the smallest quantity of water and then mixed with the aromatic water no oil will separate.
- A prescription calling for phenol mixed with an insufficient amount of water to dissolve it will form a separate layer. But if a part of the water – say 1/8 or ¼ be replaced by glycerin, a perfect solution is formed.
- A prescription calling for a certain alcoholic tincture mixed with gummy substances may precipitate the gum. If the equivalent amount of fluidextract is used, the precipitation may be avoided.
- Pills calling for ferrous sulfate, USP, or other crystalline salts are found to yield a mass that is too soft. By using the proportionate quantity of exsicated salt the mass proper consistency can be easily made.
- A prescription calling for an alkaloidal salt to be dissolved in liquid petrolatum will result in insolubility. But by using the proportionate amount of the alkaloid a good solution will be produced.
As a general
rule, it is always best to let the physician whenever a change is
made in the prescription, and always explain why the change was made.
Preparation of Mucilages
Official
mucilages are thick, viscid, adhesive liquids, made by dispersing gum
in water, or extracting the mucilagenous principle from vegetable
substances with water. All mucilages are prone to decomposition and
should never be made in large quantities that can be used immediately
unless a preservative is added. They are primarily used to aid in
suspending insoluble substances in liquids as their colloidal
character and viscosity help them prevent immediate sedimentation.
Example: sulfur in lotions, resins in mixtures and oils in emulsions.
As substitute for mucilages several synthetic mucilage-like
substances such polyvinyl alcohol, methycellulose,
carboxymethylcellulose may be used. Methylcellulose is used as a bulk
laxative since its absorbs water and swells to a hydrogel in the
intestine in much the same manner as psyllium or karaya gum.
Synthetic gums are non-glycogenetic and may be used in the
preparation of diabetic syrups.
Acacia Mucilage NF
Synonyms: Mucilago Acaciae; Mucilage of
Gum Arabic
Formula:
Acacia, in small fragments
..........................350g
Benzoic Acid
................................................2g
Purified Water, qs _________
To make
1000ml
Preparation:
Place the acacia in a wide mouth
graduated bottle with a capacity not exceeding 1000ml, wash the drug
with cold purified water, drain and add sufficient quantity of
purified water in which the benzoic acid has been dissolved to make
1000ml. Stopper and lay the bottle on its side, rotate occasionally,
and when acacia has been dissolved strain the mucilage.
It may be also prepared as follows:
Dissolve the benzoic acid in 400ml of
purified water with the aid of heat. Add the solution to 350g of
acacia in a mortar, triturating until the acacia is dissolved. Add
sufficient quantity of purified water to make 1000ml. Strain if
necessary.
Uses: Demulcent, suspending agent,
excipient in making pills and troches, and as emulsifying agent for
cod live oil and other substances.
Caution: Acacia mucilare must be free
from mold or any indication of decomposition.
Tragacanth Mucilage NF, BP
Synonym: Mucilago Tragacanthae
Formula:
Tragacanth
....................................6 g
Benzoic Acid
................................0.2g
Glycerin
........................................18g
Purified Water, qs
________
To make
100g
Preparation:
Mix 75ml of purified water with the
glycerin in a tared vessel, heat to boiling, discontinue application
of heat, add the tragacanth and the benzoic acid and macerate during
24 hours, stirring occasionally. Add sufficient quantity of purified
water to make the mucilage weigh 100g. Stir actively until of uniform
consistency and strain through muslin.
Uses: Excipient for pills or troches,
suspending agent for insoluble substances for internal mixtures and
as protective agent.
