The Anticoagulant and Antiplatelet Refresher

Anticoagulants and antiplatelets are the most common group of medications setting questioning in motion at my job.  Whether it is surgeons asking about washout periods or other colleagues admitting to not knowing the latest medications in the this category, I find myself constantly learning and relearning this topic.  I decided to put together a brief overview of what we have, how it is used and some of the nuances to remember.

1.        FACTOR Xa INHIBITORS (Anticoagulants):

• Rivaroxaban (Xarelto):  Deep vein thrombosis (DVT), pulmonary embolism (PE) treatment, Reduction in the risk of recurrent DVT/PE (in select patients), nonvalvular atrial fibrillation (to prevent stroke and systemic embolism), and postoperative DVT thromboprophylaxis.
  • Caution in pts w/moderate renal impairment (CrCl 30-50 mL/min)  and avoid in patients with severe renal impairment (CrCl <30 mL/min).
  • CYP3A4 substrate and P-gly transporters
  • No reversal agent
  • Discontinue at least 24 hours before any procedure in normal renal function.  If CrCl <50 and elderly, need 48 hours washout.
• Fondaparinux (Arixtra): Prophylaxis of DVT in patients undergoing surgery for hip replacement, knee replacement, hip fracture, or abdominal surgery, treatment of acute PE, treatment of acute DVT without PE.  Unlabeled: DVT prophylaxis with HIT
  • CrCl 30-50 mL/min: use caution.  Contraindicated in <30 mL/min.
• Apixaban (Eliquis): hip or knee replacement DVT, nonvalvular AFib, unlabeled initial tx of VTE
  • Nonvalvular atrial fibrillation 5 mg BID, adjust in serum creatinine >1.5 and either age >/=80 or body weight </=60 kg: 2.5 mg BID.

2.  DIRECT THROMBIN INHIBITORS (Anticoagulants):

• Bivalirudin (Angiomax):
  • Current recommendations are to adjust the dose for renal impairment in patients with a CrCl of 10–29 ml/min undergoing PCI and in patients with a CrCl<60 ml/min being treated for heparin-induced thrombocytopenia. Current manufacturer recommendations state that dosing modifications are not necessary in patients with hepatic impairment.
  •  No Reversal Agent.  Modified ultrafiltration and hemodialysis may facilitate removal (45-69% removal w/ultrafilt and 25% with HD).  Recombinant factor VII can be administered at a dose of 90 mcg/kg IV.  FFB, etc…
• Dabigatran (Pradaxa):
  • Dosed as a twice daily oral tablet, dabigatran reaches a peak plasma concentration after 1–2 h with a half-life of 12–17 h. Renal clearance accounts for 80–85% elimination of dabigatran. Doses should be reduced in patients with moderate renal impairment (defined as CrCl 30–50 ml/min) and should be avoided in patients with severe renal impairment (defined as CrCl 15–30 ml/min) and concomitant use of medications requiring use of P-glycoprotein). Current manufacturer recommendations state that dosing modifications are not necessary in patients with hepatic impairment.
  • No Antidote.  FFP can be tried.  HD can be effective in removing as much as 60% of circulating drug, as the majority of drug is unbound to protein; but unsuff data to support this.
  •   Withhold for 2 days in patients with normal renal function and high risk of bleeding or major surgery.  For otherwise avg risks, 24 hours.
• Desirudin (Iprivask):

3.  P2Y-12 RECEPTOR INHIBITORS (Antiplatelets):

• Clopidogrel (Plavix):
  • Peak platelet inhibition:  300 mg load 6 hours, 600 mg load 2 hours.
  • Approved for ACS medically or PCI
  • Discontinue 5 days before surgery.  CABG hold time 5 days.
  • 2C19 and 3A4 metabolism (PPIs can reduce the effect of antiplatelet by inhibiting 2C19)
  • Loading dose:  300-600 mg; Maintenance dose:  75 mg/day
• Ticagrelor (Brilinta): 
  • Peak platelet inhibition:  180 mg less than hour
  • LD: 180 mg, maintenance dose: 90 mg twice daily
  • Contraindications: ICH, severe hepatic disease
  • Not prodrug, reversible, noncompetitive binding, 3A4 (primary), 3A5, P-gp
  • Careful with asthma, bradycardia, enhanced bleeding with NSAIDs, VKA, strong 3A4 inhibitors increases Ticagrelor conc, strong 3A4 inducers decrease Ticagrelor conc, do not exceed 40 mg of simvastatin or lovastatin.  Limit ASA < 100 mg.
  • CABG hold time 5 days
  • Box warning: age-related bleeding CVA
• Prasugrel (Effient): 
  • Peak platelet inh 60 mg load 1-1.5 hrs.
  • LD: 60 mg MD: 10 mg daily (5 mg if <60 kg; bw >/=75 yrs)
  • CIs: TIA/stroke
  • Bleeding risk higher than clopidogrel
  • D/C 7 days before surgery (CABG included), avoid in patient with active bleeding or a history of TIA or stroke and over 75 old unless pt has DM or history of MI
  • Box warning: aspirin dosing > 100 mg

