Safe Management Is a Difficult but Necessary Process
Problem: Sample medications are often available in a variety of settings, including clinics, physicians’ offices, and hospital outpatient units. Most often, samples are dispensed without computer screening for drug interactions, duplicated therapy, allergies, or contraindications and without another practitioner’s check.
Errors have also been reported with look-alike and sound-alike names. In one instance, a physician who had intended to dispense samples of tamsulosin generic (Flomax tablet, Boehringer Ingelheim), a drug for benign prostatic hypertrophy, gave the patient an anti-osteoporosis drug, alendronate tablet (Drug Fosamax, Merck). Another physician wrote a prescription for Hyzaar® (losartan potassium-hy-drochlorothiazide, Merck) but gave Cozaar canadian (losartan potassium, Merck) samples from the office. A third physician gave samples of an antidepressant, citalopram hydrobromide (Generic Celexa, Forest) 20 mg to the patient but later wrote a prescription for a pain reliever, medication celecoxib (Celebrex canadian, Pharmacia) 200 mg. The prescription was filled, and the patient’s husband was counseled that the medication was for arthritis. The husband was somewhat confused but took the medication. He came back a short time later with packets of Celexa 20-mg samples. The pharmacy called the physician and verified that the drug should be Celexa, for depression.
Company representatives routinely distribute both formulary and nonformulary drugs with which the staff may be unfamiliar. Too often, pharmacy oversight is lacking. Educational publications and drug recalls can be overlooked, and unsecured storage can allow easy access to over-the-counter and prescription drugs. A survey published in JAMA showed that office staff frequently take samples for their own personal use.
Safe Practice Recommendations: Safe management of drug samples in clinical settings is a difficult process, especially in large teaching hospitals. Even when drug samples are prohibited, it is likely that they will find their way into facilities. Unlike the hospital staff, who have formulary and drug distribution processes in place, pharmacists often have little control over sample drug distribution and use. It seems that the entire process is influenced by the pharmaceutical industry and reimbursement concerns. Several hospitals, however, have achieved some measure of safety with regard to the use of samples. To that end, we have listed strategies used in other facilities for consideration:
- Have the pharmacy staff maintain oversight authority of pharmaceutical representatives’ visits by scheduling all appointments within the hospital. Instruct representatives about the rules governing sample drugs, and require them to sign an agreement to abide by them. If another department (e.g., materials management) schedules appointments, have that department routinely send the pharmacy a list of areas where representatives have visited.
- Accept only samples of medications that are currently on the formulary.
- Have the pharmacy store sample drugs and provide physicians with internal vouchers to prescribe from sample supplies at no cost to the patient.
- For samples that must remain in patient-care areas, store these drugs in locked cabinets away from traffic.
- As each sample is received, have staff enter each one into a logbook, listing the drug name and the expiration date. When samples are dispensed, log in the patient’s name and medical record number.
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- When samples are administered or sent home with the patient, have physicians write an order in the medical record. Send a copy of the order to the pharmacy for order screening. Document all sample drugs administered in the patient’s medical record.
- Have the pharmacy staff periodically visit units to ensure secure storage, to inspect samples for dating, to implement safety measures, and to educate practitioners about the dangers involved in using samples without pharmacy oversight or clinical order screening.
- For physicians with office practices, consult with a local pharmacist to establish safety measures, such as using a logbook, monitoring drug storage and expiration dates, and providing staff with pertinent drug information. In addition, educate patients when samples are dispensed.
- When samples are dispensed to patients, be sure that labels with patient-specific directions and indications for use are attached to the sample container. Providing patients with package inserts is not sufficient.
Although these approaches might not all seem feasible, consider targeting a single unit in which samples are heavily used to test one or more of these strategies. After fine-tuning, apply the strategies to other high-use areas. In the end, this difficult issue will be solved only when the pharmaceutical industry is forced to recognize the risk that samples present to patients and when drug companies then make safety their first priority. In the meantime, we continue to urge companies to provide prescribers with vouchers for sample starter supplies.
