Guiding Principles in Self-Medication · Nonprescription drug labeling (labels and/or ... tance of...

World Self-Medication Industsry 1

Guiding Principles in Self-Medication

Executive Summary ................................................................................... 2

1. Roles and Responsibilities in Self-Medication .................................. 3

2. Social and Economic Value of Self-Medication ................................. 7

3. The Classification of Medicines ........................................................11

4. Prescription-to-Nonprescription Switch —Change of Legal Classification ..........................................................15

5. Consumer Information and Nonprescription Medicines..............19

6. The Advertising Environment ...........................................................23

7. Pricing Issues for Nonprescription Medicines ................................27

8. Visibility and the Retail Environment ..............................................29

Conclusion .................................................................................................31

Appendix ....................................................................................................39

2 Guiding Principles in Self-Medication

Executive Summary.Every day people throughout the world act on their own on their health — they practice self-care. In someinstances they do so through self-medication. What areas can governments examine to help assure that self-medication takes place in a responsible framework? How can governments further promote public health andassure that products designed for self-medication are safe and effective?

This publication represents the views of the World Self-Medication Industry (WSMI), the world federationrepresenting manufacturers of nonprescription medicines and supplements. It discusses elements of a number ofgovernment policies for promoting better health through responsible self-medication.

• A philosophy of individual participation andempowerment underscores responsible self-medication — themes present in statements bythe World Health Organization, key regulatoryauthorities, and others. Industry groups, healthprofessionals, and ultimately individuals them-selves, all have roles and responsibilities inputting this philosophy into action.

• The social and economic value of responsible self-medication must be recognized. Responsible self-medication has a positive health outcome for theindividual, and also has additional positive conse-quences for society as a whole. Particularly in anera when the demand for health care outpacesoverall economic growth, consumers who prac-tice responsible self-medication free uphealthcare resources for treating conditions notsuitable for self-medication.

• The first key to developing a drug policy whichincludes self-medication is to draw a distinctionbetween those products which require moreactive involvement by a doctor or other qualifiedhealth professional for safe and effective use —prescription medicines — and those productswhich are safe and effective for use by consum-ers on the basis of their marketing authorizationand labeling (package labels or leaflets) — non-prescription medicines.

• As medical science advances and experiencewith newer medicines evolves, mechanismsneed to be in place to allow the reclassificationor switch of ingredients (or indications) fromprescription to nonprescription status.

• Providing consumer information involvesdifferent modes of communication whichcan fill different roles, with labeling bestsuited to provide necessary information forsafe and effective use. Nonprescription druglabeling (labels and/or leaflets) designed forconsumers is a fundamental requirement inresponsible self-medication. Other modes ofcommunication — consulting with healthprofessionals, books or articles, brochures, ornewer electronic media — can also play arole in health education on medicines forconsumers.

• Advertising, a lower involvement, less tar-geted communication medium, is ill-suitedto carry detailed information. It should,however, be subject to appropriate rules tobe sure it is truthful and not misleading.

• Given the competitive environment fornonprescription medicines, consumers arewell-served through a free-market in whichmanufacturers determine their own priceswithout government controls.

• The distribution of nonprescription medicinesvaries considerably around the world. Exam-ining ways to improve the visibility of nonpre-scription medicines and access to them inexisting channels of distribution where suchvisibility or access is limited is one way topromote responsible self-medication.

The sections which follow examine each of theseareas, and others, in greater detail.


1. Roles and Responsibilities inSelf-Medication.WORLD HEALTH ORGANIZATION. Many national and international organiza-tions have looked at how best to establish and structure national drug policieswithin their healthcare systems. As a starting point, one fundamental to keep inmind was noted at an International Conference on Primary Health Care, held inAlma-Ata in 1978:

“People have the right and duty to participateindividually and collectively in the planning and

implementation of their health care.”1

In line with a philosophy of individual participation and empowerment, the WorldHealth Organization has noted that responsible self-medication can:

• Help prevent and treat symptoms and ailments that do not require medicalconsultation;

• Reduce the increasing pressure on medical services for the relief of minorailments, especially when financial and human resources are limited;

• Increase the availability of health care to populations living in rural or remoteareas where access to medical advice may be difficult; and

• Enable patients to control their own chronic conditions.2

GOVERNMENTS. Self-medication is one of the first lines of defense in healthcare. It is the most accessible form of health care, and it fulfills a series of valu-able and sometimes crucial functions for individuals and healthcare systems. Thathealthcare systems as well as individuals benefit from self-medication emphasizesthe need for clear policies by national governments. Policies should recognize thepositive role played by products specifically intended for self-medication andshould meet their citizens’ interest—even demand — in taking an active role intheir health. As one U.S. official noted:

“The Food and Drug Administration accepts the concept ofself-medication. The consumer demands it; the law provides for it; and

it is in fact a vital part of our nation’s health care system.”3


The European Parliament has adopted a resolution in which it:

“Considers that responsible self-medication should be furtherpromoted, which will foster the growing desire of the European

Union’s citizens to take responsibility for their own health and alsohelp reduce health expenditure. In recent years, responsible

self-medication has been identified as an important element in longterm health policy by the institutions of the European Community.”4

These same themes have been more and more recognized in the newly democraticcountries of central and eastern Europe which had previously developed systemswhich did not foresee a high degree of individual responsibility in health care.5

PHARMACISTS AND DOCTORS. Within any system for self-care and self-medication,as in health care systems as a whole, health professionals of course can and do take anactive role. As the European Commission has noted, pharmacists — in many countriesthe most accessible health care professionals — play a key role in providing assistance,advice, and information to the public about self-medication products and the circum-stances in which a doctor should be consulted.6 Similarly, WHO has stressed the impor-tance of collaboration among pharmacists and other health providers involved in patientcare and the safe and effective administration of medicines.7 Finally, WSMI has adopted aJoint Statement on self-medication with the International Pharmaceutical Federation. Thestatement notes the common goals of the two groups to provide high-quality service tothe public and to encourage the responsible use of medicines.8

Doctors can help their patients in managing some of their chronic or recurringconditions with some nonprescription medicines, thus decreasing burdens ondoctors’ and other health care institutions’ time if it can be spent more valuablyelsewhere — a practice of integrating the complementary roles of professional careand self-medication, sometimes referred to as collaborative care.9 Doctors can alsoraise people’s awareness concerning the use of medicines, further contributing toresponsible self-medication.

One example recognizing these complementary roles comes from the U.K.,where the British Medical Association and the Department of Health have endorseda Doctor/Patient Partnership campaign to encourage people to make better use oftheir doctors’ time, including through telephone calls rather than doctor visits, orincreased self-reliance.10

CONSUMER ATTITUDES. Most importantly, governments can be reassuredthat consumers can and do practice self-medication responsibly. Evidenceshows consumers recognize and respect nonprescription medicines. As a whole,they use them appropriately, carefully, and safely; and they read nonprescriptiondrug labeling.

1. Roles and Responsibilities in Self-Medication.


Consumer practice studies in 14 countries — including countries in Asia,Europe, and the Americas — document this responsibility.

• As shown in tables 1 and 2, while there are some variations in the incidenceof studied health conditions and responses to them, people generally respondto their everyday health problems in much the same way around the world.They let the condition run its course roughly half the time; turn to nonpre-scription products about a quarter of the time.11

TABLE 1INCIDENCE OF COMMON CONDITIONS (AT LEAST ONCE A YEAR —PERCENTAGE OF POPULATION)

Condition UK US India Australia Spain Canada

Colds 66 60 69 85 73 60

Headaches 59 N/A 48 83 71 40

Digestive problems 57 59 36 59 45 29

Muscle aches 52 37 42 38 40 40

TABLE 2PERCENTAGE OF COMMON CONDITIONS TREATED WITHNONPRESCRIPTION MEDICINES

• Studies show people are cautious and careful when they do turn to nonpre-scription medicines. As illustrated in table 3, they read labels, and an MRCA


0

5

10

15

20

25

30

35 33

28

2422 21 20

16

US Australia/Germany

Spain/UK/Sweden

Switz. Mexico Italy Japan


UK

97 9690 87

83

US Canada Mexico Spain

study in the U.S. found they generally take products for less than the maximumperiod of time indicated on the label.12 Similarly, a study in Japan found lessthan half of one percent of consumers reported they do not read labels.13

TABLE 3PERCENTAGE OF CONSUMERS REPORTING THEY READ LABELSCOMPLETELY THE FIRST TIME THEY USE A NONPRESCRIPTION MEDICINE.

