The Changing Dynamics of Opioid Prescriptions ––>

Pharmacists are increasingly facing new
challenges with managing and dispensing controlled substance
medications. Market and regulatory changes have been taking place with
controlled substances, including the new opioid guidelines, electronic
ordering of CIIs using the Drug Enforcement Administration’s Controlled
Substance Ordering System (CSOS), and increased availability and
utilization of prescription drug monitoring programs (PDMPs). It is
challenging for pharmacists to stay up to date on the opioid situation
because of the constantly evolving software and guidance.

healthcare practitioners should educate themselves on the new opioid
guidelines and assess where they can have an impact. Diligently
utilizing PDMP information on prescribers and patients will help to
control misuse and abuse.
March 2016, the Centers for Disease Control and Prevention (CDC)
published updated guidelines on prescribing opioids for chronic pain.
Although the guidelines primarily serve physicians, it is beneficial for
all healthcare practitioners to understand the guidelines and their
ramifications. The guidelines include 12 recommendations; paraphrased,
as shown on the next page.

the new changes in prescribing, pharmacists may face increased
responsibilities, but see more opportunities for patient interaction.
Patients will be more likely to receive nonopioids or lower doses when
starting opioid therapy. Because of these changes, pharmacists may play
an increased role in communicating breakthrough pain to physicians.
Pharmacists can also proactively discuss naloxone with their patients
and identify high-risk patients.

some pharmacies, it may make sense to collaborate with clinics that
require their patients to sign pain contracts. Pain contracts, or pain
treatment agreements, are agreements between patients and physicians.
The contracts develop a baseline of understanding between the two
parties to facilitate treatment and improve dialogue. More physicians
are now requiring their patients to sign pain contracts prior to
initiating long-term opioid therapy. One contract clause may require the
patient pledging to use a single pharmacy for all controlled substance
medications. This allows the pharmacy-physician team to better manage a
patient’s therapy and monitor for drug misuse. The PDMP programs can
expose patients that violate this agreement clause. For pharmacies
looking to get more involved in opioid management, use of PDMP data is
an excellent avenue to explore.

Centers for Disease Control and Prevention (CDC) Guidelines on Prescribing Opioids for Chronic Pain

❑ Consider nonpharmacologic and nonopioid therapy first.

❑ Establish treatment goals with the patient, including goals for pain reduction and function.

❑ Before and during treatment, discuss risks and realistic benefits of opioid therapy.

❑ Start with immediate-release versus extended-release or long-acting opioids.

❑ Start with the lowest effective dose.

❑ For acute pain, prescribe enough medication for the expected duration of pain, generally three to seven days.

❑ For chronic pain, evaluate benefit versus risk
within one to four weeks of starting therapy, and at least every three
months thereafter.

❑ Evaluate risk of opioid-related harm before and
during therapy. Consider offering naloxone when factors that increase
risk are present.

❑ Review PDMP data before and during therapy.

❑ Use urine drug testing before starting opioids for chronic pain.

❑ Avoid the concurrent prescribing of opioids and benzodiazepines when possible.

❑ Offer or arrange treatment for patients with opioids use disorders.


the CDC published the updated guidelines in March 2016, payers were
cracking down on the overprescribing of opioids. For example, the
Massachusetts Executive Office of Health and Human Services issued
updated opioid high-dose limits. A high-dose limit was set at 120 mg of
morphine equivalents per day. While prior authorizations can occur,
generally, MassHealth (which includes the Massachusetts Medicaid
program), will no longer cover high doses of opioids due to a lack of
clinical evidence supporting their effectiveness. Having payers take
action against inappropriate opioid prescribing is key to making a
change. With all stakeholders aligned, we are much more likely to alter
Medicaid practices. Nothing changes prescriber behavior faster than
continued callbacks from pharmacies and payers.

