Session of 1999
SENATE BILL No. 193
By Committee on Public Health and Welfare
2-1
9 AN ACT concerning the prescribing of drugs by physicians' assistants;
10 amending K.S.A. 65-2896e and K.S.A. 1998 Supp. 65-1626 and 65-
11 4101 and repealing the existing sections.
12
13 Be it enacted by the Legislature of the State of Kansas:
14 Section 1. K.S.A. 1998 Supp. 65-1626 is hereby amended to read as
15 follows: 65-1626. For the purposes of this act:
16 (a) "Administer" means the direct application of a drug, whether by
17 injection, inhalation, ingestion or any other means, to the body of a patient
18 or research subject by:
19 (1) A practitioner or pursuant to the lawful direction of a practitioner,
20 or
21 (2) the patient or research subject at the direction and in the presence
22 of the practitioner.
23 (b) "Agent" means an authorized person who acts on behalf of or at
24 the direction of a manufacturer, distributor or dispenser but shall not
25 include a common or contract carrier, public warehouseman or employee
26 of the carrier or warehouseman when acting in the usual and lawful course
27 of the carrier's or warehouseman's business.
28 (c) "Board" means the state board of pharmacy created by K.S.A. 74-
29 1603 and amendments thereto.
30 (d) "Brand exchange" means the dispensing of a different drug prod-
31 uct of the same dosage form and strength and of the same generic name
32 than the brand name drug product prescribed.
33 (e) "Brand name" means the registered trademark name given to a
34 drug product by its manufacturer, labeler or distributor.
35 (f) "Deliver" or "delivery" means the actual, constructive or at-
36 tempted transfer from one person to another of any drug whether or not
37 an agency relationship exists.
38 (g) "Direct supervision" means the process by which the responsible
39 pharmacist shall observe and direct the activities of a pharmacy student
40 or pharmacy technician to a sufficient degree to assure that all such ac-
41 tivities are performed accurately, safely and without risk or harm to pa-
42 tients, and complete the final check before dispensing.
43 (h) "Dispense" means to deliver prescription medication to the ulti-
44 mate user or research subject by or pursuant to the lawful order of a
45 practitioner.
46 (i) "Dispenser" means a practitioner or pharmacist who dispenses
47 prescription medication.
48 (j) "Distribute" means to deliver, other than by administering or dis-
49 pensing, any drug.
50 (k) "Distributor" means a person who distributes a drug.
51 (l) "Drug" means: (1) Articles recognized in the official United States
52 pharmacopoeia, or other such official compendiums of the United States,
53 or official national formulary, or any supplement of any of them; (2) ar-
54 ticles intended for use in the diagnosis, cure, mitigation, treatment or
55 prevention of disease in man or other animals; (3) articles, other than
56 food, intended to affect the structure or any function of the body of man
57 or other animals; and (4) articles intended for use as a component of any
58 articles specified in clause (1), (2) or (3) of this subsection; but does not
59 include devices or their components, parts or accessories, except that the
60 term "drug" shall not include amygdalin (laetrile) or any livestock remedy,
61 as defined in K.S.A. 47-501 and amendments thereto, if such livestock
62 remedy has been registered in accordance with the provisions of article
63 5 of chapter 47 of the Kansas Statutes Annotated.
64 (m) "Electronic transmission" means transmission of information in
65 electronic form or the transmission of the exact visual image of a docu-
66 ment by way of electronic equipment.
67 (n) "Generic name" means the established chemical name or official
68 name of a drug or drug product.
69 (o) (1) "Institutional drug room" means any location where prescrip-
70 tion-only drugs are stored and from which prescription-only drugs are
71 administered or dispensed and which is maintained or operated for the
72 purpose of providing the drug needs of:
73 (A) Inmates of a jail or correctional institution or facility;
74 (B) residents of a juvenile detention facility, as defined by the Kansas
75 code for care of children and the Kansas juvenile justice code;
76 (C) students of a public or private university or college, a community
77 college or any other institution of higher learning which is located in
78 Kansas; or
79 (D) employees of a business or other employer.
