Law Exam Two

Identify the impetus for the Drug Quality and Security Act of 2013

"2012 a Massachusetts pharmacy (New England Compounding Center [NECC]) compounded and shipped large batches of contaminated sterile injectables to hospital pharmacies, physicians' offices, and other licensed entities. The products killed 64 people and injured more than 700 others, and highlighted the lack of clarity in the law regarding the FDA's authority over large batch compounders. Congress responded by enacting the DQSA of 2013."

The DQSA also created a new category of sterile compounding pharmacies under § 503B known as

"outsourcing facilities," a status for which pharmacies could voluntarily register, although an outsourcing facility need not be a pharmacy

A prescription for a controlled substance may be issued only by an individual practitioner who is both

(1) authorized to prescribe controlled substances in the state in which he or she is licensed to practice and (2) registered or exempt from registration under the CSA.

PHI is protected by HIPAA. PHI includes all forms of health information that

(1) relate to past, present, or future physical or mental health; the provision of care; or payment for care; and (2) identify the patient or could reasonably be expected to identify the patient. De-identified information is not PHI.

HIPAA regulates four aspects of health information:

(1) transaction and code sets, (2) national provider identities, (3) security, and (4) privacy.

Some of the conditions a § 503A pharmacy must meet to be exempt include

- compounding upon receipt of a prescription for an individual patient - Compounding a "limited quantity" in anticipation of receiving a prescription - Compounding copies of commercially available products only occasionally and not in inordinate amounts - Compounding in accordance with USP standards if in existence - Compounding only with FDA approved drugs that have not been withdrawn or removed from the market because of safety and efficacy issues

Describe HITECH implications for pharmacists.

1) Under HITECH, if a covered entity (pharmacy) utilizes an electronic health record, the entity will be required to account for all disclosures, including TPO disclosures, within three years prior to the date of the request. 2) Pharmacists must understand that if a patient pays for a prescription or other goods and services with cash, the patient can prevent the pharmacy from disclosing information about treatment to his or her insurers.

Any theft or significant loss of any controlled substance must be reported to the DEA in writing, using DEA Form

106, within one business day of discovery

Records must be kept for

2 years, but it is prudent to keep them longer --> statue of limitations

Each place of business dispensing controlled substances must register using DEA Form

224. Renewals (Form 224a) are required every 3 years. Registration and renewal can be performed online on the DEA website.

Distinguish pharmacy compounding from manufacturing, including the distinctions between a § 503A compounding pharmacy and a § 503B outsourcing facility.

503A Traditional Compounding → Compounding is "combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering a drug or bulk drug substance to create a drug." 503A compounding complies with USP <797> standards and focuses on customized patient-specific compounding dispensed only with a prescription 503B Outsourcing Facilities → Any facility registered with the FDA that has one geographic location engaged in the compounding of sterile drugs and complies with all 503B requirements: 503B compounding is essentially batch compounding with required compliance to the federal cGMP regulations including 100% release testing quality assurance.

Discuss the relationship and applicability of USP standards to 503A compounding.

503A requires drugs must be compounded according to the USP standards

No schedule III and IV prescription may be filled or refilled more than

6 months from the date of issuance or more than five times, whichever comes first.

Identify the titles and applicability of USP chapter <795>, <797>, and <800>.

<795> non sterile compounding products <797> sterile compounding products <800> hazardous drugs

Identify medications under the statutory definition of narcotics that are not part of the generally accepted definition of narcotics.

A narcotic controlled substance is defined as a natural or synthetic opium or opiate and any derivative such as poppy straw coca leaves, cocaine, and ecgonine.

Identify who may prescribe a controlled substance prescription under federal law.

A prescription for a controlled substance may be issued only by an individual practitioner who is authorized to prescribe controlled substances in the state in which he or she is licensed to practice and registered or exempt from registration under the CSA.

Identify who may fill a controlled substance prescription under federal law.

A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy, a registered central fill pharmacy, or registered institutional practitioner.

List all exemptions to controlled substance registration requirements.

An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance if such agent or employee is acting in the usual course of his business or employment. A common or contract carrier or warehouseman or an employee thereof whose possession of the controlled substance is in the usual course of his business or employment An ultimate user who possesses such substance for a lawful purpose (§ 822(c))

224:

Any person wishing to obtain registration with the DEA as a dispenser (e.g., retail pharmacy, hospital, or practitioner) must complete DEA Form 224 Available from the DEA's website Completed online, takes APPROX 4-6 weeks.

