— 

Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

FDA’S URGENT NOTICE


JUNE GIBBS BROWN 

Inspector General 

JULY 1996 

OEI-07-94-00631 
OFFICE OF INSPECTOR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services’ (HHS) 

programs as well as the health and welfare of beneficiaries served by those programs. This 

statutory mission is carried out through a nationwide network of audits, investigations, and 

inspections conducted by three OIG operating components: the Office of Audit Services, the 

Office of Investigations, and the Office of Evaluation and Inspections. The OIG also informs 

the Secretary of HHS of program and management problems and recommends courses to 

correct them. 

OFFICE OF AUDIT SERVICES 

The OIGS Office of Audit Services (OAS) provides all auditing services for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by others. 

Audits examine the performance of HHS programs and/or its grantees and contractors in 

carrying out their respective responsibilities and are intended to provide independent 

assessments of HHS programs and operations in order to reduce waste, abuse, and 

mismanagement and to promote economy and efficiency throughout the Department. 

OFFICE OF INVESTIGATIONS 

The 010’s Office of Investigations (01) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries and of 

unjust enrichment by providers. The investigative efforts of 01 lead to criminal convictions, 

administrative sanctions, or civil money penalties. The 01 also oversees State Medicaid fraud 

control units which investigate and prosecute fraud and patient abuse in the Medicaid program. 

OFFICE OF EVALUATION AND INSPECTIONS 

The OIGS Office of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, 

the Congress, and the public. The findings and recommendations contained in these inspection 

reports generate rapid, accurate, and up-to-date information on the efficiency, vulnerability, 

and effectiveness of departmental programs. 

This report was prepared in the Kansas City Regional Office under the direction of James H. 

Wolf, Regional Inspector General. Project staffi 

Region Headquarters 

Raymond Balandron, Project Leader	 Mary Beth Clarke, Program Specialist 

Mark Krushat, Branch Chief 

To obtain a copy of this report, call the Kansas City Regional Office at (800) 241-2527. 
Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

FDA’S URGENT NOTICE


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FDA’S URGENT NOTICE 

PURPOSE 

The purpose of this inspection was to assess the effectiveness of the Food and Drug 

Administration’s (FDA) Urgent Notice on recalled blood glucose test strips, released 

toretail pharmacies Octoberll, 1995. 

RECAU AND URGENT NOTICE OF DEFECTIVE TEST STRIPS 

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for 

regulating devices and radiological health which includes identi&ing and addressing 

postmarked safety questions that arise. In dealing with these issues, FDA will 

occasionally notify members of the heahh care community to inform them of the 

problem and to provide important follow up instructions to prevent further recurrence. 

In January 1995, a manufacturer of blood glucose test strips voluntarily recalled 

certain lots of test strips and in June 1995 extended the voluntary recall to include all 

lots current in the marketplace. Patients with diabetes make use of the strips in 

monitors to measure their blood glucose levels and, if necessary, adjust insulin doses. 

Following the extended recall in June 1995, the FDA found that recalled test strips 

were still on pharmacy shelves and available to the public. The FDA took a number 

of actions, including mailing an Urgent Notice to all pharmacies in the U.S. on 

October 11, 1995. The notice was developed in collaboration with the manufacturer 

and consequently reflects wording negotiated between FDA and the manufacturer. 

The notice described the test strip problem and requested all pharmacies to remove 

any affected stock and post an important public notice for consumers who may have 

purchased these products previously. 

While CDRH was in the process of issuing the Urgent Notice, it requested us to 

closely monitor the receipt of the notice and assess its effectiveness. We conducted a 

nationally representative telephone survey of 279 pharmacies to get a broad 

perspective of how pharmacies perceived the Urgent Notice and a multi-regional onsite survey of 183 pharmacies to validate national information and to make a personal 

examination of their test strip stock. A more detailed description of the methodology 

is found in Attachment A. 

FINDINGS 

A majoriy of the pharmacists surveyed acknowledged receiving the FDA ‘Ugent Notice 

About Recalled Blood Glucose T~t Strips.” One-third or more did not. 

