An application for a safety container that is not child-proof must be submitted by the patient as a signed waiver and may apply to all medications dispensed by a patient. The pharmacist must keep a record of the signed request for renunciation. Exceptions to these requirements exist, such as.B. packaging of oral contraceptives due to their functional design and certain types of heart drugs such as nitroglycerin. In these cases, patients may need immediate access to the drug. In addition to proper labelling, pharmacists should choose packaging that maintains the integrity of the drug. The choice of container by the pharmacist should depend mainly on the type and quantity of the drug to be dispensed and the method of administration [5]. The container must be comparable to that used by manufacturers to package medicinal products and must preserve the identity, concentration, quality and purity of a product and prevent contamination. The type of container to be used by a pharmacist when dispensing a prescription drug is listed on the manufacturer`s prescription product label and is regulated by the U.S. Food and Drug Administration (FDA).
FDA regulations do not apply to products that must be delivered in the manufacturer`s original container. The manufacturer`s packaging and storage information can usually be found on the original container or in the package leaflet. In the United States, the legal requirements for a prescription label are set by federal and state laws [2,3]. At the federal level, the information required for the prescription label can be found in section 503(b)(2) of the Federal Food, Drugs and Cosmetics Act (Table 1) [3]. States may have additional labelling requirements required by law [2]. In the United States, it is the professional responsibility of pharmacists to label the dispensed drug with the items specified in federal law in addition to the requirements of the state in which it practices. In addition to the packaging requirements for the dispensing of medicinal products, particular attention should be paid to the closure of the prescription container. Closure should inhibit the ingress of moisture and impurities that can interfere with oral dosage forms. A well-known example in pharmacy is the breakdown of aspirin into acetic acid and salicylic acid in the presence of moisture. In other words, “labelling” may refer to a manufacturer`s drug and “label” may apply to drugs dispensed by a prescription pharmacist. Studies suggest that certain groups of patients, such as the elderly, may benefit from special packaging for drugs [18]. Providing drugs in a package that identifies the day each dose is to be taken and provides information on appropriate self-administration can improve adherence to the treatment regimen and treatment outcomes in elderly patients.
Some groups of patients may need more attention to their packaging needs, but this study suggests that these needs are unlikely to be met when drugs are purchased over the internet. In addition to drug knowledge and labeling, the drug container and packaging are equally important, not only to maintain product integrity, but also to ensure ease of use for pharmacists and patients [18]. Patients have been shown to prefer types of packaging and labeling designed for safety, easier to read, and having better organized alerts with larger font sizes [16]. For patients, the label of the prescription container may be the only source of instructions on how to take their medications. In the United States, the legal requirements for a prescription label are set by federal and state laws. The container must be comparable to that used by manufacturers to package medicinal products and must preserve the identity, concentration, quality and purity of a product and prevent contamination. Safety features such as a child-resistant closure should be present. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not comply with U.S.
labeling and packaging guidelines. Our results confirm a report by Westenberger et al. in which the packaging of drug samples for virtually all samples purchased on the Internet posed a significant problem [11]. In this report, several samples did not contain any labelling information or a minimum of labelling information for the appropriate use or testing of these drugs. For example, some samples had packaging labeled in foreign languages, and others were sent in bulk in unlabeled plastic bags. In the United States, policies and laws are designed to ensure minimal health risk to patients when using prescription drugs, as reported by the U.S. Food and Drug Administration [8]. This report shows that consumers can obtain prescription drugs over the Internet without direct supervision from a health professional. It has been found that this ability to purchase drugs directly from a website poses the greatest risk of drug side effects by bypassing the traditional “doctor`s visit and pharmacist`s examination” [20], and this observation can be extended to packaging and labelling issues. Consumers who order drugs over the Internet do not have sufficient access to information and advice at the time of ordering and delivery to make informed decisions about their safe and appropriate use [21]. Here, too, poor quality packaging and labelling can increase this risk. Currently, there is a lack of information on the packaging and labelling of pharmaceutical products imported via the Internet.
The Compliance Office of the FDA`s Center for Drug Evaluation and Research has launched a study to determine the quality of a selected group of pharmaceutical products purchased over the Internet from foreign sources. Packaging has been a significant problem with virtually all internet shopping models. Many had little or no labeling information for proper use. Some drug samples were sent in bulk in unlabeled plastic bags [11]. Deviations from U.S. federal prescription label requirements and manufacturer`s prescription packaging requirements are noted. Among all the samples obtained, significant discrepancies were observed in the external appearance of the packaging, the labelling of the drug (if applicable) and the packaging of the distributed product. Medicines obtained on international markets via the Internet can pose a risk to patients` health for a variety of reasons [19]. This study showed that it is very likely that the average U.S.
consumer will receive a pharmaceutical product imported from an Internet pharmacy website that does not meet the quality specifications for packaging and labeling that meet products distributed in the U.S. – another potential safety risk. Drug acquisition and website attributes have already been described in a drug quality report, and a similar process was followed for this study [12]. For all other samples of pharmaceutical products, searches were performed on the World Wide Web using the Internet Explorer 6.0 browser. Websites of internet pharmacies were found through Google`s advanced search options (www.google.com). Keywords selected to enter the browser query area included the search terms “generic simvastatin”, “generic amlodipine”, generic sildenafil”, “online pharmacies” and “Internet pharmacy”. All proprietary forms of oral medications have been identified on the websites for the intended supply. Our point of view was that of a consumer who wanted to buy these prescription drugs online or make price comparisons. For the purchase of drugs on the Internet, a consumer credit card was used for financial transactions, as indicated on the websites. Prescription requirements were noted, and for prescription drugs (i.e., products from Canada), a prescription was issued by a physician at the Texas Tech University Health Sciences Center School of Medicine and faxed to the Internet pharmacy, as shown on the website.
The relatively small sample size in this study may not be fully representative of all drugs sold on the Internet, and generalizing our results to other drugs should be done with some caution. However, our results confirm previously published work, and further studies are warranted to identify quality trends for the labelling and packaging of pharmaceuticals on the Internet. From March 2006 to January 2007, 41 oral pharmaceutical dosage forms were collected from international pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples and 5 generic sildenafil samples. The contents of each package were observed and recorded, and the comparison of labeling and prescription packaging of these products was made with labeling and prescription packaging requirements in the United States. Of the 41 drugs from online pharmacies in 12 different countries, only 1 product (from Canada) would meet the labelling and packaging guidelines for products dispensed in the United States. .