106:

Any theft or significant loss of any controlled substance must be reported to the DEA in writing, using DEA Form 106, within one business day of discovery

List components of risk assessment and identify the reason for performing the risk assessment

Assessment of risk must include: the type of hazardous drug, dosage form, risk of exposure, packaging, and manipulation A risk assessment can be performed when someone wants to use alternative containment strategies → example: community pharmacy that handles tablets of a HD where the hazard does not pose a significant risk of exposure

Identify the purpose of the Power of Attorney for DEA Order Forms.

Because the person who signed the most recent registration or reregistration is not always available when the pharmacy needs to order forms or schedule II drugs POA are required to be licensees nor located at a registered location.

BHRT :

Bioidentical Hormone Replacement therapy

503A Traditional Compounding

Compounding is "combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering a drug or bulk drug substance to create a drug." State regulatory authority / state boards of pharmacy Adequate directions for use, CGMP, and new drug requirements are required, except when... It is for an individual patient with a prescription and compounded by a licensed pharmacist or physician It is for a "limited quantity" if prepared in advance/anticipation of a prescription. (reoccuring compounding prescription, no more than 30-day supply) It is not a copy of a commercially available product, (unless compounding only occasionally and not in inordinate amounts). It is compounded in compliance with USP chapters on compounding, using bulk substances that comply with FDA monograph standards or a component of an FDA-approved human drug product. It is compounded with bulk drugs that are manufactured by an entity registered with FDA It is compounded with ingredients that comply with USP standards It does not include drugs from an FDA list of withdrawn/removed items It does not include drug products identified by FDA as presenting difficulties for compounding because of adversely affecting safety or efficacy The compounder does not distribute more than 5% of the total prescriptions dispensed or distributed by a pharmacy "absent a memorandum of understanding (MOU) between the pharmacy's state and the FDA" ?

Identify the source of OBRA '90's authority to regulate pharmacy practice (compare with methods for regulating traditional compounding).

Congress/Federal Government

CSOS

Controlled substance ordering system

Identify the name of the electronic DEA order system alternative to the DEA Form 222.

Controlled substance ordering system (CSOS)

Identify who is covered and must comply with HIPAA.

Covered entities include HealthPlans, clearinghouses, and healthcare providers that conduct financial or administrative transactions electronically must comply.

224a:

DEA states that applications for renewal of dispensers take approximately 4 weeks to process, therefore the registrant should submit the renewal application in a timely manner prior to expiration. DEA registration and renewal is now available online, with some forms Each place of business dispensing controlled substances must register using this form . are required every 3 years Registration and renewal can be performed online on the DEA website

DQSA :

Drug quality and security act

DUR

Drug use review

Schedule One:

Drugs and other substances are placed in schedule I based upon the following criteria: Have a high potential for abuse Have no currently accepted medical use in treatment in the United States Lack accepted information on the safety of their use, even under medical supervision

Authority of 503B

FDA

503B Outsourcing Facilities

FDA is authority? But they must also notify state boards when they take action against a compounder Definition: Any facility registered with the FDA that has one geographic location engaged in the compounding of sterile drugs and complies with all 503B requirements: Complying with CGMP Permitting FDA inspections according to a risk-based schedule Prohibiting the sale or transfer of compounded products by any entity other than the outsourcing facility Compliance with DQSA labeling requirements for each container Other conditions such as reporting adverse events and providing FDA with certain product-compounding info Can also compound non sterile drugs, but must compound some sterile drugs Can dispense compounded drugs directly to individual patients (w/ prescription) Cannot have a separate 503A area

FDAMA :

Food and Drug administration modernization act

Proper disposal of PHI is required under

HIPAA. Pharmacies have been involved in violations for improper disposal of PHI in dumpsters and open containers.

Schedule Two:

Have a high potential for abuse. Have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug or other substance may lead to severe physical or psychological dependence.

Determine breaches of PHI that require patient notification.

If a breach has occurred, the pharmacy must notify the affected individuals by first-class mail within 60 days after the breach was discovered. May have to notify DHHS of breaches depending on the number of individuals affected. If the right patient was give the wrong medicine If more than 500 individuals involved then media needs to be informed

Understand which activities require registration with the Drug Enforcement Administration (DEA).

If a person (including natural person and corporation) dies, ceases legal existence, or discontinues the business or professional practice, the DEA must be notified and the registration terminated (21 C.F.R.§ 1301.52(a)). No registration can be assigned or transferred except with the approval of the DEA after submitting a written request and providing full details of the proposed transfer (21 C.F.R. § 1301.52(b)). If the registrant discontinues business (and does not transfer the business to another), the certificate of registration must be returned to the DEA together with any unexecuted order forms (21 C.F.R. § 1301.52(c)). Any controlled substances in the registrant's possession must be disposed of in accordance with DEA requirements.

