PA MPJE
new permit w/in 30d for
change in name , ownership or controlling interest
medicare LTCF
drug regimen review Qmonth
pa
drugs in written agreement rx must have superphising MD sign with PA-C
crnp
drugs in written protocol does not need md name on rx does not include: gold/ heavy metal antagonists/radioactive/oxytocics
A pharmacy technician may not
(i) Accept or transcribe an oral order or telephone prescription. (ii) Enter or be in a pharmacy if a pharmacist is not on duty. (iii) Perform any act within the practice of pharmacy that involves discretion or independent professional judgment. (iv) Perform a duty until the technician has been trained and the duty has been specified in a written protocol.
Cancer drug—A prescription drug used to treat:
(i) Cancer or its side effects. (ii) The side effects of a prescription drug used to treat cancer or its side effects.
automated medication system quality assurance
-maintain documentation for 2 yrs: *test the accuracy of the automated medication system at least every 6 months and whenever any upgrade or change is made to the system, document *a written program for preventative maintenance, document completion -written plan for recovery from a disaster
VIGIL is a collaborative prescriber/pharmacist relationship
Verification: Is this a responsible opioid user? Identification: Is the identity of this patient verifiable? Generalization: Do we agree on mutual responsibilities and expectations? Interpretation: Do I feel comfortable allowing this person to have controlled substances? Legalization: Am I acting legally and responsibly?
Methadone
"for pain" in the sig code allows the use of methadone for chronic pain management When used for opioid detoxification, methadone is dispensed in a registered treatment facility
Financial eligibility for the Cancer Drug Repository Program.
"indigent patient'' for the Cancer Drug Repository Program if the resident meets the income standards in this subsection. based upon the prior year's family income not to exceed 350% of the prior year's Department of Health and Human Services Federal Poverty Income Guidelines for the appropriate family size
rph missed timely renewal
$5 penalty every month if lapsed >1yr practicing FT in another state will be evidence of current proficiency not practicing - prove CE
Donations of cancer drugs.
(1) A pharmacy, health care facility, drug manufacturer or wholesale drug distributor may donate legally obtained cancer drugs to an approved participating pharmacy if the drugs meet the eligibility requirements under § 27.504 (relating to drugs) as determined by a licensed pharmacist employed by or under contract with an approved participating pharmacy. (2) To be considered for donation, a cancer drug must be accompanied by a cancer drug repository donor form on a form provided by the Board that: (i) Is signed by the entity's authorized representative. (ii) States that to the best of the donor's knowledge the donated drug has been properly stored and that the drug has never been opened, used, tampered with, adulterated or misbranded.
pharmacy is eligible to participate in the Cancer Drug Repository Program if (BOP refuse, revoke or suspend approval if proof of violations)
(1) Holds a current unrestricted permit in good standing to operate as a pharmacy in this Commonwealth. (2) Delegates to a licensed pharmacist employed by or under contract with the pharmacy the responsibility to receive delivery of donated cancer drugs at the designated delivery area in the pharmacy. (3) Agrees to participate in the Cancer Drug Repository Program in accordance with the act, this chapter and the Cancer Drug Repository Program Ac
rph responsibilities in compounding - quality control and label with any any additional information required by USP provisions. records kept with rx x 2yrs
(1) Inspection and approval or rejection of all components, bulk drug substances (that is, active pharmaceutical ingredients), drug product containers, closures, in-process materials and labeling. (2) Preparation and review of all compounding records to assure that errors have not occurred in the compounding process. (3) Proper maintenance, cleanliness and use of all facilities and equipment used in compounding practice. (b) If errors have occurred, the pharmacist is responsible for conducting a full investigation, and creating and maintaining a record of the investigation which must include conclusions and corrective action.
As in the dispensing of all prescription drugs, the pharmacist has the responsibility for all of the following:
(1) Inspection and approval or rejection of all components, bulk drug substances (that is, active pharmaceutical ingredients), drug product containers, closures, inprocess materials and labeling. (2) Preparation and review of all compounding records to assure that errors have not occurred in the compounding process. (3) Proper maintenance, cleanliness and use of all facilities and equipment used in compounding practice. (b) If errors have occurred, the pharmacist is responsible for conducting a full investigation, and creating and maintaining a record of the investigation which must include conclusions and corrective action.
The approved participating pharmacy may not dispense the drug if the patient does not sign a cancer drug repository informed consent form as supplied by the Board. Must be kept for 2 years from date signed.
(1) The drug being dispensed has been donated and may have been previously dispensed. (2) The drug was unused, although previously dispensed. (3) The drug was donated to the approved participating pharmacy in the drug's original unopened, sealed and tamper-evident packaging to be restocked and redistributed. (4) A visual inspection has been conducted by the pharmacist in a manner as to be able to reasonably determine that the drug has not expired, has not been adulterated or misbranded, and is in its original unopened, sealed and tamper-evident packaging. (5) The dispensing pharmacist, the prescribing or administering practitioner, the cancer drug repository, the Board and any other participant of the Cancer Drug Repository Program cannot guarantee the safety of the drug being dispensed or administered, and that the pharmacist has determined that the drug appears to be safe to dispense or administer based on the accuracy of the donor's form submitted with the donated drug and the visual inspection required to be performed by the pharmacist before dispensing or administering.
injectable medications, biologicals and immunizations- order
(1) The identity of the licensed prescriber issuing the order. (2) The identity of the patient to receive the injection. (3) The identity of the medication, immunization or vaccine, and dose, to be administered. (4) The date of the original order and the date or schedule, if any, of each subsequent administration.
injectable medications, biologicals and immunizations- written protocol either approved by a physician or authorized by the medical staff of an institution, valid for a time period not to exceed 2 years.
