The Restriction Degree of Food and Drug Administration (FDA) to Over-the-Counter Medications Essay

Introduction

Over-the-counter (OTC) drugs are medicines that may be sold without a prescription, in contrast to prescription drugs (“Over-the-Counter Drug”). The name “over-the-counter” is somewhat confusing to some, since these items are found on the shelves of stores and bought like any other packaged product, while prescription drugs are sold at a pharmacy counter (“Over-the-Counter Drug”).

At present situation of availability of non-prescription drugs to the people, the people are exposed in obtaining a longer list and more powerful medications without the need for a prescription from a physician (Kennedy). This situation indicates a more watchful eye for every concerned citizen about the possibility of over access to over-the-counter drugs, indication of increasing public knowledge about health and medicines, shift of quantity and quality of responsibilities of physicians and pharmacists, innovative and more strategies from the pharmaceutical industries, greater chance for involvement on abusing these drugs, and questions of safety of these drugs (Kennedy).

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Since over-the-counter drugs are non-prescription drugs, there is greater availability of over-the-counter drugs to the public (Kennedy). The governing policies in the sales, distribution, and control of these drugs vary around the world. For example in many European countries, over the counter drugs are available only through pharmacies, but in the United States, all over the counter drugs can be sold in general retail outlets (Kennedy). In Australia, pharmacists are required to personally advise purchasers of specific over the counter drugs (Kennedy).

There are two groupings of over-the-counter drugs in the countries of Britain and Ireland (Kennedy). These are the general and pharmacy categories. Under the general category, the over-the-counter drugs on the general sales list must only be sold in general retail premises (Kennedy). Under the pharmacy category, the over-the-counter drugs must be restrictedly sold by registered pharmacies (Kennedy).

It is therefore the responsibility of the pharmacists to give appropriate advice and guide the patients regarding the proper utilization of these drugs (Kennedy). But the problem is this critical responsibility of pharmacists is often passed to pharmacy assistants and surveys showed the increase doubts for the advices and guidance from the pharmacy assistants (Kennedy).

Still, many hesitations arise if it must be a necessity requirement for pharmacist to personally attend this kind of responsibility especially during selling of drugs that are under pharmacy category (Kennedy). Another question is if the pharmacists have to stick on the decided and settled advice and treatment (Kennedy).

The increasing recognition of the possibility and availability of over-the-counter medications for abuse and addiction has been alarming especially the life threats and deaths being recorded from it lately. The juvenile population is the age group that mostly abuse these drugs and became a past time already plus the increasing list of available of previously prescribed medicines into over-the-counter medicines already (Carr).

Discussion

In the United States, the manufacture and sale of OTC substances is regulated by the Food and Drug Afministration (FDA) (Peterson). Under the Federal Food, Drug, and Cosmetic Act any latest drugs are entitled to have a New Dug Application (NDA) before the new drug is allowed to be available in the interstate commerce. However, this act excuses any drugs that have been proven to be generally safe and effective from the NDA (“Over-the-Counter Drug”).

In order to fit the vast amount of OTC drugs that were already on the market prior to the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and categorize them as GRAS/E by regulation (“Over-the-Counter Drug”). This meant that certain classes of OTC drugs were not required to obtain an NDA and could remain on the market.

The drug manufacturers therefore have to produce drugs according to the FDA monograph (“Over-the-Counter Drug”). This should be specific and clear of the type of over-the-counter drugs, its active ingredient/s and labeling requirements, or under the New Drug Application (NDA) if the OTC drugs do not fit within the specified FDA monograph (“Over-the-Counter Drug”).

Because an NDA is extremely expensive to obtain, due primarily to testing requirements, most OTC substances produced in the USA 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 (“Over-the-Counter Drug”).

Cough and cold medicines

The reported cold and cough medicines mostly abused are Robitussin, Nyquil, Vicks Formula 44, and Coricidin HBP Cough and Cold tablets (“Youth Risk Death in Latest Drug Abuse Trend”). These medicines contain a chemical called Dextromethorphan (DXM), which was found to be present in more than 120 non-prescription cough and cold medications (“Over-the-Counter Drug Abuse”).

            Since these over-the-counter cold and cough medications containing DXM became a recreational drug from the teenage group, it has acquired different tag names such as Robo, Skittles, Triple C’s, Dex, Vitamin D, and Tussin (“Youth Risk Death in Latest Drug Abuse Trend”). Since Coricidin HBP Cough and Cold tablets have more stronger doses of DXM compared to cough syrup preparations, teenagers prefer to be addicted to tablets preparations containing DXM (“Over-the-Counter Drug Abuse”). Therefore, just taking a few DXM pills is enough to get high.

Another problem is there are no lawful constraints on purchasing the drug. The irony is that drug manufacturers have expressed commiseration of about the alarming news of DXM abuse but they have defied any efforts to control access of these patients of their over-the-counter available DXM drugs (“Over-the-Counter Drug Abuse”).

