----------------------------------------------------------------------------


10  AN ACT concerning the practice of pharmacy; pharmacy technicians and
11    students; medication profile record system information; defining the
12    practice of pharmacy; persons engaged in pharmacy practice;
13    amending K.S.A. 1996 Supp. 65-1642 65-1626, as amended by sec-
14    tion 118 of chapter 229 of the 1996 Session Laws of Kansas, and
15    repealing the existing section.
16
17  Be it enacted by the Legislature of the State of Kansas:
18    Section 1.  K.S.A. 1996 Supp. 65-1642 is hereby amended to read as
19  follows: 65-1642. (a) Each pharmacy shall be equipped with proper phar-
20  maceutical utensils, in order that prescriptions can be properly filled and
21  United States pharmacopoeia and national formulary preparations prop-
22  erly compounded, and with proper sanitary appliances which shall be kept
23  in a clean and orderly manner. The board shall prescribe the minimum
24  of such professional and technical equipment which a pharmacy shall at
25  all times possess, and such list shall include the latest revisions of the
26  United States pharmacopoeia dispensing information and all supplements
27  thereto. The ratio of supportive personnel pharmacy technicians per-
28  forming nonjudgmental functions in the compounding prescription area
29  of the pharmacy under the direction of a pharmacist, excluding phar-
30  macist interns pharmacy students, to licensed pharmacists shall not ex-
31  ceed a one-to-one ratio in other than medical care facility pharmacies and
32  a two-to-one ratio for medical care facility pharmacies except that any
33  pharmacy may be specifically authorized by the board to exceed the ratio
34  established under this subsection for that pharmacy upon the approval of
35  a specific plan describing the manner in which additional supportive per-
36  sonnel shall be supervised.
37    (b)  Each pharmacy shall keep a suitable book or file which records
38  every prescription order filled at the pharmacy and a medication profile
39  record system as provided under subsection (c). The book or file of pre-
40  scription orders shall be kept for a period of not less than five years. The
41  book or file of prescription orders shall at all times be open to inspection
SB 201--Am. by H
                                     

 1  by members of the board, the secretary of health and environment, the
 2  duly authorized agents or employees of such board or secretary and other
 3  proper authorities.
 4    (c) (1)  A medication profile record system shall be maintained in all
 5  pharmacies for persons for whom prescriptions are dispensed. The fol-
 6  lowing information shall be recorded:
 7    (A)  The name and address of the patient for whom the medication is
 8  intended;
 9    (B)  the prescriber's name, the original date the prescription is dis-
10  pensed and the number or designation identifying the prescription; and
11    (C)  the name, strength and quantity of the drug dispensed and the
12  name of the dispensing pharmacist.fsi; and
13    (D)  drug allergies and sensitivities.
14    (2)  Upon receipt of a prescription order, the pharmacist shall examine
15  the patient's medication profile record before dispensing the medication
16  to determine the possibility of a harmful drug interaction or reaction to
17  the medication according to federal and state laws or the provisions of
18  the board's rules and regulations. Upon recognizing a potential harmful
19  drug interaction or reaction to the medication, the pharmacist shall take
20  appropriate action to avoid or minimize the problem which shall, if nec-
21  essary, include consultation with the prescriber with documentation of
22  actions taken recorded on the prescription record.
23    (3)  A medication profile record shall be maintained for a period of
24  not less than five years from the date of the last entry in the record.
25    (4)  All prescription drug orders communicated by way of electronic
26  transmission shall conform to federal and state laws or the provisions of
27  the board's rules and regulations.
28    (d)  No registration shall be issued or continued for the conduct of a
29  pharmacy until or unless the provisions of this section have been complied
30  with.
31    Section. 1.  K.S.A. 65-1626, as amended by section 118 of chap-
32  ter 229 of the 1996 Session Laws of Kansas, is hereby amended to
33  read as follows: 65-1626. For the purposes of this act:
34    (a)  ``Administer'' means the direct application of a drug,
35  whether by injection, inhalation, ingestion or any other means, to
36  the body of a patient or research subject by:
37    (1)  A practitioner or pursuant to the lawful direction of a prac-
38  titioner, or
39    (2)  the patient or research subject at the direction and in the
40  presence of the practitioner.
41    (b)  ``Agent'' means an authorized person who acts on behalf of
42  or at the direction of a manufacturer, distributor or dispenser but
43  shall not include a common or contract carrier, public warehouse-
SB 201--Am. by H
                                     