(1) The identity of the participating pharmacist and physician or institution. (2) The identification of the medication, biological or immunization, which may be administered. (3) The identity of the patient or groups of patients to receive the authorized injectable medication, biological or immunization. (4) The identity of the authorized routes and sites of administration allowed. (5) A provision establishing a course of action the pharmacist shall follow to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions and accidental needle sticks. (6) A provision establishing a length of time the pharmacist shall observe an individual for adverse events following an injection. (7) The identity of the location at which the pharmacist may administer the authorized medication, biological or immunization. (8) Recordkeeping requirements and procedures for notification of administration. (9) A provision that allows for termination of the protocol at the request of any party to it at any time.
injectable records regarding each administration for a minimum of 2 years:
(1) The name, address and date of birth of the patient. (2) The date of the administration and site of the injection. (3) The name, dose, manufacturer, lot number and expiration date of the medication, biological or immunization. (4) The name and address of the patient's primary health care provider, as identified by the patient. (5) The name or identifiable initials of the administering pharmacist. (6) Documentation of informed consent for administration of injectable medications, biologicals and immunizations. (7) The nature of an adverse reaction and who was notified. (b) A pharmacist who administers an immunization shall also maintain the following records regarding each administration for a minimum of 2 years: (1) An identification of the Vaccine Information Statement (VIS) that was provided. (2) The date of publication of the VIS. (3) The date and to whom the VIS was provided. (c) In an institution, the information required to be maintained in subsections (a) and (b) may be maintained in the patients' medical records.
rx label
(1) The name, address, telephone number and DEA number of the pharmacy. (2) The name of the patient. (3) Full directions for the use of its contents. (4) The name of the prescriber. (5) The serial number of the prescription and the date originally filled. (6) The trade or brand name of the drug, strength, dosage form and quantity dispensed. If a generic drug is dispensed, the manufacturer's name or suitable abbreviation of the manufacturer's name shall also be shown. (7) On controlled substances, the statement: ''Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.''
The central processing center is exempt from: sink/ size/5k
(1) The requirement of maintaining an inventory of at least $5,000 worth of nonproprietary drugs and devices under (relating to supplies). (2) The minimum size requirements (relating to construction and equipment requirements). (3) The requirement to have a sink used solely for pharmaceutical purposes
INJECTABLE Education requirements. Complete within the 2-year period prior to application an evidence-based course that meets the following criteria:
(i) Includes study material. (ii) Includes hands-on training and techniques for administration. (iii) Requires testing with a passing score. (iv) Provides a minimum of 10 hours of instruction and experiential training. (v) Complies with current guidelines and recommendations by the Centers for Disease Control and Prevention, ACPE or a similar health authority or professional body.
A pharmacist who is party to a collaborative agreement authorizing the management of drug therapy shall:
(1) Utilize an area for in-person, telephonic or other approved electronic consultations regarding the management of drug therapy that ensures the confidentiality of the patient information being discussed. (2) Initiate the management of drug therapy only upon a written referral to the pharmacist from the physician. The written referral must include the minimum frequency in which the pharmacist shall conduct the management of the drug therapy in person. (3) Confirm that the physician who is a party to the collaborative agreement holds an active and unrestricted license and that the terms of the collaborative agreement are within the scope of the physician's current practice at the time of the execution of the collaborative agreement.
electronically transmitted prescriptions.
-The prescriber's telephone number. -The date of the transmission. -The name of the pharmacy intended to receive the transmission. -A hard copy or a readily retrievable image of the prescription information that is transmitted shall be stored for at least 2 years from the date of the most recent filling. -C II- C V is considered a written prescription order on a prescription blank
Except for a pharmacy operating as a central processing center, a pharmacy shall maintain at least the following equipment and supplies:
(1)refrigerator, for drugs only, with a thermometer or a temperature monitoring device. (2)Prescription file- 2 yrs from most recent filling (3) Current copies of the act and this chapter. (4) Federal and Commonwealth statutes and regulations pertaining to the practice of pharmacy. (5) Additional equipment and supplies necessary (6) An adequate reference library- scope of practice for particular setting: (iii) Enables the pharmacist to compound medications in a safe and effective manner consistent with accepted standards of pharmacy practice. (iv) Lists the possible drug interactions and possible adverse effects of medications dispensed by the pharmacy. (v) Lists the therapeutic equivalents for medications. (vi) Lists the therapeutic usage and dosages of medications dispensed by the pharmacy. (vii) Provides guidelines for the counseling of patients. (viii) A pharmacy that specializes in nuclear or parenteral prescriptions may limit the library it maintains under subparagraph (ii) relating to the pharmacy's own specialization. (ix) Maintains the latest editions including current supplements of each of its reference sources.
