TEXT A: A British Skin Foundation survey found that fifteen per cent of dermatologists believe lightening creams are ‘completely unsafe’ and four in five feel they are only safe when prescribed by a dermatologist. “Many skin- lightening creams contain illegal compounds that can damage your health,” says Indy Rihal of the British Skin Foundation. “The most common compounds are high-dose steroids.” Although steroids can be useful in treating some skin diseases, such as psoriasis and eczema, this must take place under the supervision of a skin specialist. “Unmonitored use of high-dose steroids can lead to many problems,” says RihaI. If you’ve used a skin-lightening cream and are worried about the effect it has had, see a G P. “Medically approved preparations prescribed by a GP or a dermatologist are not dangerous, within reason,” says Rihal. A cream that you buy over the counter is not necessarily medically approved and could permanently damage your skin.

TEXT B: The cosmetic use of skin-lightening products during pregnancy in Dakar, Senegal. Many women of childbearing age from sub-Saharan Africa use topical skin lighteners, some of which present a risk of toxic systemic effects. The goals of this study were to evaluate, in this environment, the frequency of this practice during pregnancy, as well as eventual consequences on pregnancy. Ninety nine women from 6 to 9 months pregnant were randomly selected among those attending a standard maternal centre in Dakar for a prenatal visit. Investigations consisted of questions about the use of skin lighteners, a standard clinical examination, follow-up until delivery and a morning blood sample for plasma cortisol levels. Sixty-eight of the 99 selected women used skin lighteners during their current pregnancy, the main active ingredients being hydroquinone and highly potent steroids (used by 44 and 24 women, respectively). No difference in the main outcomes of pregnancy were found between skin lightener users and the others; however, women using highly potent steroids, when compared with those who did not, had a statistically significant lower plasma cortisol level and a smaller placenta, and presented a higher rate of low-birth-weight infants. Skin lightening is a common practice during pregnancy in Dakar, and the use of steroids may result in consequences in the mother and her child.

TEXT C: Tanning: Biological and Health Effects. Tanning is the skin’s response to ultraviolet (UV) radiation, a type of light exposure. As skin cells are exposed to UV radiation, they produce a brown pigment (melanin) to protect themselves from further UV exposure. This results in a darkening of the skin (tanning), which is the body’s natural defense mechanism and attempt to prevent further damage from UV radiation. Sunlight and artificial tanning methods, such as tanning booths or salons, are sources of UV exposure. Sufficient amounts of UV exposure are known to cause adverse health effects in humans and are a public health concern. Tanning and burning play a role in health effects, including skin cancer. UV radiation damage to DNA in skin cells can result in mutations that promote or cause cancer, and recurring UV exposures may result in aging (wrinkles, loss of elasticity, and sun spots). Other short-term effects on skin are sunburns, fragility, and scarring. Cataracts are a known health effect from UV radiation exposure and eye protection is essential when tanning.

TEXT D: Banned Sunbeds. Unsupervised sunbeds have “no redeeming features”, says Wales’ chief medical officer. Dr Tony Jewell spoke as the facilities are being banned in Wales: laws to clamp down on sunbed use are extended. From Monday, businesses with unstaffed coin-operated sunbeds could be fined £5,000. Welsh cancer charity Tenovus said the ban was important as skin cancer is the most common cancer in 15 to 24-year-olds in the UK, and south Wales has one of the highest incidences in the country. “Skin cancer incidence is very strongly linked to over-exposure to ultra-violet radiation through sunbeds, levels of which can be six times stronger than the Australian midday sun,” said Tenovus head of research Dr Ian Lewis. “Wales alone has 500 cases of malignant melanoma a year, the most dangerous and potentially fatal form of skin cancer, resulting in nearly 100 deaths annually. “The rise in incidence of this type of skin cancer is truly alarming; between 2006 and 2016, Wales saw the rate of malignant melanoma in men and women double.”
In which text can you find information about

1. the contents of skin lightening creams?
2 the risks of over-exposure to UV radiation?
3 the sources of ultra-violet exposure?
4 who use topical skin lighteners?
5 reason for increase in rate of malignant melanoma?
6 the risks of repeated UV exposures?
7 the usual practice during pregnancy?

