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TSI DRUG SAFETY e-UPDATE

VIEWS: 3 PAGES: 12

									                                                                                        Page |1


                                                                                         April/May, 2011




   TSI DRUG SAFETY e-UPDATE
REGULATORY REPORTS
 2-3     NUMBING DRUG FOR MUCOUS MEMBRANES IN MOUTH AND THROAT CAUSES METHEMOGLOBINEMIA
  3      DRUG FOR TREATMENT OF MULTIPLE MYELOMA AND MYELODYSPLASTIC SYNDROME MAY RAISE RISK OF
         NEW MALIGNANCIES
  4      FEBRUARY, 2011 LISTING OF FDA SAFETY LABELING CHANGES
  5      MARCH, 2011 LISTING OF FDA SAFETY LABELING CHANGES
  6      FDA’S MEDWATCH SAFETY ALERTS: MARCH, 2011


MEDICAL LITERATURE REPORTS
 6-7     FURTHER EVIDENCE THAT ORAL CONTRACEPTIVES MAY INCREASE RISK OF VENOUS THROMBOEMBOLISM
 7-8     RAMPANT OFF-LABEL USE OF PRO-COAGULANT, DESPITE LACK OF DEMONSTRATED SAFETY AND
         EFFICACY


OTHER INFORMATION
 8-9     RAISING AWARENESS ABOUT HOW DRUG COMPANIES INFLUENCE PHYSICIAN PRESCRIBING
 9-10    MINIMIZING HEALTHCARE WORKERS’ EXPOSURE TO TOXIC MEDICATIONS
 10      MEDICATION ERRORS IN THE INTENSIVE CARE UNIT (ICU)
 11      INSTITUTE FOR SAFE MEDICATION PRACTICES (ISMP) OFFERS NUMEROUS RESOURCES FOCUSING ON
         MEDICATION SAFETY
 11      MEDSCAPE WEB SITE PROVIDES LINKS TO VALUABLE DRUG ADVERSE EVENTS INFORMATION




                       MISSION OF TSI DRUG SAFETY e-UPDATE
  This online newsletter gathers recently released information about drug safety from reliable,
  objective, evidence-based sources and summarizes/interprets and disseminates this information in
  a timely manner to clinical practitioners, pharmacists and others. Previous issues of this newsletter
  may be accessed at TSI Drug Safety e-Update .




             TO SUBSCRIBE TO THE TSI DRUG SAFETY e-UPDATE
Please send a message to smargiti@wfubmc.edu indicating that you would like to be added to the
distribution list for our free e-newsletter.




       TSI Drug Safety e-Update, April/May 2011
                                                                                     Page |2


                                 REGULATORY AGENCY REPORTS

NUMBING DRUG FOR MUCOUS MEMBRANES IN MOUTH AND THROAT CAUSES METHEMOGLOBINEMIA

Concern: FDA Public Health Advisory warning about the association between use of benzocaine1
sprays for medical procedures (e.g., intubation) and development of methemoglobinemia2. The
advisory also refers to use of OTC Benzocaine liquid and gel products that relieve minor
mouth/throat pain (e.g., sore throat, canker sores, dental procedures,mouth and gum injury) in
adults and children.

Background: In 2006, the FDA issued a Public Health Advisory warning about the development of
methemoglobinemia with use of benzocaine sprays during medical procedures.

Findings:
   Since issuance by the FDA of the 2006 Public Health Advisory, the FDA has received 72 new
   cases of serious adverse events (including three deaths) associated with methemoglobinemia
   after use of benzocaine sprays, bringing the total number of cases to 319.
   Use of the drug spray was for medical procedures such as transesophageal echocardiogram,
   endoscopy, bronchoscopy, intubation, and feeding tube placements.
   Methemoglobinemia has also been reported for all strengths of benzocaine gels and liquids,
   with cases mostly appearing in children < 2 years of age who were treated with benzocaine gel
   for teething. Signs and symptoms usually appear within minutes to hours of applying benzocaine
   and may occur with the first application of benzocaine (or after additional use).
   The development of methemoglobinemia after treatment with benzocaine sprays may not be
   related to the amount applied. In many cases, methemoglobinemia was reported following the
   administration of a single benzocaine spray.

