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For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging.
The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging.
During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States.
Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms.
Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.
For patients, the prescription container label may be the only source of instructions on how to take their medicines [
the term “labeling” designates all labels and other written, printed, or graphic matter upon an immediate container of an article or upon, or in, any package or wrapper in which it is enclosed, except any outer shipping container. The term “label” designates that part of the labeling upon the immediate container [
In other words, “labeling” can refer to drug products from a manufacturer, and “label” can apply to drug products dispensed by a pharmacist on a prescription order.
In the United States, the legal requirements for a prescription label are set by federal law and state statutes [
Guidelines for prescription labeling and packaging
Prescription Labelsa | Prescription Packagingb |
Serial number of prescription Date of prescription or date of its filling Name of prescriber Name of patient if stated on prescription Directions for use, including precautions, if contained in prescription |
Light-resistant; Protects light-sensitive product and/or contents against photochemical deterioration Moisture-proof closure Child-resistant container with safety closure Container preserves product’s identity, strength, quality, purity as Type as specified by manufacturer |
a Federal requirements only; individual state requirements may differ
b Includes requirements set by drug manufacturers dispensed to patients by licensed practitioners; exceptions include drugs requiring direct and immediate access (eg, oral contraceptives and certain cardiac drugs)
The National Association of Boards of Pharmacy (NABP) provides recommendations for state statutes on required items of information for outpatient prescription labels [
In the United States, it is the professional responsibility of pharmacists to label the dispensed drug product with the items stated in the federal law in addition to any state requirements for the state in which he or she is practicing.
In addition to proper labeling, pharmacists should select packaging that maintains the integrity of the drug product. The pharmacist’s choice of container should be based primarily on the type and quantity of medication to be dispensed and manner of use [
In addition to packaging requirements for dispensing drug products, special consideration should be made for the closure on the prescription container. The closure must inhibit penetration of moisture and contaminants that can have a deleterious effect on oral dosage forms. A well-known example in pharmaceutics is the breakdown of aspirin into acetic acid and salicylic acid in the presence of moisture.
If the original package is intended to go directly from the pharmacist to the patient, manufacturers must place prescription drugs in child-resistant packages. Similarly, pharmacists must dispense prescription drugs for oral use to the patient in containers with child-resistant safety closures unless the patient or prescriber specifically requests otherwise.
A request for a safety container that is not child resistant must be obtained by the patient as a signed waiver and may apply to all of a patient’s dispensed medications. The pharmacist must maintain a record of the signed waiver request. Exceptions exist to these requirements, such as packaging of oral contraceptives because of their functional design, and certain types of cardiac drugs, such as nitroglycerin. In these instances, patients may need immediate access to the medication.
In addition, the closure must comply with guidelines specified in the Poison Prevention Packaging Act 1970 [
Often, prescription drugs are sold in bottles with a seal that must be removed the first time the bottle is opened. This is an example of “tamper-evident” packaging that was introduced in the 1980s. The design of tamper-evident packaging makes it apparent if the packaging has been previously opened. The Tylenol crisis of 1982 highlighted the need for manufacturers to provide safeguards to altering drug product packaging [
In general, pharmaceutical products purchased from international online pharmacies are unapproved by the FDA, and in addition to possibly not meeting standards of formulation, may not meet quality standards for labeling and packaging [
Currently, there is a paucity of information on packaging and labeling of pharmaceutical products imported via the Internet. The Office of Compliance in FDA’s Center for Drug Evaluation and Research initiated a study to determine the quality of a select group of pharmaceutical products purchased via the Internet from foreign sources. Packaging was a significant problem with virtually all of the Internet purchase samples. Many had either no or minimal labeling information for proper use. Some drug samples were shipped loosely in unlabeled plastic bags [
This paper reports on the variability of labeling and packaging for drug products obtained via the Internet. The objective of this study was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. This information is valuable for identifying trends in drug quality that may exist with consumer drug importation via the Internet.
Drug product acquisition and website attributes were described previously in a report on drug quality, and a similar process was followed for this study [
Upon receipt of drug product samples, the contents for each package were observed and recorded, and data were organized in tabular format. Comparison was made between the shipped items and prescription labeling and packaging requirements in the United States. Any additional distinguishing qualities were noted.
