fda track and tracePharmacies now have until November 1 to comply with certain parts of the Drug Supply Chain Security Act (DSCSA) that were previously scheduled to go into effect on July 1.

The FDA recognizes that some pharmacies require more time to implement the electronic systems designed to capture and maintain product tracking information. The agency has no intention of taking action against pharmacies whose electronic systems are not ready to process the federally required tracking data. The FDA will also not take action against pharmacies that are accepting ownership of prescription drugs that do not have the required tracking information.

The FDA does, however, require pharmacies to adhere to the July 1 deadline to provide tracking information, down to the lot level, on prescription drugs and biologics being sent to other supply chain partners.

According to corporate director of pharmacy operations for Columbia, Maryland-headquartered MedStar Health, Raymond Lake, the reprieve will help the regional health system because it has spent a lot of time since late 2014 crafting the necessary policies and procedures for compliance with DSCSA requirements.

Lake says they were missing an important piece of the tracking system – a vendor.  The contract for the vendor has yet to be finalized, but once everything has been finalized, it’s going to be another one to two months before the system could go live.

McKesson, MedStar’s primary wholesaler, already maintains the electronic portal for product tracing information required under the DSCSA. But MedSTAR also purchases medications from 100 other vendors, not all of which are using electronic documentation. There is no standardization of the tracing documents, so there is variety in what is being provided. Lake says the July deadline had him worried about needing to store paper tracking documents from the direct vendors.

The electronic system that will be implemented soon will organize all of the tracking information in one place.

Under the DSCSA, dispensers must collect product transaction data and store it for six years.  Any data requested about product recalls or FDA investigations of illegitimate drugs must be able to be retrieved within two business days.

The FDA made adjustments to the deadline because they do not want to cause interruptions within the supply chain and if interruptions or cause, they want to minimize them. Starting in November, the failure to obtain the necessary tracking and tracing documentation may lead to the inability to get a certain product. This could affect patient care.

The FDA guidance document provided a great deal of information about the delay in compliance deadline, but it did not address issues about exemptions to documentation requirements for the transfer of medication between hospitals, ambulance services, rural clinics, and first responders. Clarity from the FDA on these situations will help pharmacists and pharmacies tremendously.


fda-approvalsIn mid-June, the FDA took another step forward for pharmacies, outsourcing facilities, regulators, and prescribers, by working to identify which prescription drugs can legally be compounded for use with humans.

This marks the second meeting at the FDA pharmacy compounding advisory committee since the enactment of the Drug Quality and Security Act, which included the Compounding Quality Act.

Three New Drugs Added to the Bulk Drug List

The committee did not agree with and FDA staff assessment of a particular substances appropriateness for inclusion on the bulk drug substances list. Most committee members said that Tranilast should be a permissible substance in topical drugs compounded by doctors and pharmacists. Nine of 13 voting committee members were convinced of the medical need for medication.

The substance is recognized by the Japanese Pharmacopoeia and available commercially in Japan as both an oral capsule and an ophthalmic solution. The FDA database says the drug has two orphan designations.

FDA personnel raised many points which were countered with evidence on the use of compounded topical drug products used to treat keloids and hypertrophic scars. In the presentation, there was emphasis on the lack of reported serious adverse events with topical applications.

All who voted in favor of including the medication on the list of approval applied it to topical formulations only, rather than oral formulation.

The other drugs added to the list were brilliant blue G and N-acetyl-D-glucosamine.

Four More Drugs Added to the Do Not Compound List

None of the committee’s voting members objected to the FDA’s idea to forbid compounding of the following drugs:

  • Acetaminophen in doses higher than 325 mg
  • Bromocriptine mesylate for the prevention of physiological lactation
  • Ondansetron hydrochloride for IV use with more than 16 mg per dose
  • Aprotinin

The do-not-compound list already has 59 entries. Pharmacists, pharmacies and outsourcing facilities are not allowed to compound these drugs that they want to be exempt from certain federal requirements.

Each one of the new additions to the do not compound list were supported by studies that found high risks, including frequency of death, associated with one or more of the drugs.