Interpretation: Benzocaine products should not be used on children two years of age or younger,
except under the advice and supervision of a healthcare professional. Although use of benzocaine
can cause this condition, drug labels for marketed benzocaine sprays are not yet required to warn
about this risk. The FDA is continuing to evaluate the safety of benzocaine products and the
Agency will update the public when it has additional information.

Recommendations:
   “Benzocaine products should not be used on children less than two years of age, except
   under the advice and supervision of a healthcare professional.”
   “Carefully monitor patients who receive benzocaine sprays for signs of methemoglobinemia
   3
     during the procedure and for at least two hours post-application…symptoms may appear
   within minutes to one or two hours after using benzocaine.
   …the amount of benzocaine contained in a single spray varies among different
   manufacturers and depends on the concentration of the solution, the amount of time the
   actuator is depressed, the residual volume in the can, and the spatial orientation of the can
   during spraying.
   Methemoglobinemia can cause unreliable oxygen saturation readings on a standard 2-
   wavelength pulse oximeter when used to assess the amount of oxygen bound to
   hemoglobin. If blood is drawn to check for methemoglobinemia, an FDA-approved co-
   oximeter should be used to reliably measure methemoglobin.




   TSI Drug Safety e-Update, April/May 2011
                                                                                              Page |3

    Patients who have breathing problems such as asthma, bronchitis, or emphysema, patients
    with heart disease, and patients who smoke are at greater risk for complications related to
    methemoglobinemia.
    Infants less than four months of age, elderly patients, and patients with certain inborn
    defects such as glucose-6-phosphodiesterase deficiency, hemoglobin-M disease, NADH-
    methemoglobin reductase (diaphorase 1) deficiency, and pyruvate-kinase deficiency may
    also be at greater risk of developing methemoglobinemia.
    Medications, foods, and water containing nitrites and nitrates may also induce
    methemoglobin formation, which will be additive to that formed by benzocaine products.”

Sources:
1. Benzocaine sprays include Hurricaine, Cetacaine, Exactacain, and Topex. Benzocaine gels and liquids are
   sold over-the-counter (Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands). Benzocaine
   is also sold as lozenges and spray solutions. These products are used to relieve pain from a variety of
   conditions, such as teething, canker sores, and irritation of the mouth and gums.
2. Methemoglobinemia is a rare, but serious (sometimes fatal) condition in which the amount of oxygen
   carried through the blood stream is greatly reduced. Symptoms include pale, gray or blue colored skin,
   lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Other
   symptoms may include cyanosis.
3. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm25
   0264.htm. Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia. April 7,
   2011.
4. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSa
   fetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm124350.htm. Public Health
   Advisory: Benzocaine Sprays marketed under different names, including Hurricaine, Topex, and
   Cetacaine. January 19, 2010.



DRUG FOR TREATMENT OF MULTIPLE MYELOMA AND MYELODYSPLASTIC SYNDROME MAY RAISE
RISK OF NEW MALIGNANCIES

Concern: Patients taking Revlimid (lenalidomide) may be at increased risk for new types of cancer
compared to patients not taking this drug.

Background: Revlimid is used to treat the blood disorder myelodysplastic syndrome, and it is used
in combination with medications such as dexamethasone to treat multiple myeloma.

Methodology: Preliminary data obtained from evaluation of outcomes from longer-term exposure
to Revlimid and from controlled clinical trials conducted within and outside of the Unites States

Findings: Early findings reveal an increased incidence of some second primary malignancies,
especially acute myelogenous leukemia (AML) and B-cell lymphoma, when compared to controls.
(No data are provided.)

Recommendations: At this time, there is no recommendation to delay, modify or restrict the use
of Revlimid for patients being treated according to the FDA-approved indications. The FDA will
continue reviewing all available new information concerning this risk, but currently recommends
caution when interpreting these findings. Since lenalidomide is an analogue of thalidomide, the
FDA is also reviewing available data to determine similar potential risks for thalidomide.

