Is accutane a restricted prescription?
Pharmaceutical Benefits Scheme
Certain medications listed on the PBS are available only for specific therapeutic indications or to patients meeting specific criteria where the PBAC has deemed that the cost-benefit analysis is favourable only in those indications/patients. These are noted as "restricted benefits" on the Schedule. Medicare Australia places the onus of policing restricted benefits on the prescribers themselves and the pharmacists dispensing (unless the listing is also 'Authority Required'). For example, the COX-2 inhibitor celecoxib is listed on the PBS as a restricted benefit for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. Prescribers using celecoxib for other indications are expected to indicate "non-PBS" on the prescription, and/or the pharmacist dispensing the celecoxib should charge the patient the full cost.
Acalabrutinib
As of February 2016, acalabrutinib had received orphan designation in the United States for CLL only, and was similarly designated as an orphan medicinal product by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for treatment of three indications - chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and lymphoplasmacytic lymphoma (Waldenström's macroglobulinaemia, MG). If the drug is ultimately approved, this designation will result in a 10-year period of market exclusivity for the stated indications within Europe.
Ulipristal acetate
The U.S. Food and Drug Administration approved the drug for use in the United States on 13 August 2010, following the FDA advisory committee's recommendation. Watson Pharmaceuticals announced the availability of ulipristal acetate in the United States on 1 December 2010, in retail pharmacies, clinics, and one on-line pharmacy, KwikMed.
Kite Pharma
Axicabtagene ciloleucel (KTE-C19, ZUMA-3) is an investigational therapy (for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)) in which a patient's T cells are genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. It has US FDA Breakthrough Therapy Designation (Dec 2015) for the treatment of patients with refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL).
Eletriptan
Eletriptan was approved by the U.S. Food and Drug Administration (FDA) on December 26, 2002, for the acute treatment of migraine with or without aura in adults. It is available only by prescription in the United States and Canada. It is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. It is available in 20 mg and 40 mg strengths.
Francisca Mutapi
Additionally her research has a focus on developing a formulation of praziquantel, the only drug effective against schistosomiasis infection, for children.. Currently the drug is a large pill which children in high-risk areas struggle and are often reluctant to take.
Prescription drug
As a general rule, "over-the-counter drugs" (OTC) are used to treat a condition that does not need care from a healthcare professional if have been proven to meet higher safety standards for self-medication by patients. Often, a lower strength of a drug will be approved for OTC use, but higher strengths require a prescription to be obtained; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid-1980s, but it is available by prescription in doses up to four times the OTC dose for severe pain that is not adequately controlled by the OTC strength.
Microfinance
Limitations
Triptan
These drugs have been available only by prescription (US, Canada and UK), but sumatriptan became available over-the-counter in the UK in June 2006. The brand name of the OTC product in the UK is Imigran Recovery. The patent on Imitrex STATDose expired in December 2006, and injectable sumatriptan became available as a generic formula in August 2008. Sumavel Dosepro is a needle-free delivery of injectable sumatriptan that was approved in the US by the FDA in July 2009. Sumatriptan became available as a generic in the US in late 2009. It used to be sold over-the-counter in Romania under the Imigran brand; however, as of August 2014 prescription is required. Zecuity, a sumatriptan transdermal patch, was approved by the US FDA in January 2013. The sumatriptan nasal powder was approved by the FDA in January 2016 and became available in the U.S. May 2016. Naritriptan is available OTC in Germany and Brazil.
Spironolactone
The combination of spironolactone with a birth control pill in the treatment of acne appears to have similar effectiveness to a birth control pill alone and the combination of a birth control pill with cyproterone acetate, flutamide, or finasteride. However, this was based on low- to very-low-quality evidence. Spironolactone may be more effective than birth control pills in the treatment of acne, and the combination of spironolactone with a birth control pill may have greater effectiveness for acne than either alone. In addition, some clinical research has found that flutamide is more effective than spironolactone in the treatment of acne. In one study, flutamide decreased acne scores by 80% within 3 months, whereas spironolactone decreased symptoms by only 40% in the same time period. However, the use of flutamide for acne is limited by its liver toxicity. Bicalutamide is a potential alternative to flutamide for acne as well. Spironolactone can be considered as a first-line treatment for acne in those who have failed other standard treatments such as topical therapies and under certain other circumstances, although this is controversial due to the side effects of spironolactone and its teratogenicity.
Tijuana
Tijuana has many pharmacies that target visitors from the United States, which sell some medicines without prescriptions and/or at much lower costs than in the U.S. Many medications still require a Mexican prescription, which can be obtained from adjacent doctors' offices. People filling up prescriptions for drugs classified in the US as Schedule II or Schedule III have found it more difficult to locate such medications, and the purchase of pseudoephedrine also has become restricted by Tijuana pharmacies, just as in the U.S. To fill a prescription in Tijuana for any drug covered by the US Controlled Substances Act and legally bring it into the United States requires a prescription from the United States for re-import. Americans can import up to a 90-day supply of non-controlled medications for personal use to the USA from Mexico and other countries.
Fluticasone
Fluticasone is a synthetic glucocorticoid which is used to treat nasal symptoms. Both the furoate and propanoate esters, fluticasone furoate and fluticasone propionate, are also used as topical anti-inflammatories and inhaled corticosteroids, and are used much more commonly in comparison.
In the United States the wholesale cost per spray is about 0.33 USD as of 2018. In 2016 it was the 16th most prescribed medication in the United States with more than 29 million prescriptions.
Ceftazidime/avibactam
Avycaz is a prescription-only medication, which was fast-tracked by the FDA due to the shortage of drugs that effectively circumvent the resistance problem. One of the active pharmacological ingredients, ceftazidime, has long been proven to be safe, which allowed the FDA to expedite its approval. The FDA relegated its use to only those patients who are refractory to other treatments because of the limited clinical safety data and also to prevent prescribers from overusing this therapy if other effective treatment exists. Additionally, the price gap between traditional therapy and Avycaz is quite large. The wholesale acquisition cost (WAC), which is the price the manufacturer will set for the wholesaler to purchase the drug, for Avycaz is $2,850 for ten 2 g vials. While this is not the price the patient pays, the cost of a single day of treatment with Avycaz is more than a full 14-day regimen of currently used medications because of the availability of generic alternatives. This financial pressure should help with the FDA regulation in restricting its use.
Glutaric aciduria type 1
5-hydroxytryptophan, the precursor of serotonin that is not metabolized to glutaryl-CoA, glutaric acid and secondary metabolites, could be used as an adjunct to selective tryptophan restriction, considering the risks associated with the procedure. However, the evidence in favour of selective tryptophan restriction remains insufficient and the consensus evolves towards the restriction of lysine only (Kolker & al. 2006).
Colchicine
Oral colchicine had been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings. On July 30, 2009 the FDA approved colchicine as a monotherapy for the treatment of three different indications (familial Mediterranean fever, acute gout flares, and for the prophylaxis of gout flares), and gave URL Pharma a three-year marketing exclusivity agreement in exchange for URL Pharma doing 17 new studies and investing $100 million into the product, of which $45 million went to the FDA for the application fee. URL Pharma raised the price from $0.09 per tablet to $4.85, and the FDA removed the older unapproved colchicine from the market in October 2010, both in oral and intravenous forms, but gave pharmacies the opportunity to buy up the older unapproved colchicine. Colchicine in combination with probenecid has been FDA-approved prior to 1982.
Over-the-counter drug
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 realize 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 analogs of Phenylethylamines/ amphetamine." However, products containing the substance are still OTC in most states, since no prescription is required.
Alitretinoin
Under the trade name Toctino (marketed by GSK, UK) it has been granted prescription rights in the UK (08/09/2008) for oral use in chronic hand eczema.
