Unit 2 Law FInal

Explain how dextromethorphan is restricted in Wisconsin

Identify the authorized prescribers of prescription drugs in Wisconsin and explain their prescribing limitations, if any

Physician (DO and MD)	No Limits
Dentistry	Limited to the oral cavity or its adjacent or associated tissues and structures or of the maxillofacial area and their impact on the human body
Podiatrist	Limited to conditions affecting the foot and ankle
Veterinarians	Cannot: Prescribe for a client a veterinary prescription drug or a drug for extra-label use without personally examining the patient unless a veterinary clint patient relationship exists
Optometrists	Limited to a drug for ocular therapeutic purposes for which the drug is intended, in accordance with minimum standards Must consult with patient PCP before prescribing beta blockers, carbonic anhydrase inhibitors, oral antivirals or any other drug that may have significant systemic adverse drug rxns
Advanced Practice Nurse Practitioner (APNP)	May issue only those prescription orders appropriate to the area of competence May not issue a prescription order for any schedule I controlled substance May not prescribe, dispense or adminster any amphetamine or schedule IIs except for Adjust to opioid analgesic compounds for treatment of cancer-related pain Treatment of narcolepsy Treatment of hyperkinesis, including attention deficit hyperactivity disorder Treatment of drug-induced brain dysfunction Treatment of epilepsy  Treatment of depression shown to be refractory to other therapeutic modalities May not prescribe, order, dispense, or administer any anabolic steroid for athletic performance or other nonmedical purpose  Shall, upon request, present evidence to where the rx is being sent that they are certified to issue prescription order
Physician Assistants	May order, prescribe procure, dispense and administer prescription drugs, medical devices and supplies within the limitations of their experience, education and training

List the requirements of a prescription order in Wisconsin and recognize when a required element is missing

• Date of issue

• First and last name and address of the practitioner

• Name and quantity of drug product (dosage form and strength)

• Directions for use of the drug product or device

• Symptom or purpose for which the drug is being prescribed if the pt wants that 

• Refills

• Practitioners written, electronic or digital signature

• Name and address of the pt unless there is an exception per statute

Explain when documentation of a prescription alteration must occur

Any alterations that modify the original intent of a prescription

Explain when a pharmacist may extend a prescription and recognize if a prescription may be extended in a given situation

Allowed

Prohibited

ALL of the following: a) The pharmacist has been unsuccessful in attempting to procure a new prescription order or refill authorization for the drug after attempting to contact the prescribing practitioner or his or her office. b) The patient is on a consistent drug therapy program and the patient has previously refilled the prescription at that pharmacy or through another pharmacy in the same pharmacy chain. c) The drug is essential to the life of the patient, or the interruption of the drug therapy could result in undesirable consequences for the patient’s health. d) The pharmacist has not received and is not aware of written or oral instructions from the prescribing practitioner prohibiting further dispensing pursuant to or extension of the prescription order

If a prescription is marked “No extensions”, the pharmacist cannot extend it. A pharmacist cannot extend a prescription for more than a 7-day supply, except when the drug’s packaging requires a larger quantity. Controlled substances cannot be extended. A prescription cannot be extended if it was previously extended within the past year. The pharmacist must notify the prescribing practitioner as soon as possible after extending a prescription.

Determine if two drug products are therapeutic equivalents using the Orange Book or are interchangeable biologics using the Purple Book

• Two drug products are therapeutic equivalents if they have the same two letter (+/- number) code in the Orange book and meet all other criteria of being therapeutic equivalents 

• Two biologic products are interchangeable if rated “I” in the purple book

Determine acceptable dispensing quantities for initial and refill prescription orders in Wisconsin

• Unless a prescription specifies a medically necessary quantity, pharmacists can adjust initial and refill amounts based on professional judgment.

• Adjustments can be made up to a 90-day supply in a single fill.

• The initial fill must match the prescription unless the patient previously received that amount within the last 2 years

Identify the required elements of a prescription label in Wisconsin for drug products, biologics, compounded products, and veterinary products and be able to recognize if any required element is missing.