4.  HEPARIN AND LOVENOX (Anticoagulants):  

• Heparin:
  • No renal adjustment required
  • Different dosing depending on indication

  • Watch for HIT:  1-2% of patients.  Typically the platelet count will fall 5-14 days after heparin is first given; if someone has received heparin in the previous three months, the fall in platelets may occur sooner, sometimes within a day.

Enoxaparin (Lovenox):

• Renal adjust < 30 mL/hr (treatment and prophylaxis)

• HIT still an issue (it is a low molecular weight heparin)

Hopefully this review will help you identify which are anticoags, which are antiplatelets, and which could overlap or not based on profile.

COPD Campaign

Healthline just launched a campaign for called "You Are Not Your COPD" where COPD patients share their story or advice about living with the disease.  You can see the homepage for the campaign here: http://www.healthline.com/health/copd/inspirational-stories

For every submission, Healthline will donate $10 to the COPD Foundation. The Healthline editorial team will also select one winner from the top five most shared submissions, and that winner will receive a $75 American Express Gift Card. Enter your submission now! 

To read more about COPD from a medical practitioner point-of-view:  Click here.  

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) works with health care professionals and public health officials to raise awareness of Chronic Obstructive Pulmonary Disease (COPD) and to improve prevention and treatment of this lung disease for patients around the world.

Does Childhood Obesity Equal Neglect?

In a world where every minute of the day is jam-packed with rushing from home to school and school to work and work to school and school to extracurricular activities, it is no wonder that parents are feeling the squeeze of where a lot of us are failing.  Our children's diets are suffering in a tremendous way which leads to things we would never wish on our children:  diabetes, obesity, high blood pressure, bone and joint problems, social and psychological problems, and poor self-esteem.  Today, childhood obesity has more than doubled in children and quadrupled in adolescents in the past 30 years according to the Journal of the American Medical Association and the National Center for Health Statistics.

There are immediate and long-term health effects.  Long-term effects are things like heart disease, type 2 diabetes, stroke, cancer, and osteoarthritis.  One study called the Bogalusa Heart Study showed that children who became obese as early as age 2 were more likely to be obese as adults.

In Britain, news was just released claiming that parents of an obese child were arrested for neglect.  Has this gone too far?  

If we spend our days putting priority on "getting somewhere" and not what goes into our bodies, we are missing a vital part of what we should prioritize.  Health.  

“Let food be thy medicine and medicine be thy food.” - Hippocrates

Should a parent be responsible for training up a child on how to be healthy?  Absolutely!  But, where we fail as a society, in America at least, is that our culture is driven around maximizing every second for work and productivity and not health.  We rush about to and fro and forget about healthy foods.  It takes too long to prepare.  McDonald's is so much faster.  Drive-thrus are so much faster.  Our hospital cafeterias are filled with the same foods that would send a patient to the cath lab over time due to the high cholesterol and high fat/sugar.  We have a society problem more than a parenting problem though the children suffering with obesity is a big symptom.

Stress Ulcer Prophylaxis - a review

PROPHYLAXIS

Indications — Based upon randomized trials and guideline recommendations from the American Society of Health System Pharmacists, stress ulcer prophylaxis should be administered to all critically ill patients who are at high risk for gastrointestinal (GI) bleeding (1999).

