OHIO STATE BOARD OF PHARMACY; 77 S. HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126
Tel: 614/466-4143 Fax: 614/752-4836 Email: email@example.com Web: www.pharmacy.ohio.gov
OHIO STATE BOARD OF PHARMACY NEWS
~~ NOVEMBER 2004 ~~
The Ohio State Board of Pharmacy News is published by the Ohio State Board of Pharmacy and the National Association of Boards of Pharmacy Foundation, Inc. to promote voluntary compliance of pharmacy and drug law. The opinions and views expressed in this publication do not necessarily reflect the official views, opinions, or policies of the Foundation or the Board unless expressly so stated.
William T. Winsley, MS, RPh - State News Editor
Carmen A. Catizone, MS, RPh, DPh - National News Editor & Executive Editor
Reneeta C. "Rene" Renganathan - Editorial Manager
State News Section
Please Report B&E Attempts to the Board
It should be no surprise to any retail pharmacist that the number of pharmacies reporting drug losses due to breaking and entering (B&E) has increased. As you know, you are required to notify the Ohio State Board of Pharmacy immediately by telephone upon discovering any theft or significant loss of prescription drugs (Rule 4729-9-15). As far as we can tell, most people are complying with this requirement. However, in our attempts to track down some of the individuals responsible for the increase in the number of B&E events, we have learned that several pharmacies have noticed attempts to break into the pharmacy that were unsuccessful. While it is not mandated by rule that such attempts be reported to us, we would greatly appreciate it if you would notify the Board office of all suspected B&E attempts (cut telephone lines, new pry marks on doors, broken glass that indicates an attempt to get in, etc). Needless to say, in terms of location, time, and method, an attempted B&E can provide us with almost as much information as a successful one. With your assistance, we may be able to track down some of these people trying to steal your drugs.
What is a Valid Prescription?
In the last Newsletter, we began to discuss things that pharmacists might use to determine whether or not a prescription was legitimate. The criteria discussed included:
1. Do you know the patient and the patient’s history?
2. Do you know the prescriber and his/her reputation and specialty?
3. Have you reviewed the prescriber’s habits, specifically whether or not there is dosage individualization?
4. Is it reasonable for the patient to be coming to your pharmacy, based on the location of the doctor’s office and the patient’s home?
In addition to these factors, the pharmacist should also consider the following:
5. What does the prescription look like? How is it written? Does it look like it was prepared by a health care professional or by an amateur? Is the spelling correct? Several years ago, we had a prescription presented at a pharmacy for “Tall One 50” instead of “Talwin® 50 mg” and the pharmacist filled it without question! Today, we are finding many forged prescriptions for “Percoset” instead of “Percocet®” being presented at pharmacies. A misspelling of the drug, unavailable strengths, or inappropriate directions may be an indication of a problem prescription. Please note the use of the word “may” in the last sentence. All prescribers are not necessarily excellent spellers, so a prescription with a misspelled word may still be legitimate. You will never know if you do not ask.
6. Is the prescription an original? With the quality of copy machines today, it is possible to photocopy prescriptions and have them filled at multiple pharmacies around town. Please check the signature closely to ensure that the signature is an original, handwritten signature and not a photocopy or a computer-generated replica.
7. If the prescription is a facsimile, did it come directly from the prescriber’s office? At a minimum, be sure the header information is correct and that the signature is the same as written signatures that you have on file.
8. Is the prescription issued in a valid doctor-patient relationship? If the prescription is from a doctor in California for a patient living in Ohio, what relationship exists? Perhaps the patient periodically visits a specialist in California. In that case, the prescription is probably valid. On the other hand, the patient could have had the prescription issued as a result of an Internet order. That prescription is certainly not valid.
9. Is the patient paying cash instead of using the insurance or Medicaid coverage that you know he or she has? There may be a good reason for this, but it is hard to think of one. If the prescription is for a controlled substance and the insurance would ordinarily cover the cost, the pharmacist should wonder why the patient is willing to pay cash. One obvious reason is that the patient has already received the drug using the insurance plan and this prescription would be rejected for payment as a duplicate charge.
After listing all of these reasons that a prescription may be a problem, it is important to note that patients should receive the medication that is appropriate to their condition. That determination is a matter of judgment on the part of the physician and the pharmacist. A particular dose may be too high for one patient and too low for another. Patients vary widely in their drug needs and responses, so the dosage of most drugs needs to be individualized.
