[peaceful]

I am required by our P&P to teach side effects and document teaching, also signed medication consent form which lists in god awful detail all side effects. Must also write patient's name on box of samples. I do all that you list below, EXCEPT prescribe the drug. Still not understanding the alarm over this subject.

Originally Posted by fiestynurse

It's not the drugs themselves that I am worried about. I agree drugs are drugs. But, there is liability involved when you receive drugs via a licensed pharmacy vs. via a drug rep through a physician. I want to make sure that we are abiding by the drug dispensing laws. Pharmacists and Physicians can dispense the prescribed drug. A nurse can only administer drugs. Dispensing involves the labeling of the drug bottle or box with the patients name and instructions on how to take the drug. It also involves teaching them about the side effects, etc. Samples can not be added to the stock medication that you get from the pharmacist. Samples can not go directly from the drug rep to the patient, without being properly dispensed by a Pharmacist or Physician.

[fiestynurse]

I don't know what state you practice in, but you are dispensing. You are acting as a Pharmacist in the handling of this sample drug. Nurses can not dispense. In most states this violates the Nurse Practice Act. You are preparing the medication for administration within your facility.

[fiestynurse]

"Dispense" or "dispensing" shall mean the preparation and delivery of a prescription drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug.

Only physicians, pharmacists, physician assistants, or nurse practitioners may dispense sample medications. Nursing personnel may, under the direction of the prescriber; obtain the sample medication, do the necessary paperwork, and deliver to the prescriber. The prescriber must give the samples to the patient. State regulations dictate that medication may not be "dispensed" by the nurse. Samples are intended for patient use only and are not to be diverted for use by others, including employees, unless prescribed by employee's physician as part of employee's treatment. In order for samples to be used by employees, all procedures must be followed, including "dispensing" only by personnel legally able to do so.

[fiestynurse]

Here is the policy and procedure that I developed. Let me know what you think. I researched all the laws and regulations. I looked at P&P examples from other facilities. I talked to several experts in the field of Corrections.

NAME OF POLICY: Sample Prescription Medications

PURPOSE:

1. To provide a consistent and safe method of receiving, storing, and
dispensing of medication samples.
2. To provide a system that allows for the recall of any medication in a
timely manner.
3. To ensure the supply of samples is secured and safe.
4. To ensure compliance with State and Federal regulations and laws.
5. To ensure samples are dispensed safely by authorized personnel
according to laws and regulations.

POLICY:

All handling of drug samples within the facility must follow the laws and regulations of the State. These laws and regulations mandate the maintenance of sample drugs to prevent the dispensing of outdated medications including the recording of lot numbers to allow for recall of previously dispensed medications. Sample medications are intended for patient use only. Legend drug samples, by law, may be dispensed only by prescription or written order in the patient chart and proper documentation must be maintained. The dispersal of these drugs in any other manner may be considered drug diversion and grounds for discipline.

PROCEDURES:

Receiving

1. Pharmaceutical sample logbook with log sheets will be provided to those areas where samples are used. Sample medication records will be kept for a period of seven years.
2. Samples will be delivered by the pharmaceutical representative or doctor to each designated area utilizing sample medications.
3. Each sample dose must include three self-adhesive labels indicating drug name, lot number, and expiration date. Labels must be affixed to each sample.
4. The person delivering the medication will log all samples into the logbook.
5. No controlled substances will be accepted as samples.
6. No samples are to be left unlogged and unattended anywhere in the facility.

Dispensing

1. Only physicians, pharmacists, physician assistants, or nurse practitioners may dispense sample medications. State regulations dictate that medication may not be “dispensed” by the nurse. The nurse may only “administer” the sample, after proper labeling and dispensing by the prescriber.
2. When dispensing samples, the following information must be indicated in the patient chart: drug name, strength, dosage form, dose, and frequency of administration. It is important that the prescriber document that a sample drug was given to the patient and the appropriate patient education was done regarding side effects.
3. Labels for dosage instructions shall be applied to samples.
4. When dispensing samples, indicate on the label, date dispensed, patient name, drug name, quantity dispensed, and initials of legally qualified person dispensing the sample.

