Interaction between linezolid (Zyvox®) and SSRIs

linezolid zyvox ssri serotonin antidepressantLinezolid is an oxazolidinone antibiotic that is active against many gram-positive organisms including those that are resistant to multiple other agents such as methicillin-resistant staphylococci, penicillin-resistant streptococci, and vancomycin-resistant enterococci.  Linezolid is also a weak, reversible, inhibitor of monoamine oxidase (MAO), predominantly MAO-A, which is responsible for the metabolism of neurotransmitters such as serotonin, in the brain.  This effect has led to an increased risk of serotonin syndrome in patients taking other medications that increase serotonergic tone.  SSRIs fall in this category as they increase synaptic serotonin concentrations by preventing transport into the presynaptic neuron.  They are commonly prescribed for numerous psychiatric conditions. Due to the high prevalence of both depressive disorders and nosocomial infections in patients with chronic medical illnesses, this medication combination may be encountered in the hospital setting.  Though case reports are few, deaths have been reported due to serotonin syndrome and a Food and Drug Administration Safety Alert was issued in 2011 specifically warning about the linezolid-SSRI interaction.

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Dealing with statin-induced myopathy

dealing statin induced myopathy myalgia myositisLet’s start with a patient case.  An 82 year old female patient presents to clinic with complaints of weakness in her lower extremities. She describes her weakness as symmetrical heaviness and identifies some stiffness and cramping. Other causes of her complaints are ruled out except for her medications. Her hyperlipidemia is currently being managed with simvastatin 40 mg orally daily and niacin ER 1 g orally daily. What are our options for dealing with suspected statin-induced myopathy?

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Emergency Situations: Prescribing Schedule II Controlled Substances

Remote Pharmacy Solutions

Emergency is defined by the Secretary of Health and Human Services as “situations in which the prescribing practitioner determines that:

(1) Immediate administration of a controlled substance is necessary, for proper treatment of the intended ultimate user;

(2) That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and

(3) It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to dispensing” (21 CFR 290.10).

  • In emergency situations, a prescription for a Schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription sent to the pharmacy within 7 (States may require that the prescription be sent to the pharmacist in a shorter time frame.)
  • Here are some additional requirements to heed when orally transmitting prescriptions in emergency situations: “In an emergency, the prescriber may give an oral prescription for a Schedule II drug if the pharmacist makes a reasonable effort to identify the prescriber and the amount is limited to what is necessary to treat the patient during the emergency. The prescriber must cause to be delivered an original prescription to the dispensing pharmacist within 7 The prescriber must write ‘Authorization for Emergency Dispensing’ on the prescription. The prescriber must document how the situation met the criteria for emergency treatment” (21 CFR 290.10).

Faxing Prescriptions for Schedule II Controlled Substances

  • Prescriptions may be faxed under certain conditions. Here are the conditions, as stated in federal regulations: “A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner’s agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance.
  • Therefore, Schedule II prescriptions can be faxed to a pharmacist, but the copy is just an alert to the pharmacist that the patient is en route with an original prescription.

Do not hesitate to contact me at ____ (insert your telephone number) should you have questions or would like more information about this matter.

Sincerely,

Joe Blog,

Pharmacist-In-Charge

XXYYZZ Pharmacy

Disclaimers

Any views or opinions represented in this blog are personal and belong solely to Accurate Order Solutions, LLC and do not represent those of people, institutions or organizations that the owner may or may not be associated with in professional or personal capacity, unless explicitly stated. Any views or opinions are not intended to malign any religion, ethnic group, club, organization, company, or individual.

All content provided on this blog is for informational purposes only. Accurate Order Solutions, LLC makes no representations as to the accuracy or completeness of any information on this site or found by following any link on this site. Accurate Order Solutions will not be liable for any errors or omissions in this information nor for the availability of this information. Accurate Order Solutions, LLC will not be liable for any losses, injuries, or damages from the display or use of this information.

Reclassification of Hydrocodone Combination Products (HCP)

Remote Pharmacy SolutionsOn August 22nd, 2014, the FDA announced the up-scheduling of hydrocodone combination products (HCP). Effective October 6th 2014, all HCP will be classified as Schedule II controlled substances which require additional safeguards with regards to prescribing, procurement, recordkeeping, inventory and storage.