In May 2009 the National Institute for Health and Clinical Excellence (NICE) issued preliminary guidance on the use of Alitretinoin for the treatment of severe chronic hand eczema in adults. The recommendation stated that only patients with severe chronic hand eczema who are unresponsive to potent topical corticosteroids, oral immunosuppressants or phototherapy should receive the drug. Final NICE guidance is expected in August 2009.
NHS treatments blacklist
In April 2017 it was proposed to restrict the prescription of 3,200 OTC drugs by means of official guidance from NHS England, and to add 18 treatments considered to have 'limited clinical value' – including homeopathy and herbal treatments – to the banned list. The 10 items of low clinical effectiveness:7 items which are clinically effective but not cost-effective:
Alfentanil
Alfentanil is a restricted drug which is classified as Schedule II in the US, according to the U.S. DEA website.
Ulipristal acetate
Ulipristal acetate, sold under the brand name Ella among others, is a medication used for emergency birth control and uterine fibroids. As emergency birth control it should be used within 120 hours of sex. For fibroids it may be taken for up to six months. It is taken by mouth.
Common side effects include headache, nausea, feeling tired, and abdominal pain. It should not be used in people who are already pregnant. It is in the selective progesterone receptor modulator (SPRM) class of medications. It works by preventing the effects of progesterone thus stopping ovulation.
Ulipristal acetate was approved for medical use in the United States in 2010. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. In the United Kingdom it costs the NHS about 17 pounds per course of emergency birth control of 2015. To improve access, some recommend all who can get pregnant be given a prescription for use if needed.
Proxalutamide
Proxalutamide (developmental code name GT-0918) is a nonsteroidal antiandrogen (NSAA) – specifically, a selective high-affinity silent antagonist of the androgen receptor (AR) – which is under development by Suzhou Kintor Pharmaceuticals for the treatment of prostate cancer. It inhibits AR-mediated gene transcription more potently than bicalutamide (by ~5- to 10-fold) and enzalutamide (by 2- to 5-fold) and maintains silent antagonism in castration-resistant prostate cancer (CRPC) cells. It has also been found to downregulate the AR, which could further confer it greater efficacy against CRPC compared to existing NSAAs. Unlike enzalutamide, the drug showed low central nervous system distribution and no induction of seizures in animals. As of 2017, it is in phase II clinical trials for prostate cancer. It is also in preclinical investigation for the treatment of AR-positive breast cancer.
Isotretinoin
In February 2002, Roche's patents for isotretinoin expired, and there are now many other companies selling cheaper generic versions of the drug. On June 29, 2009, Roche Pharmaceuticals, the original creator and distributor of isotretinoin, officially discontinued both the manufacture and distribution of their Accutane brand in the United States due to what the company described as business reasons related to low market share (below 5%), coupled with the high cost of defending personal-injury lawsuits brought by some people who took the drug. Generic isotretinoin will remain available in the United States through various manufacturers. Roche USA continues to defend Accutane and claims to have treated over 13 million people since its introduction in 1982. F. Hoffmann-La Roche Ltd. apparently will continue to manufacture and distribute Roaccutane outside of the United States.
Plecanatide
Plecanatide is being marketed by a sales force of nearly 250, and marketing is targeting the top 70% of brand name drug prescribers. SGYP reports that 60% of adult patients with CIC and commercial insurance have unrestricted access to Trulance. However, Express Scripts recently announced they would not include Trulance on its 2018 preferred drug formulary and SGYP has since taken a hit.
Pimple
Severe acne usually indicates the necessity of prescription medication to treat the pimples. Prescription medications used to treat acne and pimples include isotretinoin, which is a retinoid. Historically, antibiotics such as tetracyclines and erythromycin were prescribed. While they were more effective than topical applications of benzoyl peroxide, the bacteria eventually grew resistant to the antibiotics and the treatments became less and less effective. Also, antibiotics had more side effects than topical applications, such as stomach cramps and severe discoloration of teeth. Common antibiotics prescribed as of 2001 by dermatologists included doxycycline and minocycline. For more severe cases of acne dermatologists might recommend accutane, a retinoid that is the most potent of acne treatments. However, accutane can cause various side effects including vomiting, diarrhea, and birth defects if taken during pregnancy.
Allergic conjunctivitis
Dual-action medications are also prescribed frequently. Olopatadine (Patanol) and ketotifen fumarate (Alaway or Zaditor) both provide protection by acting as an antihistamine and a mast cell stabilizer together. Patanol is a prescription medication, whereas ketotifen fumarate is not.
Treatment of Tourette syndrome
The stimulants are the first line of treatment for ADHD, with proven efficacy, but they do fail in up to 20% of cases, even in patients without tic disorders. Current prescribed stimulant medications include: methylphenidate (brand names Ritalin, Metadate, Concerta), dextroamphetamine (Dexedrine), and mixed amphetamine salts (Adderall). Other medications can be used when stimulants are not an option. These include the alpha-2 agonists (clonidine and guanfacine), tricyclic antidepressants (desipramine and nortriptyline), and newer antidepressants (bupropion, venlafaxine and atomoxetine). A retrospective case series published in 1993 suggested that treatment with bupropion (trade name Wellbutrin) can worsen tics, but there is no data from placebo-controlled trials to support this. There is good empirical support for the use of desipramine, bupropion and atomoxetine (brand name Strattera). Atomoxetine is the only non-controlled Food and Drug Administration (FDA) approved drug for the treatment of ADHD, but is less effective than stimulants for ADHD, is associated with individual cases of liver damage, carries an FDA black box warning regarding suicidal ideation, and controlled studies show increases in heart rate, decreases of body weight, decreased appetite and treatment-emergent nausea.
Deutetrabenazine
Teva Pharmaceuticals received approvals from the Food and Drug Administration to market deutetrabenazine in early 2017, along with five years of orphan drug exclusivity for the treatment of chorea associated with Huntington's Disease. At the time, it was the only deuterated drug to have received FDA approval.
Medical uses of bicalutamide
In addition to hirsutism, bicalutamide can be used in the treatment of acne in women. Flutamide has generally been found to reduce symptoms of acne by 80 or 90% even at low doses, with several studies showing complete acne clearance. In one study, it decreased acne scores by 80% within 3 months, whereas the spironolactone decreased symptoms by only 40% in the same time period. Bicalutamide has an antiandrogenic efficacy that is comparable to or greater than that of flutamide, and would be expected to produce similar therapeutic benefits. Other androgen-dependent skin and hair conditions, such as seborrhea and pattern hair loss, may also be treated by bicalutamide. In addition to acne, flutamide has been found to produce an 80% or greater decrease in scores of seborrhea and androgen-dependent scalp hair loss. Moreover, in combination with a combined birth control pill, flutamide treatment resulted in an increase in cosmetically acceptable scalp hair density in almost all women suffering from pattern hair loss in one small study. Bicalutamide is an appealing alternative to flutamide for the treatment of androgen-dependent skin and hair conditions in women because flutamide has a considerable risk of serious liver toxicity, which bicalutamide does not share.
Management of multiple sclerosis
There are no official guidelines yet on the use of disease-modifying oral treatments due to their recent development. While some believe that they will probably reduce the usage of first-line treatments the long-term safety of interferons and glatiramer acetate will probably slow this trend. It has been recommended that at the moment oral treatments should be mainly offered in those cases where patients do not use existing treatments due to needle phobia or other reasons such as perceived inefficacy of interferons and glatiramer acetate. They could also be used in patients taking natalizumab who have developed JC virus antibodies and are therefore at an increased risk of PML. Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long term data from use in psoriasis which points towards a very good safety profile.
