11 PROPOSED ADMINISTRATIVE RULES

 

SOAHR 2005-090 DEPARTMENT OF COMMUNITY HEALTH

DIRECTOR’S OFFICE CONTROLLED SUBSTANCES

Filed with the Secretary of State on

 

These rules become effective immediately upon filing with the Secretary of State unless adopted under sections 33, 44 or 45a(6) of 1969 PA 306. Rules adopted under these sections become effective 7 days after filing with the Secretary of State.

 

(By authority conferred on the director of the department of consumer and industry services community health by sections 16145(3) and 7301 of 1978 PA 368 MCL 333.16145(3) and 333.7301 et seq. and Executive Reorganization Order No. Numbers 1996-1, 1996-2, MCL  333.7201, 333.7301, 333.7333, 333.7333a, 333.16145, and 2003-1, MCL 330.3101, 445.2001

and 445.2011)

 

Draft February 13, 2006

 

 

R 338.3101, R 338.3102, R 338.3132, R 338.3154, R 338.3161,            R 338.3162, R

338.3162b, R 338.3162c, and R 338.3162d of the Michigan Administrative Code are amended as follows:

 

PART 1. GENERAL PROVISIONS

 

R 338.3101 Definitions; A to H. Rule 1. As used in these rules:

(a)    “Act” means 1978 PA 368, MCL 333.1101 et seq.

(b)    “Deleterious drug” means a drug, other than a proprietary medicine, that is likely to be destructive to adult human life in quantities of 3.88 grams or less.

(c)    “Department” means the department of community health.

(d)    “Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record. An electronic signature also is a unique identifier protected by appropriate security measures such that it is only available for use by the intended individual and ensures nonrepudiation so that the signature may not be rejected based on its validity.

 

R 338.3102 Definitions; I to P.

Rule 2. (1) As used in these rules:

(a) “Inventory” means all stocks in finished form of a controlled substance that is manufactured or otherwise acquired by a licensee, whether in bulk or commercial

 

 

containers or contained in pharmaceutical preparations in the possession of the licensee.

(b)   “Licensee” means a person who is licensed pursuant to section 7303 of the act.

(c)   “Michigan automated prescription system (maps) claim form” means a form, to be determined by the department, that is in the format and includes the information as specified by the american society for automation in pharmacy (asap) and contains the information specified in R 338.3162b.

(d)  “National drug code number (ndc)” means a an 11-digit, 3-segment number that identifies the labeler/vendor, product, and package size and

is assigned to each drug product listed under section 510, registration of producers of drugs and devices, of the federal food, drug, and cosmetic act.

(e)   “Officer” means a state, county, or local law enforcement officer who has a duty to enforce the laws of this state.

(f)  “Patient identifier” includes all of the following information about a patient:

(i)      Full name.

(ii)    Address, including zip code.

(iii)    Date of birth.

(iv)    Any 1 of the following: (A) Social security number.

(B)  (A) Driver’s A Michigan driver’s license number.

(C)  (B) State-issued identification number. An identification number obtained from a photo identification card issued by the state of Michigan.

(C) The number zero. Zeroes shall be entered as the identification number, if the positive identification presented by the patient or the patient’s agent or caregiver does not include a license number or an identification number, as listed in subparagraphs (A) and

(B)  of this paragraph.

(v)  If a patient is an animal, any of the following:  (A) The owner’s social security number.

(B)The owner’s driver’s license number.

(C)The owner’s state-issued identification number.

(g) “Positive identification” means identification that includes a photograph of an individual in addition to his or her date of birth. Positive identification shall include an identification card issued by a governmental agency, provided the identification card meets the requirements of this rule.

 

(g h) “Prescriber” or “practitioner” means any of the following individuals who are licensed to prescribe by the laws of this state:

(i)    A dentist.

(ii)    A doctor of medicine.

(iii)    A doctor of osteopathic medicine and surgery.

(iv)    A doctor of podiatric medicine and surgery.

(v)    A veterinarian.

(vi)    An optometrist.

(2)   As used in part 5 of these rules:

(a)     “Medical institution” means an inpatient health facility which is licensed or approved by the state and which directly or indirectly provides or includes pharmacy services.

 

 

(b)    “Pharmacy services” means the direct and indirect patient care services associated with the practice of pharmacy.

 

PART 3. LICENSES

 

R 338.3132 Activities requiring separate licenses.