 1  man or employee of the carrier or warehouseman when acting in
 2  the usual and lawful course of the carrier's or warehouseman's busi-
 3  ness.
 4    (c)  ``Board'' means the state board of pharmacy created by
 5  K.S.A. 74-1603 and amendments thereto.
 6    (d)  ``Brand exchange'' means the dispensing of a different drug
 7  product of the same dosage form and strength and of the same ge-
 8  neric name than the brand name drug product prescribed.
 9    (e)  ``Brand name'' means the registered trademark name given
10  to a drug product by its manufacturer, labeler or distributor.
11    (f)  ``Deliver'' or ``delivery'' means the actual, constructive or
12  attempted transfer from one person to another of any drug whether
13  or not an agency relationship exists.
14    (g)  ``Direct supervision'' means the process by which the responsible
15  pharmacist shall observe and direct the activities of a pharmacy student
16  or pharmacy technician to a sufficient degree to assure that all such ac-
17  tivities are performed accurately, safely and without risk or harm to pa-
18  tients, and complete the final check before dispensing.
19    (g) (h)  ``Dispense'' means to deliver prescription medication to
20  the ultimate user or research subject by or pursuant to the lawful
21  order of a practitioner.
22    (h) (i)  ``Dispenser'' means a practitioner or pharmacist who dis-
23  penses prescription medication.
24    (i) (j)  ``Distribute'' means to deliver, other than by administering
25  or dispensing, any drug.
26    (j) (k)  ``Distributor'' means a person who distributes a drug.
27    (k) (l)  ``Drug'' means: (1) Articles recognized in the official
28  United States pharmacopoeia, or other such official compendiums
29  of the United States, or official national formulary, or any supple-
30  ment of any of them; (2) articles intended for use in the diagnosis,
31  cure, mitigation, treatment or prevention of disease in man or other
32  animals; (3) articles, other than food, intended to affect the struc-
33  ture or any function of the body of man or other animals; and (4)
34  articles intended for use as a component of any articles specified in
35  clause (1), (2) or (3) of this subsection; but does not include devices
36  or their components, parts or accessories, except that the term
37  ``drug'' shall not include amygdalin (laetrile) or any livestock rem-
38  edy, as defined in K.S.A. 47-501 and amendments thereto, if such
39  livestock remedy has been registered in accordance with the pro-
40  visions of article 5 of chapter 47 of the Kansas Statutes Annotated.
41    (m)  ``Electronic transmission'' means transmission of information in
42  electronic form or the transmission of the exact visual image of a document
43  by way of electronic equipment.
SB 201--Am. by H
                                     

 1    (l) (n)  ``Generic name'' means the established chemical name or
 2  official name of a drug or drug product.
 3    (m) (o) (1)  ``Institutional drug room'' means any location where
 4  prescription-only drugs are stored and from which prescription-
 5  only drugs are administered or dispensed and which is maintained
 6  or operated for the purpose of providing the drug needs of:
 7    (A)  Inmates of a jail or correctional institution or facility;
 8    (B)  residents of a juvenile detention facility, as defined by the
 9  Kansas code for care of children and the Kansas juvenile justice
10  code;
11    (C)  students of a public or private university or college, a com-
12  munity college or any other institution of higher learning which is
13  located in Kansas; or
14    (D)  employees of a business or other employer.
15    (2)  ``Institutional drug room'' does not include:
16    (A)  Any registered pharmacy;
17    (B)  any office of a practitioner; or
18    (C)  a location where no prescription-only drugs are dispensed
19  and no prescription-only drugs other than individual prescriptions
20  are stored or administered.
21    (n) (p)  ``Medical care facility'' shall have the meaning provided
22  in K.S.A. 65-425 and amendments thereto, except that the term shall
23  also include facilities licensed under the provisions of K.S.A. 75-
24  3307b and amendments thereto except community mental health
25  centers and facilities for the mentally retarded.
26    (o) (q)  ``Manufacture'' means the production, preparation, prop-
27  agation, compounding, conversion or processing of a drug either
28  directly or indirectly by extraction from substances of natural ori-
29  gin, independently by means of chemical synthesis or by a combi-
30  nation of extraction and chemical synthesis and includes any pack-
31  aging or repackaging of the drug or labeling or relabeling of its
32  container, except that this term shall not include the preparation or
33  compounding of a drug by an individual for the individual's own
34  use or the preparation, compounding, packaging or labeling of a
35  drug by: (1) A practitioner or a practitioner's authorized agent in-
36  cident to such practitioner's administering or dispensing of a drug
37  in the course of the practitioner's professional practice; (2) a prac-
38  titioner, by a practitioner's authorized agent or under a practi-
39  [chtioner's supervision for the purpose of, or as an incident to, re-
40  search, teaching or chemical analysis and not for sale; or (3) a
41  pharmacist or the pharmacist's authorized agent acting under the
42  direct supervision of the pharmacist for the purpose of, or incident
43  to, the dispensing of a drug by the pharmacist.
SB 201--Am. by H
                                     

