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The Clinician
The Outcome Resources Drug Information Newsletter
DEA Actions May Compromise Hospice Patients in SNF’s
Jim Joyner, Pharm.D., C.G.P.
Recent actions by the Drug Enforcement
Agency (DEA) may have an adverse impact
upon availability of opioids and other controlled substance medications for hospice
patients that reside in skilled nursing facilities (SNFs). The DEA has recently
launched a series of enforcement actions
against several pharmacies that provide service to SNFs in the state of Ohio. Citations were issued to the pharmacies for following common standards of practice that
have evolved over time to meet the needs of
patients in long-term care facilities. As a
result of the DEA action, many pharmacies,
nationwide, are initiating significant
changes to their policies and procedures for
dispensing prescriptions for controlled substances to patients residing in SNFs. This
includes hospice patients.
Specifically,
pharmacies may refuse to fill any prescriptions for controlled substances (including
drugs in schedules II through V) that are
written on a chart order from a SNF. The
DEA has indicated that it considers chart
orders for controlled substances to be
invalid prescriptions unless they contain the
following information:
1) Full name and address of the patient
2) The drug name, strength, dosage form,
quantity prescribed, and directions for
use
3) The name, address and registration
number of the prescriber
4) Dated and signed by the prescriber on
the date it is issued.
Most chart orders do not contain this
information and therefore the pharmacy
cannot legally fill the prescription for a
controlled substance off of a chart order.
In addition the DEA does not recognize the nurse in the SNF as an agent of
the physician and therefore the nurse
cannot legally transmit the physician’s
order for a controlled substance to the
pharmacy. For example, it is currently a
common practice in many regions for the
nurse at the SNF to fax chart orders for
schedule II controlled drugs to the pharmacy, or for the physicians to call the
orders into the pharmacy. Both of these
procedures technically violate the DEA
regulations and pharmacies cannot legally dispense these drugs based on chart
orders that are faxed by the facility or
verbal orders over the phone. In response to requests from pharmacy professional associations, the DEA has responded that it is looking into the possibility of relaxing it’s interpretation of the
law to allow for the use of chart-orders
as recognized legal prescriptions for controlled drugs in schedules III-V, but not
schedule IIs.
The DEA has clarified it’s view regarding when a pharmacist may dispense
a schedule II controlled drug upon the
verbal order of a physician. This is allowed only in an emergency situation.
The pharmacy may dispense a quantity
limited to the amount adequate to treat
the patient during the emergency period.
(continued on page 4)
In this issue:
DEA actions
may compromise
SNF hospice
patients
1
Statins offer no
protection from
Dementia
2
Drug Shortages:
Morphine,
Oxycodone,
Hydromorphone
2
April 2009
Volume 4
Issue 2
Statin Drugs Found to Have No Effect in Dementia
Nationwide Shortage of Opioids: Current Status
For some time epidemiology researchers have suggested that high cholesterol may be a contributing factor in the development of Alzheimer’s dementia (AD)
and vascular dementia. A recent Cochrane review indicates that lowering cholesterol levels with statin
drugs does not offer any protective effect from these
devastating conditions. 1
Pharmacies that serve hospices across the country are
experiencing severe shortages of opioid analgesics, including morphine, oxycodone, and hydromorphone.
This has resulted in tremendous frustration and confusion
among hospice patients, their families, as well as the
nurses, physicians, and other clinicians who care for
them.
Statins
(HMG-CoA reductase inhibitors)
Atorvastatin (Lipitor)
Fluvastatin (Lescol)
Lovastatin (Mevacor)
Pravastatin (Pravachol)
Rosuvastatin (Crestor)
Simvastatin (Zocor)
This review looked at two major studies with large
numbers of patients, approximately 26,000 patients
total. Both studies were double-blind, randomized,
placebo controlled trials for patients that were at risk
for dementia and AD. The majority of the patients
were followed for 5 years. The large numbers of
patients should have yielded some evidence of a positive effect if there was any to be seen, however, no
benefit could be discerned. The conclusions reached
by the authors of this review are summarized in the
following statement. There was no difference between
patients receiving the statin medications and patients
receiving a placebo with regard to the incidence of:
1) dementia
2) cognitive function
3) performance on specific neuropsychological tests
The lead author indicated that whether statins given in
middle age and continued for many years can protect
against dementia in later life is unknown and perhaps
unknowable.