Rule 32. (1) The following activities are deemed to be independent of each other, shall be conducted under separate licenses, and shall comply with all of the requirements and duties prescribed by law for persons who are licensed to engage in such coincidental activities:

(a)    Manufacturing and distributing a controlled substance. A person who is licensed to manufacture a controlled substance listed in schedules 2 to 5 may conduct chemical analysis and research with a substance that is listed in the schedules.

(b)    Dispensing a controlled substance listed in schedules 2 to 5. A physician who is licensed to prescribe or dispense controlled substances listed in schedules 2 to 5 may conduct research with those substances.

(c)     Conducting research and instructional activity with a controlled substance listed in schedule 1 as follows:

(i)    A person who is licensed to conduct research with controlled substances listed in schedule 1 may do both of the following:

(A)   Manufacture the substances as set forth in the research protocol that is filed and approved by the federal food and drug administration and the drug enforcement administration (DEA) pursuant to the provisions of 21 C.F.R. §1301.18 and submitted with the application for licensure. The Code of Federal Regulations, Title 21, Food and Drugs, part 1301, containing

§1301.18 is available free of charge via the Internet at web-site http://www.access.gpo.gov/nara/cfr http://www.gpoaccess.gov.  Printed copies may be purchased by mail order from the United States Government Printing Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954, USA, by calling toll free at 1- 866-512-1800, or via the Internet at web-site http://bookstore.gpo.gov at a cost of $20.00

$24.00 as of the time of adoption of these amendments. Printed copies of 21 C.F.R. §1301.18 also are available for inspection and for distribution to the public at cost at the Department of Community Health, Bureau of Health Professions, Ottawa Building – First Floor, 611 West Ottawa, Lansing, MI 48909.

(B)   Distribute the substances to other persons who are licensed or authorized to conduct research or chemical analysis with the schedule 1 substances.

(ii)    A licensed physician who is authorized to conduct research with schedule 1 substances under federal law may conduct research with those substances, upon furnishing the administrator with evidence of that federal authorization. A separate license is not required for the research activity.

(d)    Conducting research with a controlled substance listed in schedules 2 to 5. A person who is licensed or authorized to conduct research with the controlled substances listed in schedules   2 to 5 may conduct chemical analysis with the substances listed in those schedules,   manufacture the substances if, and to the extent that, such manufacture is set forth in a statement filed with the application for licensure, distribute the substances to other persons who             are licensed or authorized to conduct research, chemical analysis, or instructional activity with the substances, and conduct instructional activities with the substances.

(e)    Conducting instructional activities with a controlled substance listed in schedules 2 to 5.

 

 

(f)    Prescribing, dispensing, or administering a controlled substance to a drug-dependent person in a drug treatment and rehabilitation program.

(g)    Conducting chemical analysis with a controlled substance listed in any schedule. A person who is licensed or authorized to conduct chemical analysis with all controlled substances may manufacture such substances for analytical or instructional purposes, distribute the substances to other persons who are licensed or authorized to conduct chemical analysis, instructional activity or research with the substances, and conduct instructional activities with the substances.

(2)   A separate license is required for each principal place of business or professional practice. A principal place of business or a professional practice is the physical location where controlled substances are manufactured, grown, cultivated, processed, or by other means produced or prepared, distributed, prescribed, stored, or dispensed by a licensee.

(3)   If a principal place of business or professional practice consists of multiple locations, then each location shall obtain a separate controlled substance license if controlled substances are received, stored, administered, or dispensed at that location.

(4)   A licensed physician prescriber or practitioner who holds a controlled substance license to prescribe, administer, or dispense controlled substances at a principal place of business or professional practice consisting of multiple locations shall not be required to obtain a separate controlled substance license for each physical location of the principal place of business or professional practice if the physician prescriber or practitioner only prescribes at the location.

(5)   A pharmacist who holds a controlled substance license may dispense from any licensed pharmacy.

 

PART 5. RECORDS

 

R 338.3154 Medication records in medical institutions.

Rule 54. (1) A patient's chart shall constitute a record of medications ordered for, and actually administered to, a patient of medical institutions.

(2)   Medication records are required for all controlled substances listed in schedules 2, 3, 4, and 5 of R 338.3116 to R 338.3125. At a minimum, these records shall include all of the following information:

(a)    The number of doses of controlled substances purchased.

(b)    The number of doses dispensed to individual patients or distributed to nursing stations or both.

(c)    The number of doses administered.

(d)    The number of doses dispensed, but not administered, to the patient.

(e)    An annual physical inventory and status of any discrepancies between the inventory and the records of acquisition and the dispensing records.

(3)   If the controlled substance is not dispensed to an individual patient, all of the following provisions shall be complied with:

(a)    Medication records for those controlled substances in schedules 2, 3, 4, and 5 of R 338.3116 to R 338.3125 shall be maintained.