As was stated in the last Newsletter, please remember that the practice of medicine and pharmacy does not always consist of clear-cut choices between right and wrong. That is the reason that prescribers and pharmacists are required to make professional judgments for which they are held personally accountable. Failing to properly provide necessary care to a patient is as bad, if not worse, than accidentally filling a prescription that turns out to be false. In all cases, a pharmacist should always act in the best interests of the patient, keeping in mind that sometimes that means saying “no.”
Anyone having a question regarding the license status of a particular practitioner, nurse, pharmacist, pharmacy intern, or dangerous drug distributor in Ohio should contact the appropriate licensing board. The Web sites listed below may include disciplinary actions for their respective licensees.
State Dental Board – 614/466-2580, www.dental.ohio.gov
State Medical Board – 614/466-3934, www.med.ohio.gov
State Nursing Board – 614/466-3947, www.nursing.ohio.gov
State Optometry Board – 614/466-5115, www.optometry.ohio.gov
State Pharmacy Board – 614/466-4143, www.pharmacy.ohio.gov
State Veterinary Medical Board – 614/644-5281, www.ovmlb.ohio.gov
Drug Enforcement Administration – 800/230-6844; www.deadiversion.usdoj.gov
State Pharmacy Board
The disciplinary actions listed below include only those where the individual’s license to practice has been suspended, revoked, or restricted, and do not include any other actions taken by the Board. All actions may be seen in the minutes, which are posted on the Board’s Web site under “Board Minutes.”
Orders of the Board:
Matthew P. Bodnar, RPh; Toronto – License suspended indefinitely effective September 16, 2004, and may not be employed by or work in a facility licensed by the Board while suspended.
Zachary Daniel Hennekes, RPh; Morrow – License suspended indefinitely effective July 13, 2004, and may not be employed by or work in a facility licensed by the Board while suspended.
Anthony Kornokovich, RPh; Timberlake – License reinstated August 25, 2004 and may not work in a pharmacy more than 40 hours per week during the first 12 months of practice; May not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy, assist in, or witness the destruction of controlled substances for five years effective June 28, 2004.
Steven Ray Liles, RPh; Cold Spring, KY – License reinstated June 28, 2004; May not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy, assist in, or witness the destruction of controlled substances for one year.
Terrell L. Mundhenk, RPh; Centerville – May not dispense prescriptions for himself or for any family member; may not serve as a preceptor or train pharmacy interns; and may not serve as a responsible pharmacist for three years effective June 28, 2004.
Michelle M. Solnosky, RPh; Euclid – License reinstated July 30, 2004; May not work in a pharmacy more than 40 hours per week; may not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy, assist in, or witness the destruction of controlled substances for one year effective April 8, 2004.
Venubabu Talasila, RPh; Dublin – License reinstated August 10, 2004; May not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy, assist in, or witness the destruction of controlled substances for five years effective July 13, 2004.
Tricare Pharmacy Network, LLC, TD; Lexington, KY – License suspended one month effective September 13, 2004.
Summary Suspensions: [Sec. 3719.121 of the Ohio Revised Code]
Craig James Bryant, RPh; Rootstown. Effective August 2, 2004.
Mark Christopher Carrington, RPh; McDermott. Effective September 16, 2004.
David Michael Rebeck, RPh; Norton. Effective August 2, 2004.
Gary Nicholas Sass, RPh; Hermitage, PA. Effective September 14, 2004.
Bradley Allen Schwartz, RPh; Mansfield. Effective October 6, 2004.
Ronald Heath Stevens, RPh; Stow. Effective October 6, 2004.
National News Section
Applicability of the contents of articles in the National Pharmacy Compliance News to a particular state or jurisdiction should not be assumed and can only be ascertained by examining the law of such state or jurisdiction.
New Over-the-Counter Product Labeling
On March 24, 2004, Food and Drug Administration (FDA) passed final rulings requiring content labeling for over-the counter (OTC) medications that contain levels of calcium, magnesium, sodium, or potassium that might be harmful to persons with certain underlying medical conditions. The final rule was effective April 23, 2004, with compliance expected by September 24, 2005. The labeling changes for oral OTC products were deemed necessary as persons with certain medical conditions such as heart disease, hypertension, kidney disease, kidney stones, or other medical conditions could worsen their condition upon consumption of these products. For example, OTC use of medications containing potassium may cause hyperkalemia in persons with compromised renal function. Under the new rules, oral OTC medications must state the exact amount of a particular ingredient in each dose if they contain:
♦ 5 mg or more of sodium in a single dose,
♦ 20 mg or more of calcium in a single dose,
♦ 8 mg or more of magnesium in a single dose, or
♦ 5 mg or more of potassium in a single dose.
