Pharmacy tech unit 2

Opium

Opium was widely used for food, medicine, ritual, and as a painkiller throughout ancient civilizations including Greece, Egypt, and Islamic societies up to medieval times

Cocaine

used as a popular local anesthetic and found in many over-the-counter products during the late 19th and early 20th centuries. Its use declined due to its high potential for addiction, toxicity

DEG solvent

Toxic industrial solvent that was in new antibiotic that caused Elixir Sulfanilamide Tragedy

DEA Form 222

Submit to DEA when ordering schedule drugs, must keep on file for 2 years

Pharmaceutical equivalence

Same form (pill, injection, IV fluid, cream)

Therapeutic equivalence

Containing the same active ingredient and is absorbed into the body at same rate/efficiency.

Orange Book

List of FDA approved generics

IND

Investigational new drug application

NDA

New Drug Application

Double-blind

Neither the researcher nor the patient knows whether they received a placebo or treatment

Brand Drugs

Sold under brand name by pharmaceutical companies

Generic Drugs

Cheaper because it only has to prove therapeutic equivalence to brand drug

DAW

dispense as written, aka don't give them generic if the prescription reads brand name

Pay-for-delay deals

agreements where a brand-name drug company pays a generic drug company to delay or stop selling a lower-cost generic version of the drug

Peyote

cactus, contains psychoactive mescal and used by indigenous to connect to spiritual world (hallucinations)

Schedule I - V

Schedule I: no accepted medical use (heroin)

Schedule II : accepted medical use but high risk of abuse (morphine)

Schedule III- anabolic steroids/ trace codeine, can be refilled 5 times in 6 months (Testosterone)

Schedule IV: sleep meds, low abuse but psychological dependence. can be refilled 5 times in 6 months (zolpidem)

Schedule V: lowest abuse potential, can we sold without prescription but some states require it. requires ID age check (18+ usually) and quantity limits. (robitussin w codeine) 

Stock Medication

higher concentrations/quantity of medicine that the pharmacy keeps to fill prescription

NDC

national drug code (10-11 digits)

1st 4 digits - labeler, identifies manufacturer, packager/distributor

2nd 4 digits - product, identifies specific drug, strength, dosage form, and formulation

last 2-3 digits - package, identifies package size and type. the actual number doesn’t correspond to the size, its just a code. e.g 08 doesn’t mean 8 pills or whatever. 

Prescription Containers

block UV rays and seal out moisture to preserve meds. labeled with name+address of pharmacy, Rx number, prescriber name, date filled, discard after date (not same as expiry date, accounts for pharmacy compounding) patients name, directions for use

Federal transfer warning

Listed on schedule drug prescription bottles, stating that it is illegal to transfer the meds to someone it’s not prescribed to

OTC

over the counter

CMEA Law

Combat Methamphetamine Epidemic Act, limits psuedophedrine sales to 3.6 g daily and 9 g monthly per customer

DEA Number

First letter is the issuer (A/B for doctor, F for distributor, M for mid-level practitioner like nurse)

second letter is first letter of issuer’s last name.

numbers are only valid if (1st + 3rd + 5th) + 2(2nd, 4th, 6th) digit = 7th digit

DEA Form 222

order schedule drugs

HIPAA

health insurance portability and accountability act

PHI

personal health info→ Any information that can be linked to an individual’s health, past, present, or future. 

Ex: Patient’s name, address, phone number.

Date of birth, Social Security number.

Prescription history (insulin, antidepressants, opioids).

Insurance ID numbers and payment history.

Even small details (like overhearing what medicine someone takes) are considered PHI.

Minimum Necessary Rule

share minimum Necessary PHI to complete task

Lipitor®

atorvastatin

OxyContin®

oxycodone

Vicodin®

hydrocodone

Adderall®

amphetamine salts

Valium®

diazepam

Ativan®

lorazepam

Ambien®

zolpidem

Glucophage®

metformin

Sudafed®

pseudoephedrine

Patent

a government authority or license conferring a right or title for a set period, especially the sole right to exclude others from making, using, or selling an invention.

where does each copy of the DEA form go?