Antimicrobial Resistance
Antimicrobial resistance (AMR) is the ability to microorganisms that cause disease to withstand attack by antimicrobial medicines. The WHO estimates that, globally, about 440,000 new cases of multidrug-resistance tuberculosis (MDR-TB) emerge annually, causing at least 150,000 deaths. (WHO AMR March 2012 data)
The prevalent infections in the country to which antimicrobial resistance has steadily grown and has emerged as priority public concerns are: Multi-drug resistant Staphylococcus Aureus) and influenza. Streptococcus pneumonia and Haemophilus influenza are the two of the most common pathogens causing pneumonia and account for more than half of deaths in children below 5 years of age. (WHO report 2011)
Antimicrobial resistance occurs when a drug's effectiveness given to cure the infection is reduced or eliminated. It happens when people abuse or misuse antibiotics indiscriminately. This ultimately leads to bacterial alteration or mutation which causes it to be stronger antibiotics, consequently, resistant to the drug.
A common cause of antimicrobial resistance is self-medication or the patient buying the antibiotic drug, the store dispenses the same without a doctor's prescription and the patients, thereafter, administering the drug themselves without any physician's supervision. Another common cause of antimicrobial resistance is failure to complete the prescribed course of treatment or taking incomplete doses of the medicine. This allows the bacteria to generate a stronger "self" that can resist or fight off the drug's effect. Other causes of resistance are substandard medicines, irrational prescriptions, and poor infection prevention and control.
Diverse bacterial infection requires different antibiotics which a health professional like a doctor can advise and supervise. On the other hand, the dispensing of antibiotics or other ethical drugs is the responsibility of a registered pharmacist under the employ of the drug store. The selling or dispensing of antibiotics or other ethical drugs without the required prescription issued by a licensed physician is strictly prohibited.
The public is, therefore, enjoined to report to FDA, either in writing or through telephone call at these numbers: 807-8275, 842-5606, any drug store dispensing antibiotics without the correct prescription and/or selling suspected counterfeit antibiotics and other drugs, for immediate regulatory action. Further, the public is advised to complete the prescribed course of treatment or take the complete doses of the medicine. On the other hand, drugstores, as part of their social responsibility by helping prevent anti-microbial resistance, as well as, avoid prosecution, are strictly enjoined not to dispense antibiotics or other ethical drugs without the written prescription issued by a licensed physician. (This Article was taken from FDA Advisory No. 2012-017.)
Thursday, July 11, 2013
Philippine Pharmacists Association (PPhA) Talks About The Role of Pharmacists
The Philippine Pharmacists Association President Leonila M. Ocampo had recently appeared in one of television program in the Philippines to discuss the roles of pharmacists, the advocacy of her organization -- to improve the pharmacy setting in our country that has been behind from other countries' setting, and how would the people change their views about pharmacists as an essential health care provider, who is expert in drugs.
As she started, she has given a cliche for pharmacists to always put in their minds about drugs, she said "Always think that medicines are no ordinary products." Which she elaborated that drugs are chemicals too that can cure and/or can kill.
When the discussion is at peak, Ms. Leonila Ocampo pointed some serious issues regarding the Pharmacy Profession. As she tackled these issues:
1. Roles of Pharmacists as health providers
2. Mission of the organization
3. The optimum benefits of drugs
4. How the public views regarding pharmacists and their profession
5. Importance of Pharmacist Intervention on OTC product dispensing and counseling
6. Improvement of Laws and Regulations for betterment of the Pharmacy Profession
It is nice to know that the PPhA is really pursuing an action to alleviate the profession from the downgrade level to respectable one. I hope that someday every beautiful thing that comes out in her mouth would be happened as the Board of Pharmacy, FDA and the law will affirmed too!
Wednesday, July 10, 2013
Wanted: Ghost Pharmacists!
One main role of
pharmacist today is to supervise a drugstore or pharmacy according to
his knowledge about drugs and his expertise to counsel patients about
their drugs. Because of this role, pharmacist is obliged to commit
his loyalty to one drugstore when his license is being registered for
the establishment's registration to FDA. FDA sets standards and
policies for compliance of drugstores and other establishments,
therefore, companies conforming to it through pharmacists'
intervention. Thus, pharmacists are being hired by establishments to
comply from the FDA's regulation, and to comply on laws abiding on
it.
