Saturday, December 20, 2014

Patient friendly service or danger up ahead?

Doctors sometimes provide patients with drug samples to get them started on a needed medication in a timely manner. Hospital emergency departments (EDs) have also sent patients home with starter doses or unit dose packages from the hospital pharmacy. This allows the patient to start taking the medicine as soon as possible, giving them extra time to get the prescription filled at their local pharmacy. Dispensing samples and starter doses are often seen as “patient friendly” services, but the services can also have unintended consequences. One issue is that packaging and labeling of the medications can sometimes present problems for patients.

Patient friendly service or danger up ahead?

Doctors sometimes provide patients with drug samples to get them started on a needed medication in a timely manner. Hospital emergency departments (EDs) have also sent patients home with starter doses or unit dose packages from the hospital pharmacy. This allows the patient to start taking the medicine as soon as possible, giving them extra time to get the prescription filled at their local pharmacy. Dispensing samples and starter doses are often seen as “patient friendly” services, but the services can also have unintended consequences. One issue is that packaging and labeling of the medications can sometimes present problems for patients.Ambiguous label – 200 mg or 600 mg?

One patient experienced severe burning in her eyes and blurred vision when she instilled what she thought was eye drops. A co-worker took the bottle from her and saw the very small notation on the label: “For dermatological (skin) use only. Not for use in the eye.” The tiny sample bottle, which had no pharmacy label since it wasn’t dispensed by a pharmacist, was a professional sample of a cortisone-like medication meant to be applied to the skin. The product also contained 40% isopropyl alcohol (rubbing alcohol), which severely irritated her eyes. It had been given to her by her allergist for application after allergy shots. But she inadvertently combined it with the eye drops she keeps at work and grabbed the wrong bottle. The patient saw her eye doctor and the eye was flushed, but the patient suffered blurred vision for several hours.

Another issue is the ambiguous way that drug companies sometimes label these products. It’s not always patient-friendly. When the popular pain medication Celebrex was first marketed, the manufacturer, Pfizer, gave doctors samples to hand out to patients. Each package contained 3 capsules labeled “Celebrex 200 mg.” A rheumatologist gave one of these to a patient along with a prescription for 200 mg twice daily. When the patient got home and looked at the label she didn’t know whether she should take all three capsules for the 200 mg dose, or just one. She called the doctor's office and clarified that each capsule was 200 mg and she should take just one at a time.

Many patients might not have called to clarify the confusing Celebrex label or other drug sample packages just like it. In fact, we checked with Pfizer when the patient called us about this and a drug information professional admitted that they’d received reports of overdoses where 600 mg was taken. The FDA recently clarified that the product strength should always describe the milligram amount of drug per single unit (e.g., tablet, capsule) so there is no confusion as to how much product is contained in a single unit as compared to the total contents of the entire blister card.

Finally, the Consumer Product Safety Commission does not require sample medications to be in child-resistant containers. Manufacturers can also request exemptions for providing child-resistant packaging for medications used only in hospitals but these may sometimes be dispensed to patients by the ER. Thus, danger may be ahead if the medications are sent home and improperly stored, leaving them accessible to children. While many ERs dispense starter doses in properly labeled, child-resistant prescription containers, I’ve often seen starter doses dispensed by hospitals in plastic bags or envelopes. Patients arriving home after a visit to the ER may not be thinking about the need to place that plastic bag or envelope up and away, and out of the reach and sight of children. Instead, these medications may be temporarily placed on a kitchen table or counter.

There are other safety issues associated with dispensing drug samples and starter doses—for example, absent labeling of the product with directions for use, lack of screening for drug interactions, and failure to monitor expiration dates. While many organizations have appropriately addressed these and other issues, they may not have considered the need to assure that sample or starter doses are properly labeled and packaged. With the increased availability of 24-hour community pharmacies and drug company-provided pharmacy coupons for starter doses, these services may not be necessary.


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Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
About this blog

Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Dual Board Certified Anesthesiologist and Surgical Intensivist
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