ASHP Guidelines 1999 (great year by the way, the year I graduated pharmacy school!)
• Prophylaxis appropriate for patients admitted to the ICU with one or more of the following: 

• Mechanical ventilation >48 hours
• Coagulopathy
• GI ulcer or bleeding within the past year
• Glasgow Coma Score </= 10
• Thermal injury >35% BSA
• Partial hepatectomy
• Multiple trauma
• Transplantation patients in the ICU perioperatively
• Hepatic failure
• Spinal cord injury
• Patients with at least 2 of the following: 
  • Sepsis 
  • ICU stay >1 week 
  • Occult GI bleeding >/= 6 days 
  • Steroid therapy with >250 mg hydrocortisone or equivalent per day 

(ASHP Commission on Therapeutics. Am J Health-Syst Pharm 1999; 56:347-379)

• Choice among antacids, histamine-2 receptor antagonists (H2RAs), and sucralfate for SUP should be made on institution-specific basis
• Do not include recommendations for proton pump inhibitors (PPIs) 
• SUP is not recommended for adult patients in non-ICU settings 
  • (B) for patients with <2 risk factors 
  • (D) for patients with >/= 2 risk factors 

Possible Complications with PPIs 

• Headache, diarrhea, constipation, abdominal pain, nausea 
• Nutritional deficiencies – magnesium, calcium, iron, B-12 
• Fracture risk 
• Drug interactions 
• Infection 
  • Pneumonia 
  • C. diff infection
  • Spontaneous bacterial peritonitis 
  • Interstitial nephritis 
  • Rebound hypersecretion

Possible Complications with H2RAs 

• CNS adverse effects 
• Thrombocytopenia 
• Fracture risk 
• CYP-450 DDIs (cimetidine) 
• Infection 
  • Pneumonia 
  • CDI 

Which Agent Should be Used When SUP Indicated? 

• H2RAs over antacids and sucralfate 
• H2RAs vs. PPIs? 
• PPIs more potent inhibitors of acid secretion 
• No tolerance with PPIs (tolerance with H2RAs)
• PPIs superior to H2RAs in other settings 
• SUP is less dependent on acid suppression than in the setting of rebleeding prevention – are H2RAs sufficient? 

What is next?  The guidelines are presently in review and should be released pretty soon:

ASHP Therapeutic Guidelines

ASHP's professional policies contain varying levels of detail. Policy positions are short pronouncements on one aspect of practice. Statements express basic philosophy, and guidelines (including what were formerly called "technical assistance bulletins") offer programmatic advice. Therapeutic position statements are concise responses to specific therapeutic issues, and therapeutic guidelines are thorough, evidence-based recommendations on drug use.

Note: All ASHP therapeutic guidelines are in PDF.

Gastrointestinal Stress Ulcer Prophylaxis       New    In process      Q2 2014

I will definitely have to revisit later on in the year.

Pharmacist Provider Status (updated news links)

Photo credit: Army Medicine (Creative Commons)

Today, I gathered a couple of news stories across the country regarding the exciting changes that will be taking place in the next several years.  Pharmacists across the country can support APhA’s provider status efforts through the Pharmacists Provide Care campaign to achieve recognition for pharmacists’ patient care services.

• April 22, 2014 - Wisconsin Provider Status Bill Becomes Law 

  (And is backed by WI's medical society)

  Legislation applies to all pharmacists in the state

  In a big win in efforts toward state-level provider status, Wisconsin Act 294 was signed into law by Gov. Scott Walker of Wisconsin on April 16. The legislation provides that “a pharmacist may perform any patient care service delegated to the pharmacist by a physician.”

  There are no limitations or restrictions on what can be delegated, and no credentials are specified for pharmacists to hold in order to serve as a provider of medical services. The details of any arrangement are left to the physicians and pharmacists involved.

  “As a practicing clinical pharmacist and part-time [community] pharmacist, this is an exciting step forward on our march towards gaining formal recognition by our government as health care providers,” said Wisconsin pharmacist Joey Sweeney, PharmD, BCPS, Clinical Pharmacist at Aurora Lakeland Medical Center. “Our patients will now benefit from the unique skills and expertise pharmacists provide in this new care model opportunity. On Wisconsin!”

  Diana Yap, Senior Assistant Editor

• Pharmacy Champions in Congress (KY)

BCPS COPD: The Gold Guidelines (2013)

The Gold Guidelines for the diagnosis and treatment of COPD are the gold standard for treating COPD.  

About Us
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) works with health care professionals and public health officials around the world to raise awareness of Chronic Obstructive Pulmonary Disease (COPD) and to improve prevention and treatment of this lung disease.