Source: Revlimid FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and
possible increased risk of developing new malignancies. April 8, 2011.

    TSI Drug Safety e-Update, April/May 2011
                                                                                            Page |4

FEBRUARY, 2011 LISTING OF FDA SAFETY LABELING CHANGES

These label changes are categorized as boxed warnings* (the most serious type of warning),
contraindications, warnings, precautions, adverse reactions or patient package insert/medication
guides). Consult the reference below for more detailed information.

       Adalat CC (nifedipine)
       Adenoscan (adenosine)
       Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin hydrochloride),
       Avandaryl (rosiglitazone maleate/glimepiride)*
       Avelox (moxifloxacin hydrochloride)*
       Betapace (sotalol hydrochloride) and Betapace AF (sotalol hydrochloride)
       Brovana (arformoterol)
       Cataflam (diclofenac potassium)
       Cipro (ciprofloxacin hydrochloride) *
       Diabinese (chlorpropamide)
       Factive (gemifloxacin mesylate)*
       Flector Patch (diclofenac epolamine)
       Floxin (ofloxacin)*
       Glucotrol and Glucotrol XL (glipizide)
       Glynase (micronized glyburide)
       Heparin Sodium
       Humatrope (somatotropin [rDNA origin])
       Increlex (mecasermin [rDNA origin]
       Isentress (raltegravir potassium)
       Kaletra (lopinavir/ritonavir)
       Levaquin (levofloxacin) *
       Metaglip (glipizide/metformin HCl fixed-dose combination)
       Micronase (glyburide) tablets
       Multaq (dronedarone hydrochloride)
       NebuPent (pentamidine isethionate)
       Noroxin (norfloxacin) *
       Pegasys (ß (peginterferon alfa-2a)
       Perforomist (formoterol fumarate)
       Plavix (clopidogrel bisulfate)
       Prilosec OTC (omeprazole magnesium)
       Promacta (eltrombopag)
       Proquin XR (ciprofloxacin)*
       Remicade (Infliximab)
       Simcor (niacin extended release/simvastatin)
       Symbicort (budesonide and formoterol)
       Talwin Nx (pentazocine hydrochloride and naloxone Hydrochloride)
       Tazorac (tazarotene)
       Tekturna (aliskiren)and Tekturna HCT(aliskiren/hydrochlorothiazide)
       Toviaz (fesoterodine fumarate)
       Valturna (aliskiren/valsartan)
       Vantas (histrelin acetate)
       Viracept (nelfinavir mesylate)
       Voltaren (diclofenac sodium enteric-coated) and Voltaren-XR
       Zebeta (bisoprolol fumarate) Zometa (zoledronic acid)


Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm242998.htm February 2011 Safety
labeling changes.

    TSI Drug Safety e-Update, April/May 2011
                                                                                             Page |5
MARCH, 2011 LISTING OF FDA SAFETY LABELING CHANGES

These label changes are categorized as boxed warnings* (the most serious type of warning), contraindications,
warnings, precautions, adverse reactions or patient package insert/medication guides). Consult the reference
below the list of drugs for more detailed information.