Discuss whether a patient must sign an Acknowledgment of Notice.

If the patient does not return the acknowledgement, the pharmacist should attempt again. Failure to receive an acknowledgement is not a violation, because the pharmacy need only make a good faith effort; however, the effort should be documented.

In an effort to control rogue Internet pharmacies, which operate without a valid physician-patient relationship, the law requires the registration of

Internet pharmacies, and that a prescription is valid only if issued for a legitimate medical purpose by a prescriber who has conducted at least one in-person medical evaluation of the patient.

Understand the "legitimate medical purpose" and "corresponding responsibility" doctrine and the application to pharmacy practice.

Legitimate medical purpose → prescription was written for a real, and valid reason Corresponding responsibility doctrine → both the prescriber and the pharmacist are legally responsible for the proper prescribing and dispensing of controlled substances

225:

Manufacturers, distributors, and NTPs must complete the form, also available online or by mail.

Identify unique requirements of Schedule III-IV prescriptions.

May not be filled or refilled more than 6 months are the date of issuance of the prescription or more then five times (whichever comes first) Prescriptions must have caution federal law prohibits transfer of this drug to any person other than the person for whom it was prescribed

Determine the pharmacist's legal capacity to possess or use marijuana.

NOT ALLOWED

List additional requirements for Schedule I applications.

No accepted medical use Can not be dispensed or used even if it is legal in state

Identify the amount of codeine cough syrup federal law allows a pharmacist to dispense without prescription (note while codeine is an opium derivative, it is not opium).

No more than 240ml (8oz) or 48 dosage units of any controlled substance that contain opium nor more than 120 ml (4 oz) or 24 dosage units of any other controlled substance may be dispensed at retialed to the same purchaser in any 48 hour period.

States were required to adopt the minimal standards under

OBRA '90 to continue to participate in Medicaid; however, some states may have stricter requirements.

Haight Act → online pharmacy

Obtain a DEA modification of registration permitted it to operate Notify the DEA and state boards of intent to dispense through the internet 30 days before activity commences Display on the website a declaration of complicate with law and regulations Complete information about the pharmacy including its name and address as it appears on the DEA certificate, telephone number, email address, the name of the pharmacist in charge, professional degree, state of licensure, telephone number Include this statement on the website " this online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose.... "Needs an in person physical. Report on a monthly basis all controlled substances dispense, if they dispense 100 or more controlled substance prescriptions or 5,000 total dosage units in a month

503B is

Outsourcing Facilities.

Examples of PHI

Patient names Addresses — In particular, anything more specific than state, including street address, city, county, precinct, and in most cases zip code, and their equivalent geocodes. Dates — Including birth, discharge, admittance, and death dates. Telephone and fax numbers Email addresses Social Security numbers Driver's License information Medical record numbers Account numbers Health plan beneficiary numbers Certification/license numbers Vehicle identifiers and serial numbers, including license plate numbers Device identifiers and serial numbers Names of relatives Internet Protocol (IP) address numbers Biometric identifiers — including finger and voice prints. Full face photographic images and any comparable images.

Identify pharmacist liability threshold for incidental uses and disclosures as negligence (i.e. not a strict liability).

Pharmacies are not liable for these incidental uses and disclosures, provided they have applied "reasonable safeguards" to protect the PHI.

Identify the registration required to deliver a compounded controlled substance product directly to the practitioner.

Pharmacies are permitted to distribute limited amounts of scheduled medications to other practitioners. An invoice is required for CIII-V medications and a DEA Form 222 is required for CII medications.

List actions a pharmacy could take that would require registration as a manufacturer as a result of those actions.

Pharmacies that repackage OTC products or in any way change the container, wrapper, or labeling of these products must register as manufactures. Pharmacies that repackage prescription drug products for sale to other health care providers must register as manufactures

Describe the function and execution procedures of DEA Order Form 222.

Proper execution of DEA Form 222 is required to distribute a controlled substance in schedule I or II to another registrant. All three copies of the Form 222 must be executed simultaneously, such that the purchaser keeps Copy 3 and supplies Copies 1 and 2 to the supplier, who in turn keeps Copy 1 and submits Copy 2 to the DEA.

List requirements for transferring ongoing pharmacy business registration to another person, including timing

Proposal must be submitted at least 14 days in advance of the planned transfer, unless this requirement is waived by the special agent in charge Unless the regional administrator of the DEA notifies the transferor may distribute the controlled substances to the transferee. A complete inventory of all controlled substances must be taken on the date of transfer, and transfers of any schedule I or II substances must be pursuant to DEA form 222.