Regardless of your opinion on this issue, pharmacists must be prepared to be compliant on October 6th. This article provides a quick reference tool to help pharmacists prepare for the process by outlining steps that needs to be taken prior to October 6th.

Pharmacies must have valid state and federal (DEA) registrations to purchase and dispense Schedule II products.

Storage: take stock of the maximum quantity of HCP you normally carry in your pharmacy. Can your current stock of HCP be relocated to your schedule II vault or safe? If the answer is no then you might need to purchase or source additional vault space.

Recordkeeping: one way to prepare for this change is to close out all HCP records from your Schedule 3-5 register on September 30th, 2014. The closed records should be transferred to your Schedule 2 register on that same day meaning that you would be keeping the right records on HCP by October 6th.

Inventory: be sure to take a physical inventory count of all your HCP by September 30th, 2014. The DEA requires an exact physical count of Schedule II controlled substances and an estimated count or measure of the contents of a schedule III, IV, or V controlled substance (unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents must be made). The Controlled Substances Act also requires that all inventory records be maintained at the registered location in a readily retrievable manner for at least two years for copying and inspection. In addition, the inventory records of schedule II controlled substances must be kept separate from all other controlled substances.

Procurement: Pharmacists and agents authorized to order Schedule II controlled substances will have to use paper DEA 222 or its electronic equivalent, Controlled Substance Ordering System (CSOS), to place their orders for HCP from October 6th, 2014.

Prescribing: This aspect of controlled substances management will be impacted the most as the changes will be significant. As pharmacists, we can be proactive and take certain actions in advance to minimize the impact of this change on our patients particularly those with chronic pain.

Write to all your patients who have had HCP filled at your pharmacy in the last 90 days informing them of the change and advising those without prescription refills to make arrangements with their physicians’ offices as soon as possible. The DEA will allow patients’ with existing legitimate prescription refills issued before October 6th, 2014 to be refilled until April 8th, 2015. Click here for a sample patient letter 

Write to physicians in your local area informing them of this change and how it will affect their usual course of practice. Click here for a sample physician letter

Further information about entire rescheduling process can be found at this link Hydrocodone Combination Products – Fact Sheet

HYDROCODONE COMBINATION PRODUCTS: FACT SHEET

Hydrocodone

On August 22, 2014, the DEA published a final rule rescheduling hydrocodone combination products (HCPs) to schedule II of the Controlled Substances Act. The final rule is available at www.regulations.gov and www.DEAdiversion.usdoj.gov
This Fact Sheet contains a general summary of the effects of the rescheduling on the general public.

This Fact Sheet contains a general summary of the effects of the rescheduling on the general public.

Frequently Asked Questions

  1. What are HCPs?

HCPs are pharmaceutical drugs containing hydrocodone in certain combinations with other drugs. Common names include: Vicodin®, Lortab®, Hycodan®, Tussionex®, and several generics.

  1. What does this final rule do?

HCPs will be controlled as schedule II substances effective October 6, 2014. DEA registrants (e.g., distributors, physicians, and pharmacies) will be required to adhere to more stringent security and recordkeeping requirements with respect to HCPs.

  1. I have a current prescription for HCPs that authorizes refills. Can I still have it refilled?

Yes. Any legitimate prescriptions for HCPs that are issued before October 6, 2014 that authorize refills may be dispensed by a pharmacy if such dispensing occurs before April 8, 2015.

  1. Can my physician issue a prescription for an HCP with refills after October 6, 2014?

No; a prescription for a schedule II controlled substance may not be refilled. However your physician may issue multiple prescriptions authorizing you to receive a total of up to a 90-day supply provided certain regulatory requirements are met.

  1. Will I now have to see my physician every month?

Not necessarily – the DEA does not regulate the practice of medicine. Your physician must determine on his/her own, based on sound medical judgment, and in accordance with established medical standards, how often to see you.

  1. Will I have to show my ID at the pharmacy when I pick up my prescription?

There is no federal requirement for you to show ID; however, you may be required to do so by your pharmacy or applicable state law.