The increase abuse of dextromethorphan (DXM) is also attributed to its less cost compared to other expensive illegal drugs (“Youth Risk Death in Latest Drug Abuse Trend”). Also, Internet provides information of the dosage for DXM to get high wherein these teenagers could have an easy access (“Youth Risk Death in Latest Drug Abuse Trend”).

            The Drug Enforcement Administration categorized DXM as a “drug of concern” (“Youth Risk Death in Latest Drug Abuse Trend”). The reason behind is because of the life threat it poses if misused or abused. The drug DXM is considered an artificial drug whose chemical composition is analogous to morphine and was popularly known since the 1970’s to be an ingredient of cough and cold medications (“Over-the-Counter Drug Abuse”). An increasing apprehensions and concerns about DXM resulted in some stores and drugstores of controlled access to drugs which have DXM (“Over-the-Counter Drug Abuse”).

Diet Pills and Herbal Medicines

            It was reported also that the availability of diet and herbal pills as over-the-counter drugs lead to its abuse especially diet pills (“Over-the-Counter Drug Abuse”). The effort to lose weight quickly and get high made teenagers to overindulged themselves of these drugs (“Over-the-Counter Drug Abuse”). Also, herbal medicines are often abused since these medications are not well controlled by the FDA to think the people knew that these drugs have no therapeutic claims at all (“Over-the-Counter Drug Abuse”).

Motion sickness and Drowsiness pills

Motion sickness pills such as Dramamine are being used by teens; taken in large doses (one entire package or more), Dramamine can cause hallucinations (“Over-the-Counter Drug Abuse”). The problem with sleep aids is they can cause excessive drowsiness that could eventually lead to narcolepsy (“Over-the-Counter Drug Abuse”).

Narcolepsy is the “short sleep episodes and sudden and abrupt weakness in the arms and legs” (“Over-the-Counter Drug Abuse”). Another negative effect is the disturbance and interruption of the normal sleeping pattern especially in teenagers because sleeping pills can also have a stimulant effect (“Over-the-Counter Drug Abuse”).

Plan B emergency contraceptive pills

In the ending of year 2006, Food and Drug Administration approved the availability of emergency contraceptive pills sold as Plan B without prescription into any pharmacy (Stein; Wert). This allowed American women to buy this medication to any pharmacist without prescription issued by a doctor as long the buyer can prove she is 18 years of age or older (Stein; Wert). Below 18 years old, the availability of the emergency contraceptive pills is governed with an issuance of prescription (Stein; Wert).

The oppositions especially the social conservatives resist this act because they believed that the high amount of hormones in the pills is risky and the easy availability of these pills will encourage sexual activity resulting to more unnecessary pregnancies and sexually transmitted diseases (Stein). Opponents also liken taking the pills to abortion, because they can sometimes prevent a fertilized egg from implanting in the womb (Stein).

On the other hand, others hailed the decision as a long-overdue milestone that will make it much easier for women to prevent an unwanted pregnancy when they have unprotected sex or when another form of contraception, such as a condom, fails (Stein). It is also seen to be particularly valuable to rape victims (Stein).

As a Plan B medicine, it consists of two pills containing a synthetic version of the hormone progestin used in standard birth-control pills that is significantly effective in preventing a pregnancy if taken within 72 hours of unprotected intercourse (long before pregnancy tests usually work) (Stein).

The switch from prescription to nonprescription status of the drug

Generally, the nonprescription or over-the-counter drugs are supposedly safe and well-tolerated, thus, are used for treatment of disease conditions where the direct management of the physician is not required (“Over-the-Counter Drug Abuse”). Therefore, OTC drugs are hypothetically should not be or of little abuse potential like in codeine. This drug is usually incorporated in small or controlled amount because of its additive and abusive potential (“Over-the-Counter Drug Abuse”; Esmay and Wertheimer).

Through time, some drugs that are proven to be safe and effective when used for self-treatment where no prescription is required anymore become available as over-the-counter drugs (Esmay and Wertheimer; Kennedy; Williams and Kokotailo). Example of these are diphenhydramine, (Benadryl®), cimetidine, ibuprofen, and loratadine (Esmay and Wertheimer; Kennedy; Williams and Kokotailo). Another problem on the continuity of abuse of over-the-counter drugs is the impossibility of withdrawal of a certain OTC drug out of safety concern from the market like the case of phenylpopanolamine (“Over-the-Counter Drug Abuse”).

Lately, in United States, pharmacies began differing pseudoephedrine to be just available where a pharmacist is required (“Over-the-Counter Drug Abuse”). This action is due to the attempt and endeavors to control and decrease the methamphetamine production which is a popular regulated drug (“Over-the-Counter Drug Abuse”).

Non-steroidal anti-inflammatory over-the-counter drugs (NSAIDs)

Many studies showed that analgesics like acetaminophen, aspirin, and others cause nephropathy and even liver necrosis (Adams). These were known to lead into as much as 40, 000 deaths per year. The problem is that FDA tends to ignore such situations and if this is the herbal medicine like the ephedra case, immediate headline and conferences on announcing such health threats are already reported to the public even it is much less number of deaths compared to these analgesics manufactured by large pharmaceutical companies (Adams). This is the observed problem for FDA because they remain silent and attach to these large and known drug manufacturers instead of doing their responsibility of warning the public (Adams).

