Minimizing Medication Errors from Electronic Prescription Transmission—Digitizing Compounded Drug Preparations

Lack of standardization related to compounded drug preparations, especially in the transition of care situations, threatens patient safety by facilitating medication error. This paper outlines progress to-date from the United States Pharmacopeia (USP) Expert Panel on the Exchange of Compounded Drug Preparation Information in Health IT Systems. The work plan developed for the group is focused on proposing a set of encoding rules that would govern how compounded nonsterile drug preparations (CNSPs) are digitized and exchanged, including patient electronic health records (EHR), pharmacy systems, e-prescribing (eRx), and other Health IT (HIT) systems to ensure a seamless compounding process tailored to the needs of an individual patient. Included in this work are identifying authorized compounding monographs, surveying provider and end-user groups for information about data specificity during e-prescribing, and generating guidelines for the development of a compatible data model for clinical formulation identifiers (CF-IDs). This paper will also discuss how evolving nomenclature standards for CNSPs within HIT systems are part of a quality assurance system for comprehensive medication management (CMM) in children, thereby minimizing medication errors across the continuum of care. Finally, a network approach for the design of medication management systems for children and their families/caregivers is proposed.

Extemporaneous Compounding: Selective Pharmacists with Separate Skill

Extemporaneous compounding takes place in community and hospital pharmacies. There are usually specialist compounding pharmacies in major towns and cities, but any pharmacy may undertake compounding as long as they have appropriate facilities according to state-based legislation (e.g. allocated clean bench, specific compounding equipment). Although development is a continuous process, companies are customizing features to meet the majority of patient needs, but the very nature of the process cannot meet all patient needs. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly ‘sterile’ steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances. Article Type: Review

Evaluation of the Percutaneous Absorption of Ketamine HCl, Gabapentin, Clonidine HCl, and Baclofen, in Compounded Transdermal Pain Formulations, Using the Franz Finite Dose Model

Objective. This study evaluates the ability of four commonly used analgesics (ketamine HCl, gabapentin, clonidine HCl, and baclofen), when incorporated into two transdermal compounding bases, Lipoderm and Lipoderm ActiveMax, to penetrate human cadaver trunk skin in vitro , using the Franz finite dose model. Design. In vitro experimental study . Methods. Ketamine HCl 5% w/w, gabapentin 10% w/w, clonidine HCl 0.2% w/w, and baclofen 2% w/w were compounded into two transdermal bases, Lipoderm and Lipoderm ActiveMax. Each compounded drug formulation was tested on skin from three different donors and three replicate skin sections per donor. The Franz finite dose model was used in this study to evaluate the percutaneous absorption and distribution of drugs within each formulation. Results. Rapid penetration to peak flux was detected for gabapentin and baclofen at approximately 1 hour after application. Clonidine HCl also had a rapid penetration to peak flux occurring approximately 1 hour after application and had a secondary peak at approximately 40 hours. Ketamine HCl exhibited higher overall absorption rates than the other drugs, and peaked at 6–10 hours. Similar patterns of drug distribution within the skin were also observed using both transdermal bases. Conclusions. This study suggests that the combination of these 4 analgesic drugs can be successfully delivered transdermally, using either Lipoderm or Lipoderm ActiveMax. Compounded transdermal drug preparations may then provide physicians with an alternative to traditional oral pain management regimens that can be personalized to the specific patient with the potential for enhanced pain control.

Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split

Drug compounding is the long-standing pharmacy practice of mixing, combining, or altering ingredients to create drugs tailored to individual patient needs. Compounding is as old as the practice of pharmacy and close to the heart of the modern profession. Indeed, the mortar and pestle – an iconic emblem of compounding – have long been the prevailing symbol of pharmacy. Prior to the emergence of commercially available drug products, the practice of compounding was the practice of pharmacy – to create medicines, early pharmacists inevitably needed to extract and compound natural vegetable, animal, and mineral substances. In one impressive example of successful early compounding, God commanded Moses to “compoundeth” a holy anointing oil of myrrh, cinnamon, cassia, olive oil, and sweet calamus. Not generally one to shrink from a challenge, Moses followed God’s recipe and used his compounded oil to anoint the vessels of the Tabernacle and High Priest.