Distinguish elements of prospective DUR, and who is responsible for them.

Prospective → pharmacists generates new data concerning the dispensing of medications, and these data represent the most up-to-date patterns of actual medication use Screen of prescription prior to dispensing Patient counseling by pharmacist Pharmacist documentation of relevant info

Identify steps the pharmacy must take prior to storing records centrally.

Registrants who wish to use central recordkeeping must notify the DEA in writing by registered or certified mail. → may begin using it 14 days after if the DEA has not declined it

Identify the dispensing requirements for each schedule of controlled substances.

Required on prescription Date of issuance The full name and address of the patient The name, address, adn registration number of the practitioner The drug name, strength and dosage form The quantity prescribed Directions for use Schedule III - V May not be filled or refilled more than 6 months are the date of issuance of the prescription or more then five times (whichever comes first) Schedule II may not be refilled

Prescription Drug Monitoring Programs

Requires pharmacist and prescribers to electronically transmit to the state a record of each controlled substances prescription dispense Allows investigators to obtain pharmacy data from multiple ,oation without having to visit each Allow or mandate treating healthcare professionals to query patient specific information from the PDMP prior to prescribing or dispensing

Distinguish elements of retrospective DUR, and who is responsible for them.

Retrospective → DUR board, physicians and pharmacists Review use of medications over certain time Compare w/ prior medication criteria Ideal drug therapy Is actual matching idea

Identify unique requirements of Schedule II prescriptions, including allowances for transmission by fax.

Schedule II may not be refilled Partial fills must be picked up within 72 hours Prescription must be signed by practitioner Faxed II schedule prescriptions are permitted but only if the pharmacist receives the original written and signed prescription before the actual dispensing and the pharmacy files the original. May dispense faced prescriptions for hospice patients regardless of whether the patient lives at home or in institution

Drugs with acceptable medical uses are placed in

Schedules II through V, depending upon their relative potential for abuse and relative potential for physical or psychological dependence

Identify appropriate methods for disposal of PHI.

Shredding or burning paper records Placing labeled prescription containers in opaque bags in a secure area to be picked up by a disposal vendor.

Authority of 503A

State regulatory authority / state boards of pharmacy

PHI can be used and disclosed for

TPO; however, pharmacies are only permitted to disclose the minimum amount of PHI necessary to accomplish the objective.

Recognize the recordkeeping requirements under the Controlled Substances Act (CSA).

The CSA requires complete and accurate recordkeeping for inventory, drugs received, and drugs dispersed. Records must be kept for 2 years, but it is prudent to keep them longer. Some records (e.g., invoices and packing slips) are permitted to be kept off-site at a central location. Executed order forms, inventory records, and paper prescriptions cannot be maintained centrally.

Define TPO.

The privacy rule allows pharmacies to use and disclose PHI for Treatment, payment, and Operations. Treatment → providing coordinating managing the healthcare of patients Payment → claims for reimbursements determining patient eligibility extent of coverage sending bills Operations → activities necessary to run a pharmacy

Identify the 5% rule discussed in the reading per 21 C.F.R. § 1307.11(a)) from a list of practical scenarios.

The total number of dosing units distributed to another registrant must not exceed 5% of the total units of controlled substances distributed and dispense in 1 year, or the pharmacy may be required to register as a distributor 21 C.F.R. § 1307.11(a)).

503A is

Traditional Compounding

List ways that traditional compounding pharmacists might be regulated.

USP 797 USP 795 USP 800

What are the potential financial penalties / implications for a student accidentally leaving their clinical notes on the bus?

Unintentional violations can result in fines of $100.00 per violation up to $25,000 per person for all violations in a calendar year.

What are the potential financial penalties / implications for a Posting the information on social media?

Violations due to reasonable cause and NOT willful neglect can result in fines of $1,000 per occurrence, but not more than $50,000 for all violations in a calendar year.

Identify how a pharmacist would determine if an opioid prescription for detoxification was legitimate under DATA.

With the DEA number starting with X

List actions a pharmacist must take when dispensing a controlled substance in an emergency situation.

Write down all required information except for the signature of the prescriber, write that it is an authorization for emergency dispensing, and then date the order

Some records (e.g., invoices and packing slips) are permitted to be kept off-site at

a central location. Executed order forms, inventory records, and paper prescriptions cannot be maintained centrally

A prescription for a controlled substance must be issued for

a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of a controlled substance is upon the prescriber, but a corresponding responsibility rests with the pharmacist. Pharmacists that knowingly fill an invalid prescription are subject to the CSA penalties.