During March 2006 through January 2007, simvastatin, amlodipine, and sildenafil drug product samples were purchased from international markets from 41 websites. A checklist of attributes was created for each specific drug product (
Characteristics of pharmaceutical tablet samples from international markets obtained from the Internet
Product Name a | Manufacturer | Lot |
Product |
Product Source |
Shipping Source | Product Source |
|
|
|||||||
Apo-Simvastatin | Apotex | GP5249 | 2006 AL | Toronto, Ontario, Canada | Canada | http://www.canadamednet.comb | |
Co-Simvastatin | Cobalt | AC641 | 02-2006 | Mississauga, Ontario, Canada | Canada | http://www.minitdrugs.comb | |
Novo-Simvastatin | Novopharm | 20392C | 05-2006 | Toronto, Ontario, Canada | Canada | http://www.Canadacure.comb | |
Pms-Simvastatin | Pharmascience | 20329A | 01-2006 | Montreal, Quebec, Canada | Canada | www.universaldrugstore.comb | |
Simvastatin | Generics (United Kingdom) Limited | 5C07SH |
03-07 |
Hertfordshire, England, United Kingdom | United Kingdom | www.CanadaPharmacy.comb | |
Simlo-20 | Ipca Laboratories | VO4010R | 11-07 | Mumbai, Maharashtra, India | India | www.safemeds.com |
|
SIMLIP-20 | Okasa Pharma | NS6002 | 12-07 | Mumbai, Maharashtra, India | India | www.qualitygenerics.com | |
Starstat 20 | Mepro Pharm | 03065M | 05-07 | Mumbai, Maharashtra, India | India | overseasrxdrugs.com |
|
Simi-20 | Preet Pharm | PMI-2001 | 07-07 | Delhi, India | India | www.fairrx.com |
|
Zorced | Productos Farmaceuticos Collins SA de CV | 2734F4K | 11-06 | Guadalajara, Jalisco, Mexico | Mexico | www.pharmacymex.com |
|
Simvastatina ratiopharm | Ratiopharm Espana | Z-03 | 11-08 | Madrid, Spain | Spain | www.tristatemeds.com |
|
Simlo-20 | Ipca Laboratories | V05007R | 05-07 | Mumbai, Maharashtra India | India | www.xlpharmacy.com |
|
Simvastatin | Unicure Remedies | 24205 | 05-07 | Vadodara, Gujarat, India | India | www.worldremedium.com |
|
Simastin 20 | Zaneka Healthcare Pvt | SAA602 | 12-07 | Haridwar, India | India | www.generic-pharmacy-online.net |
|
Bestatin 20 | Berlin Pharmaceutical Industry | 06000065 | 01-09 | Bangkok, Thailand | Thailand | www.healthworldconnect.com |
|
Simlup-20 | Mepro Pharm | 08124M | 11-06 | Mumbai, Maharashtra, India | India | www.rx2world.com |
|
Simlup-20 | Mepro Pharm | 02044M | 03-06c | Mumbai, Maharashtra, India | Fiji Islands | www.inhousepharmacy.com |
|
Simvastatin | Not provided | None | 03-08 | Not provided | India | www.supersavermeds.com | |
|
|||||||
Amlodac-5 | Cadila | ZF1141 | 03-08 | Dholka, Ahmedabad, India | India | www.qualitygenerics.com |
|
Amlip-5 | Okasa Pharma | NN6004 | 01-09 | Mumbai, Maharashtra, India | India | www.freedoms-pharmacy.com | |
Amlip-5 | Okasa Pharma | NN5007 | 06-08 | Mumbai, Maharashtra, India | India | www.rx-list.net |
|
Aginal-5 | Alembic Ltd | 6931003A | 02-08 | Vadodara Gujarat |
India | www.valuepharmaceuticals.com |
|
Norvasc | Pfizer |
55805036 | 10-10 | Auckland, |
Fiji Islands | www.inhousepharmacy.com |
|
Amlopres-5 | Cipla Ltd |
Not provided | 12-08 | Mumbai Central, |
India | www.npmeds.com |
|
Amlopine | Berlin Pharmaceutical | 0600652 | 04-09 | Bangkok, Thailand | Thailand | www.1anabolic-steroids.com |
|
Amlodac-5 | Cadila | ZF1143 | 03-08 | Dholka, Ahmedabad, India | India | www.sharpmeds.com |
|
Amlibon | Ind-Swift, Ltd | AC5J02J | 09-07 | Samba, Jammu, India | India | www.xlpharmacy.com |
|
Amdepin-5 | IRM Pharma | 6001 | 02-08 | Dholka, Ahmedabad, India | India | www.aclepsa.com |
|
Delfidin | Akums Drugs & Pharmaceuti-cals | 06085AAV | 07-07 | Ranipur, Haridwar, India | Seychelles | www.budgetmedicines.com |
|
Elpress-5 | Elder Pharmaceuti-cals | CSEL6001 | 03-09 | TTC Industrial Area, Navi Mumbai, India | India | www.worldremedium.com |
|
Elpress-5 | Elder Pharmaceuti-cals | CSEL 600308 | 07-09 | TTC Industrial Area, Navi Mumbai, India | India | www.pharmacyforlife.com |
|
Norvas | Pfizer, SA de CV | 6180501101 | 05-10 | Toluca, Mexico | Mexico | www.pharmacymex.com |
|
Amlodipin | 1A Pharma | 6E0063 | 01-09 | Oberhaching, Germany | Germany | www.tristatemeds.com |
|
Amlomed-5 | Akums Drugs and Pharmaceuti-cals, Ltd | A1004 | 03-08 | Ranipur, Haridwar, India | India | www.generic-pharmacy-online.net |
|
Amlokind-5 | Unimax Labs | AD06-11 | 04-09 | Faridabad, Haryana, India | India | www.pillsbasket.net |
|
Amlogard |
Pfizer Ltd, India | 620-05022 | 05-09 | Navi Mumbai, India | India | www.discount-prescription-drugs-online.com | |
|
|||||||
Caverta | Not provided | Not provided | Not Provided | Not Provided | San Diego, California, United States | www.worldexpress.com | |
Zenegra-100 |
Mepro Pharm |
ZA 2002 |
02-03 |
Mumbai, Maharashtra, India |
Monterrey, Neuvo Leon, Mexico | www.viagrasecrets.com |
|
Vega Asia |
Not provided |
B11102 |
10-04 |
Not provided |
Delhi, India | www.blue-pills.net |
|
Suhagra-100 |
Okasa Ltd |
MR3025 | 01-06 |
