By Bob Segall

An internal document kept secret by the nation's largest drug store chain has finally been obtained. It reveals why Walgreens is now turning away some customers and refusing to fill their prescriptions.

"We were told patients are not supposed to know we're using [this]," said pharmacy technician Marianne Ryan. "But I don't think it should be some big secret. This form had to be filed out by the pharmacist, so I think patients should know what's on it."

Ryan is talking about what Walgreens calls its Good Faith Dispensing Policy checklist.

The controversial checklist – and the policy behind it -- first came to light earlier this year after 13 Investigates reported many Walgreens customers are facing problems when trying to get prescription refills for pain medication.

Walgreens patrons across the nation said their prescriptions were being delayed or denied because of a new pharmacy policy, but Walgreens would not tell them what the policy is. When The Walgreen Company corporate headquarters was contacted for more information, the pharmacy chain declined to provide a copy of its GFD Policy, explaining it is for "internal use only."

But after the investigations quickly spread across the Internet and more patients began speaking out, Ryan decided to leak the checklist to to help educate consumers. A separate source provided us with a copy of the full GFD Policy.

"I don't think [Walgreens] will be happy about it, but when patients are denied prescriptions, they should know why," Ryan said. "And this is why."

Confidential checklist exposed

Walgreens' one-page checklist must be used by its pharmacy staff each time a customer presents a prescription for a powerful narcotic. Oxycodone, Methadone, Hydromorphone (Dilaudid), Morphine, Fentanyl and Opana are included on the list of Walgreens' "target drugs" because they are all highly-addictive controlled substances that government regulators have placed in a high-risk category for prescription drug abuse.

According to the GFD checklist: a pharmacist is required to complete four mandatory steps before filling a prescription for one of the GFD Policy target drugs:

Check Walgreens' national Itercom Plus computer system to confirm the prescription has not been previously denied by another Walgreens pharmacy

Review a customer's personal prescription drug history maintained by a state Prescription Drug Monitoring Program (PDMP). In Indiana, the state tracks all residents' opiod prescriptions using an online PDMP system called INSPECT.

Photocopy a valid government photo ID for the individual(s) dropping off and picking up each prescription

Answer a series of seven questions about the prescription, patient and prescribing doctor to look for "red flags" of possible prescription drug abuse

The additional seven questions include:

Whether the patient has previously received the same medication from Walgreens (new prescription or new patient is a red flag)

Whether the prescription is written for the same medication and from the same doctor as the previous fill (new doctor is possible red flag)

Whether the patient and doctor listed on the prescription are within close geographical proximity to the drug store (far distances that cannot be explained are a red flag)

Whether the prescription is being filled on time (attempt to fill early is a red flag)

Whether the patient is paying for the prescription using insurance (cash is a red flag)

Whether the quantity of pills prescribed is considered excessive (more than 120 pills is a red flag if paying by insurance; more than 60 pills is a red flag if paying cash)

Whether the patient has been taking the same medication and dosage for a long time (more than 6 months is a red flag)

Based on the results of the previous steps and questions, Walgreen's checklist instructs pharmacists to use their "professional judgement" (sic) to determine whether the prescription should be filled or the pharmacy should take the additional step of calling the prescribing doctor to ask more questions.

If a call to the physician is needed to further verify the prescription, the checklist directs Walgreens staff to "verify/confirm any number of the following points" with the doctor:

Prescription is written within prescriber's scope of practice

Diagnosis

Therapeutic regimen is within standard of care

Expected length of treatment

Date of last physical and pain assessment

Use of alternative/lesser prescription medications for pain control

Coordination with other clinicians involved in patient care

See the checklist here

The Walgreens checklist is designed to help pharmacists identify prescription fraud and to keep addictive drugs away from those who abuse them. But critics say it's been keeping pain pills away from the people who really need them.

Patient impact

Following the implementation of the checklist, some longtime Walgreens customers report long delays to get prescribed medication they desperately need to treat chronic pain.