With knowledgeable, responsible, motivated consumers interested in taking anactive role in their health, it is clearly advisable to have sound policies in place thatboth allow and encourage responsible self-medication with products designed forsuch use.



COSTS

BENEFITS

I N D I V I D U A L

• Cost of product

• Time and cost of transport toobtain product

• Symptomatic relief or treatment

• Less time off work

• Usually less expensive than a doctorconsultation and prescription

• The individual becomes moreknowledgeable about health andmedicines

S O C I E T Y

• None

• No ambulatory care costs

• No drug reimbursement costs

• Reduced loss in output from absence from work

• Usually no loss in quality of health outcome

• Citizens more self-reliant

• Citizens more circumspect in their use of“free” public health resources

• Health outcomes benefit from reallocationof healthcare resources

TABLE 4CONCEPTUAL SUMMARY OF COSTS AND BENEFITS OF SELF-MEDICATION

• Society benefits if citizens are more self-reliant and judicious in their use ofpublic health resources through use of self-medication, as this will easepressure on limited healthcare resources.

• Studies document savings from the use of nonprescription medicines withmethodologies measuring past behavior, hypothetical savings from a shiftfrom unnecessary doctor visits to appropriate self-treatment, or based on theeconomic concept of consumer surplus.

• Self-medication fits with trends in citizens’ behavior, and fits with trends inhealthcare that governments want — and need — to encourage if theirhealth policies are to be successful.

2. Social and Economic Value ofSelf-Medication.Self-medication as a first-line therapy for appropriate conditions presents a range of benefits toindividuals and to society generally. First there is an economic value. This refers to the moneysaved by the whole society when citizens treat common health ailments with OTC medicinesand by the improvement in overall health outcomes that this money can then buy. A secondcontribution is self-medication’s social value. This can be expressed as the way self-medicationfits with and contributes to contemporary values and habits in a society. Today in more andmore countries citizens are taking greater personal control of their life, with shared decision-making and increased overall self-responsibility. Where the alternative is a doctor consulta-tion, the costs and benefits of self-medication for the individual and society are summarizedin the table below. The benefits to society are such that, in a world of scare governmentresources but more affluent, educated, and empowered citizens, every health policy shouldspecify what use it will make of self-medication.


Self-medication is a fact of life. With its broad use and social acceptance, nohealth policy should ignore self-medication. Rather, health policy should ask howthis momentum can be leveraged to help achieve its objective.

The individual bears the cost of the self-medication product and any time andtravel costs associated with obtaining it. However, these time and travel costs arealmost always less for self-medication than for a doctor consultation, and the actualcost of the self-medication product to the individual may be lower than a prescrip-tion, depending on the reimbursement and insurance position of the individual.

Society bears no costs but stands to receive financial and non-financial ben-efits. Most obviously, the costs associated with a doctor visit and prescription areavoided. These of course represent a net benefit only if the quality of thehealthcare outcome is not compromised by responsible self-medication. A num-ber of studies cited in this publication give reassurance on this point. For ex-ample, the study showing that women diagnose recurrence of vaginal yeastinfections as accurately as their physicians, and the studies showing that nearly100% of consumers report reading the label of nonprescription medicines com-pletely prior to first use (see notes 11 and 34).

Self-medication’s cost-saving potential has been documented in a range of studies.These cost savings come from factors such as fewer unnecessary doctor visits, areduction in time off from work, and the typically lower cost of a nonprescriptionmedicine as compared to prescription costs.

A Canadian economic study found, for example, that the net savings in justone province, Ontario, from the nonprescription availability of nonsedatingantihistamines was CAD16 million [USD10.4 million] in 1994, including savingfrom fewer medical visits and pharmacy fees, plus time away from work.14 A U.S.study found consumer healthcare savings attributable to self-care with nonpre-scription medicines jumped from USD10.5 billion in 1987 to USD20.6 billion in1996.15 Products switched from prescription to nonprescription status wereresponsible for over 60 percent of these savings.16

In a more targeted study, researchers examined the costs to a 260,000-memberhealth care organization of treating nonsevere heartburn or nonulcer dyspepsia.Over a five-year period, the costs were estimated at more than USD24 million. Ifinstead of prescribing medications for patients with these conditions their doctorshad recommended self-treatment, the organization would be expected to save up toUSD6 million over a similar time period—a 25 percent reduction in costs.17

A study in Germany examined what would happen if consumers shifted fromprescribed medicines for self-treatable conditions to nonprescription medicinesapproximate six percent of the time. Adding savings to the statutory healthinsurance program and working hours lost for doctor visits, and subtracting outdirect expenditures by patients, the study found DEM6.4 billion [USD4 billion]in savings.18

In Italy, a similar university study estimated savings to the country’s NationalHealth Service from substitution of prescription products with nonprescriptionproducts for self-treatable conditions in the range of LIT37.9 to 86.1 billion[USD23.6 to 53.7 million].19

2. Social and Economic Value of Self-Medication.


In short, people are prepared to self-medicate, people can afford to self-medi-cate, they use self-medication products responsibly, and encouraging self-medica-tion releases resources which can be reallocated in other health areas. Another factis that citizens are seeking out more information about their health than everbefore, and in all likelihood this trend will continue.

Responsible self-medication offers benefits beyond cost-saving. Society benefitsfrom a citizenry that is better informed about healthcare and more self-reliant, andfrom the improvement in overall health outcomes that would be possible if publicresources currently consumed treating common ailments were re-directed towardillnesses with a larger impact on overall health. These non-financial benefits may beconsidered as the social value of self-medication.

Finally, it is also possible to identify a financial benefit to society by using theeconomic concept of consumer surplus. Consumer surplus is how economistsdescribe the gap between what people actually pay for an item versus the benefitthey receive (as measured by what they would have been willing to pay). Usingthis concept, a Massachusetts Institute of Technology economist prepared anestimated demand curve and found an annual gain in consumer welfare ofUSD700 million based on prescription-to-nonprescription switches in the coughand cold area alone.20

2. Social and Economic Value of Self-Medication.


3. The Classification of Medicines.

• WSMI advocates the drug classification approach taken by many countries, includingJapan, the U.S., Canada, EU as well as WHO with 2 classes of medicines: prescriptionand nonprescription.

• Defining and listing criteria under which a product must be limited to prescriptionstatus, and where a product will have nonprescription status, is key since such aclassification system governs legitimate public access and availability to medicines,and frequently governs information for correct use.

• Classification can be seen as part of the market authorization or registration process,or as a separate process. In either case, similar safety (including the assessment ofrisk), efficacy, and quality considerations will apply.

• A specific product marketing authorization is not the sole method for product regis-tration and classification. Category or ingredient monographs are alternatives, ifassociated with quality controls.

BASIC CRITERIA FOR A PRESCRIPTION-NONPRESCRIPTION DISTINC-TION. As noted earlier, the World Health Organization recognizes the positivecontributions of self-medication. In its report on national drug policies, WHO goeson to state that “while the specific ingredients or drugs authorized for self-medica-tion may vary from country to country, the criteria for selection are common to alland should be based on evidence of efficacy and evidence of a wide margin ofsafety. In addition, the criteria and process should be transparent.”21

In many countries, these basic criteria are developed by establishing two classifi-cations of medicines: those which require a prescription from a medical practitioner,and those which do not — nonprescription (or over-the-counter — OTC) medicines.In the case of the U.S., the European Union, and Canada, their rules begin with theassumption or default status that medicines are nonprescription. The rules then spellout criteria or conditions for drugs which require a prescription.