Through the development of evidence-based guidelines for COPD management, and events such as the annual celebration of World COPD Day, GOLD is working to improve the lives of people with COPD in every corner of the globe.

Who Are We?
GOLD was launched in 1997 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization.

GOLD’s program is determined and its guidelines for COPD care are shaped by committees made up of leading experts from around the world.

COPD is an inflammatory response characterized by persistent airflow limitations that is progressive in nature.  Exacerbations and comorbidities contribute to the overall severity in patients.

Symptoms:  Dyspnea, chronic cough, chronic sputum production

Spirometry is required to make a clinical diagnosis of COPD; the presence of a post-bronchodilator FEV1/FVC < 0.70 confirms the presence of persistent airflow limitation and thus of COPD.

Causes:  Smoking, indoor air pollution, occupational dusts and chemicals, and outdoor air pollution

Differential Diagnosis:

1. COPD:  Onset in mid-life.  Symptoms slowly progress.  Usually a history of smoking.
2. Asthma:  Onset usually early in life.  Symptoms vary day-to-day.  Symptoms worse at night/morning.  Allergy, rhinitis, and/or eczema also present.  Family history.
3. CHF:  Dilated heart, pulmonary edema on chest x-ray.  Pulmonary function tests show volume restriction, not airflow limitation.
4. Bronchiectasis:  Usually associated with bacterial infection.  Lots of purulent sputum.  Chest x-ray/CT shows bronchial dilation and wall thickening.
5. TB:  can confirm with microbiological testing.  Lung infiltrates.

The complete report (lengthy) can be found
www.goldcopd.org/uploads/users/files/GOLD_Report_2013_Feb20.pdf

The At A Glance COPD Management Refernce guide (short 8 pages)
www.goldcopd.org/uploads/users/files/GOLD_AtAGlance_2013_Feb20.pdf

The pocket guide (32 pages) for Health Care Professionals for Diagnosis, Management and Prevention is 
www.goldcopd.org/uploads/users/files/GOLD_Pocket_2013_Mar27.pdf

The GOLD classifications are the main method doctors use to describe the severity of chronic obstructive pulmonary disease (COPD).

GOLD is short for the Global Initiative for Chronic Obstructive Lung Disease, a collaboration between the National Institutes of Health and the World Health Organization.

What Is GOLD Staging for COPD?

The GOLD staging system classifies people with COPD based on their degree of airflow limitation (obstruction). The airflow limitation is measured during pulmonary function tests (PFTs).

When blowing out forcefully, people with normal lungs can exhale most of the air in their lungs in one second. Pulmonary function tests measure this and other values, and are used to diagnose COPD and its severity:

• The volume in a one-second forced exhalation is called the forced expiratory volume in one second (FEV1), measured in liters.
• The total exhaled breath is called the forced vital capacity (FVC), also measured in liters.
• In people with normal lung function, FEV1 is at least 70% of FVC.

Because of lung damage, people with COPD take longer to blow air out. This impairment is called obstruction or airflow limitation. An FEV1 less than 70% of FVC can make the diagnosis of COPD in someone with compatible symptoms and history.

In GOLD COPD, classifications are then used to describe the severity of the obstruction or airflow limitation. The worse a person's airflow limitation is, the lower their FEV1. As COPD progresses, FEV1 tends to decline. GOLD COPD staging uses four categories of severity for COPD, based on the value of FEV1:

Stage I:  Mild COPD - FEV1/FVC<0.70 - FEV1 ≥ 80% normal

Stage II:  Moderate COPD - FEV1/FVC<0.70 - FEV1 50-79% normal

Stage III:  Severe COPD - FEV1/FVC<0.70 - FEV1 30-49% normal

Stage IV:  Very Severe COPD - FEV1/FVC<0.70 - FEV1 <30% normal, or <50% normal with chronic respiratory failure present*

* Usually, this means requiring long-term oxygen therapy.

What Do the GOLD COPD Classifications Mean?

The GOLD COPD criteria are an attempt by health experts to group people together based on the severity of their COPD. This process is called COPD staging. Accurate staging, or knowing the severity of your COPD, could have various benefits, such as:

• Helping people with COPD understand their disease better
• Helping doctors make better treatment recommendations for people with COPD
• Helping people with COPD plan for their future, and predict life expectancy

The GOLD COPD staging system can be helpful toward these goals. But the system is not accurate or precise enough to predict symptoms or life expectancy in individual people living with COPD.