Targeted molecular therapy for neuroblastoma
The following is a list of ALK inhibitors currently in clinical trials for treatment of neuroblastoma: 
Crizotinib was the first of these drugs to enter clinical trials and is the sole available ALK inhibitor, approved by the FDA on August 26, 2011. Thus far, it has proven its efficacy in treating adults with non-small-cell lung carcinoma (NSCLC), another form of cancer in which ALK plays a role. The drug is currently in phase III clinical trials to test its use in treating pediatric cancer types, such as neuroblastoma.
Actinic keratosis
Topical retinoids have been studied in the treatment of AK with modest results, and the American Academy of Dermatology does not currently recommend this as a first-line therapy. Treatment with adapalene gel daily for 4 weeks, and then twice daily thereafter for a total of nine months led to a significant but modest reduction in the number AKs compared to placebo; it demonstrated the additional advantage of improving the appearance of photodamaged skin. Topical tretinoin is ineffective as treatment for reducing the number of AKs. For secondary prevention of AK, systemic, low dose acitretin was found to be safe, well-tolerated and moderately effective in chemoprophylaxis for skin cancers in kidney transplant patients. Acitretin is a viable treatment option for organ transplant patients according to expert opinion.
Triptan
All triptans are contraindicated in patients with cardiovascular diseases (coronary spasms, symptomatic coronary artery disease, after a heart attack or stroke, uncontrolled hypertension, Raynaud's disease, peripheral artery disease). Most triptans are also contraindicated during pregnancy and breastfeeding and for patients younger than 18; but sumatriptan and zolmitriptan nasal sprays are also approved for youths over 12. In spite of expert opinion and evidence to the contrary, the FDA and some other drug governance bodies have stated that monoamine oxidase inhibitors are contraindicated for sumatriptan, zolmitriptan and rizatriptan, and combination with ergot alkaloids such as ergotamine for all substances.
Amphetamine
As a result of the United Nations 1971 Convention on Psychotropic Substances, amphetamine became a schedule II controlled substance, as defined in the treaty, in all 183 state parties. Consequently, it is heavily regulated in most countries. Some countries, such as South Korea and Japan, have banned substituted amphetamines even for medical use. In other nations, such as Canada (schedule I drug), the Netherlands (List I drug), the United States (schedule II drug), Australia (schedule 8), Thailand (category 1 narcotic), and United Kingdom (class B drug), amphetamine is in a restrictive national drug schedule that allows for its use as a medical treatment.
Alternating electric field therapy
Optune was approved by the FDA for newly diagnosed glioblastoma on Oct. 5, 2015, as a result of randomized phase 3 trial results that reported a 3-month advantage in overall survival and progression-free survival when added to chemotherapy with temozolomide.
Medicare (United States)
Medigap restrictions
Almotriptan
Almotriptan is prescribed to treat the acute headache phase of migraine attacks with or without aura. Almotriptan is the only oral triptan approved in the USA for the treatment of migraine in adolescent from 12 to 17 years of age.
Botulinum toxin
On July 29, 2016, Food and Drug Administration (FDA), of the United States of America approved abobotulinumtoxinA for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. AbobotulinumtoxinA is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. In the United States of America, the FDA approves the text of the labels of prescription medicines. The FDA approves which medical conditions the drug manufacturer may sell the drug for. However, those approved by the FDA to prescribe these drugs may freely prescribe them for any condition they wish, called off-label use. Botulinum toxins have been used off-label for several pediatric conditions, including infantile esotropia.
Trihexyphenidyl
Artane, or its generic form Trihexyphenidyl HCL, was approved by the FDA on June 25th, 2003 for the clinical use of all types of parkinsonism. However, it has been clinically relevant in trials pertaining to Parkinson's disease since 1949. Artane is an anticholinergic drug which is prescribed by doctors throughout the world. It is also abused, typically in combination with other drugs or delicate pharmaceutical agents. Prisons in Iraq were among the places where abuse was obvious, along with within communities of Iraqi soldiers.
Phentermine
Phentermine is still available by itself in most countries, including the US. However, because it is similar to amphetamine, it is classified as a controlled substance in many countries. Internationally, phentermine is a schedule IV drug under the Convention on Psychotropic Substances. In the United States, it is classified as a Schedule IV controlled substance under the Controlled Substances Act. In contrast, amphetamine preparations are classified as Schedule II controlled substances.
Oxycodone/aspirin
In the United States, Percodan is regulated as a Schedule II controlled substance under the Uniform Controlled Substances Act of 1970. As of October 6, 2014, Percodan is becoming something of a relic in the United States, at least, as the number of prescriptions has fallen precipitously since the 1960s in light of the alternate drugs available containing oxycodone (Percocet, Tylox, OxyContin, Roxicodone).
Emergency contraception
The Yuzpe regimen became the standard course of treatment for postcoital contraception in many countries in the 1980s. The first prescription-only combined estrogen-progestin dedicated product, Schering PC4 (ethinylestradiol and norgestrel), was approved in the UK in January 1984 and first marketed in October 1984. Schering introduced a second prescription-only combined product, Tetragynon (ethinylestradiol and levonorgestrel) in Germany in 1985. By 1997, Schering AG dedicated prescription-only combined products had been approved in only 9 countries: the UK (Schering PC4), New Zealand (Schering PC4), South Africa (E-Gen-C), Germany (Tetragynon), Switzerland (Tetragynon), Denmark (Tetragynon), Norway (Tetragynon), Sweden (Tetragynon) and Finland (Neoprimavlar); and had been withdrawn from marketing in New Zealand in 1997 to prevent it being sold over-the-counter.  Regular combined oral contraceptive pills (which were less expensive and more widely available) were more commonly used for the Yuzpe regimen even in countries where dedicated products were available.
Exenatide
Exenatide (marketed as Byetta, Bydureon) is a glucagon-like peptide-1 receptor agonist (GLP-1 receptor agonist) medication, belonging to the group of incretin mimetics, approved in April 2005 for the treatment of diabetes mellitus type 2. Exenatide in its Byetta form is administered as a subcutaneous injection (under the skin) of the abdomen, thigh, or arm, any time within the 60 minutes before the first and last meal of the day. A once-weekly injection has been approved as of January 27, 2012 under the trademark Bydureon. It is manufactured by Amylin Pharmaceuticals and commercialized by AstraZeneca.
Rebecca Abergel
Abergel’s BioActinide Research group conducts a variety of different experiments in the field of coordination chemistry, analytical chemistry, photophysics, biological chemistry, health physics, pharmacology, molecular biology, and cell biology. More specifically, her recent interests have focused on the coordination behavior of lanthanides and actinides. Her group is especially active in developing therapeutics to treat people who have been exposed to radionuclides or atoms that contain excess nuclear charge. These radionuclides can include plutonium, americium, curium, uranium, plutonium, and neptunium. Recent work by the BioActinide Research group has involved synthesis of different actinide chelating agents that could be used to selectively bind radionuclides in the human body in order to safely remove them.
Currently, the only drug approved by the Food and Drug Administration to treat radionuclide contamination is diethylenetriaminepentaacetic acid (DTPA) (Figure 1). DTPA has shown some promise is treating plutonium poisoning, but this treatment is specific only to plutonium. Furthermore, DTPA must be administered intravenously, which is an issue due to the extremely time-sensitive nature of radiation poisoning. In the quest of finding a more versatile and easily administered treatment for radiation poisoning, Abergel sees potential in developing new classes of therapeutics.