Pune, Maharashtra, India |
India | www.viagrageneric.tripod.com |
|
Vega | Not provided | Not provided | 04-04 | Not provided | Manila, Phillippines |
www.genericviagra.com |
a Product name as displayed on package at time of delivery
b Prescription required as indicated by website
c Expired at time of delivery
Label and package characteristics of pharmaceutical products obtained from the Internet are presented in
Label and package characteristics of pharmaceutical products obtained from the Internet
Pharmaceutical Product |
Meets |
Label Description | Meets |
Package Descriptionb
|
|
|
|||||
GP5249 (Canada) | Yes | Standard prescription label for products dispensed in the United States | No | Round plastic vial: white, light-resistant, screw-top closure, not child resistant; original container from manufacturer | |
AC641 (Canada) | Yes | Standard prescription label for products dispensed in the United States | No | Round plastic vial: white, light-resistant, screw-top closure, not child resistant; original container from manufacturer | |
20392C (Canada) | Yes | Standard prescription label for products dispensed in the United States | No | Round plastic vial: white, light-resistant, screw-top closure, not child resistant; original container from manufacturer | |
20329A (Canada) | Yes | Standard prescription label for products dispensed in the United States | Yes | Round plastic vial: white, light-resistant, screw-top child-resistant closure; original container from manufacturer | |
5C07SH (United Kingdom) | No | Standard prescription label for products dispensed in the United States; missing name of prescriber | No | Unit dose strip packages taped together; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
VO4010R (India) | No | No label affixed to drug product; label information printed on enclosed paper; missing address of dispenser and name of prescriber | No | Unit dose strip packages enclosed in envelope; sealed foil pack, light resistant, not childproof; original container from manufacturer | |
NS6002 (India) | No | No label affixed to drug product | No | Unit dose strip packs held together with rubber band; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
03065M (India) | No | No label affixed to drug product | No | Unit dose packages taped together; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
PMI-2001 | No | Label affixed to envelope; missing name and address of dispenser, name of prescriber, name of patient, and directions for use | No | Unit dose strip packages enclosed in envelope; sealed foil pack, light resistant, not childproof; original container from manufacturer | |
2734F4K (Mexico) | No | No label affixed to drug product | Yes | Round plastic vial: white, light-resistant, screw-top child-resistant closures; original container from manufacturer | |
Z-03 (Spain) | No | No label affixed to drug product | No | Unit dose packages in box; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
V05007R (India) | No | No label affixed to drug product; label information printed on enclosed paper; missing address of dispenser and name of prescriber | No | Unit dose strip packages enclosed in envelope; sealed foil pack, light resistant, not childproof; original container from manufacturer | |
24205 (India) | No | No label affixed to drug product | No | Unit dose strip packs held together with staples; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
SAA602 (India) | No | No label affixed to drug product | No | Unit dose boxes with strip packages enclosed in envelope; sealed foil pack, light resistant, not childproof; original container from manufacturer | |
06000065 (Thailand) | No | No label affixed to drug product | No | Unit dose strip packs in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
08124M (India) | No | No label affixed to drug product | No | Unit dose strip packs in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
02044M (India) | No | No label affixed to drug product | No | Unit dose strip packs held together with rubber band; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
Lot No. not provided (India) | No | Nonstandard label affixed to drug product contains drug name and strength | No | Capsules placed in plastic container, not light resistant or childproof | |
|
|||||
ZF1141 (India) | No | No label affixed to drug product | No | Unit dose strip packs held together with staples; blister pack with foil backing not light resistant or childproof; original container from manufacturer | |
NN6004 (India) |
No | Label affixed to envelope; missing name and address of dispenser, name of prescriber, name of patient, and directions for use | No | Unit dose boxes with strip packages enclosed in envelope; sealed foil pack, light resistant, not childproof; original container from manufacturer | |