Our study revealed that 67 percent of the pharmacists telephoned and 56 percent of 

those visited acknowledged receiving the Urgent Notice. 

1

Discussion. We are unable to explain why some pharmacists did not know about the


notice. We specifically asked to talk to the head pharmacist or other person who


should have been made aware of an important FDA notice. One possibility is that the


mail was forwarded to another department in the store or the store manager.


However, we have no data to document the prevalence of this practice.


Other possible explanations are that respondents had not yet received the FDA notice


at the time we conducted our surveys, or had received it but forgotten about it. Both


of these were minimized by our study design. We waited 10 days after FDA had


mailed the notice before we began our surveys, and completed them within a two


week period.


Another possible explanation is that the mailing list we used was different from the


one used by FDA. The FDA obtained its list from a marketing firm that used the


mailing list of the National Council for Prescription Drug Programs. We did not use


this same list for two reasons. Various logistical factors, including lack of


computerized format, precluded our using this list in a timely fashion, which was


critical for the evacuation. Second, the list we used from the controlled substances


registrant file of pharmacies maintained by the Drug Enforcement Administration was


readily available in usable format. While neither we nor FDA believed the lists to be


identical, they both represent licensed pharmacies and should be very similar. We


were unable to make a detailed comparison of the lists for this study.


Clearly, more research would be needed to determine exactly why some of the


pharmacists we interviewed did not acknowledge receipt of the notice.


l%e FDA Uigent Notice was the vehicle that made approximately one-hay of the 

pharmacies that received it aware of the blood glucose test strip problem. 

Of the pharmacists that acknowledged receipt, 45 percent of the pharmacists 

telephoned and 58 percent of the pharmacists visited learned of the recalled glucose 

strips from the Urgent Notice. 

Of the remaining pharmacists that did not receive the notice, only 35 percent of those 

surveyed by telephone and 40 percent of those visited said they were previously aware 

of the problem. 

lWu7e a majority of pharmacists reprted checking for and removtig affected stock we 

found recalled blood glucose strip in one pharmacy we Viritetl 

The FDA recommended that pharmacies check their inventories and immediately 

remove any identified lot numbers from their shelves. We asked those pharmacists 

who had acknowledged receiving the alert if they carried out this recommendation; 

84 percent of those telephoned and 71 percent of those visited reported they had in 

fact checked for and removed any recalled stock. The only reason they stated for not 

following this recommendation was not carrying the affected brands. 

2 

—— 
In all our site visits, regardless of whether the pharmacist acknowledged receipt of the 

notice, we attempted to verify that affected stock was not available for sale. We were 

unable to examine stock in all locations, and some pharmacies did not carry the 

affected brands. We did find one pharmacy with four boxes of recalled test strips on 

their shelf, which were promptly removed when brought to their attention. 

Discussion. Based on the first two findings alone one might have expected to find 

more instances of recalled product on the shelves. After all, most of those who had 

not received the FDA notice were not previously aware of the problem. 

One possible explanation is that recalled stock may already have been sold. The 

manufacturer sent out its first recall notice in January 1995, a full 9 months before 

FDA sent out its Urgent Notice. Presumably, the distributors would have ceased 

shipping the defective stock as soon as they received the manufacturer’s recall notice. 

During the ensuing 9 months, any pharmacies that were not notified of the defective 

product may well have depleted their stock through sales. 

Another possible explanation is the fact that the pharmacies carrying this brand of 

product are not randomly distributed across the country like our phone sample was 

nor concentrated in the nine metropolitan areas where we conducted our on-site 

reviews. It may be that the manufacturer’s recall effectively reached most of the 

pharmacies which carry the brand. However, we must caution that this is pure 

speculation on our part. Our study was not designed to test the effectiveness of the 

manufacturer’s recall. 