Questions 8-15. Answer each of the questions, 8-15, with a word or short phrase from one of the texts.
8 Which kind of skin lighteners are used by women in sub-Saharan Africa?
9 What type of sunbeds are subjected to penalties in Wales?
10 How many death cases of malignant melanoma were reported annually in Wales?
11 Which is the common eye disease related to damage from UV radiation exposure?
12 What was the main active ingredient in the skin lighteners used by majority of women in Dakar?
13 What are the most common sources of UV exposure other than sunlight?
14 Which skin cell pigment offers guard against UV exposure?
15 Which type of UV exposures could accelerate the aging processes?
Questions 16-20. Complete each of the sentences, 16-20, with a word or short phrase from one of the texts.
16 are proven to be effective in the treatment of some dermal conditions.
17 The soaring prevalence of is genuinely appalling.
18. Darkening of the skin plays a role in , including skin cancer.
19. Women who used had comparatively small placenta.
20. is vital when the skin is darkened.

PART B. For questions 1-6, choose (A, B or C) which you think fits best according to the text.
1. As explained in the extract, material standards are
A. absolutely helpful to inform a risk assessment.
B. insufficient to find biocompatibility risks.
C. used to find the biocompatibility evaluation.
Medical device standards: Standards specific to a particular device type or material may be helpful to inform a risk assessment; however, the extent to which the standard could be utilized may be dependent on the specificity of the standard and/or the specific material. Ideally, a standard would have sufficient specificity to provide useful information regarding material risks. For example, standards that outline both mechanical and chemical properties of a device type with pass/fail criteria may be particularly informative because of the specificity of such a standard. Standards that address bulk material composition can also be informative as a starting point for incorporating material characterization into a risk assessment. For example, it may be appropriate to use material standards to support the biocompatibility evaluation of stainless steel surgical vascular clamps, as long as any risks associated with manufacturing are appropriately considered and mitigated. Given the effects that manufacturing and processing may have on a polymer as incorporated into the final finished medical device, use of material standards may not be sufficient to identify biocompatibility risks for devices made from polymers.

2. The results of the studies described in the memo may explain why the relationship between
A. enough RN staffing and lower hospital related morbidity.
B. nurse patient ratios interpret gastrointestinal bleeding.
C. RN staffing for post- surgical patients and pulmonary compromise.
Failure To Rescue: The number of patients a Registered Nurse (RN) cares for can directly and indirectly impact patient safety during their hospitalization. “Safety” in this case refers to infection rates, patient falls, hospital-acquired pressure ulcers, and even death. Multiple studies using different methodology and from a variety of disciplines consistently show associations between adequate RN staffing and lower hospital related morbidity, mortality and adverse patient events. RN staffing levels for post- surgical patients have been shown to have an inverse relationship with urinary tract infections, pneumonia, thrombosis and pulmonary compromise; in medical patients, higher nurse patient ratios translated into a reduction in gastrointestinal bleeding, shortened length of stay, and lower rates of ‘failure to rescue’. Failure to rescue is the term used when early warning signs of upper gastrointestinal bleeding, sepsis, deep venous thrombosis, shock or cardiac arrest are not detected and acted upon.

3. What is the most recommended implantation testing?
A. clinically relevant implantation study.
B. in vivo animal study.
C. toxicology implantation study
Implantation: For implantation testing, if there are characteristics of the device geometry that may confound interpretation of this test, it may be acceptable to use device sub-components or coupons instead of the device in its final finished form, with appropriate justification. For example, it may be acceptable to use a coupon instead of a stent, if information is provided to demonstrate that the manufacturing and resulting surface properties are comparable. Instead of a traditional toxicology implantation study in subcutaneous, muscle, or bone tissues, a clinically relevant implantation assessment may be more appropriate for certain implant devices with relatively high safety risks. Clinically relevant implantation studies are critical to determine the systemic and local tissue responses to the implant in a relevant anatomical environment under simulated clinical conditions. In some cases, the toxicity outcomes that would be obtained from a clinically relevant implantation study can be assessed as part of in vivo animal studies that are performed to assess overall device safety.