Prohibition of the Sale of Dextromethorphan to Minors
(a) (1) A person commits a summary offense if he knowingly sells or purchases with the intent to sell a finished drug product containing any quantity of dextromethorphan to a person who is less than 18 years of age. (2) A person commits a summary offense if he falsely represents himself to be 18 years of age or older to another for the purpose of procuring a finished drug product containing any quantity of dextromethorphan. (b) Proof of age requirements.--A person making a retail sale of a finished drug product containing any quantity of dextromethorphan shall obtain proof of age from the purchaser before completing the sale, unless the purchaser's outward appearance is such that a person would reasonably presume the purchaser to be at least 25 years of age. (c) Penalty.--A person who is convicted of violating subsection (a) shall be sentenced to pay a fine of not less than $250 nor more than $500 for the first violation and a fine of $500 for each subsequent violation. (d) Exception.--This section does not apply to a medication containing dextromethorphan that is sold pursuant to a valid prescription.
CV
(f) No pharmacist or pharmacy may dispense, dispose of, or sell a Schedule V cough preparation containing codeine, dilaudid or other narcotic cough preparation without a prescription, except that this subsection does not apply to a preparation used within an institution. (g) Sales of Schedule V narcotic preparations are required to have affixed to the bottle or container at the time of sale a label indicating the name and address of the pharmacy and the initials of the pharmacist and the date of sale.
pharmacist manager is responsible for removing from the active stock of the pharmacy and disposing of the following:
(i) A drug whose expiration date has passed. (ii) A drug which does not meet legal standards of strength and purity. (iii) A drug which varies from the strength and purity indicated on the label of the commercial container. (iv) A drug which has been improperly stored. (v) A drug which has deteriorated. (vi) A drug which is unfit, misbranded or adulterated under Federal or State statutes. * The drugs shall be returned to the wholesaler or manufacturer for disposal or disposed of by the pharmacy according to Federal or State statutes or regulations.
The following are examples of situations in which a PDR is not required:
(i) A physician dispenses a drug to a patient being treated in the emergency room. (ii) A pharmacist dispenses a radiopharmaceutical to a physician who will administer it to a patient. (iii) A medical practitioner dispenses a drug. (iv) A pharmacist dispenses a drug to a medical practitioner which the practitioner will administer to a patient. (v) A pharmacist delivers naloxone to an identified employee of a Pennsylvania correctional facility, prison, jail or residential drug treatment facility under a prescription and for an identified individual who is pending release or discharge from the correctional facility, prison, jail or residential drug treatment facility.
The approved participating pharmacy shall record the following information for all cancer drugs received, dispensed and distributed or disposed of or destroyed in the Cancer Drug Repository Program:
(i) Name and strength of the cancer drug. (ii) Quantity of the cancer drug. (iii) Expiration date of the cancer drug. (iv) Lot number of the cancer drug. (v) Name of pharmacy that originally dispensed the cancer drug. (vi) Name of the donor of the cancer drug. (vii) Name of the person to whom the cancer drug was originally prescribed. (viii) Name of the person to whom the cancer drug was dispensed. (ix) Date the cancer drug was dispensed. (x) Name of the prescribing practitioner who wrote the prescription for the cancer drug to be dispensed under the Cancer Drug Repository Program. (xi) Date the cancer drug was disposed of or destroyed. (xii) Whether a handling fee was charged and the amount of the fee.
the pharmacist shall notify the participating physician as soon as practicable, but no longer than 72 hours after administration of the following:
(i) The identity of the patient. (ii) The identity of the medication, biological or immunization administered. (iii) The route of administration. (ORDER NOT PROTCOL) (iv) The site of the administration. (v) The dose administered. (vi) The date of administration.
Confidentiality
(i) The patient consents to the disclosure. (ii) The Board or its authorized agents require the information for any proceeding under the act. (iii) State or Federal law or regulations require or authorize the disclosure. (iv) A court orders the disclosure.
hospital orders
**oral order-urgent circumstances: date/ time/ full signature of person taking order. countersigned by prescriber within 24 hrs
Pharmacies in retail establishments
*floor to ceiling barrier device/ sealed off *hours of the pharmacy shall be posted at all points of public access *Protocols for access to the pharmacy when it is closed by nonpharmacist staff for bona fide emergencies, such as fires, natural disasters or police matters, must include notification to the pharmacist manager.
PROFESSIONAL LIABILITY INSURANCE
*required if engaged in management of drug therapy under a written protocol/ collaborative agreement *minimum amount of $1 million per occurrence or claims made *certify compliance on a form available from the Board *failure to maintain subject to disciplinary action
Pharmacist preceptor- must register with BOP
--Max 2 pharmacy interns at once. unless the program has been approved by the Board for a greater number. --When a new intern is accepted for training in the pharmacy, the pharmacist preceptor shall notify the Board of the name of the intern and his anticipated period of internship in the pharmacy.
copy of an original prescription
--copy must clearly indicate on its face that it is a copy --person requesting the copy shall show the pharmacist acceptable authorization and identification, such as a driver's license --pharmacist shall record in writing the date, to whom and by whom the copy was given.