NN5007 (India) | No | Label affixed to envelope; missing name and address of dispenser, name of prescriber, name of patient, and directions for use | No | Unit dose boxes with strip packages enclosed in envelope; sealed foil pack, light resistant, not childproof; original container from manufacturer | |
6931003A (India) | No | No label affixed to drug product | No | Unit dose strip packs in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
55805036 (New Zealand) |
No | No label affixed to drug product | No | Unit dose packages in box; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
Lot number not provided (India) | No | No label affixed to drug product | No | Unit-dose strip packs enclosed in plastic wrap and placed in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
0600652 (Thailand) | No | No label affixed to drug product | No | Unit dose boxes with strip packs enclosed in envelope; blister pack with foil backing, sealed, light resistant, not childproof; original container from manufacturer | |
ZF1143 (India) | No | No label affixed to drug product; label information printed on enclosed paper; missing address of dispenser and name of prescriber | No | Unit dose boxes with strip packs enclosed in envelope; blister pack with foil backing, sealed, light resistant, not childproof; original container from manufacturer | |
AC5J02J (India) | No | No label affixed to drug product | No | Unit dose strip packs in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
6001 (India) | No | No label affixed to drug product | No | Unit dose strip packs in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
06085AAV (India) | No | No label affixed to drug product | No | Unit dose strip packs in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
CSEL6001 (India) | No | No label affixed to drug product | No | Unit dose strip packs in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
CSEL600308 (India) | No | Label affixed to envelope; missing name and address of dispenser, name of prescriber, name of patient, and directions for use | No | Unit dose strip packs in envelope; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
6180501101 (Mexico) | No | No label affixed to drug product | No | Unit dose boxes with strip packages enclosed in envelope; blister pack with foil backing, sealed, light resistant, not childproof; original container from manufacturer | |
6E0063 (Germany) | No | No label affixed to drug product | No | One unit dose box with strip packages enclosed in envelope; blister pack with foil backing, sealed, light resistant, not childproof; original container from manufacturer | |
A1004 (India) | No | No label affixed to drug product | No | Unit dose strip packs in loose plastic; blister pack with foil backing not light resistant or childproof; original container from manufacturer | |
AD06-11 (India) | No | No label affixed to drug product | No | Unit dose strip packs wrapped in newspaper; blister pack with foil backing, not light resistant or childproof (front and back); original container from manufacturer | |
620-05022 (India) | No | No label affixed to drug product | No | Two unit dose boxes with strip packages enclosed in shipping box; blister pack with foil backing, sealed, light resistant, not childproof; original container from manufacturer | |
|
|||||
Lot number not provided (source not specified) | No | Label affixed to envelope; only contains drug name, strength, and directions | No | Loose tablets placed in small paper envelope enclosed in bubble wrap; container not light resistant, childproof, or moisture resistant | |
ZA 2002 (India) |
No | No label affixed to drug product | No | Unit dose strip pack in envelope; blister pack with foil backing not light resistant or childproof; original container from manufacturer | |
B11102 (India) |
No | Label affixed to envelope; only contains drug name and strength | No | Loose tablets placed in small foil unsealed envelope placed in bubble wrap envelope; container not light resistant, childproof, or moisture resistant | |
MR3025 (India) |
No | No label affixed to drug product | No | Twenty-four unit dose boxes held together with plastic tape; blister pack with foil backing, not light resistant or childproof; original container from manufacturer | |
Lot number not provided (source not provided) | No | Handwritten label affixed to drug product; only contains drug name and expiration date | No | Loose tablets placed in small plastic bag; container not light resistant, childproof, or moisture resistant |
a Required items for dispensing to patients in the United States
b Type of container dispensed to patients
Deviation from US federal requirements for prescription labels and manufacturer requirements for prescription packaging are noted. Among all samples obtained, significant variation was observed in external package appearance, labeling of drug product (if any), and packaging of dispensed product.