 1    (p) (r)  ``Person'' means individual, corporation, government,
 2  governmental subdivision or agency, partnership, association or
 3  any other legal entity.
 4    (q) (s)  ``Pharmacist'' means any natural person licensed under
 5  this act to practice pharmacy.
 6    (r) (t)  ``Pharmacist in charge'' means the pharmacist who is re-
 7  sponsible to the board for a registered establishment's compliance
 8  with the laws and regulations of this state pertaining to the practice
 9  of pharmacy, manufacturing of drugs and the distribution of drugs.
10  The pharmacist in charge shall supervise such establishment on a
11  full-time or a part-time basis and perform such other duties relating
12  to supervision of a registered establishment as may be prescribed
13  by the board by rules and regulations. Nothing in this definition
14  shall relieve other pharmacists or persons from their responsibility
15  to comply with state and federal laws and regulations.
16    (s) (u)  ``Pharmacy,'' ``drug store'' or ``apothecary'' means prem-
17  ises, laboratory, area or other place: (1) Where drugs are offered
18  for sale where the profession of pharmacy is practiced and where
19  prescriptions are compounded and dispensed; or (2) which has dis-
20  played upon it or within it the words ``pharmacist,'' ``pharmaceu-
21  tical chemist,'' ``pharmacy,'' ``apothecary,'' ``drugstore,'' ``druggist,''
22  ``drugs,'' ``drug sundries'' or any of these words or combinations of
23  these words or words of similar import either in English or any sign
24  containing any of these words; or (3) where the characteristic sym-
25  bols of pharmacy or the characteristic prescription sign ``Rx'' may
26  be exhibited. As used in this subsection, premises refers only to the
27  portion of any building or structure leased, used or controlled by
28  the licensee in the conduct of the business registered by the board
29  at the address for which the registration was issued.
30    (v)  ``Pharmacy student'' means an individual, registered with the
31  board of pharmacy, enrolled in an accredited school of pharmacy.
32    (w)  ``Pharmacy technician'' means an individual who, under the di-
33  rect supervision and control of a pharmacist, may perform packaging,
34  manipulative, repetitive or other nondiscretionary tasks related to the
35  processing of a prescription or medication order and who assists the phar-
36  macist in the performance of pharmacy related duties, but who does not
37  perform duties restricted to a pharmacist.
38    (x)  ``Practice of pharmacy'' means the interpretation and evaluation
39  of prescription orders; the compounding, dispensing and labeling of drugs
40  and devices pursuant to prescription orders; the participation of drug
41  selection according to state law and participation in drug utilization re-
42  views; the proper and safe storage of prescription drugs and prescription
43  devices and the maintenance of proper records thereof; consultation with
SB 201--Am. by H
                                     

 1  patients and other health care practitioners about the safe and effective
 2  use of prescription drugs and prescription devices; and the offering or
 3  performing of those acts, services, operations or transactions necessary in
 4  the conduct, operation, management and control of a pharmacy. Nothing
 5  in this subsection shall be construed to add any additional require-
 6  ments for registration under the pharmacy act of the state of Kan-
 7  sas or to prevent persons other than pharmacists from engaging
 8  in drug utilization review.
 9    (t) (y)  ``Practitioner'' means a person licensed to practice medi-
10  cine and surgery, dentist, podiatrist, veterinarian, optometrist li-
11  censed under the optometry law as a therapeutic licensee or diag-
12  nostic and therapeutic licensee, or scientific investigator or other
13  person authorized by law to use a prescription-only drug in teach-
14  ing or chemical analysis or to conduct research with respect to a
15  prescription-only drug.
16    (u) (z)  ``Preceptor'' means a licensed pharmacist who possesses
17  at least two years' experience as a pharmacist and who supervises
18  students obtaining the pharmaceutical experience required by law
19  as a condition to taking the examination for licensure as a phar-
20  macist.
21    (v) (aa)  ``Prescription'' means, according to the context, either a
22  prescription order or a prescription medication.
23    (w) (bb)  ``Prescription medication'' means any drug, including
24  label and container according to context, which is dispensed pur-
25  suant to a prescription order.
26    (x) (cc)  ``Prescription-only drug'' means any drug required by
27  the federal or state food, drug and cosmetic act to bear on its label
28  the legend ``Caution: Federal law prohibits dispensing without pre-
29  scription.''
30    (y) (dd)  ``Prescription order'' means: (1) An order to be filled by
31  a pharmacist for prescription medication issued and signed by a
32  practitioner in the authorized course of professional practice; or (2)
33  an order transmitted to a pharmacist through word of mouth, note,
34  telephone or other means of communication directed by such prac-
35  titioner.
36    (z) (ee)  ``Probation'' means the practice or operation under a
37  temporary license, registration or permit or a conditional license,
38  registration or permit of a business or profession for which a license,
39  registration or permit is granted by the board under the provisions
40  of the pharmacy act of the state of Kansas requiring certain actions
41  to be accomplished or certain actions not to occur before a regular
42  license, registration or permit is issued.
43    (aa) (ff)  ``Professional incompetency'' means:
SB 201--Am. by H
                                     

