Pharmacy Law & Regulations (12.5%)

DEA Number Verification

1) Add the 1st, 3rd, and 5th digits 2) Add the 2nd, 4th, and 6th digits and multiply sum by 2 3) Take the answer from step 1 and add it to the answer from step 2 4) The answer from step 3 will be a 2-digit number. If the number is legitimate, then the second digit of the answer will match the 7th and final digit of the ____ number.

What information must be included on a controlled substance prescription?

1) Patient's full name 2) Patient's address 3) Prescriber's full name 4) Prescribers work address 5) Prescriber's DEA number 6) Drug name 7) Drug strength 8) Dosage form 9) Quantity prescribed 10) Directions for use 11) Number of refills authorized (if any)

If a patient has a C-II prescription partially filled at the pharmacy, how long does the patient have to fill the remaining quantity?

72 hours.

T.I.P.S.

A REMS program designed to communicate the risk of cardiac arrhythmias associated with Tikosyn. Tikosyn can cause potentially fatal ventricular arrhythmias, especially in patients who are starting or re-starting therapy.

iPLEDGE

A REMS program with two primary aims: ensuring patients who begin isotretinoin therapy are not pregnant and preventing pregnancy in patients who receive isotretinoin therapy. Isotretinoin use is associated with severe birth defects when used during pregnacy.

Clozaril National Registry

A database for recording and referencing the white blood cell count of patients who receive therapy with clozapine. Clozapine can cause the potentially fatal side effect of agranulocytosis; suppression of white blood cell production

Adulterated Drug

A drug that has a different quality, strength, or purity than that which is stated on the label. Includes medications that contain decomposed substances, medications prepared in containers

C-I Substances

GHB Heroin LSD MDMA

All areas where hazardous drugs are routinely handled must contain

Hazardous drug spill kits Containment bags Disposal containers

What are 3 types of prescription orders for which a pharmacy can dispense a faxed C-II prescription without requiring presentation of the original signed prescription?

Home infusion orders Long-term care facility orders Hospice care program orders

Centers of Disease Control and Prevention

A government agency founded during World War II to help prevent and control the spread of communicable diseases. The purpose of this organization is to educate and inform the public in order to improve their decisions regarding their health. They also study public health risks such as chronic diseases, disabilities, workplace health issues, environmental health issues, obesity, birth defects, and bioterrorism.

Hazardous Drug

A medication that can cause harm to human or animal life. For example, exposure to a hazardous drug may cause reproductive toxicity, organ damage, birth defects, and/or cancer. Typically found in cancer chemotherapy, antiviral, immunosuppressant, hormone, and certain anticonvulsant drug classes.

Are C-II prescriptions valid when received by facsimile (fax machine)?

A pharmacy can use a faxed copy of a C-II prescription to fill a prescription; but prior to dispensing, the patient must present the original signed prescription.

How does the Combat Methamphetamine Epidemic Act of 2005 require pseudoephedrine products to be packaged and sold?

In blister packs.

Post-Marketing Surveillance

Information regarding the safety and effectiveness of a drug continues to be gathered after it has been approved and marketed. Some drugs are removed from the market due to revelations from ____ ____. For example, Vioxx was removed from the market when ____ ____ revealed an increased risk of heart attack and stroke.

After calling in an emergency C-II prescription, what must the prescriber do next?

Provide the pharmacy with a written and signed hard-copy, which the pharmacy files along with the verbal order.

Medicare Prescription Drug Improvement and Modernization Act of 2003

Provided senior citizens with preventive medical benefits and Medication Therapy Management. This also affected DME businesses, as it instilled the national competitive bidding program and lowered Medicare reimbursement rates.

Orange Book

Published by the FDA, the "Approved Drug Products With Therapeutic Equivalence Evaluations"; all products that have been approved by the FDA based on their proven safety and efficacy. Medications prior to 1938 are not included in this book.

What color are standard sharps containers?

Red

C-II Refills

Refills not permitted

C-V Refills

Refills permitted, no maximum

C-III and IV Refills

Refills permitted, up to 5 refills valid for 6 months

Federal Trade Commission

Regulates advertising for otc drugs, medical devices, cosmetics, and food products.

