Policies:

UMHHC Policy 05-03-024

Drug Samples in UMHHC

(Formerly entitled, "Drug Samples and Pharmaceutical Representatives in Ambulatory Care Sites")
Date Issued: 11/1989; Last Reviewed: 3/2004; Last Revised: 3/2004

I. POLICY STATEMENT

Drug samples, while convenient for patients, entail regulatory concerns, safety risks for patients, and encourage prescribing of high cost, non-preferred medications. Therefore, with limited exceptions, sample medications are not permitted in UMHHC facilities. Vouchers for starter medications approved by the Ambulatory Formulary Committee may be dispensed to patients as an alternative. Non-approved vouchers are not permitted in UMHHC facilities.

Drug samples shall not be made available for use by inpatients.

The policy regarding the distribution of drug samples shall be controlled by the Executive Committee on Clinical Affairs. Visitation of Ambulatory Care Site personnel and control of drug samples/vouchers shall be monitored jointly by the site personnel and the Department of Pharmacy Services.

II. POLICY PURPOSE

This policy and these procedures have been developed to provide:

A. Guidelines restricting the use of samples in ambulatory clinic sites.
B. A mechanism for enforcement of these guidelines

III. DEFINITIONS

Drug Samples: Prescription and non-prescription medications which are provided to the sites by pharmaceutical representatives for complimentary distribution to patients, as starter doses.

UMHCC Sites: Applicable to all UM Hospitals and Health Centers where care is provided to patients.

Pharmaceutical Sales Representatives (PSR): A representative of a pharmaceutical manufacturer who visits the ambulatory care sites for the purpose of soliciting the use of, or providing information about, pharmaceutical products. Representatives who visit UMHHC facilities for the sole purpose of initiating or monitoring research studies are exempt from these guidelines.

IV. POLICY STANDARDS

A. Sample medications are not permitted in UMHHC facilities except as noted below. This includes both patient care and non-patient care areas.

B. Vouchers approved by the University of Michigan Health System's Ambulatory Formulary Committee may be distributed by UMHHC ambulatory care sites in order for patients to receive complimentary starter medications from a pharmacy of their choice. The Ambulatory Formulary Committee will determine a formulary of UMHS-preferred medications, which then may be available through vouchers. Only vouchers approved by the Ambulatory Formulary Committee are permitted to be used by UM clinicians at UMHHC.

C. Non-approved vouchers may not be distributed by PSRs to UMHHC ambulatory care sites, nor dispensed by UMHHC personnel at UMHHC sites.

D. Under special circumstances in which there is a legitimate clinical need, with the approval noted below, sample medications may be permitted in UMHHC. Specific requests to have physical samples in a UMHHC clinic must be made on the Special Cause Sample Request Form (Exhibit A), and be approved by the Ambulatory Formulary Committee and the Site Medical Director.

V. PROCEDURE ACTIONS

A. Participating pharmaceutical companies may distribute UMHS Ambulatory Formulary Committee-approved vouchers to UMHHC clinics through their sales representatives. These vouchers are for generic medications or brand drugs that are designated as "preferred" by the Ambulatory Formulary Committee.

B. PSRs may not distribute non-approved vouchers or coupons within UMHHC sites, or to UMHS clinicians.

C. If a clinic medical director believes there is a clinical need to maintain some physical samples, a request will be made to the Ambulatory Formulary Committee and Site Medical Director using the Special Cause Sample Request Form. If the request is approved, the succeeding steps must be followed:

1. A formulary of approved sample products must be approved for the clinic. Samples of only those products are permitted at the site.

2. The approved products must be reviewed annually by the medical director.

3. Samples must be stored in a locked secure area. PSRs are not authorized to have access to drug sample storage areas.

4. When samples are received from the manufacturer, they must be recorded on the Sample Drug Log-in Form (Exhibit B).

5. The sample drugs must be inspected by the clinic medical director or designee monthly, and a copy of this review sent to the Department of Pharmacy Services (Exhibit C).

6. In the event of a drug recall, the Department of Pharmacy Services will notify the clinic. The clinic medical director or designee must review sample inventory and return recalled drugs to the pharmacy.