80 (2) "Institutional drug room" does not include:
81 (A) Any registered pharmacy;
82 (B) any office of a practitioner; or
83 (C) a location where no prescription-only drugs are dispensed and no
84 prescription-only drugs other than individual prescriptions are stored or
85 administered.
86 (p) "Medical care facility" shall have the meaning provided in K.S.A.
87 65-425 and amendments thereto, except that the term shall also include
88 facilities licensed under the provisions of K.S.A. 75-3307b and amend-
89 ments thereto except community mental health centers and facilities for
90 the mentally retarded.
91 (q) "Manufacture" means the production, preparation, propagation,
92 compounding, conversion or processing of a drug either directly or in-
93 directly by extraction from substances of natural origin, independently by
94 means of chemical synthesis or by a combination of extraction and chem-
95 ical synthesis and includes any packaging or repackaging of the drug or
96 labeling or relabeling of its container, except that this term shall not in-
97 clude the preparation or compounding of a drug by an individual for the
98 individual's own use or the preparation, compounding, packaging or la-
99 beling of a drug by: (1) A practitioner or a practitioner's authorized agent
100 incident to such practitioner's administering or dispensing of a drug in
101 the course of the practitioner's professional practice; (2) a practitioner,
102 by a practitioner's authorized agent or under a practitioner's supervision
103 for the purpose of, or as an incident to, research, teaching or chemical
104 analysis and not for sale; or (3) a pharmacist or the pharmacist's author-
105 ized agent acting under the direct supervision of the pharmacist for the
106 purpose of, or incident to, the dispensing of a drug by the pharmacist.
107 (r) "Person" means individual, corporation, government, govern-
108 mental subdivision or agency, partnership, association or any other legal
109 entity.
110 (s) "Pharmacist" means any natural person licensed under this act to
111 practice pharmacy.
112 (t) "Pharmacist in charge" means the pharmacist who is responsible
113 to the board for a registered establishment's compliance with the laws
114 and regulations of this state pertaining to the practice of pharmacy, man-
115 ufacturing of drugs and the distribution of drugs. The pharmacist in
116 charge shall supervise such establishment on a full-time or a part-time
117 basis and perform such other duties relating to supervision of a registered
118 establishment as may be prescribed by the board by rules and regulations.
119 Nothing in this definition shall relieve other pharmacists or persons from
120 their responsibility to comply with state and federal laws and regulations.
121 (u) "Pharmacy," "drug store" or "apothecary" means premises, lab-
122 oratory, area or other place: (1) Where drugs are offered for sale where
123 the profession of pharmacy is practiced and where prescriptions are com-
124 pounded and dispensed; or (2) which has displayed upon it or within it
125 the words "pharmacist," "pharmaceutical chemist," "pharmacy," "apoth-
126 ecary," "drugstore," "druggist," "drugs," "drug sundries" or any of these
127 words or combinations of these words or words of similar import either
128 in English or any sign containing any of these words; or (3) where the
129 characteristic symbols of pharmacy or the characteristic prescription sign
130 "Rx" may be exhibited. As used in this subsection, premises refers only
131 to the portion of any building or structure leased, used or controlled by
132 the licensee in the conduct of the business registered by the board at the
133 address for which the registration was issued.
134 (v) "Pharmacy student" means an individual, registered with the
135 board of pharmacy, enrolled in an accredited school of pharmacy.
136 (w) "Pharmacy technician" means an individual who, under the direct
137 supervision and control of a pharmacist, may perform packaging, manip-
138 ulative, repetitive or other nondiscretionary tasks related to the processing
139 of a prescription or medication order and who assists the pharmacist in
140 the performance of pharmacy related duties, but who does not perform
141 duties restricted to a pharmacist.