Dietary Supplement Health and Education Act of 1994

Required manufacturers of herbal supplements to identify all of its ingredients by name on the label.

Omnibus Budget Reconciliation Act of 1990

Requires drug utilization reviews and pharmacist counseling for Medicaid patients. Also requires that all long-term care facilities receive consultant pharmacist services.

National Association of Boards of Pharmacy

Responsible for discussing pharmacy trends and issues

Drug Listing Act of 1972

Responsible for implementing the NDC number used for each drug.

State Board of Pharmacy

Responsible for regulating the pharmacy practices in a given state. Also in charge of regulating traditional compounding pharmacies.

The Federal Privacy Act of 1974

Responsible for the regulation of what personal information the government is allowed to collect on private individuals.

C-III, IV, and V Storage and Security

Same as for C-II meds. Must be stored in a locked cabinet or among the non-controlled medications in such a manner as to obstruct theft or diversion.

Phase 1 Clinical Trials

Small study involving 20-80 health male volunteers Low doses are tested Data is collected on drug bio-availability and the highest dose of the new treatment that can be given safely without serious side effects.

When handling hazardous drugs, healthcare workers should follow ____ and any recommendations included in the manufacturer's ____

Standard precautions Material safety data sheet (MSDS)

Standard Precautions for Hazardous Drugs

Store hazardous drugs in a well-ventilated are separate from other inventory. Wear chemotherapy gloves whenever handling hazardous drugs Perform sterile compounding activities with hazardous drugs in an ISO class 5 biological safety cabinet or compounding aseptic containment isolator. Wear appropriate personal protective equipment

Phase 2 Clinical Trials

Study involving 25-100 patients with the disease of interest Minimum effective dose and maximum toxic dose are determined Side effects experienced by the test subjects are recorded

Phase 3 Clinical Trials

Study involving 300-3000 patients of various gender, race, lifestyle, and age Risks and benefits of using the drug are assessed Drug formulation is refined Placebo studies are conducted

C-III Anabolic Steroids

Testosterone (Androgel, Testim, Axiron, Depo-Testosterone) Oxandrolone (Oxandrin)

Drug Monograph

The FDA labeling regulations require ____ ____ to be available for each drug. Sections included: Contraindications: Lists the risks associated with taking the drug and the hazards of the drug Indications and Usage: Lists the conditions that the drug is approved to treat, the drug's pharmacological class, and limitations associated with the drug. Dosage and Administration: Lists the drug's pharmacological information, the drug's recommended dosage regimen, the drug's dosage range, and how the drug should be administered. Dosage Forms and Strengths: Lists the drug's color and scoring, the form of the drug, and the strengths of the drug.

How does the PPPA affect drug manufacturers?

The PPPA requires manufacturers to place drug products in packaging that is significantly difficult for children under the age of 5 years old to open, yet not difficult for normal adults to open.

Controlled Substances Act

The federal law giving authority to the Drug Enforcement Administration to regulate the sale and use of controlled substances.

In what setting might you find a Schedule I controlled substances?

The only setting in which a Schedule I controlled substance can be legally utilized is a research laboratory registered with the DEA.

What must the pharmacy do in the event of theft or loss of a controlled substance?

The pharmacy must notify the DEA and complete a DEA Form 106 to document the details of the theft or loss.

If an individual's PHI has been breached, what must be done according to HIPAA?

The pharmacy must notify the individual that their PHI was exposed. This is known as the "HIPAA Breach Notification Rule."

Resource Conservation and Recover Act

The principal federal law in the United States governing the disposal of solid waste and hazardous waste.

When using or disclosing PHI, what principle should you keep in mind?

The principle of "minimum necessary use and disclosure."

Prescribers that want to prescribe Schedule III-V controlled substances for treatment of narcotic addiction (i.e. products containing buprenorphine) must display what unique identifier on the face of the prescription?