"I've gone there for years and it usually took just a few minutes to get my prescriptions, but now they say it could take up to five days," explained a Walgreens customer who suffers from a debilitating combination of multiple sclerosis, fibromyalgia and peripheral neuropathy. The customer said his last prescriptions for Oxycontin and Oxycodone took Walgreens three and a half days to fill, forcing him to run out of medication and resulting in terrible pain.

Walgreens GFD Policy instructs pharmacy staff to "inform the patient that it may take additional time to process the prescription." Ryan says delays of more than 24 hours are unjustified.

"It's ridiculous," said the pharmacy technician, who was required to use the checklist while working at Walgreens. "If you don't have other things going on, it can be done in ten minutes. On a busy day, it might take 45 minutes to an hour – but not three and half days. A lot of times, the pharmacy will say it's going to take a long time because we have to call your doctor, but calling the doctor is not part of the mandatory checklist. Calling the doctor is the optional part."

If a Walgreens pharmacist refuses to fill your prescription for pain medication, that denial must now be entered into your online customer profile that can be seen by pharmacy staff at more than 8300 Walgreens nationwide. According to the GFD Policy, Walgreens pharmacists will also notify the US Drug Enforcement Administration that your prescription has been refused, and the pharmacy must maintain detailed documentation to justify the reason.

But if you want to know why Walgreens denied pain medication prescribed by your doctor, you're out of luck.

An Indianapolis mother, prescribed pain pills because of painful blood clots in her legs, was recently turned away by a Walgreens pharmacist who refused to fill her prescription for Oxycodone. According to the patient, the pharmacist would not provide an explanation, other than to say he was following his company's Good Faith Dispensing Policy.

"He said, 'We suggest you take it to CVS. At this point we're just feeding an addiction.' He was very loud and it was right in the open when he basically called me an addict. At that point, I was just so upset I left," said the customer, who requested anonymity to protect her family's safety. "I've been going to the same Walgreens for eight years. All I wanted was the same medication from the same doctor for the same medical condition, and they refused with no warning. It's very upsetting to be treated this way," she added.

Walgreens fined $80 million

Industry observers say Walgreen's decision to change its policy regarding the distribution of pain pills was borne out of necessity.

The company introduced its Good Faith Dispensing Policy and GFD checklist earlier this year as it was embroiled in a massive investigation by the US Department of Justice and US Drug Enforcement Administration. Federal agents targeted six Walgreens drug stores and a Walgreens distribution center in Florida, where they caught the company repeatedly filling bogus prescriptions for pain pills.

"These retail pharmacies filled the prescriptions for addictive prescription narcotics despite obvious red flags that clearly indicated the prescriptions were illegitimate, and the drugs were likely to be diverted for street use," said U.S. Attorney Wilfredo Ferrer, culminating a year-long investigation by the US Drug Enforcement Agency.

Walgreens agreed to pay an $80 million fine for those violations, and as part of its settlement, the company promised to improve its policies and procedures to help reduce prescription drug abuse involving addictive pain narcotics.

That's when Walgreens rolled out its GFD checklist, and told its employees to implement it – quietly.

"Managers made it clear … we don't want the patients to be made aware this what we're doing," Ryan told 13 Investigates. "They never really explained why. I just figured we had to do it to give Walgreens cover because of what happened in Florida."

Revealing a secret

While the new policy came as a shock to many customers, it did not come as a surprise to Ryan.

"Walgreens had to do something because the problem wasn't just in Florida. In our store, no prescriptions were ever being turned down," she said. "We had a reputation that we were the store that would ‘fill anything,' so we saw suspicious prescriptions all the time. Even when we'd raise flags, our pharmacy manager didn't care. He told us to fill them anyway."