A controlled substance prescription must be based on

a legitimate physician-patient relationship. Facial validity of a prescription alone does not necessarily mean that a prescription is valid.

State laws permitting the use of marijuana have advanced dramatically. However, marijuana remains

a schedule I drug under the CSA, and the federal government has the right at any time to challenge conflicting state laws or prosecute under federal law

Individual practitioners (e.g., physician, dentist) must store C-II-C-V drugs in

a securely locked, substantially constructed cabinet

API :

active pharmaceutical ingredient

The DEA is charged with

administering all parts of the CSA.

There are limited exceptions to registration, most notably for

agents or employees of registrants

The CSA regulates

all activities regarding controlled substances; however, states may also have laws regulating controlled substances pursuant to their police powers; the pharmacist must follow the stricter of the two laws.

Regulations require that electronic controlled substance prescriptions be transmitted only through

an approved application system. Pharmacies must follow specific procedures for the receipt of an e-prescription, if the transmission fails and if changes to the prescription are made.

OBRA '90 requires

an offer to counsel, although some states have stricter requirements that mandate counseling. When counseling, pharmacists are to use their professional judgment to determine what information is relevant for a particular patient.

Prescriptions under the CSA must be written for

an ultimate user (e.g., a patient); prescribers are thus prohibited from writing controlled substance prescriptions for office use.

The FDA has issued a guidance interpreting "limited quantity" for the purposes of

anticipatory compounding

AMP

average manufacturer price

Complete disclosure of PHI to the patient is required to

be given if requested by the patient. In general, covered entities have 30 days to act on requests.

The DEA permits controlled substances to be filled at

central fill pharmacies, provided they have a contractual arrangement with the originating pharmacies. The prescription must be dispensed to the patient from the originating pharmacy.

One way to verify that a prescription is valid is by

checking the DEA registration number of the prescriber. The DEA number is a nine-character number consisting of two alphabet letters followed by seven digits.

The symbol on all labeling must be

clear and large enough for identification

All states have PDMPs that

collect and provide information regarding controlled substances dispensed within the state.

Exceptions to marketing include

communications about general health issues; for patient treatment; face-to- face; for case management or care coordination; to direct or recommend alternative treatments, therapies, and more; and about health-related services offered by the entity.

Exceptions to the minimum necessary requirement include

communications to the patient; communications regarding the treatment of the patient with other providers involved in the treatment; when authorized by the patient; when required by DHHS; and when required by law.

The CSA requires

complete and accurate recordkeeping for inventory, drugs received, and drugs dispersed

CPG

compliance policy guide

Manufacturing under the CSA is different than manufacturing under the FDCA. Under the CSA, those engaged in

compounding (preparation exceeding 20% of a narcotic substance), repackaging, or relabeling must be concerned with registering as a manufacturer

Inventory records, records of receipt, and records of drugs dispersed must all

contain specific information, as outlined in DEA rules.

CSA

controlled substance act

Based on previous DEA guidance, for C-III, C-IV, and C-V medications, the pharmacist can

correct inaccurate or missing information on written prescriptions. The pharmacist is never permitted to make changes on a written prescription to the patient's name, controlled substance prescribed, or the prescriber's signature. Pharmacists should refer to state guidance on what can and cannot be corrected on C-II prescriptions.

The pharmacy label for controlled substance prescriptions dispensed must contain

date of initial fill, refill date (if applicable), pharmacy name and address, prescription number, patient name, prescriber name, directions for use, and cautionary statement (for CII-IV medications).

Prescribers must include the following information on controlled substance prescriptions:

date of issuance; name and address of patient; name, address, and registration number of prescriber; drug name, strength, and dosage form; quantity prescribed; directions for use; and prescriber signature (for written/electronic prescriptions). The pharmacist has to ensure all the required information is included on the prescription prior to filing it. In addition, prior to filing a prescription, the pharmacist must include the name or initials of the pharmacist dispensing the drug, the date dispensed, and the amount dispensed.

NIOSH does what?

defines, identifies, and maintains a list of HD

Individual practitioners may not

delegate their prescriptive authority; however, an employee or agent may communicate it to the pharmacist or prepare the prescription for the prescriber's signature.

The DEA can

deny, revoke, or suspend a registration if it is determined that the registration would not be in the public interest.