Isotretinoin
A CDC report published in 2000 showed problems with the Pregnancy Prevention Program and showed that the increase in prescriptions was from off-label use, and prompted Roche to revamp its program, renaming it the "Targeted Pregnancy Prevention Program" and adding label changes like requirements for two pregnancy tests, two kinds of contraception, and for doctors to provide pharmacists with prescriptions directly; providing additional educational materials, and providing free pregnancy tests. The FDA had another advisory meeting in late 2000 that again debated how to prevent pregnant women from being exposed to the drug; dermatologists testified about the remarkable efficacy of the drug, the psychological impact of acne, and demanded autonomy to prescribe the drug; others argued that the drug be withdrawn or much stricter measures be taken. In 2001 the FDA announced a new regulatory scheme called SMART (the System to Manage Accutane Related Teratogenicity) that required Roche to provide defined training materials to doctors, and for doctors to sign and return a letter to Roche acknowledging that they had reviewed the training materials, for Roche to then send stickers to doctors, which doctors would have to place on prescriptions they give people after they have confirmed a negative pregnancy test; prescriptions could only be written for 30 days and could not be renewed, thus requiring a new pregnancy test for each prescription.
Mitotane
Mitotane has been produced by Bristol Myers Squibb SpA but it is marketed as an orphan drug for adrenocortical carcinoma due to the small number of patients in need of it. Its main use is in those patients who have persistent disease despite surgical resection, those who are not surgical candidates, or those who have metastatic disease. A 2007 study of 177 patients shows a significant increase in the recurrence-free interval after radical surgery followed by mitotane when compared to surgery alone. The drug is also sometimes used in the treatment of Cushing's syndrome.
Nucleus accumbens
Glucocorticoids and dopamine: Glucocorticoid receptors are the only corticosteroid receptors in the nucleus accumbens shell. L-DOPA, steroids, and specifically glucocorticoids are currently known to be the only known endogenous compounds that can induce psychotic problems, so understanding the hormonal control over dopaminergic projections with regard to glucocorticoid receptors could lead to new treatments for psychotic symptoms. A recent study demonstrated that suppression of the glucocorticoid receptors led to a decrease in the release of dopamine, which may lead to future research involving anti-glucocorticoid drugs to potentially relieve psychotic symptoms.
Hyperpigmentation
Most often treatment of hyperpigmentation caused by melanin overproduction (such as melasma, acne scarring, liver spots) includes the use of topical depigmenting agents, which vary in their efficacy and safety, as well as in prescription rules. Several are prescription only in the US, especially in high doses, such as hydroquinone, azelaic acid, and koijic acid. Some are available without prescription, such as niacinamide, or cysteamine hydrochloride. Hydroquinone was the most commonly prescribed hyperpigmentation treatment before the long-term safety concerns were raised, and the use of it became more regulated in several countries and discouraged in general by WHO. For the US only 2% is at present sold over-the-counter, and 4% needs prescription. In the EU hydroquinone was banned from cosmetic applications. Oral medication with procyanidin plus vitamins A, C, and E also shows promise as safe and effective for epidermal melasma. In an 8-week randomized, double-blind, placebo-controlled trial in 56 Filipino women, treatment was associated with significant improvements in the left and right malar regions, and was safe and well tolerated. Procyanidin plus vitamins A, C, and E are used to make Pynocare, a product of Mega We Care or Mega Lifesciences public company limited. Other treatments that do not involve topical agents are also available, including fraction lasers and dermabrasion.
Ulcerative colitis
Ulcerative colitis can be treated with a number of medications, including 5-ASA drugs such as sulfasalazine and mesalazine. Corticosteroids such as prednisone can also be used due to their immunosuppressive and short-term healing properties, but because their risks outweigh their benefits, they are not used long-term in treatment. Immunosuppressive medications such as azathioprine and biological agents such as infliximab and adalimumab are given only if people cannot achieve remission with 5-ASA and corticosteroids. Such treatments are used less commonly due to their possible risk factors, including but not limited to increased risk of cancers in teenagers and adults, tuberculosis, and new or worsening heart failure (these side effects are rare).
Selective serotonin reuptake inhibitor
In 2004, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom judged fluoxetine (Prozac) to be the only antidepressant that offered a favorable risk-benefit ratio in children with depression, though it was also associated with a slight increase in the risk of self-harm and suicidal ideation. Only two SSRIs are licensed for use with children in the UK, sertraline (Zoloft) and fluvoxamine (Luvox), and only for the treatment of obsessive–compulsive disorder. Fluoxetine is not licensed for this use.
Buprenorphine/naloxone
Before the Drug Addiction Treatment Act of 2000 (DATA), physicians were not allowed to prescribe narcotics to treat opioid dependence. People with narcotic dependence would have to go to registered clinics to receive treatment. With DATA, Suboxone was the first medication approved for office-based treatment for opioid dependence. Suboxone has thus become widely used as a replacement for methadone as it can be prescribed by doctors in their offices, while methadone can only be provided at specialized addiction centers of which there are a limited number, often making access difficult. Some physicians are also leading a movement to begin prescribing it out of the emergency department (ED), as some small studies have shown ED-initiated Suboxone to be effective with patients more likely to remain in addiction treatment compared to those either referred to addiction treatment programs or those receiving just a brief intervention in the department.
Anecortave acetate
Retaane (15 mg anecortave acetate depot suspension) which is manufactured by Alcon, Inc., was a fast track designated product which was also a drug in FDA’s Pilot Continuous Marketing Application (CMA) program which often enrolls drugs which are being brought to the market and have an indication for a significant unmet medical need. This allowed Retaane to file with the FDA using a “rolling” New Drug Application, which allows specific units, Chemistry, Manufacturing, and Controls (CMC), pre-clinical, and the clinical unit, of the NDA to be reviewed as they are completed instead of as one large document. This allows the FDA to review each unit within six months of the submission. Alcon first filed the CMC unit in 2003, the Pre-clinical and Clinical units in 2004. In 2005 Alcon, Inc. announced they received the approval letter for the NDA for Retaane.
Specialty drugs in the United States
Specialty drugs may also be designated as orphan drugs or ultra-orphan drugs under the U. S. Orphan Drug Act of 1983. This was enacted to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease, myoclonus, amyotrophic lateral sclerosis, Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States.
Raymond J. Deshaies
Drug development: Deshaies, in collaboration with Craig Crews (Yale), conceived the idea of using heterobifunctional small molecules, referred to as PROTACs, to tether cellular proteins to a ubiquitin ligase, resulting in ubiquitination and degradation of the tethered protein. This concept now underlies the biotechnology companies Arvinas and C4 Therapeutics. The Deshaies group also identified small molecules that inhibit targeting of substrates to the proteasome and removal of ubiquitin chains from substrates by Rpn11. In addition, they discovered (in collaboration with Dr. Hugh Rosen of Scripps and Frank Schoenen of University of Kansas) the p97 inhibitors DBeQ and ML240. ML240 served as the basis for the development of CB-5083, which entered human clinical trials in 2014.
Antibody-drug conjugate
Brentuximab vedotin was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on August 19, 2011 for relapsed HL and relapsed sALCL and conditional Marketing authorization from the European Medicines Agency in October 2012 for relapsed or refractory HL and relapsed or refractory sALCL. Trastuzumab emtansine (ado-trastuzumab emtansine or T-DM1) was approved in February 2013 for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with trastuzumab (Herceptin, Genentech and Roche) and a taxane chemotherapy. The newest ADC, Inotuzumab ozogamicin, was approved by the European Commission as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) on June 30, 2017 under the trade name Besponsa®(Pfizer/Wyeth). On August 17, 2017 Inotuzumab ozogamicin was also approved by the US FDA for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Pharmaceutical Benefits Scheme
Some PBS medications are restricted and require prior approval from Medicare Australia. These are noted as "authority required benefits" on the Schedule. Again, the PBAC has deemed that the cost-benefit analysis is favourable only under in specific indications/patients under certain circumstances. Authority may be obtained by telephone to Medicare Australia (known as "phone approval") or in writing from an authorised delegate of the Minister for Health. Prescriptions must be written on Authority Prescription Form, and the approval number must be noted on the prescription. Pharmacists cannot dispense the item as a pharmaceutical benefit unless it has been approved by Medicare Australia (indicated by the presence of the approval number).