When a pharmacist
is out of work or abandoning such responsibility on his registered
place of work, he is known to be ghost pharmacist. Being a ghost
pharmacist is a violation against the law. It is the dereliction of
one's work with engagement of other business or affair, that could be
directly or indirectly related to his main function. May be because
his career path is diverted and not into pharmacy profession but
other specific careers, so that his license is for leasing to make
an additional income to him.
Recently, Ms.
Yolanda Robles, Philippine Pharmacists Association (PPhA) executive
vice-president and former dean of the University of the Philippines
College of Pharmacy has reported that a survey made in Camanava
(Caloocan, Malabon, Navotas and Valenzuela) in October (2012) had
found out that 70 percent of drug stores there had no pharmacists at
the time of the visit, as it was conducted by head of the
Professional Regulatory Commission’s Board of Pharmacy. She also
said that “seventy percent had no pharmacist present while while
100 percent had `certificates.’ But pharmacists should be present
at all times”. Additional to what she said, when these areas are
prone of having ghost pharmacists, even much more rampant and worst
would it be in the provinces where the the drugstores there are
unregistered or no pharmacist. They are like ordinary stores. She
included that FDA does not have enough manpower to evaluate and
target those drug establishments that do not have license or
pharmacist.
According
to the RA No. 5921 (Pharmacy Law),
Section 40.
Penal provisions.
Any person who shall violate any of the provisions ... of this Act or
any person who shall make false
representation to procure a registration certificate as pharmacist
for himself or for another; or
any person who shall allow anyone
in his employ who is not a registered pharmacist to engage in the
practice of pharmacy; or any
person who shall falsely display within the establishment the
certificate of registration of a pharmacist who is not actually and
regularly employed therein as such or to act as a dummy for any alien
or an unqualified person for the purpose of opening and operating a
retail drugstore; shall,
upon conviction thereof,
be sentenced to a fine of not less
than one thousand pesos but not exceeding four thousand pesos
or to an imprisonment of not less
than six months and one day but not more than four years,
in the discretion of the court.
Unfortunately, the fine is too small
and can be paid easily, but unless the fine is imprisonment that
would be a real and heavy punishment.
For now, the setting would be still
like that, and the ghost pharmacists are still invincible, but there
would come a time that this battle against their realm shall be
conquered. I believe that the Board of Pharmacy, PPhA, the FDA and
the law are engaging for a better regulation to stop this business.
Some reasons, the Board of Pharmacy is making a step to find the
real problems about the pharmacy settings in the Philippines,
especially on the drugstores and outlets with the support of PPhA,
and advocating for a creation of good law. The FDA also is trying its
best to add up manpower to inspect the drug establishment, to correct
them and to penalize those who are deviant and perpetrators. I hope
the legislative would pass a good law that would complement to the
real resolution to this problem and other issues that are facing by
pharmacy profession.
I would appeal also to my colleagues to
counsel and encourage their colleague friends to stop engaging to
this type of business that continuously destroying the integrity and
discipline of our profession. We must be loyal to one work only and
know our ethics, if ever sideline would come I hope it would not
associate anymore to your profession nor related anymore to pharmacy
profession. It is our action that makes the community thinks about
our profession – being only salesclerk - that we do not want to be
happened.
I am also appealing to the consumers to
be vigilant and ask the pharmacy's or drugstore's pharmacist is
he/she is available or present. If the pharmacist is not there,
report it to the nearest Center for Health Development or in FDA or
in Board of Pharmacy to reprimand him/her.
Monday, July 8, 2013
US Pharmacy Law
Historical Perspective: 1900 to 1970. Prior to 1900, pharmacy depended on compendia such as the United States Pharmacopeia (USP)-National Formulary (NF) to regulate or standardize pharmacy practice. Between 1900 and 1970, the following acts were put into effect.