LTAC -pharmacy of choice option
-medication records maintained 7 years post DC or death -outdates quarterly -rph receive monthly med profile from residents selected pharmacy provider -policy for procuring meds in urgent situation
A pharmacy may apply for approval to participate in the Cancer Drug Repository Program by submitting the following information to the Board, on a form provided by the Board:
-name, street address and telephone number of the pharmacy -ID pharmacy's ownership. -description of all pharmacy services provided and the location and manner in which those services are provided -certification by a licensed pharmacist who is employed by or under contract with the pharmacy that the pharmacy meets the eligibility requirements -name and telephone number of the licensed pharmacist
A pharmacy technician may work only under the direct, immediate, personal supervision of a pharmacist
-preparing and reconstituting parenteral products and other medications. After the parenteral product or other medication has been prepared, the supervising pharmacist shall initial the label of the product or medication to document his final inspection and to accept total responsibility for its preparation. -Assist the pharmacist in the compounding of drug products, as permitted by the written protocol (The pharmacist manager shall create and maintain a written protocol for each pharmacy technician employed in the pharmacy. The protocol shall specify each duty which the pharmacy technician may perform. The pharmacist manager and the pharmacy technician shall date and sign the protocol and each amendment to the protocol. The pharmacist manager shall make the protocol available to agents of the Board upon demand.)
Automated medication systems.- pharm mgr or pharm with LTAC contract responsible
-tested/ validated prior to use (results avail to bop & they may test) -electronic audit trail -p&P for system operation, safety, security, accuracy, access and patient confidentiality. -MONTHLY inspections for med and system -Assigning, discontinuing or changing personnel access -stocked accurately and an accountability record is maintained
software requirements for EPCS as defined in federal
-third-party audit or DEA certification of the software -identity proofing process -two-factor authentication
statutory exceptions to mandatory EPCS
-veterinarian -temporary technological or electrical failure,(practitioner seek to correct w/in 72h) -by a practitioner and dispensed by a pharmacy located outside this Commonwealth; -no Internet access or EHS -ER or a health care facility under circumstances when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical for the patient to obtain the controlled substance prescribed by electronic prescription or would cause an untimely delay resulting in an adverse impact on the patient's medical condition -pt in a hospice program or NH or residential HCF -compounded prescriptions and prescriptions containing certain elements required by the Federal Food and Drug Administration or any other governmental agency that are not able to be accomplished with electronic prescribing -pursuant to an established and valid collaborative practice agreement between a practitioner and a pharmacist, a standing order or a drug research protocol -in an emergency situation pursuant to Federal or State law and regulations of the department -under circumstances where the pharmacy that receives the prescription is not set up to process electronic prescriptions -for controlled substances that are not required to be reported to the Prescription Drug Monitoring Program system administered by the department.
state bop
6yr terms. no more than 2 consecutive - commissioner of prof and occupation affairs -director fo bureau of consumer protect or designee -2 public - 5 rph (2 indy, 2 chain, 1 acute institution)
Pharmacists may not compound any of the following:
1. Drugs identified by the FDA as withdrawn or removed from the market because the drugs were found to be unsafe or ineffective unless part of IRB reviewed study 2. copies of a commercially available drug product, 3. id by FDA or fed reg as not compounded
Address changes must be reported within
10 days to bop
advertising
10% off, 20% off, and the like, as to selected items, shall state or publish a price list from which the percentage prices are derived, so the consumer or patient knows exactly what the retail price is. not allowed for controls must be pharmacy/pharmacist
Pennsylvania Medical Society opiate prescribing guidelines
100 mg per day as the max dose
30 contact hours (3 CEU) of continuing education
2 hours= 'Patient Safety.'' 2 hours=for licensees with authority to administer injectable medications, biologicals and immunizations Excess NOT carried over new grads - exempt reciprocity- prorated quarterly 3 mo/3.75h retain for 2 yrs for audit
DEA #
2, 4, 6 x2 + 1, 3, 5
pharmacist eligibility
21 yrs, graduate ACPE or other college approved by board and meets legal requirements foreign schools/ non citizens: No reciprocity, must: practical exam and intern hours 500-1500
methadone (dolophine) dispensing
3 day while enrolling in clinic hospitalized for different condition intractable pain (terminal cancer)
1,500 hours internship
50/ wk at least 500 in pharmacy up to 1000 internship program sponsored or approved by an ACPE-accredited pharmacy degree program SP registered as preceptor- max 2 interns
DEA 222
Need POA to sign. copy 1, 2 to supplier supplier has 60 days to provide balance or endorse to another supplier on back purchaser may cancel in writing requisitioned by dea 222a
institutions
A registered pharmacist may not compound, prepare, dispense, fill, sell, or give away a drug or device on the basis of a prescription or order in an institution or hospital unless the prescription or order is an original prescription or order or direct copy thereof issued by the authorized prescriber or practitioner who may be using electronic or computerized equipment. A drug order in an institution is not required to conform to the labeling requirements of subsection (d) as long as the drug is dispensed in unit dose. A drug not in unit dose shall be labeled to indicate the patient name, drug name, drug strength, dosing instructions and lot number. The label of a parenteral, enteral or total parenteral nutrition product shall contain the name of the patient; the ingredients, including the name, strength, quantity of each, the diluent and expiration date; and the initials of the pharmacist.
POISON if not RX red ink with name of seller
A: arsenic, cynaides, mercury, thallium B: acids, chloroform, formaldehyde BUYER must be 16 A: documentation- date, name/address/signature of buyer, name/qty, statement of purpose, rph name
. Drug compounding controls.