       AccuNeb (albuterol sulfate)
       Accuretic (quinapril HCL/hydrochlorothiazide)
       Advil Cold & Sinus Liqui-Gels (ibuprofen 200 mg and pseudoephedrine HCl 30 mg)
       Aredia (pamidronate disodium)
       AndroGel (testosterone) 1% gel
       Aromasin (exemestane)
       Atacand HCT (candesartan cilexitil/hydrochlorothiazide)
       Azasite (azithromycin)
       Doryx (doxycycline hyclate)
       Dutoprol (metoprolol succinate extended release/hydrochlorothiazide)
       Dyazide (hydrochlorothiazide/triamterene)
       Etopophos (etoposide phosphate)
       Fareston (toremifene citrate)*
       Flolan (epoprostenol sodium)
       Inderal (propranolol HCL) and Inderal LA (propranolol hydrochloride)
       Inderide (propranolol hydrochloride/hydrochlorothiazide)
       Integrilin (eptifibatide)
       Letairis (ambrisentan)
       Lexapro (escitalopram oxalate)
       Lioresal (baclofen)
       Lopressor (metoprolol tartrate) and Lopressor HCT (metoprolol tartrate/hydrochlorothiazide)
       Lotensin HCT (benazapril hydrochloride/hydorchlorothiazide)
       Lupron (leuprolide acetate)
       Maxzide and Maxzide-25 (triamterene/hydrochlorothiazide) and
       Microzide (hydrochlorothiazide)
       Monodox (doxycycline monohydrate)
       Neurontin (gabapentin)
       Nexavar (sorafenib tosylate)
       Ortho Evra (norelgestromin/ethinyl estradiol)*
       PhosLo (calcium acetate)
       Precose (acarbose)
       Pristiq (desvenlafaxine)
       Propecia (finasteride)
       Reclast (zoledronic acid)
       Rotarix (Rotavirus Vaccine, Live, Oral)
       Sectral (acebutolol hydrochloride)
       Strattera (atomoxetine hydrochloride)
       Talacen (pentazocine hydrochloride and acetaminophen)
       Tekamlo (aliskiren/amlodipine)
       Topamax (topiramate)
       Tribenzor (olmesartan medoxomil / amlodipine / hydrochlorothiazide)
       Veletri (epoprostenol sodium)
       Vaseretic (enalapril maleate/hydrochlorothiazide)
       Xyzal (levocetirizine dihydrochloride)
       Yaz (drospirenone/ethinyl estradiol)
       Zestoretic (lisinopril/hydrochlorothiazide)

Source: www.fda.gov/Safety/MedWatch/SafetyInformation/ucm249643.htm March 2011 Safety label changes.


    TSI Drug Safety e-Update, April/May 2011
                                                                                       Page |6

FDA’S MEDWATCH SAFETY ALERTS: MARCH, 2011

These post-approval reports, which are based on the FDA’s MedWatch adverse events reporting system,
address the following drug safety concerns:

   Unapproved Prescription Drugs to Be Removed From Market
   Pradaxa Capsules: Special Storage and Handling Requirements
   Citalopram and Finasteride Recall
   Nexium, Prilosec, and Other Drugs: Low Magnesium Levels
   Roche Infusion Set Recall
   Topamax: Risk to Infants
   Kaletra: Serious Health Problems in Premature Babies With HIV
   Soladek Vitamin Solution: Dangerously High Levels of Vitamins
   Povidone Iodine Prep Pads Recall
   Unapproved Drugs Sold as Dietary Supplements

Source: FDA's MedWatch Safety Alerts: March 2011



                                MEDICAL LITERATURE REPORTS


FURTHER EVIDENCE THAT ORAL CONTRACEPTIVES MAY INCREASE RISK OF VENOUS THROMBOEMBOLISM

Concern: Oral contraceptives containing drospirenone (Yasmin, YAZ) may raise the risk for developing
venous blood clots.

Background: Drospirenone is a third-generation oral contraceptive that is combined with ethinylestradiol
to produce the oral contraceptives Yasmin and YAZ. While providing effective birth control, drospirenone
has been linked to venous thromboembolism. Reports regarding this association have been conflicting.

Methodology: The editorial cited below1 describes two new case control studies, 2,3 which analyzed data
from the UK General Practice Research Database (GPRD) and from Pharmetrics, a US medical claims
company.

Findings:
   The first study2 reported a three-fold increase in risk of non-fatal idiopathic venous thromboembolism
   among those using contraceptives containing drospirenone in comparison to women using the second-
   generation contraceptive levonorgestrel (adjusted odds ratio 3.3 [95% confidence interval 1.4 to
   7.6]).
   The second study3 observed that users of oral contraceptives containing drospirenone were nearly 2½
   times at risk for venous thromboembolism compared to women taking levonorgestrel-containing
   contraceptives (conditional odds ratio 2.3 [95% confidence interval 1.6 to 3.2]).
   Previous studies had reported a 1.5 to two-fold increased risk of venous thromboembolism.
   While these study results do confirm similar findings from two previous reports evaluating the
   relationship between drospirenone and venous thromboembolism, the author of the editorial cautions
   that the new studies do have some limitations that need to be considered. See study reports for
   further information, including study limitations.