One problem is that the GOLD COPD classifications only consider a person's degree of airflow obstruction. On average, people with severe airflow obstruction from COPD do have worse symptoms and a shorter life expectancy than people with mild obstruction. However, many other factors beside airflow obstruction influence breathing symptoms and life expectancy, such as:

• Overweight and obesity
• Smoking status
• Other medical conditions, especially heart disease
• Physical fitness and exercise habits

Here is a guideline summary that is pretty in-depth.

Remember what you need to make a diagnosis:  spirometry.  Remember the categories.  Remember the treatments for each category.

Cholesterol Guideline Changes

A whopping 13 million more Americans will now be taking statins due to the recent changes in the guidelines formulated by the American Heart Association and the American College of Cardiology (source:  NEJM).  The new guidelines released by the American Heart Association were released back last November.  

The new guidelines are taking a very different approach.  Rather than focusing on specific end targets for cholesterol, the guidelines focus more on risk and prevention of strokes and heart attacks.  They disregard the guideline that doctors should prescribe cholesterol-lowering drugs when a patient's LDL, or bad cholesterol, reaches a certain threshold — in recent years, above 130.  The guidelines also say everyone with known heart disease should be taking statins.

The guideline recommends statin therapy for the following groups:

• People without cardiovascular disease who are 40 to 75 years old and have a 7.5 percent or higher risk for having a heart attack or stroke within 10 years.  (According to a new risk calculator).
• People with a history of a cardiovascular event (heart attack, stroke, stable or unstable angina, peripheral artery disease, transient ischemic attack, or coronary or other arterial revascularization).
• People 21 and older who have a very high level of bad cholesterol (190 mg/dL or higher).
• People with Type 1 or Type 2 diabetes who are 40 to 75 years old.  The drugs are also recommended for younger adults if their LDL cholesterol is over 190.

(Just for reference the old guidelines, using a different calculator, prescribed statin use at a 10-year risk above 20 percent, along with an LDL-cholesterol reading above 130).

As far as side effects go:

• FDA's Guidelines

PPIs and C. Diff

One of the most prevalent problems I see in the community is the overuse of protein pump inhibitors or PPIs.  The mechanism is thought to be by raising pH and therefore preventing gastric contents from killing C. difficle spores or gastric contents of PPI-treated patients may promote germination and outgrowth of C.difficile spores. 

Available proton pump inhibitors  include:

• omeprazole (Prilosec),
• lansoprazole (Prevacid),
• rabeprazole (Aciphex),
• pantoprazole (Protonix),
• esomeprazole (Nexium), and
• Zegarid, a rapid release form of omeprazole.

The FDA issued their own warning:  (from the FDA website):

FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)

(en Español)

Safety Announcement

[02-08-2012] The U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve.

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.

Facts about Proton Pump Inhibitor (PPI) Drugs

• Marketed under various brand and generic drug names (see Tables 1 and 2) as prescription and over-the-counter (OTC) products.
• Work by reducing the amount of acid in the stomach.
• Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.
• Over-the-counter PPIs are used to treat frequent heartburn.

Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve.1 Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in the hospital. Factors that may predispose an individual to developing CDAD include advanced age, certain chronic medical conditions, and taking broad spectrum antibiotics. Treatment for CDAD includes the replacement of fluids and electrolytes and the use of special antibiotics.  

The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.

FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn. H2 receptor blockers are marketed under various brand and generic drug names (seeTables 3 and 4) as prescription and OTC products.

Today's communication is in keeping with FDA's commitment to inform the public about the Agency's ongoing safety review of drugs. FDA will communicate any new information on PPIs or H2 receptor blockers and the risk of CDAD when it becomes available.
 

Additional Information for Patients and OTC Consumers: 

• Seek immediate care if you use PPIs and develop diarrhea that does not improve. This may be a sign ofClostridium difficile–associated diarrhea (CDAD).
• Your healthcare professional may order laboratory tests to check if you have CDAD.
• Do not stop taking your prescription PPI drug without talking to your healthcare professional.
• Discuss any questions or concerns about your PPI drug with your healthcare professional.
• If you take an OTC PPI drug, follow the directions on the package carefully.
• Report any side effects you experience to the FDA MedWatch program using the information in the "Contact FDA" box at the bottom of the page.