Accountability for quality control is the responsibility of the compounding pharmacist
LTAC oversight
QA committee at least one emergency kit with P&P breakaway lock under control of prescriber
Fees
Application for pharmacy intern certificate ... $35 Application for pharmacist license ... $45 Certification of examination scores or internship hours ... $25 Verification of licensure ... $15 Assistant pharmacist biennial renewal ... $120 Registered pharmacist biennial renewal ... $190 Registered pharmacist late renewal penalty ... $25 New pharmacy permit application ... $125 Reinspection of new pharmacy after failure at first inspection ... $115 Pharmacy permit change without inspection ... $45 Pharmacy permit change when inspection required ... $125 Change in pharmacy ownership or Board of Directors ... $30 Verification of permit ... $15 Biennial renewal of pharmacy permit ... $125 Pharmacy permit late renewal penalty ... $25 Application for approval to administer injectables ... $30 Biennial renewal of approval to administer injectables ... $30
techs
Assist the pharmacist in the compounding of drug products, as permitted by the written protocol created
The written protocol must be available as follows:
At the practice site of each physician, pharmacist at the pharmacy OR institution. filed with the Bureau. Upon request, to representatives of the Bureau and the Department of Health and pts
INJECTABLE ADR
the pharmacist shall notify the patient's physician as soon as is practicable, and in no event later than 24 hours after learning of the adverse event or reaction.
CS labeling requirements waived for institutional pt if not in their possession
C II <7d C III-V <14 d or 100 dose
PA
C II initial therapy up to 72hr. notify MD w in 24hrs. then 30ds if approved by MD for ongoing therapy. MUST STATE ON RX "INITIAL" OR "ONGOING THERAPY" C III-V UP TO 5 R
CRNP
C II up to 30ds in collaborative agreement C III-V up to 90ds
dea 224
CS registeraiton application renew with 224a no more than 60 days prior to expiration modifications requested in writing
hospital **P&P for dangerous drugs with automatic stoporders not specifically prescribed for time/number of doses
CS, sedatives, anticoag, abx, oxytocics, corticosteroids
pse combat methamphetamine epidemic act 2005
DAILY limit 3.6gm 30D limit 9gm MAIL ORDER 7.5gm/30d period
Kefauver-Harris Amendment of 1962
Efficacy. GMP.
American Hospital Formulary Service Pharmacologic-Therapeutic Classification.
Eligible drugs.= in its original unopened, sealed and tamper-evident unit dose packaging.OR packaged in single unit doses, when the outside original packaging is opened but the single-unit-dose packaging is unopened. Ineligible drugs= *expiration date that is earlier than 6 months after the date the drug will be restocked *evidence of having been adulterated or misbranded. *DEA controlled substance *FDA restricted distribution *drug requires refrigeration, freezing or other special temperature requirements beyond controlled room temperature *drug has been previously compounded.
drug advert
FTC- OTC FDA rx
recalls
I harm II medicacialy reversable III not likely
automated medication system used to fill prescriptions or medication orders: at least annually, review P&P for revision prn keep copy all personnel trained (keep documentation)
Include a table of contents. (2) Include a description of all procedures of operation. (3) Set forth methods that ensure retention of each amendment, addition, deletion or other change to the policies and procedures of operation for at least 2 years after the change is made. Each change shall be signed or initialed by the registered pharmacist manager and include the date on which the registered pharmacist manager approved the change. (4) Set forth methods that ensure that a pharmacist currently licensed in the transmitting jurisdiction reviews and approves the transmission of each original or new prescription or medication order to the automated medication system before the transmission is made. (5) Set forth methods that ensure that access to the records of medications and other medical information of the patients maintained by the pharmacy is limited to licensed practitioners or personnel approved to have access to the records. (6) Set forth methods that ensure that access to the automated medication system for stocking and removal of medications is limited to licensed pharmacists or the pharmacist's designee acting under the supervision of a licensed pharmacist. An accountability record which documents all transactions relative to stocking and removing medications from the automated medication system must be maintained. (7) Identify the circumstances under which medications may be removed from the automated medication system by a licensed medical practitioner for distribution to a patient without prior order review by a licensed pharmacist.
optometrist lic number
L - NOT prescribe T prescribe topical (not parental, bb, glaucoma, systemic except as adjudicative (PO steroids). Max 6wks G glaucoma certified
C II fax
LTAC hospice infusion present rx prior to dispensing
CII partial exceptions
LTAC, terminal illness 60 DAYS RECORD: DATE, QTY, REMAINING QTY, RPH
Return to stock of undelivered medication- assessed by a pharmacist to determine whether they might safely be returned to stock
Medications held for redispensing, lacking original lot numbers and expiration dates, should only be dispensed to patients up to 6 months from the date the drugs were first prepared for dispensing. if any recall, assume affected.
Handling fee.
Method of Payment for Pharmaceutical Services provided in 55 Pa. Code Chapter 1121 An approved participating pharmacy may charge a handling fee for distributing or dispensing cancer drugs under the Cancer Drug Repository Program, not to exceed 250% of the Medical Assistance dispensing fee Donated drugs may not be resold!
prescriber who is deceased or no longer in practice.
No prescription may be knowingly filled or refilled for a patient which prescription was written for prior use
outpatient detoxification.