4. The term ‘mass immunizer’ refers to a
A. Medicare-enrolled provider offering either influenza vaccinations or pneumococcal vaccinations
B. traditional Medicare provider offering neither influenza vaccinations nor pneumococcal vaccinations
C. non-traditional provider offering influenza vaccinations, pneumococcal vaccinations, or both
Mass Immunization Providers: To increase vaccination availability to Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) created the mass immunizer program and simplified the influenza and pneumococcal vaccination claims process by creating roster billing for mass immunizers. CMS defines a ‘mass immunizer’ as a Medicare-enrolled provider offering influenza vaccinations, pneumococcal vaccinations, or both to a group of individuals (e.g., the public, senior center participants, retirement community or retirement housing residents).
A mass immunizer can be either:
• A traditional Medicare provider or supplier, such as a hospital outpatient department; or
• A non-traditional provider that is usually ineligible to enroll in the Medicare Program, such as a supermarket, senior citizen home, public health clinic or an individual practitioner.

5. The guidelines inform us that device materials should not
A. cause any exposure to the body.
B. have benefits that outweigh any potential risks.
C. have any potential risks that outweigh benefits
Evaluation of Local and Systemic Risks: Biological evaluation of medical devices is performed to determine the acceptability of any potential adverse biological response resulting from contact of the component materials of the device with the body. The device materials should not, either directly or through the release of their material constituents: (i) produce adverse local or systemic effects; (ii) be carcinogenic; or (iii) produce adverse reproductive and/or developmental effects, unless it can be determined that the benefits of the use of that material outweigh the risks associated with an adverse biological response. Therefore, evaluation of any new device intended for human use requires information from a systematic analysis to ensure that the benefits provided by the device in its final finished form will outweigh any potential risks produced by device materials over the intended duration and use of the device in or on the exposed tissues. When selecting the appropriate endpoints for biological evaluation of a medical device, one should consider the chemical characteristics of the device materials and the nature, degree, frequency, and duration of exposure to the body.

6. What point does the extract make about designated nursing units?
A. have a team of nurses, mental health technician and behavioral counselor.
B. have specially trained nurses for work exclusively using different strategies.
C. a place where medically stabilized behavioral health patients seeking care are placed.
Behavioral Health Response Plan: A robust Behavioral Health Response Plan has been established to support staff and patients for the growing number of behavioral health patients seeking care. When patients are medically stabilized, up to 11 patients may be cohorted in a specially designed unit to promote patient and staff safety while patients await placement at behavioral health specialized facilities. For patients who require medical treatment, whenever possible they are placed on designated nursing units. Nurses working on these units have received special training and are adept at various communication techniques and strategies. This specialized unit team also consists of a mental health technician and a behavioral counselor.

PART C. TEXT 1: BIRTH CONTROL PILL AND SEXUAL PROBLEMS
In the January issue of The Journal of Sexual Medicine, researchers have published a new investigation measuring sex hormone binding globulin (SHBG) before and after discontinuation of the oral contraceptive pill. The research concluded that women who used the oral contraceptive pill may be exposed to long-term problems from low values of “unbound” testosterone potentially leading to continuing sexual, metabolic, and mental health consequences. Sex hormone binding globulin (SHBG) is the protein that binds testosterone, rendering it unavailable for a woman’s physiologic needs. The study showed that in women with sexual dysfunction, elevated SHBG in “Oral Contraceptive Discontinued-Users” did not decrease to values consistent with those of “Never-Users of Oral Contraceptive”. Thus, as a consequence of the chronic elevation in sex hormone binding globulin levels, pill users may be at risk for long-standing health problems, including sexual dysfunction.