Additional Information for Healthcare Professionals 

• A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
• Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
• Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
• Report adverse events involving PPIs to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.

Data Summary

FDA has reviewed reports from the FDA's Adverse Event Reporting System (AERS) and the medical literature for cases of Clostridium difficile-associated diarrhea (CDAD) in patients undergoing treatment with PPIs. Many of the adverse event reports involved patients who were elderly, had chronic and/or concomitant underlying medical conditions, or were taking broad spectrum antibiotics that could have predisposed them to developing CDAD. Although these factors could have increased their risk of CDAD, the role of PPI use cannot be definitively ruled out in these reviewed reports. Patients who have one or more of these risk factors may have serious outcomes from CDAD with concomitant PPI use.

FDA also reviewed a total of 28 observational studies described in 26 publications. Twenty-three of the studies showed a higher risk of C. difficile infection or disease, including CDAD, associated with PPI exposure compared to no PPI exposure.2-27 Although the strength of the association varied widely from study to study, most studies found that the risk of C. difficile infection or disease, including CDAD, ranged from 1.4 to 2.75 times higher among patients with PPI exposure compared to those without PPI exposure. In the five studies that provided information on clinical outcomes, colectomies, and rarely deaths, were reported in some patients 4,6,11,12,21

The published studies varied in their ability to assess the association between C. difficile infection or CDAD and prior PPI use. There were limited data on the relationship between the risk of C. difficile infection or CDAD and PPI dose and duration of use. There also was little information on the use of OTC PPIs in community settings in these studies. Nevertheless, the weight of evidence suggests a positive association between the use of PPIs and C. difficile infection and disease, including CDAD.