A senior certified lead technician with 15 years of pharmacy experience, Ryan worked for a Walgreens in suburban Philadelphia for 18 months. She left the company this summer to accept a job at another pharmacy, but not before witnessing the GFD Policy in action.

She was not impressed.

"Any good pharmacist asks a lot of those questions anyway," Ryan said. "By giving us a checklist, they want to be able to cover themselves by saying ‘We have this policy. We went through it. We did everything we possibly could to make sure this was a good prescription to fill.' But I saw very few things change when this came out, other than people were being inconvenienced… The truth is, a lot of bad prescriptions still get approved because the pharmacy manager's bonus is based on the amount of scripts that get filled."

Ryan said the GFD Policy was applied inconsistently, with prescription approvals and denials based upon the subjective decisions of the particular pharmacy staff on duty.

Why did she make the confidential checklist public?

"I take these kinds of medications so I know what it's like to be in pain," said Ryan, who has chronic back pain caused by a herniated disc.

To deal with that pain, Ryan takes several narcotics prescribed by her doctor. Based on Walgreen's new checklist, she worries her prescriptions for pain pills would raise enough red flags to be denied.

"I've been taking these same pills for years, but they consider that a problem. And I just switched jobs. My insurance at my new company hasn't started yet so I'm paying cash for my prescriptions. With that, I could be turned down and they'd never tell me why. I just don't think that's right."

Not what the doctor ordered

Ryan is not alone. Many doctors also believe Walgreen's checklist is problematic.

Dr. Deborah Peel, founder of the Patient Privacy Rights Foundation, is both disappointed and shocked to learn what Walgreens is doing.

"This is really outrageous," the patient advocate said after looking at the GFD checklist obtained by 13 Investigates. "It's simply wrong for people not to know they are being evaluated in this fashion. If Walgreens wants to really offend its customers and prescribing physicians, this is the way to do it: have a secret policy and force people to comply with it and not tell them what it is."

Peel believes Walgreen's policy discriminates against millions of people, based solely on the type of medication they need.

"Everyone -- everyone -- who has a pain prescription is being treated as a suspected criminal," she explained. "We need programs that target the abusers, that don't treat everyone as an abuser. That's the real problem with this. It's highly offensive."

For pain specialists, frustration is running high.

Over the past several months, pain clinics in the Indianapolis area have observed a dramatic increase in complaints from patients who are having trouble getting their pain medication from Walgreens.

"They feel like they are being treated like an addict and many of them have said 'I'm not going back to Walgreens. I've got to find another pharmacy to go to because they made me feel really bad.' We hear it every day from multiple patients," said Jackie Rowles, a certified registered nurse anesthetist at Meridian Pain Group in Carmel.

Rowles says she supports any legitimate effort to improve patient safety, but she isn't sure Walgreen's new policy accomplishes that goal.

"I think the intention is good, but there's a lot of unintended consequences from this. I think it puts the pharmacist in a very difficult situation," she said, adding that even simple questions on the GFD checklist often have very complicated answers.

The longtime pain specialist offered the following explanation:

"They want to know ‘expected length of treatment?' I have no idea a lot of times how long it's going to take to treat pain. The length of treatment may be forever for some patients.

"Is the therapeutic regimen within standard of care? Many of the medications we prescribe are ‘off label' because no other therapy has worked.

"Use of alternative prescriptions and lower doses? Patients that are on higher doses than normal may actually need those doses because of the way that genetically their body works.

"My concern is: is this a checklist or is this a diagnosis list? Because I don't think many pharmacists are trained or equipped to really understand the diagnosis. Pain is a very difficult entity to treat."

Fighting back

While Rowles had not seen Walgreen's checklist until it was provided to her by 13 Investigates, she is very familiar with the issue.

Rowles is a board member of the American Academy of Pain Management, and her organization has been tracking complaints involving Walgreen's new dispensing policy for several months.

"We have lots of patients and a lot of doctors complaining, and we felt we had to have a way to communicate with the policy makers," she said.