Oral contraceptives have been the preferred method of birth control because of their ease of use and high rate of effectiveness. However, in some women oral contraceptives have ironically been associated with women’s sexual health problems and testosterone hormonal problems. Now there are data that oral contraceptive pills may have lasting adverse effects on the hormone testosterone. The research, in an article entitled: “Impact of Oral Contraceptives on Sex Hormone Binding Globulin and Androgen Levels: A Retrospective Study in Women with Sexual Dysfunction” published in The Journal of Sexual Medicine, involved 124 premenopausal women with sexual health complaints for more than 6 months. Three groups of women were defined: i) 62 “Oral Contraceptive Continued-Users” had been on oral contraceptives for more than 6 months and continued taking them, ii) 39 “Oral Contraceptive Discontinued-Users” had been on oral contraceptives for more than 6 months and discontinued them, and iii) 23 “Never-Users of Oral Contraceptives” had never taken oral contraceptives. SHBG values were compared at baseline (groups i, ii and iii), while on the oral contraceptive (groups i and ii), and well beyond the 7 day half-life of sex hormone binding globulin at 49-120 (mean 80) days and more than 120 (mean 196) days after discontinuation of oral contraceptives (group ii).

The researchers concluded that SHBG values in the “Oral Contraceptive Continued-Users” were 4 times higher than those in the “Never-Users of Oral Contraceptives”. Despite a decrease in SHBG values after discontinuation of oral contraceptive pill use, SHBG levels in “Oral Contraceptive Discontinued-Users” remained elevated when compared to “Never-Users of Oral Contraceptives”. This led to the question of whether prolonged exposure to the synthetic estrogens of oral contraceptives induces gene imprinting and increased gene expression of SHBG in the liver in some women who have used the oral contraceptives. Dr. Claudia Panzer, an endocrinologist in Denver, CO and lead author of the study, noted that “it is important for physicians prescribing oral contraceptives to point out to their patients potential sexual side effects, such as decreased desire, arousal, decreased lubrication and increased sexual pain. Also if women present with these complaints, it is crucial to recognize the link between sexual dysfunction and the oral contraceptive and not to attribute these complaints solely to psychological causes.”

“An interesting observation was that the use of oral contraceptives led to changes in the synthesis of SHBG which were not completely reversible in our time frame of observation. This can lead to lower levels of ‘unbound’ testosterone, which is thought to play a major role in female sexual health. It would be important to conduct long- term studies to see if these increased SHBG changes are permanent,” added Dr. Panzer. Dr. Andre Guay, study co- author and Director of the Center for Sexual Function/Endocrinology in Peabody, MA affirmed that this study is a revelation and that the results have been remarkable. “For years we have known that a subset of women using oral contraceptive agents suffer from decreased sex drive,” states Dr. Guay. “We know that the birth control pill suppresses both ovulation and also the male hormones that the ovaries make in larger amounts during the middle third of the menstrual cycle. SHBG binds the testosterone, therefore, these pills decrease a woman’s male hormone availability by two separate mechanisms. No wonder so many women have had symptoms.”

“This work is the culmination of 7 years of observational research in which we noted in our practice many women with sexual dysfunction who had used the oral contraceptive but whose sexual and hormonal problems persisted despite stopping the birth control pill,” said Dr. Irwin Goldstein, a urologist and senior author of the research. “There are approximately 100 million women worldwide who currently use oral contraceptives, so it is obvious that more extensive research investigations are needed. The oral contraceptive has been around for over 40 years, but no one had previously looked at the long-term effects of SHBG in these women. The larger problem is that there have been limited research efforts in women’s sexual health problems in contrast to investigatory efforts in other areas of women’s health or even in male sexual dysfunction.” To better appreciate the scope of the problem, oral contraceptives were introduced in the USA in 1960 and are currently used for reversible pharmacologic birth control by over 10 million women in the US, including 80% of all American women born since 1945 and, more specifically, 27% of women ages 15-44 and 53% of women age 20-24 years. By providing a potent synthetic estrogen (ethinyl estradiol) and a potent synthetic progesterone (for example, norethindrone), highly effective contraception is achieved by diminishing the levels of FSH and LH, thereby reducing metabolic activity of the ovary including the suppression of ovulation.

Several studies over the last 30 years reported negative effects of oral contraceptives on sexual function, including diminished sexual interest and arousal, suppression of female initiated sexual activity, decreased frequency of sexual intercourse and sexual enjoyment. Androgens such as testosterone are important modulators of sexual function. Oral contraceptives decrease circulating levels of androgens by direct inhibition of androgen production in the ovaries and by a marked increase in the hepatic synthesis of sex hormone binding globulin, the major binding protein for gonadal steroids in the circulation. The combination of these two mechanisms leads to low circulating levels of “unbound” or “free” testosterone.

