OHIO STATE BOARD OF PHARMACY; 77 S. HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126

Tel: 614/466-4143          Fax: 614/752-4836           Email: exec@bop.state.oh.us           Web: www.pharmacy.ohio.gov

 

 

OHIO STATE BOARD OF PHARMACY NEWS

~~ AUGUST 2005 ~~

 

 

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

Larissa Doucette - Editorial Manager

 

 

State News Section

 

Pharmacist License Renewal Time is at Hand

Pharmacist renewal forms were mailed out in early July to all pharmacists licensed in Ohio who are eligible for renewal. There were several pharmacists whose license number begins with 03-02 who did not receive renewal forms because they had not submitted their continuing education (CE) forms to us yet or because their CE form was in the audit process or was incomplete and, therefore, returned to them. If you have not received your renewal form by the time you receive this Newsletter, you need to check with the Ohio State Board of Pharmacy office to find out what you need to do to renew your license. If your license is not renewed before September 15, you may not continue to practice as a pharmacist in Ohio until you do get it renewed.

 

DEA Issues Rules on the Use of Automated Dispensing Systems in Long-term Care Facilities

 

After a lot of discussion over the last few years, Drug Enforce­ment Administration (DEA) has finally agreed that automated storage systems may be useful in nursing homes as a way to reduce waste and loss of controlled substances. In Ohio, the Board has al­ways considered that medications for nursing home patients should be handled the same way as medications for patients in a hospital. Unlike the Board, however, DEA has always considered nursing home patients to be outpatients rather than inpatients. As such, they have required a pharmacy to have a valid outpatient prescription before CII medications could be dispensed to a nursing home patient and they have never officially allowed any controlled substance drug stock to be maintained in a nursing home. Part of the reason for this difference is due to the fact that DEA has not traditionally licensed nursing homes, so the medications would be going from a licensed facility (the pharmacy) to an unlicensed facility (the nursing home). Ohio’s model for nursing home stock drugs over the years has been to license the pharmacy using the nursing home address so that the pharmacy could place some stock drugs (not patient-specific) in the nursing home. With these new regulation changes, DEA is doing essentially the same thing for controlled substances. If the pharmacy licenses the nursing home with DEA, the pharmacy will be permitted to place an automated floor stock system in place that will allow nursing personnel to have access to limited amounts of controlled substances, thus preventing the need for the pharmacy to dispense large quantities to multiple patients. This will cut down on losses of controlled substances and will also cut down on nursing time needed for audits. In addition, this change will tremendously increase the security and control over controlled substances stored in nursing homes.

The actual wording of the new rule can be read on the DEA Diversion Web site at www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0513.htm. Ohio’s laws and rules would have permit­ted this practice for a long time, but DEA regulations have always interfered. With this welcome change, nursing homes and nursing home pharmacies should be able to improve the security and ac­countability of their controlled substances.

 

DEA Also Issues Rules on Prescribing Controlled Substances for Maintenance or Detoxification

 

DEA also recently issued the final rules for the use of controlled substances for maintenance or detoxification in the treatment of narcotic addiction. This process has been occurring over the last couple of years as a result of a change in federal law. In the past, it was a violation of federal regulations to use opiates to maintain or detoxify an addict unless the prescriber was licensed with DEA as a treatment program. As of July 25, 2005, the effective date for the final rule, physicians may now administer, dispense, or prescribe a Schedule III, IV, or V narcotic controlled substance for maintenance or detoxification as long as it has an indication for that purpose from the Food and Drug Administration (FDA). At this time, only buprenorphine (when marketed as Subutex or Suboxone) has that indication. Please note that Schedule II controlled substances are not included in this exemption. Therefore, methadone may not be used for the treatment of addiction by anyone other than a DEA registered treatment provider.