Quinine
Though Legatrin was banned by the FDA for the treatment of leg cramps, the drug manufacturer URL Mutual has branded a quinine-containing drug named Qualaquin. It is marketed as a treatment for malaria and is sold in the United States only by prescription. In 2004, the CDC reported only 1,347 confirmed cases of malaria in the United States.
Amphetamine
According to the International Programme on Chemical Safety (IPCS) and United States Food and Drug Administration (USFDA), amphetamine is contraindicated in people with a history of drug abuse, cardiovascular disease, severe agitation, or severe anxiety. It is also contraindicated in people currently experiencing advanced arteriosclerosis (hardening of the arteries), glaucoma (increased eye pressure), hyperthyroidism (excessive production of thyroid hormone), or moderate to severe hypertension. These agencies indicate that people who have experienced allergic reactions to other stimulants or who are taking monoamine oxidase inhibitors (MAOIs) should not take amphetamine, although safe concurrent use of amphetamine and monoamine oxidase inhibitors has been documented. These agencies also state that anyone with anorexia nervosa, bipolar disorder, depression, hypertension, liver or kidney problems, mania, psychosis, Raynaud's phenomenon, seizures, thyroid problems, tics, or Tourette syndrome should monitor their symptoms while taking amphetamine. Evidence from human studies indicates that therapeutic amphetamine use does not cause developmental abnormalities in the fetus or newborns (i.e., it is not a human teratogen), but amphetamine abuse does pose risks to the fetus. Amphetamine has also been shown to pass into breast milk, so the IPCS and USFDA advise mothers to avoid breastfeeding when using it. Due to the potential for reversible growth impairments, the USFDA advises monitoring the height and weight of children and adolescents prescribed an amphetamine pharmaceutical.
Management of hypertension
The best first-line medication is disputed, but the Cochrane collaboration, World Health Organization and the United States guidelines support low-dose thiazide-based diuretic as first-line treatment. The UK guidelines emphasise calcium channel blockers (CCB) in preference for people over the age of 55 years or if of African or Caribbean family origin, with angiotensin-converting enzyme inhibitors (ACE-I) used first line for younger people. In Japan starting with any one of six classes of medications including: CCB, ACEI/ARB, thiazide diuretics, beta-blockers, and alpha-blockers is deemed reasonable, while in Canada and Europe all of these but alpha-blockers are recommended as options. When compared to placebo, beta-blockers have greater benefit in stroke reduction, but no difference on coronary heart disease or all-cause mortality. However, three-quarters of active beta-blocker treatment in the randomised controlled trials included in the review were with atenolol and none with the newer vasodilating beta-blockers.
Ampicillin/sulbactam
Ampicillin/sulbactam is a combination of the common penicillin-derived antibiotic ampicillin and sulbactam, an inhibitor of bacterial beta-lactamase. Two different forms of the drug exist. The first, developed in 1987 and marketed in the United States under the tradename Unasyn, generic only outside the United States, is an intravenous antibiotic. The second, an oral form called sultamicillin, is marketed under the trade name Ampictam outside the United States. And generic only in the United States, ampicillin/sulbactam is used to treat infections caused by bacteria resistant to beta-lactam antibiotics. Sulbactam blocks the enzyme which breaks down ampicillin and thereby allows ampicillin to attack and kill the bacteria.
Buprenorphine
The waiver, which can be granted after the completion of an eight-hour course, is required for outpatient treatment of opioid addiction with Subutex and Suboxone. Initially, the number of patients each approved physician could treat was limited to ten. This was eventually modified to allow approved physicians to treat up to a hundred patients with buprenorphine for opioid addiction in an outpatient setting. This limit was recently increased by the Obama administration, raising the number of patients to which doctors can prescribe to 275. Still, due to this patient limit and the requisite eight-hour training course, many continuing patients can find it very difficult to get a prescription, despite the drug's effectiveness.
Attention deficit hyperactivity disorder management
Atomoxetine (Strattera), guanfacine (Intuniv), and clonidine (Kapvay) are drugs approved for the treatment of ADHD that have been classified as "non-stimulant".Some medications used to treat ADHD are prescribed off-label, outside the scope of their FDA-approved indications for various reasons. The U.S. FDA requires two clinical trials to prove a potential drug's safety and efficacy in treating ADHD. The drugs below have not been through these tests, so the efficacy is unproven (however these drugs have been licensed for other indications, so have been proven to be safe in those populations), however proper dosage and usage instructions are not as well characterized.Other medications which may be prescribed off-label include certain antidepressants such as tricyclic antidepressants (TCAs), SNRIs, SSRIs, or MAOIs.
Diclofenac
On 14 January 2015, diclofenac oral preparations were reclassified as prescription-only medicines in the UK. The topical preparations are still available without prescription.
Flutamide
Flutamide, sold under the brand name Eulexin among others, is a nonsteroidal antiandrogen (NSAA) which is used primarily to treat prostate cancer. It is also used in the treatment of androgen-dependent conditions like acne, excessive hair growth, and high androgen levels in women. It is taken by mouth, usually three times per day.
Side effects in men include breast tenderness and enlargement, feminization, sexual dysfunction, and hot flashes. Conversely, the medication has fewer side effects and is better-tolerated in women. Diarrhea and elevated liver enzymes can occur in both sexes. Rarely, flutamide can cause liver damage, lung disease, sensitivity to light, elevated methemoglobin, elevated sulfhemoglobin, and deficient neutrophils. Numerous cases of liver failure and death have been reported, which has limited the use of flutamide.
Flutamide acts as a selective antagonist of the androgen receptor (AR), competing with androgens like testosterone and dihydrotestosterone (DHT) for binding to ARs in tissues like the prostate gland. By doing so, it prevents their effects and stops them from stimulating prostate cancer cells to grow. Flutamide is a prodrug to a more active form. Flutamide and its active form stay in the body for a relatively short time, which makes it necessary to take flutamide multiple times per day.
Flutamide was discovered in 1967 and was first introduced for medical use in 1983. It became available in the United States in 1989. The medication has largely been replaced by newer and improved NSAAs, namely bicalutamide and enzalutamide, due to their better efficacy, tolerability, safety, and dosing frequency (once per day), and is now relatively little-used.
Contraceptive mandate
Certain aspects of the contraception mandate did not start with the ACA. In December 2000, the Equal Employment Opportunity Commission ruled that companies that provided prescription drugs to their employees but didn't provide birth control were in violation of Title VII of the 1964 Civil Rights Act, which prevents discrimination on the basis of sex. That opinion, which the George W. Bush administration did nothing to alter or withdraw when it took office the next month, is still in effect today – and because it relies on Title VII of the Civil Rights Act, it applies to all employers with 15 or more employees. Currently, employers that do not offer prescription coverage or do not offer insurance at all are exempt, because they treat men and women equally, but the new mandate will require prescription coverage.