7. Which statement is the most accurate summary of the method of the study?
A. Levels of SHBG were monitored over a period of time in women who were using the pill.
B. Levels of SHBG were measured in women using pill and women who had stopped using pill, and these were compared to women who had never used pill.
C. Levels of SHBG were compared in women who were using the pill, women who had stopped using the pill, and women who had never used the pill.
D. Medical complications were compared between women using the pill and those who had stopped using the pill.
8. What is the role of SHBG?
A. To prevent sexual dysfunction in human females.
B. To prevent testosterone from being used in the female body.
C. To prevent women from needing to take traditional contraceptive pills.
D. To prevent oncological complications.
9. Which group had the highest level of unbound testosterone?
A. Women with a genetic predisposition for higher testosterone levels.
B. Women who had never taken the pill.
C. Women who had previously taken the pill but since stopped.
D. Women who were taking the pill during the study.
10. Which of the following reasons is given in the study for popularity of oral contraceptive pill?
A. Less interference with sexual routine than other contraceptives.
B. High percentage of contraceptive success.
C. Favorable aesthetic effects on women’s physiques due to reduced testosterone.
D. Low cost.
11. Which is the most accurate description of the study discussed in the article?
A. It involved one hundred and twenty four pre-pubescent girls.
B. It involved 124 premenstrual women who had sexual health issues for 6 months or more.
C. SHBG levels were monitored at different times in three groups of adult women with various status regarding contraceptive pill usage.
D. SHBG levels were compared at regular intervals in each of three groups of women who had different status regarding contraceptive pill usage.
12. Levels of SHBG decreased in women who had stopped using the contraceptive pill
A. due to increased gene expression of SHBG in the livers of these women.
B. in spite of lengthened exposure to artificial estrogen found in pills.
C. because of psychological factors associated with taking the pill.
D. but their levels remained elevated compared to women who had never used pill.
13. Which of the following is an opinion of Dr. Panzer?
A. SHBG levels remained higher in women who discontinued pill use for the duration of the study.
B. The use of oral contraceptives led to changes in SHBG levels which were not reversible within the timeframe of the study.
C. Physicians usually mention the sexual side effects of the pill to their patients.
D. Further studies should determine whether SHBG levels ultimately return to normal over longer periods.
14. Which of the following statements has the same meaning as a statement in the text?
A. The contraceptive pill was invented in the USA in 1960.
B. The pill has been used by over 100 million women globally.
C. Dr. Goldstein monitored women with a history of pill use and sexual dysfunction in his clinic for seven years.
D. Lower levels of unbound testosterone is a result of both higher SHBG and accelerated metabolism in the ovaries.

PART C. TEXT 2: BOVINE SPONGIFORM ENCEPHALOPATHY

Vets at the Ministry of Agriculture have identified a new disease in cows that is causing dairy farmers some consternation. The fatal disease, which they have called bovine spongiform encephalopathy, causes degeneration of the brain. Afflicted cows eventually become uncoordinated and difficult to handle. The first case was reported in 1985. Now there are 92 suspected cases in 53 herds, mostly in the south of England. So far 21 cases in 18 herds have been confirmed. All are Friesian/Holstein dairy animals. Gerald Wells and his colleagues at the Central Veterinary Laboratory in Weybridge, Surrey, describe the symptoms and pathology in the current issue of The Veterinary Record. No one yet knows the cause of the disease but there are some similarities with a group of neurological diseases caused by the so called “unconventional slow viruses”.

This group of progressive diseases includes scrapie in sheep and goats, chronic wasting disease in mule deer and transmissible mink encephalopathy. In humans Kuru and Creutzfeldt-Jakob disease, both fatal neurological diseases, come into the same category. The precise nature of the agents causing this group of diseases is a matter of intense debate but all are infectious. Like scrapie and the other diseases, bovine spongiform encephalopathy is insidious and progressive. A farmer is unlikely to suspect that a cow has the disease until it has almost run its course. Previously healthy animals become highly sensitive to normal stimuli, they grow apprehensive and their movements uncoordinated. In the final stages the cows may be frenzied and unpredictable and have to be slaughtered. At autopsy, Wells and his colleagues found that some areas of the brain were full of holes, giving it a spongy appearance. The pattern of holes shows some similarity with that in the other unconventional encephalopathies.