Few phamuzcies posted the public notice which FDA had provided 

The FDA also recommended that pharmacies post an attached important public 

notice about the defective test strips where it would be visible to consumers. We 

found that, of the pharmacies receiving the Urgent Notice, only 29 percent of the 

telephoned pharmacies and 13 percent of the visited pharmacies posted the public 

notice. The pharmacies not posting the notice gave the primary reasons as the brands 

were not stocked, they did not realize they were supposed to post the public notice, 

and they did not read the Urgent Notice thoroughly enough to realize there was an 

attached notice. Comments offered by some of the pharmacists indicated that they 

did not understand the importance of posting the notice. They suggested that FDA: 

more clearly indicate the importance of posting it; highlight the existence of the public 

notice clearly at the front of the Urgent Notice; and clarifj whether it is necessary to 

post a notice regarding a product that is not stocked. 

ISSUES FOR CONSIDERATION 

Our study leaves several issues unanswered. FDA’s urgent notice did reach many 

pharmacists that would not have otherwise been aware of the defective product. Why 

it did not reach the others is not evident from our study. Clearly, more research on 

how to effectively reach this kind of audience is warranted. 

3 
We were pleased to be of assistance to FDA in its efforts to improve the urgent 

notification process. We strongly encourage CDRH to continue in its efforts to 

improve notification of the health care community on important safety issues with 

medical devices. Based on our review of this single Urgent Notice, we offer the 

following issues for consideration as CDRH explores other dissemination methods and 

evaluates possible changes in format for notices and alerts. We recognize the 

budgetary constraints that exist in piloting or implementing any new options. As the 

responsibility of communicating safety information to the health care community is 

shared with other Centers, cooperation and more focused attention by several Centers 

may yield the best results. 

l%e FDA should consider other diwemination tnethodk for zugent alert informatio~ 

especially for those sz”tuationswhere complete dissemination k essential 

The process of using first class mail was not successful in reaching the entire target 

audience for this Urgent Notice. The success of any dissemination through mail will 

be highly dependent on several variables, such as the accuracy of the mailing list and 

internal mail distribution within businesses or offices. No doubt, situations will 

continue to arise where first class mail may be the only option available. Also, as a 

more “official” document of the agency, with emblems and signatures, first class mail 

may always be useful as a follow up to other dissemination vehicles. However, where 

timeliness or complete dissemination is essential, other methods may provide more 

reliable, efficient means. These methods might include telephone, fax, or electronic 

means, such as on-line systems used by claims processors or third party programs. 

Health care professional groups and associations may be helpful in identi@ing or 

creating networks for facilitating dissemination. 

Ilze FDA should consider r#onnattingjitture alertr and notices to clarifi the actkms 

healih care profem”onalr are recommended to carry out. 

Not all those who said they had received the notice carried out the recommendation 

to post the consumer notice. Comments from our survey indicated that some did not 

see the instructions, perhaps not reading the notice completely, while others exercised 

judgment and determined that it was not necessary. For future alerts, clearly stated 

recommended actions may need to be highlighted or prominently placed to focus 

reader attention. These issues of clarity and format will also be relevant if other 

dissemination vehicles are adopted. 

AGENCY COMMENTS AND OIG RESPONSE 

We received comments from FDA on the draft report and they are included as 

Attachment B. They were generally supportive of the evaluation and results, and have 

agreed to undertake a broader review of the program, including an in-depth look at 

new technologies for communication. The FDA did disagree with our conclusion in 

the draft report that first class mail could not be relied upon to reach all pharmacies. 

We agree that this conclusion was stated too broadly. We did not measure whether 

4 
the notice was delivered to pharmacies, but rather examined whether the responsible 

pharmacist was aware of the information that had been mailed. We modified our 

report to clarify that our conclusion related to the pharmacists, not the pharmacies. 

The FDA also provided a number of helpful technical comments, and we have made 

changes where appropriate. The FDA also asked us for any specific recommendations 

we might have on reformatting the urgent notices to make them more effective. 

While we have our opinions on the matter, we feel that it would be best if any 

changes in reformatting notices should be considered as part of a broader strategy and 

developed by professionals knowledgeable in the communications field. At FDA’s 

suggestion, we have included copies of the Urgent Notice (Attachment C) and survey 

instruments (Attachments D and E). 