Drug products	Name, address, and telephone number of dispensing pharmacy* The date of dispensing (date of filling)* Prescription order number assigned by the pharmacy* Prescribing practitioner’s name* First and last name of patient (with special exceptions)* Directions for use as written in the prescription order* Name and strength of the prescribed drug or device dispensed (unless prescriber requests omission of name or strength) Symptom/purpose of prescribed drug or device if included on the prescription order Date after which prescribed drug or device should not be used Quantity dispensed Number of refills or quantity remaining Federal: cautionary statements if stated in the prescription
Veterinary Additional	Last name of owner, Name of animal and animal species (replaced FL name pt) Veterinarian signature? Date prescription issued? Withdrawal time for food producing animal
Compounded Drug Additional	Storage conditions if other than controlled room temp Special handling instructions, when applicable Indication that the preparation is compounded unless administered by health care personnel Sterile product label: Route of admin Statement stating single-dose container Statement stating multiple dose container Sterile Product Labeling(Doesnt have to be on container) Compound facility name and contact info if CSP to be sent outside of the system which it was compounded

Explain the PPPA requirements for prescription drugs and exemptions related to prescription drugs (including institutionalized patients)

Requirements

Exemptions

The intent is to protect children from accidental poisonings with “household substances”, and by law, a food, drug, or cosmetic under FDCA falls in this category. Requires the use of child-resistant containers for packaging most OTC drugs and nearly all prescription drugs that the pharmacist will dispense directly to the consumer. These containers must be manufactured such that 80% of children less than 5 years old cannot open them, whereas 90% of adults can. A drug may only be dispensed ONE time in a child-resistant container or vial unless the container is glass or threaded plastic (in that case, only needs a new safety closure). Reversible closures are acceptable as long as the drug product is dispensed with the child-resistant side fastened.

List of prescription drugs in the textbook (such as SL nitroglycerin) Prescription drug exemptions: The physician prescribing the drug requests a noncompliant container (blanket request NOT allowed except for refills of a specific drug) The patient receiving the drug requests a noncompliant container (blanket request allowed) Manufacturers can market one size of an OTC product in noncompliant packaging for adult patients who are unable to open child-resistant containers. Label must state: “This Package for Households Without Young Children” Small packages: “Package Not Child-Resistant” Drugs dispensed to institutionalized patients if the drugs are administered by the institution’s employees.

List the final check requirements in Wisconsin

DUR in WI

Compare and contrast the requirements for collecting and documenting patient information for OBRA ’90 and Wisconsin

Counseling Requirements: OBRA ’90 vs. Wisconsin

Category	OBRA ’90	Wisconsin
General Rule	Must offer to discuss medications with every patient or caregiver.	Counseling is required only in certain situations.
When Required	Always offer counseling.	Required if: 1) Drug not dispensed before 2) Change in therapy 3) Patient requests 4) Pharmacist deems it necessary
When Not Required	Patient can refuse the offer.	Not required if: 1) Patient refuses 2) Drug administered by licensed provider (within scope of practice)

Explain how to deliver prescriptions in accordance with US Postal Service and Wisconsin regulations

Mailing & Delivery of Prescription Medications

• Only a pharmacist or medical practitioner may mail prescription medications.

• Medications must be:

  • Securely packaged to prevent damage.

  • Shipped in a plain outer wrapper or packaging (no identifying pharmacy info visible).

Delivery Requirements

• Delivery method:

  • Must use a common carrier or delivery service.

  • Delivery must be made to a location of the patient’s choice.

  • The method must be appropriate to prevent drug adulteration (i.e., no exposure to heat, moisture, etc.).

• If a prescription is lost during delivery:

  • The pharmacy must replace it at no additional cost to the patient.

• Pharmacy must provide a way for patients to report any delivery issues, including:

  • Delays or untimely delivery

  • Damaged medication upon arrival

  • Wrong or missing prescription drug or device

Explain the pharmacist and pharmacy’s responsibility regarding the duty to dispense contraceptives

● Pharmacist must deliver contraceptive drugs and devices to patient without delay unless:

 ○ Error or inadequate Rx order

 ○ Contraindicated

 ○ Potential fraud

● Fee if you violate this: $250–$2,500

● Abortion in WI

 ○ Legal, but prescriber may have to be present in room when drug is given

 ○ Cannot mail meds to patient in WI

Describe the requirements for dispensing prescriptions that are not patient-specific (opioid antagonists, epinephrine delivery systems, short-acting bronchodilators in schools, and glucagon in schools) and explain how these prescriptions are written differently

Recognize required elements of a Notice of Privacy Practices for a pharmacy

Explain when PHI may be fully disclosed, only the minimum disclosed, and not disclosed without authorization (including unique protections for psychotherapy notes and SUD records)

