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According to Florida Pharmacy Law, which of the following is/are included in a negative drug formulary?


According to Florida Pharmacy Law, which of the following is/are included in a negative drug formulary?

I. Theophylline
II. Conjugated estrogen
III. Dicumarol

a. I only
b. I and II only
c. II and III only
d. All

Answer: d

The negative drug formulary is composed of medicinal drugs which have been specifically determined by the Florida Board of Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, could produce adverse clinical effects, or could otherwise pose a threat to the health and safety of patients receiving such prescription medications. The following are included on the negative drug formulary:

(1). Digitoxin.
(2). Conjugated Estrogen.
(3). Dicumarol.
(4). Chlorpromazine (Solid Oral Dosage Forms).
(5). Theophylline (Controlled Release).
(6). Pancrelipase (Oral Dosage Forms).

Substitution by a dispensing pharmacist on a prescription written for any brand name equivalent of a generic named drug product listed on the negative formulary or for a drug within the class of certain dosage forms as listed, is strictly prohibited.

In cases where the prescription is written for a drug listed on the negative drug formulary but a brand name equivalent is not specified by the prescriber, the drug dispensed must be one obtained from a manufacturer or distributor holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, United States Department of Health and Welfare permitting that manufacturer or distributor to market those medicinal drugs or when the former is non-applicable, those manufacturers or distributors supplying such medicinal drugs must show compliance with other applicable Federal Food and Drug Administration marketing requirements.


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Which of the following amino acids becomes an essential amino acid...


Which of the following amino acids becomes an essential amino acid in a patient suffering from Phenylketonuria (PKU) disorder?

a. alanine
b. serine
c. tyrosine
d. glycine
e. glutamic acid

Answer: C

Amino acids play central roles both as building blocks of proteins and as intermediates in metabolism. The 20 amino acids that are found within proteins convey a vast array of chemical versatility.

Humans can produce 10 of the 20 amino acids. The others must be supplied in the food. Failure to obtain enough of even 1 of the 10 essential amino acids, those that we cannot make, results in degradation of the body's proteins—muscle and so forth—to obtain the one amino acid that is needed. Unlike fat and starch, the human body does not store excess amino acids for later use—the amino acids must be in the food every day.

The 10 amino acids that we can produce are alanine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine and tyrosine.

The amino acids regarded as essential for humans are phenylalanine, valine, threonine, tryptophan, isoleucine, methionine, leucine, lysine, and histidine. Additionally, cysteine (or sulphur-containing amino acids), tyrosine (or aromatic amino acids), and arginine are required by infants and growing children.[5][6] Essential amino acids are "essential" not because they are more important to life than the others, but because the body does not synthesize them. They must be present in the diet or they will not be present in the body.

In addition, the amino acids arginine, cysteine, glycine, glutamine, histidine, proline, serine and tyrosine are considered conditionally essential, meaning they are not normally required in the diet, but must be supplied exogenously to specific populations that do not synthesize them in adequate amounts. An example would be with the disease phenylketonuria (PKU). Individuals living with PKU must keep their intake of phenylalanine extremely low to prevent mental retardation and other metabolic complications. However, they cannot synthesize tyrosine from phenylalanine, so tyrosine becomes essential in the diet of PKU patients.

Citation: http://www.biology.arizona.edu/biochemistry/problem_sets/aa/aa.html and http://en.wikipedia.org/wiki/Essential_amino_acid.


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DEA's rule, "Electronic Prescriptions for Controlled Substances" revises DEA's regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations...


Electronic Prescription For Controlled Substances

DEA's rule, "Electronic Prescriptions for Controlled Substances" revises DEA's regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. The rule was published in the Federal Register Wednesday, March 31, 2010 and becomes effective on June 1, 2010.

A practitioner will be able to issue electronic controlled substance prescriptions only when the electronic prescription or electronic health record (EHR) application the practitioner is using complies with the requirements in the interim final rule.

The application provider must either hire a qualified third party to audit the application or have the application reviewed and certified by an approved certification body. The auditor or certification body will issue a report that states whether the application complies with DEA's requirements and whether there are any limitations on its use for controlled substance prescriptions.