References

1. U.S. National Library of Medicine. National Institutes of Health. Health topics-Clostridium difficileinfections. http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&query=clostridium+difficile+infections. Accessed January 31, 2012.
2. Al-Tureihi FIJ, Hassoun A, Wolf-Klein G, et al. Albumin, length of stay, and proton pump inhibitors: key factors in Clostridium difficile-associated disease in nursing home patients. J Am Med Dir Assoc.2005;6:105-108.
3. Cunningham R, Dale B, Undy B, et al. Proton pump inhibitors as a risk factor for Clostridium difficilediarrhoea. J Hosp Infect. 2003;(54):243-245.
4. Dial S, Alrasadi K, Manoukian C, et al. Risk of Clostridium difficile diarrhea among hospital inpatients prescribed proton pump inhibitors: cohort and case-control studies. CMAJ. 2004;171(1):33-38.
5. Dial S, Delaney JAC, Barkun A, et al. Use of gastric acid-suppressive agents and the risk of community-acquired Clostridium difficile-associated disease. JAMA 2005;294(23):2989-2995.
6. Muto C, Pokrywka M, Shutt K, et al. A large outbreak of Clostridium difficile associated disease with an unexpected proportion of deaths and colectomies at a teaching hospital following increased fluoroquinolone use. Infect Control Hosp Epidemiol. 2005;26:273-280.
7. Pepin J, Saheb N, Coulombe M-A, et al. Emergence of fluoroquinolones as the predominant risk factor forClostridium difficile-associated diarrhea: a cohort study during an epidemic in Quebec. Clin Infect Dis. 2005;41(9):1254-1260.
8. Shah S, Lewis A, Leopold D, et al. Gastric acid suppression does not promote clostridial diarrhoea in the elderly. QJM .2000;93:175-181.
9. Dial S, Delaney JAC, Schneider V, et al. Proton pump inhibitor use and risk of community-acquiredClostridium difficile-associated disease defined by prescription for oral vancomycin therapy. CMAJ. 2006;175(7):745-748.
10. Dial S, Kezouh A, Dascal A, et al. Patterns of antibiotic use and risk of hospital admission for Clostridium difficile infection among elderly people in Quebec. CMAJ. 2008;179:767-772.
11. Loo VG, Poirier L, Miller MA, et al. A predominantly clonal multi-institutional outbreak of Clostridium diffcile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005;353:2442-2449.
12. Akhtar AJ, Shaheen M. Increasing incidence of Clostridium difficile-associated diarrhea in African-American and Hispanic patients: association with the use of proton pump inhibitor therapy. J Natl Med Assoc. 2007;99(5):500-504.
13. Aseeri M, Schroeder T, Kramer J, et al. Gastric acid suppression by proton pump inhibitors as a risk factor for Clostridium difficile-associated diarrhea in hospitalized patients. Am J Gastroenterol. 2008;103(9):2308-2313.
14. Beaulieu M, Williamson D, Pichette G, et al. Risk of Clostridium difficile associated disease among patients receiving proton-pump inhibitors in a Quebec medical intensive care unit. Infect Control Hosp Epidemiol. 2007;28(11):1305-1307.
15. Cadle R, Mansouri M, Logan N, et al. Association of proton-pump inhibitors with outcomes in Clostridium difficile colitis. Am J Health Syst Pharm. 2007;64(22):2359-2363.
16. Dalton B, Lye-Maccannell T, Henderson E, et al. Proton pump inhibitors increase significantly the risk ofClostridium difficile infection in a low-endemicity, non-outbreak hospital setting. Aliment Pharmacol Ther. 2009;29(6):626-634.
17. Dubberke ER, Reske KA, Yan Y, et al. Clostridium difficile-associated disease in a setting of endemicity: identification of novel risk factors. Clin Infect Dis. 2007;45(12):1543-1549.
18. Howell MD, Novack V, Grgurich P, et al. Iatrogenic gastric acid suppression and the risk of nosocomialClostridium difficile infection. Arch Intern Med. 2010;170(9):784-790.
19. Janarthanan S, Ditah I, Kutait A, et al. A meta-analysis of 16 observational studies on proton pump inhibitor use and risk of Clostridium difficile associated diarrhea [abstract]. American College of Gastroenterology Conference 2010;Abstract 378.
20. Jayatilaka S, Shakov R, Eddi R, et al. Clostridium difficile infection in an urban medical center: five-year analysis of infection rates among adult admissions and association with the use of proton pump inhibitors. Ann Clin Lab Sci. 2007;37(3):241-247.
21. Kazakova SV, Ware K, Baughman B, et al. A hospital outbreak of diarrhea due to an emerging epidemic strain of Clostridium difficile. Arch Intern Med. 2006;166(22):2518-2524.
22. Kim JW, Lee KL, Jeong JB, et al. Proton pump inhibitors as a risk factor for recurrence of Clostridium-difficile-associated diarrhea. World J Gastroenterol. 2010;16(28):3573-3577.
23. Leonard J, Marshall JK, Moayyedi P. Systematic review of the risk of enteric infection in patients taking acid suppression. Am J Gastroenterol. 2007;102(9):2047-2056.
24. Linsky A, Gupta K, Lawler EV, et al. Proton pump inhibitors and risk for recurrent Clostridium difficileinfection. Arch Intern Med. 2010;170(9):772-778.
25. Lowe DO, Mamdani MM, Kopp A, et al. Proton pump inhibitors and hospitalization for Clostridium difficile-associated disease: a population-based study. Clin Infect Dis. 2006;43(10):1272-1276.
26. Turco R, Martinelli M, Miele E, et al. Proton pump inhibitors as a risk factor for paediatric Clostridium difficile infection. Aliment Pharmacol Ther. 2010;31(7):754-759.
27. Yearsley K, Gilby L, Ramadas A, et al. Proton pump inhibitor therapy is a risk factor for Clostridium difficile-associated diarrhoea. Aliment Pharmacol Ther. 2006;24(4):613-9.

Move Over Fatty Acids?

A systematic review or meta-analysis of the association of fatty acids and cardiovascular health was released by the Annals of Internal Medicine basically showing that current evidence does not clearly support cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats.

The findings released Monday in the Annals of Internal Medicine are the latest to show that supplements and vitamins don't work as well as touted to help patients prevent diseases. While past studies showed fish oil can lower unhealthy blood fats, blood pressure and reduce the risk of a second heart attack, research in recent years contradicted those findings, suggesting it has limited heart benefits. Researchers analyzed 72 studies that looked at more than 600,000 patients from 18 countries. Of those, 40 studies involved initially healthy people, 10 studies recruited people with elevated cardiovascular risk factors and 22 studies recruited people with cardiovascular disease.

The problem with the way TIME and other media outlets present the analysis is that they sort of give a negative slant toward lack of benefit meaning causing harm camp.  That was never the result of the review.  There can be no benefit and no harm.

Pharmacists and Provider Status

What is provider status?  Why is it important to the profession to gain?