Only buprenorphine/naloxone with a special DEA number
Emergency dispensing of C-II
PA law receive rx w/in 72 hrs "auth for emergency dispensing" notify DEA
administer injectable medications, biologicals and immunizations
active lic education/training- submitted to BOP CPR- submitted to BOP renewal: every 2 yrs with pharmacy lic. complete form in advance, fee, certification of CPR and 2 HOURS OF CE
EPCS (Electronic Prescribing of Controlled Substances) mandatory to issue electronic prescriptions for Schedule II-V controlled substances not fax
Per Act 96 of 2018 practitioners, excluding those with statutory exceptions, are required to issue electronic prescriptions for Schedule II-V controlled substances as of October 24, 2019
FDA form 1571- investigational drugs for general population IND-
Phase I pharmacology / toxicology 20-80 Phase II efficacy 100-300 Phase III 1000-3000 ,then submit NDA Phase IV after FDA approval
Locked compartment.
Space shall be provided in the prescription area for a substantially constructed cabinet or safe to contain controlled substances unless the pharmacy disperses controlled substances throughout the stock of noncontrolled substances in a manner that obstructs the theft of controlled substances. If the pharmacy stocks Schedule I controlled substances, these substances shall be stored in a securely locked, substantially constructed cabinet or safe.
Repositories
The cancer drugs may be distributed to another participating physician's office, pharmacy, hospital, health care facility or health clinic for dispensing by a pharmacist as allowed by Federal or State law. stored separately from the rest of the approved participating pharmacy's stock must have Theft and diversion policy
Refusal to accept counselling or to provide information.
The documentation must include the name or initials of the pharmacist or designee noting the refusal. The following kinds of documentation are acceptable: (i) A notation made by the pharmacist or designee on the prescription or patient profile or the electronic records of the pharmacy. (ii) A writing signed by the patient or caregiver
mailing rx- first class/ common carrier unless purchaser otherwise notified and agrees
The mailing of antibiotics which have been reconstituted is prohibited refrigerated, etc: permissible if it is shipped in a manner which would preserve the integrity of the drug
Patient profile.
The patient profile shall be maintained for at least 2 years after the last entry.
Offer to counsel....Only a pharmacist may counsel.
The pharmacist or designee of the pharmacist shall orally make the offer in person if a patient or caregiver comes to the pharmacy. pharmacist might substitute a written offer, must include the telephone number of the pharmacy.
This order is authorization for pharmacists to dispense Naloxone and devices for its administration SOLELY in the forms prescribed herein
This standing order may be used by Eligible Persons as a prescription or third-party prescription to obtain Naloxone from a pharmacy in the event that they are unable to obtain Naloxone or a prescription for Naloxone from their regular health care providers or another source. Act 139 does not require training; however, training is necessary in order to ensure that Eligible Persons are protected from legal liability to the extent that Act 139 provides that the receipt of DOH/DDAP-approved training
DEA Form 106
To report theft of controlled substances
penalties for practitioners who do not comply with Act 96
administrative penalties: 1. $100 per violation for the first through 10th violations 2. $250 per violation for the 11th and any subsequent violations 3. The maximum cumulative fine per calendar year cannot exceed $5,000. NO disciplinary action or report to lic boards
Compounding of preparations.
accordance with section 503a of the Federal Food, Drug, and Cosmetic Act current version of the USP chapter
Prescription Drug Monitoring Program (PDMP)
all Schedule II-V dispensed prescriptions must be reported to the PDMP no later than the close of the subsequent business day.
schedule III
anabolic steroiods, buprenorphine, codeine fiorinal/cod, , paregoric, XYREM (GHA- gamma hydroxybutyric acid- note medical NEED on FACE of RX), suboxone (bup/naloxone)amobarbital/secobarbital, pentobarbital, dronabilol
Pharmacy inventory
at least $5,000 worth of nonproprietary drugs/devices, at cost, from a licensed wholesaler or manufacturer. The inventory may not go below this figure at any time
schedule IV
benzos, pentazocine, modafinil, eszopiclone, zaleplon, phenobarb, carisoprodol, chloral hydrate
Midwives
c II LIMITED TO 72HRS C III-V LIMITED TO 30DS
transfers
cancels the original
To be eligible for the Cancer Drug Repository Program, a patient shall certify that the patient meets the following criteria:
cancer dx none or limited drug coverage not eligible for State Medical Assistance Program that provides prescription drug coverage related to the treatment of cancer.
alone on 222
carfentanil, etorphine, diprenorphine
position prevention - consumer product safety commision
child resistent 80% under 5 cant and 90% of adults can waiver- only pt can request blanket
schedule II
cocaine, amobarbital, fentanyl, meperidine, methamphetamine, morphine, oyxodone, pentobarbital, oxymorphoe, nabilone, amphetamine, diphenoxylate, hyromorphone, methadone, methylphenidate, mscontin, oxycontin, secobarbital tapentadol, hydrocodone
schedule V- authority is AG
codeine cough (2mg/ml), lomotilpregabalin
Centralized prescription processing
contracted or same owner share a common electronic file delivering pharm: on label (DEA) and offer to counsel
LTAC orders NEEDS policy
dated/countersigned in 48hrs (maybe via fax) if given to PA/NP, md have 7 days to countersign read back in entirety CII only oral in emergency
tamper evident packaging exceptions
derms, dentrifices, insulin, lozenges
Repositories.Donation site receipt.