     TSI Drug Safety e-Update, April/May 2011
                                                                                          Page |7


Interpretation: Although these findings are based on observational study data, they do add further
credence to a possible link between use of drospirenone and increased risk of venous thromboembolism.
The author of the editorial notes that “there is little evidence to support their [i.e., drospirenone
contraceptives) superiority over other low dose oral contraceptives.”

Recommendations: “When prescribing oral contraceptives, the patient’s individual risk-benefit profile
should be carefully considered, because such patients are often young, healthy, and may take the
chosen pill for a long time. It seems sensible to prescribe an oral contraceptive with a well known
favourable safety profile (one that contains levonorgestrel) unless there is a persistent reason to use
another type. The number of patients with such a specific indication for drospirenone is likely to be
small.”

Sources:
1. http://www.bmj.com/content/342/bmj.d2519.extract The risk of deep venous thrombosis with
   oral contraceptives containing drospirenone. Dunn N. BMJ 2011; 342:d2519.
2. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or
   levonorgestrel: nested case-control study based on UK General Practice Research Database
   Parkin L, Sharples K, Hernandez RK et al. BMJ 2011; 342:d2139.
3. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing
   drospirenone compared with women using oral contraceptives containing levonorgestrel: case-
   control study using United States claims data Jick SS and Hernandez RK. BMJ 2011; 342:d2151.




RAMPANT OFF-LABEL USE OF PRO-COAGULANT, DESPITE LACK OF DEMONSTRATED SAFETY AND
EFFICACY

Concern: FDA-approved use of recombinant factor VIIa (rFVIIa; NovoSeven, Novo Nordisk) for
management of bleeding in hemophiliac patients dwarfs off-label use of the drug for trauma,
intracerebral hemorrhage and bleeding complications from cardiovascular surgery, despite lack of
efficacy and safety data.

Background:
   A 2006 analysis of off-label prescribing patterns for office-based physicians reported that 73% of off-
   label prescribing was not backed by scientific evidence.
   While only a small subgroup of hemophiliac patients benefit from the approved use of recombinant
   rFVIIa, off-label use of this agent has sky rocketed in recent years.

                                                           1
Methodology: An editorial in Annals of Internal Medicine describes two companion studies published in
the same journal, one analyzing hospital records for trends in prescribing off-label rFVIIa (Logan et al.)2,
the other focusing on a review of published articles that explored the safety and efficacy of off-label
use of rFVIIa for a number of unapproved indications (Yang et al)3. See references below for details
about these analyses.

Findings:
   Logan et al.: “…use of rFVIIa in hospitalized patients without hemophilia grew more than 140-fold
   from 2000 to 2008. By the end of that period, its approved indication for hemophilia comprised only
   3% of its in-hospital use, with 97% of its use for off-label indications, including cardiovascular
   surgery, trauma, intracerebral hemorrhage, and other purposes.”



    TSI Drug Safety e-Update, April/May 2011
                                                                                             Page |8

   Yank et al.: Based on the 64 papers published in the medical literature that met the study inclusion
   criteria (16 randomized, controlled trials, 26 comparative observational studies and 22 non-
   comparative observational studies), the investigators reported no evidence that off-label use of rFVIIa
   reduced mortality; conversely its use increased risk of venous thromboembolism. These findings are
   consistent with previous reports.

See study reports for further information, including study limitations.

