ABC Pharmacy

Policy and Procedures

ABC Pharmacy will utilize unlicensed pharmacy personnel in full compliance with statutes and regulations governing the practice of pharmacy, including the specific references to unlicensed pharmacy personnel (COMAR 10.34.21) and the portions of Title 4 that deals with the confidentiality of medical records, and any other federal, state or local laws related to confidentiality of medical records that may apply.

      The Permit holder shall determine the tasks that unlicensed persons may perform, in accordance with these policies and procedures, taking into consideration the advise of pharmacists employed by the pharmacy.  Unlicensed persons must be deemed competent by the permit holder in each task that they are authorized to perform or they are not permitted to perform that (those) task(s).

  1. Each person regularly assigned to aid the pharmacist in any dispensing function will be allowed to perform only those duties for which they have been approved by the permit holder and with which the pharmacist on duty is comfortable delegating.
  2. Unlicensed personnel who have been deemed competent in these areas may perform any of the following functions as delegated by the pharmacist on duty:
    1. Entering information about the patient and the prescription into the computer.
    2. Entering appropriate insurance information into the computer and transmitting information to the insurer for payment or instructions.
    3. Obtaining the prescription medication from stock
    4. Counting, measuring and packaging the products, provided the original package is left with the final product for the pharmacist to be able to verify.
    5. Affixing the label to the container.
    6. Placing appropriate auxiliary labels on the container.
    7. Preparing the prescription bag and any required receipts and patient information.
    8. Calling prescribers for refill authorizations that do not involve CDS prescriptions and accepting the information only when the prescriber or prescriber’s agent does not make any changes to the prescription.  If either of these two factors enter into the authorization call, the pharmacist will be told to complete the call.
    9. Giving the medication to the patient or delivery person after a final check by the pharmacist.
    10. Asking the patient if counseling by the pharmacist is desired.
    11. Other legal functions as they become necessary.
  3. Unlicensed personnel will NOT perform any of the following functions.  The pharmacist will be asked to perform any of the following tasks that present themselves:
    1.  Ensuring the appropriateness of the prescription or prescriber’s order.
    2.  Ensuring the accuracy of the compounding and preparation of the prescription or order.
    3. Receiving oral prescriptions from prescribers.
    4. Receiving refill information when CDS prescriptions are involved or changes in the order are offered.
    5. Handling the transferring of prescription between pharmacies.
    6. Monitoring drug therapy.
    7. Providing information to the public or a health care professional concerning prescription or non-prescription drugs or devices.
    8. Providing any other function of pharmaceutical care.
  4. All unlicensed personnel shall have either passed the Pharmacy Technician Certification Board Examination or an equivalent acceptable to the Board of Pharmacy, or be certified by the permit holder and at least one pharmacist who will be supervising this person.  Unlicensed personnel may be certified in one or more of the above functions and may not perform functions for which they are not certified.  A list of functions that each qualified person may perform shall be maintained at the pharmacy along with the job description for the position.  
  5. The unlicensed person shall be made aware of pertinent laws and regulations that apply to his or her activities, including the need for the confidentiality of patient specific information.  All persons working in the pharmacy area, whether or not certified to perform certain functions, who have access to patient information shall undergo training regarding patient confidentiality which will minimally include:
    1. The circumstances under which patient specific information may be provided, and to whom.
    2. The proper storage and disposal of papers, labels, containers, prescriptions, electronic media and other objects that display or contain information related to specific patients.
    3. The need and methodology for maintaining confidentiality when speaking on the phone, communicating with a patient or exchanging information with another member of the pharmacy staff.
  6. The unlicensed person shall be alerted to practices that may increase the potential for medication errors and shall receive education in techniques designed to minimize errors.  The unlicensed person shall be counseled to promptly report all errors and potential errors to the pharmacist.
  7. At least once every 3  months, a supervising pharmacist or the pharmacist permit holder shall review the activities and actions of each unlicensed person and take appropriate action if the person is not deemed  competent in 1 or more functions.
  8. A person in training to perform function(s) must do so under the direct supervision of a pharmacist until he or she is certified by the permit holder and pharmacist to perform the function(s) for which they are being trained.
  9.  All unlicensed personnel will be identified by badges that say ‘pharmacy technician’ or words with similar meaning.  Pharmacists may wear uniforms or badges that identify themselves as ‘pharmacists’, ‘PharmD’, or other appropriate designation.
  10.  A person who has NOT been certified may perform the following functions in the pharmacy area, if the pharmacist on duty approves and if the individual has undergone training regarding confidentiality as described above.

a.  Ordering pharmaceutical products

b.  Putting inventory on the shelves from incoming orders

c.  Cleaning and any other non-pharmacy related tasks

d.      Counting solid dosage forms or pouring a single liquid dosage form into a  container, --in full view of the pharmacist, who has chosen the medication to be used.