Hydrocodone Combination Products:

  • What are hydrocodone combination products (HCPs)?
  • HCPs are pharmaceutical drugs containing specified doses of hydrocodone in combination with other drugs in specified amounts. These products are approved for marketing for the treatment of pain and cough suppression.
  • All pharmaceutical drug products containing hydrocodone approved for marketing in the United States by the U.S. Food and Drug Administration are HCPs, except ZohydroTM ER which is a single-entity hydrocodone product and as such is already a schedule II controlled substance.
  • There are several hundred brand name and generic hydrocodone products marketed with the most frequently prescribed combination being hydrocodone and acetaminophen (e.g., Vicodin®, Lortab®). Currently marketed cough suppressants containing HCPs include Hycodan®, Mycodone®, Tussionex®, Pennkinetic®, Tussigon®, and several generics.
  • HCPs have been controlled in schedule III since enactment of the Controlled Substances Act in 1971.
  • HCPs are the most frequently prescribed opioid in the United States: nearly 137 million prescriptions for HCPs were dispensed in 2013.

 

  • What is the purpose of this rescheduling action?
  • Effective October 6, 2014, HCPs will be controlled as schedule II substances under the Controlled Substances Act (CSA).
  • For prescribers, the change primarily means that they may not authorize refills for any HCP prescriptions. However they may issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of HCPs, in accordance with 21 CFR 1306.12.
  • The DEA is allowing legitimate HCP prescriptions issued before October 6, 2014 that authorizes refills to be refilled until April 8, 2015.
  • For pharmacies, the primary changes are that they must utilize a DEA Form 222 in order to obtain HCPs from a distributor, and they must keep HCP records separate or readily retrievable.
  • For distributors, the primary change is that they must physically store HCPs in a vault that meets specific requirements.
  • Manufacturers are relatively unaffected by the rescheduling action, except manufacturers that repackage or relabel HCPs will be required to obtain a quota in order to repackage or relabel HCPs.
  • DEA is allowing HCPs to be repackaged and relabeled without the requirement of a quota until December 8, 2014.

 

  • Why did the DEA reschedule HCPs into schedule II of the CSA?
  • Schedule II controlled substances are substances that have a currently accepted medical use in the United States, but also have a high potential for abuse, and the abuse of which may lead to severe psychological or physical dependence. After considering the analysis and rescheduling recommendation of Department of Health and Human Services (HHS) and reviewing available data, the DEA found that HCPs meet the statutory definition of a schedule II controlled substance.
  • Various drug abuse indicators for HCPs indicate that HCPs are widely diverted and abused at rates largely similar to that of oxycodone products (schedule II). The data indicate that HCPs have an abuse potential similar to schedule II opioid analgesics such as oxycodone and their abuse is associated with severe psychological or physical dependence.
  • Abuse of HCPs is also associated with large numbers of individuals being admitted to addiction treatment centers. Individuals are taking these drugs in sufficient quantities to create a hazard to their health, and abuse of HCPs is associated with large numbers of deaths.
  • Summarized timeline
  • DEA received the petition in 1999.
  • On July 28, 2004, DEA forwarded the petition and related materials to Department of Health and Human Services (HHS) for a scientific and medical evaluation and scheduling recommendation
  • On March 6, 2008, Department of Health and Human Services (HHS) forwarded to the DEA a scientific and medical evaluation and recommended that HCPs continue to be subject to control under schedule III of the CSA.
  • On February 13, 2009, the DEA submitted the reanalyzed data to Department of Health and Human Services (HHS) and requested a reevaluation and scheduling recommendation.
  • As mandated by the Food and Drug Administration Safety and Renovation Act of 2012, on   January 24-25, 2013, the FDA held an Advisory Committee meeting. The Committee voted in favor of rescheduling HCPs from schedule III to schedule II.
  • On December 16, 2013, Department of Health and Human Services (HHS) forwarded to the DEA its scientific and medical evaluation and recommendation that HCPs be controlled in schedule II.
  • On February 27, 2014, DEA published the Notice of Proposed Rule Making, Economic Impact Analysis, and the DEA and Department of Health and Human Services (HHS) 8-factor analyses.
  • On August 22, 2014, DEA published the final rule.