 1    (1)  One or more instances involving failure to adhere to the ap-
 2  plicable standard of pharmaceutical care to a degree which consti-
 3  tutes gross negligence, as determined by the board;
 4    (2)  repeated instances involving failure to adhere to the appli-
 5  cable standard of pharmaceutical care to a degree which constitutes
 6  ordinary negligence, as determined by the board; or
 7    (3)  a pattern of pharmacy practice or other behavior which
 8  demonstrates a manifest incapacity or incompetence to practice
 9  pharmacy.
10    (bb) (gg)  ``Retail dealer'' means a person selling at retail non-
11  prescription drugs which are prepackaged, fully prepared by the
12  manufacturer or distributor for use by the consumer and labeled
13  in accordance with the requirements of the state and federal food,
14  drug and cosmetic acts. Such nonprescription drugs shall not in-
15  clude: (1) A controlled substance; (2) a drug the label of which is
16  required to bear substantially the statement ``Caution: Federal law
17  prohibits dispensing without prescription''; or (3) a drug intended
18  for human use by hypodermic injection.
19    (cc) (hh)  ``Secretary'' means the executive secretary of the board.
20    (dd) (ii)  ``Unprofessional conduct'' means:
21    (1)  Fraud in securing a registration or permit;
22    (2)  intentional adulteration or mislabeling of any drug, medi-
23  cine, chemical or poison;
24    (3)  causing any drug, medicine, chemical or poison to be adul-
25  terated or mislabeled, knowing the same to be adulterated or mis-
26  labeled;
27    (4)  intentionally falsifying or altering records or prescriptions;
28    (5)  unlawful possession of drugs and unlawful diversion of
29  drugs to others;
30    (6)  willful betrayal of confidential information under K.S.A. 65-
31  1654 and amendments thereto;
32    (7)  conduct likely to deceive, defraud or harm the public;
33    (8)  making a false or misleading statement regarding the licen-
34  see's professional practice or the efficacy or value of a drug;
35    (9)  commission of any act of sexual abuse, misconduct or ex-
36  ploitation related to the licensee's professional practice; or
37    (10) performing unnecessary tests, examinations or services
38  which have no legitimate pharmaceutical purpose.
39    New Sec. 2.  (a) For the purpose of the pharmacy act of the state of
40  Kansas, the following persons shall be deemed to be engaged in the prac-
41  tice of pharmacy:
42    (1)  Persons who publicly profess to be a pharmacist, or publicly pro-
43  fess to assume the duties incident to being a pharmacist and their knowl-
SB 201--Am. by H
                                     

 1  edge of drugs and/or drug actions;
 2    (2)  persons who attach to their name the title R.Ph., PharmD, P.D.,
 3  registered pharmacist or licensed pharmacist, or the abbreviation
 4  R.Ph., or any words or abbreviation indicating that they are a pharmacist;
 5  or
 6    (3)  persons who provide services to other persons based on their
 7  knowledge of drugs and drug actions gained in a qualified school of phar-
 8  macy and being licensed as a pharmacist in another state.
 9    (b)  It shall be unlawful for any person who is not licensed under the
10  pharmacy act of the state of Kansas or whose license has been revoked
11  or suspended to engage in the practice of pharmacy as defined in the
12  pharmacy act of the state of Kansas. Each day that the person performs
13  the practice of pharmacy in violation of this section shall constitute a
14  separate offense.
15    (c)  This section shall not apply to any person licensed by the board
16  whose license was expired or lapsed and reinstated within a six-month
17  period.
18    (d) (b)  This section shall be part of and supplemental to the pharmacy
19  act of the state of Kansas.
20    Sec. 3.  K.S.A. 1996 Supp. 65-1642 65-1626, as amended by sec-
21  tion 118 of chapter 229 of the 1996 Session Laws of Kansas, is hereby
22  repealed.
23    Sec. 4.  This act shall take effect and be in force from and after its
24  publication in the statute book.