Even though the physician does not have to be licensed with DEA as a treatment provider, there are still special requirements that must be met before the physician can begin using these products to treat narcotic addiction. The physician must have a special registration number to do this on a regular basis, although one patient may be treated during the time that it takes to get the special registration number from DEA. After receiving the registration number, the physician (or physician practice) may treat a maximum of 30 patients. The final regulations may be found at www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0623.htm. Pharmacists need to be aware of the restrictions on this issue, but do not need to go overboard in trying to ensure that physicians are in strict compliance. The DEA statement about pharmacists’ responsibilities in the Federal Register on June 23, 2005, says it best:

Pharmacists only need to be sure that the practitioner either has received an identification number or is claiming the good faith exception. Pharmacists are not responsible for ensuring that only one patient is treated by the practitioner prior to receipt of the identification number. The language in §1301.28(e)(3) has been revised in the Final Rule to make this clear. Pharmacists are also not covered by the 30-patient rule.

Pharmacists are not required to investigate the validity of the practitioners’ good faith claim nor their compliance with the 30-patient rule. DEA wishes to note, however, that if a pharmacy becomes aware of circumstances in which it has reason to believe that a qualifying physician is violating either the good faith exception or the limit regarding the applicable number of patients [which] a qualifying physician is permitted to treat, DEA would expect the pharmacy to report this information to DEA as a matter of public interest.

 

Ohio’s Prescription Drug Monitoring Program Bill Has Passed

 

House Bill 377, the prescription drug monitoring bill, was passed by the Legislature in late 2004 and signed by the Governor Bob Taft in January 2005. This bill will allow the Board of Pharmacy to set up a program to collect the data for all controlled substance prescriptions dispensed to Ohio patients by both Ohio and out-of-state pharmacies. The Board will also have the ability to add other drugs to the list by rule if there is an indication that they might be subject to abuse or misuse. The Board is now in the preliminary stages of planning and implementing this program. Obviously, it will be necessary for us to hire some staff, find space to house the program, and buy computers and other equipment before we can get started. In addition, we will have to notify all of the pharmacies and train them on how to transmit the information to us. That will take some time, so we do not expect the program to be operational for about a year or so. Once the program is operational, prescribers and pharmacists will be able to obtain reports on individuals by contacting the program. These reports will show all of the prescriptions filled for a patient, thus giving the prescriber and/or pharmacist a clearer picture of the patient’s treatment. On the one hand, it will show those patients who are doctor shopping in an attempt to get more drugs than are appropriate; however, on the other hand, it will also show those patients who are compliant with their treatment plan. This should give prescribers and pharmacists alike a greater comfort level when it comes to providing controlled substances to patients. In Kentucky, where there is a similar program, over 80% of their requests for information are from physicians. Based upon the number of telephone calls we get from concerned physicians, pharmacists, and patients, we are hoping that this program will assist everyone in providing legitimate patient care. When it is appropriate, the program will also provide information to law enforcement officers for the purpose of dealing with those individuals, patients, and health care practitioners who are prescribing, dispensing, or using drugs for illegitimate purposes. The ability of law enforcement to quickly get reports that identify trends of abuse will certainly save time and effort over the manual system of investigation in place now. Obviously, the quality of the prescription monitoring program will be determined by the accuracy of the data it contains. That accuracy depends on the pharmacists who are verifying the information that is entered into their computer systems. Misspelled names, incorrect addresses, and other errors can seriously impede the ability of the monitoring program to provide accurate data to prescribers, pharmacists, and law enforcement. One particular error that has been repeatedly addressed by our agents on inspection is the use of a hospital or clinic name as the prescriber when the doctor is not known. This will become even more crucial after the monitoring program is up and running as it will mean that the system may not be able to access the needed information about a doctor or a patient. Even though we are not collecting data yet, pharmacists need to begin being more careful about the quality of the information entered into their computer systems.

 

Disciplinary Actions

 

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 – 1-800/230-6844, www.deadiversion.usdoj.gov

 

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 Board Will Oversee Management of Drug Safety Monitoring

 

Food and Drug Administration (FDA) has unveiled a program that aims to improve oversight of drug safety monitoring and to bolster openness in agency product review and decision making. Included is the creation of an independent Drug Safety Oversight Board, made up of medical experts from FDA and other gov­ernment agencies. Also planned are Web postings of emerging drug data and risk information as well as written materials that provide targeted drug safety information to the public. For more information, see www.fda.gov/oc/factsheets/drugsafety.html.

