Recent TN Pharm Law
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What is DEA?
Drug Enforcement Administration (DEA)
Per DEA, what four (4) items on a Schedule II prescription MAY NOT BE CHANGED?
- 1. Name of the patient
- 2. Name of the drug (except for generic substitution permitted by state law)
- 3. Name of the prescribing practitioner (including signature)
- 4. Date of the prescription
Per DEA, what three (3) items on a Schedule II prescription MAY BE CHANGED?
- 1. strength of the drug
- 2. quantity of the drug
- 3. directions for use
To change anything on a Schedule II prescription, what two (2) things must the pharmacist do?
- 1. Contacts the prescribing practitioner and obtains verbal permission for the change; and
- 2. Documents on the prescription the following information;
- a. Change that was authorized
- b. Name/initials of the individual granting the authorization; and
- c. Initials of the pharmacist
According to the Department of Health, before any person who will be providing direct care is hired, health care facilities, emergency medical services, and individual health professionals are required by to conduct what?
Background Checks Required to provide patient care
What is NPLEx?
The National Precursor Log Exchange (NPLEx) is a real-time electronic logging system used by pharmacies and law enforcement to track sales of OTC cold and allergy medications containing precursors to the illegal drug, methamphetamine.
The NPLEx system enables pharmacies to easily enter the same pseudoephedrine (PSE) sales data currently being gathered online rather than recording the information into a manual log or in-store computer system.
Who provides the NPLEx at no cost to states?
The National Association of Drug Diversion Investigators (NADDI)
Tennessee laws require pharmacies with what three (3) drugs selling OTC to participate in the NPLEx?
- 1. ephedrine
- 2. pseudoephedrine (PSE)
- 3. phenylpropanolamine
TN laws exempt a pharmacy from participating in the NPLEx if...
If your pharmacy only administers PSE by prescription
Per TN Public Chapter 292, all pharmacies that dispense PSE OTC should report to NLEx by...
January 1, 2012
How do I submit PSE purchase transactions to NPLEx?
- 1. NPLEx Retail Web Portal
- 2. Point-of-Sale Integrated Method
Schedule II prescriptions must be on separate prescription orders/blanks
As of January 1, 2011, any Schedule II prescription written, printed, or computer generated by a prescribing praactitioner, must be written, printed, or typed as a separate prescription order.
Prescribing practitioners no longer required to include medication quantity written out in both letters and numerals
As of January 1, 2011, prescribing practitioners will no longer be required to include the medication quantity written out in both letters and in numericals. Prescribers will now be able to legally choose only one of these (two) options.
Which two (2) non-controlled drugs were changed to a C-IV controlled substance in Tennessee in 2011?
Tramadol (Ultram) - is a centrally acting opioid analgesic, used in treating moderate to severe pain.
Carisoprodol (Soma) - is a centrally-acting skeletal muscle relaxant.
New Label Law Allows Legend Drug Indications for All Patients
Any person dispensing a legend drug for a patient shall include on the label of the container in which the legend drug is dispensed the indication or indications for which the drug is being prescribed if requested by the prescriber, patient, or patient's caregiver and the prescriber, patient, or patient's caregiver provides the indication or indications to the person dispensing the legend drug.
FDA Asks Manufacturers to Limit Acetaminophen Strength
In the interest of patient safety, FDA asked drug manufacturers to limit the strength of acetaminophen in prescription drug products - which are predominantly combinations of acetaminophen and opiods - to 325mg per tablet, capsule, or other dosage unit. However, the total numbers of tablets or capsules that may be prescribed and the time intervals at which they may be prescribed will not change as a result of the lower amount of acetaminophen.
In addition, FDA reports that the labels of all prescription drug products that contain acetaminophen will now include a boxed warning that highlights the potential for severe liver injury and a warning that hilights the potential for allergic reaction,
FDA notes that OTC products containing acetaminophen are not affected by the action.
TN Pharmacy Rules on Take-Back Programs
It is unlawful for any pharmacy practice site, pharmacist, or pharmacy intern or pharmacy technician under the supervision of a pharmacist, or any other place of business engaged in compounding and dispensing prescription drugs and devices and related materials for human consumption to receive from any patient or other person the return of any portion of an order that has been taken from the premises of the pharmacy practice site or other place of business.