Their unique DEA registration number that begins with the letter "X" must be displayed, which is granted to prescribers that have obtained a special waiver from the DEA (in addition to their standard DEA registration number). Typically, controlled substances used to treat narcotic. Addiction can only be prescribed, administered, and/or dispensed within a Narcotic Treatment Facility (NTF), but the DEA grants waivers to certain prescribers, allowing them to prescribe, administer, and/or dispense C-III through V prescriptions for treatment of narcotic addiction outside of a NTF.

FDA Recall Class I

These recalls are the most serious. Drugs affected by this recall are likely to cause serious adverse health conditions or death.

FDA Recall Class III

These recalls are used when a drug has violated an FDA regulation, but adverse health consequences are unlikely to occur.

Combat Methamphetamine Epidemic Act of 2005

This act positioned pseudoephedrine, phenylpropanolamine, and ephedrine in a Controlled Substance Act category. This movement subjected methamphetamines to sales restriction, record-keeping requirements, and storage requirements. Requires that customers are limited to the amount of pseudoephedrine they can purchase on a daily and montly basis, and the pharmacy must record each sale.

Nitroglycerin

This drug is exempt from PPPA law because it is used to restore blood flow to the heart during an exacerbation of angina. Child resistant packaging may cause an individual on the verge of a heart attack to struggle with opening the container.

United State Pharmacopoeia

USP Responsible for establishing sterile compounding requirements. Also responsible for developing and publishing standards for drug substances, drug products excipients, and dietary supplements.

The United Stated Pharmacopeia and the National Formulary

USP-NF The official source of medication info for drugs approved by FDA; updated every 5 years All medications sold in the US, both prescription and OTC must comply w/ the standards set in this formulary

UPIN

Unique Provider Identification Number Replaced by NPI starting in 2007

What organizations provide information regarding the storage, handling, and disposal of hazardous drugs

United State Pharmacopoeia (USP) American society of Health-System Pharmacists (ASHP) National Institute for Occupational Safety and Health (NIOSH) Occupatinal Safety and Health Administration (OSHA)

What is the purpose of a black pharmaceutical waste container?

Used for the disposal of bulk hazardous drug waste (e.g. disposal of a partially empty vial of a cancer chemotherapy drug).

A patient presents six prescriptions for Adderall 5 mg. Each prescription is written for 30 tablets with the instructions to take 1 tablet by mouth every morning an d1 tablet by mouth every afternoon at 3 pm. Is it legal for the patient to possess this many prescriptions for a C-II drug?

While it would be prudent to verify the prescriptions with the prescriber before dispensing, federal law does permit prescribers to issue multiple C-II prescriptions at one time as long as the total days' supply does not exceed 90 days. Note: these prescriptions would need to have the earliest fill date written on them (e.g. do not fill until 4/15)

Material Safety Data Sheets are for ____ & ____

Workers that will potentially be exposed to chemicals Emergency response personnel (e.g. firefighters)

What color are chemotherapy sharps containers

Yellow

Does the law allow for C-III, C-IV, and C-V prescription refills?

Yes, a prescriber can issue up to 5 refills for C-III, C-IV prescriptions, but the original prescription and any refills must be filled within 6 months of the date written. Refill limitations do not apply to C-V prescriptions.

Does HIPAA set standards for protecting electronic PHI, such as electronic medical records (EMR)?

Yes.

What consequence can a manufacturer face for failing to comply with REMS

a fine of at least $250,000 per incident

The Joint Commission

a nonprofit, independent organization that certifies and accredits health care organizations such as hospitals througout the US. Their goal is to ensure the best possible healthcare for all patients at all facilities, nationwide.

What are some of the most frequently used REMS programs?

iPLEDGE, THALIDOMID REMS, T.I.P.S., and Clozaril National Registry

DEA Form 106

Form used for reporting the loss or theft of controlled substances.

When emergency C-II prescriptions are called in, a prescriber has how many days to furnish the pharmacy with a written and signed prescription hard-copy?

7 days according to federal law.

How many different items can be placed on a DEA Form 222?

10

DEA forms must be maintained for how many years?

2 years

How long must the pharmacy keep controlled substance return records, prescription records, and inventory records?