Flutamide
Flutamide has been found to be equal to slightly more potent than cyproterone acetate and substantially more potent than spironolactone as an antiandrogen in bioassays. This is in spite of the fact that hydroxyflutamide has on the order of 10-fold lower affinity for the AR relative to cyproterone acetate. Hydroxyflutamide shows about 2- to 4-fold lower affinity for the rat and human AR than does bicalutamide. In addition, whereas bicalutamide has an elimination half-life of around 6 days, hydroxyflutamide has an elimination half-life of only 8 to 10 hours, a roughly 17-fold difference. In accordance, at dosages of 50 mg/day bicalutamide and 750 mg/day flutamide (a 15-fold difference), circulating levels of flutamide at steady-state have been found to be approximately 7.5-fold lower than those of bicalutamide. Moreover, whereas flutamide at this dosage has been found to produce a 75% reduction in prostate-specific antigen levels in men with prostate cancer, a fall of 90% has been demonstrated with this dosage of bicalutamide. In accordance, 50 mg/day bicalutamide has been found to possess equivalent or superior effectiveness to 750 mg/day flutamide in a large clinical trial for prostate cancer. Also, bicalutamide has been shown to be 5-fold more potent than flutamide in rats and 50-fold more potent than flutamide in dogs. Taken together, flutamide appears to be a considerably less potent and efficacious antiandrogen than is bicalutamide.
Prescription drug prices in the United States
Prescription drugs known as "specialty" drugs have become integral to the treatment of certain complex diseases including certain cancers and autoimmune diseases. Additionally, some notoriously treatment-resistant infectious diseases such as HIV and Hepatitis C have now become manageable (and the latter curable) using so-called “specialty pharmaceuticals”. “Specialty pharmaceuticals” are generally classified as such by possessing  one or more of the following characteristics: high cost, high complexity, or high touch (ie requiring special monitoring, follow-up, or administration technique or assistance). The number of specialty pharmaceuticals has increased dramatically since 1990 when only ten were available; by 2015, 300 specialty products were available with more than 700 in development (Pew 2016). The high costs of specialty pharmaceuticals, in addition to the generally high costs of prescription drugs in the United States, have generated a great deal of debate. It is becoming increasingly difficult, at both the individual and societal level, to afford to pay for such medications, as the use of specialty pharmaceuticals continues to increase along with their cost, which had, through 2015, risen faster than inflation for many consecutive years (AARP 2015). In 2015, 1-2% of the US population used specialty drugs, but these drugs represented 38% of drug expenditures for that year. A path forward must be found that provides specialty drugs to those who need them in an affordable, sustainable manner. A recent policy change by the Centers for Medicare and Medicaid Services will allow Medicare Advantage Plans to utilize formulary management tools used in commercial plans, such as step therapy requirements, in order to manage drug costs, including specialty pharmaceuticals  Chambers et al may have identified one path to identifying the value of Specialty Pharmaceuticals using cost-effectiveness analysis:“Conducting cost-effectiveness analyses may be desirable to convey the value of a medication relative to a previous standard of care. Even if a new therapy is expensive, its incremental cost-effectiveness may be within a willingness-to-pay threshold, as specialty drugs, though more expensive, often are also associated with the greatest gains in QALYs.”
Glatiramer acetate
A 2010 Cochrane review concluded that glatiramer acetate had partial efficacy in "relapse-related clinical outcomes" but no effect on progression of the disease. As a result, it is approved by the FDA for reducing the frequency of relapses, but not for reducing the progression of disability.
Medical uses of bicalutamide
Bicalutamide has a small risk of elevated liver enzymes and hepatotoxicity at dosages of 50 mg/day and above. As a result, it is recommended that liver function tests periodically be performed. The risk of elevated liver enzymes and liver failure with bicalutamide appears to be much smaller than with cyproterone acetate, which is the most widely used antiandrogen in transgender women in Europe and elsewhere in the world. In the United States, one of the only countries where cyproterone acetate has not been approved for medical use, the relatively weak and non-selective antiandrogen spironolactone is commonly used in transgender women instead. Bicalutamide is a favorable alternative option to these antiandrogens in transgender females.
Fluclorolone acetonide
Fluclorolone acetonide (INN, or flucloronide, USAN, trade names Cutanit, Topicon) is a corticosteroid for topical use on the skin.
Management of Crohn's disease
Acupuncture is used to treat inflammatory bowel disease in China, and is being used more frequently in Western society. Evidence has been put forth suggesting that acupuncture can have benefits beyond the placebo effect, improving quality of life, general well-being and a small decrease in blood-bound inflammatory markers. This study however had a very small test set and did not reach the threshold for benefit.
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, can cause flares of inflammatory bowel disease in approximately 25% of patients. These flares tend to occur within one week after starting regular use of the NSAID. In contrast, acetaminophen (paracetamol) and aspirin appear to be safe. Celecoxib (Celebrex), a cox-2 inhibitor, also appears to be safe, at least in short-term studies of patients in remission and on medication for their Crohn's disease.
Quinolone antibiotic
Fluoroquinolones had become the class of antibiotics most commonly prescribed to adults in 2002. Nearly half (42%) of these prescriptions were for conditions not approved by the U.S. FDA, such as acute bronchitis, otitis media, and acute upper respiratory tract infection, according to a study supported in part by the Agency for Healthcare Research and Quality. In addition, they are commonly prescribed for medical conditions, such as acute respiratory illness, that are usually caused by viral infections.
Ibuprofen
In some countries, ibuprofen lysine (the lysine salt of ibuprofen, sometimes called "ibuprofen lysinate") is licensed for treatment of the same conditions as ibuprofen; the lysine salt is used because it is more water-soluble. In 2006, ibuprofen lysine was approved in the US by the Food and Drug Administration (FDA) for closure of "patent ductus arteriosus" in premature infants weighing between , who are no more than 32 weeks gestational age when usual medical management (such as fluid restriction, diuretics, and respiratory support) is not effective.
Pregnenolone acetate
Pregnenolone acetate (brand names Antofin, Previsone, Pregno-Pan), also known as pregn-5-en-3β-ol-20-one 3β-acetate, is a synthetic pregnane steroid and an ester of pregnenolone which is described as a glucocorticoid and as a skin-conditioning and skin anti-aging agent. It has been found to significantly reduce wrinkles in elderly women when applied in the form of a 0.5% topical cream, effects which were suggested to be due to improved hydration of the skin. Pregnenolone acetate has been marketed in France in a topical cream containing 1% pregnenolone acetate and 10% "sex hormone" for the treatment of premature skin aging but was withdrawn from the market in 1992. Although the medication has been described by some sources as a glucocorticoid, other authors have stated that systemic pregnenolone acetate has no undesirable metabolic or toxic effects even at high dosages.
Ketamine
In Australia Ketamine is listed as a schedule 8 controlled drug under the Poisons Standard (October 2015). A schedule 8 drug is outlined in the Poisons Act 1964 as "Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence."
Apixaban
Only apixaban can be used in patients with severely decreased renal function and those on hemodialysis. The FDA-approved prescription information states that full dose apixaban (5 mg [bid]) can be used in such patients, unless at least two of the following characteristics apply: patient age is 80 years or older, body weight is 60 kg or less, and serum creatinine is 1.5 mg/dL or higher, in which case dose reduction to 2.5 mg bid is indicated.
Codeine
Preparations containing pure codeine (e.g., codeine phosphate tablets or codeine phosphate linctus) are available on prescription and are considered S8 (Schedule 8, or "Controlled Drug Possession without authority illegal"). Schedule 8 preparations are subject to the strictest regulation of all medications available to consumers.
Acne
Flutamide, a pure antagonist of the androgen receptor, is effective in the treatment of acne in women. It has generally been found to reduce symptoms of acne by 80 or 90% even at low doses, with several studies showing complete acne clearance. In one study, flutamide decreased acne scores by 80% within 3 months, whereas spironolactone decreased symptoms by only 40% in the same time period. In a large long-term study, 97% of women reported satisfaction with the control of their acne with flutamide. Although effective, flutamide has a risk of serious liver toxicity, and cases of death in women taking even low doses of the medication to treat androgen-dependent skin and hair conditions have occurred. As such, the use of flutamide for acne has become increasingly limited, and it has been argued that continued use of flutamide for such purposes is unethical. Bicalutamide, a pure androgen receptor antagonist with the same mechanism as flutamide and with comparable or superior antiandrogenic efficacy but without its risk of liver toxicity, is a potential alternative to flutamide in the treatment of androgen-dependent skin and hair conditions in women.
