Published in the May 2006 Ohio State Board of Pharmacy Newsletter
Please Note: Throughout this article, the term “drug(s)” refers only to controlled substances (CS) (all schedules), carisoprodol, and tramadol.
In 2002, the Ohio Attorney General’s Office and the Ohio Bureau of Criminal Identification and Investigation conducted a non-scientific survey of Ohio law enforcement agencies that conduct investigations involving prescription drugs and asked specifically about the abuse of OxyContin®. The survey results indicated that between 49% and 78% of individuals arrested used doctor shopping to obtain OxyContin illegally. This statistic is not surprising. Since 1988, the Ohio State Board of Pharmacy has been involved in the arrest of over 2,300 individuals for prescription drug abuse and has documented over 18,000,000 doses of CS diverted for illegal use. Most of the diverted drugs were Schedule III and Schedule IV CS; specifically, the hydrocodone-containing products and the benzodiazepines.
In the War on Drugs, Ohio is still using revolvers while surrounding states have machine guns. Kentucky, Indiana, Michigan, Pennsylvania, and West Virginia have active or pending electronic prescription drug monitoring programs. Since the inception of Kentucky’s monitoring program in 1999, Ohio has seen an influx of Kentucky residents coming to Ohio intending to divert drugs by doctor shopping. These individuals were aware that Ohio did not have a prescription monitoring program (PMP) at the time and, therefore, the chances of being identified and prosecuted were greatly reduced. The Ohio Board recently had cases involving two alleged pain management physicians located in central Ohio. Of the 2,683 patients seen by these physicians, 2,322 patients (86%) were from Kentucky, 188 patients (7%) were from Ohio, 145 patients (5.4%) were from West Virginia, 8 patients (0.3%) were from Indiana, 7 patients (0.26%) were from Michigan, and various other patients came from Tennessee, Virginia, Florida, Maryland, Maine, North Carolina, and Pennsylvania. Not only has the Board of Pharmacy seen an increase in prescription drug diversion and drug abuse attributed to residents from outside the state, but it has also seen an increase in drug diversion among residents of Ohio.
Currently, the only method to investigate a potential diversion case on an individual patient or prescriber is to obtain information by physically visiting each pharmacy in an area to obtain drug profiles. This information must then be manually entered into a computer system to be sorted and studied before the actual investigation begins. The investigation of a prescriber can take up to six months just to collect, enter, and review this data. Law enforcement agencies close serious criminal cases every year due to a lack of personnel resources to investigate. Such a time-consuming process is not only expensive, it is also invasive to the pharmacy and potentially damaging to the prescriber if the complaint is unfounded.
In 2002, and again in 2004, Representative Tom Raga introduced legislation to allow the Board to create a PMP. In December 2004, the legislation passed both the House and the Senate and Governor Bob Taft signed it in February 2005. Key provisions of the legislation include (1) collection of prescription data from pharmacies, (2) collection of wholesale transaction data from wholesalers and pharmacies, (3) data analysis by Board personnel, (4) dissemination of data as allowed by the statute, to pharmacists and prescribers who are treating patients, and (5) reporting to the legislature.
Our contractor, Atlantic Associates, Inc, collects the prescription data. Pharmacists submit the data twice a month to Atlantic either directly from the pharmacy or via their agent such as a pharmacy chain headquarters or a software vendor. Atlantic will audit the data to be sure it is readable and it meets the criteria set by the Board. Valid records are accepted and forwarded to the Board. Atlantic will notify the submitting pharmacy of rejected records along with the reason for rejection. The pharmacist must correct the records and resubmit.
Wholesale transactions must be reported directly to the Board office. This affects every pharmacy that sells drugs to a prescriber, clinic, ambulance service, etc. (Note: Pharmacies are allowed to sell drugs directly to prescribers and others even if they do not have a wholesale license. However, the pharmacy must report all sales except sales to other pharmacies, hospitals, wholesalers, or manufacturers.) Data includes the Drug Enforcement Administration numbers of the buyer and seller, date of the transaction, National Drug Code number, and quantity of the drug sold.
The law requires that all reports, prescriptions, and wholesale transactions be electronic and be sent twice a month. Once the prescription data is in the system, pharmacists and prescribers may request reports on their patients.
Prescribers should request a report when:
- Treatment with a CS is necessary beyond what the prescriber initially anticipated;
- A condition is diagnosed that will require treatment with a CS for an extended period of time; or
- Suspicions of drug abuse, misuse, or addiction arise.
In general, pharmacists should be using PMP data in the same way that physicians use it – to evaluate patients for whom they are providing treatment. A pharmacist should be looking at patient drug histories (within their own pharmacy or chain, depending on how much data is available to them) every time a prescription is filled. He or she may see something in the record or in the patient encounter that leads them to wonder what the patient may be obtaining elsewhere. As you know, pharmacists see many things that the prescriber does not see and the pharmacist may realize that PMP information could be helpful even though the prescriber may not. For example, a patient on hydrocodone/acetaminophen might need to be monitored. Even if there’s no misuse of the hydrocodone, the acetaminophen consumption can be a health risk if combined with other products that contain acetaminophen. The information gained is utilized in the same manner as information obtained through traditional sources – to consult with prescribers and patients in order to provide appropriate patient care.
The Ohio law limits prescribers and pharmacists to obtaining reports on their own patients. Therefore, a pharmacist cannot request a report on a person who is not his or her patient, even if a physician asks them to do so. A pharmacist who obtains a report and discusses the information with the physician should not release the written report to the physician due to liability issues. The treating physician should obtain his or her own report.
How to Obtain a Report
Register to obtain access to the secure Web site. Information and forms will be available on the Web site; however, the process will require mailing a notarized application and supporting documents.
- Check the Board’s Web site for details.
- Log in to the Web site with your registration information.
- Enter patient’s identifying information – full name, address, date of birth, and telephone number.
- You will receive an e-mail when the report is ready. Go back to the Web site and view or print the report.
- Treat the report like all protected health information and protect it from unauthorized disclosure.
Additional details, that were not available at press time, will be posted on the Web site. Check the Board’s Web site, www.pharmacy.ohio.gov, after July 1, 2006.
Physicians and law enforcement officers will be able to obtain information in a similar manner.
In addition to providing patient utilization reports, the Board staff is required to analyze the data for potential violations of law and refer those cases to the appropriate licensing board or law enforcement agency.
The Board is very excited about this new tool that is available to pharmacists, prescribers, and law enforcement. Based on the experience of other states, it has great potential to improve the health care provided to legitimate patients who take CS and to minimize the abuse and misuse of these drugs.
By Danna E. Droz, RPh, JD, Prescription Monitoring Program Administrator