Sample Physician Letter

Dear Dr. XXX,

On August 22nd 2014, the Food and Drug Administration (FDA) announced stricter regulations and controls for Hydrocodone-Containing Products (HCP). Examples of hydrocodone-containing products are Norco, Vicodin, Lortab, Hycodan, Tussionex and several generics. These new laws will take effect on October 6th 2014 and means that all prescriptions for Hydrocodone-Containing Products will have to be written on state-approved prescription pads. State approved prescription pads for schedule II substances can usually be obtained from individual state’s Department of Public Safety.

How does this affect you?

  • Prescriptions with refills for a HCP written before October 6th 2014 will still be valid up until April 8th 2014 or 6 months from the date on the prescription, whichever comes sooner.
  • Patients’ requiring prescriptions for HCP from October 6th 2014 will have to contact their physicians’ offices for new prescriptions written on the state approved prescription pads.
  • Prescriptions for the reclassified HCP are usually not allowed by state and federal laws to “called-in” (verbal) or faxed to the pharmacy from the physician’s office except in emergency situations as defined by federal law. Reminder: prescriptions for Schedule II controlled substances must be written in ink or indelible pencil or typewritten and must be signed manually by the practitioner. Signature stamps are not legal.
  • Nurse practitioners and physician assistants can no longer write prescriptions for HCP when they are reclassified schedule II controlled substances.
  • Starting from October 6th 2014, new prescriptions for HCP will be valid for only specific period of time as determined by individual state laws. For the state of Texas, the validity of Schedule II prescriptions is 30 days.
  • The refilling of a prescription for a controlled substance listed in schedule II is prohibited by law.
  • Federal law prohibits prescribers from pre-signing prescriptions (21 CFR, Section 1306.05).
  • The practice whereby the physician pre-signs prescriptions and Nurse Practitioners write in the medication, route, dosage, and amount is illegal. Do not do either of these things and do not post-date a prescription. If you need to provide a prescription for November’s dose of a schedule II controlled substance in October, date the prescription for the day you write the prescription and write “Dispense after November 1, 2014.”

Do not hesitate to contact me at ____ (insert your telephone number) should you have questions or would like more information about this matter.

Sincerely,

Joe Blog,

Pharmacist-In-Charge

XXYYZZ Pharmacy

Disclaimers

Any views or opinions represented in this blog are personal and belong solely to Accurate Order Solutions, LLC and do not represent those of people, institutions or organizations that the owner may or may not be associated with in professional or personal capacity, unless explicitly stated. Any views or opinions are not intended to malign any religion, ethnic group, club, organization, company, or individual.

All content provided on this blog is for informational purposes only. Accurate Order Solutions, LLC makes no representations as to the accuracy or completeness of any information on this site or found by following any link on this site. Accurate Order Solutions will not be liable for any errors or omissions in this information nor for the availability of this information. Accurate Order Solutions, LLC will not be liable for any losses, injuries, or damages from the display or use of this information.

Sample Patient Letter

Dear Mr. XXX,

On August 22nd 2014, the Food and Drug Administration (FDA) announced stricter regulations and controls for Hydrocodone-Containing Products (HCP). Examples of hydrocodone-containing products are Norco, Vicodin, Lortab, Hycodan, Tussionex and several generics. These new laws will take effect on October 6th 2014 and means that all prescriptions for Hydrocodone-Containing Products will have to be written on State-specific serial-numbered (physician-specific) prescription pads.

How does this affect you?

  • If you no longer require hydrocodone-containing products, please ignore this letter.
  • If you currently have a valid prescription with refills for a HCP written before October 6th 2014, you will still be able to fill this prescription up until 6 months from the date on the prescription.
  • Patients’ requiring prescriptions for HCP from October 6th 2014 will have to contact their physicians’ offices for new prescriptions written on the approved state-issued serial-numbered pads.
  • Under normal circumstances prescriptions for the reclassified HCP cannot longer be called in (verbal) or faxed to the pharmacy by the physician’s office.
  • Nurse practitioners and physician assistants can no longer write prescriptions for the reclassified HCP.
  • Starting from October 6th 2014, new prescriptions for HCP will be valid for only specific period of time as determined by individual state laws.
  • The refilling of a prescription for a controlled substance listed in schedule II is prohibited by law.