Ceftazidime/avibactam
Ceftazidime/avibactam (CAZ-AVI) is a fixed-dose combination drug containing an antibiotic—3rd generation cephalosporin ceftazidime and a novel non-β-lactam β-lactamase inhibitor avibactam. It was approved for use in the United States in February 2015, and is sold under the brand name Avycaz, marketed by Allergan. In Europe, it was approved by the European Medicines Agency in 2016 and is sold as Zavicefta.
Isotretinoin
Isotretinoin was first marketed as Accutane by Hoffmann-La Roche. It sold well for many years, but in 2009, Roche decided to remove Accutane from the US market after juries had awarded millions of dollars in damages to former Accutane users over inflammatory bowel disease claims. The American College of Gastroenterologists has released a position paper stating that people with inflammatory bowel disease should not be precluded from having their acne treated with isotretinoin. It then became generic and as of 2017 was marketed under many brand names worldwide.
Isotretinoin is used primarily for severe cystic acne and acne that has not responded to other treatments. Many dermatologists also support its use for treatment of lesser degrees of acne that prove resistant to other treatments, or that produce physical or psychological scarring. Isotretinoin is not indicated for treatment of prepubertal acne and is not recommended in children less than 12 years of age.
Rizatriptan
Rizatriptan is available only by prescription in Australia, Finland, the United States, Canada and New Zealand. Similarly, it is classed as a POM (Prescription Only Medicine) in the United Kingdom, Italy (as Rizaliv), France, Israel (as Rizalt), The Netherlands, Croatia and Spain (as "Maxalt"). It is classified as OTC (over-the-counter) in Brazil (also as "Maxalt").
Azathioprine
Azathioprine (AZA), sold under the brand name Imuran among others, is an immunosuppressive medication. It is used in rheumatoid arthritis, granulomatosis with polyangiitis, Crohn's disease, ulcerative colitis, and in kidney transplants to prevent rejection. It is taken by mouth or injected into a vein.
Common side effects include bone marrow suppression and vomiting. Bone marrow suppression is especially common in people with a genetic deficiency of the enzyme thiopurine S-methyltransferase. Other serious risk factors include an increased risk of lymphoma. Use during pregnancy may result in harm to the baby. Azathioprine is in the purine analogue and antimetabolite family of medication. It works via 6-thioguanine to disrupt the making of RNA and DNA by cells.
Azathioprine was first made in 1957. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The wholesale cost in the developing world is about US$7.63–17.19 a month. The wholesale cost in the United States is about US$35.34 per month.
Azathioprine is used alone or in combination with other immunosuppressive therapy to prevent rejection following organ transplantation, and to treat an array of autoimmune diseases, including rheumatoid arthritis, pemphigus, systemic lupus erythematosus, Behçet's disease, and other forms of vasculitis, autoimmune hepatitis, atopic dermatitis, myasthenia gravis, neuromyelitis optica (Devic's disease), restrictive lung disease, and others. It is also an important therapy and steroid-sparing agent for inflammatory bowel disease (such as Crohn's disease and ulcerative colitis) and for multiple sclerosis.
Zopiclone
In the United States, zopiclone is not commercially available, although its active stereoisomer, eszopiclone, is sold under the name Lunesta. Zopiclone is a controlled substance in the United States, Japan, Brazil, and some European countries, and may be illegal to possess without a prescription. However, it is readily available in other countries where it is marketed under the brand name Imovane, and is not a controlled substance in its available 10 mg, 7.5 mg, 5 mg, and 3.75 mg oral tablet formulations.
Dextroamphetamine
It quickly became apparent that dextroamphetamine and other amphetamines had a high potential for misuse, although they were not heavily controlled until 1970, when the Comprehensive Drug Abuse Prevention and Control Act was passed by the United States Congress. Dextroamphetamine, along with other sympathomimetics, was eventually classified as Schedule II, the most restrictive category possible for a drug with a government-sanctioned, recognized medical use. Internationally, it has been available under the names AmfeDyn (Italy), Curban (US), Obetrol (Switzerland), Simpamina (Italy), Dexedrine/GSK (US & Canada), Dexedrine/UCB (United Kingdom), Dextropa (Portugal), and Stild (Spain).
Norethisterone
Norethisterone was previously available alone in 5 mg tablets under the brand names Norlutin in the United States, but this formulation has since been discontinued in this country. However, NETA remains available alone in 5 mg tablets under the brand name Aygestin in the United States. It is one of the only non-contraceptive progestogen-only drug formulations that remains available in the United States. The others include progesterone, medroxyprogesterone acetate, megestrol acetate, and hydroxyprogesterone caproate, as well as the atypical agent danazol.
Chronic myelomonocytic leukemia
Azacitidine is a drug approved by the US Food & Drug Administration (FDA) for the treatment of CMML and by the European Medicines Agency for high risk non-proliferative CMML with 10-19% marrow blasts. It is a cytidine analogue that causes hypomethylation of DNA by inhibition of DNA methyltransferase. Decitabine is a similar drug to azacitidine and is approved by the FDA for treatments of all subtypes of MDS, including CMML. Hydroxyurea is a chemotherapy that is used in the myeloproliferative form of CMML to reduce cell numbers.
Paracetamol/metoclopramide
Whilst the individual component drugs may be prescribed individually, as a combination, it is only available as the branded Paramax preparation in the UK. In the UK there are only two other combination analgesics with antiemetics (i.e., anti-nausea) products available: MigraMax (aspirin with metoclopramide) and the over-the-counter drug Migraleve (paracetamol and codeine for analgesia, with buclizine as the antiemetic). The role for these products is between just the use of simple analgesics (paracetamol or ibuprofen) and the triptan class of drugs; although the latter are not options during pregnancy. In the elderly although triptans are generally avoided, so too are antiemetics such as metoclopramide due to higher risks of side effects. In Australia and New Zealand, the combination is available without prescription from pharmacies.
Phenobarbital
The level of regulation includes Schedule IV Non-Narcotic (depressant) (ACSCN 2285) in the United States under the Controlled Substances Act 1970—but along with a few other barbiturates and at least one benzodiazepine, and codeine, dionine, or dihydrocodeine at low concentrations, it also has exempt prescription and had at least one exempt OTC combination drug now more tightly regulated for its ephedrine content. The phenobarbitone/phenobarbital exists in subtherapeutic doses which add up to an effective dose to counter the overstimulation and possible seizures from a deliberate overdose in ephedrine tablets for asthma, which are now regulated at the federal and state level as: a restricted OTC medicine and/or watched precursor, uncontrolled but watched/restricted prescription drug & watched precursor, a Schedule II, III, IV, or V prescription-only controlled substance & watched precursor, or a Schedule V (which also has possible regulations at the county/parish, town, city, or district as well aside from the fact that the pharmacist can also choose not to sell it, and photo ID and signing a register is required) exempt Non-Narcotic restricted/watched OTC medicine.
Fentanyl
In the U.S., fentanyl is a Schedule II controlled substance per the Controlled Substance Act. Distributors of Abstral are required to implement an FDA-approved risk evaluation and mitigation strategy (REMS) program. In order to curb misuse, many health insurers have begun to require precertification and/or quantity limits for Actiq prescriptions.