The European Union directive puts it this way:

“Medicinal products shall be subject to medical prescription where they:

• are likely to present a danger either directly or indirectly, evenwhen used correctly, if utilized without medical supervision, or

• are frequently and to a very wide extent used incorrectly, and asa result are likely to present a direct or indirect danger to humanhealth, or

• contain substances or preparations thereof the activity and/orside effects of which require further investigation, or

• are normally prescribed by a doctor to be administeredparenterally.”22

The United States law uses different language for a similar concept to define pre-scription status:

“A drug intended for use by man which —

(A) is a habit-forming drug to which section 502(d) [concerningspecified narcotic substances] applies; or


(B) because of its toxicity or other potentiality for harmful effect,or the method of use, or the collateral measures necessary to itsuse, is not safe for use except under the supervision of a practi-tioner licensed by law to administer such drug; or

(C) is limited by an approved application under section 505 [thesection describing the process of approval for new drugs] to useunder professional supervision of a practitioner licensed by lawto administer such drug;

shall be dispensed only (I) upon a written prescription of a practitio-ner licensed by law to administer such drug…”23

There are three key, common points to the EU and U.S. sets of rules: (1) Theystart with the premise of nonprescription status, with prescription status specifi-cally defined. (2) Safety considerations weigh strongly — based either on toxicityor side effects, because the ingredient may be habit-forming, or because of thedosage form a prescription is needed for safe use. (3) They do not subdivide non-prescription products into categories such as pharmacist or pharmacy only, generalsale, etc. While some EU Member States subdivide nonprescription medicines, asthe European Court of Justice noted, the EU “acknowledges the existence of apharmacists’ monopoly in member states, but does not, in view of the fact that it isnot a [European] Community concept, give any definition to it.”24

In addition, both sets of rules require that medicines — prescription andnonprescription — be effective and follow appropriate assurances for quality.25

MARKET AUTHORIZATION VERSUS CLASSIFICATION. Typically, a product’sprescription or nonprescription status is considered as part of the market authorizationor registration process — which is most logical and efficient. However, separatingclassification from authorization or registration is still practiced in some countries. Inthe EU, for example, if a product is authorized in EU Member States through theMutual Recognition Procedure, individual Member States are still able to classify theproduct differently than other Member States, although they should take the classifica-tion in the Reference Member State into consideration.26 Two other examples areBelarus and Argentina. Under a U.S. Food and Drug Administration-Belarus HealthMinistry Memorandum of Understanding, Belarus recognizes FDA approvals as thebasis for expediting registration of products in Belarus, but separates out a decision onthe product’s classification.27 In Argentina, products imported from 15 listed countriesgo through an expedited application procedure, but the classification decision is madeindependently by the Argentine health authorities.28 (The classification status in theoriginating country is, however, a significant factor in the decision.) That said, there areobviously efficiencies from considering market authorization and classification as awhole, particularly since classification will typically flow from the assessment of thelevel and degree of risk as the authorization is being considered. In addition, as dis-cussed in section 5, the importance of labeling for consumer use can be studied moreefficiently when authorization and classification are considered together.



EXPEDITED AUTHORIZATION. A more basic consideration when classifying andauthorizing a product is the mechanism for authorization itself. While an indi-vidual product license or individual registration with a full dossier of informationmight be thought of as the primary mechanism, in fact regulatory authorities use anumber of other methods.

For many, if not most, nonprescription drugs, the U.S. FDA uses a Mono-graph system based on a review of ingredients by class (antacids, internal analge-sics, etc.) rather than individual product registrations. The Monograph system,established through a process known as the OTC Drug Review, looks at nonpre-scription drugs which are “Generally Recognized As Safe and Effective” by quali-fied experts, and thus do not require an individual product authorization orregistration to be marketed.29 Instead, they can be sold by meeting the terms ofthe Monograph for that class of ingredients, including references to other FDArequirements, such as current Good Manufacturing Practice regulations, whichcover quality requirements.

A somewhat similar approach underlies how the Australian Therapeutic GoodsAdministration (TGA) handles registration of certain types of low risk healthcareproducts including sunscreens, vitamin and mineral products, and complementarymedicines. For these eligible medicines, a company may use the TGA’s ElectronicLodgement Facility (ELF) where it submits only limited information about theproduct and a signed declaration of the company’s compliance with requiredstandards. It may then, via this self-assessment approach, proceed to market theproduct. The system is extremely time and resource efficient for industry andgovernment, and consumers benefit from more rapid availability. As a qualityassurance check, the TGA routinely audits a broadly representative sample ofproducts that have gained entry through the ELF system. Australia is consideringchanges to its self-assessment and notification approach to further emphasizesponsor responsibility and to make it even more efficient for the government.30

Finally, authorities can choose to rely on the approval of another specifiedregulatory authority as the basis for registering a product in their own country. Forexample, a working group from the authorities of a number of central and easternEuropean countries has issued a standard operating procedure to facilitate accep-tance of European Union-central marketing authorizations in these countries.Memoranda of Understanding between the U.S. FDA and the Russian Ministry ofHealth and the Belarus Ministry of Health are further examples, where the authori-ties in the latter expedite the registration of pharmaceutical products based ondocumentation of FDA approval with simplified information requirements that donot include clinical, analytical, or other scientific review requirements.31 Manyother countries also accept registration in the country of origin as sufficient forimportation, especially where regulatory authority resources are very limited.

TRADITIONAL MEDICINES. In many parts of the world, traditional medicinesare an important part of self-medication. These medicines are closely related tonational culture and tradition. However, recent work by the World Health Orga-



nization demonstrated that for a large number of medicinal plants internationalstandards, such as monographs, can be developed.32 Such monographs reflect aworldwide consensus on the assessment of safety, quality, and efficacy of certainplants. These WHO monographs could provide a useful route to market for plant-based medicines that meet monograph standards without unnecessary additionalregulatory requirements. Use and implementation of the WHO guidelines on theassessment of plant-based medicines could further facilitate this process.33



4. Prescription-to-NonprescriptionSwitch.

• The reclassification or switch of medicines from prescription to nonprescriptionstatus has a proven record of serving consumers well in many countries.

• Approaches that build on data developed under prescription drug use andexperience in other countries should be used in evaluating candidates for pre-scription to nonprescription switch.

With criteria to classify medicines as prescription or nonprescription to underpinself-medication (as discussed in the previous section), there must also be a mecha-nism (or mechanisms) to transfer ingredients, indications, or products from pre-scription to nonprescription status if they are shown to be safe and effective forconsumer use without a prescription. This is typically referred to as prescription-to-nonprescription (“Rx-to-OTC”) switch.

There are a number of social trends that support or promote prescription-to-nonprescription switch:

• A trend toward self-medication and increased self-autonomy and reliance inmany parts of the world;

• The cost-effectiveness of nonprescription medicines (rather than placing in-creased strains on the formal healthcare system for self-treatable illnesses orconditions); and

• The aging of populations, since the elderly typically take more medicines thanother age groups and are more likely to suffer from chronic or recurring condi-tions which can sometimes be helped through self-medication.

Prescription-to-nonprescription switch has received a good deal of attentionin many countries, particularly where switches have occurred for new classes ofmedicines or for new or expanded indications not previously available on anonprescription basis. These switches have been based on solid evidence. Someexamples include:

• Nonprescription smoking cessation products to help those trying to stopsmoking — a serious individual as well as public health problem.

• H2 antagonists at the dose appropriate for heartburn not only treat, but can

prevent the condition.

• Nonprescription products can now help stimulate hair regrowth to turn backcertain types of baldness.

• Nonprescription topical antivirals can now treat cold sores.


• Many members of a class of antifungal ingredients, imidazoles, have beenswitched from prescription to nonprescription status for women to treat recur-ring vaginal yeast infections. Medicines for the condition were long thought toalways require a doctor’s prescription, but the switch applicants presentedstudies to the regulatory authorities which first authorized the transfer demon-strating that, after initial diagnosis by a doctor, women in whom the conditionrecurred could diagnose it as accurately as their doctors.34

• A number of countries have authorized the prescription-to-nonprescriptionswitch of several nasal steroid sprays to both treat and prevent certain allergysymptoms.

But while there is increased attention to prescription-to-nonprescriptionswitch, the switch trend is not new. Many prescription-to-nonprescriptionswitches now have a long record of bringing new self-medication opportunitiesto consumers and a solid track record of safety and effectiveness. A few ex-amples include acetaminophen/paracetamol — switched in the 1950s in anumber of countries as an analgesic; a number of countries switched a range ofnasal decongestants and antihistamines from prescription to nonprescriptionstatus in the 1970s; athlete’s foot products — first to treat and later to preventthe condition — were switched to nonprescription status in the 1970s in manycountries.

The appendix compares over 180 ingredients as to their prescription ornonprescription (OTC) status in 22 countries. Where available as nonprescrip-tion medicines, many of them have been switched to that status over the pastgeneration.