Of the 41 drug products obtained, only 1 product from Canada would meet both labeling and packaging guidelines for products dispensed in the United States. In all, 4 products from Canada were labeled in a manner that would meet US guidelines, and although the Canadian products were packaged in similar containers to those dispensed in the United States, 3 of 4 containers were not child resistant, and no offer was made to patients to dispense in this manner on the websites. A total of 7 products were dispensed in paper envelopes with a label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package. In all, 28 products did not have labels affixed to the drug product, while 39 of the 41 drug products’ packaging would not meet guidelines established in the United States. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that woul meet US guidelines. Of the 41 products, 35 were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands or staples, or a combination of these packaging forms.
Results of this study indicate that drug products sold on the Internet—often accessible to consumers without prescription—present insufficient labeling and packing characteristics compared with products dispensed in the United States For example, picutred in
Generic sildenafil tablet obtained via the Internet without prescription
Of the 41 drug products, 36 did not meet criteria for prescription drug labeling, and 39 did not meet criteria for prescription drug containers and packaging as required in the United States. For all international products, the only drug products that met US standards for labeling were those from Canada. Only 1 container from Canada and 1 container from Mexico met US guidelines. No relationship could be ascertained between packaging standards and prescription requirements.
Our findings corroborate a report by Westenberger et al, where drug sample packaging was a significant concern for virtually all of the Internet purchased samples [
Medication errors have been attributed to improper labeling and packaging of medications. A major report from the Institute of Medicine (IOM) noted that problems with prescription drug labeling were cited as the cause of a large number of outpatient medication errors and adverse drug events (ADEs) [
Patients may unintentionally misuse a prescribed medicine because of misunderstanding of instructions. Individuals who manage complex medication regimens were found to be at greater risk for making errors in interpreting container label instructions, particularly the elderly with limited literacy skills. The patient’s ability to understand prescription label instructions can be critical to safe use of medications since other sources of information on medicines for patients may not be adequate and pharmacists may not always have the opportunity to provide counseling to patients on prescribed medications [
Research in health literacy underscores the high prevalence of misunderstanding of seemingly simple instructions and warnings placed on prescription container labels by patients. Studies have demonstrated that the literacy level of patients has an impact on their ability to understand directions on a label [
In addition to literacy and drug product labeling, of equal importance are the drug product’s container and packaging, not only to preserve the product’s integrity, but to provide ease of use for both pharmacist and patient [
Studies suggest that certain patient groups such as the elderly may benefit from specialized packaging for drug products [
Drugs obtained from international markets via the Internet can present a health risk to patients for a variety of reasons [
In the United States, policies and legislation are directed toward ensuring minimal health risk to patients in the use of prescription drugs, as reported by the US Food and Drug Administration [
This study has shown that a variety of packaging and labeling exists for pharmaceuticals obtained via the Internet. Based on the findings of this study, Canadian drug products dispensed are in many respects similar if not identical to US products, with similar prescription requirements [
The relatively small sample size in this study may not be wholly representative of all drugs sold on the Internet and generalizing our findings to other drugs should be done with a degree of caution. However, our findings corroborate previously published work, and further studies are warranted to identify trends in quality for Internet drug product labeling and packaging.
A goal of this study was to assess quality attributes that may indirectly convey information on safety and effectiveness through packaging and labeling properties. Many factors contribute to quality of packaging and labeling and although significant, the list of attributes observed in this study was not exhaustive. Until a direct association between packaging and labeling of Internet drug products and clinical outcomes is established, again, one must interpret these findings with some reservation.
Our findings indicate nonequivalent labeling and packaging for drug products available to consumers via the Internet compared with prescription drug products sold in the United States. These findings suggest dissimilar and substandard distribution processes compared with the United States, which in turn offer a greater challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. In the United States, consumers need to be aware that, irrespective of advertising claims on Internet pharmacy websites, consumers may receive a drug product that is not equivalent to the US. counterpart and that may be dissimilar to products that would be allowed for consumers in the United States. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-produced drugs via the Internet.
The author wishes to thank the Texas Affiliate of the American Heart Association for their financial support in the preparation of this research report.
None declared
adverse drug event
Food and Drug Administration
Institute of Medicine
Medication Errors Reporting
National Association of Boards of Pharmacy
over the counter
United States Pharmacopeia