(b)    Distribution of a controlled substance to a nursing unit shall not be more than 25 doses per container.

(c)    A distribution record for each multiple of 25 doses shall be used to account for delivery to a nursing unit. The record shall include all of the following information:

 

 

(i)    The name and dose of the controlled substance.

(ii)    The quantity of the substance.

(iii)    The date of delivery.

(iv)    The location of the nursing unit.

(v)    The name of the distributing pharmacy and address if a different location from the medical institution.

(vi)    Name of distributing pharmacist.

(vii)     The name of the individual on the nursing unit who receives the substance.

(d)    A proof of use record shall be maintained to account for all doses of an administered substance. The record shall include all of the following:

(i)    The name of the substance.

(ii)    The dose administered.

(iii)    The date and time a dose was administered.

(iv)    The name of the patient.

(v)    The signature of the individual who administered the dose.

(4)   The use of mechanical devices in medical institutions is contingent upon any approval which may be required by rule. If a controlled substance or any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial numbers, content, policies, procedures, and location within the facility shall be maintained on- site in the pharmacy for review by the department. When patient medication is stocked in an automated device, the pharmacy responsible for the device shall obtain an additional controlled substance license for each hospital, skilled nursing facility, county medical care facility, or nursing home when the pharmacy is not located at the same address as the facility and controlled substances are dispensed from the automated device. Only facilities that are identified as skilled nursing facilities, as defined in 1978 PA 368, MCL 333.20109, may have automated devices.

The documentation shall include at least all of the following information:

(a)    Name and address of the pharmacy or facility responsible for the operation of the automated device.

Manufacturer name and model number.

(c)    Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.

(d)    Policy and procedure for system operation that includes all of the following:

(i)    Safety.

(ii)    Security.

(iii)    Accuracy.

(iv)    Patient confidentiality.

(v)    Access.

(vi)    Controlled substances.

(vii)     Data retention or archival.

(viii)     Definitions.

(ix)    Downtime procedures.

(x)    Emergency procedures.

(xi)    Inspection.

(xii)     Installation requirements.

(xiii)     Maintenance.

(xiv)     Medication security.

 

 

(xv)     Quality assurance.

(xvi)     Medication inventory.

(xvii)     Staff education and training.

(xviii)     System set-up and malfunction.

(xix)     List of medications qualifying for emergency dose removal without pharmacist prior review of the prescription or medication order.

(5)   Automated devices shall have adequate security systems and procedures, evidenced by written pharmacy policies and procedures that document all of the following information:

Prevention of unauthorized access or use.

Compliance with any applicable federal and state regulations. Maintenance of patient confidentiality.

(6)   Records and electronic data kept by automated devices shall meet all of the following requirements:

(a)    All events involving access to the contents of the automated devices shall be recorded electronically.

(b)    Records shall be maintained by the pharmacy responsible for the device and shall be readily retrievable. The records shall include all of the following information:

(i)    The unique identity of device accessed.

(ii)    Identification of the individual accessing the device.

(iii)    The type of transaction.

(iv)    The name, strength, dosage form and quantity of the drug accessed.

(v)    The name of the patient for whom the drug was ordered.

(vi)    Identification of the pharmacist checking for the accuracy of the medications to be stocked or restocked in the device.

(vii)     If the pharmacist delegates the stocking of the device, then technologies shall be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention technology that is in compliance with R 338.490. This subdivision takes effect 1 year after the effective date of this amendatory rule April 11, 2003.

(viii)     Additional information as the pharmacist-in-charge pharmacy may deem necessary.

(7)   For medication removed from the system for on-site patient administration, the system shall document all of the following information:

(a)    The name of the patient.

(b)    The date and time medication was removed from the device.

(c)    The name, initials, or other unique identifier of the person removing the drug.

(d)    The name, strength, and dosage form of the drug. The documentation may be on paper or electronic medium.

(8)   The automated device shall provide a mechanism for securing and accounting for medications once removed from and subsequently returned to, the automated device return bin. Neither medication nor a device may be returned directly to the system for immediate reissue  or reuse. Medication or devices once removed shall not be reused or reissued, except as indicated in R 338.486(7).

(9)   The automated device shall provide a mechanism for securing and accounting for wasted or discarded medications.

(10)   The internal quality assurance documentation for the use and performance of the automated device shall include at least all of the following:

(a)    Safety monitors that include wrong medications removed and administered to patient.

 

 

(b)    Accuracy monitors that include filling errors and wrong medications removed.