Interpretation:
    While no regulations preclude physicians from engaging in off-label prescribing of medications
    approved for other indications, there are real concerns that this practice has become very prevalent,
    despite absence of evidence documenting drug benefit and lack of harm. In the case of rFVIIa, there is
    also the financial consideration, since its cost is estimated to be $10,000 per dose.
    The investigators suggest that pharmaceutical manufacturers have likely contributed to the popularity
    of off-label prescribing of rFVIIa, creating “a market for the unauthorized and increasingly implausible
    prescribing of its product.”
    The authors advocate the need for research into “real-world use of medications” that can “adequately
    address the efficacy and associated harms of individual agents in the contexts in which they are most
    commonly used.”
    They also urge hospital administrators to oversee off-label prescribing of approved medications to
    determine if any troubling trends exist, especially in the absence of evidence describing efficacy and
    safety.
    “There is reason to wonder how the use of an obscure recombinant coagulation factor marketed
    exclusively to hematologists came to be used so widely by cardiac surgeons, neurologists, and trauma
    specialists. Further investigation may cast additional light on this question.”

   Sources:
1. http://www.annals.org/content/154/8/566.extract A Hemorrhage of Off-Label Use. Avorn J, Kesselheim A. Ann
   Intern Med April 19, 2011 154: 566-567.
   vol. 154 no. 8 566-567.
2. http://www.annals.org/content/154/8/516.abstract Off-Label Use of Recombinant Factor VIIa in U.S. Hospitals:
   Analysis of Hospital Records. Logan AC, Yank V, Stafford RS. Ann Intern Med April 19, 2011 154:516-522.
3. http://www.annals.org/content/154/8/529.abstract Systematic Review: Benefits and Harms of In-Hospital Use
   of Recombinant Factor VIIa for Off-Label Indications. Yank V. Tuohv CV, Logan et al. Ann Intern Med April 19,
   2011 154:529-540.




                                        OTHER INFORMATION

RAISING AWARENESS ABOUT HOW DRUG COMPANIES INFLUENCE PHYSICIAN PRESCRIBING

This report describes ways in which pharmaceutical industry representatives market their products to
physicians in an effort to affect physician prescribing patterns, and how these approaches can compromise
patient safety and public health. The report 1) employs the “pharmaceutical inverse benefit law” 1 to
facilitate clinicians’ understanding of how drug company marketers influence physicians’ decisions about
which medications to prescribe for their patients and 2) describes marketing strategies that
pharmaceutical representatives use to promote especially their most recently approved drug products. The
marketing strategies discussed include:




     TSI Drug Safety e-Update, April/May 2011
                                                                                                 Page |9


   Reducing Thresholds for Diagnosing Disease and Creating New Diseases: Promoting, without adequate
   evidence, the creation of new medical diagnoses such as pre-hypertension and pre-diabetes, thus
   exposing a whole new population of patients to medical interventions that may not be needed and may
   yield harmful effects (e.g., aggressive marketing of rosiglitazone that lead to cardiovascular mortality-
   associated adverse effects).
   Relying on Surrogate Endpoints: Promoting a drug’s efficacy and safety based on more easily obtainable
   “intermediate” outcomes (e.g., hypercholesterolemia) rather than conducting longer trials with greater
   numbers of participants that evaluate clinical event outcomes such as MI and stroke. This approach
   presumes the existence of a proven link between the surrogate and the hard endpoint, an association
   that cannot be assumed without hard evidence to confirm the connection.
   Exaggerating safety claims: Drug companies tend to overstate a new drug’s safety, drawing a “leap-of-
   faith” conclusion that safety findings from pre-approval trials (which are typically of short-term
   duration and include relatively few patients) can be extrapolated to long-term use of the new product
   in large populations.
   Exaggerating efficacy claims: Another strategy to increase sales of new drug products involves over-
   emphasizing a drug’s efficacy in comparison to older medications, which are cheaper and have much
   longer safety/efficacy track records. This approach of claiming superiority is often accomplished by
   targeting a small subset of a patient population, then claiming that the tested drug will benefit a
   broader population of patients.
   Encouraging unapproved uses: Pharmaceutical representatives manage to avoid outright (and illegal)
   promotion of off-label use of a medication by “manipulating the content of continuing medical
   education programs, hiring leading physicians to give presentations recommending off-label use, and
   sponsoring ghostwritten articles on off-label indications.”

