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Pharmacy news

Safety Culture Includes “Good Catches”

by pharmacy on October 7, 2015

pill safety pharmacist hospitalHospitals working to recognize interceptions of medication errors or other safety related issues before they make it to the patient show that doing the right thing can be personally rewarding while supporting the hospital’s effort to continuously improve patient care. [click to continue…]


Got drugs? National Prescription Drug Take-Back Day

by pharmacy on September 23, 2015

National Prescription Drug Take-Back Day takes place this Saturday, September 26,2015. national prescription drug take back day collection sitesDo you have unused or expired medications in your household? Do your part in preventing medication abuse by disposing of your unused and expired medications in a designated collection site near you[click to continue…]


national childhood obesity awareness monthThe American College of Sports Medicine sponsors September as National Childhood Obesity Awareness Month. In America, one out of every three children qualifies as either overweight or obese, putting them at an increased risk for health issues that were once limited to adults: high blood pressure, type 2 diabetes, and even heart disease. [click to continue…]


Naloxone Access Expands and Price Increases

by pharmacy on September 2, 2015

naloxone factsNaloxone, a drug used to reverse the effects of opioids and other narcotic medicines, is becoming more accessible. The medication, especially in the hands of first responders, seems to be doing a good job at providing treatment before an opioid overdose occurs. But, the success of the drug is certainly coming with a price – and one that doesn’t seem like it will be coming down anytime soon. [click to continue…]


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.


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