Pharmaceutical Prescribing and Labeling Information Online: The Challenge of National Regulations and the Global Internet
Brian G. BAGNALL <firstname.lastname@example.org>
The subject of prescribing information for pharmaceuticals (also known as labeling information, package inserts, patient information, etc.) is attracting much comment and was discussed at the September 3-5, 1997, World Health Organization (WHO) Internet Working Group meeting in Geneva.
There seems to be much confusion about who owns the information and how it can be made available to the general public via the Internet. Some people think that only the manufacturers can provide up-to-date prescribing information and others think that public service Web sites can provide it. The matter is made very complex by national regulatory systems which generate differing prescribing information for each country and differing rules about whether this information should be restricted to doctors only. There are also intellectual property issues to consider, such as copyright and trademarks.
Information for prescription pharmaceuticals must be error-free and completely up-to-date. This information is subject to frequent change as new clinical information becomes available and new government regulatory policies are implemented. The information must also be secure so that malicious or unintended alteration of dosages cannot be made and warnings cannot be tampered with.
Making this complex information available on the global Internet poses many technical, legal, and regulatory hurdles which are still being addressed. Progress is being made, however, in providing prescribing information for certain national audiences with appropriate safeguards and disclaimers to ensure that there is no confusion for the intended readers.
The research-based pharmaceutical industry is currently working with national regulatory authorities and the WHO to resolve issues on this subject so that patients, consumers, and health care professionals can access the latest product prescribing information via the Internet at no cost.
Examples of the issues outlined will be given in the presentation as well as a glimpse of Web sites that are currently providing online prescribing information.
Keywords: Internet, pharmaceuticals, prescription drugs, legal, regulation, prescribing information, labeling, patient information, package inserts, physicians, patients, consumers, healthcare professionals.
The subject of prescribing information for prescription pharmaceuticals is attracting much comment and was discussed at the September 3-5, 1997 World Health Organization (WHO) Internet Working Group meeting in Geneva. Information for patients or healthcare professionals is also known as labeling information, package inserts, data sheets, and patient or user information, but these terms have different meanings in various countries.
The research-based pharmaceutical industry is having discussions with regulatory authorities and the WHO to resolve issues on this subject so that patients, consumers, and healthcare professionals can access the latest product prescribing information via the Internet at no cost.
The movement to allow much wider consumer access to drug information is inhibited in many countries by a long tradition of regarding any such efforts as "promotion" of prescription pharmaceuticals, which is forbidden except to physicians.
Prescription pharmaceutical drugs around the world are primarily restricted by requiring a doctor's prescription and dispensation by a pharmacist. Because of the thousands of available drugs and their complex treatment indications and warnings, it is essential to provide healthcare professionals with extremely detailed medical information about each individual product. This data is strictly regulated by government authorities and the resultant prescribing information now resembles a legal document with many implications for product liability.
This critical "prescribing information" is generally made available to physicians and nurses in the form of various printed compendia. In the US, for example, the omnipresent Physicians Desk Reference (PDR) book, which contains prescribing information on a selection of about two thousand branded and currently marketed products, is already a hefty tome of over three thousand pages. It is, after the Holy Bible, one of the best-selling books in the nation.
Such annual publications are, by their hard-copy nature, out-of-date soon after printing because the information is always being revised and more new drugs are marketed every month. The Internet now offers an opportunity to provide the updated information online, although it is recognized in many countries that physicians make little use of the Internet for this purpose.
There is, however, another much wider audience -- consumers who are patients or family and friends of patients -- who now expects to find information about prescription drugs on the Internet. Although the information in printed physician-book form is generally available to them in local public libraries, people may not have the time or inclination to make the trip. Often, the need to find the information is prompted by symptoms which might be drug-related or by healthcare Websurfing after a diagnosis of a particular disease has been made.
Consumers are often intimidated by prescribing information intended for physicians. Long lists of potential side effects and the use of medical jargon and statistics may frighten them. For this reason there is a strong movement towards simpler patient-oriented drug information. This can be in the form of information on the product label, in a "package insert," or in a leaflet provided by the dispensing pharmacist.
There seems to be much confusion about who owns the information and how it can be made available to the general public via the Internet. Some people think that only the manufacturers can provide up-to-date prescribing information and others think that public service Web sites can provide it.
Because the information has been filed with the national regulatory authorities, it is generally regarded, but not universally agreed upon, as being in the public domain and free for the public to copy at will. This has led to a proliferation of healthcare Web sites which provide a wide variety of drug information which, although mostly of great value to the consumer, can also cause confusion as to whether the information is authentic and up-to-date.
Confusion for Internet-seeking consumers, however, is caused by the inescapable fact that prescription drug information is regulated on a national basis and there is little international "harmonization" of prescribing information. As a result, the same drug might have quite different labels, clinical indications, warnings, and dosages according to the requirements and evaluations reviewed by local regulatory authorities.