PHI Use & Disclosure Summary

Category	Details
TPO (Treatment, Payment, Operations)	• PHI can be used/disclosed without patient authorization for treatment, payment, and operations purposes
Fully Disclosed (No Authorization Needed)	• To patient or personal representative • To other providers for treatment • Authorized by patient • Required by DHHS • Required by law
Minimum Necessary Disclosure	• Applies to all other situations not covered under TPO or listed exceptions
Not Disclosed Without Authorization	• Psychotherapy notes (unless required by law) • Must track disclosures not related to TPO for past 6 years under HIPAA
Do NOT Disclose	• If patient requests non-disclosure for an item/service they fully paid for out-of-pocket
SUD (Substance Use Disorder) Notes	• Patient must give consent at least once for future TPO disclosures • De-identified records may be shared with public health
Incidental Disclosure	• PHI disclosed unintentionally • Pharmacy not liable if reasonable safeguards were in place

List requirements of a chart order and identify how chart orders are different from outpatient prescription orders

1. The date of issue

2. The name of the practitioner

3. The name, strength, form, and quantity of the drug product or device prescribed

4. Directions for the use of the drug product or device

5. The symptom or purpose for which the drug is being prescribed if required (requested by patient to appear on the label)*

6. If the order is written by the practitioner, the signature of the practitioner (handwritten or electronic)

7. First and last name and address of the patient

8. Patient’s medical record number OR date of birth

9. If the order is prepared by a delegate of the practitioner, the first and last name and signature of the delegate (handwritten or electronic) AND the first and last name of the practitioner

No need for a practitioner address

Differentiate the requirements for emergency kits and contingency supplies in a nursing home

Emergency Medication Kits in Nursing Homes

Contingency Supply of Medications in Nursing Homes

A facility may have one or more emergency medication kits. All emergency medication kits shall be under the control of a pharmacist. The emergency kit shall be sealed and stored in a locked area.

Maintenance. A facility may have a contingency supply of medications not to exceed 10 units of any medication. Any contingency supply of medications must be under the control of a pharmacist. Storage. Contingency drugs shall be stored at a nursing unit, except for those medications requiring refrigeration, which shall be stored in a refrigerator. Single units. Contingency medications shall be stored in single unit containers, with a unit being defined as a single capsule, tablet, ampule, tubex, or suppository. Committee authorization. The quality assessment and assurance committee shall determine which medications and strengths are to be stocked in the contingency storage unit, as well as the procedures for use and restocking. Control. Unless controlled by a “proof-of-use” system [for controlled substances], as provided by sub. (6)(e), a copy of the pharmacy communication order shall be placed in the contingency storage unit when any medication is removed.

Explain how medications for nursing home residents are stored and packaged, including requirements for unit doses

1. Storage. Medications shall be stored near nurse's stations, in locked cabinets, closets, or rooms, conveniently located, well-lit, and kept at a temperature of no more than 85°F (29°C).

2. Transfer between containers. Medications shall be stored in their original containers and not transferred between containers, except by a physician or pharmacist.

3. (Missing from the list in the slide but possibly exists in the regulation.)

4. Separation of medications. Medications packaged for individual residents shall be kept physically separated.

5. Refrigeration. Medications requiring refrigeration shall be kept in a separate covered container and locked unless the refrigeration is available in a locked drug room.

6. External use of medications. Poisons and medications for external use only shall be kept in a locked cabinet and separate from other medications, except that time-released transdermal drug delivery systems, including nitroglycerin ointments, may be kept with internal medications.

7. Accessibility to drugs. Medications shall be accessible only to the registered nurse or designee. In facilities where no registered nurse is required, the medications shall be accessible only to the administrator or designee. The key shall be in the possession of the person on duty and assigned to administer the medications.

Define and differentiate the responsibilities of the central shared service pharmacy, labeling pharmacy, and originating pharmacy

central shared service pharmacy	"Central shared services pharmacy" means a pharmacy licensed in this state acting as an agent of an originating pharmacy.	Must maintain a record of all originating pharmacies it serves. May only conduct final verification checks if it has access to the originating pharmacy’s system. Ensures compliance with state and federal laws through a written protocol with the originating pharmacy. Must maintain records identifying the pharmacists responsible for final checks.
labeling pharmacy	"Labeling pharmacy" means the central shared services pharmacy or originating pharmacy which is responsible for product [and label] verification.	Ensures the prescription label contains the name and address of the labeling or originating pharmacy. Includes the date on which the labeling pharmacy filled the prescription order on the label. Responsible for verifying that medications meet all legal requirements before dispensing.
originating pharmacy	"Originating pharmacy" means a pharmacy licensed in this state that uses a central shared services pharmacy.	Must have ownership or a written contract with the central shared services pharmacy. Maintains records of all prescription orders received. Shares a computer system with the central shared services pharmacy for compliance. Ensures that drug utilization review is performed if the central shared services pharmacy does not conduct it.

