Review of Prescription Drug Monitoring Programs in the United States
Lecture1 6/18 PRESCRIPTION REVIEW
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Transcript of Lecture1 6/18 PRESCRIPTION REVIEW
DISPENSING AND MEDICATION DISPENSING AND MEDICATION COUNSELINGCOUNSELING
DEFINE: PRESCRIPTION
PRESCRIPTION
• A written order by the doctor to a pharmacist specifying the medications to be dispensed to a specific patient and usually accompanied by directions for use and administration.
• "pre"- before• "script" - written
Enumerate the parts of a prescription:
parts of a prescription
• prescriber's information• patient's information• date• superscription• inscription• subscription• transcription• special labeling/other instruction
such as refill number
sample prescription
Three Types of Unethical Prescription.
Describe Violative Rx.
types of unethical prescription
• violative prescription
» where generic name is not written» where the generic name is not legible
while the brand name is legibly written» when the brand name is indicated with
instruction such as "no substitution" is written which hinder proper generic dispensing
violative prescription
1
2
3
Describe Erroneous Rx.
types of unethical prescription
• erroneous prescription
» where the brand name precedes the generic name
» where the generic name is the one in the parenthesis
» where the brand name is not in parenthesis
» where more than one product is prescribed on one prescription form
erroneous prescription
Describe Impossible Rx.
types of unethical prescription
• impossible prescription
» where only the generic name is written but is not legible
» where the generic name does not correspond to the brand name
» where both the generic name and the brand name are not legibly written
» when the drug product prescribed is not registered with FDA
impossible prescription
» BFAD Advisory No. 02-02 || MISOPROSTOL (CYTOTE): Unregistered Drug Product
What to do with this kinds of Rx?
what to do if you receive such type of prescription
• erroneous prescription» shall be filled» such prescription shall be kept and
reported to the nearest FDA office for appropriate action
• violative and impossible prescriptions
» shall not be filled » pharmacist shall advise the prescriber of
the problem and instruct the customer to get te proper prescription
» such prescription must be kept and reported to the nearest FDA office for appropriate action
What to do upon receipt of Rx?
Proper handling of Prescription
1. Receiving the prescription2. Reading & checking the prescription3. Numbering & dating4. Labeling5. Preparing the prescription6. Packaging7. Rechecking8. Delivery & counseling9.Recording & filing10.Pricing the prescription
Prescription then what?What to check out for?
Read and Check Rx for:
I - InteractionD- DoseE- Evidence of harm/ benefitA- AppropriateL- Legal and completeC- Cost effectiveA- Acceptable to the pxS-E-
Prescription vs non-rx?
Broad classification of medication
• OTC / Non-prescription Drug
» drugs that do not require a doctor's prescription
» can be bought off-the-shelf in stores» regulated by FDA through the OTC drug
monograph
Broad classification of medication
• Prescription / Legend Drug
» prescribed by a doctor» can only be bough at a pharmacy» prescribed for and intended to be used by
one patient» regulated by FDA through the New Drug
Application process
What is a narcotic drug?
NARCOTICS
• a drug that produce analgesia, narcosis, and addiction
• narcotic prescription(should be in triplicate)
» one copy for the medical practitioner» one copy for the pharmacy/pharmacist» one copy for the patient
Controlled (Regulated) drug substance
• Any drug or therapeutic agent–commonly understood to include narcotics, with a potential for abuse or addiction, which is held under strict governmental control and are placed in specific schedules.
• Require specialized prescription blanks.
FDA Controlled Substances
• Drugs, substances, and certain chemicals used to make drugs are classified into five (5) distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential.
FDA Controlled Substances
Schedule I
• drugs with no currently accepted medical use
• high potential for abuse• most dangerous drugs of
all the drug schedules with potentially severe psychological or physical dependence.
No prescriptions
may be written for Schedule I
substances, and they are not readily
available for clinical use.
Give an example of drugs under Schedule I.
