What is an Over-the-Counter Drug?

Introduction

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription.

In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician’s care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

The term OTC refers to a medication that can be purchased without a medical prescription. In contrast, prescription drugs require a prescription from a doctor and should only be used by the prescribed individual. Some drugs may be legally classified as OTC (i.e. no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient’s needs or the provision of patient education. Regulations detailing the establishments where drugs may be sold, who is authorised to dispense them, and whether a prescription is required vary considerably from country to country.

Usage

As of 2011, around a third of older adults in the US reportedly used OTC drugs. By 2018, the prevalence of use by adults in the US as first-line treatment for minor illnesses had reached 81%.

Regulation by Country

Canada

In Canada, there are four drug schedules:

  • Schedule 1: Requires a prescription for sale and is provided to the public by a licensed pharmacist.
  • Schedule 2: Does not require a prescription but requires an assessment by a pharmacist prior to sale. These drugs are kept in an area of the pharmacy where there is no public access and may also be referred to as “behind-the-counter” drugs.
  • Schedule 3: Does not require a prescription but must be kept in an area under the supervision of a pharmacist. These drugs are kept in an area of the retail outlet where self-selection is possible, but a pharmacist must be available to assist in the self-selection of medication if required.
  • Unscheduled: Does not require a prescription and may be sold in any retail outlet.

All medications other than Schedule 1 may be considered an OTC drug, as they do not require prescriptions for sale. While the National Association of Pharmacy Regulatory Authorities provides recommendations on the scheduling of drugs for sale in Canada, each province may determine its own scheduling. The drugs found in each schedule may vary from province to province.

Indonesia or India

In November 2016, India’s Drug Consultative Committee announced it was embarking on establishing a definition of drugs which could be dispensed without a prescription. Prior to this, the general assumption was that any drug which did not fall into a prescription schedule could be purchased without a prescription. However, the needed definition had not been enacted by early 2018. The lack of a legal definition for OTC drugs has led to this US$4 billion market segment being effectively unregulated.

Netherlands

In the Netherlands, there are four categories:

  • UR (Uitsluitend Recept): prescription only.
  • UA (Uitsluitend Apotheek): pharmacist only.
  • UAD (Uitsluitend Apotheek of Drogist): pharmacist or drugstore only.
  • AV (Algemene Verkoop): may be sold in general stores.

A drug that is UA may be sold OTC but only by pharmacists. The drug can be on the shelves like any other product. Examples are domperidone, 400 mg ibuprofen up to 50 tablets and dextromethorphan. A drug that is UAD can also be sold at drugstores, stores where no prescription can be filed and there is only a relatively small selection of popular drugs like painkillers and cough medicine. The drugs are usually on the shelves, and the store also sells items like toys, gadgets, perfumes and homeopathic products. The drugs in this category have limited risk and addiction potential. Examples are naproxen and diclofenac in small amounts, cinnarizine, 400 mg ibuprofen up to 20 tablets and also 500 mg paracetamol up to 50 tablets. Drugs in the AV category can be sold at supermarkets, gas stations, etc. and include only drugs with minimal risk to the public, like paracetamol up to 20 tablets, 200 mg ibuprofen up to 10 tablets, cetirizine and loperamide.

United States

In the United States, the manufacture and sale of OTC substances are regulated by the Food and Drug Administration (FDA). The FDA requires that all “new drugs” obtain a New Drug Application (NDA) before entering interstate commerce, but the act exempts any drugs generally recognised as safe and effective (GRAS/E). To deal with the vast number of OTC drugs that were already on the market before the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and to categorise them as GRAS/E after review by expert panels. Certain classes of OTC drugs would not be required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labelling, and warnings finalized in the Code of Federal Regulations.

Thus, an OTC drug product is allowed to be marketed either (1) pursuant to an FDA monograph or (2) pursuant to an NDA for products that do not fit within a specific monograph. There is also the possibility that certain OTC drug products are marketed under the grandfathering provisions of the Federal Food, Drug, and Cosmetic Act, but the FDA has never formally acknowledged that any legitimate grandfathered OTC drug exists.

Examples of OTC substances approved in the United States are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as lidocaine and aspirin, psoriasis and eczema topical treatments, anti-dandruff shampoos containing coal tar, and other topical products with a therapeutic effect.

The Federal Trade Commission regulates advertising of OTC products, in contrast to prescription drug advertising, which is regulated by the FDA.

The FDA requires OTC products to be labelled with an approved “Drug Facts” label to educate consumers about their medications. The labels comply to a standard format and are intended to be easy for typical consumers to understand. Drug Facts labels include information on the product’s active ingredient(s), indications and purpose, safety warnings, directions for use, and inactive ingredients.