Conclusion

Over the counter drugs can be extremely dangerous resulting in overdose, and even death (“Over-the-Counter Drug Abuse”). Parents should be aware of the dangers and to any possible abuse of these potentially dangerous over-the-counter medications. It has been reported lately that over-the-counter drugs are becoming a trendy addiction and past time drugs. Of these drugs most abused are for cough and cold medications. The most reported age group is from teenagers aged 13 to 16 years old. Records from hospitals showed cases of overdoses and from these cases, deaths from over-the-counter drugs abuse have been reported.

The greater availability of drugs over the counter could profoundly change the roles of doctors and pharmacists, turning them from paternalistic controllers of access to medicines into patients’ advisers and collaborators (Kennedy). Greater ease of access to medicines carries benefits and risks, and we must ensure that full consideration is given to the implications for drug safety, health care costs, education, and rational drug use (Kennedy). The remuneration system for community pharmacists must be adapted to reward those who give accurate advice to patients and liaise with general practitioners; and it is essential for doctors to expand their knowledge of over the counter drugs, to record use of over the counter drugs in patients’ notes, and to detect and report adverse drug reactions (Kennedy).

            The Food and Drug Administration (FDA) should therefore put more restrictions on the availability of over-the-counter medications and conduct follow-up researches if their action for certain drug availability as over-the-counter has more disadvantages or advantages. This is not to question the science behind the invention of a drug but to be more aware and have more critical decision when such over-the-counter is a risk, a threat, or a help to the patients especially households where juvenile population is more at large.

            It is also frustrating and wearisome that the selective restrictions of FDA expose the consumers to consume those over-the-counter drugs that cause more harm, and those which are safer are being pulled out from the market. Also, the FDA which is supposedly to safeguard the public health and be the number one advocate of substance abuse control does not do their responsibility sensitively and committedly.

            Another frustrating situation is there is no available data on what is the effect of a certain approved drug when it already became available as over-the-counter. With appropriate and sufficient data, the FDA could have monitored if the decisions are right and critical when such approval is done.

            The parents should also be critically decisive when utilizing over-the-counter medications as first aid medications for home use. They should be aware of the ingredients and be intellectual enough if what is to believe or not. Advertisements on certain over-the-counter medicines are usually exaggerated and analyzing the message of such media is not further thought about.

            The students especially teenagers who tend to depend on over-the-counter drugs to self-medicate themselves are not equipped enough that they should be responsible consumers of these drugs. Therefore, university and schools should have proper education of their students about these pharmacology products for them to be cognizant of the effects of these drugs.

References

Adams, Mike. “Long-Term Use of Tylenol (Acetaminophen) Found to Cause Kidney Damage, Says New Study”.  2004. April 10 2007. <http://www.newstarget.com/001523.html>.

Carr, B. C. “Efficacy, Abuse, and Toxicity of over-the-Counter Cough and Cold Medicines in the Pediatric Population.” Current Opinion on Pediatrics 18.2 (2006): 184-8.

“Diet Pills  These Days Teens Are Crazy About Looking Good”.  2004. April 10 2007. <http://www.tqnyc.org/nyc051524/dietpills.htm>.

Esmay, J. B., and A. I. Wertheimer. “A Review of over-the-Counter Drug Therapy.” Journal on Community Health 5.1 (1979): 54-66.

Kennedy, James G. “Changing the Roles of Doctors and Pharmacists.” British Medical Journal, 1996. 593-94. Vol. 312.

“Over-the-Counter Drug Abuse”.  2006. April 10 2007. <http://www.teendrugabuse.us/over_the_counter_drug_abuse.html>.

“Over-the-Counter Drug”.  2007.  Wikimedia Foundation, Inc. April 10 2007. <http://en.wikipedia.org/wiki/Over-the-counter_drug>.

Peterson, Marcus. “Buying Medications”. 2007. April 10 2007. <http://ezinearticles.com/?Buying-Medications&id=408999>

Stein, Rob. “Fda Approves Plan B’s over-the-Counter Sale.” Washington Post August 25, 2006 2006: A04.

Wert, Laura Van. “What’s the Future of Plan B?: Fda Seeks Age Restrictions on Emergency Contraception as Others Request Accessibility.” The Daily Orange Front Page, 2005.

Whelton, A. “Renal Effects of over-the-Counter Analgesics.” Journal of Clinical Pharmacology 35.5 (1995): 454-63.

Williams, J. F., and P. K. Kokotailo. “Abuse of Proprietary (over-the-Counter) Drugs.” Adolescence Medical Clinic 17.3 (2006): 733-50; abstract xiii.

“Youth Risk Death in Latest Drug Abuse Trend”.  2003. USA Today. April 10 2007. <http://www.usatoday.com/news/health/2003-12-29-drug_abuse-cover_xhtm>.