7. When dispensing a sample medication to a patient, the physician must select the drug, dose and quantity of medication to be dispensed. This must be recorded in the patient's medical record. The physician must review the dose-pack and patient label with written instructions prior to the medication being dispensed to the patient. Distribution of sample medications for purposes other than starter doses is prohibited by the Michigan Public Health Code.

8. The physician may delegate to a medical assistant or nurse the following steps:

a. complete the Sample Drug Sign-Out Log (Exhibit D)
b. Complete the Sample Medication Label (Exhibit E)
c. Document the patient waiver of a child-proof container
d. Obtain final approval from the physician before dispensing
e. Provide patient education regarding the medication

D. The Department of Pharmacy Services will inspect the sample medication storage, log, and dispensing process at least annually. If adherence to this policy is not being met, the privilege of maintaining samples will be revoked.

E. If PSRs distribute non-approved samples or vouchers to a UMHHC site, the UMHHC reserves the right to take disciplinary action against the representative and/or company including prohibition from visiting UMHHC facilities.

VI. EXHIBITS

    Printable Version
Exhibit A Special Cause Sample Request Form (MS Word Doc)
Exhibit B Sample Drug Log-In Form (MS Word Doc)
Exhibit C Monthly Clinic Medication Inspection Form (MS Word Doc)
Exhibit D Sample Drug Sign-out Log (MS Word Doc)
Exhibit E Sample Medication Label (MS Word Doc)

Authors: John E. Billi, M.D.
Arthur Poremba, MS
James Stevenson, PharmD
Jeoffrey Stross, M.D.

Approved: Ambulatory Formulary Committee, June 26, 2002; November 26,2003
Pharmacy & Therapeutics Committee, July 16, 2002
Executive Committee on Clinical Affairs, July 23, 2002
Director and Chief Executive Officer, UMHHC, September 20, 2002; March 31, 2004

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Policy 05-03-024 - Exhibit A

Special Cause Sample Request Form

Definition: Special Cause is defined as a patient population or situation with the likelihood of a poor outcome without the sample medication (e.g., eye drops following ophthalmologic surgery or procedures).

Process: The following information must be completed prior to evaluation. The submitted form must be approved by the Department Chair and the Ambulatory Formulary Committee.

1. Description of the Population or High Risk Situation

2. Justification for the Need for Sample Medications

3. Name of Drug or Drugs Needed

4. Description of Process to Ensure Compliance with Michigan Public Health Code and JCAHO

5. Name of Person Responsible for Assuring Documentation and Compliance with Policy

Approved:

________________________________ _____ ______________________________ _____
Requestor Date Requestor Date


_________________________________
Chair Date
Ambulatory Formulary Committee

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Policy 05-03-024 - Exhibit B

University of Michigan Hospitals & Health Centers
Ambulatory Care Services

DRUG SAMPLE LOG-IN FORM
(Use Separate Sheet for each Drug/Strength)

DRUG/STRENGTH ________________________________________

MANUFACTURER ________________________________________

DATE QUANTITY LOT NUMBER EXP DATE CLINIC NAME
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         


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Policy 05-03-024 - Exhibit C


Medication Area Review
University of Michigan Hospitals and Health Centers


SITE:_____________________________________
MONTH/YEAR:____________________________

 
GENERAL CRITERIA FOR ALL AREAS
   Yes No N/A
1
 Are all medications locked in OMNICELL, a cabinet, drawer and/or refrigerator/freezer? 1 a a  aa 
2
 Can patients access medications in exam rooms, storage areas, etc? 2 a  a  a 
3
 Are all medication storage areas including OMNICELL clean, well organized, and clearly labeled? 3 a  a  a 
4
 Are outdated, contaminated, discontinued, recalled or otherwise unusable medications removed from stock and returned to Pharmacy for proper disposal? 4 a  a  a 
5
 Are substances labeled "For External Use" or "Poison" stored separately from internal medications? 5 a  a  a 
6
 For Insulin not stored in the refrigerator, are vials dated and discarded after 30 days? 6 a  a  a 
7
 FOR JULY 1st ONLY: Have all opened multidose vials been discarded (including refrigerated insulin)? 7 a  a  a 
8
 Are all reconstituted medications properly labeled with the date of reconstitution, initials of the individual who reconstitute the medication, concentration, and expiration date?
 8 a  a  a 
9
 Are irrigation solutions dated when opened, and discarded within 24 hours? 9 a  a  a 
10
 Medication Refrigerator/Freezer: 10 a  a  a 
a 

a. Is the medication refrigerator/freezer used only for medication?