Copy 1 goes to the Supplier.
Copy 2 sent of DEA, but routed through Supplier
Copy 3 is pharmacy record

DEA 41

destruction of controlled substances

DEA 106

report of theft or loss

DEA 224

new pharmacy registration

DEA 225/225a

manufacturers and distributors

DEA 363

narcotic treatment programs

Class I recall

dangerous/defective products that could cause serious harm

Class II recall

products that could cause temporary/reversible harm (incorrect dosage strength)C

Class III recall

unlikely to cause harm but violate FDA manufacturing/labeling laws (typo on package insert)

Pure Food and Drug Act 1906

→ Before - many medicines were unsafe and sold with false claims and dangerous ingredients (opium, cocaine in tonics)

→What the law did - Prohibited sale of misbranded or adulterated drugs and foods. Required drugs to meet purity and labeling standards. Laid the foundation for all future FDA regulation. (regulate pharmaceuticals)

Elixir Sulfanilamide Tragedy

Mass poisoning - 107 deaths, mostly children, from diethylene glycol solvent (S.E. Massengill Company created a new liquid antibiotic using the toxic industrial chemical diethylene glycol (DEG) as a solvent, without conducting safety tests)

Federal Food, Drug, Cosmetic Act (FDCA) 1938

• Triggered by elixir tragedy

• What the law did - established FDA, Required proof of safety before marketing drugs. Authorized factory inspections. Extended regulation to cosmetics and medical devices (now, every prescription and OTC drug must meet FDCA standards

Controlled Substances Act (CSA) 1970

• Started with rising abuse of drugs (heroin, cocaine, amphetamines) in the 1960s

• What the law did - classified drugs into the 5 schedules (I = highest abuse, no medical use; V = lowest abuse), created DEA 1973, regulated ordering, dispensing, recordkeeping, and inventory of controlled substances

Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) 1984

• Balancing innovation (reward for brand drug research) with affordable access (generics)

• What the law did - Allowed manufacturers to apply for generic drug approval after patent expiration. Required generics to prove bioequivalence (same rate/extent of absorption). Extended patents up to 5 years to make up for time lost during FDA review.

FDA New Drug Approval

1. Preclinical Testing - Test new compounds in the lab and on animals before human trials (toxicity and side effects) → file an Investigational New Drug (IND) application

→ IND Application - request to the FDA to begin clinical trials in humans, FDA must approve before human testing begins

2. Clinical Trials 

   • Phase I – Safety First

   • Who: 20–100 healthy volunteers.

   • Purpose: Determine safe dosage range and identify side effects.

   • Duration: Months.

   • Phase II – Effectiveness

   • Who: 100–500 patients with the disease.

   • Purpose: Test if the drug actually works for its intended condition.

   • Also monitors: Short-term side effects.

   • Phase III – Large-Scale Testing

   • Who: Thousands of patients across hospitals and clinics.

   • Purpose: Confirm effectiveness, compare to existing treatments, monitor longer-term side effects.

   • Design: Often random

3. FDA Review and Approval - after Phase III, manufacturer files a New Drug Application (NDA), FDA reviews (can take years ~10+)

4. Post-Marketing (Phase IV) - Monitor real-world use. Some side effects don’t appear until a drug is used by millions. → FDA: Requires warning label updates. Issues drug recalls if risks outweigh benefits

Stock medications labeling reqs

1. Brand and/or generic names

2. Dosage form (tablet, capsule, solution, etc.)

3. Strength (mg, mL, %)

4. Quantity (e.g., 100 tablets)

5. Lot or Batch number (for recalls)

6. Expiration date

7. Manufacturer name

8. National Drug Code (NDC) number

Controlled Substance Labeling Reqs

1. All same as prescription, plus schedule classification (CII, CIII, etc.)

2. Federal transfer warning: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

OTC meds labeling reqs- regulated by FDA

1. Active ingredients & purpose

2. Uses (indications)

3. Warnings (allergies, pregnancy, interactions)

4. Directions (dosage and timing)

5. Inactive ingredients (important for allergies)

6. Lot number and expiration date

HIPAA Legal Consequences

• Civil fines (up to $50,000 per violation, higher for repeated offenses).

• Criminal charges in cases of intentional misuse.

HIPAA Professional Consequences

• Loss of job or termination.

• Loss of certification or inability to work as a pharmacy technician.

HIPAA Ethical Consequences

• Loss of patient trust.

• Damaged reputation for the pharmacy.

Ethical Responsibilities of Pharmacy Technician

Confidentiality: Never gossip about patients.

Respect: Speak in private areas when discussing sensitive information.

Professionalism: Always put patient trust and dignity first.