 

ACPE Changes Provider Criteria Regarding Drug and Device Manufacturers

 

In early 2005, the Accreditation Council for Pharmacy Educa­tion (ACPE) ceased accepting applications from pharmaceutical and biomedical device manufacturers seeking accreditation as providers of continuing education (CE). Effective July 1, 2005, the organization will no longer recognize pharmaceutical and biomedical device manufacturers as accredited providers. In ad­dition, any CE issued by a pharmaceutical or device manufacturer after June 30, 2005, is not valid. These changes were approved by the ACPE Board of Directors at its January 2005 meeting after the organization determined that manufacturers could not meet both ACPE’s requirements and the recommended restrictions as stated in a Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of the Inspector General of the United States (OIG).

In 2003, OIG stated that manufacturers could be subjected to liability under federal statutory provisions if they maintain any influence over CE subject matter or presenters, or provide funding for attendees or other incentives with respect to CE attendance. Strict compliance with OIG’s guidelines would relegate manufacturers to solely providing educational grants to CE providers in order to be free of liability. Meanwhile, ACPE’s Criteria for Quality require that the CE provider control the content speakers or authors of a CE program, putting ACPE’s requirements in opposition to OIG’s guide­lines; hence, ACPE, out of responsibility to health regulatory boards, the profession, and the public, must now accredit only those providers who are in compliance with the ACPE criteria and the OIG guidelines.

In accordance with ACPE’s new policies, organizations with a commercial interest and any proprietary entity producing health care goods or services, with the exception of nonprofit or govern­ment organizations and non-health care-related companies, will not be eligible for ACPE accreditation status.

For more information, contact ACPE Executive Di­rector Peter Vlasses at 312/664-3575, or via e-mail at pvlasses@acpe-accredit.org.

 

Let’s Get to the ‘Point’: Prescription Misinterpretations Due to Decimal Points

 

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: ismpinfo@ismp.org.

Problem: Numbers containing decimal points are a major source of error and, when misplaced, can lead to misinter­pretation of prescriptions. Decimal points can be easily overlooked, especially on prescriptions that have been faxed, prepared on lined order sheets, or written or typed on carbon and no-carbon-required (NCR) forms (often used in hospitals and long-term care facilities). If a decimal point is missed, an overdose may occur. The importance of proper decimal point placement and prominence cannot be overstated.

For one, a decimal point should always be preceded by a whole number and never be left “naked.” Decimal expres­sions of numbers less than one should always be preceded by a zero (0) to enhance the visibility of the decimal. For example, without a leading zero, a prescription for “Haldol® .5 mg” (see image shown on next page) was misinterpreted and dispensed as “Haldol 5 mg.” We have received similar reports with Risperdal® (risperidone) in which “Risperdal .5 mg” was prescribed (instead of Risperdal 0.5 mg), but the patient received several 5 mg doses because the decimal point was overlooked.

In addition, a whole number should never be followed with a decimal point and a zero. These “trailing zeros” (eg, “3.0”) are a frequent cause of 10-fold overdoses and should never be used. For example, when prescriptions have been written for “Couma­din® 1.0 mg,” patients have received 10 mg in error. Similarly, a prescription for “Synthroid® 25.0 mcg” could be misread as “Synthroid 250 mcg.”

Dangerous use of decimals can also be problematic if they appear in electronic order entry systems or on computer-generated labels. A newly admitted hospital patient told her physician that she took Phenobarbital® 400 mg PO three times daily. Subsequently, the physician wrote an order for  the drug in the dose relayed by the patient. A nurse saw the prescription vial and verified that this was the correct dose. However, prior to dispensing, a hospital pharmacist investigated the unusually high dose. When he checked the prescription vial, he found that it was labeled as “phenobarbital 32.400MG tablet.”

The label indicated that 30 tablets were dispensed with instructions to take one tablet three times daily. The hospital pharmacist contacted the outpatient pharmacy and suggested that the computer expressions including trailing zeros be changed to avoid serious medication errors. The pharmacy management agreed that trailing zeros appearing on labels might pose a risk and made the change immediately.