The 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes reforms that modernise the way certain OTC drugs are regulated in the United States. Many OTC monographs need to be updated but updating or changing an OTC monograph requires the slow and burdensome notice-and-comment rulemaking process. The CARES Act includes OTC monograph reform provisions that replace the rulemaking process with an administrative order process.

Restricted Over-the-Counter Substances (US)

An ill-defined third category of substances is products having over-the-counter status from the FDA while being simultaneously subject to other restrictions on sale. While they are legally classified as OTC drugs, they are typically stored behind the counter and are sold only in stores that are registered with their state. They may be unavailable in convenience and grocery stores that stock other non-restricted OTC medications.

For example, many drugstores have moved products containing pseudoephedrine, an OTC product, into locations where customers must ask a pharmacist for them. A prescription is not required; the change has been made in an effort to reduce methamphetamine production. Since the passage of the Illinois Methamphetamine Precursor Control Act and the subsequent federal Combat Methamphetamine Epidemic Act of 2005, the purchase of pseudoephedrine is restricted. Sellers of pseudoephedrine must obtain and record the identity of the purchaser and enforce quantity restrictions. Some states may have more stringent requirements (such as Oregon, where a medical prescription is required to purchase any quantity of pseudoephedrine). After initial attempts to control methamphetamine use (by requiring documentation of sale with government issued ID as well as limits on the quantity an individual could purchase) failed to realise meaningful reductions in methamphetamine use and production, Mississippi passed House Bill 512 in the State Senate on February 2, 2010 “to require a prescription from a licensed medical professional to purchase over-the-counter medicines with pseudoephedrine, ephedrine, or any other precursor chemical that can readily and illicitly be converted into methamphetamine, Methcathinone or any active/scheduled analogues of Phenylethylamines/ amphetamine.” However, products containing the substance are still OTC in most states, since no prescription is required.

A similar regulation once applied to some forms of emergency contraception. However, on 25 February 2014, the FDA approved generic one-pill emergency contraception products for unrestricted sale on the shelf. There is no age limit or need for ID to purchase.

Furthermore, some Schedule V controlled substances may be classified as OTC products in certain states. Such drugs are sold without a prescription but are subject to record-keeping rules and quantity and/or age restrictions, and they must be dispensed by a pharmacy. Finally, pharmacies frequently require a prescription for Schedule V drugs as a matter of policy, despite their OTC status according to applicable laws and regulations.

United Kingdom

In the United Kingdom, medication is governed by the Medicines Regulations 2012. Medication falls into one of three categories:

  • Prescription Only Medication (POM), which are legally available only with a valid prescription from a prescriber.
    • A pharmacist has to be on the premises for POM medicines to be dispensed, required by law.
    • The medicine has been specifically prescribed for the patient holding the prescription, so it is considered safe for only the recipient to take.
    • Just a small example of these include most antibiotics and all antidepressants or antidiabetic medications.
    • Drugs included as POM are high-strength painkillers such as oxycodone and tramadol, medications such as Zolpidem (Ambien), diazepam (Valium), and certain topical preparations such as corticosteroids.
    • These medicines are often sold by drug dealers, especially those marked as “CD POM,” which are controlled due to abuse risk such as dipipanone, temazepam, and methadone.
  • General Sales List (GSL), available off the shelf with no pharmacy training required to sell (so they can be sold anywhere, such as supermarkets).
    • In general, they are considered safe for most people when taken correctly.
    • Examples of these include 16-packs (or less) of painkillers such as paracetamol and ibuprofen as well as a host of other safe medications such as small pack sizes of antiallergy tablets, laxative medication, and skin creams.
  • Pharmacy Medicines (P) are medicines that are legally neither a POM or GSL medication.
    • These can be sold from a registered pharmacy but should not be available for self-selection (although directions to discuss a ‘P’ product may be allocated shelf space with associated GSL items).
    • ‘P’ medications are reserved from the GSL list as they are either associated with a need for advice on use, or used in conditions which may require referral to a medical prescriber.
    • Suitable trained counter assistants may sell a ‘P’ medication under the supervision of a pharmacist and will ask questions to determine if the customer needs to be referred for a discussion with a pharmacist.
    • Some ‘POM’ medicines are available for use in certain situations and doses as ‘P’ medicines.

If it is not appropriate to sell a ‘P’ medication – i.e. the condition is not suitable for self-management and requires referral to a medical prescriber – then a sale should not occur and the pharmacist has a legal and professional obligation to refer this on to an appropriate service.