designate an area within the pharmacy at which its licensed pharmacist shall personally receive delivery from the donor or its designee, and provide the donor or its designee with written acknowledgement
waxman hatch amendment to fdc act 1984
drug price competition and patent term restoration act generic only needs to show bioavailable and bioequivalent
MATTERS OF CONSCIENCE
ensure that protocols are in place that will avoid results that cause harm or potential harm to any patients
inventories
every 2 yrs. kept for 2 years. not mailed anywhere
CS inventory Biennial Q2 yrs
exact C I, II. keep records for 2 yrs, not mailed anywhere
C III-C V, non control
fax may be original rx file for 2 yrs
Partial dispensing of CII
filled w/in 72 hrs or notify prescribe for new rx/notice of non receipt
emergency prescriptions
first attempt auth from prescriber not CS essential to life/ continuation of therapy ONLY 1 refill limited to 72 HR supply. W/IN 72 hrs notify prescriber.
fines
http://www.pacodeandbulletin.gov/Display/pacode?file=/secure/pacode/data/049/chapter43b/s43b.7.html&d=reduce
partial filling C II
if not filled balance w/in 72 hrs then notify prescriber LTAC/ terminal illness- note on RX. up to 60 days
Computerized recordkeeping systems must be designed so that it is capable of providing by means of monitor, hard-copy printout or other transfer medium (including Identification of entry pharmacist)
immediate retrieval- patient information for all prescriptions filled within the previous 12 months retrieval within 3 working days- of all prescriptions dispensed within the previous 24 months from the last activity date
closing
immediately return to the Board its current permit and shall immediately inform the Board of the disposition of the prescription files and nonproprietary drugs. After 30 days, neither prescription files nor nonproprietary drugs may be sold, transferred or disposed of without prior permission from the Board
Collaborative agreement for management of drug therapy in a non-institutional setting. management of drug therapy for diseases or for conditions or symptoms of diseases. voluntary. rph/ md access each others records
initiating MD id/ signature/ date referred to RPH id/ signature/ date regimens terms, provision when unavailable types of management of drug therapy authorized rph functions/ tasks, documentation communication within 72hrs pt refusal
Written protocol for the management of drug therapy in an institutional setting. effective for 2yrs, contains:
initiating MD id/ signature/ date referred to RPH id/ signature/ date regimens types of management of drug therapy authorized rph functions/ tasks, documentation communication within 72hrs pt refusal
CSA inspections
inspector required to provide purpose, credentials and written notice of inspection. Rph can refused (BUT not a search warrant)
Sales of hypodermic needles and syringes
made by a pharmacist or under the direct, immediate and personal supervision of a pharmacist may be sold without a prescription kept in the prescription area of the pharmacy
Inspection reports
maintain the reports and notices on the licensed premises in such a manner as to make them readily available upon request of the Board or its agents for a period of 2 years from date of issuance
if they are not accepted into the Cancer Drug Repository Program for the purpose of dispensing- Record of destruction / disposal
maintained by the participating pharmacy for at least 2 years, and include the following: (1) The date of destruction. (2) The name, strength and quantity of the cancer drug destroyed. (3) The name of the person or firm that destroyed the drug. (4) The source of the drugs destroyed.
Adulteration
making unpure poorer in quality
substitution permissible on sig line
md must write brand necessary sign posted and pt must be notified by person authorized to assist the rph
Schedule I No accepted medical use
methaqualone, heroin, mescaline, GHB, LSD, marijuana, peyote
pharmacy permit display
name and address current owner & pharmacy mgr
generic sub
narrow therapeutic drugs are not equivalent refills use same mfg emergency doesn't need prior auth but need to notify MD asap
dispensing container
new and clean container or in the manufacturer's original container refill: may reuse the original container of that prescription if the container is clean and reuseable with new label
Construction and equipment requirements.
new/change location- submit to BOP prior- Within 90 days of receiving the plans, the Board will notify alterations- submitted to the Board at least 30 days before the beginning of alteration work. If the Board raises no objection during that time, the pharmacy is authorized to proceed
Address change
notify BOP w/in 10 days
central record keeping
notify dea 14 days in advance in triplicate access w/in 2 bus days DEA can show up without warrant
pharmacist manager
one pharmacy at a time -Board may grant a waiver which would authorize a pharmacist manager to serve as pharmacist manager of more than one pharmacy for up to 60 days after the initial 15 days permitted
emergency C II
only enough to get patient through the emergency period. Fed law 7 days, PA law 72 hrs (delivered/ postmarked) with "auth for emergency dispensing"
hospital regs title 28 chapter 113
open 20hrs/wk for pharmacy permit P&T committee meet quarterly- drug storage checked by rph all floor stock controlled by rph
pharmacy permits -- qualified institutions
open a minimum of 20 hours per week under the supervision of a registered pharmacist manager. institutions accredited by the Joint Commission on Accreditation of Hospitals or the Commission on Hospital Accreditation of the American Osteopathic Association or meeting the requirements of the ''Conditions of Participation for Extended Care Facilities,'' Federal Health Insurance for the Aged, or licensed by the Department of Welfare or Department of Health
The prescription area of a pharmacy may not be open without a licensed pharmacist on duty at all times. A sole pharmacist on duty may take up to a 30-minute break while the pharmacy remains open
patient-related services, including: (i) The receipt of new written prescriptions. (ii) The preparation of prescriptions for final verification by the pharmacist. (iii) The delivery of prescription medications that have been verified by the pharmacist.
change in pharmacy manager
pharmacy permit holder shall inform the Board in writing of this fact and of the new pharmacist manager not more than 15 days later. If the Board does not object within 30 days of notification, the new pharmacist manager may be deemed approved. If the permit holder is unable to replace the pharmacist manager within those 15 days, the permit holder may request in writing an extension of up to 30 additional days to obtain a replacement. A pharmacy may not operate without a pharmacist manager for more than 15 days unless the pharmacy first obtains from the Board an extension of time for obtaining a replacement.
