From Coverys Risk Management

Many physicians offer their patients sample drugs. For patients who might not be able to afford the medication, getting started with samples can be the difference between getting better and continuing to suffer from what ails them. And all patients, regardless of financial means, are more likely to begin and continue treatment when given an initial dose at no cost. 

But dispensing medication samples is not risk-free. 

Case in Point

Imagine yourself in the following situation: 

You’re reviewing your already-overbooked patient schedule on a Friday morning when the receptionist enters your office. She tells you that one of your favorite long-term patients has come in, asking you to see her 1-year-old granddaughter who is visiting from another state. The child has a temperature of 103°F and was awake most of the night because of her discomfort. 

You agree to see her, and your examination reveals that the child has a double ear infection. The child’s mother, who is also on hand, mentions that they have a flight to catch and asks if it would be possible to get a sample dose of antibiotics in order to begin treatment right away. You review your medical assistant’s notes and see “no known allergies,” so you prescribe a penicillin antibiotic with a free sample for the initial dose. Unfortunately, after leaving your office, the child has an allergic reaction to the medication, resulting in difficulty breathing. 

How did it happen? The child’s mother did indicate a penicillin allergy on the health history form, but because she was distracted by her crying child, she didn’t mention the allergy when asked by your medical assistant. Your review only included your assistant’s notes, not the health history form itself. And, because the mother wasn’t familiar with the antibiotic you prescribed and gave as a sample, it didn’t occur to her to mention the child’s allergy to penicillin. This oversight on your part likely would have been caught by the pharmacist if you had sent the family away with just a prescription and no sample doses.

Could this type of error occur in your office? What could have been done differently to prevent this from happening, while still endeavoring to provide excellent service to this family?

Risks of Dispensing Medication Samples

Some of the risk involved with giving medication samples stems from the fact that the pharmacist is removed from the process. This eliminates an important safety check with respect to allergies and contraindications with other conditions or medications. Pharmacists also remind patients how and when to take medications and inform them about possible side effects. 

Other risks include expired sample medications and the lack of a secure location for storage. Even in a physician practice, medication labeling, record keeping, and storage must be handled in the same manner as in a pharmacy. If medications are not routinely checked, an expired medication could be given to a patient and may cause a negative reaction or may not be effective. Also, sample medications should be stored in a secure location in plain view of office staff members. Some practices simply do not have the space to provide adequate security for medication samples.   

Safety Practices for Dispensing Medications

While the FDA has approved the practice of dispensing medications out of a physician’s office, some state laws may restrict or prohibit you from doing so. It is recommended that you check the laws and regulations in your state for any applicable restrictions. 

If you or your organization does dispense medications to patients, you should implement the following safety practices:

Dispensing
  • Ensure that patients receive the correct medication, including the correct dose and instructions regarding when and how often to take the medication.Ask patients (or their parents) to identify or confirm any medication allergies.
  • Provide patients with education regarding the medication, including any expected and unexpected effects, and confirm that the patient understands.
  • Consider potential drug-drug interactions.
  • Confirm that samples have not expired.
  • Check the patient’s pregnancy status, as appropriate.

Labeling

When dispensing medications from the office practice, samples must be properly labeled. The Institute for Safe Medication Practices (ISMP) recommends that drug samples be labeled as follows to be safely distributed:
  • Name of patient
  • Reason for prescribing the medication (i.e., condition being treated)
  • Amount of medication the patient should take
  • Frequency with which the medication is to be taken
  • Precautions the patient should take
  • Any significant side effects

Storage

It is also important to have safety measures in place for monitoring the receipt, storage, and distribution of sample medications, such as:
  • Require pharmaceutical representatives to sign in and out at each visit.
  • Maintain a log of all medication samples, including the name of the medication, lot number, quantity, and expiration dates. All distributed samples should be signed out in the log.
  • Document in the medical record any sample medications provided to patients, including the medication name, lot number, expiration date, dosage, quantity, and any instructions given to the patient. 
  • Store medication samples in a room or secured cabinet that is locked at all times.
And, to further reduce the risk of patient injury:
  • Do not store non-medications, such as Hemoccult® Developer, in the sample medication room.
  • Do not store topical or suppository formulations on the same shelf as oral medications.
  • Do not store medications with look-alike or sound-alike names or similar packaging near each other.
  • Do not store medications alphabetically.
  • Designate a staff member to routinely check the expiration dates on medication samples and dispose of expired medications.

So, while there are pros and cons of dispensing medication samples in your practice, the risks can be easily overcome and the benefits are many. Sample medications can help your patients save time and money, and they are more likely to follow the course of treatment you prescribe if they start with a sample. By taking the precautions outlined above, you can help ensure that the use of sample medications is a safe way for patients to get the medications they need.


COPYRIGHTED
No legal or medical advice intended. This post includes general risk management guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.