2 years

Hazardous Antiviral Drugs

Abacavir Entecavir Ganciclovir Valganciclovir Zidovudine

Schedule 2 Controlled Substance

Accepted medical use Available by prescription only High potential for abuse High potential for physical/psychological dependence Example: MS Contin

Schedule 5 Controlled Substance

Accepted medical use Available by prescription only Low potential for abuse Low potential for physical/psychological dependence Example: Cheratussin AC

Schedule 4 Controlled Substance

Accepted medical use Available by prescription only Mild potential for abuse Mild potential for physical/psychological dependence Example: Alprazolam

Schedule 3 Controlled Substances

Accepted medical use Available by prescription only Moderate potential for abuse Moderate-low potential for physical/psychological dependence Example: Buprenorphine

C-IV Depressants Benzodiazepines

Alprazolam (Xanax) Chlordiazepoxide (Librium) Clonazepam (Klonopin) Clorazepate (Tranxene) Diazepam (Valium) Estrazolam (Prosom) Flurazepam (Dalmane) Lorazepam (ativan) Midazolam (Versed) Temazepam (Restoril)

C-II Depressants

Amorbarbital (Amytal) Pentobarbital (Nembutal) Secobarbital (Seconal)

C-II Stimulants

Amphetamine/Dextroamphetamine (Adderall) Cocaine Methamphetamine (Desoxyn) Methylphenidate (Concerta, Meta date, Ritalin)

The Durham-Humphrey Act of 1951

An amendment to the Food, Drug, and Cosmetic Act of 1938 and required all products to have sufficient directions for use.

Hazardous Cancer Chemotherapy Drugs

Anastrozole Bicalutimide Cisplatin Exemestane 5-Fluorouracil Letrozole Mercaptopurine Methotrexate Oxaliplatin Tamoxifen Vinblastine Vincristine

THALIDOMID REMS

Formally known as S.T.E.P.S., Thalomid (thalidomide) can be used for the treatment of multiple myeloma and erythema nodosum leprosum, but causes severe birth defects and venous thromboembolic events.

How does a drug obtain the FDA's approval for use in humans

Drugs are approved by the FDA only after they are proven to be safe and effective through clinical trial data. Clinical trials are composed of 4 phases, and the process usually takes several years.

DEA Form 222a

Form used for ordering additional DEA 222 Forms.

DEA Form 224a

Form used for renewing DEA registration (renewal is required every 3 years).

DEA Form 104

Form used for reporting a pharmacy closure or surrender of a pharmacy permit.

After an initial inventory of controlled substances has been taken, how frequently must an inventory of controlled substances be conducted?

At least once every 2 years.

Hazardous Immune System Suppressant Drugs

Azathioprine cyclosporine Mycophenolate Sirolimus Tacrolimus

C-III Depressants

Barbituric acid and its derivatives Ketamine (Ketalar) The following C-II _____ are considered ____ ____ when they exist in a compound, mixture, or suppository form: Amobarbital Pentobarbital Secobarbital

C-III Stimulants

Benzphetamine (Didrex, Regimex) Phendimetrazine (Bontril)

Manufacturing

Bulk mixing or preparation of non-patient specific medications.

C-III Opioids

Buprenorphine (Subutex) Buprenorphine/Naloxone (Suboxone) Camphorated tincture of opium (Paregoric) Codeine (Tylenol 3, Fioricet w/ codeine)

C-IV Opioid Agonist/Antagonist

Butorphanol (Stadol) Pentazocine (Talwin)

DEA Form 41

Form used for reporting the destruction of controlled substances.

What should you do if you've been exposed to a hazardous drug?

Call for help if necessary Remove any contaminated clothing Wash affected eye(s) with water for at least 15 minutes clean affected skin with soap and water. Rinse well Seek medical attention and document the exposure

What information is provided in a product's material safety data sheet?