Biennial renewal.every 2 years,
pharmacy permit odd-number years pharmacist license even-numbered years
Biennial renewal->completion of a form mailed to the holder by the Board in advance of the renewal period, and payment of the specified fee.
pharmacy permit shall renew the permit every 2 years, in odd-number years pharmacist shall renew the license every 2 years, in even-numbered years- submit proof of compliance with ce
Building standards
prescription working counter: 10 x2. (increased by 5 linear feet for an additional pharmacist. Institutions with special considerations may apply to the Board for a waiver.) Telephone. Sanitary facilities. hot/cold water Lighting and ventilation No Television set.
central record keeping can not
prescriptions, inventory records, executed 222 forms (can have unexecuted)
midwife prescrib
psychotropic can only be rx based on prior consult with MD
administration of injectable medications, biologicals and immunizations
pt MORE than 18 years of age (day following bday) Pharmacist ONLY, not delegated in accordance with CDC guidelines approved by BOP
Pharmacies register with AG for CS
q3 yrs triennially (Manf/dist are annually)
Recordkeeping x 2YRS. The approved participating pharmacy must record
receipt of the drug on a repository donor form as developed by the Board. dispensing the drug on a repository dispensing form as developed by the Board
partial filling III- V
recorded in same manner as refill
CIII-V PARTIAL
recorded in same manner as refill. greater than 5 partials may be done. Max 5R, 6mo
PA pharmacy regs
title 49 chapter 27
DEA Form 41
to destroy controlled substances Qyr auth if sending to reverse distributor they fill out 222 and then 41
Ryan Haight online pharmacy consumer protection act
register w/ dea 30 days prior for modification of registration monthly reports to DEA IF in the month dispeased 100 rx or 5,000 dosage units exempt refills of C 3-5 (new order, prior one filled not at internet)
sole rph 30min break
remain in bldg for emergency/counseling. pharmacy can remain open
PSE loss
reported to DEA orally immediately followup written in 15d
radiopharmaceutical
require the name of the patient if the pharmacist obtains the name of the patient within 72 hours after dispensing the radiopharmaceutical or, if the radiopharmaceutical is not administered to a patient, marks the prescription ''not used.'
20/5 % rule
rph manufacturer C 2-5 in proportion not to exceed 20% w/o registering as manufacturer distribute CS to another pharm / md w/o registering as distributor if under 5% of all CS sales in year (LTAC dispensings do not count)
pharmacy tech
rph mgr create a written protocol for each tech that specific each duty. date and sign and any amendments/training. may assist in reconstituting parenterals, etc
only pharmacist may counsel
rph or designee can document refuse
refills and ad lib prn
rx: good for 1 yr C II: no refills, rx expires 6mos C III-V: 5 R, expires 6mos A pharmacist may only refill a prescription at a reasonable time prior to the time when the contents of the prescription shall be consumed according to prescriber's directions
FD&C Act of 1938
safety and adequate directions for use
HIPPA
save signed acknowledgement for 6 years TPO: treatment, payment, operations
Intern Activities
scrutinizing prescriptions or drug orders, taking oral orders for prescriptions by telephone or otherwise, compounding medications and filling prescriptions.
oral order, telephone or otherwise
shall be received and transcribed by either a registered pharmacist or a pharmacy intern under the direct, immediate and personal supervision of a pharmacist.
Compounding records
shall be retained as the original records and shall be readily available at the pharmacy for inspection and photocopying by agents of the Board or other authorized authorities for at least 2 years following the date of the record.
OTP opoid treament programs
short term <30d long term 30-180 maintenance >21d
Pharmacy permit
show the name and address of the pharmacy, the name of the current owner and the name of the current pharmacist manager. Applications for new permits shall be filed within 30 days of the change in name, ownership or controlling interest.
PSE log book exception
single sale <60mg
Subutex buprenorphine initial C III
suboxone beureorphine and naloxone maintenance C III
Pharmacy internship - valid for 6 yrs
successfully completed at least 2 years of college and is enrolled or accepted as a student of pharmacy in an ACPE-accredited pharmacy degree program
misbranding
the label is false or misleading
Prepacking and labeling in convenient quantities for subsequent use
under the direct personal supervision of a registered pharmacist. A container shall have a label containing the name of the drug and, if the name is generic, the name of the manufacturer, its strength, the manufacturer's control number or other code control number and the expiration date, if any. A log shall be kept in the pharmacy
CANCER DRUG REPOSITORY PROGRAM
unused cancer drugs may be redispensed to cancer patients by pharmacies approved by the Board for the purpose of dispensing unused cancer drugs to Pennsylvania residents who are indigent.
pharmacy intern working under the direct, immediate, personal supervision of a pharmacist may perform procedures which require professional skill and training.
verifying ingredients, weighing ingredients, compounding ingredients and other similar processing of ingredients.
Can practitioners electronically prescribe multiple Schedule II prescriptions to a patient for the same controlled substance to be dispensed on different dates?
yes
Durham-Humphrey Amendment of 1951
• Created a distinction between "OTC" and "Legend Drugs". rx statement and label