DHHS

department of human health services

Registered distributors and manufacturers are required to

design and operate a system that is able to detect suspicious orders of controlled substances and inform the DEA upon discovery of suspicious orders

In the screening function, pharmacists are required to

detect potential problems (therapeutic duplication, drug- disease contraindications, drug-drug interactions, incorrect drug dosage or duration of treatment, drug-allergy interactions, and clinical abuse/misuse) and react to concerns appropriately.

Recordkeeping requirements for individual practitioners (e.g., prescribers)

differ from the recordkeeping requirements of pharmacies

Pharmacists employed by a pharmacy registered with the DEA can

dispense controlled substance prescriptions.

It is illegal for a pharmacist to

dispense narcotic drugs for maintaining an addiction or detoxifying an addict. A limited exception to this includes authorized prescribers treating patients under the DATA.

Patients may utilize take-back events, mail-back programs, and collection receptacles to

dispose of unused or expired controlled medications. For retail pharmacies to offer a collection receptacle, they have to voluntarily register with the DEA as a collector.

Proper execution of DEA Form 222 is required to

distribute a controlled substance in schedule I or II to another registrant.

Pharmacies must make a good faith effort to

distribute and obtain a written acknowledgment of receipt of their "Notice of Privacy Practices." Only one signed acknowledgment is required for each patient.

Schedule Five:

drugs and other substances include those That: Have a low potential for abuse relative to the drugs or other substances in schedule IV Have a currently accepted medical use in treatment in the United States When abused may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV

Schedule Four:

drugs and other substances include those that: Have a low potential for abuse relative to the drugs or other substances in schedule III Have a currently accepted medical use in treatment in the United States When abused may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III

Partial fills of schedule III, IV, and V prescriptions are permitted; however, the total quantity dispensed in all partial fillings cannot

exceed the total quantity prescribed.

The CSA classifies controlled substances into

five schedules

When pharmacists are faced with conflicting federal and state laws or a federal law where there is no comparable state law, they must

follow the federal law

OBRA '90 recognizes a public expectation of pharmacists that

goes beyond oversight of drug distribution to include the detection and resolution of problems with drug therapy.

In addition to TPO, pharmacies may disclose PHI for

governmental-type reasons, including public health activities, law enforcement purposes, and as required by law.

HD :

hazardous drugs

HCFA

health care financing administration

HIT

health information technology

HITECH

health information technology for economic and clinical health

HIPAA

health insurance portability and accountability act (1996)

HMO

health maintenance organizations

"Notice of Privacy Practices" must include

how the pharmacy intends to use and disclose information, the pharmacy's obligation to notify the patient of a breach of unsecured PHI, a statement that the individual can restrict certain disclosures to a health plan when they pay for the treatment out of pocket in full, a description of the legal duties of the pharmacy to protect PHI, a statement regarding uses and disclosures that require authorization, a statement of the patient's rights and how they can exercise those rights, a statement that the patient may complain to DHHS and how to file a complaint, and contact information for a company representative to contact with privacy concerns.

Pharmacies are not liable for

incidental uses and disclosures of PHI, provided they applied "reasonable safeguards."

Inventories for schedule I and II substances must

include an exact count. Schedule III, IV, and V substances can be estimated; however, an exact count is required if the container holds more than 1,000 units

Schedule Three:

includes those drugs and other substances that: Have a potential for abuse less than that of the drugs or other substances in schedules I and II Have a currently accepted medical use in treatment in the United States When abused may lead to moderate or low physical dependence or high psychological dependence

A pharmacy may authorize a POA to

individuals it wishes to have CII order authority

Pharmacists must be vigilant for

invalid prescriptions (e.g., fraudulent prescriptions, prescriptions exceeding the scope of practice, or prescriptions by individual practitioners not issued for a legitimate medical purpose), recognize red flags, and take appropriate steps to verify identified concerns.

Newly scheduled medications must be

inventoried on the effective date of scheduling.

Records of receipt include

invoices for schedule III, IV, and V substances and DEA Form 222 for schedule I and II substances, and must include the date of receipt.

LTCF

long-term care facilities

USP 800 requires at a minimum that a healthcare entity handling HDs must

maintain a list of HDs, proper facility and engineering controls, competent personnel, safe work practices, proper use of PPEs, and policies for HD waste segregation and disposal

When handling of an HD does not present a significant risk, the entity may

make an assessment of risk and determine alternative containment strategies rather than have to comply with all the standards of the chapter.

MOU :

memorandum of understanding

DEA registrations may be

modified, transferred, or terminated, provided that the DEA is notified and approves of any change.

222:

must be used for the return of any schedule I When dealing with transfers, It keeps records of a complete inventory of all controlled substances. These controlled substances must be taken on the date of transfer, and transfers of any schedule I or II substances must be pursuant to this form (or electronic equivalent).