1906: The Pure Food and Drug Act (PFDA)
- Restricted manufacture and scale of drugs and established USP/NF as official standard
- Required all food and drugs to meet a standard of strength and purity.
1907: Wiley Heyburn Act
- Prohibited adulteration and misbranding of food and drugs and required proper labeling of drugs.
1911: The Sherley Amendment to the PFDA
- Prohibited any company from making false therapeutic claims when labeling medicines for the purpose of defrauding the purchaser and put the responsibility of proving fraud on the government.
1914: The Harrison Narcotic Act
- Regulated the importation, sale, manufucture, and use of opium, cocaine, marijuana, many synthetic analgesics, and derivatives that produce or sustain physical or psychologic dependence.
- Established the work "Narcotic" as a legal term
1931: The Food and Drug Administration (FDA)
- It was renamed in order to enforce existing drug laws.
1938: The Federal Food, Drug, and Cosmetic Act (FFDCA)
- It was resulted from the "Elixir of Sulfanilamide" tragedies, in which 107 people died from taking elixir of sulfanilamide that contained the toxic solvent ethylene glycol.
- This act required that the following criteria be met.
1938: Amendment to Sherley Act
- It mandated that drug manufacturers test all drug for harmful effects before they enter the market. All drugs including OTC should be properly labeled.
1952: The Durham-Humphrey Amendments to the FFDCA
- It further clarified the distinction between prescription and over-the-counter drugs based on whether or not the drugs were habit-forming, narcotic, hypnotic, or potentially harmful. These amendments required a physician's consent in order to dispense refills, giving rise to the legend, "Caution: Federal law prohibits dispensing without a prescription."
1962: The Kefauver-Harris Amendments to the FFDCA
- It required drug manufacturers to prove the efficacy of their products before approval was given by the FDA for marketing. These amendments resulted from the thalidomide tragedies in which the sedative thalidomide was used in Europe as an antinauseant for pregnant women, and it caused severe deformities in their offspring. Thalidomide was never approved for use in the United States.
1966: The Drug Efficacy Study Implementation (DESI) review
- It took place when the FDA contracted an outside agency (the National Academy of Sciences/National Research Council) to establish panels of scientists in order to examine the efficacy of all drugs that were manufactured between 1938 and 1962. Approximately 4000 of these drugs were then rated as effective, probably effective, possibly effective, or ineffective.
Significant Federal Drug Laws: 1970 to 1991. Many of the laws and regulation that pharmacists must follow are partly due to amendments of the FFDCA of 1938.
1970: Controlled Substances Act (CSA)
- The CSA is Title II of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention And Control Act of 1970, which was enacted to improve the administration and regulation of all parties involved with the manufacturing, distribution and dispensing of controlled substances.
See the Complete Schedule Here.
See the Complete Schedule Example Here.
1970: Poison Prevention Packaging Act
- It was passed in response to accidental poisonings in children. With certain qualifications, the act generally requires a child-resistant closure on aspirin, acetaminophen, methylsalicylate, controlled substances, iron-containing drugs, diphenhydramine, and most oral prescription drugs.
1972: OTC drug review
- The FDA appointed advisory panels to evaluate approximately 80 therapeutic classes of drugs in order to assure that they are safe and effective for use by the public for self treatment. Ingredients for OTC use were classified in one of three categories:
- It was enacted in response to the 1982 deliberate contamination of Tylenol R capsules. This act requires the following:
- It allows manufacturers to gain incentives for the research, development, and marketing of drug products that are used to treat rare disease or conditions that would otherwise be unprofitable.
1984: The Drug Price Competition and Patent Term Restoration Act (Waxmann-Hatch Amendments to the FFDCA)
- It was enacted to create a fair environment between the pioneer drug manufacturer and the emerging generic drug industry.
- It was enacted to address the problems associated with the diversion of prescription drugs from legitimate commercial channels. This act:
1906: The Pure Food and Drug Act (PFDA)
- Restricted manufacture and scale of drugs and established USP/NF as official standard
- Required all food and drugs to meet a standard of strength and purity.