Schedule I• Gamma-Hydroxybutyric Acid (GHB)• 12-Methoxyibogamine (Ibogaine)• Marijuana (cannabis)• Methaqualone• Diacetylmorphine (Heroin)• Pholcodine• methylenedioxymethamphetamine (MDMA) or (ecstasy)• Mescaline (Peyote)• alpha-methyltryptamine (AMT)• Bufotenin• dextorphan (DXO)• Benzylpiperazine (BZP)• lysergic acid diethylamide (LSD)
FDA Controlled Substances
Schedule II• drugs with a high
potential for abuse but less abuse potential than S- I drugs
• with use potentially leading to severe psychological or physical dependence
Substance II drugs may not be
dispensed without written prescription
from a doctor. Prescriptions of
substance II drugs are in a "closed
system". This means, the prescription may not be refilled, unless medically required.
Give an example of drugs under Schedule II.
Schedule II• Methylphenidate (Ritalin)• Meperidine (Demerol)• Cocaine• Opium• Methadone (Dolophine)• Oxycodone (OxyContin)• Fentanyl (Sublimate)• Morphine• Mixed Amphetamine Salts (Adderall)• Lisdexamfetamine (Vyvanse)• Dextroamphetamine (Dexedrine)• Methamphetamine (Desoxyn)• Hydrocodone (Vicodin)• Hydromorphone (Dilaudid)• Secobarbital (Seconal)• Pethidine• Nabilone (Cesamet)• Tapentadol
FDA Controlled Substances
Schedule III
• drugs with a moderate to low potential for physical and psychological dependence.
• with a currently accepted medical use in treatment
Schedule III drugs may not be used without prescription from
a doctor. Prescriptions may not be refilled after six months of the date they were issued
for use.
Give an example of drugs under Schedule III.
Schedule III• Anabolic Steroids• Buprenorphine• Amphetamine• Dihydrocodeine• Ketamine• Xyrem• Hydrocodone/Codeine• Marinol• Lysergic Acid Amide (LSA)• Paregoric• Barbiturates (Short acting)
FDA controlled substances
Schedule IV
• drugs with a low potential for abuse and low risk of physical or psychological dependence.
• with a currently accepted medical use in treatment.
Prescriptions for Schedule IV
drugs may be refilled up to five times within six
months.
Give an example of drugs under Schedule IV.
Schedule IV• Alprazolam (Xanax)• Diazepam (Valium)• Lorazepam (Ativan)• Temazepam (Restoril)• Barbiturates (Long acting)• Modafinil (Provigil)• Dextropropoxyphene (Darvon)• Carisoprodol (Soma)• Propoxyphene (Darvon)• Zolpidem (Ambien)• Tramadol• Difenoxin
FDA Controlled Substances
Schedule V
• drugs with lower potential for abuse than S- IV and consist of preparations containing limited quantities of certain narcotics.
• Abuse of the drug may lead to limited physical dependence or psychological dependence.
• generally used for antidiarrheal, antitussive, and analgesic purposes.
No drug found in schedule V may be dispensed or distributed for anything other than medicinal
use.
Give an example of drugs under Schedule V.
Schedule V• cough preparations with less than 200 mg of
codeine (Robitussin AC)• Lomotil• Motofen• Lyrica• Parepectolin
Give one tip to avoid ambiguity in prescription.
Conventions in avoiding ambiguity
1. Careful use of decimal point2. Directions in full english3. Direction should be specific4. Use of permanent ink5. Avoid units such as tsp/ tbsp6. Writing out numbers as words7. Use of apothecary units8. Use of degree symbol
How can we classify if a drug is considered safe for Pregnant women?
FDA Pregnancy Categories
• The FDA has established five categories to indicate the potential of a drug to cause birth defects if used during pregnancy. The categories are determined by the reliability of documentation and the risk to benefit ratio.
FDA Pregnancy Categories
• Category A• Adequate and well-controlled studies have
failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
• levothyroxine• folic acid• magnesium sulfate• liothyronine
FDA Pregnancy Categories
• Category B• Animal reproduction studies have failed to
demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
• metformin• hydrochlorothiazide• cyclobenzaprine• amoxicillin• pantoprazole
FDA Pregnancy Categories
• Category C• Animal reproduction studies have shown an
adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• tramadol• gabapentin• amlodipine• trazodone• prednisone
FDA Pregnancy Categories
• Category D• There is positive evidence of human fetal risk
based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• lisinopril• alprazolam• losartan• clonazepam• lorazepam
FDA Pregnancy Categories
• Category X• Studies in animals or humans have
demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
• atorvastatin• simvastatin• warfarin• methotrexate• finasteride