Do not hesitate to contact me at ____ (insert your telephone number) should you have questions or would like more information about this matter.

Sincerely,

Joe Blog,

Pharmacist-In-Charge

XXYYZZ Pharmacy

Disclaimers

Any views or opinions represented in this blog are personal and belong solely to Accurate Order Solutions, LLC and do not represent those of people, institutions or organizations that the owner may or may not be associated with in professional or personal capacity, unless explicitly stated. Any views or opinions are not intended to malign any religion, ethnic group, club, organization, company, or individual.

All content provided on this blog is for informational purposes only. Accurate Order Solutions, LLC makes no representations as to the accuracy or completeness of any information on this site or found by following any link on this site. Accurate Order Solutions will not be liable for any errors or omissions in this information nor for the availability of this information. Accurate Order Solutions, LLC will not be liable for any losses, injuries, or damages from the display or use of this information.

Spotlight on CUBICIN©

CUBICINCUBICIN is the trade name for Daptomycin, a lipopeptide antibacterial agent marketed by Cubist Pharmaceuticals. The chemical name of Daptomycin is N-decanoyl-L-tryptophyl-L-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine[egr]1-lactone.

CUBICIN is indicated in the treatment of Vancomycin-resistant enterococcus (VRE) infection and fatal gram positive infections caused by MRSA (methicillin-resistant Staphylococcus aureus) and MSSA (Methicillin-sensitive Staphylococcus aureus). Daptomycin disrupts multiple bacterial cell membrane functions of gram positive organisms by binding to it, which causes rapid depolarization. This leads to loss of membrane potential, which in turn inhibits protein, DNA and RNA synthesis, hence causing bacterial cell death.

CUBICIN is administered only once daily at a dose of 4mg/kg for the treatment of complicated skin, skin structure (cSSSI) and soft tissue infections. These infections are often caused by susceptible strains of the Gram-positive microorganisms such as: Staphylococcus aureus (including MRSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

CUBICIN can also be dosed at 6 mg/kg for the treatment of S. aureus bloodstream infections (bacteremia), including right-sided infective endocarditis (native valve) caused by MRSA and MSSA bacteremia. CUBICIN has not been studied for the treatment of prosthetic valve infections. Proponents of CUBICIN for treating invasive S. aureus infections argue it does not worsen renal dysfunction or is less nephrotoxic in nature compared to Vancomycin.
However, CUBICIN is not approved for the treatment of left-sided infective endocarditis caused by S. aureus. The efficacy of CUBICIN has been shown to diminish in the presence of renal impairment (creatinine clearance 30-50ml/min). The frequency of side effects such as myopathy and rhabidomyolysis are increased in patients with renal impairment. CUBICIN is excreted by filtration through the kidneys.

Daptomycin molecules are inactivated in vitro by pulmonary surfactants; hence the CUBICIN is not indicated for the treatment of pneumonia. It may cause patients suffering from pneumonia to develop eosinophilic pneumonia.
Common adverse effects include muscle ache or muscle weakness known as myopathy, rhabidomyolysis, diarrhea, and peripheral neuropathy have been reported with the use of Cubicin. Patients receiving CUBICIN should be monitored closely for signs and symptoms of myopathy which maybe manifested as elevated creatine phosphokinase (CPK). Patients receiving CUBICIN may have abnormal laboratory values in relation to phosphorus level and international normalized ratio (INR) values.

Disclaimers

Any views or opinions represented in this blog are personal and belong solely to Accurate Order Solutions, LLC and do not represent those of people, institutions or organizations that the owner may or may not be associated with in professional or personal capacity, unless explicitly stated. Any views or opinions are not intended to malign any religion, ethnic group, club, organization, company, or individual.

All content provided on this blog is for informational purposes only. Accurate Order Solutions, LLC is a remote pharmacy service organization makes no representations as to the accuracy or completeness of any information on this site or found by following any link on this site. Accurate Order Solutions will not be liable for any errors or omissions in this information nor for the availability of this information. Accurate Order Solutions, LLC will not be liable for any losses, injuries, or damages from the display or use of this information.