Monitoring

1. Samples must be monitored monthly for expiration.
2. Outdated medications shall be subtracted from the inventory log and properly bagged and given to the Pharmacy for disposal.
3. All manufacturer recalls must be brought to the attention of the service area. The receiving logbook must be checked to see if any of the recalled drug/lot number was received into stock. If so, all recalled medication will be pulled from the sample inventory and subtracted from the log. All patients who received samples of the recalled drug must be contacted. It should be documented in the chart that the patient was notified of the recall. Recalled medications must be bagged and given to the Pharmacy for disposal or return to the manufacturer.

Storage

1. All samples will be stored in a lockable area following the storage specifications from the manufacturer. Samples must be stored under conditions that will maintain their integrity, stability, and effectiveness.
2. Access will be limited to the Physicians and designated healthcare personnel.

[nurseT]

I Work In A Small County Jail, 200 Beds. The Doctor Works 2 Other County Jails Besides Mine, He Has Been In Corrections For 25 Years And Also Ran A Large Er For 22 Of Those Years. He Says Not To Write Alot Of Policies And Procedures Because They Are A Trap. The First Time One Step In A Policy Is Not Used Is What Gets You Into Trouble. He Says Keep It Simple. The Jail Is Not A Health Care Facility And Does Not Have To Go By The Same Rules. He Says Just Do Everything The Way You Know It Should Be Done, Weather It Be A Task Or Documentation, According To The Community Standards. He Is Careful Not To Do Any Procedures In The Jail, But Sends People Out As Needed. I Do Not Even Draw Blood, But Can If Necessary. I Have Some Inmates Who Have Family Bring Samples. I Instruct Them To Take It To Our Pharmacy Near By And Our Pharmacy Puts The Samples In The Blistercards We Use And Labels It. That Way I'm Out Of It. I Do Have Some Inmates Who Are Serving A Few Days Or A Week. I Just Write Thier Name On The Boxes And We Keep Those In The Narc Drawer In The Cart. I Really Don't Worry About It. I'm Careful To Keep Everything Legal. I Don't Consider It Dispensing To Allow An Inmate To Use His Own Samples He Got From His Doctor. And They Are Never Labeled At The Doctors Office. I Do Clarify The Med, Dose And Frequency With The Inmate's Doctor And Identify The Med With A Drug Bible. Also I Make Sure The Sample Is Sealed.

[fiestynurse]

I am just so flabergasted by your post, I can't even respond. Ignorance is bliss!

[ComposMentisBlonde]

Originally Posted by fiestynurse

"Dispense" or "dispensing" shall mean the preparation and delivery of a prescription drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug.

Only physicians, pharmacists, physician assistants, or nurse practitioners may dispense sample medications. Nursing personnel may, under the direction of the prescriber; obtain the sample medication, do the necessary paperwork, and deliver to the prescriber. The prescriber must give the samples to the patient. State regulations dictate that medication may not be "dispensed" by the nurse. Samples are intended for patient use only and are not to be diverted for use by others, including employees, unless prescribed by employee's physician as part of employee's treatment. In order for samples to be used by employees, all procedures must be followed, including "dispensing" only by personnel legally able to do so.

You seem very knowledgeable....a good person to ask this question to. What if the HU holds a pharmacy license....would the nurses be dispensing in this instance?

[fiestynurse]

Pharmacy licensing is a whole other issue. Generally, there has to be a "consulting" pharmacist or a pharmacist "in charge" for a pharmacy license to be issued. It depends on the State Pharmacy laws. In this case, the Pharmacist would dispense the samples to be administered by the nurse..

What most facilities have is a medication room and they obtain medications from an outside pharmacy. The DEA license is under the doctor's name for stock narcotics. (because you can not obtain a DEA license for the facility without a Pharmacist on site) Most facilities can not afford to run a full fledge Pharmacy with a Pharmacist, only the larger facilities.

Nurses can not dispense, they can only administer the medication after proper dispensing has taken place. It is important that nurses understand the difference between dispensing a prescription medication and administering a medication. I think that is where the confusion is. In general, I think the use of sample medications in corrections puts nurses in a gray area. It is not as black and white as people have stated here. I would consult your BON.