List the requirements to be a pharmacist delegate for a remote dispensing site

Be 18 years or older with at least a high school education

Have 1,500 hours of dispensing experience within the last three years or have completed an accredited pharmacy technician training program

Delegates may include:

• Post-2nd-year pharmacy students

• Out-of-state pharmacists seeking WI licensure

• Registered pharmacy technicians

• Pharmacy graduates

Explain when remote dispensing is not allowed to occur

• The pharmacist is unavailable remotely

• The patient or delegate cannot communicate with the pharmacist

List the qualifications to be a pharmacy product verification technician

(b) Completed an accredited pharmacy technician training program or has 500+ hours of experience in product selection, labeling, and packaging.

(c) Completed a didactic and practical training curriculum approved by the supervising pharmacist, including training in six key domains.

(d) Successfully completed a validation process.

(e) Individuals who completed the board’s pilot program (Oct 1, 2016 – Sept 30, 2019) qualify unless they fail to meet quality assurance standards.

Contrast who is responsible for a delivery system vs. an automated direct-to-patient dispensing system

• A licensed pharmacy controls the delivery system, with a managing pharmacist responsible for policies.

• A supervising practitioner ensures compliance for practitioner dispensing in healthcare facilities, offices/clinics, and correctional/rehab facilities.

Explain who can administer a vaccine in Wisconsin and the requirements these individuals must meet

For patients 6 years and older:

Pharmacists	12 hours of approved training  have liability insurance covering at least $1M per occurrence and $2M per year.
Pharmacy students & out-of-state pharmacists	12 hours of training  be supervised by a qualified healthcare provider (if a pharmacist, they must meet the same criteria as above).
Pharmacy technicians	2 hours of training direct supervision by a pharmacist basic life support/CPR certification, certified pharmacy technician status.

For patients under 6 years:

Pharmacists

A prescription order must be issued within 29 days before vaccine administration. Pharmacists need 12 hours of training plus an approved course specifically for vaccinating children under 6. Must have liability insurance covering at least $1M per occurrence and $2M per year. Pharmacy students, licensure applicants, and technicians CANNOT administer vaccines to this age group.

Describe when a pharmacist must make a report to their local health department or DHS in Wisconsin

A pharmacist (or pharmacy) must make a report to their local health department when:

•  there is an unusual increase in prescriptions for antibiotics,

• when a drug is dispensed for a relatively uncommon disease or may be associated with bioterrorism.

Describe the two ways a consumer could access a poison in Wisconsin

A consumer can access a poison through:

•  a prescription order,

• the “labeled delivery” process. The “labeled delivery” process requires labeling, recordkeeping, informing the customer of the poisonous nature of the substance, and determining the poison will be used for a lawful purpose.

Identify the types of products and transactions included in DSCSA

Explain the four responsibilities of a dispenser under DSCSA

1) Engage in business only with licensed, registered [authorized] trading partners:	a) Manufacturers and repackagers must have a current registration with the FDA b) Wholesale distributors and third-party logistics providers must be licensed (state or federal) c) Dispensers must be licensed (state)
2) Properly manage product tracing documentation:	a) Only accept prescription pharmaceutical products if they arrive with transaction history (TH), transaction information (TI), and transaction statement (TS). b) Keep all product tracing information securely for six (6) years. c) When selling prescription products to a trading partner, include product tracing information (does not apply for patient-specific dispensing or selling). d) Tracing documentation is not required when returning non-saleable products. * Will not be required/enforced when electronic track and trace recordkeeping begins.
3) Implement a system and process to properly manage (investigate and handle) suspect and illegitimate prescription pharmaceutical products	a) Quarantine any suspect prescription pharmaceutical product(s). b) Collaborate with the manufacturer to ensure patients do not receive illegitimate product(s). c) Report findings of illegitimate prescription products to the FDA and trading partners. d) Respond to information requests within 2 business days. Note: Store-related documentation for 6 years after the conclusion of the investigation or disposition.
4) Pharmacies must have policies and procedures in place that allow for unit-level traceability under DSCSA, including:	a) Ensuring that all required TI (Transaction Information) and TS (Transaction Statement) are exchanged via a secure, interoperable, electronic system. b) Checking for a package identifier (PI) to verify prescription products at the package level and ensuring product identifiers can be confirmed by trading partners. c) Ensuring trading partners can provide TI and TS securely when requested by authorized agents. d) Using secure electronic systems to promptly produce TI for transactions linked to the manufacturer. e) Managing saleable returns with secure systems that return TI and TS with the product. Exemptions: Dispensers with 26+ FTE pharmacists/technicians: Exempt until 11/27/25 Dispensers with 25 or fewer FTE pharmacists/technicians: Exempt until 11/27/26