Examples of these include some sleep aid tablets such as Nytol, human deworming tablets such as Mebendazole, painkillers with small amounts of codeine (up to 12.8 mg per tablet), and pseudoephedrine. Medication available only with a prescription is marked somewhere on the box/container with [POM]. Pharmacy-only products are marked with [P]. A prescription is not required for [P] medicines, and pharmacy sales assistants are required by Royal Pharmaceutical Society codes to ask certain questions, which varies for what the customer says. If they ask for a specific product, the pharmacy assistant must ask “Who is it for,” “How long have you had the symptoms,” “Are you allergic to any medication,” “Are you taking any medication” (‘WHAM’ questions). If a customer asks for a remedy, e.g. hay fever, then the two WHAM questions must be followed “Who is it for,” “What are the symptoms,” “How long have you had the symptoms,” “Have you taken any action towards your symptoms,” and “Are you taking any other medication.” It is with this information that the pharmacist can halt the sale, if need be. No [POM], [P] or [GSL] products that are stocked in a pharmacy can be sold, dispensed, or pre-made until a responsible pharmacist is signed in and on the premises. Some medication available in supermarkets and petrol stations is sold only in smaller packet sizes. Often, larger packs will be marked as [P] and available only from a pharmacy. Frequently, customers buying larger-than-usual doses of [P] medicines (such as DXM, promethazine, codeine or Gee’s linctus) will be queried, due to the possibility of abuse.

Transitions between Prescription and OTC

As a general rule, over-the-counter drugs have to be used primarily to treat a condition that does not require the direct supervision of a doctor and must be proven to be reasonably safe and well tolerated. OTC drugs are usually also required to have little or no abuse potential, although in some areas drugs such as codeine are available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase).

Over time, often 3-6 years, drugs that prove themselves safe and appropriate as prescription medicines may be switched from prescription to OTC.[citation needed] An example of this is diphenhydramine (Benadryl), an anti-histamine which once required a prescription but now is available OTC nearly everywhere. More recent examples are cimetidine and loratadine in the United States, and ibuprofen in Australia.

It is somewhat unusual for an OTC drug to be withdrawn from the market as a result of safety concerns, rather than market forces, though it does happen occasionally. For example, phenylpropanolamine was removed from sale in the United States over concern regarding strokes in young women. A study has been done examining consumer’s perceptions about the risk of and access to non-prescription medication. The study concluded that a small percentage of consumers prefer having access to medication over potential risks of taking non-prescribed medication. Ranitidine was withdrawn from multiple markets due to concerns over the carcinogen N-nitrosodimethylamine (NDMA).

In the United Kingdom, it was announced in February 2007 that Boots the Chemist would try OTC sales of Viagra in stores in Manchester, England (previous available as prescription only). Men aged between 30 and 65 could buy four tablets after a consultation with a pharmacist.

Deprescribing & Antidepressant Use in Older Adults

Research Paper Title

Long term antidepressant use in a cohort of older people.

Background

Depression is the most common mental health problem in older adults and untreated is associated with significant burden of illness for patients. This study aimed to examine longitudinal patterns of antidepressant use in older adults and determine which factors were associated with changes in use.

Methods

Adults aged 50 and over, from the Irish Longitudinal Study on Ageing, who participated at any one of the four TILDA waves (n = 8,175) were included in the analysis. Repeated measures latent class analysis (RMLCA) is the model-based approach we used to identify underlying subgroups in a population.

Results

The researchers found antidepressant use ranged from 6% to 10%, over a 6-year period. RMLCA identified three distinct classes of anti-depressant use. Notably, 6% of older adults were categorised in a ‘long-term antidepressant use’ class, with consistent use across all four waves, and 6% were categorised in an ‘Intermittent/ Developing Use’ class. We found long-term antidepressant use to be a characteristic of older adults with chronic conditions at baseline of study and striking low uptake of psychological and psychiatric services.

Conclusions

These findings provide evidence of the complex presentations of depression with comorbidities in long-term antidepressant users. While prolonged use of antidepressants in an older cohort is often rationalised due to recurrent depression and comorbidities, this study suggests little deprescribing of antidepressants and a need for greater access and provision of psychological services tailored to later life seem necessary to improve management of this condition.

Reference

O’Neill, A., McFarland, J. & Kelly, D. (2021) Long term antidepressant use in a cohort of older people. International Journal of Geriatric Psychiatry. doi: 10.1002/gps.5518. Online ahead of print.

Dosed (2019)

Introduction

An award-winning documentary film about treating anxiety, depression and addiction with psychedelic medicine.