TN Board of Pharmacy Increases Pharmacy Technician Civil Penalties
Board of Pharmacy Rule states that "registered technicians shall immediately notify the board in writing of any change of address or employer." Based upon the volume of complaints, the Board of Pharmacy has implemented a $100 civil penalty to the pharmacy technician for not notifying the Board of Pharmacy of changes in home address and work place address.
Registered Pharmacy Technician Certificate Display
A registered technician shall maintain his or her registration certificate at the pharmacy practice site; additionally, all certified technicians shall display in like manner evidence of certification. Pharmacy technicians shall possess at all times, while on duty, proof of certification, if applicable.
What can a "certified pharmacy technician" do?
- 1. receive new or transferred oral medical prescription
- 2. receive and transfer copies of oral medical prescripton orders between pharmacy practice site; and
- 3. verify the contents of unit dose carts prepared by other registered technicians when an additional verification by use of bar code technology or a licensed health care professional is performed prior to administration to the patient
What is a technician registry, and what type of pharmacy practic site must keep one?
A technician registry is simply a list of your registered technicians that must be maintained at the pharmacy practice site, according to Board of Pharamcy Rule.
Pharmacy students are not technicians and should not be included on the registry.
Cashiers or clerks who never perform technician duties and are not registered with the TN Board of Pharmacy do not need to be added to the list.
All pharmacies should have an up-to-date technician registry available at the pharmacy practice site.
Do pharmacists need access to the Controlled Substance Monitoring Database?
As of January 1, 2010, all pharmacist must be able to access the Controlled Substance Monitoring Database (CSMDB) at their pharmacy practice site.
Can a pharmacy technician counsel a patient if the pharmacist tells the technician what to say or if the technician knows the answer to the question?
The technician can ONLY ask the patient if he/she has any questions for the pharmacist if the medication is a refill and NOT a new Rx
The following functions must be performed personally by a pharmacist or by a pharmacy intern under the personal supervision and in the presence of a pharmacists...providing patient counseling.
Pharmacist will counsel "face-to-face" on all new prescriptions
New Rule in Effect for Dispensing after Death of a Prescriber
Effective July 1, 2010, when a pharmacist becomes aware that a healthcare practitioner authorized to prescribe by the law of TN has dies, a prescription issued by the pracitioner may continue to be dispensed based on the pharmacist's professional judgement and in accordance withe the following requirements:
(1) If the Rx is a new prescription that has not been previously dispensed, it may be dispensed within ninety (90) days of the date on which the practitioner has died.
(2) If the Rx has already been previously dispensed and has valid authorization to be refilled, the refills may be dispensed but not for a period of more than ninety (90) days from the date on which the practitioner died for the schedule III, IV, & V drugs and one hundred eighty (180) days from the date on which the practitioner died for the non-scheduled drugs.
(3) These provisions shall NOT apply to a schedule II controlled substance.
Be Aware of the "Refill Too Soon"
The recommendation of the Board was to authorize a formal hearing & levy a $500 fine to each pharmacist on duty for early refill(s).
So how does a pharmacist make the decision to allow or decline an early refill?
If you fill a 30-day supply of a controlled substance medication every 27 days, for six months, you have basically given the patient 18 extra days of medication for the life of that Rx. And, if it is renewed for another six months, then you have now dispensed 36 extra days. This amount would be more than the equivalent of an extra refill, which is not filling the prescription in strict conformity with any directions of the prescriber. From past history, the Board has demonstrated that they can understand the difference between extraordinary circumstances and a trend in excessive, early refills.
PRN Pharmacist Will Be Held Accountable
While visiting a pharmacy during inspection, many times the PRN pharmacist is on duty and does not realize that he or she is responsible for all actions of the pharmacy, pharmacists, and technicians. Whether it be a technician not offering counsel by the pharmacist on refills, or the pharmacy neglecting to send in a controlled substance database report to the Board, the pharmacist on that particular day is held accountable for all pharmacy operations.
Therefore, if you are "just filling in" for another pharmacist, or float for several locations, it may be wise to carry your own pharmacy law book, educate your technicians on counseling rules and regulations, and listen to make sure your rules are enforced! While on duty, you are the pharmacist-in-charge!