Chemical and physical properties Health, safety, fire, and environmental hazards Information on what to do if the product is accidentally spilled

C-II Opioids

Codeine Hydrocodone (includes all hydrocodone combinations) Morphine (MS Contin, Kadian, Roxanol) Meperidine (Demerol) Methadone (Dolophine, Methadose) Fentanyl (Duragesic) Hydromorphone (Dilaudid, Exalgo) Oxycodone (Roxicodone, Oxycontin) Oxymorphone (Opana)

C-V Opioids

Codeine w/ guaifenesin (Robitussin AC) Diphenoxylate/Atropine (Lomotil)

United States Nuclear Regulatory Committee

Creates standards to proved safety from radiation. Ensures that patients receive the correct dose of ration as required to treat the condition, and ensures that radioactive substances used in nuclear medication are properly controlled, stored, and disposed of following use.

Pseudoephedrine Limits

Customer must present a photo ID at POS Manufacturers must package pseudoephedrine tablets and capsules in blister packs Individual daily limit is 3.6 grams Individual monthly limit is 9 grams; and 7.5 grams for products purchased via mail order. Records must be kept for at least 2 years Customer signature required These limits and record-keeping requirements do not apply to patients receiving a ____ product with a valid prescription

When C-II controlled substances are sent to a reverse distributor because they are expired, damaged or otherwise unusable, what form should be used?

DEA Form 222 The entity receiving the substance is always the one responsible for filling this form out.

Situations when the principle of "minimum necessary use and disclosure" do not apply

Disclosures to a healthcare provider for treatment. Disclosures to the patient upon request. Disclosures authorized by the patient. Disclosures necessary to comply with other laws. Disclosures to the Department of Health and Human Services for a compliance investigation, review, or enforcement.

How to properly dispose of medication

Do not flush medications down the toilet unless the package specifically indicates to do so. If community take-back programs are offered in your area, take advantage of them. Before disposing of medications in the trash, medications should be removed from the original containers and mixed with a substance such as used coffee grounds or cat litter, and be placed in a sealed bag or other empty container to prevent leakage. Before disposing of a medication container, destroy the label or make it unreadable.

C-III Hallucinogens

Dronabinol (Marinol)

DEA Number

Drug Enforcement Administration registration number Required on all prescriptions for controlled substances The first letter in this sequence identifies the type of practitioner or registrant A, B, or F for physicians, dentists, veterinarians, hospitals, and pharmacies M for midlevel practitioners P or R for drug distributors X: for prescribers with a ____ waiver to write prescriptions for Subutex or Suboxone outside of a narcotic treatment facility The second letter of this sequence will be the same as the first letter of the prescribers last name or the first letter in the name of the business

Hatch-Waxman Act of 1984

Drug Price Competition and Patent Term Restoration Act Promoted the manufacturing of generic drugs and new medications.

According to the federal Controlled Substances ACT, how should you store C III-V prescription files

Either separately from all other prescription records or in such a way that they are readily retrievable from the non-controlled prescription records. (i.e. if each controlled substance prescription is marked with the letter C in red ink).

Who provides employees with material safety data sheets (MSDS)?

Employer.

Health Insurance Portability and Accountability Act of 1996

Enacted in 1996 and went into effect in 2003 Protects the privacy of individual health information known as PHI.

Drug Enforcement Administration

Enforces the federal Controlled Substances Act and makes decisions regarding the classification of certain drugs as controlled substances

The Pure Food and Drug Act of 1906

Established to outlaw the interstate transport or transaction of contaminated and mis-branded drugs.

C-IV Depressants

Eszcopiclone (Lunesta) Zaleplon (Sonata) Zolpidem (Ambien) Phenobarnital (Luminal) Carisoprodol (Soma) Tramadol (Ultam)

Food and Drug Administration

FDA Responsible for monitoring the purity, safety, and effectiveness of all pharmaceutical products. Also responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, allergenics, prescription and otc pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic rradiation emitting devices (ERED), cosmetics, animal foods, and feed, and veterinary products.

Misbranded Drugs

False or misleading labeling Legally non-compliant packaging/labeling Unclear wording on label Inadequate directions for use Drug poses a danger if used as prescribed Generic name is not displayed in a font size at least half as large as the brand name.

True or False. C-II prescriptions may be refilled up to 5 times in 6 months.

False, C-II prescription refills are legally prohibited.

True or False. For controlled substance prescriptions, the maximum quantity that can be dispensed according to federal law is 30-day supply.