Outline

After years of prescription medications failed her a suicidal woman, Adrianne, turns to underground healers to try and overcome her depression, anxiety, and opioid addiction with illegal psychedelic medicine like magic mushrooms and iboga.

Production & Filming Details

  • Director(s): Tyler Chandler.
  • Producer(s): Robert J. Barnhart, Tyler Chandler, Jason Hodges, Kelley Hodges, Chris Mayerson, Nicholas Meyers, and Nick Soares.
  • Writer(s): Tyler Chandler, Nicholas Meyers, and Jessie Deeter (Story consultant).
  • Music: Jayme McDonald.
  • Cinematography: Nicholas Meyers.
  • Editor(s): Tyler Chandler and Nicholas Meyers.
  • Production: Golden Teacher Films.
  • Release Date: 20 March 2019 (US).
  • Running Time: 82 minutes.

A New Understanding: The Science of Psilocybin (2015)

Introduction

A New Understanding explores the treatment of end-of-life anxiety in terminally ill cancer patients using psilocybin, a psychoactive compound found in some mushrooms, to facilitate deeply spiritual experiences.

Outline

The documentary explores the confluence of science and spirituality in the first psychedelic research studies since the 1970’s with terminally ill patients.

As a society we devote a great deal of attention to treating cancer, but very little to treating the human being who is dying of cancer. The recent resurgence of psychedelic research is once again revealing the power of compounds like psilocybin to profoundly alter our understanding of both life and death. Through the eyes of patients, their loved ones, therapists, and researchers, A New Understanding examines the use of psilocybin in a controlled setting to reduce psychospiritual anxiety, depression, and physical pain.

The treatment aims to help the patient understand that a ‘good’ death is possible, and to help the patient’s family deal well with the dying process. A New Understanding shows patients and their families coming to terms with dying through the skillful treatment of the whole human being. If we can learn to work more skillfully with dying, we will also learn to take better care of life.

Production & Filming Details

  • Director(s): Roslyn Dauber.
  • Producer(s): Robert J Barnhart, Roslyn Dauber, Brady Dial, Matt Humble, Steve McDonald, Jeff Porter, and Mitch Schultz.
  • Music: Brian Satterwhite.
  • Editor(s): Jason Uson.
  • Studio: Red Phoenix Productions.
  • Production: Golden Teacher Films.
  • Release Date: March 2015 (US).
  • Running Time: 55 minutes.
  • Country: US.
  • Langauge: English.

Book: Preventing Bipolar Relapse

Book Title:

Preventing Bipolar Relapse: A Lifestyle Program to Help You Maintain a Balanced Mood & Live Well.

Author(s): Ruth C. White (PhD, MPH, MSW).

Year: 2014.

Edition: First (1st).

Publisher: New Harbinger Publications.

Type(s): Paperback and Kindle.

Synopsis:

There is an old saying: “Prevention is better than cure.” If you have bipolar disorder, this is especially true. For you, it is incredibly important to read the warning signs of a possible episode. For instance, you may find you are not sleeping as well as usual, or you might be sleeping too much. You may stop doing things that you normally enjoy, or you may start acting out your impulses in ways that alienate those around you or get you into trouble.

While the path to wellness for those with bipolar may involve psychiatric visits and medication adjustments, preventing manic and depressive episodes is the true key to staying healthy and happy. So how do you do it? And most importantly, how can you keep yourself motivated?

In this powerful, breakthrough book, bipolar expert Ruth C. White shares her own personal approach to relapse prevention using the innovative programme SNAP (Sleep, Nutrition, Activity, and People).

White also offers practical tips and tracking tools you can use anytime, anywhere. By making necessary lifestyle adjustments, you can maintain balanced moods, recognise the warning signs of an oncoming episode, and make the necessary changes to reduce or prevent it.

This is the first and only book on bipolar disorder that focuses exclusively on prevention. To help you stay well, White includes links to helpful online tracking tools so that you can manage your symptoms, anytime, anywhere. If you are ready to stop living in fear of your next episode, this life-changing book can help you take charge of your diagnosis – and your life.

Benzodiazepine & Prescribing Behaviour

Research Paper Title

An Intervention to Decrease Benzodiazepine Prescribing by Providers in an Urban Clinic.

Background

The objective of this quality improvement project was to decrease the amount of benzodiazepines (BZDs) prescribed by providers at a Midwestern university outpatient clinic.

Methods

Clinic providers participated in a brief, live educational intervention combining academic detailing (i.e., the provision of current evidence about BZD) and pharmaceutical detailing (i.e., a sales technique borrowed from pharmaceutical companies).