1907: Wiley Heyburn Act
- Prohibited adulteration and misbranding of food and drugs and required proper labeling of drugs.
1911: The Sherley Amendment to the PFDA
- Prohibited any company from making false therapeutic claims when labeling medicines for the purpose of defrauding the purchaser and put the responsibility of proving fraud on the government.
1914: The Harrison Narcotic Act
- Regulated the importation, sale, manufucture, and use of opium, cocaine, marijuana, many synthetic analgesics, and derivatives that produce or sustain physical or psychologic dependence.
- Established the work "Narcotic" as a legal term
1931: The Food and Drug Administration (FDA)
- It was renamed in order to enforce existing drug laws.
1938: The Federal Food, Drug, and Cosmetic Act (FFDCA)
- It was resulted from the "Elixir of Sulfanilamide" tragedies, in which 107 people died from taking elixir of sulfanilamide that contained the toxic solvent ethylene glycol.
- This act required that the following criteria be met.
- Manufacturers of drugs and cosmetics must prove that their products are safe.
- Medical devices must be proven effective.
1938: Amendment to Sherley Act
- It mandated that drug manufacturers test all drug for harmful effects before they enter the market. All drugs including OTC should be properly labeled.
1952: The Durham-Humphrey Amendments to the FFDCA
- It further clarified the distinction between prescription and over-the-counter drugs based on whether or not the drugs were habit-forming, narcotic, hypnotic, or potentially harmful. These amendments required a physician's consent in order to dispense refills, giving rise to the legend, "Caution: Federal law prohibits dispensing without a prescription."
1962: The Kefauver-Harris Amendments to the FFDCA
- It required drug manufacturers to prove the efficacy of their products before approval was given by the FDA for marketing. These amendments resulted from the thalidomide tragedies in which the sedative thalidomide was used in Europe as an antinauseant for pregnant women, and it caused severe deformities in their offspring. Thalidomide was never approved for use in the United States.
1966: The Drug Efficacy Study Implementation (DESI) review
- It took place when the FDA contracted an outside agency (the National Academy of Sciences/National Research Council) to establish panels of scientists in order to examine the efficacy of all drugs that were manufactured between 1938 and 1962. Approximately 4000 of these drugs were then rated as effective, probably effective, possibly effective, or ineffective.
Significant Federal Drug Laws: 1970 to 1991. Many of the laws and regulation that pharmacists must follow are partly due to amendments of the FFDCA of 1938.
1970: Controlled Substances Act (CSA)
- The CSA is Title II of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention And Control Act of 1970, which was enacted to improve the administration and regulation of all parties involved with the manufacturing, distribution and dispensing of controlled substances.
See the Complete Schedule Here.
See the Complete Schedule Example Here.
1970: Poison Prevention Packaging Act
- It was passed in response to accidental poisonings in children. With certain qualifications, the act generally requires a child-resistant closure on aspirin, acetaminophen, methylsalicylate, controlled substances, iron-containing drugs, diphenhydramine, and most oral prescription drugs.
1972: OTC drug review
- The FDA appointed advisory panels to evaluate approximately 80 therapeutic classes of drugs in order to assure that they are safe and effective for use by the public for self treatment. Ingredients for OTC use were classified in one of three categories:
- Category I - Drugs are safe and effective and not misbranded (i.e. do not include false, misleading, or incomplete labeling).
- Category II - Drugs are not safe and effective, or they are misbranded.
- Category III - The data available are insufficient for classification of these drugs.
- It was enacted in response to the 1982 deliberate contamination of Tylenol R capsules. This act requires the following:
- Tamper-resistant packaging must be used for certain OTC products, cosmetics, and medical devices.
- Packages "must have an indicator or barrier to entry that, when breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred."