Pharmacology of bicalutamide
All of the approved for the treatment of prostate cancer have been found to possess an off-target action of acting as weak non-competitive inhibitors of human GABA receptor currents "in vitro" to varying extents. The values are 44 μM for flutamide (as hydroxyflutamide), 21 μM for nilutamide, 5.2 μM for bicalutamide, and 3.6 μM for enzalutamide. In addition, flutamide, nilutamide, and enzalutamide have been found to cause convulsions and/or death in mice at sufficiently high doses. Bicalutamide was notably not found to do this, but this was likely simply due to the limited central nervous system penetration of bicalutamide in this species. In any case, enzalutamide is the only approved that has been found to be associated with a significantly increased incidence of seizures and other associated side effects clinically, so the relevance of the aforementioned findings with regard to bicalutamide and the other is unclear.
Prescription drug
A patient visits a medical practitioner or dentist, who may prescribe drugs and certain other medical items, such as blood glucose-testing equipment for diabetics. Also, qualified and experienced nurses and pharmacists may be independent prescribers. Both may prescribe all POMs (including controlled drugs), but may not prescribe Schedule 1 controlled drugs, and 3 listed controlled drugs for the treatment of addiction; which is similar to doctors, who require a special license from the Home Office to prescribe schedule 1 drugs. Schedule 1 drugs have little or no medical benefit, hence their limitations on prescribing. District nurses and health visitors have had limited prescribing rights since the mid-1990s; until then, prescriptions for dressings and simple medicines had to be signed by a doctor. Once issued, a prescription is taken by the patient to a pharmacy, which dispenses the medicine.
Abiraterone acetate
Abiraterone acetate was approved by the United States Food and Drug Administration on April 28, 2011. The FDA press release made reference to a phase III clinical trial in which abiraterone use was associated with a median survival of 14.8 months versus 10.9 months with placebo; the study was stopped early because of the successful outcome. Abiraterone acetate was also licensed by the European Medicines Agency. Until May 2012 the National Institute for Health and Clinical Excellence (NICE) did not recommend use of the drug within the NHS on cost-effectiveness grounds. This position was reversed when the manufacturer submitted revised costs. The use is currently limited to men who have already received one docetaxel-containing chemotherapy regimen.
Proscaline
Proscaline is unscheduled and unregulated in the United States, although it could possibly be considered an analogue of a schedule I drug under the Federal Analog Act and thus be subject to the same control measures and penalties for possession and manufacture as a Schedule I drug.__notoc__
Acetylmethadol
In the United States, acetylmethadol and its individual isomers are all Schedule I drugs under the Controlled Substances Act, except LAAM, which is Schedule II and was used clinically until 2003. Acetylmethadol has an ACSCN of 9601. The isomers have individual ACSCNs, which are as follows: Alphacetylmethadol 9603, Betacetylmethadol 9607, LAAM 9648. All of the above have annual manufacturing quotas of 2 grammes as of 2013, except LAAM, which is 4 grammes.
Janus kinase 3 inhibitor
The only indication for a JAK3 inhibitor at the moment, rheumatoid arthritis, is for the non-selective JAK1/JAK3 inhibitor Tofacitinib. Other indications like psoriasis, alopecia areata and ulcerative colitis are in clinical trials. Cytokines have an important role in autoimmune diseases and as the common γ chain cytokines interleukin IL-2, IL-4, IL-7, IL-9, IL-15, and IL-21 signal via JAK3, the inhibition of JAK3 and blocking of the signaling of these cytokines could affect many immune diseases and lead to development of new effective immunosuppressive drugs.
Eskatrol
In August 1970 the F.D.A. sought to limit the use of stimulants by calling for changes in labeling which decreased the number of allowable claims and intensified the warnings about possible hazards. F.D.A. Commissioner,
Charles C. Edwards, criticized the drug industry for not helping to prevent the abuse of amphetamines. Thomas M. Rauch, president of SmithKline & French laboratories, responded that his company had long promoted stricter drug abuse legislation and tighter controls
on production and distribution. SmithKline & French also made Dexedrine and Benzedrine. The F.D.A. began to restrict amphetamine manufacturer claims to only three medical uses, two of them uncommon. The two rare conditions specified were narcolepsy
and hyperactivity. The third permitted use was for suppressing appetite among persons who needed to lose weight. However, this would only be allowed for a total of a few weeks, and as a part of
treatment for obesity.
Convention on Psychotropic Substances
The Expert Committee on Drug Dependence cautiously began investigating ketamine at its thirty-third meeting, noting, "Its use in veterinary medicine must also be considered in relation to its control". Ketamine remains uncontrolled internationally, although many nations (e.g. USA and UK) have enacted restrictions on the drug.
Glucosamine
Oral glucosamine is a dietary supplement and is not a pharmaceutical drug. It is illegal in the US to market any dietary supplement as a treatment for any disease or condition. Glucosamine is marketed to support the structure and function of joints, and the marketing is targeted to people suffering from osteoarthritis.
Amphetamine
In addition to the neuronal monoamine transporters, amphetamine also inhibits both vesicular monoamine transporters, VMAT1 and VMAT2, as well as SLC1A1, SLC22A3, and SLC22A5. SLC1A1 is excitatory amino acid transporter 3 (EAAT3), a glutamate transporter located in neurons, SLC22A3 is an extraneuronal monoamine transporter that is present in astrocytes, and SLC22A5 is a high-affinity carnitine transporter. Amphetamine is known to strongly induce cocaine- and amphetamine-regulated transcript (CART) gene expression, a neuropeptide involved in feeding behavior, stress, and reward, which induces observable increases in neuronal development and survival "in vitro". The CART receptor has yet to be identified, but there is significant evidence that CART binds to a unique . Amphetamine also inhibits monoamine oxidases at very high doses, resulting in less monoamine and trace amine metabolism and consequently higher concentrations of synaptic monoamines. In humans, the only post-synaptic receptor at which amphetamine is known to bind is the receptor, where it acts as an agonist with micromolar affinity.
Combined oral contraceptive pill
Oral contraceptives are sometimes prescribed as medication for mild or moderate acne, although none are approved by the U.S. FDA for that sole purpose. Three different oral contraceptives have been FDA approved to treat moderate acne if the person is at least 14 or 15 years old, have already begun menstruating, and need contraception. They include Ortho Tri-Cyclen, Estrostep, and YAZ.
Vitamin A
Vitamin A, and more specifically, retinoic acid, appears to maintain normal skin health by switching on genes and differentiating keratinocytes (immature skin cells) into mature epidermal cells. Exact mechanisms behind pharmacological retinoid therapy agents in the treatment of dermatological diseases are being researched.
For the treatment of acne, the most prescribed retinoid drug is 13-cis retinoic acid (isotretinoin). It reduces the size and secretion of the sebaceous glands. Although it is known that 40 mg of isotretinoin will break down to an equivalent of 10 mg of ATRA — the mechanism of action of the drug (original brand name Accutane) remains unknown and is a matter of some controversy. Isotretinoin reduces bacterial numbers in both the ducts and skin surface. This is thought to be a result of the reduction in sebum, a nutrient source for the bacteria. Isotretinoin reduces inflammation via inhibition of chemotactic responses of monocytes and neutrophils. Isotretinoin also has been shown to initiate remodeling of the sebaceous glands; triggering changes in gene expression that selectively induce apoptosis. Isotretinoin is a teratogen with a number of potential side-effects. Consequently, its use requires medical supervision.
Controlled Drug in the United Kingdom
Substances subject to the full controlled drug requirements; e.g. diamorphine (heroin), pethidine, cocaine, methadone, methylphenidate, dextroamphetamine, fentanyl and oxycodone. Under the Act, a prescription for these drugs need to show full details including the form and strength of the preparation, with the total quantity written out in both words and figures. It is an offence for a doctor to issue an incomplete prescription or for a pharmacist to dispense a controlled drug unless all the required details are given.