Those countries that have led the world in switching prescription productsto nonprescription status have been very thorough in that process, recognizingthat consumer safety remains the highest priority. While no product, medicineor otherwise, is completely safe, regulatory authorities in these countries havedemanded appropriate evidence from applicants of a wide margin of safety,along with convincing evidence of effectiveness, before transferring the productto nonprescription status.35 The safety profile has typically been established anddocumented through years of experience and an extensive number of uses as aprescription medicine.36

In a few instances, the introduction of a new nonprescription ingredientdoes not come from the prescription-to-nonprescription switch route. Rather,the new product comes directly to market as a nonprescription medicine. Thisis particularly true for expanded indications, different strengths, or new dosageforms of an active ingredient. For example, some of the strengths or dosageforms of products to treat vaginal yeast infections were originally introduced asnonprescription products in the U.S., as was triclosan as an antigingivitisingredient. Bentoquatum for poison ivy protection is another U.S. example. InEurope, the nicotine inhalator for smoking cessation is an example. While theintroduction of a product on nonprescription status without prescriptionexperience is fairly rare, the larger point is that the data on safety and effective-ness should drive such a decision, not an arbitrary time-on-the-market limita-

4. Prescription-to-Nonprescription Switch.

“…THE LARGER POINT IS

THAT THE DATA ON

SAFETY AND

EFFECTIVENESS SHOULD

DRIVE SUCH A DECISION,

NOT AN ARBITRARY

TIME-ON-THE-MARKET

LIMITATION.”


tion. Direct nonprescription status without prior prescription experienceshould not, therefore, be automatically prohibited.

As science advances and more is known about an ingredient, if new evidencedevelops leading authorities to believe an ingredient on nonprescription status —switched or otherwise — can no longer be considered safe or effective for nonpre-scription use, they can and indeed have an obligation to either return it to prescrip-tion status or remove it from the marketplace altogether. The fact that very fewingredients have required reverse switches is testimony to the careful evaluationgiven to applications for switch. One method for tracking what is known aboutingredients is through adverse event reporting systems. Even where such systemsare not formal government requirements for well-known, established nonprescrip-tion medicines, nongovernmental systems, including poison control centers, orpublished case studies in medical literature, serve a similar function.

Today, some regulatory authorities are looking at guidelines for prescription-to-nonprescription switch. The EU, for example, has issued a “Guideline onchanging the classification for the supply of a medicinal product for human use.”The guideline includes criteria for classifying a product as prescription or non-prescription in the EU and recommendations on data requirements for applica-tions for switch. The guideline is for use by switch applicants, and by nationalauthorities, to facilitate EU harmonization on prescription and nonprescriptionclassification.37 While the U.S. does not have formal switch guidelines, the U.S.Food, Drug & Cosmetic Act and the requirements adopted through the OTCDrug Review provide a complete framework for classifying or switching medi-cines.38

With the extensive and data-driven nature of the prescription-to-nonprescrip-tion switch process in those countries that have led in this trend, WSMI encour-ages other authorities to consider these countries’ decisions and safe marketexperience as an element in favor of switching such products to nonprescriptionstatus in their own countries. For example, in 1998 the Mexican Ministry ofHealth accepted a recommendation from AFAMELA, the WSMI member associa-tion in Mexico, on the prescription-to-nonprescription switch of 31 ingredients.39

An international comparison of the prescription or nonprescription status of theingredients was the main element in the recommendation.

One final aspect of prescription-to-nonprescription switch is the need toconsider research incentives and the ability to protect proprietary data for thosefirms who conduct research to first launch a prescription-to-nonprescriptionswitch. Recognizing that regulatory environments differ, WSMI encouragessystems that include an appropriate period of data protection in order to encour-age innovation in new self-medication treatments.

Through prescription-to-nonprescription switches, hundreds of millions ofconsumers from different cultures and countries around the globe have benefitedfrom wider appropriate self-treatment options. For the future, prescription-to-nonprescription switches hold promise for governments by helping to easepressures on the formal healthcare system, as consumers can treat more of their

ULTIMATELY, THE FINAL

IMPACT OF

PRESCRIPTION-TO-

NONPRESCRIPTION

SWITCHES IS THAT THEY

OFFER CONSUMERS

MORE OPPORTUNITIES

AND CHOICES IN THEIR

OWN HEALTH CARE.

4. Prescription-to-Nonprescription Switch.


everyday health conditions without the costs associated with the formal system.Future switches can enable doctors to spend more of their time and attention onmore involved illnesses.

Ultimately, the final impact of prescription-to-nonprescription switches is thatthey offer consumers more opportunities and choices in their own health care.


5. Consumer Information andNonprescription Medicines.A demand and need for information about nonprescription medicines naturallyfollows from the public interest in self-medication and a clear prescription-nonpre-scription classification distinction. Information can come in various forms fromvarious sources, of course, including product labeling; product advertising; discus-sions between consumers and pharmacists, doctors, or other health professionals;and through consumer education. Some of the newer electronic media provide yetanother set of communication and information tools. One study estimated thatover 40 percent of Internet users were seeking health-related information.40 Each ofthese information sources can fill different roles. Section 6 (p. 23) focuses onadvertising, including its role in alerting consumers to the availability of productsfor conditions suitable for self-medication. But advertising is a low involvementmedium ill suited and demonstrably ineffective for carrying detailed or highlyspecific information. Rather, detailed information is more relevant at the time aproduct is selected for purchase, and later when the product is used. This moredetailed information can come from discussions with pharmacists, doctors, or otherknowledgeable trained sources, and needs to be in the labeling of nonprescriptionmedicines — the focus of this section.

The World Health Organization, summarizing a report by the InternationalAdvertising Association, described the role and purpose of labeling this way:

“The purpose of labeling is to establish clearly the brand of the prod-uct, and it should include all relevant information that the individual

purchaser must have to make proper use of it…Labeling is a ‘highinvolvement medium’ and tends to carry a heavier load of product

information for the consumer than does advertising. Most readers oflabels are motivated to concentrate on them, to comprehend them, to

follow directions, and to take the indicated precautions. However,what is important is not the extent to which consumers actually read

• Different forms of communication are best suited to different roles. Labeling*(label and/or leaflet) is the best way to deliver the information needed forconsumers to use nonprescription medicines correctly and without profes-sional supervision.

• WSMI supports information standards or requirements for labeling neededfor safe use — either on product labels themselves or in package leaflets.

• WSMI recognizes that effective labeling is a fundamental requirement forself-medication.

• Brand names are an efficient shorthand communication tool to aid consum-ers in identifying the source of nonprescription medicines.

* In this publication, we use the term labeling to refer to the printed information that is provided with a product — be iton a label on an outer package, a label on a product container inside an outer package, or on a leaflet that accompanies a product.The precise definitions of these terms and precisely where the printed information appears varies among countries.


each and every label, but that they know that the labels contain de-tailed information about product use so that they can consult them on

questions of usage and safety.”41

Labeling for consumer use is a fundamental requirement for responsible self-medication. It is often said that, in addition to the physical product itself, labelingis an equally important product provided by the nonprescription medicine industry.The information consumers need to use nonprescription medicines correctly andwithout professional supervision must be on the label or in the leaflet which comeswith the product. WSMI and its member associations urge consumers to read theouter label before purchasing, and to read all the labeling with nonprescriptionmedicines before the first use and before each period of use after that.42 The latter isparticularly important since labeling can change through new dose recommenda-tions, warnings and other instructions, or because of a change in ingredients.

Some countries, such as the U.S., Canada, or Australia, require that the labelthe consumer sees on the product at the point of purchase on the store shelf con-tain the information required for correct use. This is particularly important when,as in the U.S., consumers can self-select all nonprescription medicines directly offstore shelves. Other countries, including Japan and most countries in Europe,require some information on the outer package label, with the rest of the informa-tion needed for correct use included on a package leaflet or insert. In either event,labels or leaflets for nonprescription medicines should include:

• The name of the product

• The active ingredient(s) in the product (by established name, if any, thename from an authoritative pharmacopeia, or INN, for example)

• What the product will do — its purpose and/or its use

• Directions on how to use the medicine — the amount of each dose, how totake it (by mouth, with water, etc.), and how often to take it

• Who the product is for and when not to take the product, including neces-sary, relevant warnings for safe use by consumers — limits on use, if any;side effects, if any; drug interactions, if any; circumstances which mayrequire a doctor’s advice before taking the medicine

• The net contents of the product

• The name and location of the manufacturer, distributor, or packager

• Other necessary information, such as certain inactive ingredients; specialstorage instructions, if any; a batch or lot number; an expiration date, ifthe product’s stability deteriorates over time; references to special packag-ing (such as child-resistant packaging), if any.