- It allows manufacturers to gain incentives for the research, development, and marketing of drug products that are used to treat rare disease or conditions that would otherwise be unprofitable.
1984: The Drug Price Competition and Patent Term Restoration Act (Waxmann-Hatch Amendments to the FFDCA)
- It was enacted to create a fair environment between the pioneer drug manufacturer and the emerging generic drug industry.
- Title I o this act allows generic drug firms to use Abbreviated New Drug Applications (ANDA) to gain quicker FDA approval for their products.
- Title II provides pioneer drug companies with patent extensions for those products that lose marketing time while in the regulatory review process.
- It was enacted to address the problems associated with the diversion of prescription drugs from legitimate commercial channels. This act:
- Requires states to license wholesalers
- Bans the sale, trade, or purchase of drug samples
- Requires that all requests for drug samples by practitioners be made in writing and that records be maintained concerning the receipt and storage of drug samples.
Sunday, July 7, 2013
Structure of the Foreign Pharmacy Graduate Equivalency Examination (FPGEE)
The 250 questions on the FPGEE are divided among four content areas:
The FPGEE Blueprint offers in-depth information about the four content areas covered on the test.
The FPGEE Competency Statements serve as a blueprint of the topics covered on the examination. They offer important information about the knowledge, judgment, and skills you are expected to demonstrate while taking the FPGEE. A strong understanding of the Competency Statements will aid you in your preparation to take the examination.
- Basic biomedical sciences – 16%
- Pharmaceutical Sciences – 30%
- Social, behavioral, administrative pharmacy sciences – 22%
- Clinical sciences – 32%
FPGEE Blueprint
The FPGEE Blueprint offers in-depth information about the four content areas covered on the test.
The FPGEE Competency Statements serve as a blueprint of the topics covered on the examination. They offer important information about the knowledge, judgment, and skills you are expected to demonstrate while taking the FPGEE. A strong understanding of the Competency Statements will aid you in your preparation to take the examination.
Area 1 - Basic Biomedical Sciences (16%)
1A Physiology- 1A01 structure and function of major body systems; as it applies to integumentary, muscular skeletal, cardiovascular, lymphatic, respiratory, digestive, nervous, endocrine, urinary, reproductive, and body fluids and electrolytes, cells in tissue
- 1B01 chemistry of biomacromolecules (proteins, lipids, carbohydrates, and DNA)
- 1B02 nucleic acid biosynthesis and metabolism
- 1B03 enzymology and coenzymes and kinetics
- 1B04 metabolic pathways to energy utilization
- 1C01 general principles of microbial concepts
- 1C02 principles of infectious diseases
- 1C03 host-parasite relationships
- 1C04 pathogenic microorganisms of man
- 1C05 inflammatory responses to infectious agents
- 1D01 gene expression
- 1D02 carrier proteins/membrane transport
- 1D03 mechanics of cell division
- 1D04 ion channels and receptor physiology
- 1D05 chromosomes and DNA
- 1D06 gene transcription and translation processes
- 1D07 recombinant DNA technology
- 1E01 human immunity and immune responses
- 1E02 principles of antigen-antibody relationships
- 1E03 antibody synthesis, development, function, and immunopathology
Area 2 – Pharmaceutical Sciences (30%)
2A Medicinal Chemistry- 2A01 physiochemical properties of drugs in relation to drug absorption, distribution, metabolism, and excretion (ADME)
- 2A02 chemical basis for drug action
- 2A03 fundamental pharmacophores for drugs used to treat diseases
- 2A04 structure activity relationships in relation to drug-target interactions
- 2A05 chemical pathways of drug metabolism
- 2A06 applicability to making drug therapy decisions
- 2B01 mechanisms of action of drugs of various categories
- 2B02 pharmacodynamics of drug action and absorption, distribution, metabolism, and elimination
- 2B03 adverse effects and side-effects of drugs
- 2B04 drug-target interactions
- 2B05 drug discovery and development
- 2B06 mechanism of toxicity and toxicokinetics