Sources:
1. “The inverse benefit law…states that the ratio of benefits to harms among patients taking new drugs tends to vary
   inversely with how extensively the drugs are marketed.”
2. http://ajph.aphapublications.org/cgi/content/abstract/101/3/399 The Inverse Benefit Law: How Drug Marketing
   Undermines Patient Safety and Public Health. Brody H, Light DW. AJPH Online, 22 Feb 2011.
3. http://jama.ama-assn.org/content/305/11/1083.extract New “law” attempts to explain drug strategies
   marketers use to sway prescribing. Mitka, M. JAMA. 2011;305(11):1083-1084.




MINIMIZING HEALTHCARE WORKERS’ EXPOSURE TO TOXIC MEDICATIONS

This report1 describes ways in which healthcare workers are exposed to toxic medications being
administered to patients2, and offers “safe-handling guidelines” to minimize contamination. The report
also references a list of hazardous drugs issued by the National Institute for Occupational Safety and Health
(NIOSH) in 2010.3 While most drugs listed in the NIOSH report are anti-neoplastic agents, about one third
represent medications used as therapy for other diseases.

Situations that can compromise healthcare worker safety include contamination of the outer surface of
medication vials with the product that comes from the pharmaceutical manufacturer, breakage of vials
during shipping and receiving, and contaminated surfaces used by workers.

The report makes the following recommendations: “Using biological safety cabinets that are properly
vented, implement clean room technology, use closed-system transfer equipment for drug preparation and
administration, training and evaluating of workers in jeopardy of being exposed to…, employ protective
equipment (e.g., double gloves, nonpermeable and disposable “gowns” and respiratory protection).


       TSI Drug Safety e-Update, April/May 2011
                                                                                               P a g e | 10



The authors conclude by noting that “Unintended gaps, lapses, or breaches in safe working practices can
have serious adverse effects. Vials can be dropped, IV bags can leak, IV lines can become loose or
separated, and bedpans can spill, all of which can result in substantial exposure of healthcare workers to
unsafe substances.”

Sources:
1.   http://www.medscape.com/viewarticle/738076?src=mp&spon=17 Hazardous drugs in healthcare. Connor TH.
     Medscape News Today. Posted March 3, 2011. (Medscape requires a free login to access all articles.)
2.   Ways in which healthcare workers are exposed to hazardous medications: “Shipping and receiving personnel --
     when handling contaminated medication vials and/or spills; pharmacists and pharmacy technicians -- when
     compounding and checking drug preparations or counting out tablets; nursing personnel -- when administering
     agents and handling contaminated wastes; physicians -- when treating patients with or administering hazardous
     drugs; operating room personnel -- when administering medications in the operating room; home healthcare
     personnel -- when transporting drugs, treating patients, and handling wastes; workers in nursing home and long-
     term care facilities; environmental services personnel -- when removing contaminated waste and cleaning
     contaminated areas or dealing with medication spills; research laboratory personnel -- during drug research and
     development; and personnel in veterinary practices -- when hazardous agents are administered to animals.”
3.   http://www.cdc.gov/niosh/docs/2010-167/pdfs/2010-167.pdf NIOSH List of antineoplastic and other hazardous
     drugs in healthcare settings 2010. DHHS (NIOSH) Pub No. 2010-167, September 2010. Accessed January 15, 2010.




MEDICATION ERRORS IN THE INTENSIVE CARE UNIT (ICU)
             1
This report compiled data from six studies, three of which were conducted in the US, the other three
originating from Iran, France and the Netherlands. The contributing studies had evaluated levels of
nursing medication errors2 occurring in the ICU, as detected through direct observation (rather than via
chart review). These types of errors represent a particular challenge in the ICU setting, where twice as
many drugs are administered to critically ill patients compared to general care units, and where chances
for error are increased due to factors such as “high clinical severity and high number of organ
failures,…frequent interruptions, and workload.”

