Recent TN Pharm Law

Drug Enforcement Administration (DEA)

• 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

• 1. strength of the drug
• 2. quantity of the drug
• 3. directions for use

• 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

Background Checks Required to provide patient care

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.

The National Association of Drug Diversion Investigators (NADDI)

• 1. ephedrine
• 2. pseudoephedrine (PSE)
• 3. phenylpropanolamine

If your pharmacy only administers PSE by prescription

January 1, 2012

• 1. NPLEx Retail Web Portal
• 2. Point-of-Sale Integrated Method

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.

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.

Tramadol (Ultram) - is a centrally acting opioid analgesic, used in treating moderate to severe pain.

Carisoprodol (Soma) - is a centrally-acting skeletal muscle relaxant.

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.

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.

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.

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.

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.

• 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

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.

As of January 1, 2010, all pharmacist must be able to access the Controlled Substance Monitoring Database (CSMDB) at their pharmacy practice site.

NO!

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

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.

The recommendation of the Board was to authorize a formal hearing & levy a $500 fine to each pharmacist on duty for early refill(s).

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.

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!

"shall" means that compliance is manditory. Simply put, there is little to no room for excuse or exception for what shall be done

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.

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.

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

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.

The State Board

No

No, each pharmacist must has his/her own password

• 30 CE hours every 2 years
• 15 hrs live & 15 hours un-live

Tamper-Resistant Paper

• 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

• C-II = 0
• C-III, IV, & V = 5

No!

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.

• 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 window.

C-II = No

The DEA does not allow electronic C-II

C-III, C-IV, & C-V = Yes

1 year

No

No

No!

They have to request it from the CSMD.

• 1. A proper DUR for each prescription & refill
• 2. Counseling

• 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