(A limited set of prescriptions require information that may need revision of the basic prescription standard before they can be reliably accommodated, such as hospital prescriptions issued to staff members with an identifying suffix.) The application provider must provide a copy of the report to practitioners who use or are considering use of the electronic prescription application to allow them to determine whether the application is compliant with DEA's requirements.

[Citation source: http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/practitioners.htm]


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In Florida, medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility are considered to be the part of the inventory of that LTCF.

True or False


In Florida, medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility are considered to be the part of the inventory of that LTCF.

True or False

----------------------------------------------------------------------

False, [Florida Pharmacy Act 465.0235(2)].

Medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility, hospice, or correctional institution are part of the inventory of the pharmacy (NOT of LTCF since LTCF does not have its own pharmacy) providing pharmacy services to that facility, hospice, or institution, and drugs delivered by the automated pharmacy system are considered to have been dispensed by that pharmacy.


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A patient visits to a pharmacy and asks for a refill on his blood pressure maintenance medication.


A patient visits to a pharmacy and asks for a refill on his blood pressure maintenance medication. Upon reviewing, the pharmacist revealed that the original prescription for the requested refill was filled by another pharmacy. The patient has presented an empty prescription container which shows all the required information regarding originally issued pharmacy and prescribing physician. The pharmacist tries to contact the pharmacy and prescribing physician without any success. Under these circumstances, which of the following is TRUE?

a. Request the patient to obtain a new prescription.
b. Direct the patient to go to the original pharmacy.
c. Fill a 3-day supply.
d. Tell the patient, you won't be able to help him.

Fill a 3-day supply, [Texas Administrative Code Title 22, Part 15, Chapter 291, Subchapter B, 291.34(7)(E)(vii)].

If a pharmacist is unable to contact the prescribing practitioner after a reasonable effort, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:      

(i). failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;      

(ii). the quantity of prescription drug dispensed does not exceed a 72-hour supply;      

(iii). the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;      

(iv). the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;      

(v). the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection;      

(vi). the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title; and      

(vii). if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:        

(I). the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information;        

(II). after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;        

(III). the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and        

(IV). the pharmacist complies with the requirements of clauses (ii) - (vi) of this subparagraph.


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Carisoprodol is now CIV Controlled Drug...


A Drug Enforcement Administration (DEA) announcement provides information regarding the scheduling of carisoprodol, effective as of January 11, 2012.

The DEA Final Rule making the drug a Schedule IV controlled substance was published December 12, 2011, and states that effective January 11, 2012, all prescriptions for drugs containing carisoprodol shall comply with DEA regulations.

Specifically, a pharmacy may only fill or refill a prescription for a drug containing carisoprodol if all of the following requirements are met:

1. the prescription was issued for a legitimate medical purpose by a DEA-registered practitioner acting in the usual course of professional practice (21 CFR §1306.04);

2. the prescription contains all the information required by 21 CFR §1306.05; and

3. the number of refills authorized by the prescribing practitioner is five or less (21 USC §829(b)).

 


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FDA Issues New Guidelines for Sleep Aids Containing Zolpidem...


Food and Drug Administration (FDA) has issued new dosing recommendations for sleep aids containing Zolpidem. The new recommendations are based upon new data that shows that when taken at night, blood levels of Zolpidem remain high enough in the morning to impair activities that require alertness, such as driving.


The new guidelines halve the dosage for women because the new data showed that their bodies take longer to eliminate the drug.


FDA urges drug manufacturers and health care providers to follow the new dosing instructions, which apply to brand name and generic drugs containing Zolpidem:


Ambien®, EdluarTM, and Zolpimist®: 5 mg for women, 5 mg or 10 mg for men
Ambien CR®: 6.25 mg for women, 6.25 mg or 12.5 mg for men


Additionally, manufacturers of these drugs have been instructed to follow the new guidelines and print new patient information drug labels containing the new recommendations.


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A question for students preparing for Arizona Pharmacy Law...


The prescription order for a Schedule V controlled drug may be refilled as authorized by the prescribing medical practitioner but shall not be filled or refilled more than one year after the date of issuance. Please reply: Agree or Disagree.

Answer: Agree, [Arizona Revised Statues Title 36, Chapter 27, 36-2525(I)].

Only Arizona Pharmacy Law allows "The prescription order for a Schedule V controlled drug may be refilled as authorized by the prescribing medical practitioner but shall not be filled or refilled more than one year after the date of issuance."




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