It is also complicated by the fact that some drugs may be prescription-only in one country and over-the-counter in another. The Internet, borderless and immediately accessible worldwide, is now highlighting these national differences which have hitherto been quite obscure to the general public.
Research-based pharmaceutical manufacturers are loath to incur the displeasure of any national regulatory authority and, as could be expected, are being extremely conservative about providing prescription drug information via their company Web sites. In many countries they are unwilling to provide it unless the practice has been officially sanctioned by the national government and the laws prohibiting this practice are amended.
There now appears, however, to be a slow worldwide movement in the direction of encouraging governments to allow consumer access to physician-oriented drug information via the Internet. In the meantime, Internet surfers might generally find disclaimers such as these which are currently posted on the SmithKline Beecham corporate Web site (Reference 1):
This conservatism about intended audiences has naturally led to the popularity of many differing independent third-party Web sites which fulfill the unofficial role of "electronic drug compendia." The information contained therein is usually retyped or optically scanned from the manufacturer's information and there is often no indication as to the version number or date. It is obvious that the information is intended primarily for consumers despite the fact that it was written for use by physicians.
Some Web sites are trying hard to provide consumer-oriented abbreviated drug information. The situation is being confused by frequent links to anecdotal newsgroup information about drugs which is provided by private individuals based on their own patient experience. It is here that the Internet consumers are entering uncharted, unauthorized informational waters, and they should be made aware of the risks that might be involved.
The United States is virtually the only major country that has so far allowed direct-to-consumer promotion of prescription pharmaceuticals. As a result, the Internet is replete with product and disease Web sites which provide detailed information about recommended drugs for US consumers. This information is, of course, accessible to non-US Internet surfers who are officially denied the privilege in their own country.
Prescription drugs which have expired patents in any particular country may go "off-patent" as a generic product manufactured by a number of different manufacturers. Not only will these compounds lose their originator's brand name, but they will also lose their branded prescribing information and the "protection" this information once had when owned by the company which first launched it.
For Internet users, the confusion caused by multiple brand names and multiple sources of the same drug can often be helped by Web sites which provide drug information by both brand and generic names.
From the patient's point of view, it is critical that online prescribing information for prescription pharmaceuticals be error-free and completely up-to-date. This information is subject to frequent change as new clinical information becomes available and new government regulatory policies are implemented. The information must also be secure so that malicious or unintended alteration of dosages and warnings cannot occur.
Although HTML is the most convenient Internet language in which to provide drug information, many companies are not comfortable with its security. Copying and translating HTML from one site to another might result in typographical errors or, even worse, errors in dosages which might pose a safety hazard. For this reason, many pharmaceutical companies, such as SmithKline Beecham, have opted to provide prescribing information on their own Web sites in the form of scanned images of the actual package insert.
These scanned images have several disadvantages for consumers in that they are slow to load, require multiple scan pages, are less legible, and are more difficult to print out. Efforts are under way to explore ways in which HTML can be made more secure by use of validation programs which check that the content is identical to the original version.
Other companies, such as GlaxoWellcome, provide prescribing information online in the form of PDF files. These are also more secure, but have the disadvantages of being unable to be read immediately onscreen, being slow to print, and requiring downloading and possession of Adobe Acrobat software.
To simulate the situation of an average US consumer, we recently searched the Internet for prescribing information, either physician-oriented or patient-oriented, on four prescription pharmaceuticals: Paxil (paroxetine hydrochloride), Hismanal (astemizole), Augmentin (amoxicillin/clavulanate potassium), and a generic drug, cimetidine. We used several common US search engines: Yahoo, AltaVista, and HotBot. We also looked for information about the products on five popular independent consumer healthcare Web sites (References 2, 3, 4, 5, and 6).
In addition we looked for other product information on several major pharmaceutical company Web sites.
Our results can be briefly summarized as follows:
Empowerment of worldwide consumers to take a more active interest in their own healthcare is rapidly being achieved by use of the Internet's increasingly rich healthcare content. Access to patient-oriented information about prescription pharmaceuticals lags behind that of physician-oriented data which is more readily regulated by national health authorities.
Research-based pharmaceutical companies are exploring ways to provide information for both healthcare professionals and consumers as allowed by local laws. The rapid growth of the Internet has, however, outpaced the speed of the regulatory process and its legal basis. There is daunting administrative complexity in providing online drug information which differs in each country, is being continually revised, and is in multiple languages.
On the other hand, companies would like to be able to ensure that online information about their own prescription products is legal, easy for the consumer to find, authenticated, up-to-date, secure, and obvious as to its intended audience.
The worldwide Internet community will no doubt join the debate on how best to achieve these worthwhile goals of the borderless technology in the face of an informational system which has traditionally been bound by both paper and national regulatory boundaries.
Examples of the issues outlined as well as a glimpse of Web sites which are currently providing online prescribing information will be given in the presentation.
Thanks to Mary Ellen Kupcho and Mark Bodnar for their help with the information search exercise. Also to Tom Fulp for HTML assistance.