False, although some states and some insurance companies may limit controlled substance quantities to a 30-day supply, there are no specific federal limits. Note: When federal and state laws differ, you must follow the more stringent law.

True or False. Federal law prohibits e-prescribing of C-II drugs.

False, federal law permits e-prescribing of C-II through C-v drugs; however, the software used by the prescriber sending the prescription and the pharmacy receiving the prescription must be certified by the DEA.

Can pharmacies dispense Schedule I controlled substances with a valid, hand-signed prescription?

False, schedule I controlled substances are not legal for medical use.

According to federal law, C-II prescriptions must be filled within how many days after being signed by the prescriber?

Federal law places no time limit within which a C-II prescription must be filled (i.e. the prescription is considered legally valid for an unlimited period of time after it is issued). Note, however, that individual state laws may impose a time limit.

FDA Recall Class II

For recalls in this class the possibilities of death or serious health consequences are unlikely, but temporary health problems may occur because of taking the drug.

DEA Form 224

Form used for applying for a DEA registration number.

DEA Form 222

Form used for ordering Schedule II controlled substances. Each form contains 2 carbon copies (the original, plus 2 attached copies) The first page (original) is brown and must be retained by the drug supplier. The second page is green and must be forwarded to the DEA by the drug supplier. The first 2 pages should not be separated. For the form to be valid, the brown and green copies must be intact with the carbon paper between them The third page is blue and must be retained by the pharmacy. Mistakes cannot be corrected. When an erroneous entry is made, all copies of the form must be voided and retained by the pharmacy

C-III, IV, and V Prescription Records

Kept separate from all other prescriptions, or mark in the lower right corner with the letter "C" At least 1-inch high in red ink and store in the same file with non-controlled substance prescriptions. For pharmacies that dispense controlled substance e-prescriptions, the prescription records can be stored electronically as long as they can be sorted by prescriber name, patient name, drug dispensed, and date filled and the records are printable or capable of being transferred to a government or law enforcement agency.

Poison Prevention Packaging Act of 1970

Law that requires child-resistant packaging for drug products

Prescription Drug Marketing Act of 1987

Makes sure that all drugs being marketed to consumers are both safe and effective and prevents risk to consumers from counterfeit, misbranded, adulterated, expired or subpotent medication. Required "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian" to be placed on all prescriptions given to animals.

Kefauver-Harris Amendment of 1962

Mandated that all U.S. drugs be pure, safe, and effective

Food, Drug, and Cosmetic Act of 1938

Mandated that all new drugs be recorded with the FDA.

Hazardous Drug Spill Kit Requirements

Material to absorb about 1000 mL of liquid Personal protective equipment: 2 pair of gloves, gown, shoe covers, face shield Two or more sealable plastic hazardous waste disposal bags One disposable scooper and one puncture-resistant container for collecting and disposing of broken glass.

Risk Evaluation and Mitigation Strategies

Meant to ensure that the benefits of using a particular medication outweigh the associated risks.

C-IV Stimulants

Modafinil (Provigil) Phentermine (Adipex-P) Phentermine/Topiramate (Qsymia) Sibutramine (Meridia)

C-II Storage and Security

Must be stored in a locked cabinet or among the non-controlled medications in such a manner as to obstruct theft or diversion.

C-II Prescription Records

Must keep separate from all other prescriptions.

C-II Hallucinogens

Nabilone (Cesamet)

C-III Mixed Opioid/Agonist/Antagonist

Nalorphine (Nalline)

NPI

National Provider Identifier number

Schedule 1 Controlled Substance

No accepted medical use Not legal for prescribing purposes High potential for abuse Lack safety Example: Heroin

Can Schedule II controlled substance prescription records be stored in the same file as other prescription medications?

No, Schedule II prescription records must be stored separate from all other prescription records.

Are prescribers required to personally send faxes when C III - V prescriptions are transmitted to pharmacies by fax?

No, a prescriber's agent may send faxes for C-III, IV

For non-controlled substance prescriptions, a prescriber's agent (e.g. nurse or secretary) may call in a verbal prescription. Can a prescriber's agent call in Schedule III-V prescription?