Understanding the Legal Word "Shall"
"shall" means that compliance is manditory. Simply put, there is little to no room for excuse or exception for what shall be done
Exactly how many technicians are allowed per pharmacist?
If no certified technicians are in the pharmacy, the technician to pharmacist ratio is 2:1 (two technicians to one pharmacist). If one certified technician is in the pharmacy, the ratio increases to 3:1. If two technicians are in the pharmacy and certified, the ratios increases to 4:1 (four total technicians to one pharmacist).
Remember that all technicians, certified or not, must registered with the TN Board of Pharmacy.
What is a technician affidavit?
Submit an affidavit from his/her employer attesting that the applicant has read and understands the statutes and regulations pertaining to the practice of pharmacy in TN.
A copy of this affidavit shall be retained at the place of employment.
Schedule II Prescriptions Must Be On Separate Prescription Orders/Blanks
As of January 1, 2011, any Schedule II prescription written, printed, or computer generated by a prescribing practitioner, must be written, printed, or typed as a separated prescription order UNLESS
- 1. inpatient hospital
- 2. outpatient where the Rx is unobtainable to the patient
- 3. nursing home
- 4. inpatients/residents of a mental health hospital
- 5. federal correctional facility
What is an independent double-check of a high-alert medication?
An independent double-check of a high-alert medication is a procedure in which two pharmacists, alone & apart from each other, separately check each component of dispensing & verifying the high-alert medication, then compare results before gicing it to the patient to self-administer.
Who's in charge of the controlled substance monitoring database (CSMD)?
The State Board
Are pharmacists allow to search for or look up a patient in the CSMD once that patient has been transferred to another retail store?
Can pharmacists from the same retail store use the same password to get access to the CSMD?
No, each pharmacist must has his/her own password
How many hours & how often should pharmacist performs their CE live & un-live?
- 30 CE hours every 2 years
- 15 hrs live & 15 hours un-live
What kind of paper must a prescription be on in order to be a legit Rx?
What are the four (4) requirements for a tamper-resistant Rx?
- 1. Water-marking & has the word "void" or "illegal" showing up if it were to be photocopy
- 2. quantity check boxes
- 3. non-white paper with consistant pattern
- 4. the secure features must be listed somewhere on the Rx
How many refills can a schedule II, III, IV,& V have?
- C-II = 0
- C-III, IV, & V = 5
Can a patient pick-up half of the quantity of their C-II & get the rest later?
If a patient can only afford a certain quantity of their C-II meds, how many that is left will be discard and cannot be refill.
However, this rule can be overcomed if the pharmacy ran out of stock for that C-II med...the pharmacy will then have 72 hrs to refill that med to the patient.
In which circumstances can a pharmacist partial a C-II?
- Only if the patient is
- 1. hospice ptn
- 2. in long-term facility care
- 3. terminal-ill ptn
Which ever the reason is, the pharmacist must document
it on the Rx.
The partial fill must be within 60 days
Can a schedule II, III, IV, & V fax over to a pharmacy?
C-II = No
The DEA does not allow electronic C-II
C-III, C-IV, & C-V = Yes
How long is a legend drug prescription last for?
If a physician write "do not fill until 30 days," can a pharmacy fill that prescription on a Friday evening if the store closed on Saturday & Sunday?
Can a physician pre-date their Rx?
Can a law enforcer comes into a retail pharmacy & requests a printout of patient controll substance record?
They have to request it from the CSMD.
A majority of misfills that result in formal complaints to the BOP appear to be preventable with focus on two steps of the filling/dispensing process
- 1. A proper DUR for each prescription & refill
- 2. Counseling
Requirements of Pharmacy Technician
- 1. All technicians must be registered with BOP
- 2. Certification is not required, but recognized
- 3. Must have signed an affidavit from his/her employer attesting that the applicant has read and understands the statutes & regulations pertaining to the practice of pharmacy in TN. (A copy of this affidavit shall be retained at the place of employment)
- 4. Must post registration
- 5. Must keep proof of licensure and certification, if applicable, at all times while on duty
- 6. Must wear name tags with appropriate designation
- 7. Must immediately notify the Board office, in writing, of any change of address or employer
- 8. Registrations must be renewed every two (2) years
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