Drug Enforcement Administration (DEA) is also focusing on reducing
inappropriate and fraudulent opioid prescribing. In late June, a major
chain was fined $3.5 million to settle allegations that its northeastern
stores filled forged prescriptions for oxycodone, hydrocodone, and
other opioids. The DEA stated that the pharmacies dispensed over 500
forged prescriptions between 2011 and 2014 at approximately 50
pharmacies. Although it is a pharmacist’s job to identify cases of fraud
and curb the inappropriate dispensing of opioids, we all understand
that this can be a difficult task. Some forgeries are not easy to spot,
and with a busy workflow, pharmacists may overlook some subtle warning
signs. Accessing PDMP information provides insight into the patient’s
use of controlled substances and is now required at this same chain’s
stores for specific opioids, due to a separate settlement. MassHealth
has a “lock in” program where patients flagged for potential abuse are
required to fill their prescriptions at a single pharmacy. When a
maximum quantity is exceeded or duplicate therapy is detected, coverage
is denied. Some pharmacies bypass this safety measure by allowing
customers to pay cash, violating state law. The dedicated use of PDMP
systems should help to curtail these issues in the future.

Access Integration

using these systems may add time to dispensing, PDMPs are highly
effective at reducing prescription opioid overuse, abuse, and diversion.
PDMPs allow healthcare workers, including physicians and pharmacists,
to collect, monitor, and analyze dispensing data related to scheduled
substances. This information can be used to help detect cases of overuse
or inappropriate prescribing. Currently, 49 states have operational
PDMPs. Using the PDMP-provided data not only limits pharmacists’ legal
culpability, but also improves patient care. As the functionality of
pharmacy management systems evolves, more pharmacies will have PDMP
access integrated into the pharmacy management software, creating a
seamless process.

For PDMP data to be
effective, it has to be used. An August audit by the State of Ohio Board
of Pharmacy found that one-third of Ohio physicians were either not
registered or not properly using the state’s PDMP.

PDMP data to be effective, it has to be used. An August audit by the
State of Ohio Board of Pharmacy found that one-third of Ohio physicians
were either not registered or not properly using the state’s PDMP. Over
12,000 physicians were violating the policy requiring them to check
patients’ prescription histories before prescribing opioids. The audit
findings show that the top 25 identified physicians failed to run
reports on over 7,500 patients. Consequently, the State Medical Board of
Ohio will focus on these top offenders. Increased physician
registration and training on using the PDMP data should reduce these
policy violations in the future.

Better Inventory Control

has already vastly improved the controlled substance ordering process.
Because of the CSOS, pharmacies are more likely to order controlled
substances daily or multiple times per week. Previously, the
inconvenience of using the DEA’s paper Form 222 often led to weekly
ordering for pharmacies. Weekly orders caused fluctuating inventory
levels with peaks and troughs. With daily ordering, these peaks and
troughs are much less pronounced. The improved efficiency and increased
ordering frequency resulting from the CSOS reduces pharmacy inventory
carrying cost and limits the potential for theft, as less product is in
stock at any given time. Equally important, the CSOS helps pharmacies
stay within the DEA’s ordering algorithm, since large orders and high
inventory levels are much less common.

the combined efforts of physicians, pharmacists, payers, and
government, it will be unlikely that efforts to curb the overuse and
abuse of opioids will be effective. The breadth of this epidemic
necessitates a multifaceted approach encompassing prescribing,
dispensing, and regulation. All healthcare practitioners should educate
themselves on the new opioid guidelines and assess where they can have
an impact. Diligently utilizing PDMP information on prescribers and
patients will help to control misuse and abuse. Pharmacists should also
be educated on the use of naloxone and create a referral plan to assist
patients struggling with opioid abuse.


Ann Johnson, Pharm.D., is a consultant with
Pharmacy Healthcare Solutions, Inc., which provides consulting solutions
to pharmaceutical manufacturers, PBMs, retail pharmacy chains, and
software companies on strategic business and marketing issues. Her
current emphasis is in analytics and pricing reimbursement, financial
models, drug compendia review, indirect manufacturer contracting,
contract review, and market research. Ann can be reached at