Tel: 614/466-4143 Fax: 614/752-4836 Email: firstname.lastname@example.org Web: www.pharmacy.ohio.gov
~~ AUGUST 2005 ~~
William T. Winsley, MS, RPh - State News 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
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
The actual wording of the new
rule can be read on the DEA Diversion Web site at
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.
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
having a question regarding the license status of a particular practitioner,
nurse, pharmacist, pharmacy intern, or dangerous drug distributor in
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
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 email@example.com.
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:
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
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:
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.