Reference:
1. Cochrane Database Syst Rev. 2009;1:CD007514
Page 2
Drug shortages are nothing new, however, the depth
and breadth of this one are more severe than any in recent memory. There are a number of factors that have
contributed to the current situation that we face with the
opioid medications. The FDA’s recent actions against
nine separate drug manufacturers regarding unapproved
drugs is probably generating a significant negative impact relating to this shortage. On April 2nd the FDA
issued warning letters to 9 manufacturer’s of marketed
but unapproved products which contain morphine, oxycodone, and hydromorphone. This included every source
of the concentrated oral morphine solution 20mg/ml,
which is a mainstay of severe pain management in hospice and palliative care. The FDA letter notified the
manufacturers that they have 60 days (from the date of
the letter) to cease production of the products. Distributors have 90 days to cease further shipments of the existing products.
The history leading up to this is quite long. Each of
the drug products targeted by the FDA have been on the
market for decades, but have never been submitted to
FDA for review of safety and efficacy. FDA notified
the various manufacturers several years ago to obtain
FDA approval for their products or be subject to enforcement action. The manufacturers that did not take any
action have now received the warning letters to cease
production. The nine companies that received an FDA
letter include: Mallinckrodt, Boehringer Ingelheim Roxane, Roxane Laboratories, Glenmark, Lannett, Lehigh
Valley Technologies, Physician’s Total Care, Xanodyne
Pharmaceuticals, and Cody Laboratories.
The medications addressed in the FDA letter include
Morphine oral solution 20mg/ml, Morphine 15 & 30mg
immediate-release tablets, Hydromorphone 2 & 4mg
tablets, and Oxycodone 5mg immediate-release tablets.
There are limited alternative sources available for the
Hydromorphone and Oxycodone products, however, the
FDA’s action essentially would shut-down all production
The Clinician
of the concentrated oral morphine solution 20mg/ml.
FDA initially indicated that there should be no need for
concern, since the Morphine oral solution in strengths
of 10mg/5ml and 20mg/5ml were present in the marketplace in adequate supply. They grossly miscalculated the negative impact that this would have upon
hospice patients.
On April 9th, bowing to intense pressure from a coalition of hospice & palliative care organizations, pharmacy associations, and physician groups, the FDA partially reversed its decision to force a suspension of the
production of concentrated oral morphine 20mg/ml
solution. The FDA has indicated that it will allow continued manufacture of this unapproved product for an
undetermined amount of time. Unfortunately, the initial shock-wave of the FDA action may have resulted
in some severe disruptions to the inventory-supply
chain that will continue to be felt for some time.
Other factors contributing to the current shortage
include some voluntary and forced recalls related to
problems in the production and manufacturing processes as well as government imposed quotas on how
much raw materials the manufacturers can receive to
produce the drugs. Last year the FDA took action to
block the importation of a number of drug products
from the India based company, Ranbaxy, due to concerns over questionable manufacturing practices. One
of these drugs was their morphine solutab. Now, there
are no longer any morphine solutabs available in the
U.S. Earlier this year the U.S. company, Ethex, voluntarily recalled many of their products including these
opioids: hydromorphone 2,4,and 8mg tablets; Oxycodone immediate-release tablets in 10, 15, 20 and
30mg strengths; morphine immediate release tablets in
15 and 30mg strengths; morphine extended release tablets in 15, 30, 60, 100, and 200mg strengths; and oral
morphine concentrate 20mg/ml. The shortage in immediate release Oxycodone tablets due to the Ethex
recall has resulted in a reflexive draw-down of oxycodone/acetaminophen supplies as patients have been
switched to these products in an effort to maintain
some continuity of oxycodone usage. Following the
voluntary recall by Ethex, the FDA obtained a permanent injunction against the parent company of Ethex
(KV Pharmaceuticals) in March to prohibit them from
producing any drugs until the FDA signs-off that the
company’s procedures and products meet Current
Good Manufacturing Practice regulations. Other
manufacturers that have tried to step-up production
to fill the void created by the Ranbaxy and Ethex
recalls have been limited due to government imposed
constraints on the amount of raw materials that they
can acquire. The Drug Enforcement Agency (DEA)
establishes quotas for how much raw material each
manufacturer may acquire for the production of
opioid drugs for a given year. Some of the manufacturers have already met their quota for the year
and have stopped production of certain opioids. This
seems to be the case for morphine at some manufacturers. The higher strengths of Morphine extended
release (100mg and 200mg tablets) are in very short
supply related to this issue. Even if the DEA relaxes
the quotas for these manufacturers, it will take time
for them to gear up for full production again. So we
can continue to expect shortages into the near term
and possibly longer.