Pharmacists and pharmacists’ patient care services are not included in key sections of the Social Security Act (SSA), which determines eligibility for health care programs such as Medicare Part B. In the case of Medicare Part B, the omission of pharmacists as listed providers limits Medicare beneficiaries’ access to pharmacists’ services in the outpatient setting. Other health care professionals who are listed as providers in Part B of the SSA include physicians, physician’s assistants, certified nurse practitioners, qualified psychologists, clinical social workers, certified nurse midwives, and certified registered nurse anesthetists. In addition to providers, Part B provides the list of medical and other health services covered.

Many state and private health plans often cite the omission from Medicare Part B as a reason for lack of coverage for beneficiaries or lack of compensation of pharmacists for providing comprehensive, patient-centered care. Omission from Medicare Part B can also result in barriers to optimizing the use of pharmacists’ patient care services in emerging integrated care delivery models promoted by the Affordable Care Act (ACA), such as medical homes and accountable care organizations (ACOs), which are located in another section of the SSA.

The American Pharmacists Association has a full page of the hows and whys.

The American Society of Health-System Pharmacists is on board as well.

California has passed legislation and just like most bills starting in CA, it will sweep the country.

Here's a summary of what was passed in California last year:

Pharmacist Provider Status Legislation SB 493 (Hernandez) Summary

Now that the pharmacist provider status bill has been signed by the Governor, many pharmacists are asking: “what does this bill do for me?” SB 493 grants all pharmacists certain authorities in all practice settings that had previously been limited to inpatient settings or integrated systems. The bill also establishes a new “Advanced Practice Pharmacist” recognition. This recognition can be granted when specified experience and/or certification requirements are met. The Advanced Practice Pharmacist recognition is not mandatory, but it does allow pharmacists to provide additional services. Below is a summary of SB 493’s changes, which take effect January 1, 2014, though some provisions require regulations by the Board of Pharmacy and will not take effect until those regulations are approved.

• Declares pharmacists as healthcare providers who have the authority to provide health care services.
• Authorizes all licensed pharmacists to:
• Administer drugs and biologics when ordered by a prescriber. Previously, this was limited to oral and topical administration. SB 493 allows pharmacists to administer drugs via other methods, including by injection. 
• Provide consultation, training, and education about drug therapy, disease management and disease prevention. 
• Participate in multidisciplinary review of patient progress, including appropriate access to medical records. 
• Furnish self-administered hormonal contraceptives (the pill, the patch, and the ring) pursuant to a statewide protocol. This authority is similar to the existing emergency contraception protocol. Once a statewide protocol is adopted by the Board of Pharmacy, it will automatically apply to all pharmacists. 
• Furnish travel medications recommended by the CDC not requiring a diagnosis. 
• Furnish prescription nicotine replacement products for smoking cessation pursuant to a statewide protocol if certain training, certification, recordkeeping, and notification requirements are met. Once a statewide protocol is adopted by the Board of Pharmacy, it will automatically apply to all pharmacists. 
• Independently initiate and administer immunizations to patients three years of age and older if certain training, certification, recordkeeping, and reporting requirements are met. A physician protocol is still required to administer immunizations on children younger than three years of age. 
• Order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies, in coordination with the patient’s primary care provider or diagnosing prescriber. 
• Establishes an Advanced Practice Pharmacist (APP) recognition, and authorizes APPs to:  

1. Perform patient assessments
2. Order and interpret drug therapy-related tests in coordination with the patient’s primary care provider or diagnosing prescriber. 
3. Refer patients to other healthcare providers. 
4. Initiate, adjust, and discontinue drug therapy pursuant to an order by a patient’s treating prescriber and in accordance with established protocols. 
5. Participate in the evaluation and management of diseases and health conditions in collaboration with other healthcare providers. 
6. Requires pharmacists seeking recognition as APPs to complete any two of the following three criteria: Earn certification in a relevant area of practice, such as ambulatory care, critical care, oncology pharmacy or pharmacotherapy. Complete a postgraduate residency program. Have provided clinical services to patients for one year under a collaborative practice agreement or protocol with a physician, APP pharmacist, CDTM pharmacist, or health system.

I want recognition for the value brought to patients and the health care team.

Pharmacists are an integral part of the healthcare team.  I hope to see this sweep across the country in the next few years and that board certification propels us into a whole new recognized role.