Growing a Compounding Practice: Successful Marketing to Underserved Populations.

In this article, we provide an example of an effective novel therapy plan (the Stanley Protocol) that compounders can offer or use as a template for other services to grow their pharmacy practice, expand their role in patient care, and provide essential assistance for prescribers. We also share our successful consultative strategy for marketing that plan, which consists of several elements: identifying a treatment vacancy in underserved populations, changing the paradigm of compounding services, developing strategies that reach target populations, and dedicating the time and effort necessary to implement those strategies. Since we introduced the Stanley Protocol to prescribers and patients in 2020, our compounding practice has grown substantially in a number of aspects, which we describe in detail in this article.

The Stanley Prostate-cancer Treatment Protocol for Erectile Dysfunction After Prostatectomy and/or Radiotherapy: A Case Report.

Even when a diagnosis of prostate cancer is anticipated, many patients are unprepared for the persistence and severity of sequelae such as erectile dysfunction, which frequently results from lifesaving treatment for that disease. Erectile dysfunction in particular can exert a powerful impact on quality of life as the patient's self-esteem diminishes, intimacy erodes, and a sustained level of stress and anxiety that impairs work performance and personal relationships becomes a part of his everyday experience. The Stanley Prostate-cancer Protocol for treating erectile dysfunction after prostatectomy and/or radiotherapy was developed to better assist the underserved patient population faced with that challenge.

Reversing Erectile Dysfunction and Urinary Incontinence After Prostatectomy or Radiotherapy: The Stanley Prostate-Cancer Treatment Protocol.

Although prostatectomy and radiotherapy yield excellent- long term survival rates for men with prostate cancer, adverse effects (erectile dysfunction and/or urinary incontinence with subsequent undesired lifestyle modifications, anxiety about the loss of intimacy, negative self-perception, and the effects of such stressors on work performance and family relationships) frequently afflict patients who have undergone these procedures. Surgeons who specialize in the treatment of prostate cancer are dedicated to ensuring the optimal clinical result but often do not provide information about the likelihood of experiencing those sequelae or the additional support and aftercare necessary to ensure posttreatment sexual and urologic function to their patients' satisfaction. In response to the needs of these underserved patients, the authors designed the Stanley Prostate-cancer Treatment Protocol for erectile dysfunction and urinary incontinence.

U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies.

The reasons for which pharmaceutical compounding is the focus of intense state and federal scrutiny are now well known. Compounders are faced with an ever-increasing need to prove, by objective standards, the safety, purity, and potency of the formulations they dispense. They must also demonstrate their compliance with regulations often based on current good compounding practices designed for the pharmaceutical industry.

Compounding for pediatric patients: case reports and formulations.

When no commercially available agent is appropriate for a pediatric patient, a compounded formulation often assures successful treatment. In the following case reports of five children, a pharmaceutical compound is an essential component of long-term therapy for a disorder best managed with customized medications and supplements.

Evidence for Intracellular and Extracellular Dimethylsulfoniopropionate (DMSP) Lyases and DMSP Uptake Sites in Two Species of Marine Bacteria.

Volume 63, no. 8, p. 3183, column 1, line 3 from the bottom: "0.

Release of dimethylsulfide from dimethylsulfoniopropionate by plant-associated salt marsh fungi.

The range of types of microbes with dimethylsulfoniopropionate (DMSP) lyase capability (enzymatic release of dimethylsulfide [DMS] from DMSP) has recently been expanded from bacteria and eukaryotic algae to include fungi (a species of the genus Fusarium [M. K. Bacic and D.

In Vivo Characterization of Dimethylsulfoniopropionate Lyase in the Fungus Fusarium lateritium.

A fungus, Fusarium lateritium, with dimethylsulfoniopropionate (DMSP) lyase activity was isolated from both seawater and a salt marsh due to its ability to grow on DMSP (with the evolution of dimethyl sulfide) as the sole source of carbon. This is the first reported case of DMSP lyase activity in a fungus. Several other common fungal genera tested did not have DMSP lyase activity.

Nuclear magnetic resonance analysis of [1-13C]dimethylsulfoniopropionate (DMSP) and [1-13C]acrylate metabolism by a DMSP lyase-producing marine isolate of the alpha-subclass of Proteobacteria.