 

Safe Practice Recommendations

 

In order to avoid misinterpretations due to decimal point placement, pharmacists should consider the following:

  • Always include a leading zero for dosage strengths or concentrations less than one.
  • Never follow a whole number with a decimal point and a zero (trailing zero).
  • Educate staff about the dangers involved with expressing doses using trailing zeros and naked decimal points.
  • Eliminate dangerous decimal dose expressions from pharmacy and prescriber electronic order entry screens, computer-generated labels, preprinted prescriptions, etc.
  • Avoid using decimals whenever a satisfactory alternative exists. For example, use 500 mg in place of 0.5 gram, 125 mcg instead of 0.125 mg, or 2 ˝ mg instead of 2.5 mg.
  • Identify drugs with known 10-fold differences in dosage strength (eg, Cytomel® 5 mcg and 50 mcg, Coumadin 1 mg and 10 mg, levothyroxine 25 mcg and 250 mcg) and place reminders in electronic order entry systems and on pharmacy shelves to alert practitioners to double-check the dosage strength.
  • When sending and receiving prescriptions via fax, health care practitioners should keep in mind that decimal points can be easily missed due to “fax noise.” Whenever possible, encourage prescribers to give original prescriptions (with an indication that it has been faxed) to their patients to take to the pharmacy for verification. Pharmacists should carefully review faxed prescriptions and clarify prescriptions that contain fax noise.
  • Eliminate the lines on the back copy of NCR forms so that a person receiving can clearly see decimal points or other marks that were made on the top copy.
  • Notify prescribers of the potential for error if misinterpretations due to decimal point usage are discovered.

 

DEA Issues Final Rules for Electronic Orders for Controlled Substances

 

On April 1, 2005, Drug Enforcement Administration (DEA) issued final rules regarding electronic orders for controlled substances. DEA revised its regulations to provide an electronic equivalent to the DEA official order form (Form 222), which is legally required for all distributions involving Schedule I and II controlled substances. The regulations will allow, but not require, registrants to order Schedule I and II substances electronically and maintain the records of these orders electronically. The regulations will reduce paperwork and transaction times for DEA registrants who handle, sell, or purchase Schedule I or II controlled substances.

The effective date of the final rules was May 31, 2005. The final rules were issued via the Federal Register on April 1, 2005, and may be downloaded from the following Web site address: www.access.gpo.gov/su_docs/fedreg/a050401c.html.

 

FDA Publishes Final Rule on Chlorofluorocarbons in Metered Dose Inhalers

 

FDA announced that albuterol metered-dose inhalers (MDI) using chlorofluorocarbon propellants must no longer be produced, marketed, or sold in the US after December 31, 2008.The Health and Human Services (HHS) is encouraged that the manufacturers of three environmentally friendly albuterol inhalers are implementing programs to help assure access to these albuterol MDI for patients for whom price could be a significant barrier to access to this important medicine. These programs include MDI giveaways, coupons for reducing the price paid, and patient assistance programs based on financial need.In a final rule, published March 31, 2005, in the Federal Register, HHS stated that sufficient supplies of two approved, environmentally friendly albuterol inhalers will exist by December 31, 2008, to allow the phasing out of similar, less environmentally friendly versions.

 

FDA Develops PSAs to Educate Consumers About Purchasing Medications Online

 

FDA recently released two public service announcement (PSA) brochures, which educate consumers about the advantages and disadvantages of purchasing medication online. The brochures also advise consumers to ensure a Web site is a US-licensed pharmacy by contacting their state board of pharmacy. Consumers may want to refer to the list of Verified Internet Pharmacy Practice Sites™ (VIPPS®) on www.nabp.net to find out if a Web site has been checked to make sure it it has met state and federal rules. Consumers also will know if an online pharmacy is VIPPS-accredited when they notice the VIPPS Seal on that particular Web site.For more information on these PSAs visit www.fda.gov/cder/consumerinfo/Buy_meds_online_all_resources.htm.