Identify when a compounded drug violates FDCA 503A

Failure to meet any of the following:

1) Compounded drug must be for an individual patient pursuant to a valid prescription order and compounded by a licensed pharmacist or physician.
2) If the compounded drug is prepared in anticipation of receiving a prescription, a limited quantity is prepared:	Amount anticipated must be legitimately based on the established practice history. Limited quantity is no more than a 30-day supply, based on previous history of valid prescriptions received during a 30-day period within the previous year. Dispensing should not occur until the patient-specific order is receive
3) The compounded drug cannot essentially be a copy of a commercially available product, unless compounded occasionally and not in inordinate amounts	NOT A COPY: A change has been made from the commercial product for an individual patient that produces a significant difference for that patient. Guidance provides additional detail: A commercial drug is any marketed drug product, except those discontinued, no longer marketed, or on the FDA drug shortage list. A copy consists of the same active pharmaceutical ingredient, with a same/similar/easily substitutable dosage strength (within 10% of the commercial product) and used by the same route of administration.
4) It is compounded in compliance with USP chapters on compounding [USP <795> and <797>] and using bulk substances that comply with monograph standards, if one exists.	If no monograph exists, the drug must be a component of an FDA-approved human drug product. If neither of those are true, it must appear on a list of bulk drug substances developed by FDA regulation. FDA will not take action against entities that do not meet this as long as: The entity is using Category 1 drugs for 503A. The manufacturer is registered, and the bulk drug has a certificate of analysis. Note: USP <795> and <797> have the force of federal law for compounding under the federal definition!
5) The bulk drugs used for compounding are manufactured by an entity registered with the FDA.	6) It is compounded with ingredients (other than bulk substances) that comply with USP standards.
7) It does not include drugs from an FDA list of items withdrawn from the market due to safety or efficacy concerns.	8) It does not include drug products identified by the FDA as presenting difficulties for compounding due to safety or efficacy risks
9) The compounder does not distribute more than 5% of total prescriptions dispensed or distributed by the pharmacy unless an MOU exists between the pharmacy and the FDA.

Describe how a 503B outsourcing facility is different from a 503A pharmacy

• 503B outsourcing facilities can compound sterile products in unlimited quantities without individual prescriptions, which 503A pharmacies cannot. 

• 503B outsourcing facilities do not have to be licensed pharmacies, but compounding must be done by or under direct supervision of a pharmacist. 

• 503B outsourcing facilities have less flexibility to compound drugs that are “essentially a copy” compared to 503A.

  • Identical copies cannot be compounded just for a clinical difference.

  • Non-identical copies with a meaningful change for the patient are allowed.

Identify if a repackaged product is compliant with FDA guidance

1) The drug being repackaged is an FDA-approved prescription drug or an unapproved drug on the drug shortage list.	2) Repackaging happens in a state-licensed pharmacy, outsourcing facility, or federal facility.
3) The drug is repackaged by or under the supervision of a licensed pharmacist.	4) If repackaged in a state-licensed pharmacy or federal facility, distribution happens only after receiving a valid prescription for a specific patient.
5) The drug is repackaged, stored, and shipped in a way that does not conflict with approved labeling (except for single-dose or single-use labeling changes).	6) The container used for repackaging must be suitable for storage through the drug product’s BUD (Beyond-Use Date).
7) Repackaged drug labeling must include the same storage and handling instructions as the approved drug product.	8) The repackaged drug is assigned a BUD based on guidance, unless scientific data supports a shorter BUD.
9) If repackaged in a state-licensed pharmacy or federal facility: Nonsterile drugs must follow USP <795>. Sterile drugs must follow USP <797>, but use the BUD in guidance. Outsourcing facilities must follow CGMP (Current Good Manufacturing Practices).	10) The repackaged drug cannot be on a list of drugs withdrawn from the market due to safety or efficacy concerns.
11) A repackaged drug cannot be sold or transferred by any entity other than the one that repackaged it.	12) Repackaged drugs can only be distributed in states where the repackaging facility meets all applicable state requirements.
13) Drugs repackaged by an outsourcing facility must meet specific label and container requirements.