The organization responded by creating an online complaint form for doctors and patients who are experiencing difficulty in getting prescriptions for controlled substances filled at Walgreens.

"The information in these reports will be communicated directly to Walgreens administration so that they may clear up misunderstandings and retrain their employees as needed," American Academy of Pain Management policy director Robert Twillman explained in a recent memo.

The online form allows doctors and patients to submit a complaint without their identity being released to Walgreens.

"Physicians in more than 20 states say that several national pharmacy chains may be inappropriately restricting patients' access to legitimate pain medication. Such roadblocks are creating serious barriers to patient access to needed medications – including those in hospice," wrote Dr. Steven Stack.

Response from pharmacists

The state organization that represents Indiana pharmacists declined to discuss Walgreens' Good Faith Dispensing Policy. "We really don't have anything to say or anyone for you to talk to," said Larry Sage, executive vice president of the Indiana Pharmacists Alliance. "We have no comment at this time."

Individual pharmacists who spoke up, offered a wide variety of reactions to the Walgreens policy. Some said a written checklist that provides clear instructions to curb prescription drug abuse is a positive and long-overdue development for both pharmacists and patients. Others were more skeptical, expressing disdain for a policy that was apparently adopted in reaction to pressure from federal regulators and that puts pharmacists in the cross hairs of angry patients and physicians.

Few pharmacists were surprised that Walgreens implemented a new policy.

"These medicines can be fatal and the government says they must be dispensed properly," said Bruce Clayton, associate dean at Butler University's College of Pharmacy.

He said pharmacists must determine each prescription is medically necessary and appropriate before it is dispensed. Those who fill questionable prescriptions for pain pills without asking questions can face severe consequences.

"If you're doing that, you are not following federal law and state law regarding controlled substances and if prosecuted, one can lose one's license over it. So the pharmacist really has no choice but to collect that info when the prescription is filled," Clayton explained.

Many drug stores, however, do not require their pharmacists to perform patient background checks and to answer a long list of questions before filling a prescription for controlled pain medication.

That may change, according to Clayton.

"I think we'll see some growing pains as pharmacies try to reign in this problem with prescription drug abuse. A pharmacy does have to be really cautious and do its due diligence. I think we'll start seeing a lot more of that," he said.

Walgreens has declined multiple requests for interviews. Asked why the pharmacy chain instructed its pharmacists to keep the GFD checklist confidential, company spokesman Jim Graham wrote "in general we do not make any of our internal policy documents open to the public."

While Walgreens would not provide a copy of its GFD Policy or checklist, it did send the following statement in July:

"With the sharp rise in the abuse of prescription painkillers in recent years, health care professionals in all practices are continuously striving to find better ways of ensuring those medications are used only for legitimate medical purposes. We are working to ensure our patients continue to have access to the medications they need while fulfilling our role in reducing the potential abuse of controlled substances. We have recently taken a number of steps to provide additional guidance and training to our pharmacies on the proper handling of controlled substances. Because of the legal requirements placed on pharmacists to verify that controlled substance prescriptions are issued for a legitimate medical purpose, pharmacists may need to gather additional patient information from their prescribing physician's office. This diligence may take extra time. For example, under our good faith dispensing policy, pharmacists may determine that they first need to check the state's Prescription Drug Monitoring Program database (called INSPECT in Indiana) for anything unusual. They may also decide to contact the prescribing doctor's office to verify the diagnosis and confirm that the patient has had a recent examination. Often, this information can be obtained from a member of the doctor's staff. Our good faith dispensing policy is intended to be used consistently by our pharmacists for each individual prescription to determine whether the doctor's office needs to be contacted. Our policy does not require prescriber contact for every prescription. We firmly believe that addressing prescription drug abuse will require all parties – including leaders in the community, physicians, pharmacies, distributors and regulators – to play a role in finding practical solutions to combating abuse while balancing patient access to critical medication."