 a a  a  a 
a 

b. Is the refrigerator/freezer kept clean & defrosted regularly?

 b a  a  a 
a 

c. Is the refrigerator kept at the required temperature (36-46F/2-8C) and was appropriate action taken for temperatures out of range?
Recorded Temperature___________

 c a  a  a 
a 

d. Is the refrigerator and/or freezer temperature log updated daily?

 d a  a  a 
a 

e. If the freezer is used for medication storage, is the temperature within the appropriate range (-13F to 14F or -25C to -10C) and was appropriate action taken for temperatures out of range? Recorded Temperature___________

 e a  a  a 
a 

f. Is there a frozen cup of water in the freezer with a coin on top for identification of interim elevations of temperature above freezing?

 f a  a  a 
11

Check items not available:

( ) On-line Pharmacy references: CareWeb (Micromedex)
( ) Poison Control Phone Number
( ) UMH Drug Formulary (www.pharm.med.umich.edu)
( ) Metric Apothecary Conversion Chart

 11 a  a  a 
12
 Are all prescription pads kept in a secure location at all times? 12 a  a  a 
13
 Are all syringes, needles and sharps kept in a secure location at all times? 13 a  a  a 
14
 Is the emergency bag or cart checked daily for expired medications? If medications expire within 30 days of today's date, exchange the box for a new box from Pharmacy.
 14 a  a  a 
CRITERIA SPECIFIC FOR INPATIENT MEDICATION AREAS:
15
 If controlled substances are stored in OMNICELL, is the OMNICELL unit locked? 15 a  a  a 
16
 Have all OMNICELL controlled substance discrepancies that were not resolved by nursing been reported to Pharmacy? 16 a  a  a 
17
 Are patient medications not taken home by the patient promptly returned to Pharmacy for appropriate handling? 17 a  a  a 
CRITERIA SPECIFIC FOR AMBULATORY CARE SERVICE MEDICATION AREAS:
18
 Is the controlled substance cabinet locked and the key secure? 18 a  a  a 
19
 Has controlled substance count been verified daily and Verification Log signed by two (2) staff members? 19 a  a  a 
20
 If there was a discrepancy in the controlled substance count, was it reported to Pharmacy? 20 a  a  a 
21
 Drug Samples: 21 a  a  a 
a 

a. Are drug samples provided to patients according to the drug sample policy?

 a a  a  a 
a 

b. Are the sample medications stored separately from clinic stock medications?

 b a  a  a 
a 

c. Are drug samples logged in appropriately by staff or pharmaceutical representative?

 c a  a  a 
a 

d. Is dispensing information recorded in patient record?

 d a  a  a 
a 

e. Are the patient name, medication name and lot number recorded in dispensing log?

 e a  a  a 
a 

f. Are sample medications dispensed to patients labeled with the following Information: name of clinic and phone number; patient name, drug name, strength, amount dispensed, directions for use, physician name, date?

f a  a  a 
a 

g. Are outdated samples disposed of properly?

 g a  a  a 

Corrective Action Plan:
I have reviewed area and retained a copy of this report. Name________________________________________Date:______________

Send to: Pharmacy Quality Improvement Coordinator, UH B2D301, Box 0008 or Fax (734)936-7027

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Policy 05-03-024 - Exhibit D


University of Michigan Hospitals & Health Centers
Ambulatory Care Services

DRUG SAMPLE SIGN-OUT FORM
(Use Separate Sheet for each Drug/Strength)

DRUG/STRENGTH _________________________________________

DATE
PATIENT'S NAME
LOT NUMBER
AMOUNT GIVEN
CPC
DECLINED*
(YES OR NO)
STAFF
INITIALS
           
           
           
           
           
           
           
           
           
           
           
           
           
           

*Child Proof Container - if CPC is required, sample drug will not be given to patient

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Policy 05-03-024 - Exhibit E

University of Michigan Hospitals & Health Centers


SAMPLE MEDICATION LABEL

 

Sample Medication Label

Original policies are held by Carolyn Ladd, Policy Coordinator, Office of the Director and CEO, UMHHC, telephone 647-2510

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