A number of WSMI member associations are working with their regulatoryauthorities to improve nonprescription medicine labeling — through increasedattention to technical factors which increase readability, through precisely whatinformation is presented, through the format of the information, and by payingcareful attention to consumer understandability. These efforts are aimed at makingnonprescription medicine labels even more consumer-friendly.

5. Consumer Information and Nonprescription Medicines.


The information in nonprescription medicine labeling is the key to safe andeffective use. Labeling tells consumers what the medicine is supposed to do, whoshould or should not take it, and how to use and not use it. Nonprescriptionmedicine makers want consumers to have the information they need to use suchproducts safely and effectively. But industry efforts and government efforts cannothelp consumers unless they read and use the information. For this reason, a num-ber of projects have focused on public education in the responsible use of medi-cines. While a description of these efforts is beyond the scope of this publication,contact WSMI for more information about education projects by member associa-tions. There are also consumer education sections in a number of web sites spon-sored by member associations, including www.chic.org.uk, www.ndmac.ca, orwww.chpa-info.org.

THE IMPORTANCE OF BRAND NAMES. One final aspect of the label and howmanufacturers give consumers information about their products is the brandname. A famous judge in the U.S. characterized the brand or trade name this way:“[A merchant’s] mark is his authentic seal; by it he vouches for the goods whichbear it; it carries his name for good or ill.”43 Brand names communicate in a verypersonal way with consumers. Brand names provide consumers with informationthey can readily use to identify the source of a product as trusted and familiar.But brands do not always communicate in a direct, tangible way. Rather, they areusually a bundle of subjective thoughts we as consumers have when we see thebrand name and then think about the product. As a shorthand, subjective com-munication tool, brand names can raise awareness about products and self-medication categories, and manufacturers need flexibility in their presentationand use of them.

In many instances, having built and established a brand, a manufacturer willextend that brand through a line extension. By using an already known brandname, line extensions can be the most effective and economical method by which acompany can recoup its earlier investment in developing the original core brand.As with brand names and trade names in general, line extensions aid consumers byproviding immediate information to identify the source of a product. Similarly,manufacturers will typically extend a brand name for products which are reclassi-fied or switched from prescription to nonprescription status. The European Com-mission has noted that relaxation on restrictions on the use of brand names forswitched products, where they exist, can help reduce marketing costs and reinforcecompetition in the pharmaceutical sector.44

“[A MERCHANT’S]

MARK IS HIS

AUTHENTIC SEAL;

BY IT HE VOUCHES

FOR THE GOODS

WHICH BEAR IT; IT

CARRIES HIS NAME

FOR GOOD OR ILL.”

5. Consumer Information and Nonprescription Medicines.


6. The Advertising Environment.

• The different and distinct roles of advertising and labeling need to be recognized.

• Basic standards for advertising should ensure that it is truthful (including appro-priate substantiation for claims) and not misleading to consumers.

• A mix of government and self-regulatory tools that encourage greater industryinvolvement, responsibility, and accountability can be used effectively to controladvertising.

• Government preclearance of advertising is the least efficient control system.

As noted in the previous section, another primary aspect of an information or com-munication system — indeed, the initial, attention alerting aspect in such a system —relates to advertising. As with brand names, advertising sometimes communicatessubjectively and in shorthand. It focuses on awareness. The World Health Organiza-tion, summarizing a report by the International Advertising Association, describes thepurpose of advertising as:

“Attract[ing] attention, offering choices, and provid[ing] limited gen-eral information to mass audiences of consumers. It must stimulate the

interest of prospective buyers in a…product [and] inform them ofwhat it may do for them…Therefore, advertising should not be over-loaded with information to the point that the individual prospective

buyer may fail to comprehend it or may even ignore it.” 45

To look at it another way, advertising is a low involvement medium, and assuch, it is limited in how much it can reasonably convey. Recognizing theselimitations, it must be focused on what it can do: attract the viewer, listener, orreader’s attention and communicate the availability of a product. A study byTaylor Nelson Research Ltd. for the Proprietary Association of Great Britainshowed that consumers generally recall two or fewer messages from an advertise-ment.46 While the study found that advertisements with full label informationwere well recalled, recall was unspecific — that is, viewers did not rememberdetails. Further, the full text significantly decreased the communication of themain product messages of the commercial: the product name and what it was for.Full-text advertisements were also more likely to be described as unclear, compli-cated, confusing, and with too much information.47 Similar results were obtainedin a parallel study in Thailand.48 A German university study of print advertise-ments similarly found that the greater the volume of information, the smaller thelikelihood of a particular item being remembered.49 At the same time the numberof viewers who can remember not one item of information rises.50

In the 1970s and early 1980s, the U.S. Federal Trade Commission (FTC), whichis responsible for overseeing U.S. consumer advertising, recognized the limitationsof advertising when the five FTC Commissioners unanimously rejected a rulewhich would have required warnings in advertising for certain nonprescriptiondrugs.51 FTC’s rejection concluded an eight-year proceeding which included over


three thousand pages of testimony. Quite simply, the FTC came to understandadvertising’s limitations, and that if too much information is included, listeners willtune out the message, diminishing the impact of the information.

Rather than relying on advertising, labels or leaflets are the place to effectivelyconvey fuller information to consumers.

With this background in mind, the World Self-Medication Industry believesthat government policies which regulate advertising should, first of all, rest on twobasic standards:

(1) Claims must be truthful: Another way of saying this is that objective claimsmade by advertisements should be supported by adequate substantiation. In theU.S., for instance, the concept is examined by looking at the type of claim, theproduct involved, consequences of a false claim, and the amount of substantia-tion viewed as sufficient in determining what is adequate or reasonable.52

Similar criteria are used in many countries. In evaluating claim substantiationfor nonprescription medicines, the U.S. Federal Trade Commission, which hasauthority in the area, generally looks to FDA determinations or works with theFDA.53 The European Union takes the approach that a claim must be based oninformation in a product’s government-approved marketing authorization — amore narrow, alternative way to look at substantiation.54 A third approachtoward the same end is to assure that claims are not false, such as the require-ment in Japan that advertising must not, explicitly or implicitly, include false orexaggerated statements regarding the name, manufacturing process, indicationor effects, or properties of a drug.55

(2) Advertising should not be misleading: This may seem the same as saying anadvertisement must be truthful, but in fact the focus is different. The U.S.Federal Trade Commission approaches this aspect from the deception perspec-tive: material representations, omissions, or practices likely to mislead consum-ers acting reasonably under the circumstances.56 An Australian court applied asimilar analysis in looking at their Trade Practices Act and its prohibition on“conduct that is misleading or deceptive.”57

There are a variety of mechanisms — both governmental and self-regulatory —governments can use to that ensure that nonprescription drug advertisements aretruthful and nonmisleading. Where they can be applied effectively, WSMI stronglyfavors self-regulatory or co-regulatory methods and government post-publicationenforcement (i.e., taking action against violations rather than government pre-clearing or pre-vetting advertisements). Where adequate mechanisms to enforcesuch systems are not present, WSMI encourages their adoption and is available toadvise on their creation.

The U.K. provides one example of a self-regulatory or co-regulatory system(i.e., a system where an industry or self-regulatory body acts on behalf of thegovernment in enforcing or controlling advertising standards) for nonprescrip-tion medicine advertising which is underpinned in law. Meanwhile, the govern-ment continues to have oversight. The Proprietary Association of Great Britainpre-vets member company advertising under a system started in 1919. Under the

“WSMI STRONGLY

FAVORS SELF-

REGULATORY OR CO-

REGULATORY

METHODS AND

GOVERNMENT POST-

PUBLICATION

ENFORCEMENT.”



association’s Code of Standards of Advertising Practice, member company non-prescription drug advertisements to the public are submitted for prior approvalusing both general and specific standards.58 In addition, television and radioadvertisements are approved in advance by either the Broadcast AdvertisingClearance Centre or the Radio Advertising Clearance Centre. In turn, the PAGBand the clearance centres take into account the legal requirements for medicineadvertising in the U.K., such as the Medicines Advertising Regulations of 1994,the Indepdendent Television Commission Code of Advertising Standards andPractice, and the Radio Advertising Authority Advertising and Sponsorship Code.Australia and Canada have similar systems, taking self-regulatory preclearanceone step further: the government has designated non-governmental bodies as defacto agents of the government in preclearing nonprescription medicine adver-tisements. In Australia an advisory council continues to advise the governmenton oversight of the system.

