Section 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.

(e)    Subrule 3 of this rule does not apply to automated dispensing devices.

(4)    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,  county medical care facility, nursing home, hospice, or other skilled nursing facility as defined in 1978 PA 368, MCL 333.20109, when the pharmacy is not located at the same address as the facility and controlled substances are dispensed from the automated device. 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 April 11, 2003.

(viii)     Additional information as the pharmacist 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 provided in R 338.486(4)(i).

(b)     The system is being used in place of an emergency kit as 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 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 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 pharmacy responsible for the device for 2 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.

History: 1979 AC; 1980 AACS; 1992 AACS; 2002 AACS; 2007 AACS.