The rules also require warnings to alert consumers on sodium-, calcium-, magnesium-, or potassium-restricted diets to consult their physician before using oral products that contain maximum daily doses of:
♦ more than 140 mg sodium,
♦ more than 3.2 grams calcium,
♦ more than 600 mg magnesium, or
♦ more than 975 mg potassium.
Currently the new label requirements do not include mouth rinses, fluoride toothpastes, or mouth washes. Detailed information on the rulings can be found in the Federal Register at www.fda.gov/OHRMS/DOCKETS/98fr/04-6479.htm and www.fda.gov/OHRMS/DOCKETS/98fr/04-6480.htm.
FDA Requests Antidepressant Manufacturers to Strengthen Warnings
On March 22, 2004, FDA issued a public health advisory that cautions physicians, their patients, and families and caregivers to closely monitor adults and children with depression. Results of antidepressant studies in children since June 2003 appeared to suggest an increased risk of suicidal thoughts and actions in those children taking certain antidepressants. FDA has initiated a review of these reports, but it is not clear whether or not antidepressants contribute to suicidal thinking and behavior.
As a result of the studies, FDA is asking manufacturers to change the labels of 10 drugs to include stronger cautions and warnings to monitor patients for worsening depression and the emergence of suicidal ideation. The drugs affected include bupropion (Wellbutrin®), citalopram (Celexa™), escitalopram (Lexapro™), fluvoxamine (Luvox® – not FDA approved for treatment of depression in the US), fluoxetine (Prozac®), mirtazapine (Remeron®), nefazodone (Serzone®), paroxetine (Paxil®), venlaxafine (Effexor®), and sertraline (Zoloft®). It should be noted that Prozac is the only drug approved for use in children with major depressive disorder. Prozac, Zoloft, and Luvox are approved for pediatric patients with obsessive-compulsive disorder.
Patients taking these antidepressants should be monitored for behaviors associated with the drugs such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania. Physicians are urged to closely monitor patients with bipolar disorder as monotherapy with antidepressants is believed to have the potential to induce manic episodes in such patients. A causal relationship has not been established between physical symptoms and suicidal ideation; however, medications may need to be discontinued when the symptoms are severe, abrupt in onset, or were not part of the presenting symptoms. Further information can be found on CDER’s Web site: www.fda.gov/cder/drug/antidepressants/default.htm.
Let Past Experience with Chloral Hydrate Syrup Guide its Safe Use
This column was prepared by the Institute for Safe Medication Practices (ISMP). ISMP is an independent nonprofit agency that works closely with United States Pharmacopeia (USP) and FDA in analyzing medication errors, near misses, and potentially hazardous conditions as reported by pharmacists and other practitioners. ISMP then makes appropriate contacts with companies and regulators, gathers expert opinion about prevention measures, then publishes its recommendations. If you would like to report a problem confidentially to these organizations, go to the ISMP Web site (www.ismp.org) for links with USP, ISMP, and FDA. Or call 1-800/23-ERROR to report directly to the USP-ISMP Medication Errors Reporting Program. ISMP address: 1800 Byberry Rd, Huntingdon Valley, PA 19006. Phone: 215/947-7797. E-mail: firstname.lastname@example.org.
Chloral hydrate can be used safely to sedate pediatric patients for diagnostic procedures such as endoscopic procedures, CT scans, or MRIs. However, in several error reports over the years we have seen the sad stories of fatalities that have occurred after excessive doses of the drug were dispensed in error. Typically, deaths have occurred in cases where the order was not clear or when untrained individuals, both staff and parents, were involved without adequate supervision or the knowledge that they were administering an overdose. In some cases, to save time, chloral hydrate has been prescribed for use at home prior to travel to the practice site. In one instance, a 500 mg/5 mL concentration was dispensed instead of 250 mg/5 mL, which also is available. Unfortunately, the dose was prescribed by volume (teaspoonful), which made detection of the twofold overdose impossible. In another incidence, 120 mL of syrup was incorrectly dispensed instead of the prescribed 12 mL. The label instructed the mother to give her child the entire bottle, which she did. Without trained personnel and emergency equipment present to treat these accidental overdoses, the children in both cases died.