NIOSH :

national institute for Occupational safety and health

NPI

national provider identifier

A pharmacy that compounds an OTC product not pursuant to prescription would likely be violating the

new drug provision of the FDCA, § 503A, and state law.

NECC :

new england compounding center

Only drugs in Schedule I are deemed to have

no acceptable medical use.

NRC :

nuclear regulatory commission

Pharmacists must make a reasonable effort to

obtain, record, and maintain patient information. This includes the patients name, address, telephone number, birthdate, gender, significant medical history, and pharmacist comments.

OSHA :

occupational safety and health administration

the FDA will not take action against a pharmacy or outsourcing facility that meets the conditions

of its compliance guidance for non- exempted activities, such as repackaging and compounding of biologics and radiopharmaceuticals.

Controlled substance prescriptions must be dated as

of the date of issuance and may not be pre- or postdated.

OCR

office of civil rights

ONCHIT

office of national coordinator for HIT

OBRA

omnibus budget reconciliation act (1990)

Registrants must notify the DEA within

one day of discovery, by using Form 106, of any theft or significant loss of controlled substances

Prescriptions for controlled substances must be filed using

one of two options. One option includes three separate files (CII; CIII-V; and noncontrolled drugs) and the other option includes two separate files (CII; CIII-V together with noncontrolled drugs).

Controlled substance prescriptions with refills may be transferred to a different pharmacy

one time, if state law allows. Specific information must be documented by both pharmacies.

Pharmacies are permitted to distribute limited amounts of scheduled medications to

other practitioners. An invoice is required for CIII-V medications and a DEA Form 222 is required for CII medications. The pharmacy will have to register as a distributor if it exceeds the 5% rule

"Notice of Privacy Practices" must be provided in

paper form on the day the pharmacy first provides service, unless the patient consents to electronic transmission. The notice must also be posted in a prominent and visible location and made available upon request as well as posted on the company website, if they have one.

PPE :

personal protective equipment

Covered entities, such as

pharmacies as well as business associates must comply with HIPAA.

In addition to meeting HIPAA requirements for PHI,

pharmacies must also comply with FTC and FCC regulations regarding unfair and deceptive business practices, telemarking, and advertising.

The DEA permits pharmacies to

place sealed emergency kits in LTCFs; however, specific protocol has to be followed to remove a drug from the kit.

A medication order in a hospital or institution is not a

prescription and is not required to comply with the strict requirements of the CSA.

Records of dispersal include

prescriptions, record books, DEA Form 222, invoices, institutional records, records of disposal, and records of theft or loss

A controlled substance inventory is required to be conducted

prior to a new business opening and every 2 years thereafter. An inventory can occur at the beginning of the business day or at the close of business.

PHI

protected health information

Before scheduling or rescheduling can occur, the secretary of DHHS must

provide to the attorney general a scientific and medical evaluation of a drug and a recommendation regarding whether the drug should be controlled.

The DQSA of 2013 reinstated the

provisions of § 503A (less the unconstitutional provisions) and again stripped the FDA of its authority to declare exempt pharmacy - compounded drugs as new drugs

Lost or stolen Form 222 forms require the

purchaser to execute another Form 222 with required information about the lost or stolen forms

Distributions of controlled substances to a prescriber for office use must be

pursuant to an invoice and not by the issuance of a prescription.

Pharmacists should not use the legitimate medical purpose rule as a

reason to deny legitimate pain patients controlled substances because alternative therapies may exist. Rather, decisions should be based upon the exercise of professional judgment weighing all clinical factors in the best interests of the patient.

The basic framework of OBRA '90 includes

rebates, demonstration projects, and DUR.

The DEA requires specific information to be

recorded by the pharmacy for each fill and refill.

LTCFs do not have to

register with the DEA and have numerous challenges regarding excess supplies of controlled substances. Pharmacies servicing LTCFs may utilize ADSs to decrease the stock of controlled substances. In addition, pharmacies servicing LTCFs may register as a collector to provide LTCFs with an option to dispose of unwanted medications.

DEA Form 41 is to be used by

registrants to request authority to dispose of controlled substances in their inventory.

The CSA achieves control and accountability for activities involving controlled substances through

registration. There are 10 categories of registration, and dispensers must renew their registration every 3 years.

Patients have a right to

request an accounting and disclosure of PHI.

Dispensers may engage in

research as a coincidental activity, provided they comply with the conditions

The DUR process includes

retrospective review, educational programs, and prospective review.