142 (x) "Practitioner" means a person licensed to practice medicine and
143 surgery, dentist, podiatrist, veterinarian, optometrist licensed under the
144 optometry law as a therapeutic licensee or diagnostic and therapeutic
145 licensee, or scientific investigator or other person authorized by law to
146 use a prescription-only drug in teaching or chemical analysis or to conduct
147 research with respect to a prescription-only drug.
148 (y) "Preceptor" means a licensed pharmacist who possesses at least
149 two years' experience as a pharmacist and who supervises students ob-
150 taining the pharmaceutical experience required by law as a condition to
151 taking the examination for licensure as a pharmacist.
152 (z) "Prescription" means, according to the context, either a prescrip-
153 tion order or a prescription medication.
154 (aa) "Prescription medication" means any drug, including label and
155 container according to context, which is dispensed pursuant to a prescrip-
156 tion order.
157 (bb) "Prescription-only drug" means any drug required by the federal
158 or state food, drug and cosmetic act to bear on its label the legend "Cau-
159 tion: Federal law prohibits dispensing without prescription."
160 (cc) "Prescription order" means: (1) An order to be filled by a phar-
161 macist for prescription medication issued and signed by a practitioner or
162 a mid-level practitioner in the authorized course of professional practice;
163 or (2) an order transmitted to a pharmacist through word of mouth, note,
164 telephone or other means of communication directed by such
165 practitioner.
166 (dd) "Probation" means the practice or operation under a temporary
167 license, registration or permit or a conditional license, registration or per-
168 mit of a business or profession for which a license, registration or permit
169 is granted by the board under the provisions of the pharmacy act of the
170 state of Kansas requiring certain actions to be accomplished or certain
171 actions not to occur before a regular license, registration or permit is
172 issued.
173 (ee) "Professional incompetency" means:
174 (1) One or more instances involving failure to adhere to the appli-
175 cable standard of pharmaceutical care to a degree which constitutes gross
176 negligence, as determined by the board;
177 (2) repeated instances involving failure to adhere to the applicable
178 standard of pharmaceutical care to a degree which constitutes ordinary
179 negligence, as determined by the board; or
180 (3) a pattern of pharmacy practice or other behavior which demon-
181 strates a manifest incapacity or incompetence to practice pharmacy.
182 (ff) "Retail dealer" means a person selling at retail nonprescription
183 drugs which are prepackaged, fully prepared by the manufacturer or dis-
184 tributor for use by the consumer and labeled in accordance with the
185 requirements of the state and federal food, drug and cosmetic acts. Such
186 nonprescription drugs shall not include: (1) A controlled substance; (2) a
187 drug the label of which is required to bear substantially the statement
188 "Caution: Federal law prohibits dispensing without prescription"; or (3)
189 a drug intended for human use by hypodermic injection.
190 (gg) "Secretary" means the executive secretary of the board.
191 (hh) "Unprofessional conduct" means:
192 (1) Fraud in securing a registration or permit;
193 (2) intentional adulteration or mislabeling of any drug, medicine,
194 chemical or poison;
195 (3) causing any drug, medicine, chemical or poison to be adulterated
196 or mislabeled, knowing the same to be adulterated or mislabeled;
197 (4) intentionally falsifying or altering records or prescriptions;
198 (5) unlawful possession of drugs and unlawful diversion of drugs to
199 others;
200 (6) willful betrayal of confidential information under K.S.A. 65-1654
201 and amendments thereto;
202 (7) conduct likely to deceive, defraud or harm the public;
203 (8) making a false or misleading statement regarding the licensee's
204 professional practice or the efficacy or value of a drug;
205 (9) commission of any act of sexual abuse, misconduct or exploitation
206 related to the licensee's professional practice; or
207 (10) performing unnecessary tests, examinations or services which
208 have no legitimate pharmaceutical purpose.
209 (ii) "Mid-level practitioner" means a practitioner other than those
210 defined in K.S.A. 65-1626 and 65-4101 and amendments thereto who has
211 authority to prescribe drugs under K.S.A. 65-2896e and amendments
212 thereto.