(c)     Security monitors that include unauthorized access, patients not in the system, system security breaches, and controlled substance audits.

(d)    Policies that establish corrective measures taken to address the problems and errors identified in the internal quality assurance program and its integration to the overall quality assurance policies.

(11)   Policy and procedures for the use of the automated device shall include a requirement for pharmacist review of the prescription or medication order before system profiling or removal of any medication from the system for immediate patient administration. This subrule does not apply to the following situations:

(a)    The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as defined provided in                            R 338.486(4)(i).

(b)    The system is being used in place of an emergency kit as defined provided in R 338.486(4)(c).

(c)     The system is being accessed to remove medication required to treat the emergent needs of a patient as defined provided in                                     R 338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to review the medication order.

(d) In each of the situations specified in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders and authorize any further dispensing within 48 hours.

(12)   A copy of all pharmacy policies and procedures related to the use of an automated device shall be maintained at the pharmacy responsible for the device’s specific location and be available for board of pharmacy review by an agent of the board.

(13)   A controlled substance that is maintained at a nursing unit shall be stored in a securely locked cabinet or medication cart that is accessible only to an individual who is responsible for the administration or distribution of the medication.

(14)   Records and documents required under this rule shall be maintained or controlled by the pharmacist in charge pharmacy responsible for the device for 2 5 years.

(15)   An individual who is responsible for administering a controlled substance or a portion thereof shall record the quantity, disposition and an explanation of the destruction of the controlled substance on the proper accountability record. If the institution has a policy that reflects current practice standards and delineates the method of destruction, an explanation would only be required if policy was not followed.

 

PART 6. DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS

 

R 338.3161 Prescriptions Controlled substance prescriptions.

Rule 61. (1) A prescription that is issued for a controlled substance shall be dated and signed when issued and shall contain all of the following information:

(a)    The full name and address of the patient for whom the substance is being prescribed.

(b)    The prescriber's drug enforcement administration (dea) registration number, printed name, address, and professional designation.

(c)    The drug name, strength, and dosage form.

(d)    The quantity prescribed. For a prescription received in writing, the prescription shall contain the quantity in both written and numerical terms. A written prescription is in

 

 

compliance if it contains preprinted numbers representative of the quantity next to which is a box or line the prescriber may check.

(e)    The directions for use.

(f)    In addition, if the prescription is for an animal, then the species of the animal and the full name and address of the owner.

(2)   A written prescription for a controlled substance in schedules 2 to 5 shall be written with ink or an indelible pencil, or prepared using a printer and shall be signed by the prescriber.

(3)   An agent of the prescriber may prepare a prescription for the signature of the prescriber, but, pursuant to the act, the prescriber is liable if the prescription does not conform to these rules. A pharmacist who dispenses a controlled substance pursuant to a prescription not prepared in the form required by these rules is liable pursuant to the act.

(4)   If the controlled substance prescription or order in a medical institution is issued  pursuant to delegation under R 338.2304, R 338.2305, R 338.108a, or R 338.108b then the printed name of the delegatee, the licensure designation, the delegating prescriber, and the signature of the delegatee shall be on the written prescription. In medical facilities, orders shall contain the signatures of the delegatee and the printed name of the delegating prescriber.

(5)   A prescription shall not be issued by a prescriber to obtain a stock of a controlled substance for the purpose of dispensing or administering the substance to patients.

 

R 338.3162 Dispensing by pharmacists; delivery of controlled substances.

Rule 62. (1) A controlled substance shall be dispensed by a pharmacist or a pharmacy intern in the presence, and under the immediate supervision, of a pharmacist.

(2)   A pharmacist may require identification of individuals to whom controlled substances are delivered. A pharmacist shall require positive identification of individuals to whom controlled substances are dispensed or delivered when the individual is not known to the pharmacist or pharmacy employees. The following provide for waiver of this requirement:

(a)   When positive identification is not available and a pharmacist, who in exercising his or her professional judgment, determines that the prescription is valid and a delay in dispensing the controlled substance may be detrimental to a patient.

(b)   Subdivision (a) of this subrule does not exempt a pharmacist from the requirement to submit a patient identifier, as defined in R 338.3102(1)(f).

(3) The dispensing pharmacist and pharmacy are responsible for compliance with this rule.

(3)(4) Except as provided by R 338.3162a, a pharmacist may dispense a controlled substance which is listed in schedules 3 to 5 and which is a prescription drug pursuant to the provisions of the federal food, drug, and cosmetic act of 1991, 21 U.S.C. §201.100(b)(i) et seq., only pursuant to a written, electronically transmitted, or oral order of a prescriber that contains all of the required information under R 338.3161, except that the signature of the prescriber is not required if the controlled substance is obtained pursuant to an oral order.