The prominence of the alpha-subclass of Proteobacteria in the marine bacterioplankton community and their role in dimethylsulfide (DMS) production has prompted a detailed examination of dimethylsulfoniopropionate (DMSP) metabolism in a representative isolate of this phylotype, strain LFR. [1-(13)C]DMSP was synthesized, and its metabolism and that of its cleavage product, [1-(13)C]acrylate, were studied using nuclear magnetic resonance (NMR) spectroscopy. [1-(13)C]DMSP additions resulted in the intracellular accumulation and then disappearance of both [1-(13)C]DMSP and [1-(13)C]beta-hydroxypropionate ([1-(13)C]beta-HP), a degradation product.

Phylogenetic analysis of culturable dimethyl sulfide-producing bacteria from a spartina-dominated salt marsh and estuarine water.

Dimethylsulfoniopropionate (DMSP), an abundant osmoprotectant found in marine algae and salt marsh cordgrass, can be metabolized to dimethyl sulfide (DMS) and acrylate by microbes having the enzyme DMSP lyase. A suite of DMS-producing bacteria isolated from a salt marsh and adjacent estuarine water on DMSP agar plates differed markedly from the pelagic strains currently in culture. While many of the salt marsh and estuarine isolates produced DMS and methanethiol from methionine and dimethyl sulfoxide, none appeared to be capable of producing both methanethiol and DMS from DMSP.

Metabolism of acrylate to beta-hydroxypropionate and its role in dimethylsulfoniopropionate lyase induction by a salt marsh sediment bacterium, Alcaligenes faecalis M3A.

Dimethylsulfoniopropionate (DMSP) is degraded to dimethylsulfide (DMS) and acrylate by the enzyme DMSP lyase. DMS or acrylate can serve as a carbon source for both free-living and endophytic bacteria in the marine environment. In this study, we report on the mechanism of DMSP-acrylate metabolism by Alcaligenes faecalis M3A.

Evidence for Intracellular and Extracellular Dimethylsulfoniopropionate (DMSP) Lyases and DMSP Uptake Sites in Two Species of Marine Bacteria.

The kinetics of dimethylsulfoniopropionate (DMSP) uptake and dimethylsulfide (DMS) production from DMSP in two bacterial species, Alcaligenes sp. strain M3A, an isolate from estuarine surface sediments, and Pseudomonas doudoroffii, from seawater, were investigated. In Alcaligenes cells induced for DMSP lyase (DL) activity, DMS production occurred without DMSP uptake.

Differential Metabolism of Dimethylsulfoniopropionate and Acrylate in Saline and Brackish Intertidal Sediments.

In anoxic Spartina alterniflora-dominated sediments along a naturally occuring salinity gradient (the Cooper River estuary, South Carolina, U.S.A.

Amino acid sequence of ferredoxin II from the phototroph Rhodospirillum rubrum: Characteristics of a 7Fe ferredoxin.

The complete sequence of amino acids of ferredoxin II (FdII) from Rhodospirillum rubrum was determined by repetitive Edman degradation using pyridylethylated-ferredoxin and oxidized, denatured ferredoxin. Peptides derived from trypsin, pepsin, Glu-C endoproteinase, Arg-C endoproteinase, tryptophan specific cleavage and partial acid hydrolysis and C-terminal sequence from carboxypeptidase digestion were used to construct the total sequence. RrFdII is a polypeptide of 104 amino acids having a calculated molecular weight of 11556 excluding the iron and sulfur atoms.

Comparative Physiology of Dimethyl Sulfide Production by Dimethylsulfoniopropionate Lyase in Pseudomonas doudoroffii and Alcaligenes sp. Strain M3A.

Dimethylsulfoniopropionate (DMSP) lyase enzymatically cleaves DMSP, an algal metabolite, to produce acrylate, a proton, and dimethyl sulfide (DMS), the most abundant volatile sulfur compound emitted from oceans. The physiology of DMS production by DMSP lyase was studied in vivo in an Alcaligenes-like organism, strain M3A, a salt marsh bacterial isolate, and in a marine strain, Pseudomonas doudoroffii. Enzymes from both strains were induced at optimum rates by 1 mM DMSP and vigorous aeration.

Purification and characterization of dimethylsulfoniopropionate lyase from an alcaligenes-like dimethyl sulfide-producing marine isolate.