Here are some suggestions to help weather this
“perfect-storm” of an opioid shortage:
1) Check with your pharmacies regularly to determine which opioids are available at which pharmacies. Availability may change frequently.
This seems to vary not just from one region of
the country to another but from one pharmacy to
another within the same town.
2) Communicate and share this current supply
information among nurses and physicians to reduce problems and delays related to ordering
products that are not available.
3) Physicians and nurses should be prepared to
convert patients from one opioid to another in
the event of specific product shortages.
4) Have equianalgesic conversion references
available to help nurses and physicians with
opioid conversions.
We have included an abbreviated opioid conversion
chart on page 4 of this newsletter to help. For more
information about conversion to methadone, refer to
our article in volume 1, issue #2 of The Clinician,
“Methadone for Chronic Pain” which is available at
our website, outcomeresources.com.
Page 3
President & CEO: Martin McDonough, PharmD, CGP, DAAPM
Director of Operations: Ann McLaughlin
Director of Clinical Operations, Editor: Jim Joyner, PharmD, CGP
National Director of Business Development: Autumn Spence
Director of Client Services: Mary Davies
2217 Plaza Dr. Suite 200
Rocklin, Ca. 95765
Phone: 866-877-2053
Fax:
888-500-9023
DEA Actions (continued from page 1)
The DEA defines an emergency in the
following way: 1) immediate administration of the drug is necessary for
proper treatment, 2) no appropriate alternative is available, and 3) it is not
reasonably possible for the physician to
provide a written prescription to be presented to the pharmacist prior to dispensing.
Pharmacist and physician groups
have expressed concern that many physicians will likely be resistant to complying with the changes that are necessary to meet this new strict compliance
with the law. Some physicians may
decide to forgo practicing in the longterm care environment altogether, further exacerbating the problem.
Pharmacies are striving to comply
with the DEA’s new strict interpretation
of their rules and regulations to avoid
potential fines and penalties. As a result, standard operating procedures that
have been in place for many years at
pharmacies are being evaluated and
revised. This may result in significant
delays in availability of certain critical
medications for hospice patients that
reside in a SNF. DEA is apparently
aware of the potentially serious negative impact that their actions will have
upon the timely availability of controlled substance drugs for hospice patients in the SNF. They have indicated
they are considering sending out a
“Dear Physician” letter to inform physicians and other health care providers
about the need for strict compliance.
In the mean time, don’t be surprised to
see new standard operating procedures
emerging from the pharmacies with regard to controlled drug prescription requirements for your SNF hospice patients. The situation is still
rapidly evolving and we will keep you informed as new details become
available.
OPIOID EQUIANALGESIC CONVERSION CHART
DRUG
ORAL DOSE
Morphine
30mg
PARENTERAL
DOSE
10mg
Oxymorphone
10mg
-
Hydromorphone
7.5mg
1.5mg
Oxycodone
20mg
-
Methadone
Varied: pharmacist consultation recommended
1/2 of the oral dose
Hydrocodone
30mg
-
Codeine
200mg
-
Propoxyphene
180mg
-
Meperidine
300mg
75mg
Fentanyl patch
25mcg patch is approximately equivalent to 50mg oral
Morphine/day
-
Morphine: MS-Contin, MS IR, Roxanol
Oxymorphone: Opana ER, Opana
Hydromorphone: Dilaudid
Oxycodone: Oxycontin, Oxyfast, Oxy IR, Percocet, Percodan
Methadone: Methadose
Hydrocodone: Lortab, Norco, Vicodin
Codeine: Tylenol w/ Codeine
Propoxyphene: Darvocet, Darvon
Meperidine: Demerol
Fentanyl patch: Duragesic