Japan, Germany, and the U.S. are examples of post-publication control, includ-ing both governmental and self-regulatory components. In all three cases, theirgovernments and other parties have ample enforcement tools against violativeadvertisements.59

Finally, another method of monitoring advertising is through complaints bycompetitors to either nongovernmental or governmental bodies (or to the companyitself, and including to the courts). As one company chief executive officer put it,“there is no doubt in my mind that the best policeman on the beat is one’scompetitor…They never sleep.”60

In contrast to self-regulatory approaches — either including preclearance orbased on post-publication measures — and post-publication measures by govern-ment, preclearance by government can be more costly and more prone to delays.Experience in Australia with increased reliance on co-regulatory mechanismsserves as an example of a shift away from government preclearance. An Austra-lian official noted that “the Trade Practices Commission believes that codes ofpractice can serve an important role in the overall regulatory mix, and in certaincircumstances can be a more cost-effective way of reaching the desiredoutcome…The Commission supports initiatives such as the Proprietary Medi-cines Association of Australia’s Code which are designed to achieve desirableoutcomes for consumers.”61

Regardless of the system or systems chosen, WSMI requires its memberassociations to either introduce their own Codes of Advertising Practice or, wheresuch Codes already exist, to periodically re-examine them when necessary. WSMIhas prepared Guidelines for the Production of Voluntary Codes of AdvertisingPractice to aid member associations in this area. WSMI does not believe, however,that a single Code applicable to all parts of the world would be appropriate, giventhe wide variety of advertising control systems in place, and the need to ensurethat national codes reflect cultural diversity in relation to healthcare generallyand the use of medicines specifically.

“WSMI ENCOURAGES

THEIR ADOPTION AND IS

AVAILABLE TO ADVISE ON

THEIR CREATION.”



7. Pricing Issues for NonprescriptionMedicines.

• Given the competitive environment for nonprescription medicines, consumersare well-served through a free market in which manufacturers determine theirown prices without government controls.

The pricing of nonprescription medicines, or at least those which are not reim-bursed by national social security or health insurance coverage programs, is notsubject to price controls in most countries around the world. The European Com-mission has stated on several occasions that the positive experience with freepricing for manufacturers of nonprescription medicines should even be taken intoaccount when discussing prescription medicines and has therefore recommendedto all European Union Member States that they remove price controls for nonpre-scription medicines.62 The Commission goes on to note that accompanying mea-sures aimed at reinforcing competition could reduce costs.63 Given the high level ofcompetition among nonprescription medicine manufacturers, consumers have beenwell-served through a free market in which manufacturers set prices based onsupply and demand. In Germany, for example, prices for nonprescription medicinesincreased only 1.1 percent in 1995 and 1996.64 Canadian price increases haveaveraged less than one percent per year for the past several years.

While recognizing that many governments have some form of price control orcost-containment measures in place for reimbursed medicines (be they prescriptionor nonprescription), the World Self-Medication Industry urges governments toallow manufacturers to set their own prices for nonprescription medicines based onmarket conditions.


8. Visibility and the RetailEnvironment.

• WSMI encourages examining ways to improve the visibility of nonprescriptionmedicines and access to them in countries that limit visibility and access.

• While access to safe and effective nonprescription medicines through a varietyof outlets and with self-selection encourages retail competition, brings savingsto consumers, and improves consumer choice, convenience, and autonomy,WSMI recognizes that the distribution of nonprescription medicines hasevolved differently around the world. It is WSMI policy, therefore, to respectnational cultural differences.

With past practices of the pharmaceutical industry, community pharmacists, andothers adopted over many, many years, retail distribution patterns for nonprescrip-tion medicines vary significantly from country to country. In most instances, suchdistribution patterns have been translated into national legislation. These distribu-tion patterns range from limiting the sale of all nonprescription medicines solely topharmacies to allowing all nonprescription medicines to be sold in any retail outletwith self-selection off store shelves by consumers. Where pharmacists are few, somecountries have developed specialized non-pharmacy outlets, such as drug sellershops and traditional Chinese medicine shops in China or other parts of Asia.

Countries that allow consumers to self-select nonprescription medicines di-rectly from store shelves include the United States, Nordic countries such as Nor-way, Sweden, and Finland, and, for a more limited range of nonprescription medi-cines, the United Kingdom, Canada, Australia, Argentina, Hong Kong, Malaysia,Singapore, Switzerland, and Germany. The United States is most notable in itsopenness, as it allows all nonprescription medicines to be sold with self-selection inany and all retail outlets.65

A study done by the Proprietary Association of Great Britain with the NationalPharmaceutical Association showed that consumers welcome the opportunity toself-select.66 Three out of four of the UK consumers in the study felt that re-config-ured pharmacies with easier access to nonprescription medicines was a good idea,half because it would save their own time or that of their doctor, and the remainderbecause it offered greater choice.67

A number of countries and individual pharmacies have introduced changes inrecent years to either increase the visibility of nonprescription medicines or accessto them. Giving consumers more control and power in their own health care andcurrent economic trends have been among the forces behind these changes. Goodpresentation and visibility of nonprescription medicines not only informs consum-ers of the range of products available, it can encourage them to seek informationand advice from pharmacists or other health professionals, as demonstrated byexperience in Sweden.68

One example of broadened access is seen in the U.K., where the MedicinesControl Agency has noted increased interest in expanding the list of General Sales


List medicines (those nonprescription medicines that can be sold in any retailoutlet) in that country, citing 35 applications for the year ending March 31, 1997.69

The U.K. has also developed a transparent system for such changes to sale in anyoutlet.70

Brazil, Venezuela, the Czech Republic, and the Shanghai province in China arefour other areas where mechanisms are under development to allow some nonpre-scription medicines to be sold outside of pharmacies. Finally, an advisory body toJapan’s Ministry of Health — the Central Pharmaceutical Affairs Committee — hasrecommended that fifteen OTC drug categories be shifted to “quasi-drug” statuswith sale allowed in any retail outlet.71 The categories include throat lozenges,antibacterial and wound care products, menthol or camphor-containing products,and certain vitamin/mineral products, among others.72

WSMI believes examining ways to improve the visibility of nonprescriptionmedicines and access to them is in the public interest, but WSMI also recognizesthat an attempt to harmonize retail distribution patterns among countries wouldnot be practical. WSMI takes this view because of the many variations in practicebased on local circumstances (including ease of access to pharmacies, historicalpatterns, or consumer preferences, among other considerations).

8. Visibility and the Retail Environment


Conclusion.WSMI hopes this publication can stimulate discussions that improve consumerchoice and interest in responsible self-medication. WSMI and its member associa-tions welcome opportunities to discuss the issues raised and how they might beadapted or implemented by regulatory authorities. Specifically, WSMI encouragesgovernments and interested stakeholders to focus on nine areas in developingpolicies for self-medication and nonprescription medicines.

1. Consumers have demonstrated an interest and responsibility in self-care,including the use of nonprescription medicines. This increasing self-reliance isconsidered a positive social development. Statements from leading governmentauthorities and officials referenced in this document illustrate acceptance ofthis fundamental fact.

2. Encouraging responsible self-medication can lead to more cost-effective utiliza-tion of health care systems and benefit society as a whole.

3. A clear distinction should be drawn between medicines that are designed foruse under a doctor’s supervision — prescription — and those safe and effec-tive for use on the basis of the marketing authorization and labeling —nonprescription. Once drawn, this distinction must be enforced. Safety,effectiveness, and quality considerations will apply in all cases. One clear wayto accomplish a prescription-nonprescription distinction is to define criteriafor prescription medicines, and to then define nonprescription medicines asthe opening assumption or default status. In registering and classifyingmedicines, attention should be given to methods other than full individualproduct licenses, such as expedited registration methods for well-knownsubstances (such as monographs, abridged registration, bibliographic applica-tions, or mutual recognition).

4. With a prescription-nonprescription distinction in place, there must be amechanism to allow ingredients, products, or indications to transfer or switchfrom prescription to nonprescription status. Prescription-to-nonprescriptionswitches have been the focus of increased regulatory attention in many coun-tries in recent years. Many switched products now have a long track record ofbringing hundreds of millions of consumers more opportunities to self-treattheir everyday health conditions safely and effectively. We can do a better job ofbenefiting and learning from prescription-to-nonprescription switch experi-ences in countries other than where the switch initiated.