Dimethyl sulfide (DMS) is quantitatively the most important biogenic sulfur compound emitted from oceans and salt marshes. It is formed primarily by the action of dimethylsulfoniopropionate (DMSP) lyase which cleaves DMSP, an algal osmolyte, to equimolar amounts of DMS and acrylate. This report is the first to describe the isolation and purification of DMSP lyase.

Molecular cloning and sequencing of the ferredoxin I fdxN gene of the photosynthetic bacterium Rhodospirillum rubrum.

Using an oligonucleotide probe derived from the amino acid sequence of Rhodospirillum rubrum ferredoxin I, the gene (fdxN) was identified, cloned and sequenced. The FdxN coding region is 183 nucleotides which codes for a 61 amino acid (7267 Da) protein. Phylogenetic comparisons between the R.

Formate dehydrogenase from the methane oxidizer Methylosinus trichosporium OB3b.

Formate dehydrogenase (NAD+ dependent) was isolated from the obligate methanotroph Methylosinus trichosporium OB3b. When the enzyme was isolated anaerobically, two forms of the enzyme were seen on native polyacrylamide gels, DE-52 cellulose and Sephacryl S-300 columns; they were approximately 315,000 and 155,000 daltons. The enzyme showed two subunits on sodium dodecyl sulfate-polyacrylamide gels.

Complementation of a pleiotropic Nif-Gln regulatory mutant of Rhodospirillum rubrum by a previously unrecognized Azotobacter vinelandii regulatory locus.

A spontaneous pleiotropic Nif- mutation in Rhodospirillum rubrum has been partially characterized biochemically and by complementation analysis with recombinant plasmids carrying Azotobacter vinelandii DNA in the vicinity of ORF12 [Jacobson et al. (1989) J. Bacteriol 171: 1017-1027].

Isolation, characterization, and biological activity of ferredoxin-NAD+ reductase from the methane oxidizer Methylosinus trichosporium OB3b.

A ferredoxin-NAD+ oxidoreductase (EC 1.18.1.

Relationship between nitrogen-fixing sulfate reducers and fermenters in salt marsh sediments and roots of Spartina alterniflora.

A combination of inhibitors and carbon substrates was used to determine the relative contribution of sulfate-reducing bacteria (SRB) and fermenting bacteria to nitrogen fixation in a salt marsh sediment and on the roots of Spartina alterniflora. Because a lag period precedes acetylene-reducing activity (ARA) in amended sediments, an extensive analysis was done to be sure that this activity was due to the activation of dormant cells, not simply to cell proliferation. Since ARA was not affected by metabolic inhibitors such as rifampin, nalidixic acid, or methionine sulfoximine, it appeared that cell growth was not responsible for this activity.

Ammonia switch-off of nitrogenase from Rhodobacter sphaeroides and Methylosinus trichosporium: no evidence for Fe protein modification.

In vivo switch-off of nitrogenase activity by NH4+ is a reversible process in Rhodobacter sphaeroides and Methylosinus trichosporium OB3b. The same pattern of switch-off in Rhodospirillum rubrum is explained by ADP-ribosylation of one of the Fe protein subunits, however, no evidence of covalent modification could be found in the subunits from either R. sphaeroides or M.

Regulation of two nickel-requiring (inducible and constitutive) hydrogenases and their coupling to nitrogenase in Methylosinus trichosporium OB3b.

Two uptake hydrogenases were found in the obligate methanotroph Methylosinus trichosporium OB3b; one was constitutive, and a second was induced by H2. Both hydrogenases could be assayed by measuring methylene blue reduction anaerobically or by coupling their activity to nitrogenase acetylene reduction activity in vivo in an O2-dependent reaction. The H2 concentration for half-maximal activity of the inducible and constitutive hydrogenases in both assays was 0.

Changes in amino acid and nucleotide pools of Rhodospirillum rubrum during switch-off of nitrogenase activity initiated by NH4+ or darkness.

Amino acid and nucleotide pools were measured in nitrogenase-containing Rhodospirillum rubrum cultures during NH4+- or dark-induced inactivation (switch-off) of the Fe protein. A big increase in the glutamine pool size preceded NH4+ switch-off of nitrogenase activity, but the glutamine pool remained unchanged during dark switch-off. Furthermore, methionine sulfoximine had no effect on the rate of dark switch-off, suggesting that glutamine plays no role in this process.