5

Attachment A 

METHODOLOGY


We held several discussions with representatives of the CDRH to determine the focus 

of the study. We decided to assess the Urgent Notice by conducting two surveys of 

community pharmacies in the United States. Two separate samples were drawn for 

the surveys. The first sample was intended to be representative of all pharmacies in 

the country. This sample was used for the national telephone survey to assess the 

effectiveness of the FDA urgent notice by obtaining a broad perspective of how both 

urban and rural pharmacies throughout the country perceived the Urgent Notice. The 

second sample included only pharmacies located in specified urban areas. This was 

used for the second survey, which was a regional on-site survey, to validate national 

information solicited and to make a personal examination of their blood glucose test 

strip stock. 

To develop our sampling frame of pharmacies in the United States, we obtained the 

Controlled Substances Registrant File of pharmacies maintained by the Drug 

Enforcement Administration, Department of Justice. This file contained the names 

and addresses of 60,970 registered pharmacies with a business activity code of ‘A’, 

indicating the entity was a pharmacy. This was the only source we used to obtain 

sample pharmacies for data collection. 

National Telephone Survey 

This survey involved contacting, by telephone, a simple random sample of 330 retail 

pharmacies from the list of 60,970. Based upon our sampling assumptions, this sample 

size would give us a 90 percent assurance that the true proportion of pharmacies 

recognizing the Urgent Notice would be within five percent of our estimate. 

The actual number of pharmacies completing the telephone survey was 279 or 85 

percent. There are various reasons why some pharmacies did not complete the survey 

which included (1) no longer in business, (2) non-cooperation by the pharmacist, and 

(3) the business was not a retail pharmacy. 

R~”onal On-sile Survey 

Using simple random sampling, we selected 25 pharmacies in each of the following 

metropolitan areas; Boston, New York, Philadelphia, Atlanta, Kansas City, Chicago, 

Dallas, San Francisco, and Washington D. C., for a total of 225 pharmacies. This 

sample size was dictated by resource constraints rather than desired precision levels. 

Any pharmacies selected in the national sample that fell within the sampling frame of 

any of the nine metropolitan areas was automatically included in the regional sample. 

6

Of the 225 pharmacies in the sample, the actual number of pharmacies visited and 

completing the on-site survey was 183 or 81 percent. Among the reasons for not 

completing all the on-site visits were (1) pharmacy no longer in business, (2) business 

was not a retail pharmacy, and (3) pharmacy location was outside the area to be 

visited. 

Both surveys were conducted during a two week period starting 10 days after FDA 

sent out its Urgent Notice. 

The questions used in both survey documents were identical. However, the on-site 

visits included examining the pharmacies’ test strip inventory for the brands listed in 

the Urgent Notice and any identified lot numbers. 

The following table provides our estimates of the standard errors and lower and upper 

95 percent confidence intervals for figures presented in this report. Estimates for the 

local site visits are appropriately weighted to reflect the sampling design. only in the 

case of posting the notice does there appear to be a significant difference in the 

proportions. Of those acknowledging receiving the Urgent Notice, 29 percent of those 

contacted by telephone claim to have posted the notice. Less than half of that 

proportion made a similar claim among the local site visits, 13 percent. The 

confidence intervals of these two estimates do not overlap. 

Estimates, Standard Errors and Confidence Intervals 

for Values Presented in Report 

95% Conf. Interval 

Est. Std. Err. Lower Urmer 

Proportion of Pharmacies Receiving Urgent Notice 

Telephone Survey 0.667 0.028 0.612 0.722 

Local Visit Survey 0.561 0.044 0.475 0.647 

Proportion Learning of Recall horn Urgent Notice* 

Telephone Survey 0.452 0.036 0.381 0.523 

Local Visit Survey 0.579 0.060 0.461 0.697 

Proportion Posting Urgent Notice* 

Telephone Survey 0.290 0.033 0.225 0.355 

Local Visit Survey 0.130 0.039 0.054 0.206 

*Among Those Acknowledging Receipt 
We conducted our review in accordance with the Qzdi~ fhndtm. for Inspections 

issued by the President’s Council on Integrity and Efficiency. 