213 Sec. 2. K.S.A. 65-2896e is hereby amended to read as follows: 65-
214 2896e. (a) A person whose name has been entered on the register of
215 physicians' assistants may perform, only under the direction and super-
216 vision of a physician, acts which constitute the practice of medicine and
217 surgery to the extent and in the manner authorized by the physician re-
218 sponsible for the physician's assistant and only to the extent such acts are
219 consistent with rules and regulations adopted by the board which relate
220 to acts performed by a physician's assistant under the responsible physi-
221 cian's direction and supervision. A physician's assistant may not prescribe
222 drugs but may transmit a prescription order for drugs pursuant to a writ-
223 ten protocol as authorized by the responsible physician. Before a physi-
224 cian's assistant shall perform under the direction and supervision of a
225 physician, such physician's assistant shall be identified to the patient and
226 others involved in providing the patient services as a physician's assistant
227 to the responsible physician. A physician's assistant may not perform any
228 act or procedure performed in the practice of optometry except as pro-
229 vided in K.S.A. 65-1508 and 65-2887 and amendments thereto.
230 (b) The board shall adopt rules and regulations governing the trans-
231 mitting of prescription orders for prescribing of drugs by physicians' as-
232 sistants and the responsibilities of the responsible physician with respect
233 thereto. Such rules and regulations shall establish such conditions and
234 limitations as the board determines to be necessary to protect the public
235 health and safety. In developing rules and regulations relating to the trans-
236 mitting of prescription orders for prescribing of drugs by physicians' as-
237 sistants, the board shall take into consideration the amount of training
238 and capabilities of physicians' assistants, the different practice settings in
239 which physicians' assistants and responsible physicians practice, the de-
240 gree of direction and supervision to be provided by a responsible physi-
241 cian and the needs of the geographic area of the state in which the phy-
242 sician's assistant and the responsible physician practice. In all cases in
243 which a physician's assistant is authorized to transmit prescription orders
244 for prescribe drugs by a responsible physician, a written protocol between
245 the responsible physician and the physician's assistant containing the es-
246 sential terms of such authorization shall be in effect. In no case shall the
247 scope of the authority of the physician's assistant to transmit prescription
248 orders for prescribe drugs exceed the normal and customary practice of
249 the responsible physician in the prescribing of drugs.
250 (c) The physician's assistant may not dispense drugs, but may request,
251 receive and sign for professional samples and may distribute professional
252 samples to patients. In order to prescribe controlled substances, the phy-
253 sician's assistant shall register with the federal drug enforcement
254 administration.
255 (d) As used in this section, "drug" means those articles and substances
256 defined as drugs in K.S.A. 65-1626 and 65-4101 and amendments thereto.
257 Sec. 3. K.S.A. 1998 Supp. 65-4101 is hereby amended to read as
258 follows: 65-4101. As used in this act: (a) "Administer" means the direct
259 application of a controlled substance, whether by injection, inhalation,
260 ingestion or any other means, to the body of a patient or research subject
261 by: (1) A practitioner or pursuant to the lawful direction of a practitioner;
262 or
263 (2) the patient or research subject at the direction and in the presence
264 of the practitioner.
265 (b) "Agent" means an authorized person who acts on behalf of or at
266 the direction of a manufacturer, distributor or dispenser. It does not in-
267 clude a common or contract carrier, public warehouseman or employee
268 of the carrier or warehouseman.
269 (c) "Board" means the state board of pharmacy.
270 (d) "Bureau" means the bureau of narcotics and dangerous drugs,
271 United States department of justice, or its successor agency.
272 (e) "Controlled substance" means any drug, substance or immediate
273 precursor included in any of the schedules designated in K.S.A. 65-4105,
274 65-4107, 65-4109, 65-4111 and 65-4113, and amendments to these
275 sections.
276 (f) "Counterfeit substance" means a controlled substance which, or
277 the container or labeling of which, without authorization bears the trade-
278 mark, trade name or other identifying mark, imprint, number or device
279 or any likeness thereof of a manufacturer, distributor or dispenser other
280 than the person who in fact manufactured, distributed or dispensed the
281 substance.