Patent rights of a drug manufacturer supersede the

rights of a pharmacy to compound t hat product even pursuant to prescription

OBRA '90 primary goal is to

save money.

Various states allow for the nonprescription dispensing of

schedule V medications when specific criteria are met

The attorney general has the authority to

schedule or transfer drugs between schedules. Recent examples include tramadol and hydrocodone combination products

The components of the prospective review are

screening of prescriptions prior to dispensing, the offer of patient counseling, and documentation of patient information.

Pharmacies and institutional practitioners may store C-II-C-V drugs in a

securely locked, substantially constructed cabinet or they may disperse them throughout their stock of noncontrolled substances in a manner that will obstruct theft.

Registrants must keep executed DEA 222 Forms

separate from all other records for 2 years

Penalties for HIPAA can be

severe and could be the basis for lawsuits in state court.

A prescriber can provide a patient multiple prescriptions on the same day for the same schedule II medication, if

specific criteria are met

Schedule II medications may be prescribed orally in emergency situations, if

specific criteria are met.

All healthcare entities, including pharmacies, whether they compound or not that handle HDs, must follow the

standards established in USP chapter <800

The secretary must forward to the attorney general any new drug application for a drug having a

stimulant, depressant, or hallucinogenic effect, if it appears the drug has abuse potential.

For practitioners that handle schedule I controlled substances, these must be

stored in a securely locked, substantially constructed cabinet.

To obtain Form 222, the registrant must

submit an order form requisition to the DEA

The FDA has determined that pharmacies may not

supply compounded drugs for "office use" to physician offices and other healthcare entities. However, this determination is controversial

To reduce diversion, the CSA has a

system of national registry, which also serves the purpose of establishing national uniformity

TCPA

telephone consumer protection act

Commercial containers of controlled substances must be labeled with

the "C" symbol and schedule designation. The symbol must be prominently located on the label or labeling.

The primary federal law that regulates controlled substances is called

the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, more commonly known as the CSA

A registrant may use the CSOS as an alternative to

the Form 222 and may order other than only CII substances.

The DEA has interpreted that dispensing does not include

the act of delivering a compounded product to a practitioner pursuant to prescription for a particular patient. The DEA considers this activity distribution and requires registration as a manufacturer.

Pharmacies and pharmacists are included under the definition of practitioner, but not under

the definition of individual practitioner or institutional practitioner

Under the CSA, the term "dispense" includes

the delivery, prescribing, and administering of controlled substances. State law determines which of these activities a practitioner (e.g., physician, pharmacy, hospital, mid-level providers) may perform.

Individual practitioners may be authorized to prescribe controlled substances under

the hospital or institutional registration, provided all conditions are met. These prescriptions can be dispensed in the community setting.

Medication or chart orders for controlled substances must include

the minimum information required of records of dispersal and must be maintained in such a manner as to be readily retrievable.

Prescriptions for schedule II medications may be faxed as

the original in three limited circumstances.

Prescriptions for large quantities and doses of opioid medications may be valid, but

the pharmacist should not hesitate to verify the legitimacy of prescriptions for pain patients.

All three copies of the Form 222 must be executed simultaneously, such that

the purchaser keeps Copy 3 and supplies Copies 1 and 2 to the supplier, who in turn keeps Copy 1 and submits Copy 2 to the DEA.

Patients may refuse counseling, but

the refusal must be informed and voluntary. Pharmacies may request a written waiver from the patient.

Dispensers may distribute, without being registered as distributors, controlled substances to other practitioners for the purpose of general dispensing by these practitioners to their patients, provided that

the total number of dosage units does not exceed 5% of the total units of controlled substances distributed and dispensed in 1 year.

The DEA permits prescribers

to have an agency relationship with an LTCF or hospice employee, provided there is a formal, written agreement.

TPO

treatment, payment, operations

Pharmacies are required to address breaches of

unsecured PHI with limited exceptions and notify affected individuals.

Schedule II prescriptions are not permitted to be refilled; however, they may be partially filled

up to 30 days or up to 60 days for LTC or terminally ill patients.

The FDCA exempts compounding pharmacies from registering as manufacturers

when doing so in the regular course of dispensing and selling drugs or devices at retail

Sale of PHI and use of PHI for marketing

with limited exceptions requires individual authorization.

Schedule II prescriptions can be

written or electronically prescribed. States may have additional or stricter requirements for the prescribing of schedule II medications.

Schedule III, IV, or V prescriptions may be transmitted as

written, faxed, electronic, or orally ordered.

Neither 503A nor 503B allow an exemption to

§ 501(a)(2)(A) related to insanitary conditions.