A 1% decrease in BZD prescribing was set as the measure of success.

Using data from the electronic medical record, the monthly average of BZD prescriptions written within calendar year 2017 (before project launch) was compared to the number written 30 days after the intervention.

Results

Following the intervention, an 80% reduction in BZD prescribing was calculated.

Conclusions

Combined academic and pharmaceutical detailing could be an effective way to change prescribing behaviour in this provider population.

Further investigation is needed to ascertain whether the change in prescribing behaviour can be sustained, and that no harm is being done to patients who are currently dependent on BZD medications.

Reference

Platt, L., Savage, T.A. & Rajagopal, N. (2020) An Intervention to Decrease Benzodiazepine Prescribing by Providers in an Urban Clinic. Journal of Psychosocial Nursing and Mental Health Services. 58(1), pp.39-45. doi: 10.3928/02793695-20191218-08.

A Provider’s Experience of Making Alliances With Patients Dependent on Benzodiazepines

Research Paper Title

Making Alliances With Patients Dependent on Benzodiazepines: A Provider’s Experience.

Background

Tens of millions of benzodiazepine (BZD) prescriptions are written annually for the outpatient management of anxiety disorders and insomnia.

Many prescribers do not follow published treatment guidelines for these disorders. Psychiatric-mental health nurse practitioners (PMHNPs) regularly meet patients who have been treated with BZDs for years.

The dangers posed by outpatient BZD use are recognised, especially among older adults, and their use should be minimised or eliminated.

There are multiple manualised approaches to outpatient down-titration of BZDs, but little evidence about which methods really work.

To effect change, it is essential that PMHNPs establish a sound therapeutic alliance with these patients, especially by using their skills in therapeutic communication.

One major conflict that may occur early in the relationship is the patient’s expectation that the BZD medication regimen will continue indefinitely and their unwillingness to risk discontinuing the drug.

This conflict commonly raises non-adherence to a down-titration plan or patient termination of the relationship.

It is essential that PMHNPs take the time and patience to build strong therapeutic alliances with patients to design and implement a successful BZD discontinuation regimen.

Reference

Amberg, A. (2020) Making Alliances With Patients Dependent on Benzodiazepines: A Provider’s Experience. Journal of Pyschosocial Nursing and Mental Health Services. 58(1), pp.29-32. doi: 10.3928/02793695-20191218-06.

A Study into an Intervention to Decrease Benzodiazepine Prescribing by Providers in an Urban Clinic

Research Paper Title

An Intervention to Decrease Benzodiazepine Prescribing by Providers in an Urban Clinic.

Background

The objective of this quality improvement project was to decrease the amount of benzodiazepines (BZDs) prescribed by providers at a Midwestern university outpatient clinic.

Methods

Clinic providers participated in a brief, live educational intervention combining academic detailing (i.e., the provision of current evidence about BZD) and pharmaceutical detailing (i.e., a sales technique borrowed from pharmaceutical companies).

A 1% decrease in BZD prescribing was set as the measure of success.

Using data from the electronic medical record, the monthly average of BZD prescriptions written within calendar year 2017 (before project launch) was compared to the number written 30 days after the intervention.

Results

Following the intervention, an 80% reduction in BZD prescribing was calculated.

Conclusions

Combined academic and pharmaceutical detailing could be an effective way to change prescribing behaviour in this provider population.

Further investigation is needed to ascertain whether the change in prescribing behaviour can be sustained, and that no harm is being done to patients who are currently dependent on BZD medications.

Reference

Platt, L., Savage, T.A. & Rajagopal, N. (2020) An Intervention to Decrease Benzodiazepine Prescribing by Providers in an Urban Clinic. Journal of Psychosocial Nursing and Mental Health Services. 58(1):39-45. doi: 10.3928/02793695-20191218-08.

Mental Health Needs & Visits: Rural vs Urban Residents

Research Paper Title

Rural Residents With Mental Health Needs Have Fewer Care Visits Than Urban Counterparts.

Background

Analysis of a nationally representative sample of adults with mental health needs shows that rural residents have fewer ambulatory mental health visits than their urban counterparts do.

Even among people already on prescription medications for mental health conditions, rural-urban differences are large.

Reference

Kirby, J.B., Zuvekas, S.H., Borsky, A.E. & Ngo-Metzger, Q. (2019) Rural Residents With Mental Health Needs Have Fewer Care Visits Than Urban Counterparts. Health Affairs (Project Hope). 38(12), pp.2057-2060. doi: 10.1377/hlthaff.2019.00369.