282 (g) "Deliver" or "delivery" means the actual, constructive or at-
283 tempted transfer from one person to another of a controlled substance,
284 whether or not there is an agency relationship.
285 (h) "Dispense" means to deliver a controlled substance to an ultimate
286 user or research subject by or pursuant to the lawful order of a practi-
287 tioner, including the packaging, labeling or compounding necessary to
288 prepare the substance for that delivery.
289 (i) "Dispenser" means a practitioner or pharmacist who dispenses.
290 (j) "Distribute" means to deliver other than by administering or dis-
291 pensing a controlled substance.
292 (k) "Distributor" means a person who distributes.
293 (l) "Drug" means: (1) Substances recognized as drugs in the official
294 United States pharmacopoeia, official homeopathic pharmacopoeia of the
295 United States or official national formulary or any supplement to any of
296 them; (2) substances intended for use in the diagnosis, cure, mitigation,
297 treatment or prevention of disease in man or animals; (3) substances
298 (other than food) intended to affect the structure or any function of the
299 body of man or animals; and (4) substances intended for use as a com-
300 ponent of any article specified in clause (1), (2) or (3) of this subsection.
301 It does not include devices or their components, parts or accessories.
302 (m) "Immediate precursor" means a substance which the board has
303 found to be and by rule and regulation designates as being the principal
304 compound commonly used or produced primarily for use and which is
305 an immediate chemical intermediary used or likely to be used in the
306 manufacture of a controlled substance, the control of which is necessary
307 to prevent, curtail or limit manufacture.
308 (n) "Manufacture" means the production, preparation, propagation,
309 compounding, conversion or processing of a controlled substance either
310 directly or indirectly by extraction from substances of natural origin or
311 independently by means of chemical synthesis or by a combination of
312 extraction and chemical synthesis and includes any packaging or repack-
313 aging of the substance or labeling or relabeling of its container, except
314 that this term does not include the preparation or compounding of a
315 controlled substance by an individual for the individual's own use or the
316 preparation, compounding, packaging or labeling of a controlled sub-
317 stance: (1) By a practitioner or the practitioner's agent pursuant to a lawful
318 order of a practitioner as an incident to the practitioner's administering
319 or dispensing of a controlled substance in the course of the practitioner's
320 professional practice; or
321 (2) by a practitioner or by the practitioner's authorized agent under
322 such practitioner's supervision for the purpose of or as an incident to
323 research, teaching or chemical analysis or by a pharmacist or medical care
324 facility as an incident to dispensing of a controlled substance.
325 (o) "Marijuana" means all parts of all varieties of the plant Cannabis
326 whether growing or not, the seeds thereof, the resin extracted from any
327 part of the plant and every compound, manufacture, salt, derivative, mix-
328 ture or preparation of the plant, its seeds or resin. It does not include the
329 mature stalks of the plant, fiber produced from the stalks, oil or cake
330 made from the seeds of the plant, any other compound, manufacture,
331 salt, derivative, mixture or preparation of the mature stalks, except the
332 resin extracted therefrom, fiber, oil, or cake or the sterilized seed of the
333 plant which is incapable of germination.
334 (p) "Narcotic drug" means any of the following whether produced
335 directly or indirectly by extraction from substances of vegetable origin or
336 independently by means of chemical synthesis or by a combination of
337 extraction and chemical synthesis: (1) Opium and opiate and any salt,
338 compound, derivative or preparation of opium or opiate;
339 (2) any salt, compound, isomer, derivative or preparation thereof
340 which is chemically equivalent or identical with any of the substances
341 referred to in clause (1) but not including the isoquinoline alkaloids of
342 opium;
343 (3) opium poppy and poppy straw;
344 (4) coca leaves and any salt, compound, derivative or preparation of
345 coca leaves, and any salt, compound, isomer, derivative or preparation
346 thereof which is chemically equivalent or identical with any of these sub-
347 stances, but not including decocainized coca leaves or extractions of coca
348 leaves which do not contain cocaine or ecgonine.