5. Nonprescription medicine labeling designed for consumer use is a fundamentalrequirement for responsible self-medication. Labeling should tell consumers


what the medicine is, what it is supposed to do, who should or should not takeit, and how to use or not use it. Nonprescription medicine manufacturers knowconsumers should have the information needed to use such medicines safelyand effectively.

6. Brand names are an efficient shorthand communication tool to aid consumersin identifying the source of nonprescription medicines. As an efficient means toreach consumers, restrictions on the use of brand names should be relaxed.

7. Advertising must be truthful and not misleading. Advertising must be recog-nized for both its strengths and weaknesses. It can attract attention and com-municate the availability of a product, but, as a low-involvement medium in acommunication context filled with competing messages, it is ill-suited as aneffective vehicle for detailed information messages. A wide variety and mix ofgovernment and self-regulatory tools exist to control or monitor advertising.Especially where well-established, well-understood advertising regulationsystems do not already exist, WSMI urges governments to adopt self-regulatorymethods or government post-publication enforcement (i.e., taking actionagainst violations rather than government pre-clearance of advertisements,which is costly and time-consuming).

8. Given the competitive environment for nonprescription medicines, a freemarket in which manufacturers determine their own prices without govern-ment controls can best serve consumers. This is supported by the fact that priceincreases for nonprescription medicines have frequently been in the range of, orlower than, inflation as a whole.

9. Increased visibility of nonprescription medicines in the retail setting providesconsumers with more information on the range of products available for self-care, and can stimulate discussion between consumers and pharmacists orother healthcare professionals. WSMI recognizes that the distribution of non-prescription medicines has evolved differently around the world. Some coun-tries allow self-selection and distribution of some or all nonprescription medi-cines in any retail outlet. Others limit the sale of some or all nonprescriptionmedicines to pharmacies and limit self-selection. WSMI respects these nationalcultural differences regarding where nonprescription medicines are sold.

Conclusion.


Endnotes.1 Primary Health Care. Report of the International Conference on Primary

Health Care, Alma-Ata, USSR, September 6-12, 1978. World Health Organization,Geneva, Switzerland, 1978 (“Health for All” series, No. 1).

2 Report of the WHO Expert Committee on National Drug Policies, Geneva,Switzerland, June 19-23, 1995. World Health Organization document WHO/DAP/95.9.

3 Speech by FDA Commissioner Dr. Charles C. Edwards, 1972 (announcing thestart of a regulatory review of nonprescription medicines in the U.S.).

4 Report on the “Communication from the European Commission to the Coun-cil and the European Parliament on the outlines of an industrial policy for thepharmaceutical sector in the European Community,” adopted by the EuropeanParliament, April 16, 1996.

5 See Developing Self-Medication in Central and Eastern Europe, Association ofthe European Self-Medication Industry (AESGP), Brussels, Belgium, 1993.

6 See “Communication from the European Commission concerning healthpromotion, information, education and training within the framework for Commu-nity action in the field of public health,” June 1, 1994. (COM (94) 202 final.)

7 See WHO resolution, “Role of the pharmacist in support of the WHO reviseddrug strategy,” EB93.R12, 1994.

8 Joint Statement by the International Pharmaceutical Federation (FIP) and theWorld Self-Medication Industry (WSMI) on Responsible Self-Medication, Novem-ber 4, 1998.

9 See The individual and healthcare: Added value through self-medication,AESGP, June 1994, at 24.

10 See Promoting Responsible Consumer Health Care: Proprietary Association ofGreat Britain Annual Report–1997, PAGB, July 1997 (discussing the launch of theprogram).


11 Jerome A. Reinstein, Ph.D., “Worldwide Studies on Self-Medication: What DoThey show?” Swiss Pharma vol. 13, number 11a, 1991, 21-25; Consumer Usageand Attitude Study 1991, Canadian Facts, Toronto, Ontario, 1991.

12 Id.13 “Report of 15th Survey of Consumer Awareness of OTC Drugs,” PAJ Newslet-

ter, Proprietary Association of Japan, November 14, 1997.14 See The Economics of Self-Medication, Queen’s Health Policy, Queen’s Univer-

sity, Kingston, Ontario, Canada, June 1995.15 See Economic Benefits of Self-Medication — A Report to NDMA, Kline &

Company, Inc., May 15, 1997.16 Id.17 Kimberly Kunz, et al., “Economic Implications of Self-Treatment of Heart-

burn/Nonulcer Dyspepsia with Nonprescription Famotidine in a Managed CareSetting,” Journal of Managed Care Pharmacy, May/June 1996, at 263.

18 See U. May, “Die volkswirtschaftliche Bedeutung der Selbstmedikation inDeutschland,” Pharm. Ind 59 HedH6 (1997), as summarized in Encouraging Self-Medication Can Reduce the Healthcare Cost Burden: An Economic Analysis of Self-Medication, AESGP, 1998.

19 See Dr. Giovanni Fattore, Bocconi University, “The Economic and SocialValue of Self-Medication: Italy,” AESGP Proceedings: From Paternalism to Au-tonomy—The Importance of Responsible Self-Medication, Budapest, Hungary, June18-21, 1997, at 39.

20 See Peter Temin, “Realized Benefits from Switching Drugs,” Journal of Lawand Economics, October 1992, at 351.

21 Report of the WHO Expert Committee on National Drug Policies, 1995,supra.

22 Council Directive 92/26/EEC, art. 3, 1992 O.J. L 113/5.23 21 U.S.C.353(b)(1) (1988) (also known as the Federal Food, Drug, and

Cosmetic Act, section 503(b)(1)).24 Case C-369/88 Re Delattre, 1991 E.C.R. I-1487.25 See Council Directives 65/65/EEC, 75/318/EEC, and 75/319/EEC, as

amended, which lay down the principles for granting marketing authorizations inthe European Union; and for the U.S., 21 U.S.C. 321(p) (referencing generalrecognition of safety and effectiveness for drugs which are not new), 21 U.S.C.355(b) and (j) (including evidence of effectiveness in drug applications), and 21U.S.C. 351(a)(2)(B) (requiring conformance with good manufacturing practices).

In Japan, similar assurance is gained through a dual registration system. Aproduct must obtain: (1) Shonin — official confirmation that a product is registeredas a drug and that its safety and efficacy have been established; and (2) Kyoka —

Endnotes.


certification that the manufacturer is qualified as an applicant and meets bothpersonal requirements and structural/operational requirements from the Ministry ofHealth and Welfare. See PAJ Guide, Proprietary Association of Japan, 1996, at 13.

26 See Council Directive 93/39/EEC, 1993 O.J. L 214, amending Directives 65/65/EEC, 75/318/EEC, and 75/319/EEC re: the decentralized or Mutual RecognitionProcedure. (Under the decentralized procedure, an applicant obtains a marketingauthorization in one Member State and then applies for recognition of that market-ing authorization in other Member States using an Assessment Report from theinitial (or Reference) Member State and the same registration dossier. The subse-quent Member States then either recognize the initial decision or raise objectionson serious health concerns. In the latter case, an arbitration process conductedthrough the European Agency for the Evaluation of Medicinal Products (EMEA)Committee for Proprietary Medicinal Products follows.)

27 See “Memorandum of Understanding Between the Food and Drug Adminis-tration of the United States and Ministry of Health of the Republic of Belarus,”March 25, 1996. Under the Memo, applicants can seek expedited registration basedon documentation of U.S. approval (including via FDA Monographs, which arediscussed below) without clinical, analytical, or other scientific review require-ments by Belarus.

28 See International Federation of Pharmaceutical Manufacturers AssociationsCompendium, “Argentina,” 1994; and letter from the Latin American OTC Associa-tion (ALPO) to Nonprescription Drug Manufacturers Association, January 5, 1998.

29 See 21 C.F.R. Part 330 for the detailed procedures covering the OTC DrugReview. (The U.S. OTC Review Monograph process, largely completed but withsome Monographs still to be finalized, has been extremely extensive, involving over22,000 volumes of data submitted by the industry. The FDA and Congressionalcommittees have noted that the Monographs serve as the government’s “stamp ofapproval” for the products within the Monographs.)

30 See “Draft Model for a New Process for the Listing of Drug Products on TheAustralian Register of Therapeutic Goods,” Therapeutic Goods Administration,August 28, 1998.