11.The unlicensed person shall be trained to work in an orderly manner, maintain the cleanliness of the work area, and adopt techniques to minimize the potential for medication errors. The pharmacist shall closely monitor the work habits and work environment of the unlicensed person.

Documentation of training required

1.  Unlicensed personnel who are certified in the pharmacy based on training from an external source, shall have noted in the documentation:

Their name, date of certification, and the person or group which certified the technician for that/those function(s). and the type of training received. 

2. Unlicensed personnel who are certified based on training in the pharmacy shall have noted in the documentation:

a     The task(s) for which they were certified, using the letters from that section of this document

b.      date certified.

c.       The person who certified

                       d.   The pharmacist who did most of the direct supervision during training, if not c above.

e.   A brief description of the training as appropriate.

      f    The length of the training period.

    1.     Any additional or outside education that was required or considered in the evaluation.

b.                  Any other pertinent information.

Documentation that unlicensed personnel have achieved appropriate levels of competency and have maintained that level

The Pharmacy will maintain a listing of the following information as an addendum to this document:

1.The names of all unlicensed persons who regularly work in the pharmacy area.

  1. The tasks which they are allowed to perform:
    1. The tasks.  This will be noted by the use of the letters A-J from the list of those allowed to be performed, with explanations listed for any K items.
    2. The name of any pharmacist who aided the permit holder in approving the unlicensed person to perform specific tasks. 
    3. The formal education which allowed this task to be performed, if any.
    4. Documentation that a pharmacist has observed and determined that the person is competent to perform the tasks listed and therefore is certified and/or
    5. Documentation that one or more pharmacists have certified that the person has demonstrated during a training period that he or she is competent to perform that task.
    6. Each of the entries shall be dated.

3.     Notation of each quarterly review of competency including the name of the pharmacist who did the review, determination of continued competency, date and signed approval.

Quality Assurance Program-.

1.                              A pharmacist will review each process in which the unlicensed personnel is allowed to participate, on a random basis, at least once a quarter by closing observing each process as it takes place, and shell document the results and impressions.

2.                              All errors made at any time by unlicensed persons shall be recorded and reviewed monthly to determine if the person is still considered competent and/or if there is a ‘system’ problem which should be rectified, such as drugs with similar names too close on the shelf, changes are required in the work flow, etc.

3.                              The pharmacist may offer ‘test’ prescriptions to review the work of the unlicensed person.

4.                              The pharmacist will review problems with the unlicensed person.

   

Job Description 

Each unlicensed person who is utilized in tasks which are covered in the policy and procedures will have a written job description which will include what tasks they are allowed to perform in the prescription process.  This can include other tasks required in the establishment and can be used for the required documentation from Policy & Procedures.

Use the following as guide and fill in

Addendum I –job descriptions/tasks which unlicensed persons may perform in prescription process”

---List each name, tasks authorized from Permit Holder & Pharmacist a-j, by letter (i.e. Jane Doe may perform all tasks a-j), and list descriptions for k (or add it to P&P)

(one suggestion is to say that compounding of  progesterone capsules and suppositories may be done only under close supervision of pharmacist)  

If you want, add other tasks to give her/them full job descriptions (cashier, book work, whatever)

Addendum II – documentation that competency has been achieved and appropriate training was done.

(Since your unlicensed people have not have pharmacy tech training, you have to show in-store documentation.)

i.e.  Jane Doe,  allowed to perform a-j and ____ ,  has been supervised and observed by licensed pharmacist in each task and is competent.   The training period  was from  ? to ?  (pick some date from about when she started and make it at least 30 days) 

The need for confidentiality of prescriptions as medical records has been discussed, including the requirements to not give information to anyone except the patient, with the patient’s permission.   Date the entry.

Addendum III –documentation that competency has been maintained.

i.e.   4th Quarter, 2001  Jane Doe has been observed  by licensed pharmacist in the tasks she performs in the pharmacy area and is determined to be competent. The need for confidentiality of prescriptions as medical records has been reinforced.

 

Addendum IV – QA Program

1.      A pharmacist will review at least once a quarter, and more often as needed, each task the unlicensed person is performing, looking at technique, efficiencies, and actual or potential errors.

2.      All errors made in which the unlicensed person is involved will be recorded, with information about the error, notations as to whether it was caught before or after dispensing, and information about patient reaction to the error.

3.      At least once a month these errors will be reviewed to  determine if the unlicensed person is competent and/or if there are systems errors which must be corrected, such as work flow, work load, placement of stock, etc.

4.      This information shall be kept confidential and destroyed after six months, so that the last two cycle reviews are available to compare with current reviews.

5.      If felt necessary, the pharmacist will offer test prescriptions or situations to the unlicensed person to help determine competency.