The investigators report that the most common types of medication errors related to wrong dose, wrong
administration time and rate, and dose omission. In contrast, administration of the wrong drug or
administration to the wrong patient was generally rare. The three classes of drugs most commonly
associated with errors were antibiotics, electrolytes and cardiovascular drugs. Some of the component
studies attributed errors to factors such as lack of drug knowledge, insufficient communication and
unreliable measurement of patients’ weights at admission (leading to incorrect dose calculations). See
report for more details about this study as well as study limitations.

Sources:
1.   http://ajcc.aacnjournals.org/content/20/1/36.abstract Medication Errors in Critically Ill Adults: A Review of
     Direct Observation Evidence. Kiekkas P, Karga M, Lemonidou C et al. Am J Crit Care December 31, 2010 vol. 20
     no. 1 36-44.
2.   ICU nurses focus much of their efforts on drug preparation and administration.




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  INSTITUTE FOR SAFE MEDICATION PRACTICES (ISMP) OFFERS NUMEROUS RESOURCES
  FOCUSING ON MEDICATION SAFETY

  The Institute for Safe Medication Practices (ISMP) has posted a list of oral medications that
  should never be crushed1. The ISMP also provides valuable write-ups and tools that offer
  guidance to healthcare practitioners concerning prevention of medication errors2. Some of
  the topics include:

      “Abbreviations toolkit”
       “Black box warnings”
      “Brochures for consumers on medication misuse”
      “Guidelines for preventing medication errors in pediatrics”
      “Improving medication safety with anticoagulant therapy.”

  Sources:
  1. http://www.ismp.org/Tools/DoNotCrush.pdf Oral dosage forms that should not be crushed.
      Mitchell JF. April 7, 2011.
  2. http://www.ismp.org/tools/default.asp ISMP Medication safety tools and resources.




  MEDSCAPE WEB SITE PROVIDES LINKS TO VALUABLE DRUG ADVERSE EVENTS INFORMATION

  The Medscape website referenced below provides links to numerous reports that describe
  medication-induced adverse events. Topics covered include:

      Thyroid Drug Linked to Fracture Risk in Older Adults
      FDA: Safety Issue With Investigational Merck Hepatitis Drug
      FDA Adds Further Risk Information to Natalizumab Label
      Nine Drugs Added to FDA Watch List
      More Evidence That Gastric Acid-Suppressive Drugs Raise Pneumonia Risk
      Paracetamol Use in Pregnancy Linked to Childhood Asthma
      EU Agency Flags Narcolepsy Risk With GSK Flu Shot
      New vs Old Contraceptives Have Similar Gallbladder Disease Risk
      Diet Drug Orlistat Linked to Kidney, Pancreas Injuries
      FDA Investigating Cancer Risk With Lenalidomide
      Perilous Infection Control Practices With Needles, Syringes, and Vials Suggest Stepped-
      Up Monitoring is Needed


  Source:: http://www.medscape.com/resource/adverse-drug-events-reporting Adverse drug events
  reporting. Medscape requires a free login to access all articles.




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  The FDA urges both healthcare professionals and patients to report adverse drug
   experiences to the FDA's MedWatch Adverse Event Reporting Program, online at
   www.fda.gov/medwatch/report.htm, by fax (800-FDA-0178), by mail using the postage-
   paid address form provided on line or by telephone (800-FDA-1088).
  Clinicians and pharmacists are encouraged to review the FDA website for the latest
   information regarding new drug safety information:
   http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalP
   roducts/default.htm
  Clinicians should routinely discuss with their patients the benefits of new or continued
   drug therapy vs. the risks associated with drug side effects or the risks associated with
   untreated illness, emphasizing that patients should not stop or change their medications
   without first consulting with the healthcare professional who is responsible for their care.




 WFUBMC DRUG SAFETY COMMITTEE
 Curt Furberg, MD, PhD1
 Susan Margitić, MS1, 2
 Robert Sherertz, MD
 Sonal Singh, MD, MPH1
 Ronald Small, MBA
 Beth Williams, PharmD
 _____________
 1. TSI Drug Safety e-Update Editors
 2. TSI Drug Safety e-Update Managing Editor




TSI Drug Safety e-Update, April/May 2011

								
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