In all these diseases an important diagnostic feature is the presence of proteinaceous fibrils seen in brain extracts in the electron microscope. No one knows for certain what the fibrils are – whether they are the agents of the disease, a type of subviral particle, as some researchers suggest, or are a product of the disease. The veterinary researchers analyzed the brain tissue from cows that died from the disease and found similar fibrils. Brain tissue from healthy cows did not contain fibrils. At the moment researchers at the Central Veterinary Laboratory are keeping an open mind on the cause of the disease. If it is not a scrapie-like agent it might be something to do with the genetics of Friesian cows. Another suggestion is that contaminated food might be to blame. “It is too early to come to conclusions,” said a spokesman at the Ministry of Agriculture. “It might be caused by toxic products, or food, or it might be genetic.”

According to Richard Kimberlin, of the AFRC/MRC Neuropathogenesis Unit in Edinburgh: “The similarities are enough to make us think that it’s in the scrapie family, but without evidence of transmission it’s impossible to say anything more certain”. Scientists at the Neuropathogenesis Unit will look for evidence of transmission in experiments on mice, while Wells and his colleagues try to transmit the disease in cows. It will take at least two years of experiments before transmission can be proved. What is certain is that the number of reported cases is increasing rapidly. Not all reports will turn out to be bovine spongiform encephalopathy. Farmers and vets might just be getting better at recognizing symptoms. In the past farmers probably got rid of nutty middle-aged cows without thinking too much about it. If the disease turns out to be transmissible then it might spread to other breeds of cows. Many countries ban the import of sheep from areas where scrapie occurs.

In the US, consumer rights groups won a ban on the purchase of meat from scrapie flocks because no one could rule out absolutely the possibility of transmission to humans. If bovine spongiform encephalopathy turns out to be infectious, it could cause problems out of proportion to the number of cases. Vacuoles in the brain prevent the passage of nerve impulses (left). Fibrils in brain tissue resemble those that are diagnostic of scrapie.

15. Bovine spongiform encephalopathy is a disease which is currently found in
A. all dairy cows.
B. some beef cows.
C. beef and dairy cows.
D. Freisian/Holstein dairy cows.
16. When bovine spongiform encephalopathy is confirmed in cows, which of the following symptoms do they not exhibit?
A. chronic wasting.
B. ungainly action.
C. frantic and agitated behavior.
D. sensitivity to usual stimuli.
17. Bovine spongiform encephalopathy is similar to other neurological diseases caused by ‘unconventional slow viruses’, which
A. is transmitted rapidly.
B. develops inconspicuously.
C. is caused by the same agents.
D. can be treated when detected early.
18. Pathology tests conducted on brains of cows which died of bovine spongiform encephalopathy show the presence of
A. fibrils which cause the disease.
B. fibrils which are caused by the disease.
C. fibrils which are also found in other animals infected with unconventional encephalopathies.
D. fibrils similar to those found in healthy cows.
19. Which of the following is not being considered as a cause of bovine spongiform encephalopathy?
A. the intake of contaminated food.
B. a genetic deficiency peculiar to Freisian cows.
C. parasite-produced vacuoles in the brain.
D. exposure to toxic products.
20. Bovine spongiform encephalopathy in cows appears similar to scrapie in sheep because
A. it is transmitted in a similar way.
B. the fibrils in diseased brains are similar.
C. it occurs in animals of a similar age.
D. of the rate at which the disease is transmitted.
21. Vets in Surrey are conducting experiments which will attempt to
A. infect healthy mice with bovine spongiform encephalopathy.
B. infect healthy sheep with bovine spongiform encephalopathy.
C. infect healthy humans through milk from bovine spongiform encephalopathy infected cows.
D. infect healthy cows with bovine spongiform encephalopathy.
22. The purchase of meat from scrapie infected flocks is banned in some countries because
A. the disease may then be transmitted to humans.
B. the disease will then be transmitted to humans.
C. it may lead to the spread of scrapie to other sheep.
D. it will lead to the spread of scrapie to other sheep.

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