- 2B07 acute and chronic toxic effect of xenobiotics, including drug and chemical overdose and toxic signs of drugs of abuse
- 2B08 interpretation of drug screens
- 2B09 principles of antidotes and alternative approaches to toxic exposures
- 2B10 functions of poison control centers
- 2B11 bioterrorism and disaster preparedness and management
- 2C01 concepts of crude drugs, semi-purified, and purified natural products
- 2C02 evaluation of alternative and complementary medicine purity, bioavailability, safety, and efficacy
- 2C03 classes of pharmacologically active natural products
- 2C04 Science of dietary supplements (vitamins, minerals, and herbals)
- 2C05 Dietary Health Supplement and Education Act and Impact on regulation of dietary supplements and herbal products
- 2D01 physiochemical principles of dosage forms
- 2D02 principles of drug delivery via dosage forms (eg, liquid, solid, semi-solid, controlled release, patches, and implants)
- 2D03 principles of dosage form stability and drug degradation in dosage forms
- 2D04 materials and methods used in preparation and use of drug forms
- 2E01 biological principles of dosage forms
- 2E02 basic principles of in vivo drug kinetics (linear and nonlinear)
- 2E03 principles of bioavailability/bioequivalence
- 2E04 physiologic determinates of drug onset and duration
- 2E05 drug, disease, and dietary influences on absorption, distribution, metabolism, and excretion
- 2E06 the pharmacokinetic-pharmacodynamic interface
- 2F01 genetic basis for disease and drug action
- 2F02 genetic basis for alteration and drug metabolism
- 2F03 genome and proteomic principles in relation to disease and drug development
- 2F04 genetic basis for individualizing drug doses
- 2G01 United States Pharmacopeia guidance on compounding and FDA Compliance Policy Guidelines
- 2G02 techniques and principles used to prepare and dispense individual extemporaneous prescriptions including dating of compounded dosage forms
- 2G03 extemporaneous liquid (parenteral, enteral), solid, semi-solid, and topical preparations
- 2G04 dosage form preparation calculations
-
2G05 sterile admixture techniques
- a United States Pharmacopeia (USP) Chapter <797>
- b stability and sterility testing and dating
- c clean room requirements
- d infusion devices and catheters
Area 3 – Social/Behavioral/Administrative Sciences (22%)
3A Health Care and Public Health Delivery Systems- 3A01 introduction to United States, state, and local health care delivery systems and their interfaces and how they compare to those in other industrialized countries
- 3A02 social, political, and economic factors influencing the delivery of health care (including financing and reimbursement mechanisms, health disparities, reform, etc)
- 3A03 pharmacy and health care organizations (private and public insurers of third party administration, pharmaceutical industry, managed care organizations, PBMs, etc)
- 3A04 health policy development and evaluation
- 3A05 importance of involvement in pharmacy organizational, regulatory, state, and federal issues
- 3A06 conflict between medical care and public health
- 3A07 contributions of public health efforts to health status improvements (infectious disease control, chronic disease preventions, demographics, and social and physical environmental factors, etc)
- 3B01 use of pharmacoeconomic analyses (ie, cost-benefit analysis, cost-effectiveness analysis, cost-minimization analysis, cost-utility analysis)
- 3B02 applications of economic, clinical, and humanistic outcomes to improve allocation of limited health care resources
- 3B03 general macro and micro economic principles
- 3C01 management principles (planning, organizing, directing, and controlling pharmacy resources) applied to various pharmacy practice setting and patient outcomes
- 3C02 personnel management – including leadership
- 3C03 managing goods and services (marketing, purchasing/inventory management, and merchandising)
- 3C04 financial accounting
- 3C05 risk management in pharmacy practice
- 3D01 application of epidemiological study designs to study drug use and outcomes in large populations
- 3D02 data sources and analytic tools that provide an estimate of the probability of beneficial or adverse effects of medication use in large populations
- 3D03 methods for continually monitoring unwanted effects and other safety-related aspects of medication use in large populations