Investigational New Drug Application is Now an Option

There is no absolute prohibition against compounding a drug product from a substance that is not named on the bulk drug list, or a drug that is named in the do not compound list. A doctor or pharmacist may submit an application to use a substance or drug in compounding a product for a patient. The application, if approved by the FDA, would permit the use of the substance as an investigational drug under the expanded access, or compassionate use, pathway.


August is Cataract Awareness Month

by pharmacy on August 12, 2015

cataract_pharmacist_treatmentAccording to the American Academy of Ophthalmology, cataracts are the leading cause of vision loss in adults age 65 and older. Cataracts are essentially a cloudy film of protein on the lens of the eye.  They prevent the light from coming in and you from seeing out. This month is National Cataract Awareness Month.

Cataracts start small and develop slowly over time. This is why so many sufferers are over the age of 60, but they can develop at any age.

Symptoms include:

  • Blurred vision
  • Double vision
  • Colors that appear faded
  • Halos around headlights at night

What are the Risk Factors for Cataracts?

In 2009, several gene mutations associated with age-related cataracts were located. Family history however, is just one of the risk factors. If you suffer from diabetes, are a smoker, or have had extensive exposure to sunlight, take steroids, or have sustained serious injury to the eye, you are at an increased risk. One of the best ways you can reduce your risk of cataract is by wearing sunglasses to protect your eyes from UV rays.

Cataract Treatment Options

Cataracts are treated with a simple outpatient surgery that breaks up the proteins in the cataract to restore clear vision. To prevent cataracts, beyond wearing sunglasses anytime you’re in the sun, eat a healthy diet rich in vitamin E, vitamin C, lutein, and zeaxanthin to keep them from developing in the first place.

What Can Pharmacists Do?

As a pharmacist, there are plenty of things you can do to help your patients learn more about cataracts, and healthy eye care. Encourage patients to see an eye doctor on a regular basis. Patients who wear glasses should be advised to see their eye doctor once a year, whereas patients who do not wear glasses or contacts can safely get by with an eye exam every two years. Educate older patients on the importance of routine eye care and if cataracts appear in their family history, ask about their most recent eye exam.

Partner with other medical professionals and eye doctors in your community to host an event to educate the public. Offer free basic screenings, and discounted full exams to help diagnose cataracts and those who may not otherwise be able to afford an exam.

Use the power of social media to educate patients who may not physically appear in your pharmacy over the course of the month. Share information about health, wearing sunglasses even if you wear contacts, and more to ensure everyone knows how to protect themselves and prevent cataracts.

Don’t forget to notify senior citizens about the public service program EyeCare America. The Seniors EyeCare program provides access to high exams and one year of eye care at no out-of-pocket expense for qualifying seniors.


antibiotic-resistance-pharmacistPaul W. Abramowitz, PharmD, ScD, CEO of American Society of Health System Pharmacists (ASHP) visited the White House along with national leaders from more than 150 major food companies, retailers, and human and animal health stakeholders. He took part in the White House Forum on Antibiotic Stewardship, announcing commitment to make changes over the course of the next five years to slow down the emergence of antibiotic resistant bacteria, find resistant strains, prevent the spread of resistant infections, and continue to preserve the efficacy of antibiotics currently available today. [click to continue…]


hypertension-drug-dosageAccording to a recently published report, delaying treatment intensification and follow-up care in patients with high blood pressure can prove fatal.

Researchers at Brigham and Women’s Hospital and of the Beth Israel Deaconess Medical Center in Boston reported in BMJ in February that three factors increase the risk of acute cardiovascular events or death in patients with hypertension. These three factors are: patients whose systolic blood pressure or SPB is greater than 150 mm Hg, delay of treatment intensification by more than 1.4 months, and delay in subsequent follow-up by more than 2.7 months. [click to continue…]


A study recently published in The BMJ has deteracetaminophen-clinical-studymined that acetaminophen does not do much to provide relief from osteoarthritis pain and low back pain. Some clinical guidelines have recommended using acetaminophen as a first-line therapy. [click to continue…]


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