No, the individual prescriber must personally make the call to submit a C-III through V prescription verbally.

When C III-V controlled substances are returned, is a DEA Form 222 necessary?

No, they may be transferred via invoice.

Can a controlled substance be delivered or shipped to an individual in another country if they have a valid prescription?

No. The prescriber might try to do this when he/she doesn't want the patient to have the prescription filled until 8/14/16, but they should record the written date as 8/12/16 and writ on the face of the prescription "do not fill until 8/14/16."

Can a prescriber post-date a prescription for a controlled substance (e.g. record the date written as 8/14/16 when he/she actually wrote the prescription on 8/12/16)?

No. The prescriber might try to do this when he/she doesn't want the patient to have the prescription filled until 8/14/16, but they should record the written date as 8/12/16 and writ on the face of the prescription "do not fill until 8/14/16."

C-II Prescription Transfers

Not transferable between pharmacies

If a pharmacy is robbed and the thief takes several bottles of scheduled medications what must the pharmacy do?

Notify the DEA.

Are verbal orders for C-II prescriptions permitted?

Only in emergencies (as determined by the pharmacist). Note: The pharmacist must immediately document the verbal order in writing and the quantity of medication must be limited to an amount adequate to treat the patient only for the duration of the emergency period.

Limited Authority

Optometrists and midlevel practitioners have ____ ____. Additionally, midlevel practitioners can only prescribe specific medications as outlined in a signed written agreement between them and their supervising physician. A licensed physician must approve every prescription written by a midlevel practitioner Optometrists: Doctor of Optometry (OD) Midlevel Practitioners: Physician Assistant (PA) and Nurse Practitioner (NP)

By what means can a prescriber issue C-III, C-IV, and C-V prescriptions?

Orally/Verbally In writing By facsimile Electronically where state law permits

C-II Partial Fills

Partial fills permitted if the remainder can be filled within 72 hours

C-III, IV, and V Partial Fills

Partial fills permitted with no time limit for filling the remainder.

C-III, IV, and V Prescription Transfers

Patients can transfer each prescription to another pharmacy one time; however, multiple transfers may take place between pharmacies that share real-time online database. Licensed pharmacists must complete all controlled substance transfers. Pharmacy technicians cannot transfer controlled substance prescriptions. The transferring pharmacy must send an invoice to the receiving pharmacy.

How does the PPPA change the way we dispense drugs?

Pharmacies now dispense prescriptions in bottles/vials with child-safety caps. There are few exceptions; including nitroglycerin sublingual tablets and birth control pills.

Occupational Safety and Health Administration

Plays a major role in reducing the risk of employee exposure to blood borne pathogens. This is particularly relevant for places where employees routinely work with needles.

C-V Depressants

Pregabablin (Lyrica) Lacosamide (Vimpat)

Compounding

Preparing patient specific doses of medications as prescribed by a physician. Pharmacies violate the law for ____ when they: ____ drugs ahead of time in anticipation of prescriptions ____ drugs from ingredients that have been withdrawn from market ____ drugs from ingredients not approved by the FDA ____ drugs using commercial scale manufacturing or testing equipment ____ drugs for third-party resale ____ drugs that are otherwise commercially available.

Full Authority

Prescribers with this access can prescribe any medication as long as they are acting within their scope of practice. There are four groups of healthcare professionals that have this type of access: Physicians: Doctor of Medicine (MD) and Doctor of Osteopathic Medicaine (DO) Dentists: Doctor of Dental Medicine (DMD) and Doctor of Dental Surgery (DDS) Podiatrists: Doctor of Podiatric Medicine (DPM) Veterinarians: Doctor of Veterinary Medicine (DVM)

Americans with Disabilities Act

Prohibits discrimination against the disabled and requires organizations to reasonably accommodate an individual's disabilities.

Consumer Product Safety Commission

Protects the public from unnecessary risks associated with manufactured products. Does not regulate drugs, but the containers in which medications are sold do fall under this agency's jurisdiction (including child resistant caps). Conducts research on products that may be considered worrisome, especially warranted by consumer complaints, issues recalls when necessary or bans products that are considered dangerous.