31 See “U.S. FDA-Belarus Health Ministry Memo of Understanding,” supra; and“Memorandum of Understanding Between the Food and Drug Administration ofthe U.S. and the Ministry of Health and Medical Industry and the State Committeefor Sanitary and Epidemiological Surveillance of the Russian Federation,” 59Federal Register 46054 (September 6, 1994).

32 See WHO Monographs of Widely Used Medicinal Plants, vol. I, Geneva [in press,1999].

33 See WHO Guidelines for the Assessment of Herbal Medicines, Geneva, 1991.34 See generally Kristie Egstrand, Schering-Plough HealthCare Products, “Case

Study on the Switch of Gyne-Lotrimin,” in NDMA Conference on Rx-to-OTC

Endnotes.


Switch: Proceedings, September 15, 1992 (Washington, D.C.), at 80 (describing theprescription-to-nonprescription switch process in the U.S., including the studiesand company activities that went into that process).

35 See, for example, Dr. Debra Bowen, U.S. Food and Drug Administration, “Mak-ing the Switch to OTC,” Cosmetics & Toiletries Magazine, May 1996, at 102, andTamar Nordenberg, U.S. Food and Drug Administration, “Now Available Without aPrescription,” FDA Consumer (published by the U.S. Food and Drug Administra-tion), November 1996, at 6, for general descriptions of the considerations FDA goesthrough in evaluating nonprescription drug applications. See also Dr. MichaelWeintraub, U.S. Food and Drug Administration, “FDA’s Perspective on Switch Today,”in NDMA Conference on Rx-to-OTC Switch: Proceedings, September 15, 1992(Washington, D.C.), at 13, for a similar description of the prescription-to-nonpre-scription switch process and what FDA looks for in switch applications.

36 Id.37 See “A Guideline on changing the classification for the supply of a medicinal

product for human use,” European Commission, September 29, 1998. NewZealand’s Guidelines on the classification of medicines are another example.

38 See R. William Soller, Ph.D., “OTCness,” Drug Information Journal, number2, 1998, for a description of the U.S. framework used in assessing classification.

39 See letter from Dr. Guillermo Bierzwinsky, Director of Medicines Control,Mexico Ministry of Health, to AFAMELA, February 25, 1998.

40 Thomas E. Miller, Interactive Demography, FIND/SVP, April 8, 1997, atwww.cyberatlas.com.

41 Report on the WHO Survey on Ethical Criteria for Medicinal Drug Promo-tion, World Health Organization, at 16, WHO Doc. DGO/ETHCDP/87.3, summa-rizing Labelling and Advertising: Their Functions in Consumer Information,International Advertising Association, 1987.

42 See, for example, Expert Opinions on OTC Drugs — Proper Use of OTCDrugs, Proprietary Association of Japan, 1997, which the assocation distributedwidely to consumer centers and local health authorities, describing proper use ofnonprescription medicines and their labeling.

43 Judge Learned Hand in Yale Electric Corp. v. Robertson, 26 F.2d 972 (2d Cir.1928).

44 See “Commission Communication on the Single Market in Pharmaceuticals,”COM (98) 588, November 25, 1998, at 12.

45 International Advertising Association, Labelling and Advertising: TheirFunctions in Consumer Information, as summarized in Report on the WHO Surveyon Ethical Criteria for Drug Promotion, supra.

46 See Taylor Nelson Research Ltd., Information or Communication? A Con-sumer Study of Television Advertising (Proprietary Association of Great Britain,1990).

Endnotes.


47 Id.48 See V. Chirapravati in WFPMM 2nd Asia/Pacific meeting proceedings, No-

vember 20-22, 1995 (Bangkok, Thailand), at 63.49 See H.M. Kepplinger, “Advertising — To inform or to communicate? How far

can advertising be used to inform?” Swiss Pharma 12 (1990), 73-77.50 Id.51 See 6 Trade Reg. Rep. (CCH) ¶ 38044.52 See In re Pfizer Inc., 81 F.T.C. 23 (1972).53 See Eve E. Bachrach, “Over-the-Counter Drug Advertising: FTC and FDA

Concerns,” 7 Food, Drug and Cosmetic Section Newsletter (New York State BarAssociation), September 1990, at 7.

54 See Council Directive 92/28/EEC, art. 2, 1992 O.J. L 113/13.55 See “Standards for Fair Advertising Practices of Drugs, Quasi-drugs, Cosmet-

ics, and Medical Devices,” Pharmaceutical Affairs Bureau Notification No. 1339,October 9, 1980, and “Comments on the Standards for Fair Advertising Practices ofDrugs, Quasi-drugs, Cosmetics, and Medical Devices,” Pharmaceutical AffairsBureau/Inspection and Guidance Division Notification No. 121, October 9, 1980.

56 See Bachrach, supra, at 7, and Thompson Medical Co., 104 FTC 648 (1984).57 See PMAA submission to the Commonwealth Government, supra, at 20,

citing Trade Practices Act, section 52, and as analyzed in Farquhar v. Bottom, 2NSWLR 380 (1980), where the court noted the test to be applied was one of rea-sonableness. The opinion stressed that the test is one of what an ordinary, reason-able reader would take from the advertisement, including based on its context andthe fact that ordinary readers can and do read between the lines in light of day-to-day experience.

58 See European Advertising Standards Alliance, Advertising Self-Regulation inEurope Medicine Advertising Regulation and Self-Regulation in 54 Countries,Brussels, Belgium (1997).

59 See, for example, “Standards for Fair Advertising Practices of Drugs, Quasi-drugs, Cosmetics, and Medical Devices,” Pharmaceutical Affairs Bureau Notifica-tion No. 1339, October 9, 1980, and “Comments on the Standards for Fair Adver-tising Practices of Drugs, Quasi-drugs, Cosmetics, and Medical Devices,” Pharma-ceutical Affairs Bureau/Inspection and Guidance Division Notification No. 121,October 9, 1980, describing Japanese advertising standards. See James D. Cope,“Nonprescription Drugs and the Regulation of Advertising,” Journal of Drug Issues,at 257 (1992), for a description of U.S. advertising controls.

60 William E. LaMothe, “Over-Regulation vs. Self-Regulation,” The Advertiser(Association of National Advertisers), fall 1991, at 24.

61 Trade Practices Commissioner Allan Asher to the Proprietary MedicinesAssociation of Australia members meeting, May 1994.

Endnotes.


62 See “Communication from the Commission to the Council and the EuropeanParliament on the Outlines of an Industrial Policy for the Pharmaceutical sector inthe European Community,” COM (93) 718, March 2, 1994, at 17; and “CommissionCommunication on the Single Market in Pharmaceuticals,” COM (98) 588, Novem-ber 25, 1998, at 12.

63 Id.64 See Dr. Hermann Kortland, BAH, “Health Economics,” in AESGP Proceed-

ings: From Paternalism to Autonomy — The Importance of Responsible Self-Medication, Budapest, Hungary, June 18-21, 1997, at 80.

65 As a matter of individual state law in the U.S., some states limit certaincontrolled substances with a low level of abuse potential to sale in pharmacies.These nonprescription Schedule 5 controlled substances are not the focus of thispublication, and more information is available from WSMI’s U.S. member associa-tion, the Consumer Healthcare Products Association.

As to where consumers choose to purchase nonprescription medicines, for thethree largest classes of trade, the market research firm Information Resources, Inc.,estimates 34% of nonprescription medicines and other health-related items arepurchased from mass merchandise outlets, 33% from pharmacy outlets, and 32.5%from food stores in the U.S. Many U.S. mass merchandisers and food stores have apharmacy within the store. “The OTC Marketplace: The Figures Suggest Competi-tion is Fierce,” Drug Topics, 1998.

66 PAGB/NPA 1993 study.67 PAGB/NPA supra68 See Anders Uppfeldt, “Case Study Sweden,” Improving Visibility of Self-

Medication in Pharmacies, AESGP, May 1998.69 See “High GSL Demand Experienced by UK MCA,” OTC Bulletin, August 29,

1997, at 9, reporting on the Medicine Control Agency’s annual report.70 See “Changing the Legal Classification in the United Kingdom of Medicine

for Human Use from Pharmacy to General Sale List,” Medicines Act Leaflet 82,March 1996.

71 PAJ Newsletter, No. 37-02-98, May 11, 1998, at 1-2.72 Id.

Endnotes.

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