349 (q) "Opiate" means any substance having an addiction-forming or
350 addiction-sustaining liability similar to morphine or being capable of con-
351 version into a drug having addiction-forming or addiction-sustaining lia-
352 bility. It does not include, unless specifically designated as controlled
353 under K.S.A. 65-4102 and amendments thereto, the dextrorotatory iso-
354 mer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan).
355 It does include its racemic and levorotatory forms.
356 (r) "Opium poppy" means the plant of the species Papaver somni-
357 ferum l. except its seeds.
358 (s) "Person" means individual, corporation, government, or govern-
359 mental subdivision or agency, business trust, estate, trust, partnership or
360 association or any other legal entity.
361 (t) "Poppy straw" means all parts, except the seeds, of the opium
362 poppy, after mowing.
363 (u) "Pharmacist" means an individual currently licensed by the board
364 to practice the profession of pharmacy in this state.
365 (v) "Practitioner" means a person licensed to practice medicine and
366 surgery, dentist, podiatrist, veterinarian, optometrist licensed under the
367 optometry law as a therapeutic licensee or diagnostic and therapeutic
368 licensee, or scientific investigator or other person authorized by law to
369 use a controlled substance in teaching or chemical analysis or to conduct
370 research with respect to a controlled substance.
371 (w) "Production" includes the manufacture, planting, cultivation,
372 growing or harvesting of a controlled substance.
373 (x) "Ultimate user" means a person who lawfully possesses a con-
374 trolled substance for such person's own use or for the use of a member
375 of such person's household or for administering to an animal owned by
376 such person or by a member of such person's household.
377 (y) "Isomer" means all enantiomers and diastereomers.
378 (z) "Medical care facility" shall have the meaning ascribed to that
379 term in K.S.A. 65-425 and amendments thereto.
380 (aa) "Cultivate" means the planting or promotion of growth of five
381 or more plants which contain or can produce controlled substances.
382 (bb) (1) "Controlled substance analog" means a substance the chem-
383 ical structure of which is substantially similar to the chemical structure of
384 a controlled substance listed in or added to the schedules designated in
385 K.S.A. 65-4105 or 65-4107 and amendments thereto; and:
386 (A) Which has a stimulant, depressant or hallucinogenic effect on the
387 central nervous system substantially similar to the stimulant, depressant
388 or hallucinogenic effect on the central nervous system of a controlled
389 substance included in the schedules designated in K.S.A. 65-4105 or 65-
390 4107 and amendments thereto; or
391 (B) with respect to a particular individual, which the individual rep-
392 resents or intends to have a stimulant, depressant or hallucinogenic effect
393 on the central nervous system substantially similar to the stimulant, de-
394 pressant or hallucinogenic effect on the central nervous system of a con-
395 trolled substance included in the schedules designated in K.S.A. 65-4105
396 or 65-4107 and amendments thereto.
397 (2) "Controlled substance analog" does not include:
398 (A) A controlled substance;
399 (B) a substance for which there is an approved new drug application;
400 (C) a substance with respect to which an exemption is in effect for
401 investigational use by a particular person under section 505 of the federal
402 food, drug, and cosmetic act (21 U.S.C. 355) to the extent conduct with
403 respect to the substance is permitted by the exemption; or
404 (D) any substance to the extent not intended for human consumption
405 before an exemption takes effect with respect to the substance.
406 (cc) "Mid-level practitioner" means a practitioner other than those
407 defined in K.S.A. 65-1626 and 65-4101 and amendments thereto, who has
408 authority to prescribe drugs under K.S.A. 65-2896e and amendments
409 thereto.
410 Sec. 4. K.S.A. 65-2896e and K.S.A. 1998 Supp. 65-1626 and 65-4101
411 are hereby repealed.
412 Sec. 5. This act shall take effect and be in force from and after its
413 publication in the statute book.