8 

— 
Attachment B 

,+’”“’’’’”%, Public Health Service 

DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 

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Memorandum 

Date NAY 3 / /996 

From 

Deputy Commissioner for Management and Systems (Acting) 

Subject	 Food and Drug Administration’s (FDA) Comments on the Office of Inspector General’s 

(OIG) Draft Report, “FDA’s Urgent Notice, “ (OEI-07-94-00631) - INFORMATION 

To 

Deputy Inspector General for Evaluation and Inspections 

We reviewed the referenced draft report and prepared the attached comments, 

We are pleased to report that FDA’s Deputy Commissioner for Operations has agreed to 

conduct a review of your report’s suggestions. 

If your staff has any questions, please have them contact Jim Dillon on (301) 443-6392. 

%’hmyd

Robert J. Byrd 

Attachment 
COMMENTS OF THE FOOD AND DRUG ADMINISTRATION ON THE OFFICE 

OF INSPECTOR GENERAL (OIG) DRAFT REPORT, “FDA’S URGENT NOTICE,” 

0EI-07-94-O0631, APRIL 9, 1996 

General Comments 

The Food and Drug Administration (FDA) appreciates the opportunity to review and 

comment on the draft report. We acknowledge the OIG’S prompt response and 

thoughtful efforts to our request to evaluate the effectiveness of the Agency’s October I I, 

1995 Urgent Notice on recalled blood glucose test strips. We believe the report will 

provide useful information to improve the Agency’s Center for Devices and Radiological 

Health’s (CDRH) Postmarked Safety Notification Program. 

The FDA agrees with the OIG draft report that recognizes the tremendous importance of 

rapidly and accurately communicating safety information to the health care community. 

The FDA also agrees that we must assure that our outreach capabilities are of the highest 

quality and are received by the health care community in a format that is maximumly 

useful. The OIG draft report serves as a timely catalyst for encouraging FDA to 

undertake a broader examination and to improve the overall program. To this end, the 

Deputy Commissioner for Operations has agreed to conduct a prompt review of the OIG 

suggestions, including an indepth look at new technology (such as electronic 

communications) and new approaches to older technology (such as reformatting existing 

alerts and notices). 

The FDA disagrees with the OIG’S conclusion that states FDA’s process of using first 

class mail cannot be relied upon to reach all pharmacies. This conclusion is based on 

the OIG’S finding that one-third or more of the pharmacies surveyed did not 

acknowledge receiving the “urgent notice. ” This finding is incongruent with FDA’s rate 

of returned notices. Of the approximately 66,OOO urgent notices sent to pharmacies, 

fewer than 1,000 were returned to FDA resulting in a return rate of 1,5°/0. In addition, 

OIG gave FDA a list of names and addresses of the pharmacists who stated they did not 

receive the notice so that we could reissue it. The Agency did not receive any returned 

notices after they reissued them. As discussed in our technical comments, we asked OIG 

to provide more explanations concerning the issues addressing the acknowledgment of 

notices. Since there are many unanswered issues, we believe more research is needed 

before drawing a conclusion concerning the use of first class mail. 
Attachment C 

HFZ-51O 

U.S. DEPARTMENT OF


tHEA1-TH AND HUMAN SERVICES


Public Health Service


Food and Drug Administration


Center for Devices and Radiological Health


Rockville, Maryland 20857


FIRST CLASS MAIL 

POSTAGE AND FEES PAID 

PHS/FDA 

PERMIT NO. G-285 

FDA IMPORTANT NOTICE


For Users of Blood G[ucose Test Strips 
IMPORTANT NOTICE 

FOR USERS OF 

BLOOD GLUCOSE TEST STRIPS 

WHAT’S THE PROBLEM? 

Some brands of blood glucose test strips for use in blood glucose meters may give 

incorrect high or low readings, leading to serious health problems. The 

manufacturer has recalled the product and asked that these strips be taken off the 

store shelves, but some people may still be using the recalled strips. 

HOW DO I KNOW IF I HAVE THE RECALLED TEST STRIPS? 