- 3E01 administrative, civil, and criminal liability
- 3E02 a pharmacist’s responsibilities and limits under the law
- 3E03 the authority, responsibilities, and operation of agencies and entities that administer laws and regulations related to prescription, and over-the-counter medications
- 3F01 commonly used experimental and observational study designs
- 3F02 commonly used statistical tests and their appropriate application
- 3F03 evaluation of statistical results including an understanding of statistical versus clinical significance
- 3G01 principles of biomedical ethics
- 3G02 ethical dilemmas in the delivery of patient-centered care, including
- a conflicts of interest
- b end-of-life decision making
- c development, promotion, sales, prescription, and use of drugs
- d working in groups
- 3G03 research ethics
- 3G04 professional behavior (ie, professionalism, code of ethics, oath of the pharmacist)
- 3H01 patient counseling skills including active listening and empathy
- 3H02 assertiveness and problem-solving techniques, handling difficult situations – patients and other core providers
- 3H03 interviewing techniques
- 3H04 health literacy
- 3H05 cultural competency
- 3I01 health, illness, and sick role behaviors
- 3I02 principles of behavior modification
- 3I03 patient adherence
- 3I04 caregiving throughout the life cycle
- 3I05 death and dying
- 3I06 patients’ and other health care providers’ perceptions of pharmacists’ capabilities
- 3J01 safe and effective preparation and dispensing of medications in all types of practice settings
- 3J02 development and maintenance of patient medication profiles
- 3J03 role of automation and technology
- 3J04 continuous quality improvement programs or protocols in the medication-use process, including identification and prevention of medication errors and establishment of error reduction programs, technology of drug information retrieval for quality assurance
Area 4 – Clinical Sciences (32%)
4A Literature Evaluation – Practice Guidelines and Clinical Trials- 4A01 principles of clinical practice guidelines for various disease states and their interpretation in the clinical setting
- 4A02 integration of core scientific and systems-based knowledge in patient care decisions
- 4A03 reinforcement of basic science principles relative to drug treatment protocols and clinical practice guidelines
- 4A04 evaluation of clinical trials that validate treatment usefulness
- 4B01 fundamentals of the practice of drug information
- 4B02 application of drug information skills for delivery of medication therapy management
- 4B03 the ability to judge the reliability of various sources of information
- 4C01 pathophysiology of disease states amenable to pharmacist intervention
- 4D01 clinical pharmacokinetics/pharmacogenomics of commonly used and low-therapeutic-index drugs
- 4D02 clinical basis for individualizing drug therapy
- 4E01 promotion of wellness and nonpharmacologic therapies
- 4E02 disease prevention and monitoring
- 4F01 concepts of pharmacist-provided patient care and medication therapy management services
- 4F02 importance of and techniques for obtaining a comprehensive patient history
- 4F03 patient assessment (eg, inspection, palpation, percussion, auscultation), terminology, and the modifications caused by common disease states and drug therapy
- 4F04 common clinical laboratory values and diagnostic tests and their clinical role
- 4F05 OTC point-of-care testing devices (eg, glucometers, pregnancy tests, home testing for HbA1c, drug screening).
- 4F06 false positive and false negative results
- 4F07 therapeutic drug concentrations and their interpretation
- 4F08 problem identification (eg, duplication dosage, drug interactions, dietary interactions, adverse drug reactions and interactions, frequency dosage form, indication mismatches) and resolution planning
- 4F09 triage and referral skills
- 4F10 designing of patient-centered, culturally relevant treatment plans
- 4F11 application of evidence-based decision making to patient care
- 4F12 nonprescription and dietary supplements
- 4F13 drug monitoring for positive and negative outcomes (including drug induced disease)
- 4F14 clinical management of drug toxicity and overdosage
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