Recently the tragedy happened again. A prescription was written for a 17-month-old child; the pharmacist read the directions as “30 cc before office visit” and instructed the mother to give her child that amount. In truth, the physician wanted the child to receive 500 mg 30 minutes before the office visit. The double hash-mark symbol ("), which the physician intended to mean minutes, was misread as cc. Actually, a double hash mark stands for seconds; a single hash mark (') is used for minutes. Neither symbol should be used in medicine, however, because not everyone understands their meaning.
Errors also happen in diagnostic areas where technical support personnel often administer oral conscious sedation even though they are not properly trained. In some cases, an ambiguous physician order such as “give chloral hydrate 5 cc prn sedation” or “. . . prn agitation,” rather than a specific milligram amount and maximum dose, has led to events where multiple doses of chloral hydrate were dispensed from the supply available to personnel. By the time the child fell asleep, the amount administered was a massive overdose leading to respiratory arrest.
Please consider reviewing your process for dispensing oral liquids used for conscious sedation in children, whether to a medical facility or to a family member. We suggest that the following precautions, in addition to package insert recommendations, be employed. Advise physicians that the drug should not be prescribed by volume (eg, “5 mL,” “one teaspoonful,” etc). There are two available concentrations of this drug. Instead, the specific milligram dose should be expressed. The prescription should state that it is for pre-procedure sedation. In hospital situations or when pharmacies dispense to health care facilities, prescriptions are best dispensed for each patient in labeled, unit dose, oral syringes; providing the product in bulk packages as floor stock is less safe. We believe it is safest for pharmacists to not dispense prescriptions for patient use in the home when it is for pre-procedure sedation. Should the caregiver receive such a prescription, he or she should be advised that they are safest for the dose to be administered where the procedure will be performed. Official labeling for Versed® Syrup, another drug used for conscious sedation in children, notes that the syrup is intended for use only in monitored settings, never the home. Also, as noted in the product’s boxed warning, only health care professionals trained in conscious sedation procedures and authorized to administer conscious sedation drugs should do so. Careful monitoring by direct visual observation is necessary and age-/size- appropriate resuscitation equipment must be readily available. The American Academy of Pediatrics agrees; the Academy’s current “Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures” (Pediatrics 2002; 110:836-838) recommend that children should not receive sedative or anxiolytic medications without supervision by skilled medical personnel. These medications should be administered by, or in the presence of, individuals skilled in airway management and cardiopulmonary resuscitation and administered in a health care facility where appropriate monitoring, including continuous pulse oximetry, can be instituted.
One final argument for administering children’s sedation on site is to ensure proper timing in case of unpredictable schedule delays.
NABP Releases Updated NAPLEX Blueprint
NABP has released the updated blueprint for the North American Pharmacist Licensure Examination™ (NAPLEX®). The blueprint is available for viewing on NABP’s Web site, www.nabp.net, as of September 2004. Examinations based on the updated blueprint will be administered beginning spring 2005.
Changes to the NAPLEX blueprint include the addition of competency statements addressing dietary supplements and pharmacotherapeutic equivalency as well as integration of the skill of communicating with patients and other health care providers in the entire examination blueprint instead of focusing it within a single competency area as with the current NAPLEX. The examination continues to consist of three major areas that are divided into several competency and subcompetency statements.
The updated blueprint and competency statements require a new passing standard. However, the NAPLEX continues to be a computer-adaptive examination that requires a scaled score of 75 or greater to pass. Calculation of the score is the same as in the past: the score is calculated by first determining the candidate’s ability level on the NAPLEX and then comparing this to the predetermined minimum acceptable ability level established for the NAPLEX. The new passing standard will go into effect along with the updated blueprint in spring 2005. For more information about the NAPLEX, contact the Customer Service Department by calling 847/698-6227 or visit the Association’s Web site at www.nabp.net.
December 2004 FPGEE Date and Location Announced
On December 4, 2004, NABP will again administer a paper-and-pencil Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®). The examination is being offered at three United States locations: Northlake (Chicago area), IL; New York, NY; and San Mateo, CA. Candidates who have been accepted to sit for the December 4, 2004 administration were mailed their admission tickets in early fall.
To prepare for the December examination, candidates may take the Pre-FPGEE™, a Web-based practice examination for the FPGEE. The practice examination is accessible at www.nabp.net and www.pre-fpgee.com.
For more information on the FPGEE, visit NABP’s Web site at www.nabp.net.