You must look at two things: 

1. Check the brand. The following brands were recalled: 

BRJl_E- LIFE HEALTH MART QUICK CHECK ONE


BROOKS LONGS QUICK CHECK 3


BROOKS 1 MK (MEDICAL) RELIEF PLUS


FAMILY PHARMACY PERRY 1 RELIEF PLUS ONE


FULL VALUE PERRY HEALTH CARE TOP CARE


GIANT EAGLE QUALITEST 3 VALU-RITE


GOOD NEIGHBOR


2.	 Check the lot number on the container. The recalled strips have lot numbers 

beginning with 30, 31, 41, or 43. These brands are OK if they have other lot 

numbers. 

IF YOU ARE USING BLOOD GLUCOSE TEST STRIPS THAT MATCH THE 

ABOVE BRANDS AND LOT NUMBERS: 

1. Stop using these test strips and purchase a fresh supply. 

2.	 Continue using your blood glucose meter with your new test strips and follow 

your doctor’s instructions. 

3. Contact your pharmacist or doctor if you have concerns or questions. 

4.	 For information on how to exchange recalled test strips, call the manufacturer at 

1-800-446-4374 from 8:00 a.m. to 4:00 p.m. Pacific Time and 11:00 a.m. to 7:00 

p.m. Eastern Time. 
Diagnostic Solutions, Inc. has improved the manufacturing process to correct the 

problem and the company is now manufacturing new strips under these same brand 

names. The new strips are sold in containers that look almost identical to those in 

which the recalled test strips are packaged. Therefore, to identify the recalled test 

strips, it is important to examine the lot numbers, 

OTHER RECOMMENDED ACTIONS 

In the interest of safety to patients, who may still have the recalled strips in their homes, 

FDA and the manufacturer are also asking that: 

� Health care facilities stop use of the recalled strips 

�	 Health care professionals display and disseminate the attached 

Important Notice and advise patients to discontinue use of the recalled 

test strips, and 

�	 Organizations notify their members. (This document and the attached 

Important Notice may be reproduced.) 

In the meantime, FDA will continue to monitor the effectiveness of the recall. it is 

critical that- all pharmacies complete the reoall process that the company has-initiated 

by following the above recommendations. 

Diagnostic Solutions, Inc., will replace the recalled test strips. For more information, 

call 1-800-446-4374. This number is available to health care professionals and 

consumers. The hours of operation are 8:00 a.m. to 4:00 p.m. Pacific Time/l 1:00 a.m. 

to 7:00 p.m. Eastern Time. 

D. Bruce Burlington ‘


Director


Center for Devices and


Radiological Health

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~: DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service J 

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Rockville MD 20857 

October 11, 1995 

URGENT’ NOTICE ABOUT 

RECALLED BLOOD GLUCOSE TEST STRIPS 

Dear Health Care Professionals: 

A number of blood glucose test strips were recently recalled by the manufacturer 

because they may give inaccurate readings, both high and low, posing a potentially 

serious health risk to users. 

The strips were recalled and a press release issued by the manufacturer. However, 

FDA and the manufacturer have recently found recalled strips in some retail outlets and 

health care facilities, such as nursing homes. The recalled test strips may also be in 

home medicine cabinets. 

Retailers are hereby notified by FDA in conjunction with Diagnostic Solutions, 

Inc., that notifications concerning recalled blood glucose test strips should not 

be ignored. 

RECOMMENDED ACTIONS 

FDA and the manufacturer are urging that pharmacies and health care facilities: 

� check inventories and immediately remove the indicated test strips 

from their shelves, and 

� post the attached Important Notice where it is visible to consumers. 

HOW TO IDENTIFY THE PROBLEM TEST STRIPS 

The recalled test strips, all manufactured by Diagnostic Solutions, Inc., were sold under 

nineteen brand names, as listed below. All the recalled test strips have lot numbers 

beginning with 30, 31, 41, or 43 and expiration dates ranging from February 1993 to 

December 1996. Other lot numbers of these brands are not affected. 