(4)   (5) If an oral order for a controlled substance listed in schedule 3 to 5 is transmitted by the prescriber’s agent under delegation then all of the following shall be recorded on the prescription generated at the pharmacy:

The information required by R 338.3161. The transmitting agent’s identity.

The individual who received the prescription at the pharmacy.

 

 

(5)    (6) Only an order that is issued in the usual course of professional treatment or in the course of legitimate and authorized research is a prescription.

 

R 338.3162b Electronic system for monitoring schedules 2, 3, 4, and 5 controlled substances.

Rule 62b. (1) A pharmacist, dispensing prescriber, and veterinarian licensed under Part 177 who dispenses a prescription drug which is a controlled substance listed in schedules 2 to 5 or a pharmacy licensed by the state that dispenses in this state or dispenses to an address in this state a controlled substance listed in schedules 2 to 5 shall report to the department or the department’s contractor by means of an electronic data transmittal process the following information for each prescription of a schedules 2 to 5 controlled substance prescription dispensed:

(a)    The patient identifier, as defined in R 338.3102(1)(f). The following apply:

(i)    An identification number, as specified in R 338.3102(1)(f)(iv)(A) or (B), is not required for patients under the age of 16.

(ii)    If the patient is under 16 years of age, zeroes shall be entered as the identification number.

(iii)    If the patient is an animal, positive identification of the animal’s owner that meets the requirements of R 338.3102(1)(f)(iv).

(b)    The name of the controlled substance dispensed.

(c)    The metric quantity of the controlled substance dispensed.

(d)    The national drug code number (ndc) of the controlled substance dispensed.

(d)  (e) The date of issue of the prescription.

(e)   (f)The date of dispensing.

(f)  (g)The estimated days of supply of the controlled substance dispensed.

(g)   (h) The prescription number assigned by the dispenser.

(h)   (i)The dea registration number of the prescriber and the dispensing pharmacy.

(i)   (j) The Michigan license number of the dispensing pharmacy.

(2)   A pharmacist, dispensing prescriber, or veterinarian may presume that the patient identification information provided by a patient or a patient’s representative is correct.

 

R 338.3162c Format for electronic transmission of data; waiver.

Rule 62c. (1) A pharmacist, dispensing prescriber, or veterinarian who dispenses a prescription drug which is a controlled substance listed in schedules 2 to 5 shall transmit the data, as specified under R 338.3162b, by one 1 of the following methods:

(a)     An electronic device compatible with the receiving device of the department or the department’s contractor.

A computer diskette or a compact disk.  (c ) A magnetic tape or cartridge.

(d) (c) Other medium media, as approved by the department or the department’s contractor.

(2)   The data shall be transmitted in the format established by the american society for automation in pharmacy (asap) telecommunications format for controlled substances.

(3)   A pharmacist, dispensing prescriber, or veterinarian who dispenses controlled substances and who does not have an automated record-keeping system capable of producing an electronic report in the format established by subrule (2) of this rule may request a waiver from electronic reporting. The request shall be made in writing to the department.

(4)   A pharmacist, dispensing prescriber, or veterinarian may be granted a waiver, if he or she demonstrates an inability to report as required by R 338.3162b and he or she agrees in

 

 

writing to report the data to the department or the department’s contractor by submitting a completed maps claim form as defined in R 338.3102(c) or transmitting data via an internet web portal that is provided by the Department or the Department’s contractor for this purpose.

 

R 338.3162d Required reporting of prescription data; error reporting.

Rule 62d. (1) A pharmacist, dispensing prescriber, or veterinarian shall report all schedules 2 to 5 controlled substances dispensed beginning on the date that these amendatory rules take effect.

(2)   The data required by R 338.3162b shall be forwarded by on-line transmission, computer diskette, magnetic tape or cartridge, compact disk, or other approved medium, as specified in R 338.3162c to the department or the department’s contractor at least every 30 days and no  later than the 15th calendar day of the month following the month in which the prescription is dispensed. twice monthly, by the first calendar day and the 15th calendar day of each month immediately following the month in which the prescription was dispensed, and

shall include the data for all controlled substances dispensed since the previous transmission or report. A pharmacist, dispensing prescriber, or veterinarian may choose 2 different dates to report each month, provided that they are within 2 calendar days of the first calendar day and the 15th calendar day of each month and they include all controlled substances dispensed since the previous transmission or report.