Brand Names 

BRITE- LIFE HEALTH MART QUICK CHECK ONE 

BROOKS LONGS QUICK CHECK 3 

BROOKS 1 MK (MEDICAL) RELIEF PLUS 

FAMILY PHARMACY PERRY 1 RELIEF PLUS ONE 

FULL VALUE PERRY HEALTH CARE TOP CARE 

GIANT EAGLE QUALITEST 3 VALU-RITE 

GOOD NEIGHBOR 
Attachment D 

Office of Inspector General 

Office of Evaluation and Inspections 

Kansas City Regional Office 

TELEPHONE SURVEY DOCUMENT


FDA’s URGENT NOTICE PROCESS


Inspection #OEI-07-94-00631


Pharmacy Name Date 

Pharmacy Address Phone# 

Respondent/Pharmacist Name 

NOTE: You will need to determine if the pharmacist on duty 

will be able to answer the questions. The senior 

pharmacist or pharmacist-manager would be preferable; at a 

minimum, you should speak with a full-time (or close to 

full-time) pharmacist who regularly works in that 

pharmacy. Pharmacists who work part-time (or p.r.n. or 

on-call basis) or in several pharmacies will probably not 

be the best source of information. If the only pharmacist 

available is in this latter category, ask when the senior 

pharmacist will be available and call back. 

1.	 Did you receive the Urgent Notice about Recalled Blood


Glucose Strips issued by FDA on October 11, 1995 (the


title was in bold red letters)?


Yes No


If no, explain to them that you will advise FDA so it can 

nail them the Urgent Notice. 

2.	 Were you previously aware of the problem with these 

glucose strips? 

Yes No


If yes, when and how did you learn of the problem? 

NOTE: IF RESPONDENT DID NOT RECEIVE THE URGENT NOTICE END


THE INTERVIEW AT THIS POINT.

3.	 Did you follow the 

your inventory and 

strips? 

Yes


If no, why not?


recommendation in FDA’s Notice checking 

immediately removing the indicated test 

No


4.	 Did you post the attached important Notice where it was 

visible to consumers? 

Yes No


If yes, describe where the Notice was posted.


If no, why didnlt you post the important Notice?


5.	 Have you disseminated the important Notice and/or advised 

individuals to discontinue use 

strips? 

Yes No


If yes, to whom?


6. Did the Notice raise questions


you to contact FDA?


of the recalled-test


or concerns which required


Yes No


If yes, what were those questions/concerns?


7.	 Did you think the Urgent Notice was clearly and


understandably written?


Yes No


If no, what particular portion of the Notice caused you


problems?


8.	 Do you have any additional comments or suggestions that


could improve future FDA Notices?


Yes No


If yes, please explain.

Attachment E


Office of Inspector General


Office of Evaluation and Inspections


ON-SITE SURVEY DOCUMENT


FDA’s URGENT NOTICE PROCESS


INSPECTION #oEI-07-94-00631


Pharmacy Name Date


Pharmacy Address Phone#


Respondent/Pharmacist Name


Upon entering the pharmacy, ask to see the head pharmacist.


NOTE: You will need to determine if the pharmacist on duty


will be able to answer the questions. The senior


pharmacist or pharmacist-manager would be preferable; at a


minimum, you should speak with a full-time (or close to


full-time) pharmacist who regularly works in that


pharmacy. Pharmacists who work part-time (or p.r.n. or


on-call basis) or in several pharmacies will probably not


be the best source of information. If the only pharmacist


available is in this latter category, ask when the senior


pharmacist will be available and do a revisit.


1.	 Did you receive the Urgent Notice about Recalled Blood


Glucose Strips issued by FDA on October 11, 1995?


Yes No


NOTE: If they did not receive the Urgent Notice provide


them with a copy of the Urgent Notice and the attached


notice to be posted for their review.


If the pharmacy is located in a Csstore,lCask


if it is possible that the ‘sstore~t
manager received the


Urgent Notice in the mail and it didntt qet to the


pharmacy? If the pharmacist believes this is a strong 

possibility, ask the ‘tstore’smanager if he/she did get the


notice.


2.	 Were you previously aware of the problem with the blood


glucose strips?


Yes No


If yes, when and how did you learn of the problem? 
7.	 Did you think the Urgent Notice was clearly and 

understandably written? 

Yes No


If no, what particular portion of the Notice caused you


problems?


8.	 Do you have any additional comments or suggestions that


could improve future FDA Notices?


Yes No


If yes, please explain.